WorldWideScience

Sample records for safety assessment systematic

  1. Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety

    DEFF Research Database (Denmark)

    Aiassa, E.; Higgins, J.P.T.; Frampton, G. K.

    2015-01-01

    for answering questions in health care, and can be implemented to minimise biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all......Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare and the environment. Systematic review and meta-analysis are established methods...... parameters in the risk model. This approach to planning and prioritising systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment....

  2. Safety assessment, safety performance indicators at the Paks Nuclear Power Plant

    International Nuclear Information System (INIS)

    Baji, C.; Vamos, G.; Toth, J.

    2001-01-01

    The Paks Nuclear Power Plant has been using different methods of safety assessment (event analysis, self-assessment, probabilistic safety analysis), including performance indicators characterizing both operational and safety performance since the early years of operation of the plant. Regarding the safety performance, the indicators include safety system performance, number of scrams, release of radioactive materials, number of safety significant events, industrial safety indicator, etc. The Paks NPP also reports a set of ten indicators to WANO Performance Indicator Programme which, among others, include safety related indicators as well. However, a more systematic approach to structuring and trending safety indicators is needed so that they can contribute to the enhancement of the operational safety. A more comprehensive set of indicators and a systematic evaluation process was introduced in 1996. The performance indicators framework proposed by the IAEA was adapted to Paks in this year to further improve the process. Safety culture assessment and characterizing safety culture is part of the assessment process. (author)

  3. Study on systematic integration technology of design and safety assessment for HLW geological disposal. 2. Research document

    International Nuclear Information System (INIS)

    Ishihara, Yoshinao; Fukui, Hiroshi; Sagawa, Hiroshi; Matsunaga, Kenichi; Ito, Takaya; Kohanawa, Osamu; Kuwayama, Yuki

    2003-02-01

    The present study was carried out relating to basic design of the Geological Disposal Technology Integration System' that will be systematized as knowledge base for design analysis and safety assessment of HLW geological disposal system by integrating organically and hierarchically various technical information in three study field. The key conclusions are summarized as follows: (1) As referring to the current performance assessment report, the technical information for R and D program of HLW geological disposal system was systematized hierarchically based on summarized information in a suitable form between the work flow (work item) and processes/characteristic flow (process item). (2) As the result of the systematized technical information, database structure and system functions necessary for development and construction to the computer system were clarified in order to secure the relation between technical information and data set for assessment of HLW geological disposal system. (3) The control procedure for execution of various analysis code used by design and safety assessment in HLW geological disposal study was arranged possibility in construction of 'Geological Disposal Technology Integration System' after investigating the distributed computing technology. (author)

  4. A systematic approach to safety case maintenance

    International Nuclear Information System (INIS)

    Kelly, T.P.; McDermid, J.A.

    2001-01-01

    A crucial aspect of safety case management is the ongoing maintenance of the safety argument through life. Throughout the operational life of any system, changing regulatory requirements, additional safety evidence and a changing design can challenge the corresponding safety case. In order to maintain an accurate account of the safety of the system, all such challenges must be assessed for their impact on the original safety argument. This is increasingly being recognised by many safety standards. However, many safety engineers are experiencing difficulties with safety case maintenance at present, the prime reason being that they do not have a systematic and methodical approach by which to examine the impact of change on safety argument. The size and complexity of safety arguments and evidence being presented within safety cases is increasing. Nowhere is this more apparent than for Electrical, Electronic and Programmable Electronic systems attempting to comply with the requirements and recommendations of software and hardware safety standards such as and UK Defence Standards 00-54 [MoD. 00-54 Requirements of Safety Related Electronic Hardware in Defence Equipment. Ministry of Defence, Interim Defence Standard, 1999], 00-55 []. However, this increase in safety case complexity exacerbates problems of comprehension and maintainability later on in the system lifecycle. This paper defines and describes a tool-supported process, based upon the principles of goal structuring, that attempts to address these difficulties through facilitating the systematic impact assessment of safety case challenges

  5. Using systematic review in occupational safety and health.

    Science.gov (United States)

    Howard, John; Piacentino, John; MacMahon, Kathleen; Schulte, Paul

    2017-11-01

    Evaluation of scientific evidence is critical in developing recommendations to reduce risk. Healthcare was the first scientific field to employ a systematic review approach for synthesizing research findings to support evidence-based decision-making and it is still the largest producer and consumer of systematic reviews. Systematic reviews in the field of occupational safety and health are being conducted, but more widespread use and adoption would strengthen assessments. In 2016, NIOSH asked RAND to develop a framework for applying the traditional systematic review elements to the field of occupational safety and health. This paper describes how essential systematic review elements can be adapted for use in occupational systematic reviews to enhance their scientific quality, objectivity, transparency, reliability, utility, and acceptability. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  6. Integrated Plant Safety Assessment, Systematic Evaluation Program: Yankee Nuclear Power Station (Docket No. 50-29)

    International Nuclear Information System (INIS)

    1987-10-01

    The US Nuclear Regulatory Commission (NRC) has prepared Supplement 1 to the final Integrated Plant Safety Assessment Report (IPSAR) (NUREG-0825), under the scope of the Systematic Evaluation Program (SEP), for Yankee Atomic Electric Company's Yankee Nuclear Power Station located in Rowe, Massachusetts. The SEP was initiated by the NRC to review the design of older operating nuclear power plants to reconfirm and document their safety. This report documents the review completed under the SEP for those issues that required refined engineering evaluations or the continuation of ongoing evaluations after the Final IPSAR for the Yankee plant was issued. The review has provided for (1) an assessment of the significance of differences between current technical positions on selected safety issues and those that existed when Yankee was licensed, (2) a basis for deciding how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. 2 tabs

  7. Assessment of safety culture: Changing regulatory approach in Hungary

    International Nuclear Information System (INIS)

    Ronaky, Jozsef; Toth, Andras

    2002-01-01

    Hungarian Atomic Energy Authority (HAEA) is changing its inspection practice and assessment methods of safety performance and safety culture in operating nuclear facilities. The new approach emphasises integrated team inspection of safety cornerstones and systematic assessment of safety performance of operators. (author)

  8. Systematic evaluation of non-animal test methods for skin sensitisation safety assessment.

    Science.gov (United States)

    Reisinger, Kerstin; Hoffmann, Sebastian; Alépée, Nathalie; Ashikaga, Takao; Barroso, Joao; Elcombe, Cliff; Gellatly, Nicola; Galbiati, Valentina; Gibbs, Susan; Groux, Hervé; Hibatallah, Jalila; Keller, Donald; Kern, Petra; Klaric, Martina; Kolle, Susanne; Kuehnl, Jochen; Lambrechts, Nathalie; Lindstedt, Malin; Millet, Marion; Martinozzi-Teissier, Silvia; Natsch, Andreas; Petersohn, Dirk; Pike, Ian; Sakaguchi, Hitoshi; Schepky, Andreas; Tailhardat, Magalie; Templier, Marie; van Vliet, Erwin; Maxwell, Gavin

    2015-02-01

    The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitization potency prediction. The results of the first phase – systematic evaluation of 16 test methods – are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data,potential for throughput, transferability and accessibility in cooperation with the test method developers.A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy – combined with bioavailability and skin metabolism data and exposure consideration – is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients.

  9. Benefits of a systematic approach to maintenance for safety and safety related systems

    International Nuclear Information System (INIS)

    Dam, R.F.; Ayazzudin, S.; Nickerson, J.H.

    2003-01-01

    For safety and safety-related systems, nuclear plants have to balance the requirements of demonstrating the reliability of each system, while maintaining the system and plant availability. With the goal of demonstrating statistical reliability, these systems have extensive testing programs, which often results in system unavailability and this can impact the plant capacity. The inputs to the process are often safety and regulatory related, resulting in programs that provide a high level of scrutiny. In such cases, the value of the application of a Systematic Assessment of Maintenance (SAM) process, such as Reliability Centered Maintenance (RCM), is questioned. The special case of Standby-Safety systems was discussed in a previous paper, where it was demonstrated how SAM techniques provide useful insight into current system performance, the impact of testing on component and system reliability, and how PSA considerations can be integrated into a comprehensive Maintenance, Surveillance, and Inspection (MSI) strategy. Although the system reliability requirements are an important part of the strategy evaluation, SAM techniques provide a systematic assessment within a broader context. Testing is only one part of an overall strategy focused on ensuring that component function is maintained through a combination of monitoring technologies (including testing), predictive techniques, and intrusive maintenance strategies. Each strategy is targeted to known component degradation mechanisms. This thinking can be extended to safety and safety related systems in general. Over the past 6 years, AECL has been working with CANDU utilities in the development and implementation of a comprehensive and integrated Plant Life Management (PLiM) program. As part of developing a comprehensive plant asset management approach, SAM techniques are used to develop a technical basis that not only works towards ensuring reliable operation of plant systems, but also facilitates the optimization and

  10. Triage for action: Systematic assessment and dissemination of construction health and safety research.

    Science.gov (United States)

    Baker, Robin; Chang, Charlotte; Bunting, Jessica; Betit, Eileen

    2015-08-01

    Research translation too often relies on passive methods that fail to reach those who can impact the workplace. The need for better research to practice (r2p) approaches is especially pressing in construction, where a disproportionate number of workers suffer serious injury illness. A triage process was designed and used to systematically review completed research, assess r2p readiness, establish priorities, and launch dissemination follow-up efforts. A mixed quantitative and qualitative approach was used. The process proved effective in ensuring that significant findings and evidence-based solutions are disseminated actively. Key factors emerged in the selection of follow-up priorities, including availability of partners able to reach end users, windows of opportunity, and cross-cutting approaches that can benefit multiple dissemination efforts. Use of a systematic triage process may have an important role to play in building r2p capacity in construction safety and health. © 2015 Wiley Periodicals, Inc.

  11. Integrated plant safety assessment. Systematic evaluation program, Big Rock Point Plant (Docket No. 50-155). Final report

    International Nuclear Information System (INIS)

    1984-05-01

    The Systematic Evaluation Program was initiated in February 1977 by the U.S. Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final Integrated Plant Safety Assessment Report has been issued. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

  12. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  13. Safety Culture Perceptions in a Collegiate Aviation Program: A Systematic Assessment

    OpenAIRE

    Adjekum, Daniel Kwasi

    2014-01-01

    An assessment of the perceptions of respondents on the safety culture at an accredited Part 141 four year collegiate aviation program was conducted as part of the implementation of a safety management system (SMS). The Collegiate Aviation Program Safety Culture Assessment Survey (CAPSCAS), which was modified and revalidated from the existing Commercial Aviation Safety Survey (CASS), was used. Participants were drawn from flight students and certified flight instructors in the program. The sur...

  14. Intergrated plant safety assessment. Systematic evaluation program. Palisades plant, Consumers Power Company, Docket No. 50-255. Final report

    International Nuclear Information System (INIS)

    1982-10-01

    The Nuclear Regulatory Commission (NRC) has published its Final Integrated Plant Safety Assessment Report (IPSAR) (NUREG-0820), under the scope of the Systematic Evaluation Program (SEP), for Consumers Power Company's Palisades Plant located in Covert, Van Buren County, Michigan. The SEP was initiated by the NRC to review the design of older operating nuclear reactor plants to reconfirm and document their safety. This report documents the review completed under the SEP for the Palisades Plant. The review has provided for (1) as assessment of the significance of differences between current technical positions on selected safety issues and those that existed when the Palisades Plant was licensed, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when all supplements to the Final IPSAR and the Safety Evaluation Report for converting the license from a provisional to a full-term license have been issued. The report also addresses the comments and recommendations made by the Advisory Committee on Reactor Safeguards in connection with its review of the Draft Report, issued in April 1982

  15. The Safety Assessment Framework Tool (SAFRAN) - Description, Overview and Applicability

    International Nuclear Information System (INIS)

    Alujevic, Luka

    2014-01-01

    The SAFRAN tool (Safety Assessment Framework) is a user-friendly software application that incorporates the methodologies developed in the SADRWMS (Safety Assessment Driven Radioactive Waste Management Solutions) project. The International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of all types of radioactive waste, including disused sources, small volumes, legacy and decommissioning waste, operational waste, and large volume naturally occurring radioactive material residues. SAFRAN provides aid in: Describing the predisposal RW management activities in a systematic way, Conducting the SA (safety assessment) with clear documentation of the methodology, assumptions, input data and models, Establishing a traceable and transparent record of the safety basis for decisions on the proposed RW management solutions, Demonstrating clear consideration of and compliance with national and international safety standards and recommendations. The SAFRAN tool allows the user to visibly, systematically and logically address predisposal radioactive waste management and decommissioning challenges in a structured way. It also records the decisions taken in such a way that it constitutes a justifiable safety assessment of the proposed management solutions. The objective of this paper is to describe the SAFRAN architecture and features, properly define the terms safety case and safety assessment, and to predict the future development of the SAFRAN tool and assess its applicability to the construction of a future LILW (Low and Intermediate Level Waste) storage facility and repository in Croatia, taking into account all the capabilities and modelling features of the SAFRAN tool. (author)

  16. A new assessment method for demonstrating the sufficiency of the safety assessment and the safety margins of the geological disposal system

    International Nuclear Information System (INIS)

    Ohi, Takao; Kawasaki, Daisuke; Chiba, Tamotsu; Takase, Toshio; Hane, Koji

    2013-01-01

    A new method for demonstrating the sufficiency of the safety assessment and safety margins of the geological disposal system has been developed. The method is based on an existing comprehensive sensitivity analysis method and can systematically identify the successful conditions, under which the dose rate does not exceed specified safety criteria, using analytical solutions for nuclide migration and the results of a statistical analysis. The successful conditions were identified using three major variables. Furthermore, the successful conditions at the level of factors or parameters were obtained using relational equations between the variables and the factors or parameters making up these variables. In this study, the method was applied to the safety assessment of the geological disposal of transuranic waste in Japan. Based on the system response characteristics obtained from analytical solutions and on the successful conditions, the classification of the analytical conditions, the sufficiency of the safety assessment and the safety margins of the disposal system were then demonstrated. A new assessment procedure incorporating this method into the existing safety assessment approach is proposed in this study. Using this procedure, it is possible to conduct a series of safety assessment activities in a logical manner. (author)

  17. Integrated plant safety assessment, Systematic Evaluation Program: Dresden Nuclear Power Station, Unit 2 (Docket No. 50-237)

    International Nuclear Information System (INIS)

    1989-10-01

    The US Nuclear Regulatory Commission (NRC) has prepared Supplement 1 to the final Integrated Plant Safety Assessment Report (IPSAR) (NUREG-0823), under the scope of the Systematic Evaluation Program (SEP), for the Commonwealth Edison Company (CECo) Dresden Nuclear Power Station, Unit 2 located in Grundy County, Illinois. The NRC initiated the SEP to provide the framework for reviewing the design of older operating nuclear reactor plants to reconfirm and document their safety. This report documents the review completed by means of the SEP for those issues that required refined engineering evaluations or the continuation of ongoing evaluations subsequent to issuing the final IPSAR for Dresden Unit 2. The review was provided for (1) an assessment of the significance of differences between current technical positions on selected issues and those that existed when Dresden Unit 2 was licensed, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. The final IPSAR and this supplement forms part of the bases for considering the conversion of the existing provisional operating license to a full-term operating license. 83 refs., 9 tabs

  18. Human factors in safety assessment. Safety culture assessment

    International Nuclear Information System (INIS)

    Zhang Li; Deng Zhiliang; Wang Yiqun; Huang Weigang

    1996-01-01

    This paper analyses the present conditions and problems in enterprises safety assessment, and introduces the characteristics and effects of safety culture. The authors think that safety culture must be used as a 'soul' to form the pattern of modern safety management. Furthermore, they propose that the human safety and synthetic safety management assessment in a system should be changed into safety culture assessment. Finally, the assessment indicators are discussed

  19. Independent assessment for new nuclear reactor safety

    Directory of Open Access Journals (Sweden)

    D'Auria Francesco

    2017-01-01

    Full Text Available A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On the one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs. Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry. The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty approach.

  20. Independent assessment for new nuclear reactor safety

    International Nuclear Information System (INIS)

    D'Auria, F.; Glaeser, H.; Debrecin, N.

    2017-01-01

    A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs). Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry). The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty (BEPU) approach. (authors)

  1. Systematic safety evaluation of old nuclear power plants

    International Nuclear Information System (INIS)

    Dredemis, G.; Fourest, B.

    1984-01-01

    The French safety authorities have undertaken a systematic evaluation of the safety of old nuclear power plants. Apart from a complete revision of safety documents (safety analysis report, general operating rules, incident and accident procedures, internal emergency plan, quality organisation manual), this examination consisted of analysing the operating experience of systems frequently challenged and a systematic examination of the safety-related systems. This paper is based on an exercise at the Ardennes Nuclear Power Plant which has been in operation for 15 years. This paper also summarizes the main surveys and modifications relating to this power plant. (orig.)

  2. Integrated Approaches to Occupational Health and Safety: A Systematic Review.

    Science.gov (United States)

    Cooklin, A; Joss, N; Husser, E; Oldenburg, B

    2017-09-01

    The study objective was to conduct a systematic review of the effectiveness of integrated workplace interventions that combine health promotion with occupational health and safety. Electronic databases (n = 8), including PsychInfo and MEDLINE, were systematically searched. Studies included were those that reported on workplace interventions that met the consensus definition of an "integrated approach," published in English, in the scientific literature since 1990. Data extracted were occupation, worksite, country, sample size, intervention targets, follow-up period, and results reported. Quality was assessed according to American College of Occupational and Environmental Medicine Practice Guidelines. Heterogeneity precluded formal meta-analyses. Results were classified according to the outcome(s) assessed into five categories (health promotion, injury prevention, occupational health and safety management, psychosocial, and return-on-investment). Narrative synthesis of outcomes was performed. A total of 31 eligible studies were identified; 23 (74%) were (quasi-)experimental trials. Effective interventions were most of those aimed at improving employee physical or mental health. Less consistent results were reported from integrated interventions targeting occupational health and safety management, injury prevention, or organizational cost savings. Integrated approaches have been posed as comprehensive solutions to complex issues. Empirical evidence, while still emerging, provides some support for this. Continuing investment in, and evaluation of, integrated approaches are worthwhile.

  3. Towards Clinical Application of Neurotrophic Factors to the Auditory Nerve; Assessment of Safety and Efficacy by a Systematic Review of Neurotrophic Treatments in Humans

    NARCIS (Netherlands)

    Bezdjian, Aren; Kraaijenga, Véronique J C; Ramekers, Dyan; Versnel, Huib; Thomeer, Hans G X M; Klis, Sjaak F L; Grolman, Wilko

    2016-01-01

    Animal studies have evidenced protection of the auditory nerve by exogenous neurotrophic factors. In order to assess clinical applicability of neurotrophic treatment of the auditory nerve, the safety and efficacy of neurotrophic therapies in various human disorders were systematically reviewed.

  4. Safety assessment and verification for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2001-01-01

    This publication supports the Safety Requirements on the Safety of Nuclear Power Plants: Design. This Safety Guide was prepared on the basis of a systematic review of all the relevant publications including the Safety Fundamentals, Safety of Nuclear Power Plants: Design, current and ongoing revisions of other Safety Guides, INSAG reports and other publications that have addressed the safety of nuclear power plants. This Safety Guide also provides guidance for Contracting Parties to the Convention on Nuclear Safety in meeting their obligations under Article 14 on Assessment and Verification of Safety. The Safety Requirements publication entitled Safety of Nuclear Power Plants: Design states that a comprehensive safety assessment and an independent verification of the safety assessment shall be carried out before the design is submitted to the regulatory body. This publication provides guidance on how this requirement should be met. This Safety Guide provides recommendations to designers for carrying out a safety assessment during the initial design process and design modifications, as well as to the operating organization in carrying out independent verification of the safety assessment of new nuclear power plants with a new or already existing design. The recommendations for performing a safety assessment are suitable also as guidance for the safety review of an existing plant. The objective of reviewing existing plants against current standards and practices is to determine whether there are any deviations which would have an impact on plant safety. The methods and the recommendations of this Safety Guide can also be used by regulatory bodies for the conduct of the regulatory review and assessment. Although most recommendations of this Safety Guide are general and applicable to all types of nuclear reactors, some specific recommendations and examples apply mostly to water cooled reactors. Terms such as 'safety assessment', 'safety analysis' and 'independent

  5. Integrated plant safety assessment: systematic evaluation program. Haddam Neck Plant, Connecticut Yankee Atomic Power Company. Docket No. 50-213

    International Nuclear Information System (INIS)

    1983-03-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of Haddam Neck Plant, operated by Connecticut Yankee Atomic Power Company. The Haddam Neck Plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review

  6. Integrated plant safety assessment: Systematic Evaluation Program. LaCrosse Boiling Water Reactor, Dairyland Power Cooperative, Docket No. 50-409

    International Nuclear Information System (INIS)

    1983-04-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of the La Crosse Boiling Water Reactor, operated by Dairyland Power Cooperative. The La Crosse plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addresed. Equipment and procedural changes have been identified as a result of the review

  7. Do safety checklists improve teamwork and communication in the operating room? A systematic review.

    Science.gov (United States)

    Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

    2013-12-01

    The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and

  8. The impact of eHealth on the quality and safety of health care: a systematic overview.

    Science.gov (United States)

    Black, Ashly D; Car, Josip; Pagliari, Claudia; Anandan, Chantelle; Cresswell, Kathrin; Bokun, Tomislav; McKinstry, Brian; Procter, Rob; Majeed, Azeem; Sheikh, Aziz

    2011-01-18

    There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care. We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment

  9. The impact of eHealth on the quality and safety of health care: a systematic overview.

    Directory of Open Access Journals (Sweden)

    Ashly D Black

    Full Text Available BACKGROUND: There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care. METHODS AND FINDINGS: We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1 storing, managing, and transmission of data; (2 clinical decision support; and (3 facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice

  10. Analysis on evaluation ability of nonlinear safety assessment model of coal mines based on artificial neural network

    Institute of Scientific and Technical Information of China (English)

    SHI Shi-liang; LIU Hai-bo; LIU Ai-hua

    2004-01-01

    Based on the integration analysis of goods and shortcomings of various methods used in safety assessment of coal mines, combining nonlinear feature of mine safety sub-system, this paper establishes the neural network assessment model of mine safety, analyzes the ability of artificial neural network to evaluate mine safety state, and lays the theoretical foundation of artificial neural network using in the systematic optimization of mine safety assessment and getting reasonable accurate safety assessment result.

  11. Formal safety assessment based on relative risks model in ship navigation

    Energy Technology Data Exchange (ETDEWEB)

    Hu Shenping [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: sphu@mmc.shmtu.edu.cn; Fang Quangen [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: qgfang@mmc.shmtu.edu.cn; Xia Haibo [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: hbxia@mmc.shmtu.edu.cn; Xi Yongtao [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: xiyt@mmc.shmtu.edu.cn

    2007-03-15

    Formal safety assessment (FSA) is a structured and systematic methodology aiming at enhancing maritime safety. It has been gradually and broadly used in the shipping industry nowadays around the world. On the basis of analysis and conclusion of FSA approach, this paper discusses quantitative risk assessment and generic risk model in FSA, especially frequency and severity criteria in ship navigation. Then it puts forward a new model based on relative risk assessment (MRRA). The model presents a risk-assessment approach based on fuzzy functions and takes five factors into account, including detailed information about accident characteristics. It has already been used for the assessment of pilotage safety in Shanghai harbor, China. Consequently, it can be proved that MRRA is a useful method to solve the problems in the risk assessment of ship navigation safety in practice.

  12. Formal safety assessment based on relative risks model in ship navigation

    International Nuclear Information System (INIS)

    Hu Shenping; Fang Quangen; Xia Haibo; Xi Yongtao

    2007-01-01

    Formal safety assessment (FSA) is a structured and systematic methodology aiming at enhancing maritime safety. It has been gradually and broadly used in the shipping industry nowadays around the world. On the basis of analysis and conclusion of FSA approach, this paper discusses quantitative risk assessment and generic risk model in FSA, especially frequency and severity criteria in ship navigation. Then it puts forward a new model based on relative risk assessment (MRRA). The model presents a risk-assessment approach based on fuzzy functions and takes five factors into account, including detailed information about accident characteristics. It has already been used for the assessment of pilotage safety in Shanghai harbor, China. Consequently, it can be proved that MRRA is a useful method to solve the problems in the risk assessment of ship navigation safety in practice

  13. Integrated plant safety assessment. Systematic Evaluation Program. La Crosse Boiling Water Reactor. Dairyland Power Cooperative, Docket No. 50-409. Final report

    International Nuclear Information System (INIS)

    1983-06-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of the La Crosse Boiling Water Reactor, operated by Dairyland Power Cooperative. The La Crosse plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review

  14. Integrated Plant Safety Assessment: Systematic Evaluation Program. Yankee Nuclear Power Station, Yankee Atomic Electric Company, Docket No. 50-29. Final report

    International Nuclear Information System (INIS)

    1983-06-01

    The Systematic Evaluation program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of Yankee Nuclear Power Station, operated by Yankee Atomic Electric Company. The Yankee plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review

  15. Integrated Plant Safety Assessment, Systematic Evaluation Program. Yankee Nuclear Power Station, Yankee Atomic Electric Company, Docket No. 50-29. Draft report

    International Nuclear Information System (INIS)

    1983-02-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of Yankee Nuclear Power Station, operated by Yankee Atomic Electric Company. The Yankee plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review

  16. Integrated Plant Safety Assessment: Systematic Evaluation Program. Haddam Neck Plant, Connecticut Yankee Atomic Power Company, Docket No. 50-213. Final report

    International Nuclear Information System (INIS)

    1983-01-01

    The Systematic Evaluation Progam was initiated in February 1977 by the US Nuclear Regulatory Commission review the designs of older operating nuclear reactor plants to confirm and document their safety. The review provides: (1) an assessment of how these plants compare with curent licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of Haddam Neck Plant, operated by Connecticut Yankee Atomic Power Company. The Haddam Neck Plant is one of 10 plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review

  17. Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

    Science.gov (United States)

    Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

    2018-05-01

    To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

  18. The practice of pre-marketing safety assessment in drug development.

    Science.gov (United States)

    Chuang-Stein, Christy; Xia, H Amy

    2013-01-01

    The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

  19. Operational safety assessment of underground test facilities for mined geologic waste disposal

    International Nuclear Information System (INIS)

    Elder, H.K.

    1993-01-01

    This paper describes the operational safety assessment for the underground facilities for the exploratory studies facility (ESF) at the Yucca Mountain Project. The systematic identification and evaluation of hazards related to the ESF is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach based on the analysis of potential accidents was used since radiological safety analysis was not required. The risk assessment summarized credible accident scenarios and the design provides mitigation of the risks to a level that the facility can be constructed and operated with an adequate level of safety. The risk assessment also provides reasonable assurance that all identifiable major accident scenarios have been reviewed and design mitigation features provided to ensure an adequate level of safety

  20. Integrated Safety and Security Risk Assessment Methods: A Survey of Key Characteristics and Applications

    OpenAIRE

    Chockalingam, Sabarathinam; Hadziosmanovic, Dina; Pieters, Wolter; Teixeira, Andre; van Gelder, Pieter

    2017-01-01

    Over the last years, we have seen several security incidents that compromised system safety, of which some caused physical harm to people. Meanwhile, various risk assessment methods have been developed that integrate safety and security, and these could help to address the corresponding threats by implementing suitable risk treatment plans. However, an overarching overview of these methods, systematizing the characteristics of such methods, is missing. In this paper, we conduct a systematic l...

  1. Non-technical issues in safety assessments for nuclear disposal facilities

    International Nuclear Information System (INIS)

    Kallenbach-Herbert, Beate; Brohmann, Bettina

    2010-09-01

    The paper highlights that a comprehensive approach to safety affords the consideration of technology, organisation, personnel and social environment. In several safety relevant contexts of nuclear waste disposal these fields are closely interrelated. The approach for the consideration of socio-scientific aspects which is sketched in this paper supports the systematic treatment of safety relevant non-technical issues in the safety case or in safety assessments for a disposal project. Furthermore it may foster the dialogue among specialists from the technical, the natural- and the socio-scientific field on questions of disposal safety. In this way it may contribute to a better understanding among the affected scientific disciplines in nuclear waste disposal.

  2. Integrated-plant-safety assessment Systematic Evaluation Program. Dresden Nuclear Power Station, Unit 2, Commonwealth Edison Company, Docket No. 50-237

    International Nuclear Information System (INIS)

    1982-10-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues; (2) a basis for deciding on how these differences should be resolved in an integrated plant review; and (3) a documented evaluation of plant safety. This report documents the review of Dresden Nuclear Generating Station, Unit 2 owned and operated by the Commonwealth Edison Company and located in Grundy County, Illinois. Dresden Unit 2 is one of ten plants reviewed under Phase II of this program, which indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review. It is expected that this report will be one of the bases in considering the issuance of a full-term operating license in place of the existing provisional operating license

  3. A review of international sources for road safety measures assessment.

    NARCIS (Netherlands)

    Yannis, G. Weijermars, W. & Kauppila, J.

    2012-01-01

    The efficiency assessment of road safety measures is considered to be an extremely useful tool in decision making; in particular, cost-benefit and cost-effectiveness analyses are carried out in several countries, in a more or less systematic way. The objective of this paper is to present findings

  4. Edible safety requirements and assessment standards for agricultural genetically modified organisms.

    Science.gov (United States)

    Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

    2008-05-01

    This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

  5. Safety of licensed vaccines in HIV-infected persons: a systematic review protocol

    Science.gov (United States)

    2014-01-01

    Background Safety of vaccines remains a cornerstone of building public trust on the use of these cost-effective and life-saving public health interventions. In some settings, particularly Sub-Saharan Africa, there is a high prevalence of HIV infection and a high burden of vaccine-preventable diseases. There is evidence suggesting that the immunity induced by some commonly used vaccines is not durable in HIV-infected persons, and therefore, repeated vaccination may be considered to ensure optimal vaccine-induced immunity in this population. However, some vaccines, particularly the live vaccines, may be unsafe in HIV-infected persons. There is lack of evidence on the safety profile of commonly used vaccines among HIV-infected persons. We are therefore conducting a systematic review to assess the safety profile of routine vaccines administered to HIV-infected persons. Methods/Design We will select studies conducted in any setting where licensed and effective vaccines were administered to HIV-infected persons. We will search for eligible studies in PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Africa-Wide, PDQ-Evidence and CINAHL as well as reference lists of relevant publications. We will screen search outputs, select studies and extract data in duplicate, resolving discrepancies by discussion and consensus. Discussion Globally, immunisation is a major public health strategy to mitigate morbidity and mortality caused by various infectious disease-causing agents. In general, there are efforts to increase vaccination coverage worldwide, and for these efforts to be successful, safety of the vaccines is paramount, even among people living with HIV, who in some situations may require repeated vaccination. Results from this systematic review will be discussed in the context of the safety of routine vaccines among HIV-infected persons. From the safety perspective, we will also discuss whether repeat vaccination strategies may be

  6. Integrated plant safety assessment systematic evaluation program. R.E. Ginna Nuclear Power Plant, Rochester Gas and Electric Corporation, Docket No. 50-244

    International Nuclear Information System (INIS)

    1982-05-01

    The Systematic Evaluation Program was initiated in February 1978 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of the R.E. Ginna Nuclear Power Plant (located in Wayne County near Rochester, NY), one of ten plants reviewed under Phase II of this program, and indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review. It is expected that this report will be one of the bases in considering the issuance of a full-term operating license in place of the existing provisional operating license

  7. Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

    International Nuclear Information System (INIS)

    Tronea, M.

    2010-01-01

    The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

  8. A safety assessment of the SEAFP fuel cycle systems

    International Nuclear Information System (INIS)

    Natalizio, A.; Kalyanam, K.; Ciattaglia, S.; Pace, L. di

    1995-01-01

    CFFTP and ENEA participated in a joint safety assessment of the fuel cycle design developed for the SEAFP fusion power reactor study (SEAFP: Safety and Environmental Assessment of Fusion Power). The assessment considered both conventional (deflagation/detonation) and radioactive hazards associated with the handling of significant quantities of hydrogen isotopes (H, D and T). Accordingly, the assessment focused on systems or equipment where either the flow rate, or inventory, of hydrogen isotopes was large. A systematic and thorough assessment of initiating events that can lead to an accidental release of tritium into the environment was the first step of the analysis process. This review demonstrated that, in all cases, there are at least two lines of defence available for mitigating the consequences of such accidents -i.e., secondary confinement (glove box, second pipe, caisson, etc.) and the building confinement, backed-up by an air detritiation capability. Therefore, large releases of tritium to the environment will occur only at very low frequencies. (orig.)

  9. Integrated-plant-safety assessment Systematic Evaluation program. Millstone Nuclear Power Station, Unit 1, Northeast Nuclear Energy Company, Docket No. 50-245

    International Nuclear Information System (INIS)

    1982-11-01

    The Systematic Evaluation Program was initiated in February 1977 to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of the Millstone Nuclear Power Station, Unit 1, operated by Northeast Nuclear Energy Company (located in Waterford, Connecticut). Millstone Nuclear Power Station, Unit 1, is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review. It is expected that this report will be one of the bases in considering the issuance of a full-term operating license in place of the existing provisional operating license

  10. Novi Han Radioactive Waste Repository post-closure safety assessment, ver.2

    International Nuclear Information System (INIS)

    Mateeva, M.

    2003-01-01

    The methodology for the post-closure safety assessment is presented. The assessment context includes regulatory framework (protection principles); scope and time frame; radiological and technical requirements; modeling etc. The description of the Novi Han disposal system contains site location. meteorological, hydrological and seismological characteristics; waste and repository description and human activities characteristics. The next step in the methodology is scenario development and justification. The systematic generation os exposure scenarios is considered as central to the post-closure safety assessment. The most important requirements for the systematic scenario generation approach are: transparency, comprehensiveness (all possible FEPs influencing the the disposal system and the radionuclide release should be considered); relevant future evolutions; identification of critical issues and investigation of the robustness of the system. For the source-pathway-receptor analysis the Process System is divided into near-field, geosphere/atmosphere and biosphere, describing the key facets controlling the potential radionuclide migration to the environment. The schematic division of the Novi Han near-field Process System into lower-level conceptual features is presented and discussed. As a result of the examinations of the FEPs three classes of scenarios are identified for the Novi Han post-closure safety assessment: Environmental evolution scenarios (geological change and climate change); future human action scenarios (human intrusion and archaeological action); Scenarios with very low probability (terrorism, crashes, explosions). The safety assessment iteration leads to identification of a modern scenario generation approach, assessment of key radionuclide releases, geological and hydrological evaluation, identification of the key parameters from sensitivity analysis etc. Examples of conceptual models are given. For the mathematical modeling the AMBER code is used

  11. Effectiveness of public health interventions in food safety: a systematic review.

    Science.gov (United States)

    Campbell, M E; Gardner, C E; Dwyer, J J; Isaacs, S M; Krueger, P D; Ying, J Y

    1998-01-01

    To summarize evidence on the effectiveness of public health interventions regarding food safety at restaurants, institutions, homes and other community-based settings. This systematic review of published and unpublished studies involved a comprehensive literature search, screening for relevance, quality assessment of relevant studies, data extraction and synthesis. The interventions identified in 15 studies included in this review were grouped into three categories: inspections, food handler training, and community-based education. The evidence suggests that: routine inspection (at least once per year) of food service premises is effective in reducing the risk of foodborne illness; food handler training can improve the knowledge and practices of food handlers; and selected community-based education programs can increase public knowledge of food safety. There is some evidence for the effectiveness of multiple public health interventions on food safety. Future research needs include evaluation of HACCP and community-based education programs.

  12. Integrated plant safety assessment: Systematic Evaluation Program, San Onofre Nuclear Generating Station, Unit 1 (Docket No. 50-206): Final report

    International Nuclear Information System (INIS)

    1986-12-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides: (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues; (2) a basis for deciding on how these differences should be resolved in an integrated plant review; and (3) a documented evaluation of plant safety. This report documents the review of San Onofre Nuclear Generating Station, Unit 1, operated by Southern California Edison Company. The San Onofre plant is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review. This report will be one of the bases in considering the issuance of a full-term operating license in place of the existing provisional operating license. This report also addresses the comments and recommendations made by the Advisory Committee on Reactor Safeguards in connection with its review of the draft report issued in April 1985

  13. Operating experience and systems analysis at Trillo NPP: A program intended for systematic review of plant safety systems to assess design basis requirements compliance

    International Nuclear Information System (INIS)

    Vega, R. de la

    1996-01-01

    The program was defined to apply to all plant safety systems and/or systems included in plant Technical Specifications. The goal of the program was to ensure, by systematic design, construction, and commissioning review, the adequacy of safety systems, structures and components to fulfill their safety functions. Also, as a result of the program, it was established that a complete, unambiguous, systematic, design basis definition shall take place. And finally, a complete documental review of the plant design shall result from the program execution

  14. Systematic assessment of laser safety in otolaryngology

    Science.gov (United States)

    Oswal, V. H.

    2001-01-01

    Risk management of lasers can be broadly define das a process of identification of the risk, assessment of the risk and steps taken to avert the risk. The risk management may be divided into: Risk inherent to the technology and risk in clinical use. Within the National Health Service in the UK, a useful document, which provides hospital laser users with advice on safety, is the 'Guidance on the Safe Use of Lasers in Medical and Dental Practice' issued by the Medical Devices Agency for the Department of Health in the UK. It recommends the appointment of a Laser Protection Adviser (LPA) who is knowledgeable in the evaluation of laser hazards. One of the duties LPA is to ensure that Local Rules are drawn up for each specific application of a laser. A Laser Protection Supervisor (LPS) should also be appointed with responsibility to ensure that the Local Rules are observed. It is a sensible precaution that laser users should be those approved by the Laser Protection Supervisor in consultation with the Laser Protection Advisor. All laser users should sign a statement that they have read and understood the Local Rules.

  15. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

    Science.gov (United States)

    Pai, Sarayu A; Kshirsagar, Nilima A

    2016-11-01

    With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  16. Safety Assessment for Decommissioning

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-06-15

    In the past few decades, international guidance has been developed on methods for assessing the safety of predisposal and disposal facilities for radioactive waste. More recently, it has been recognized that there is also a need for specific guidance on safety assessment in the context of decommissioning nuclear facilities. The importance of safety during decommissioning was highlighted at the International Conference on Safe Decommissioning for Nuclear Activities held in Berlin in 2002 and at the First Review Meeting of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management in 2003. At its June 2004 meeting, the Board of Governors of the IAEA approved the International Action Plan on Decommissioning of Nuclear Facilities (GOV/2004/40), which called on the IAEA to: ''establish a forum for the sharing and exchange of national information and experience on the application of safety assessment in the context of decommissioning and provide a means to convey this information to other interested parties, also drawing on the work of other international organizations in this area''. In response, in November 2004, the IAEA launched the international project Evaluation and Demonstration of Safety for Decommissioning of Facilities Using Radioactive Material (DeSa) with the following objectives: -To develop a harmonized approach to safety assessment and to define the elements of safety assessment for decommissioning, including the application of a graded approach; -To investigate the practical applicability of the methodology and performance of safety assessments for the decommissioning of various types of facility through a selected number of test cases; -To investigate approaches for the review of safety assessments for decommissioning activities and the development of a regulatory approach for reviewing safety assessments for decommissioning activities and as a basis for regulatory decision making; -To provide a forum

  17. Quantification of human reliability in probabilistic safety assessment

    International Nuclear Information System (INIS)

    Hirschberg, S.; Dankg, Vinh N.

    1996-01-01

    Human performance may substantially influence the reliability and safety of complex technical systems. For this reason, Human Reliability Analysis (HRA) constitutes an important part of Probabilistic Safety Assessment (PSAs) or Quantitative Risk Analyses (QRAs). The results of these studies as well as analyses of past accidents and incidents clearly demonstrate the importance of human interactions. The contribution of human errors to the core damage frequency (CDF), as estimated in the Swedish nuclear PSAs, are between 15 and 88%. A survey of the FRAs in the Swiss PSAs shows that also for the Swiss nuclear power plants the estimated HE contributions are substantial (49% of the CDF due to internal events in the case of Beznau and 70% in the case of Muehleberg; for the total CDF, including external events, 25% respectively 20%). Similar results can be extracted from the PSAs carried out for French, German, and US plants. In PSAs or QRAs, the adequate treatment of the human interactions with the system is a key to the understanding of accident sequences and their relative importance to overall risk. The main objectives of HRA are: first, to ensure that the key human interactions are systematically identified and incorporated into the safety analysis in a traceable manner, and second, to quantify the probabilities of their success and failure. Adopting a structured and systematic approach to the assessment of human performance makes it possible to provide greater confidence that the safety and availability of human-machine systems is not unduly jeopardized by human performance problems. Section 2 discusses the different types of human interactions analysed in PSAs. More generally, the section presents how HRA fits in the overall safety analysis, that is, how the human interactions to be quantified are identified. Section 3 addresses the methods for quantification. Section 4 concludes the paper by presenting some recommendations and pointing out the limitations of the

  18. Organizational analysis and safety for utilities with nuclear power plants: perspectives for organizational assessment. Volume 2

    International Nuclear Information System (INIS)

    Osborn, R.N.; Olson, J.; Sommers, P.E.

    1983-08-01

    This two-volume report presents the results of initial research on the feasibility of applying organizational factors in nuclear power plant (NPP) safety assessment. Volume 1 of this report contains an overview of the literature, a discussion of available safety indicators, and a series of recommendations for more systematically incorporating organizational analysis into investigations of nuclear power plant safety. The six chapters of this volume discuss the major elements in our general approach to safety in the nuclear industry. The chapters include information on organizational design and safety; organizational governance; utility environment and safety related outcomes; assessments by selected federal agencies; review of data sources in the nuclear power industry; and existing safety indicators

  19. Role and meaning of safety assessment from the point of view of IAEA

    International Nuclear Information System (INIS)

    Lyubarskiy, A.

    2012-01-01

    In 2006, the IAEA published its revised Safety Fundamentals. This states that the ''fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation''. This objective has to be achieved for all facilities and activities and for all stages over the lifetime of a facility by adherence to ten fundamental principles. This leads, inter alia, to the requirement for a safety assessment to be carried out. In particular, the text accompanying Principle 3 on leadership and management for safety states that: ''3.15. Safety has to be assessed for all facilities and activities, consistent with a graded approach. Safety assessment involves the systematic analysis of normal operation and its effects, of the ways in which failures might occur and of the consequences of such failures. Safety assessments cover the safety measures necessary to control the hazard, and the design and engineered safety features are assessed to demonstrate that they fulfill the safety functions required of them. Where control measures or operator actions are called on to maintain safety, an initial safety assessment has to be carried out to demonstrate that the arrangements made are robust and that they can be relied on. A facility may only be constructed and commissioned or an activity may only be commenced once it has been demonstrated to the satisfaction of the regulatory body that the proposed safety measures are adequate.'' Principle 3 further states that the process of safety assessment for facilities and activities is repeated in the conduct of operations in order to take into account changed circumstances (such as the application of new standards or scientific and technological developments), the feedback of operating experience, modifications and the effects of ageing. Continuation of operations over long periods of time requires reassessments demonstrating that the safety measures remain adequate. (orig.)

  20. Use of operational experience in fire safety assessment of nuclear power plants

    International Nuclear Information System (INIS)

    2000-01-01

    Fire hazard has been identified as a major contributor to a plant's operational risk and the international nuclear power industry has been studying and developing tools for defending against this hazard. Considerable progress in design and regulatory requirements for fire safety, in fire protection technology and in related analytical techniques has been made in the past two decades. Substantial efforts have been undertaken worldwide to implement these advances in the interest of improving fire safety both at new and existing nuclear power plants. To assist in these efforts, the IAEA initiated a programme on fire safety that was intended to provide assistance to Member States in improving fire safety in nuclear power plants. In order to achieve this general objective, the IAEA programme aimed at the development of guidelines and good practices, the promotion of advanced fire safety assessment techniques, the exchange of state of the art information between practitioners and the provision of engineering safety advisory services and training in the implementation of internationally accepted practices. During the period 1993-1994, the IAEA activities related to fire safety concentrated on the development of guidelines and good practice documents related to fire safety and fire protection of operating plants. One of the first tasks was the development of a Safety Guide that formulates specific requirements with regard to the fire safety of operating nuclear power plants. Several documents, which provide advice on fire safety inspection, were developed to assist in its implementation. In the period 1995-1996, the programme focused on the preparation of guidelines for the systematic analysis of fire safety at nuclear power plants (NPPs). The IAEA programme on fire safety for 1997-1998 includes tasks aimed at promoting systematic assessment of fire safety related occurrences and dissemination of essential insights from this assessment. One of the topics addressed is the

  1. Development of the KINS Safety Culture Maturity Model for Self and Independent Assessment

    International Nuclear Information System (INIS)

    Sheen, C.; Choi, Y.S.

    2016-01-01

    Safety culture of an organization is cultivated and affected not only by societal and regulatory environment of the organization, but by its philosophies, policies, events and activities experienced in the process of accomplishing its mission. The safety culture would be continuously changed by the interactions between its members along with time as an organic entity. In order to perform a systematic self- or independent assessment of safety culture, a safety culture assessment model (SCAM) properly reflecting cultural characteristics should be necessary. In addition, a SCAM should be helpful not only to establish correct directions, goals, and strategies for safety culture development, but should anticipating obstacles against safety culture development in the implementation process derived from the assessment. In practical terms, a SCAM should be useful for deriving effective guidelines and implementing of corrective action programs for the evaluated organization. Korea Institute of Nuclear Safety (KINS) performed a research project for six years to develop a SCAM satisfying the above prerequisites for self- and independent assessment. The KINS SCAM was developed based on the five stage safety culture maturity model proposed by Professor Patrick Hudson and was modified into four stages to reflect existing safety culture assessment experiences at Korean nuclear power plants. In order to define the change mechanism of safety culture for development and reversion, the change model proposed by Prochaska and DiClemente was introduced into KINS SCAM and developed into the Spiral Change Model.

  2. Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

    DEFF Research Database (Denmark)

    Pilegaard, Kirsten

    preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications...... in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements....

  3. HSE's safety assessment principles for criticality safety

    International Nuclear Information System (INIS)

    Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

    2008-01-01

    The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf). (memorandum)

  4. Safety assessment and surveillance of decommissioning operations at DOE's nuclear facilities

    International Nuclear Information System (INIS)

    Cowgill, M.G.; Prochnow, D.; Worthington, P.R.

    1995-01-01

    A description is provided of a systematic approach currently being developed and deployed at the Department of Energy to obtain assurance that post-operational activities at nuclear facilities will be conducted in a safe manner. Using this approach, personnel will have available a formalized set of safety principles and associated question sets to assist them in the conducting of safety assessments and surveillance. Information gathered through this means will also be analyzed to determine if there are any generic complex-wide strengths or deficiencies associated with decommissioning activities and to which attention should be drawn

  5. Systematic impact of institutional pressures on safety climate in the construction industry.

    Science.gov (United States)

    He, Qinghua; Dong, Shuang; Rose, Timothy; Li, Heng; Yin, Qin; Cao, Dongping

    2016-08-01

    This paper explores how three types of institutional pressure (i.e., coercive, mimetic and normative pressures) systematically impact on the safety climate of construction projects. These impacts are empirically tested by survey data collected from 186 questionnaires of construction companies operating in Shanghai, China. The results, obtained by partial least squares analysis, show that organizational management commitment to safety and employee involvement is positively related to all three institutional pressures, while the perception of responsibility for safety and health is significantly influenced by coercive and mimetic pressure. However, coercive and normative pressures have no significant effect on the applicability of safety rules and work practices, revealing the importance of external organizational pressures in improving project safety climate from a systematic view. The findings also provide insights into the use of institutional forces to facilitate the improvement of safety climate in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. The quality, safety and governance of telephone triage and advice services - an overview of evidence from systematic reviews.

    Science.gov (United States)

    Lake, Rebecca; Georgiou, Andrew; Li, Julie; Li, Ling; Byrne, Mary; Robinson, Maureen; Westbrook, Johanna I

    2017-08-30

    Telephone triage and advice services (TTAS) are increasingly being implemented around the world. These services allow people to speak to a nurse or general practitioner over the telephone and receive assessment and healthcare advice. There is an existing body of research on the topic of TTAS, however the diffuseness of the evidence base makes it difficult to identify key lessons that are consistent across the literature. Systematic reviews represent the highest level of evidence synthesis. We aimed to undertake an overview of such reviews to determine the scope, consistency and generalisability of findings in relation to the governance, safety and quality of TTAS. We searched PubMed, MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane Library for English language systematic reviews focused on key governance, quality and safety findings related to telephone based triage and advice services, published since 1990. The search was undertaken by three researchers who reached consensus on all included systematic reviews. An appraisal of the methodological quality of the systematic reviews was independently undertaken by two researchers using A Measurement Tool to Assess Systematic Reviews. Ten systematic reviews from a potential 291 results were selected for inclusion. TTAS was examined either alone, or as part of a primary care service model or intervention designed to improve primary care. Evidence of TTAS performance was reported across nine key indicators - access, appropriateness, compliance, patient satisfaction, cost, safety, health service utilisation, physician workload and clinical outcomes. Patient satisfaction with TTAS was generally high and there is some consistency of evidence of the ability of TTAS to reduce clinical workload. Measures of the safety of TTAS tended to show that there is no major difference between TTAS and traditional care. Taken as a whole, current evidence does not provide definitive answers to questions about the quality of care

  7. The Demon-Angel method in systematic safety assessment

    International Nuclear Information System (INIS)

    Vassakis, A.G.

    1999-01-01

    Since 'design for safety' of large engineering systems with a high level of innovation requires an exhaustive safety analysis and since a subsequent corrective action may become a very large bottleneck in improving such a system, fundamental knowledge in designing safe systems is essential. The lack of any 'rule of thumb' makes such knowledge a matter of personal experience rather than the subject of an academic course. This paper proposes a new method for the theoretical safety study of different system configurations independently of any particular application. This method aims to help the construction of a 'rule of thumb' for what is a safe system and what is not. The Demon and Angel ideas are explained and the schematic presentation of these elements is introduced. Four representative case studies demonstrate the use of this method

  8. Overview of fourth generation reactors. Assessment in terms of safety and radiation protection

    International Nuclear Information System (INIS)

    Couturier, J.; Baudrand, O.; Blanc, D.; Bourgois, T.; Hache, G.; Ivanov, E.; Bonneville, H.; Meignen, R.; Nicaise, G.; Bruna, G.; Clement, B.; Kissane, M.; Monhardt, B.

    2012-01-01

    Based on a systematic analysis of the different concepts of fourth generation nuclear reactors, this report gives an overview of specific aspects regarding safety and radiation protection for six concepts: sodium fast reactors (SFR), gas fast reactors (GFR), lead fast reactors (LFR), molten salt reactors (MSR), very high or high temperature reactors (V/HTR) and supercritical water reactors (SCWR). This assessment is based on different studies and researches performed by the IRSN at an international level. For each reactor concept, the report proposes a presentation of the current status of development and its perspectives, describes the safety aspects which are specific to this concept, identifies and discusses elements for safety analysis, and assesses the concept with respect to the Fukushima accident and IAEA recommendations and predefined themes

  9. Safety assessment for TA-48 radiochemical operations

    International Nuclear Information System (INIS)

    1994-08-01

    The purpose of this report is to document an assessment performed to evaluate the safety of the radiochemical operations conducted at the Los Alamos National Laboratory operations area designated as TA-48. This Safety Assessment for the TA-48 radiochemical operations was prepared to fulfill the requirements of US Department of Energy (DOE) Order 5481.1B, ''Safety Analysis and Review System.'' The area designated as TA-48 is operated by the Chemical Science and Technology (CST) Division and is involved with radiochemical operations associated with nuclear weapons testing, evaluation of samples collected from a variety of environmental sources, and nuclear medicine activities. This report documents a systematic evaluation of the hazards associated with the radiochemical operations that are conducted at TA-48. The accident analyses are limited to evaluation of the expected consequences associated with a few bounding accident scenarios that are selected as part of the hazard analysis. Section 2 of this report presents an executive summary and conclusions, Section 3 presents pertinent information concerning the TA-48 site and surrounding area, Section 4 presents a description of the TA-48 radiochemical operations, and Section 5 presents a description of the individual facilities. Section 6 of the report presents an evaluation of the hazards that are associated with the TA-48 operations and Section 7 presents a detailed analysis of selected accident scenarios

  10. Specifications of the International Atomic Energy Agency's international project on safety assessment driven radioactive waste management solutions

    International Nuclear Information System (INIS)

    Ghannadi, M.; Asgharizadeh, F.; Assadi, M. R.

    2008-01-01

    Radioactive waste is produced in the generation of nuclear power and the production and use of radioactive materials in the industry, research, and medicine. The nuclear waste management facilities need to perform a safety assessment in order to ensure the safety of a facility. Nuclear safety assessment is a structured and systematic way of examining a proposed facility, process, operation and activity. In nuclear waste management point of view, safety assessment is a process which is used to evaluate the safety of radioactive waste management and disposal facilities. In this regard the International Atomic Energy Agency is planed to implement an international project with cooperation of some member states. The Safety Assessment Driving Radioactive Waste Management Solutions Project is an international programme of work to examine international approaches to safety assessment in aspects of p redisposal r adioactive waste management, including waste conditioning and storage. This study is described the rationale, common aspects, scope, objectives, work plan and anticipated outcomes of the project with refer to International Atomic Energy Agency's documents, such as International Atomic Energy Agency's Safety Standards, as well as the Safety Assessment Driving Radioactive Waste Management Solutions project reports

  11. Safety assessment of multi-unit NPP sites subject to external events

    International Nuclear Information System (INIS)

    Samaddar, Sujit; Hibino, Kenta; Coman, Ovidiu

    2014-01-01

    This paper presents a framework for conducting a probabilistic safety assessment of multi-unit sites against external events. The treatment of multiple hazard on a unit, interaction between units, implementation of severe accident measures, human reliability, environmental conditions, metric of risk for both reactor and non-reactor sources, integration of risk and responses and many such important factors need to be addressed within the context of this framework. The framework facilitates the establishment of a comprehensive methodology that can be applied internationally to the peer review of safety assessment of multi-unit sites under the impact of multiple external hazards. In summary, it can be said that the site safety assessment for a multi-unit site will be quite complex and need to start with individual unit risk assessments, these need to be combined considering the interactions between units and their responses, and the fragilities of the installations established considering the combined demands from all interactions. Using newly established risk metric the risk can then be integrated for the overall site. Fig. 2 shows schematically such a proposal. Much work has to done and the IAEA has established a working group that is systematically establishing the structure and process to incorporate the many issues that are a part of a multi-unit site safety assessment. (authors)

  12. Towards harmonised self assessment of research reactor safety status in operating organisations

    International Nuclear Information System (INIS)

    Kirchsteiger, C.; Boeck, H.

    2006-01-01

    The objective of this paper is to describe the development of a methodology and corresponding web-based tool for mapping and cross-comparing the safety approaches in European and other Research Reactor (RR) facilities in order to detect the principal similarities and differences. As an example, the performance of a Probabilistic Safety Assessment (PSA) for RRs is mapped, as follows: is PSA performed at all? (Yes/No); if so, is PSA mandatory or just recommended? (Yes/No); what is the scope of PSA?, its objective? and practical use? (set of more detailed questions), etc. In this way, information on different types of safety verification practices and requirements for RRs from Europe, Argentina, Australia, Canada, South Africa and the USA has been collected in a systematic way and included in the web-based benchmarking tool DARES (DAtabase for REsearch Reactor Safety). DARES has been developed and filled with sample data by the European Commission's Joint Research Centre (JRC) together with members of the European Research Reactors Operator Group (RROG). A systematic mapping by using DARES in parallel to an international Working Group, consisting of both operators and authorities could be the starting point towards harmonisation of RR safety verification on an international level. In addition, the availability of a user-friendly Information System on the Internet such as DARES containing this information is considered a useful mechanism to exchange international experiences and practices in the area among qualified users. This approach is currently considered to be proposed to the International Atomic Energy Agency (IAES) as one possible application of the recently adopted IAEA Code of Conduct on the Safety of Research Reactors. The resulting process would be a self-assessment of the RR safety status in regulatory bodies and operating organisations relative to the guidance in the Code, practically realised and monitored by an Information System similar to DARES. (orig.)

  13. Current status and applications of intergrated safety assessment and simulation code system for ISA

    Energy Technology Data Exchange (ETDEWEB)

    Izquierdo, J. M.; Hortal, J.; Perea, M. Sanchez; Melendez, E. [Modeling and Simulation Area (MOSI), Nuclear Safety Council (CSN), Madrid (Spain); Queral, E.; Rivas-Lewicky, J. [Energy and Fuels Department, Technical University of Madrid (UPM), Madrid (Spain)

    2017-03-15

    This paper reviews current status of the unified approach known as integrated safety assessment (ISA), as well as the associated SCAIS (simulation codes system for ISA) computer platform. These constitute a proposal, which is the result of collaborative action among the Nuclear Safety Council (CSN), University of Madrid (UPM), and NFQ Solutions S.L, aiming to allow independent regulatory verification of industry quantitative risk assessments. The content elaborates on discussions of the classical treatment of time in conventional probabilistic safety assessment (PSA) sequences and states important conclusions that can be used to avoid systematic and unacceptable underestimation of the failure exceedance frequencies. The unified ISA method meets this challenge by coupling deterministic and probabilistic mutual influences. The feasibility of the approach is illustrated with some examples of its application to a real size plant.

  14. A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

    Science.gov (United States)

    Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

    2009-08-31

    A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

  15. Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle–Ottawa Scale and the RTI item bank

    Directory of Open Access Journals (Sweden)

    Margulis AV

    2014-10-01

    Full Text Available Andrea V Margulis,1 Manel Pladevall,1 Nuria Riera-Guardia,1 Cristina Varas-Lorenzo,1 Lorna Hazell,2,3 Nancy D Berkman,4 Meera Viswanathan,4 Susana Perez-Gutthann,1 1RTI Health Solutions, Barcelona, Spain; 2Drug Safety Research Unit, Southampton, UK; 3Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK; 4RTI International, Research Triangle Park, NC, USA Background: The study objective was to compare the Newcastle–Ottawa Scale (NOS and the RTI item bank (RTI-IB and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. Methods: We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31, the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1 statistic. Results: The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%; median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86. Conclusion: The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB's developers. Keywords: systematic review, meta-analysis, quality assessment, AC1

  16. Integrated Plant Safety Assessment, Systematic Evaluation Program, Palisades Plant (Docket No. 50-255)

    International Nuclear Information System (INIS)

    1983-11-01

    This report documents the review completed under the SEP for those issues that required refined engineering evaluations or the continuation of ongoing evaluations after the Final IPSAR for the Palisades Plant was issued. The review has provided for (1) an assessment of the significance of differences between current technical positions on selected safety issues and those that existed when the Palisades Plant was licensed, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final IPSAR and the Safety Evaluation Report for converting the license from a provisional to a full-term license have been issued. The Final IPSAR and its supplement will form part of the bases for considering the conversion of the provisional operating license to a full-term operating license

  17. Organizational analysis and safety for utilities with nuclear power plants: perspectives for organizational assessment. Volume 2. [PWR; BWR

    Energy Technology Data Exchange (ETDEWEB)

    Osborn, R.N.; Olson, J.; Sommers, P.E.; McLaughlin, S.D.; Jackson, M.S.; Nadel, M.V.; Scott, W.G.; Connor, P.E.; Kerwin, N.; Kennedy, J.K. Jr.

    1983-08-01

    This two-volume report presents the results of initial research on the feasibility of applying organizational factors in nuclear power plant (NPP) safety assessment. Volume 1 of this report contains an overview of the literature, a discussion of available safety indicators, and a series of recommendations for more systematically incorporating organizational analysis into investigations of nuclear power plant safety. The six chapters of this volume discuss the major elements in our general approach to safety in the nuclear industry. The chapters include information on organizational design and safety; organizational governance; utility environment and safety related outcomes; assessments by selected federal agencies; review of data sources in the nuclear power industry; and existing safety indicators.

  18. The role of risk assessment and safety analysis in integrated safety assessments

    International Nuclear Information System (INIS)

    Niall, R.; Hunt, M.; Wierman, T.E.

    1990-01-01

    To ensure that the design and operation of both nuclear and non- nuclear hazardous facilities is acceptable, and meets all societal safety expectations, a rigorous deterministic and probabilistic assessment is necessary. An approach is introduced, founded on the concept of an ''Integrated Safety Assessment.'' It merges the commonly performed safety and risk analyses and uses them in concert to provide decision makers with the necessary depth of understanding to achieve ''adequacy.'' 3 refs., 1 fig

  19. Safety assessment plans for authorization and inspection of radiation sources

    International Nuclear Information System (INIS)

    2002-05-01

    The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

  20. Safety assessment plans for authorization and inspection of radiation sources

    International Nuclear Information System (INIS)

    1999-09-01

    The objective of this TECDOC is to enhance the efficacy, quality and efficiency of the whole regulatory process. It provides advice on good practice administrative procedures for the regulatory process for preparation of applications, granting of authorizations, inspection, and enforcement. It also provides information on the development and use of standard safety assessment plans for authorization and inspection. The plans are intended to be used in conjunction with more detailed advice related to specific practices. In this sense, this TECDOC provides advice on a systematic approach to evaluations of protection and safety while other IAEA Safety Guides assist the user to distinguish between the acceptable and the unacceptable. This TECDOC covers administrative advice to facilitate the regulatory process governing authorization and inspection. It also covers the use of standard assessment and inspection plans and provides simplified plans for the more common, well established uses of radiation sources in medicine and industry, i.e. sources for irradiation facilities, industrial radiography, well logging, industrial gauging, unsealed sources in industry, X ray diagnosis, nuclear medicine, teletherapy and brachytherapy

  1. Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

    Science.gov (United States)

    Ancel, Ersin; Shih, Ann T.

    2014-01-01

    NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

  2. Assessment of the safety of foods derived from genetically modified (GM) crops.

    Science.gov (United States)

    König, A; Cockburn, A; Crevel, R W R; Debruyne, E; Grafstroem, R; Hammerling, U; Kimber, I; Knudsen, I; Kuiper, H A; Peijnenburg, A A C M; Penninks, A H; Poulsen, M; Schauzu, M; Wal, J M

    2004-07-01

    This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative. Copryright 2004 Elsevier Ltd.

  3. Safety assessment of pipes with multiple local wall thinning defects under pressure and bending moment

    International Nuclear Information System (INIS)

    Peng Jian; Zhou Changyu; Xue Jilin; Dai Qiao; He Xiaohua

    2011-01-01

    The safety assessment of pipes with local wall thinning defects is highly important in engineering. Most attention has been paid on the safety assessment of pipe with single local wall thinning defect, while the studies about multiple local wall thinning defects are not nearly enough. However, the interaction of multiple local wall thinning defects in some conditions is great, and may have a great impact on the safety assessment. In the present standard API 579/ASME FFS, the safety assessment of pipes with multiple local wall thinning defects is given, while as well as the influence of load condition, the influences of arrangement and relative depth of defects are ignored, which may influence the safety assessment considerably. In this paper, the influence of the interaction between multiple local wall thinning defects on the remaining strength of pipes at different arrangements and depths of defects under different load conditions (pressure, tension-bending moment and compression-bending moment) are studied. A quantified index is defined to describe the interaction between defects quantitatively. For different arrangements and relative depths of defects, based on a limit value 0.05 of the quantified index of the interaction between defects, a relatively systematic safety assessment of pipes with multiple local wall thinning defects under different load conditions has been proposed.

  4. Outage Risk Assessment and Management (ORAM) technology to improve outage safety and economics

    International Nuclear Information System (INIS)

    Kalra, S.P.

    2004-01-01

    The Electric Power Research Institute (EPRI) has undertaken an aggressive program, called ORAM (Outage Risk Assessment and Management), to provide utilities with tools and technology to assist in managing risk during the planning and conduct of outages. The ORAM program consists of the following 6 steps: i) Perform utility surveys and visits on shutdown risk management needs, ii) Perform probabilistic shutdown safety assessments (PSSAs) to identify generic insights that can be incorporated into risk management guidelines and identify selected areas for the development of contingency actions, iii) Develop risk management guidelines (RMG's) that provide a systematic approach to the planning and conduct of outages from a safety perspective. Incorporate insights from the shutdown safety assessments and other operating experience into the RMG's. iv) Develop selected contingency actions including a thermalhydraulic tool kit to address higher risk time periods and activities identified in the shutdown safety assessments, v) Develop computer software that integrates all of the above capability into an easy to use tool for effective shutdown operation management for utilities, vi) Provide assistance in the transfer of this technology and the application of these tools. This paper briefly describes the technical approach and tools developed under EPRI's ORAM program and its applications for improving outage safety and economics. (author)

  5. Assessment of Safety Culture

    International Nuclear Information System (INIS)

    Bilic Zabric, T.; Kavsek, D.

    2006-01-01

    A strong safety culture leads to more effective conduct of work and a sense of accountability among managers and employees, who should be given the opportunity to expand skills by training. The resources expended would thus result in tangible improvements in working practices and skills, which encourage further improvement of safety culture. In promoting an improved safety culture, NEK has emphasized both national and organizational culture with an appropriate balance of behavioural sciences and quality management systems approaches. In recent years there has been particular emphasis put on an increasing awareness of the contribution that human behavioural sciences can make to develop good safety practices. The purpose of an assessment of safety culture is to increase the awareness of the present culture, to serve as a basis for improvement and to keep track of the effects of change or improvement over a longer period of time. There is, however, no single approach that is suitable for all purposes and which can measure, simultaneously, all the intangible aspects of safety culture, i.e. the norms, values, beliefs, attitudes or the behaviours reflecting the culture. Various methods have their strengths and weaknesses. To prevent significant performance problems, self-assessment is used. Self-assessment is the process of identifying opportunities for improvement actively or, in some cases, weaknesses that could cause more serious errors or events. Self-assessments are an important input to the corrective action programme. NEK has developed questionnaires for safety culture self-assessment to obtain information that is representative of the whole organization. Questionnaires ensure a greater degree of anonymity, and create a less stressful situation for the respondent. Answers to questions represent the more apparent and conscious values and attitudes of the respondent. NEK proactively co-operates with WANO, INPO, IAEA in the areas of Safety Culture and Human

  6. Integrated plant safety assessment: systematic evaluation program. Oyster Creek nuclear generating station. GPU Nuclear Corporation and Jersey Central Power and Light Company. Docket No. 50-219

    International Nuclear Information System (INIS)

    1982-09-01

    The Systematic Evaluation Program was initiated in February 1978 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding on how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety. This report documents the review of the Oyster Creek Nuclear Generating Station (located in Ocean County, New Jersey), one of ten plants reviewed under Phase II of this program, and indicates how 137 topics selected for review under Phase I of the program were addressed. Equipment and procedural changes have been identified as a result of the review. It is expected that this report will be one of the bases in considering the issuance of a full-term operating license in place of the existing provisional operating license

  7. A Systematic Analysis of Functional Safety Certification Practices in Industrial Robot Software Development

    Directory of Open Access Journals (Sweden)

    Tong Xie

    2017-01-01

    Full Text Available For decades, industry robotics have delivered on the promise of speed, efficiency and productivity. The last several years have seen a sharp resurgence in the orders of industrial robots in China, and the areas addressed within industrial robotics has extended into safety-critical domains. However, safety standards have not yet been implemented widely in academia and engineering applications, particularly in robot software development. This paper presents a systematic analysis of functional safety certification practices in software development for the safety-critical software of industrial robots, to identify the safety certification practices used for the development of industrial robots in China and how these practices comply with the safety standard requirements. Reviewing from Chinese academic papers, our research shows that safety standards are barely used in software development of industrial robot. The majority of the papers propose various solutions to achieve safety, but only about two thirds of the papers refer to non-standardized approaches that mainly address the systematic level rather than the software development level. In addition, our research shows that with the development of artificial intelligent, an emerging field is still on the quest for standardized and suitable approaches to develop safety-critical software.

  8. Explaining the food safety behaviours of food handlers using theories of behaviour change: a systematic review.

    Science.gov (United States)

    Young, Ian; Thaivalappil, Abhinand; Greig, Judy; Meldrum, Richard; Waddell, Lisa

    2018-06-01

    Theories of behaviour change can explain the factors affecting food handlers' use of food safety practices. A systematic review was conducted on this topic to identify which theories have been applied in this area and to determine which theories are the most consistent predictors of food handlers' behaviours. Standard systematic review procedures were followed: comprehensive search strategy; relevance screening of abstracts; article characterization; data extraction; risk-of-bias assessment; and descriptive analysis. Among 19 relevant studies, the most commonly investigated theories were the Theory of Planned Behaviour (n = 9 studies) and Health Belief Model (n = 5). All investigated theories were useful to explain food handlers' behavioural intentions and behaviours related to food safety across different settings, and could serve as useful frameworks for future research and practice. However, there was wide variability in the predictive ability of the theories and their specific constructs, indicating theories should be adapted to the local context of application.

  9. IAEA safety requirements for safety assessment of fuel cycle facilities and activities

    International Nuclear Information System (INIS)

    Jones, G.

    2013-01-01

    The IAEA's Statute authorises the Agency to establish standards of safety for protection of health and minimisation of danger to life and property. In that respect, the IAEA has established a Safety Fundamentals publication which contains ten safety principles for ensuring the protection of workers, the public and the environment from the harmful effects of ionising radiation. A number of these principles require safety assessments to be carried out as a means of evaluating compliance with safety requirements for all nuclear facilities and activities and to determine the measures that need to be taken to ensure safety. The safety assessments are required to be carried out and documented by the organisation responsible for operating the facility or conducting the activity, are to be independently verified and are to be submitted to the regulatory body as part of the licensing or authorisation process. In addition to the principles of the Safety Fundamentals, the IAEA establishes requirements that must be met to ensure the protection of people and the environment and which are governed by the principles in the Safety Fundamentals. The IAEA's Safety Requirements publication 'Safety Assessment for Facilities and Activities', establishes the safety requirements that need to be fulfilled in conducting and maintaining safety assessments for the lifetime of facilities and activities, with specific attention to defence in depth and the requirement for a graded approach to the application of these safety requirements across the wide range of fuel cycle facilities and activities. Requirements for independent verification of the safety assessment that needs to be carried out by the operating organisation, including the requirement for the safety assessment to be periodically reviewed and updated are also covered. For many fuel cycle facilities and activities, environmental impact assessments and non-radiological risk assessments will be required. The

  10. Experiences in assessing safety culture

    International Nuclear Information System (INIS)

    Spitalnik, J.

    2002-01-01

    Based on several Safety Culture self-assessment applications in nuclear organisations, the paper stresses relevant aspects to be considered when programming an assessment of this type. Reasons for assessing Safety Culture, basic principles to take into account, necessary resources, the importance of proper statistical analyses, the feed-back of results, and the setting up of action plans to enhance Safety Culture are discussed. (author)

  11. Patient participation in patient safety and nursing input - a systematic review.

    Science.gov (United States)

    Vaismoradi, Mojtaba; Jordan, Sue; Kangasniemi, Mari

    2015-03-01

    This systematic review aims to synthesise the existing research on how patients participate in patient safety initiatives. Ambiguities remain about how patients participate in routine measures designed to promote patient safety. Systematic review using integrative methods. Electronic databases were searched using keywords describing patient involvement, nursing input and patient safety initiatives to retrieve empirical research published between 2007 and 2013. Findings were synthesized using the theoretical domains of Vincent's framework for analysing risk and safety in clinical practice: "patient", "healthcare provider", "task", "work environment", "organisation & management". We identified 17 empirical research papers: four qualitative, one mixed-method and 12 quantitative designs. All 17 papers indicated that patients can participate in safety initiatives. Improving patient participation in patient safety necessitates considering the patient as a person, the nurse as healthcare provider, the task of participation and the clinical environment. Patients' knowledge, health conditions, beliefs and experiences influence their decisions to engage in patient safety initiatives. An important component of the management of long-term conditions is to ensure that patients have sufficient knowledge to participate. Healthcare providers may need further professional development in patient education and patient care management to promote patient involvement in patient safety, and ensure that patients understand that they are 'allowed' to inform nurses of adverse events or errors. A healthcare system characterised by patient-centredness and mutual acknowledgement will support patient participation in safety practices. Further research is required to improve international knowledge of patient participation in patient safety in different disciplines, contexts and cultures. Patients have a significant role to play in enhancing their own safety while receiving hospital care. This

  12. Project SAFE. Update of the SFR-1 safety assessment. Phase 1

    International Nuclear Information System (INIS)

    Andersson, Johan; Riggare, P.; Skagius, K.

    1998-10-01

    improvements proposed as a part of the prestudy concerns the development of a systematic description of the SFR process system. Such an exercise may reveal additional improvements or new issues of importance for the safety assessment

  13. Implementation of the safety assessment in the practice of industrial radiography

    International Nuclear Information System (INIS)

    Alfonso Pallarés, C.; Pérez Reyes, Y.

    2015-01-01

    The CNSN as regulatory authority has regulatory control processes based on regulations, permits, inspections and limitation to ensure the supervision and control of the practice of industrial radiography. On the other hand in the light of the new regulations approved and being implemented such as: Resolution 334/2011 CITMA 'Regulation on Notification and authorization of practices and activities associated with the use of ionizing radiation sources' and Resolution 17 / 2012, Security Guide: Security Assessment Practices and Activities associated with the use of ionizing radiation (recommendatory), it is necessary for compliance with regulatory requirements concerning the safety assessment. Since 2009 it has been applied this experience in different medical practices and industry, providing a systematic and consistent basis, to the safety assessment of all facilities and activities, which has helped increase the confidence that has been achieved an adequate level of security. The work was able to identify that there is a group of barriers operating in the risk reduction in various accident sequences and therefore have a relative importance in risk reduction, recommendations in this regard to improve the program management of safety in the practice of industrial radiography. [es

  14. Frequency, Expected Effects, Obstacles, and Facilitators of Disclosure of Patient Safety Incidents: A Systematic Review.

    Science.gov (United States)

    Ock, Minsu; Lim, So Yun; Jo, Min-Woo; Lee, Sang-Il

    2017-03-01

    We performed a systematic review to assess and aggregate the available evidence on the frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents (DPSI). We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for this systematic review and searched PubMed, Scopus, and the Cochrane Library for English articles published between 1990 and 2014. Two authors independently conducted the title screening and abstract review. Ninety-nine articles were selected for full-text reviews. One author extracted the data and another verified them. There was considerable variation in the reported frequency of DPSI among medical professionals. The main expected effects of DPSI were decreased intention of the general public to file medical lawsuits and punish medical professionals, increased credibility of medical professionals, increased intention of patients to revisit and recommend physicians or hospitals, higher ratings of quality of care, and alleviation of feelings of guilt among medical professionals. The obstacles to DPSI were fear of medical lawsuits and punishment, fear of a damaged professional reputation among colleagues and patients, diminished patient trust, the complexity of the situation, and the absence of a patient safety culture. However, the factors facilitating DPSI included the creation of a safe environment for reporting patient safety incidents, as well as guidelines and education for DPSI. The reported frequency of the experience of the general public with DPSI was somewhat lower than the reported frequency of DPSI among medical professionals. Although we identified various expected effects of DPSI, more empirical evidence from real cases is required.

  15. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review

    Science.gov (United States)

    Hall, Louise H.; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O’Connor, Daryl B.

    2016-01-01

    Objective To determine whether there is an association between healthcare professionals’ wellbeing and burnout, with patient safety. Design Systematic research review. Data Sources PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Eligibility Criteria for Selecting Studies Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Results Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Conclusions Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. Implications This review illustrates the need for healthcare organisations to consider improving employees’ mental health as well as creating safer work environments when planning interventions to improve patient safety. Systematic Review Registration PROSPERO registration number: CRD42015023340. PMID:27391946

  16. Assessment of Human Performance and Safety Culture at the Paks Nuclear Power Plant

    International Nuclear Information System (INIS)

    Toth, Janos; Hadnagy, Lajos

    2002-01-01

    Evaluation of human performance and safety culture of the personnel at a Nuclear Power Plant is a very important element of the self assessment process. At the Paks NPP a systematic approach to this problem started in the early 90's. The first comprehensive analysis of the human performance of the personnel was performed by the Hungarian Research Institute for Electric Power (VEIKI). The analysis of human failures is also a part of the investigation and analysis of safety related reported events. This human performance analysis of events is carried out by the Laboratory of Psychology of the plant and a supporting organisation namely the Department of Ergonomics and Psychology of the Budapest University of Technical and Economical Sciences. The analysis of safety culture at the Paks NPP has been in the focus of attention since the implementation of the INSAG-4 document started world-wide. In 1993 an IAEA model project namely 'Strengthening Training for Operational Safety' was initiated with a sub-project called 'Enhancement of Safety Culture'. Within this project the first step was the initial assessment of the safety culture level at the Paks NPP. It was followed by some corrective actions and safety culture improvement programme. In 1999 the second assessment was performed in order to evaluate the progress as a result of the improvement programme. A few indicators reflecting the elements of safety culture were defined and compared. The assessment of the safety culture with a survey among the managers was performed in September 2000 and the results are being evaluated at the moment. The intention of the plant management is to repeat the assessment every 2-3 years and evaluate the trend of the indicator. (authors)

  17. Systematic review and meta-analysis of behavioral interventions to improve child pedestrian safety.

    Science.gov (United States)

    Schwebel, David C; Barton, Benjamin K; Shen, Jiabin; Wells, Hayley L; Bogar, Ashley; Heath, Gretchen; McCullough, David

    2014-09-01

    Pedestrian injuries represent a pediatric public health challenge. This systematic review/meta-analysis evaluated behavioral interventions to teach children pedestrian safety. Multiple strategies derived eligible manuscripts (published before April 1, 2013, randomized design, evaluated behavioral child pedestrian safety interventions). Screening 1,951 abstracts yielded 125 full-text retrievals. 25 were retained for data extraction, and 6 were later omitted due to insufficient data. In all, 19 articles reporting 25 studies were included. Risk of bias and quality of evidence were assessed. Behavioral interventions generally improve children's pedestrian safety, both immediately after training and at follow-up several months later. Quality of the evidence was low to moderate. Available evidence suggested interventions targeting dash-out prevention, crossing at parked cars, and selecting safe routes across intersections were effective. Individualized/small-group training for children was the most effective training strategy based on available evidence. Behaviorally based interventions improve children's pedestrian safety. Efforts should continue to develop creative, cost-efficient, and effective interventions. © The Author 2014. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. OSART Independent Safety Culture Assessment (ISCA) Guidelines

    International Nuclear Information System (INIS)

    2016-01-01

    Safety culture is understood as an important part of nuclear safety performance. This has been demonstrated by the analysis of significant events such as Chernobyl, Davis Besse, Vandellos II, Asco, Paks, Mihamma and Forsmark, among others. In order to enhance safety culture, one essential activity is to perform assessments. IAEA Safety Standard Series No. GS-R-3, The Management System for Facilitites and Activities, states requirements for continuous improvement of safety culture, of which self, peer and independent safety culture assessments constitute an essential part. In line with this requirement, the Independent Safety Culture Assessment (ISCA) module is offered as an add-on module to the IAEA Operational Safety Review Team (OSART) programme. The OSART programme provides advice and assistance to Member States to enhance the safety of nuclear power plants during commissioning and operation. By including the ISCA module in an OSART mission, the receiving organization benefits from the synergy between the technical and the safety culture aspects of the safety review. The joint operational safety and safety culture assessment provides the organization with the opportunity to better understand the interactions between technical, human, organizational and cultural aspects, helping the organization to take a systemic approach to safety through identifying actions that fully address the root causes of any identified issue. Safety culture assessments provide insight into the fundamental drivers that shape organizational patterns of behaviour, safety consciousness and safety performance. The complex nature of safety culture means that the analysis of the results of such assessments is not as straightforward as for other types of assessment. The benefits of the results of nuclear safety culture assessments are maximized only if appropriate tools and guidance for these assessments is used; hence, this comprehensive guideline has been developed. The methodology explained

  19. Integrated plant-safety assessment, Systematic Evaluation Program: Big Rock Point Plant (Docket No. 50-155)

    International Nuclear Information System (INIS)

    1983-09-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

  20. Metrics design for safety assessment

    NARCIS (Netherlands)

    Luo, Yaping; van den Brand, M.G.J.

    2016-01-01

    Context:In the safety domain, safety assessment is used to show that safety-critical systems meet the required safety objectives. This process is also referred to as safety assurance and certification. During this procedure, safety standards are used as development guidelines to keep the risk at an

  1. Classification of antecedents towards safety use of health information technology: A systematic review.

    Science.gov (United States)

    Salahuddin, Lizawati; Ismail, Zuraini

    2015-11-01

    This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future

  2. Stalking: A Multidimensional Framework for Assessment and Safety Planning.

    Science.gov (United States)

    Logan, T K; Walker, Robert

    2015-09-03

    Despite the high prevalence of stalking and the risk of harm it poses to victims, arrest rates, prosecutions, and convictions for stalking continue to be low in the United States. The overall goal of this article is to introduce a multidimensional framework of stalking that adds to the current literature by (1) providing a conceptual framework consistent with legal elements of many stalking statutes to facilitate assessment, communication, documentation, and safety planning for stalking several victims; (2) introducing a more systematic way of assessing course of conduct and the context of fear in stalking situations in order to increase the understanding of cumulative fear for stalking victims; (3) emphasizing the aspects of stalking harm that go beyond violence and that show how harm from stalking accumulates over time including life sabotage; and (4) discussing 12 risk factors derived from the overall multidimensional framework that can be used to describe the big picture of stalking and to facilitate safety planning for victims. Implications for future research are discussed. © The Author(s) 2015.

  3. Correlation between safety climate and contractor safety assessment programs in construction.

    Science.gov (United States)

    Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

    2013-12-01

    Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

  4. Safety assessment principles for nuclear plants

    International Nuclear Information System (INIS)

    1992-01-01

    The present Safety Assessment Principles result from the revision of those which were drawn up following a recommendation arising from the Sizewell-B enquiry. The principles presented here relate only to nuclear safety; there is a section on risks from normal operation and accident conditions and the standards against which those risks are assessed. A major part of the document deals with the principles that cover the design of nuclear plants. The revised Safety assessment principles are aimed primarily at the safety assessment of new nuclear plants but they will also be used in assessing existing plants. (UK)

  5. Development of safety related technology and infrastructure for safety assessment

    International Nuclear Information System (INIS)

    Venkat Raj, V.

    1997-01-01

    Development and optimum utilisation of any technology calls for the building up of the necessary infrastructure and backup facilities. This is particularly true for a developing country like India and more so for an advanced technology like nuclear technology. Right from the inception of its nuclear power programme, the Indian approach has been to develop adequate infrastructure in various areas such as design, construction, manufacture, installation, commissioning and safety assessment of nuclear plants. This paper deals with the development of safety related technology and the relevant infrastructure for safety assessment. A number of computer codes for safety assessment have been developed or adapted in the areas of thermal hydraulics, structural dynamics etc. These codes have undergone extensive validation through data generated in the experimental facilities set up in India as well as participation in international standard problem exercises. Side by side with the development of the tools for safety assessment, the development of safety related technology was also given equal importance. Many of the technologies required for the inspection, ageing assessment and estimation of the residual life of various components and equipment, particularly those having a bearing on safety, were developed. This paper highlights, briefly, the work carried out in some of the areas mentioned above. (author)

  6. Thinking of the safety assessment of HLW disposal

    International Nuclear Information System (INIS)

    Li Honghui; Zhao Shuaiwei; Liu Jianqin; Liu Wei; Wan Lei; Yang Zhongtian; An Hongxiang; Sun Qinghong

    2014-01-01

    The function and the research methods of safety assessment are discussed. Two methods about safety assessment and the requirement of safety assessment are introduced. The key parameters and influence factors in nuclide transport of safety assessment are specialized. The works will be done on safety assessment is discussed which will give some suggests for the development of safety assessment. (authors)

  7. Prevention of MSD within OHSMS/IMS: a systematic review of risk assessment strategies.

    Science.gov (United States)

    Yazdani, Amin; Wells, Richard

    2012-01-01

    The purpose of this systematic review was to identify and summarize the research evidence on prevention of Musculoskeletal Disorders (MSD) within Occupational Health and Safety Management Systems (OHSMS) and Integrated Management Systems (IMS). Databases in business, management, engineering and health and safety were systematically searched and relevant publications were synthesized. The number of papers that could address the research questions was small. However, the review revealed that many of the techniques to address MSD hazards require substantial background knowledge and training. This may limit employees' involvement in the technical aspects of the risk assessment process. Also these techniques did not usually fit into techniques used by companies to address other risk factors within their management systems. This could result in MSD prevention becoming a separate issue that cannot be managed with company-wide tools. In addition, this review also suggested that there is a research gap concerning the MSD prevention within companies' management systems.

  8. ALARP considerations in criticality safety assessments

    International Nuclear Information System (INIS)

    Bowden, Russell L.; Barnes, Andrew; Thorne, Peter R.; Venner, Jack

    2003-01-01

    Demonstrating that the risk to the public and workers is As Low As Reasonably Practicable (ALARP) is a fundamental requirement of safety cases for nuclear facilities in the United Kingdom. This is embodied in the Safety Assessment Principles (SAPs) published by the Regulator, the essence of which is incorporated within the safety assessment processes of the various nuclear site licensees. The concept of ALARP within criticality safety assessments has taken some time to establish in the United Kingdom. In principle, the licensee is obliged to search for a deterministic criticality safety solution, such as safe geometry vessels and passive control features, rather than placing reliance on active measurement devices and plant administrative controls. This paper presents a consideration of some ALARP issues in relation to the development of criticality safety cases. The paper utilises some idealised examples covering a range of issues facing the criticality safety assessor, including new plant design, operational plant and decommissioning activities. These examples are used to outline the elements of the criticality safety cases and present a discussion of ALARP in the context of criticality safety assessments. (author)

  9. Safety culture assessment developed by JANTI

    International Nuclear Information System (INIS)

    Hamada, Jun

    2009-01-01

    Japan's JCO accident in September 1999 provided a real-life example of what can happen when insufficient attention is paid to safety culture. This accident brought to light the importance of safety culture and reinforced the movement to foster a safety culture. Despite this, accidents and inappropriate conduct have continued to occur. Therefore, there is a strong demand to instill a safety culture throughout the nuclear power industry. In this context, Japan's nuclear power regulator, the Nuclear and Industrial Safety Agency (NISA), decided to include in its safety inspections assessments of the safety culture found in power utilities' routine safety operations to get signs of deterioration in the organizational climate. In 2007, NISA constructed guidelines for their inspectors to carry out these assessments. At the same time, utilities have embarked on their own independent safety culture initiatives, such as revising their technical specifications and building effective PDCA cycle to promote safety culture. In concert with these developments, JANTI has also instituted safety culture assessments. (author)

  10. Rad waste disposal safety analysis / Integrated safety assessment of a waste repository

    International Nuclear Information System (INIS)

    Jeong, Jongtae; Choi, Jongwon; Kang, Chulhyung

    2012-04-01

    We developed CYPRUS+and adopted PID and RES method for the development of scenario. Safety performance assessment program was developed using GoldSim for the safety assessment of disposal system for the disposal of spnet fuels and wastes resulting from the pyrpoprocessing. Biosphere model was developed and verified in cooperation with JAEA. The capability to evaluate post-closure performance and safety was added to the previously developed program. And, nuclide migration and release to the biosphere considering site characteristics was evaluated by using deterministic and probabilistic approach. Operational safety assessment for drop, fire, and earthquake was also statistically evaluated considering well-established input parameter distribution. Conservative assessment showed that dose rate is below the limit value of low- and intermediate-level repository. Gas generation mechanism within engineered barrier was defined and its influence on safety was evaluated. We made probabilistic safety assessment by obtaining the probability distribution functions of important input variables and also made a sensitivity analysis. The maximum annual dose rate was shown to be below the safety limit value of 10 mSv/yr. The structure and element of safety case was developed to increase reliability of safety assessment methodology for a deep geological repository. Finally, milestone for safety case development and implementation strategy for each safety case element was also proposed

  11. Frequency, Expected Effects, Obstacles, and Facilitators of Disclosure of Patient Safety Incidents: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Minsu Ock

    2017-03-01

    Full Text Available Objectives We performed a systematic review to assess and aggregate the available evidence on the frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents (DPSI. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA guidelines for this systematic review and searched PubMed, Scopus, and the Cochrane Library for English articles published between 1990 and 2014. Two authors independently conducted the title screening and abstract review. Ninety-nine articles were selected for full-text reviews. One author extracted the data and another verified them. Results There was considerable variation in the reported frequency of DPSI among medical professionals. The main expected effects of DPSI were decreased intention of the general public to file medical lawsuits and punish medical professionals, increased credibility of medical professionals, increased intention of patients to revisit and recommend physicians or hospitals, higher ratings of quality of care, and alleviation of feelings of guilt among medical professionals. The obstacles to DPSI were fear of medical lawsuits and punishment, fear of a damaged professional reputation among colleagues and patients, diminished patient trust, the complexity of the situation, and the absence of a patient safety culture. However, the factors facilitating DPSI included the creation of a safe environment for reporting patient safety incidents, as well as guidelines and education for DPSI. Conclusions The reported frequency of the experience of the general public with DPSI was somewhat lower than the reported frequency of DPSI among medical professionals. Although we identified various expected effects of DPSI, more empirical evidence from real cases is required.

  12. Assessing harmful effects in systematic Reviews

    Directory of Open Access Journals (Sweden)

    Woolacott Nerys F

    2004-07-01

    Full Text Available Abstract Background Balanced decisions about health care interventions require reliable evidence on harms as well as benefits. Most systematic reviews focus on efficacy and randomised trials, for which the methodology is well established. Methods to systematically review harmful effects are less well developed and there are few sources of guidance for researchers. We present our own recent experience of conducting systematic reviews of harmful effects and make suggestions for future practice and further research. Methods We described and compared the methods used in three systematic reviews. Our evaluation focused on the review question, study designs and quality assessment. Results One review question focused on providing information on specific harmful effects to furnish an economic model, the other two addressed much broader questions. All three reviews included randomised and observational data, although each defined the inclusion criteria differently. Standard methods were used to assess study quality. Various practical problems were encountered in applying the study design inclusion criteria and assessing quality, mainly because of poor study design, inadequate reporting and the limitations of existing tools. All three reviews generated a large volume of work that did not yield much useful information for health care decision makers. The key areas for improvement we identified were focusing the review question and developing methods for quality assessment of studies of harmful effects. Conclusions Systematic reviews of harmful effects are more likely to yield information pertinent to clinical decision-making if they address a focused question. This will enable clear decisions to be made about the type of research to include in the review. The methodology for assessing the quality of harmful effects data in systematic reviews requires further development.

  13. A systematic approach and tool support for GSN-based safety case assessment

    NARCIS (Netherlands)

    Luo, Y.; Brand, M. van den; Li, Z.; Saberi, A.K.

    2017-01-01

    Context. In safety-critical domains, safety cases are widely used to demonstrate the safety of systems. A safety case is an argumentation for showing confidence in the claimed safety assurance of a system, which should be comprehensible and well-structured. Typically, safety cases can be represented

  14. Safety of Patient Mobilization and Rehabilitation in the Intensive Care Unit. Systematic Review with Meta-Analysis.

    Science.gov (United States)

    Nydahl, Peter; Sricharoenchai, Thiti; Chandra, Saurabh; Kundt, Firuzan Sari; Huang, Minxuan; Fischill, Magdalena; Needham, Dale M

    2017-05-01

    Early mobilization and rehabilitation of patients in intensive care units (ICUs) may improve physical function, and reduce the duration of delirium, mechanical ventilation, and ICU length of stay. However, safety concerns are an important barrier to widespread implementation. To synthesize safety data regarding patient mobilization and rehabilitation in the ICU, including falls, removal of endotracheal tubes, removal or dysfunction of intravascular catheters, removal of other catheters/tubes, cardiac arrest, hemodynamic changes, and desaturation. Systematic literature review, including searches of five databases. Eligible studies evaluated patients who received mobilization-related interventions in the ICU. Exclusion criteria included: (1) case series with fewer than 10 patients; (2) majority of patients under 18 years of age; and (3) data not reported to permit calculation of incidence of safety events. Number of patients, mobilization/rehabilitation sessions, potential safety events, and events with negative consequences (e.g., requiring intervention or additional therapy). Heterogeneity was assessed by I 2 statistics, and bias assessed by the Newcastle-Ottawa Scale and Cochrane risk of bias assessment. The literature search identified 20,660 titles. There were 48 eligible publications evaluating 7,546 patients, with 583 potential safety events occurring in 22,351 mobilization/rehabilitation sessions. There was a total of 583 (2.6%) potential safety events with heterogeneity in the definitions for these events. For the safety event types that could be meta-analyzed, pooled incidences per 1,000 mobilization/rehabilitation sessions (95% confidence interval), were: hemodynamic changes, 3.8 (1.3-11.4), and desaturation, 1.9 (0.9-4.3). A total of 24 studies of 3,404 patients reported on any consequences of potential safety events (e.g., needing to increase dose of vasopressor due to mobility-related hypotension), with a frequency of 0.6% in 14,398 mobilization

  15. The Safety Case and Safety Assessment for the Disposal of Radioactive Waste

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-09-15

    This Safety Guide provides guidance and recommendations on meeting the safety requirements in respect of the safety case and supporting safety assessment for the disposal of radioactive waste. The safety case and supporting safety assessment provide the basis for demonstration of safety and for licensing of radioactive waste disposal facilities and assist and guide decisions on siting, design and operations. The safety case is also the main basis on which dialogue with interested parties is conducted and on which confidence in the safety of the disposal facility is developed. This Safety Guide is relevant for operating organizations preparing the safety case as well as for the regulatory body responsible for developing the regulations and regulatory guidance that determine the basis and scope of the safety case. Contents: 1. Introduction; 2. Demonstrating the safety of radioactive waste disposal; 3. Safety principles and safety requirements; 4. The safety case for disposal of radioactive waste; 5. Radiological impact assessment for the period after closure; 6. Specific issues; 7. Documentation and use of the safety case; 8. Regulatory review process.

  16. Safety assessment for facilities and activities. General safety requirements. Pt. 4

    International Nuclear Information System (INIS)

    2009-01-01

    The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF 6 ; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

  17. Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

    International Nuclear Information System (INIS)

    2009-01-01

    The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

  18. Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

    International Nuclear Information System (INIS)

    2010-01-01

    The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

  19. Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

    International Nuclear Information System (INIS)

    2009-01-01

    The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation.? read more The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are

  20. Safety Culture Monitoring: How to Assess Safety Culture in Real Time?

    International Nuclear Information System (INIS)

    Zronek, B.; Maryska, J.; Treslova, L.

    2016-01-01

    Do you know what is current level of safety culture in your company? Are you able to follow trend changes? Do you know what your recent issues are? Since safety culture is understood as vital part of nuclear industry daily life, it is crucial to know what the current level is. It is common to perform safety culture survey or ad hoc assessment. This contribution shares Temelin NPP, CEZ approach how to assess safety culture level permanently. Using behavioral related outputs of gap solving system, observation program, dedicated surveys, regulatory assessment, etc., allows creating real time safety culture monitoring without the need to perform any other activities. (author)

  1. A systematic review of human factors and ergonomics (HFE)-based healthcare system redesign for quality of care and patient safety.

    Science.gov (United States)

    Xie, Anping; Carayon, Pascale

    2015-01-01

    Healthcare systems need to be redesigned to provide care that is safe, effective and efficient, and meets the multiple needs of patients. This systematic review examines how human factors and ergonomics (HFE) is applied to redesign healthcare work systems and processes and improve quality and safety of care. We identified 12 projects representing 23 studies and addressing different physical, cognitive and organisational HFE issues in a variety of healthcare systems and care settings. Some evidence exists for the effectiveness of HFE-based healthcare system redesign in improving process and outcome measures of quality and safety of care. We assessed risk of bias in 16 studies reporting the impact of HFE-based healthcare system redesign and found varying quality across studies. Future research should further assess the impact of HFE on quality and safety of care, and clearly define the mechanisms by which HFE-based system redesign can improve quality and safety of care.

  2. Use of reliability engineering tools in safety and risk assessment of nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    Raso, Amanda Laureano; Vasconcelos, Vanderley de; Marques, Raíssa Oliveira; Soares, Wellington Antonio; Mesquita, Amir Zacarias, E-mail: amandaraso@hotmail.com, E-mail: vasconv@cdtn.br, E-mail: raissaomarques@gmail.com, E-mail: soaresw@cdtn.br, E-mail: amir@cdtn.br [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil). Serviço de Tecnologia de Reatores

    2017-07-01

    Safety, reliability and availability are fundamental criteria in design, construction and operation of nuclear facilities, as nuclear power plants. Deterministic and probabilistic risk assessments of such facilities are required by regulatory authorities in order to meet licensing regulations, contributing to assure safety, as well as reduce costs and environmental impacts. Probabilistic Risk Assessment has become an important part of licensing requirements of the nuclear power plants in Brazil and in the world. Risk can be defined as a qualitative and/or quantitative assessment of accident sequence frequencies (or probabilities) and their consequences. Risk management is a systematic application of management policies, procedures and practices to identify, analyze, plan, implement, control, communicate and document risks. Several tools and computer codes must be combined, in order to estimate both probabilities and consequences of accidents. Event Tree Analysis (ETA), Fault Tree Analysis (FTA), Reliability Block Diagrams (RBD), and Markov models are examples of evaluation tools that can support the safety and risk assessment for analyzing process systems, identifying potential accidents, and estimating consequences. Because of complexity of such analyzes, specialized computer codes are required, such as the reliability engineering software develop by Reliasoft® Corporation. BlockSim (FTA, RBD and Markov models), RENO (ETA and consequence assessment), Weibull++ (life data and uncertainty analysis), and Xfmea (qualitative risk assessment) are some codes that can be highlighted. This work describes an integrated approach using these tools and software to carry out reliability, safety, and risk assessment of nuclear facilities, as well as, and application example. (author)

  3. Use of reliability engineering tools in safety and risk assessment of nuclear facilities

    International Nuclear Information System (INIS)

    Raso, Amanda Laureano; Vasconcelos, Vanderley de; Marques, Raíssa Oliveira; Soares, Wellington Antonio; Mesquita, Amir Zacarias

    2017-01-01

    Safety, reliability and availability are fundamental criteria in design, construction and operation of nuclear facilities, as nuclear power plants. Deterministic and probabilistic risk assessments of such facilities are required by regulatory authorities in order to meet licensing regulations, contributing to assure safety, as well as reduce costs and environmental impacts. Probabilistic Risk Assessment has become an important part of licensing requirements of the nuclear power plants in Brazil and in the world. Risk can be defined as a qualitative and/or quantitative assessment of accident sequence frequencies (or probabilities) and their consequences. Risk management is a systematic application of management policies, procedures and practices to identify, analyze, plan, implement, control, communicate and document risks. Several tools and computer codes must be combined, in order to estimate both probabilities and consequences of accidents. Event Tree Analysis (ETA), Fault Tree Analysis (FTA), Reliability Block Diagrams (RBD), and Markov models are examples of evaluation tools that can support the safety and risk assessment for analyzing process systems, identifying potential accidents, and estimating consequences. Because of complexity of such analyzes, specialized computer codes are required, such as the reliability engineering software develop by Reliasoft® Corporation. BlockSim (FTA, RBD and Markov models), RENO (ETA and consequence assessment), Weibull++ (life data and uncertainty analysis), and Xfmea (qualitative risk assessment) are some codes that can be highlighted. This work describes an integrated approach using these tools and software to carry out reliability, safety, and risk assessment of nuclear facilities, as well as, and application example. (author)

  4. Intermediate probabilistic safety assessment approach for safety critical digital systems

    International Nuclear Information System (INIS)

    Taeyong, Sung; Hyun Gook, Kang

    2001-01-01

    Even though the conventional probabilistic safety assessment methods are immature for applying to microprocessor-based digital systems, practical needs force to apply it. In the Korea, UCN 5 and 6 units are being constructed and Korean Next Generation Reactor is being designed using the digital instrumentation and control equipment for the safety related functions. Korean regulatory body requires probabilistic safety assessment. This paper analyzes the difficulties on the assessment of digital systems and suggests an intermediate framework for evaluating their safety using fault tree models. The framework deals with several important characteristics of digital systems including software modules and fault-tolerant features. We expect that the analysis result will provide valuable design feedback. (authors)

  5. Safety assessments for potential exposures

    International Nuclear Information System (INIS)

    Dunn, D.I.

    2012-04-01

    Safety Assessment of potential exposures have been carried out in major practices, namely: industrial radiography, gamma irradiators and electron accelerators used in industry and research, and radiotherapy. This paper focuses on reviewing safety assessment methodologies and using developed software to analyse radiological accidents, also review, and discuss these past accidents.The primary objective of the assessment is to assess the adequacy of planned or existing measures for protection and safety and to identify any additional measures that should be put in place. As such, both routine use of the source and the probability and magnitude of potential exposures arising from accidents or incidents should be considered. Where the assessment indicates that there is a realistic possibility of an accident affecting workers or members of the public or having consequences for the environment, the registrant or licensee should prepare a suitable emergency plan. A safety assessment for normal operation addresses all the conditions under which the radiation source operates as expected, including all phases of the lifetime of the source. Due account needs to be taken of the different factors and conditions that will apply during non-operational phases, such as installation, commissioning and maintenance. (author)

  6. Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

    International Nuclear Information System (INIS)

    Song, Tae Young

    2007-01-01

    At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas

  7. Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

    Energy Technology Data Exchange (ETDEWEB)

    Song, Tae Young [Nuclear Engineering and Technology Institute, Daejeon (Korea, Republic of)

    2007-07-01

    At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas.

  8. FOOD safety and hygiene - Systematic layout planning of food processes

    NARCIS (Netherlands)

    Van Donk, DP; Gaalman, G

    2004-01-01

    Hygiene and food safety have been dealt with from different fields of science such as biology and health, and from different angles such as HACCP and GMP. Little systematically ordered knowledge is available for the analysis of a layout, taking hygienic factors into account. HACCP and GMP are

  9. Teamwork Assessment Tools in Obstetric Emergencies: A Systematic Review.

    Science.gov (United States)

    Onwochei, Desire N; Halpern, Stephen; Balki, Mrinalini

    2017-06-01

    Team-based training and simulation can improve patient safety, by improving communication, decision making, and performance of team members. Currently, there is no general consensus on whether or not a specific assessment tool is better adapted to evaluate teamwork in obstetric emergencies. The purpose of this qualitative systematic review was to find the tools available to assess team effectiveness in obstetric emergencies. We searched Embase, Medline, PubMed, Web of Science, PsycINFO, CINAHL, and Google Scholar for prospective studies that evaluated nontechnical skills in multidisciplinary teams involving obstetric emergencies. The search included studies from 1944 until January 11, 2016. Data on reliability and validity measures were collected and used for interpretation. A descriptive analysis was performed on the data. Thirteen studies were included in the final qualitative synthesis. All the studies assessed teams in the context of obstetric simulation scenarios, but only six included anesthetists in the simulations. One study evaluated their teamwork tool using just validity measures, five using just reliability measures, and one used both. The most reliable tools identified were the Clinical Teamwork Scale, the Global Assessment of Obstetric Team Performance, and the Global Rating Scale of performance. However, they were still lacking in terms of quality and validity. More work needs to be conducted to establish the validity of teamwork tools for nontechnical skills, and the development of an ideal tool is warranted. Further studies are required to assess how outcomes, such as performance and patient safety, are influenced when using these tools.

  10. Safety assessment for spent fuel storage facilities

    International Nuclear Information System (INIS)

    1994-01-01

    This Safety Practice has been prepared as part of the IAEA's programme on the safety assessment of interim spent fuel storage facilities which are not an integral part of an operating nuclear power plant. This report provides general guidance on the safety assessment process, discussing both deterministic and probabilistic assessment methods. It describes the safety assessment process for normal operation and anticipated operational occurrences and also related to accident conditions. 10 refs, 2 tabs

  11. Efficacy and Safety of Chinese Medicinal Herbs for the Treatment of Hyperuricemia: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Jianping Lin

    2016-01-01

    Full Text Available Background. Chinese medicinal herbs may be useful for the treatment of hyperuricemia, but there has been no systematic assessment of their efficacy and safety. Objectives. To systematically assess the efficacy and safety of Chinese medicinal herbs for the treatment of hyperuricemia. Methods. Six electronic databases were searched from their inception to December 2015. Randomized controlled clinical trials (RCTs were included. Cochrane criteria were applied to assess the risk of bias. Data analysis was performed using RevMan software version 5.2. Results. Eleven RCTs with 838 patients were included. There was no significant difference in serum uric acid between Chinese medicinal herbs and traditional Western medicine (SME: 0.19, 95% CI: −0.04 to 0.43; p=0.10. In terms of overall efficacy, the Chinese medicinal herbs were significantly superior to Western medicine (RR: 1.11; 95% CI: 1.04 to 1.17; p=0.0007. The Chinese medicinal herbs were better than Western medicine in reducing the adverse reactions (RR: 0.30; 95% CI: 0.15 to 0.62; p=0.001. And all these funnel plots showed unlikelihood of publishing bias. Conclusions. The results indicate that Chinese medicinal herbs may have greater overall efficacy with fewer adverse drug reactions, although the evidence is weak owing to the low methodological quality and the small number of the included trials.

  12. Safety assessment methodologies for near surface disposal facilities. Results of a co-ordinated research project (ISAM). Volume 1: Review and enhancement of safety assessment approaches and tools. Volume 2: Test cases

    International Nuclear Information System (INIS)

    2004-07-01

    For several decades, countries have made use of near surface facilities for the disposal of low and intermediate level radioactive waste. In line with the internationally agreed principles of radioactive waste management, the safety of these facilities needs to be ensured during all stages of their lifetimes, including the post-closure period. By the mid 1990s, formal methodologies for evaluating the long term safety of such facilities had been developed, but intercomparison of these methodologies had revealed a number of discrepancies between them. Consequently, in 1997, the International Atomic Energy Agency launched a Co-ordinated Research Project (CRP) on Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities (ISAM). The particular objectives of the CRP were to provide a critical evaluation of the approaches and tools used in post-closure safety assessment for proposed and existing near-surface radioactive waste disposal facilities, enhance the approaches and tools used and build confidence in the approaches and tools used. The CRP ran until 2000 and resulted in the development of a harmonized assessment methodology (the ISAM project methodology), which was applied to a number of test cases. Over seventy participants from twenty-two Member States played an active role in the project and it attracted interest from around seven hundred persons involved with safety assessment in seventy-two Member States. The results of the CRP have contributed to the Action Plan on the Safety of Radioactive Waste Management which was approved by the Board of Governors and endorsed by the General Conference in September 2001. Specifically, they contribute to Action 5, which requests the IAEA Secretariat to 'develop a structured and systematic programme to ensure adequate application of the Agency's waste safety standards', by elaborating on the Safety Requirements on 'Near Surface Disposal of Radioactive Waste' (Safety Standards Series No. WS-R-1) and

  13. Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

    Science.gov (United States)

    Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

    2018-01-31

    Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved

  14. Systematic approach to training for competence building in radiation safety

    International Nuclear Information System (INIS)

    Asiamah, S.D.; Schandorf, C.; Darko, E.O.

    2003-01-01

    Competence building involves four main attributes, namely, knowledge, skills, operating experience and attitude to radiation safety. These multi-attribute requirements demand a systematic approach to education and training of regulatory staff, licensees/registrants and service providers to ensure commensurate competence in performance of responsibilities and duties to specified standards. In order to address issues of competencies required in radiation safety a national programme for qualification and certification has been initiated for regulatory staff, operators, radiation safety officers and qualified experts. Since the inception of this programme in 1993, 40 training events have been organized involving 423 individuals. This programme is at various levels of implementation due to financial and human resource constraints. A department for Human Resource Development and Research was established in 2000 to enhance and ensure the sustainability of the effectiveness of capacity building in radiation safety. (author)

  15. Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning.

    Science.gov (United States)

    Lin, Yeong-Liang; Wu, Ya-Chi; Gau, Churn-Shiouh; Lin, Min-Shung

    2012-02-01

    The objective of this study was to systematically evaluate whether preapproval safety data for nonhepatotoxic drugs and hepatotoxic drugs can be compared to improve preapproval prediction of postapproval hepatic safety and to assess the legitimacy of applying class warnings. Drugs within a therapeutic class that included at least one drug that had been withdrawn from the market because of liver toxicity or had a warning of potential liver toxicity issued by major regulatory agencies, and at least one drug free from such regulatory action, were identified and divided into two groups: drugs with and drugs without regulatory action. Preapproval clinical data [including the elevation rates of alanine aminotransferse (ALT) and withdrawal due to liver toxicity, the number of patients with combined elevation of ALT and bilirubin, and liver failure] and nonclinical data (including chemical structures, metabolic pathways, and other significant findings in animal studies) were compared between the two groups. Six drug classes were assessed in this study: thiazolidinediones, cyclooxygenase-2 inhibitors, fluoroquinolones, catechol-O-methyltransferase (COMT) inhibitors, leukotriene receptor inhibitors, and endothelin receptor antagonists. In two classes (COMT inhibitors and endothelin receptor antagonists), drugs with regulatory action had significantly higher rates of ALT elevation of more than threefold and greater numbers of patients with combined elevation of ALT and bilirubin than drugs without regulatory action. Drugs with regulatory action also had chemical structures or metabolic pathways associated with the toxicity. The legitimacy of class warnings was refuted in all six classes of drugs. Preapproval safety data may help predict postapproval hepatic safety and can be used to assess the legitimacy of applying class warnings.

  16. Consideration of aging in probabilistic safety assessment

    International Nuclear Information System (INIS)

    Titina, B.; Cepin, M.

    2007-01-01

    Probabilistic safety assessment is a standardised tool for assessment of safety of nuclear power plants. It is a complement to the safety analyses. Standard probabilistic models of safety equipment assume component failure rate as a constant. Ageing of systems, structures and components can theoretically be included in new age-dependent probabilistic safety assessment, which generally causes the failure rate to be a function of age. New age-dependent probabilistic safety assessment models, which offer explicit calculation of the ageing effects, are developed. Several groups of components are considered which require their unique models: e.g. operating components e.g. stand-by components. The developed models on the component level are inserted into the models of the probabilistic safety assessment in order that the ageing effects are evaluated for complete systems. The preliminary results show that the lack of necessary data for consideration of ageing causes highly uncertain models and consequently the results. (author)

  17. Effectiveness and safety of amphetamine for ADHD in population between 6 and 19 years: a systematic review

    Directory of Open Access Journals (Sweden)

    José Calleja

    2012-09-01

    Full Text Available Introduction: Attention deficit hyperactivity disorder (ADHD drug treatment is based on psychostimulants, and methylphenidate is still the most widely used one. Other psychostimulants used include amphetamines, hence the importance of knowing both its effectiveness and safety. Purpose: To identify, synthesize and evaluate the best available evidence on the effectiveness and safety of amphetamine in ADHD in the 6-19 year-old population. Methods: A systematic review of studies that evaluated the effectiveness of interventions comparing amphetamine to methylphenidate was conducted. The outcomes measured were educational performance, psychosocial functioning, quality of life and adverse effects. The following databases were searched up to February 2012 in English and Spanish: PubMed/MEDLINE, LILACS, Cochrane, DARE and National Guideline Clearinghouse. The articles that met inclusion criteria were assessed by two researchers independently. Results: Of the 114 studies found initially, four were included, among which a systematic review, a primary article and two clinical guidelines. Conclusions: The evidence on amphetamine for ADHD treatment recommends its use as an alternative to MPH. Further good-quality studies are needed.

  18. A Methodology for Safety Culture Impact Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

    2014-05-15

    The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively.

  19. A Methodology for Safety Culture Impact Assessment

    International Nuclear Information System (INIS)

    Han, Kiyoon; Jae, Moosung

    2014-01-01

    The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively

  20. NUSS safety standards: A critical assessment

    International Nuclear Information System (INIS)

    Minogue, R.B.

    1985-01-01

    The NUSS safety standards are based on systematic review of safety criteria of many countries in a process carefully defined to assure completeness of coverage. They represent an international consensus of accepted safety principles and practices for regulation and for the design, construction, and operation of nuclear power plants. They are a codification of principles and practices already in use by some Member States. Thus, they are not standards which describe methodologies at their present state of evolution as a result of more recent experience and improvements in technological understanding. The NUSS standards assume an underlying body of national standards and a defined technological base. Detailed design and industrial practices vary between countries and the implementation of basic safety standards within countries has taken approaches that conform with national industrial practices. Thus, application of the NUSS standards requires reconciliation with the standards of the country where the reactor will be built as well as with the country from which procurement takes place. Experience in making that reconciliation will undoubtedly suggest areas of needed improvement. After the TMI accident a reassessment of the NUSS programme was made and it was concluded that, given the information at that time and the then level of technology, the basic approach was sound; the NUSS programme should be continued to completion, and the standards should be brought into use. It was also recognized, however, that in areas such as probabilistic risk assessment, human factors methodology, and consideration of detailed accident sequences, more advanced technology was emerging. As these technologies develop, and become more amenable to practical application, it is anticipated that the NUSS standards will need revision. Ideally those future revisions will also flow from experience in their use

  1. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  2. Patient Safety Learning Systems: A Systematic Review and Qualitative Synthesis.

    Science.gov (United States)

    2017-01-01

    A patient safety learning system (sometimes called a critical incident reporting system) refers to structured reporting, collation, and analysis of critical incidents. To inform a provincial working group's recommendations for an Ontario Patient Safety Event Learning System, a systematic review was undertaken to determine design features that would optimize its adoption into the health care system and would inform implementation strategies. The objective of this review was to address two research questions: (a) what are the barriers to and facilitators of successful adoption of a patient safety learning system reported by health professionals and (b) what design components maximize successful adoption and implementation? To answer the first question, we used a published systematic review. To answer the second question, we used scoping study methodology. Common barriers reported in the literature by health care professionals included fear of blame, legal penalties, the perception that incident reporting does not improve patient safety, lack of organizational support, inadequate feedback, lack of knowledge about incident reporting systems, and lack of understanding about what constitutes an error. Common facilitators included a non-accusatory environment, the perception that incident reporting improves safety, clarification of the route of reporting and of how the system uses reports, enhanced feedback, role models (such as managers) using and promoting reporting, legislated protection of those who report, ability to report anonymously, education and training opportunities, and clear guidelines on what to report. Components of a patient safety learning system that increased successful adoption and implementation were emphasis on a blame-free culture that encourages reporting and learning, clear guidelines on how and what to report, making sure the system is user-friendly, organizational development support for data analysis to generate meaningful learning outcomes

  3. Safety Auditing and Assessments

    Science.gov (United States)

    Goodin, James Ronald (Ronnie)

    2005-01-01

    Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

  4. Confidence building in safety assessments

    International Nuclear Information System (INIS)

    Grundfelt, Bertil

    1999-01-01

    Future generations should be adequately protected from damage caused by the present disposal of radioactive waste. This presentation discusses the core of safety and performance assessment: The demonstration and building of confidence that the disposal system meets the safety requirements stipulated by society. The major difficulty is to deal with risks in the very long time perspective of the thousands of years during which the waste is hazardous. Concern about these problems has stimulated the development of the safety assessment discipline. The presentation concentrates on two of the elements of safety assessment: (1) Uncertainty and sensitivity analysis, and (2) validation and review. Uncertainty is associated both with respect to what is the proper conceptual model and with respect to parameter values for a given model. A special kind of uncertainty derives from the variation of a property in space. Geostatistics is one approach to handling spatial variability. The simplest way of doing a sensitivity analysis is to offset the model parameters one by one and observe how the model output changes. The validity of the models and data used to make predictions is central to the credibility of safety assessments for radioactive waste repositories. There are several definitions of model validation. The presentation discusses it as a process and highlights some aspects of validation methodologies

  5. Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

    Energy Technology Data Exchange (ETDEWEB)

    Chernowski, John

    2009-02-27

    Division Self-Assessment annually. The primary focus of the review is workplace safety. The MESH review is an evaluation of division management of ES&H in its research and operations, focusing on implementation and effectiveness of the division's ISM plan. It is a peer review performed by members of the LBNL Safety Review Committee (SRC), with staff support from OCA. Each division receives a MESH review every two to four years, depending on the results of the previous review. The ES&H Technical Assurance Program (TAP) provides the framework for systematic reviews of ES&H programs and processes. The intent of ES&H Technical Assurance assessments is to provide assurance that ES&H programs and processes comply with their guiding regulations, are effective, and are properly implemented by LBNL divisions. The Appendix B Performance Evaluation and Measurement Plan (PEMP) requires that LBNL sustain and enhance the effectiveness of integrated safety, health, and environmental protection through a strong and well-deployed system. Information required for Appendix B is provided by EH&S Division functional managers. The annual Appendix B report is submitted at the close of the fiscal year. This assessment is the Department of Energy's (DOE) primary mechanism for evaluating LBNL's contract performance in ISM.

  6. [Road safety measures and their effects on traffic injuries: a systematic review].

    Science.gov (United States)

    Aguilera, Sandra Lúcia Vieira Ulinski; Moysés, Simone Tetú; Moysés, Samuel Jorge

    2014-10-01

    To identify and summarize the findings of studies describing interventions aimed at reducing road traffic injuries. An integrative systematic review without meta-analysis was performed. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were used to synthesize the findings of the articles reviewed. The keywords "traffic accidents", "review" and "public policy" were used in isolation or combined with boolean operator "And" to search PubMed, Web of Science, SciELO, and LILACS for the period between 2006 and 2011 RESULTS: Twenty-two studies were included in the systematic review. Of these, two described engineering strategies, two described other road safety policies, three described education strategies, and 15 described law enforcement policies. Law enforcement had the most effective immediate results. Engineering strategies proved important to promote a safe environment. Finally, education strategies had an informative role and served to support other strategies, but did not seem sufficient to promote cultural changes regarding road safety. Law enforcement seems to be the most effective strategy to change the behavior of drivers, especially regarding speed limits and drinking and driving.

  7. Safety inspection guide, Mod III (a systematic approach to conducting a safety inspection)

    International Nuclear Information System (INIS)

    Davidson, J.E.

    1977-06-01

    This guide was developed as a comprehensive/systematic approach to the problem of performing a safety inspection. Five basic sections (categories) are considered in the guide: physical work place; machines/mechanical equipment; hazardous materials/processes/environments; energy sources; and management hazard . control factors. The basic concept is that one starts evaluating hazard potentials from the physical work place and continues considering other elements as they are added to the physical work place. This approach provides a better understanding of the interfaces of each section to the entire group. The guide is supported by an Area Safety Inspection Result form to record defects or conditions found, the evaluation (best estimate) of the urgency or priority for correcting deficiencies or areas of noncompliance, and the status of corrective action. Additionally, the guide serves as an educational tool in accident prevention for supervisors and employees

  8. Determinants of safety outcomes and performance: A systematic literature review of research in four high-risk industries.

    Science.gov (United States)

    Cornelissen, Pieter A; Van Hoof, Joris J; De Jong, Menno D T

    2017-09-01

    In spite of increasing governmental and organizational efforts, organizations still struggle to improve the safety of their employees as evidenced by the yearly 2.3 million work-related deaths worldwide. Occupational safety research is scattered and inaccessible, especially for practitioners. Through systematically reviewing the safety literature, this study aims to provide a comprehensive overview of behavioral and circumstantial factors that endanger or support employee safety. A broad search on occupational safety literature using four online bibliographical databases yielded 27.527 articles. Through a systematic reviewing process 176 online articles were identified that met the inclusion criteria (e.g., original peer-reviewed research; conducted in selected high-risk industries; published between 1980-2016). Variables and the nature of their interrelationships (i.e., positive, negative, or nonsignificant) were extracted, and then grouped and classified through a process of bottom-up coding. The results indicate that safety outcomes and performance prevail as dependent research areas, dependent on variables related to management & colleagues, work(place) characteristics & circumstances, employee demographics, climate & culture, and external factors. Consensus was found for five variables related to safety outcomes and seven variables related to performance, while there is debate about 31 other relationships. Last, 21 variables related to safety outcomes and performance appear understudied. The majority of safety research has focused on addressing negative safety outcomes and performance through variables related to others within the organization, the work(place) itself, employee demographics, and-to a lesser extent-climate & culture and external factors. This systematic literature review provides both scientists and safety practitioners an overview of the (under)studied behavioral and circumstantial factors related to occupational safety behavior. Scientists

  9. Safety Management and Safety Culture Self Assessment of Kartini Research Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Syarip, S., E-mail: syarip@batan.go.id [Centre for Accelerator and Material Process Technology, National Nuclear Energy Agency (BATAN), Yogyakarta (Indonesia)

    2014-10-15

    The self-assessment of safety culture and safety management status of Kartini research reactor is a step to foster safety culture and management by identifying good practices and areas for improvement, and also to improve reactor safety in a whole. The method used in this assessment is based on questionnaires provided by the Forum for Nuclear Cooperation in Asia (FNCA), then reviewed by experts. Based on the assessment and evaluation results, it can be concluded that there were several good practices in maintaining the safety status of Kartini reactor such as: reactor operators and radiation protection workers were aware and knowledgeable of the safety standards and policies that apply to their operation, readily accept constructive criticism from their management and from the inspectors of regulatory body that address safety performance. As a proof, for the last four years the number of inspection/audit findings from Regulatory Body (BAPETEN) tended to decrease while the reactor utilization and its operating hour increased. On the other hands there were also some comments and recommendations for improvement of reactor safety culture, such as that there should be more frequent open dialogues between employees and managers, to grow and attain a mutual support to achieve safety goals. (author)

  10. Determination of Safety Performance Grade of NPP Using Integrated Safety Performance Assessment (ISPA) Program

    International Nuclear Information System (INIS)

    Chung, Dae Wook

    2011-01-01

    Since the beginning of 2000, the safety regulation of nuclear power plant (NPP) has been challenged to be conducted more reasonable, effective and efficient way using risk and performance information. In the United States, USNRC established Reactor Oversight Process (ROP) in 2000 for improving the effectiveness of safety regulation of operating NPPs. The main idea of ROP is to classify the NPPs into 5 categories based on the results of safety performance assessment and to conduct graded regulatory programs according to categorization, which might be interpreted as 'Graded Regulation'. However, the classification of safety performance categories is highly comprehensive and sensitive process so that safety performance assessment program should be prepared in integrated, objective and quantitative manner. Furthermore, the results of assessment should characterize and categorize the actual level of safety performance of specific NPP, integrating all the substantial elements for assessing the safety performance. In consideration of particular regulatory environment in Korea, the integrated safety performance assessment (ISPA) program is being under development for the use in the determination of safety performance grade (SPG) of a NPP. The ISPA program consists of 6 individual assessment programs (4 quantitative and 2 qualitative) which cover the overall safety performance of NPP. Some of the assessment programs which are already implemented are used directly or modified for incorporating risk aspects. The others which are not existing regulatory programs are newly developed. Eventually, all the assessment results from individual assessment programs are produced and integrated to determine the safety performance grade of a specific NPP

  11. Systematic Review Protocol for the IRIS Chloroform Assessment (Inhalation) (Preliminary Assessment Materials)

    Science.gov (United States)

    In January 2018, EPA released the Systematic Review Protocol for the IRIS Chloroform Assessment (Inhalation). As part of developing a draft IRIS assessment, EPA presents a methods document, referred to as the protocol, for conducting a chemical-specific systematic revie...

  12. Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

    International Nuclear Information System (INIS)

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-01-01

    Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design

  13. Effectiveness and safety of alpha agonists for ADHD in population between 6 and 19 years: a systematic review

    Directory of Open Access Journals (Sweden)

    José Calleja

    2012-09-01

    Full Text Available Introduction: Attention deficit hyperactivity disorder (ADHD is generally treated with pharmacological interventions; psychostimulants are first choice. Other alternatives have been used such as alpha agonists (clonidine, hence it is important to know its effectiveness and safety. Purpose: To identify, synthesize and evaluate the best available evidence on the effectiveness and safety of alpha agonists in treating ADHD in the 6-19 year-old population. Methods: A systematic review of intervention studies that evaluated effectiveness comparing alpha agonists to methylphenidate was conducted. Outcomes measured were educational performance, psychosocial functioning, quality of life and adverse effects. The following databases were searched up to February 2012 in English and Spanish: PubMed/MEDLINE, Lilacs, Cochrane, DARE and National Guideline Clearinghouse. The articles that met the inclusion criteria were assessed by two researchers independently. Results: Of the 34 studies found initially, three were included, among which a systematic review and two clinical guidelines. Conclusions: Clonidine is considered an effective second and third line treatment for ADHD symptoms, but it is less effective than stimulants. Its use is associated with many side effects.

  14. Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

    Science.gov (United States)

    Reeves, Fairleigh; Batty, Lachlan; Pitt, Veronica; Chau, Marisa; Pattuwage, Loyal; Gruen, Russell L

    2013-10-01

    Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future

  15. The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

    International Nuclear Information System (INIS)

    1992-01-01

    The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

  16. A Tool for Assessment of Animal Health Laboratory Safety and Biosecurity: The Safety Module of the Food and Agriculture Organization’s Laboratory Mapping Tool

    Directory of Open Access Journals (Sweden)

    Beatrice Mouillé

    2018-03-01

    Full Text Available The Laboratory Management Tool (LMT is a standardized spreadsheet-based assessment tool developed to help support national, regional, and global efforts to maintain an effective network of animal health and veterinary public health laboratories. The safety and biosecurity module of the LMT (LMT-S includes 98 measures covering administrative, operational, engineering, and personal protective equipment practices used to provide laboratory safety and biosecurity. Performance aspects of laboratory infrastructure and technical compliance considered fundamental for ensuring that a laboratory is able to appropriately function in a safe and biosecure manner are systematically queried and scored for compliance on a four-point scale providing for a semi-quantitative assessment. Data collected is used to generate graphs and tables mapping levels of compliance with international standards and good practices, as well as for documenting progress over time. The LMT-S was employed by trained auditors in 34 laboratories located in 19 countries between 2015 and 2017. The tool is intended to help standardize animal health laboratory assessments, document compliance with recognized laboratory safety and biosecurity measures, serve as a self-help and training tool, and assist global laboratory development efforts by providing an accurate measurement of laboratory safety and biosecurity at local, national, and regional levels.

  17. [A systematic review of the effectiveness of workplace safety interventions].

    Science.gov (United States)

    Baldasseroni, A; Olimpi, Nadia; Bonaccorsi, G

    2009-01-01

    The authors carried out a systematic review of the effectiveness of workplace safety interventions, as a part of a wider project funded by CCM, Centre for Disease Control. Several electronic bibliographic databases were checked, using a standardized string selection. The string contained the following four items: the intervention; job features; type of injury; efficacy/effectiveness. Of the various databases consulted, Web of Science was the most efficient. Overall 5531 articles were selected. After reading the title and abstract, 4695 were excluded and eventually 35 systematic reviews were selected, which synthesized 769 original articles. The main topics of the selected systematic reviews were: certain sectors (building industry, agriculture, health care); personal protective equipment; work organization and prevention management at plant level; evaluation of prevention policies by national and regional authorities. A clear need for multiple bibliographical data-base search emerged at the end of this study.

  18. Reactor Safety Assessment System

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  19. Reactor safety assessment system

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSA is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  20. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

    Science.gov (United States)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

    2017-12-01

    Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

  1. AGR core safety assessment methodologies

    International Nuclear Information System (INIS)

    McLachlan, N.; Reed, J.; Metcalfe, M.P.

    1996-01-01

    To demonstrate the safety of its gas-cooled graphite-moderated AGR reactors, nuclear safety assessments of the cores are based upon a methodology which demonstrates no component failures, geometrical stability of the structure and material properties bounded by a database. All AGRs continue to meet these three criteria. However, predictions of future core behaviour indicate that the safety case methodology will eventually need to be modified to deal with new phenomena. A new approach to the safety assessment of the cores is currently under development, which can take account of these factors while at the same time providing the same level of protection for the cores. This approach will be based on the functionality of the core: unhindered movement of control rods, continued adequate cooling of the fuel and the core, continued ability to charge and discharge fuel. (author). 5 figs

  2. A Conceptual Model of Agile Software Development in a Safety-Critical Context: A Systematic Literature Review

    DEFF Research Database (Denmark)

    Tordrup Heeager, Lise; Nielsen, Peter Axel

    2018-01-01

    challenges of agile software development of safety-critical systems. The conceptual model consists of four problematic practice areas and five relationships, which we find to be even more important than the problematic areas. From this review, we suggest that there are important research gaps that need...... processes or agile processes that are purportedly faster and promise to lead to better products. Objective: To identify the issues and disputes in agile development of safety-critical software and the key qualities as found in the extant research literature. Method: We conducted a systematic literature...... review as an interpretive study following a research design to search, assess, extract, group, and understand the results of the found studies. Results: There are key issues and propositions that we elicit from the literature and combine into a conceptual model for understanding the foundational...

  3. Food safety performance indicators to benchmark food safety output of food safety management systems.

    Science.gov (United States)

    Jacxsens, L; Uyttendaele, M; Devlieghere, F; Rovira, J; Gomez, S Oses; Luning, P A

    2010-07-31

    There is a need to measure the food safety performance in the agri-food chain without performing actual microbiological analysis. A food safety performance diagnosis, based on seven indicators and corresponding assessment grids have been developed and validated in nine European food businesses. Validation was conducted on the basis of an extensive microbiological assessment scheme (MAS). The assumption behind the food safety performance diagnosis is that food businesses which evaluate the performance of their food safety management system in a more structured way and according to very strict and specific criteria will have a better insight in their actual microbiological food safety performance, because food safety problems will be more systematically detected. The diagnosis can be a useful tool to have a first indication about the microbiological performance of a food safety management system present in a food business. Moreover, the diagnosis can be used in quantitative studies to get insight in the effect of interventions on sector or governmental level. Copyright 2010 Elsevier B.V. All rights reserved.

  4. Systematic Assessment for University Sexuality Programming.

    Science.gov (United States)

    Westefeld, John S.; Winkelpleck, Judy M.

    1982-01-01

    Suggests systematic empirical assessment is needed to plan university sexuality programing. Proposes the traditional approach of asking about students' attitudes, knowledge, and behavior is useful for developing specific programing content. Presents an assessment model emphasizing assessment of students' desires for sexuality programing in terms…

  5. Review of SKB's interim report of SR-Can: SKI's and SSI's evaluation of SKB's up-dated methodology for safety assessment

    International Nuclear Information System (INIS)

    Dverstorp, Bjoern; Moberg, Leif; Wiebert, Anders; Xu Shulan; Stroemberg, Bo; Kautsky, Fritz; Lilja, Christina; Simic, Eva; Sundstroem, Benny; Toverud, Oeivind

    2005-07-01

    This report presents the findings of a review of the Swedish Nuclear Fuel and Waste Management Co.'s (SKB) interim report of the safety assessment SR-Can (SKB TR 04-11), conducted by the Swedish Radiation Protection Authority (SSI) and the Swedish Nuclear Power Inspectorate (SKI). SKB's interim report describes and exemplifies the safety assessment methodology that SKB plans to use in the oncoming licence applications for an encapsulation plant and a final repository for spent nuclear fuel. The authorities' review takes into account the findings of an international peer review of SKB's interim report. The authorities conclude that SKB has improved its safety assessment methodology in several aspects compared to earlier safety reports. Among other things the authorities commend SKB for giving a comprehensive account of relevant regulations and guidance, and for the systematic approach to identification and documentation of features, events and processes that need to be considered in the safety assessment. However, the authorities also conclude that important parts of SKB's method need to be further developed before they are mature enough to be used as a basis for a license application. The authorities' overall assessment is summarised in chapter 8 of this report

  6. Effects and safety of acupuncture for DFUs: a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Ting Shuai

    2016-01-01

    Full Text Available Objective: To systematically evaluate the effect and safety of acupuncture for the treatment of diabetic foot ulcers (DFUs. Methods: Six databases, including Pubmed, Web of Science, EMbase, the Cochrane Library, the Chinese Biomedical Literature Database (CBM, and the China National Knowledge Infrastructure (CNKI, were electronic searched for randomized controlled trials (RCTs. Retrieval periods from each database were stopped until 30 October, 2014. Cochrane risk of bias assessment tool was used to assess the methodological quality of included studies. Results: A total of 8 trials involving 481 participants met the inclusion criteria. The results of meta and descriptive analysis suggested that acupuncture effectively improved total effective rate of DFUs, shortened ulcer healing time , and improved the blood flow volume, but acupuncture did not ameliorate vessel diameter and peak velocity. No serious adverse events were identified in acupuncture group. Conclusions: Acupuncture is more effective in shortening overall treatment time. Acupuncture has advantages over the control group in curative effect.

  7. The Safety Assessment Education and Training Programme (SAET). Education and Training in the Area of Safety Assessment

    International Nuclear Information System (INIS)

    Mellinger-Deroy, M.

    2014-01-01

    • The SAET Programme provides a systematic approach for training regulatory, operational and technical support staff in the skills needed for informed decision-making and technical review of NPP safety case documentation. • The objective of the Programme is to support the IAEA Member States in developing the knowledge and skills necessary for making the right decisions in NPP design, licensing and operation. (author)

  8. Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

    Science.gov (United States)

    Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

    2017-06-01

    Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

  9. Procedures for self-assessment of operational safety

    International Nuclear Information System (INIS)

    1997-08-01

    Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and and the safety culture as a whole. The concepts developed in this report present the basic approach to self-assessment taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject

  10. Radiation safety assessment of cobalt 60 external beam radiotherapy using the risk-matrix method

    International Nuclear Information System (INIS)

    Dumenigo, C; Vilaragut, J.J.; Ferro, R.; Guillen, A.; Ramirez, M.L.; Ortiz Lopez, P.; Rodriguez, M.; McDonnell, J.D.; Papadopulos, S.; Pereira, P.P.; Goncalvez, M.; Morales, J.; Larrinaga, E.; Lopez Morones, R.; Sanchez, R.; Delgado, J.M.; Sanchez, C.; Somoano, F.

    2008-01-01

    External beam radiotherapy is the only practice in which humans are placed directly in a radiation beam with the intention to deliver a very high dose. This is why safety in radiotherapy is very critical, and is a matter of interest to both radiotherapy departments and regulatory bodies. Accidental exposures have occurred throughout the world, thus showing the need for systematic safety assessments, capable to identify preventive measures and to minimize consequences of accidental exposure. Risk-matrix is a systematic approach which combines the relevant event features to assess the overall risk of each particular event. Once an event sequence is identified, questions such as how frequent the event, how severe the potential consequences and how reliable the existing safety measures are answered in a risk-matrix table. The ultimate goal is to achieve that the overall risk for events with severe consequences should always be low o very low. In the present study, the risk-matrix method has been applied to an hypothetical radiotherapy department, which could be equivalent to an upper level hospital of the Ibero American region, in terms of safety checks and preventive measures. The application of the method has identified 76 event sequences and revealed that the hypothetical radiotherapy department is sufficiently protected (low risk) against them, including 23 event sequences with severe consequences. The method has revealed that the risk of these sequences could grow to high level if certain specific preventive measures were degraded with time. This study has identified these preventive measures, thus facilitating a rational allocation of resources in regular controls to detect any loss of reliability. The method has proven to have an important practical value and is affordable at hospital level. The elaborated risk-matrix can be easily adapted to local circumstances, in terms of existing controls and safety measures. This approach can help hospitals to identify

  11. Uncertainty analysis in safety assessment

    International Nuclear Information System (INIS)

    Lemos, Francisco Luiz de; Sullivan, Terry

    1997-01-01

    Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author)

  12. NUMO's approach for long-term safety assessment - 59404

    International Nuclear Information System (INIS)

    Ebashi, Takeshi; Kaku, Kenichi; Ishiguro, Katsuhiko

    2012-01-01

    One of NUMO's policies for ensuring safety is staged and flexible project implementation and decision-making based on iterative confirmation of safety. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; a key aspect is uncertainty management. This paper presents NUMO's basic strategies for long-term safety assessment based on the above policy. NUMO's approach considering Japanese boundary conditions is demonstrated as a starting-point for evaluating the long-term safety of an actual site. In Japan, the Act on Final Disposal of Specified Radioactive Waste states that the siting process shall consist of three stages. The Nuclear Waste Management Organization of Japan (NUMO) is responsible for geological disposal of vitrified high-level waste and some types of TRU waste. NUMO has chosen to implement a volunteer approach to siting. NUMO decided to prepare the so-called 2010 technical report, which sets out three safety policies, one of which is staged project implementation and decision-making based on iterative confirmation of safety. Based on this policy, NUMO will gradually integrate relevant interdisciplinary knowledge to build a safety case when a formal volunteer application is received that would allow site investigations to be initiated. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; one of a key aspect is uncertainty management. This paper presents the basic strategies for NUMO's long-term safety assessment based on the above policy. In concrete terms, the common procedures involved in safety assessment are applied in a stepwise manner, based on integration of knowledge obtained from site investigations/evaluations and engineered measures. The results of the safety assessment are then reflected in the planning of site investigations and engineered

  13. Probabilistic safety assessment

    International Nuclear Information System (INIS)

    Hoertner, H.; Schuetz, B.

    1982-09-01

    For the purpose of assessing applicability and informativeness on risk-analysis methods in licencing procedures under atomic law, the choice of instruments for probabilistic analysis, the problems in and experience gained in their application, and the discussion of safety goals with respect to such instruments are of paramount significance. Naturally, such a complex field can only be dealt with step by step, making contribution relative to specific problems. The report on hand shows the essentials of a 'stocktaking' of systems relability studies in the licencing procedure under atomic law and of an American report (NUREG-0739) on 'Quantitative Safety Goals'. (orig.) [de

  14. A Systematic Review of Community Health Workers' Role in Occupational Safety and Health Research.

    Science.gov (United States)

    Swanberg, Jennifer E; Nichols, Helen M; Clouser, Jessica M; Check, Pietra; Edwards, Lori; Bush, Ashley M; Padilla, Yancy; Betz, Gail

    2018-03-03

    We systematically reviewed the literature to describe how community health workers (CHWs) are involved in occupational health and safety research and to identify areas for future research and research practice strategies. We searched five electronic databases from July 2015 through July 2016. Inclusion criteria were as follows: (1) study took place in the United States, (2) published as a full peer-review manuscript in English, (3) conducted occupational health and safety research, and (4) CHWs were involved in the research. The majority of 17 included studies took place in the agriculture industry (76%). CHWs were often involved in study implementation/design and research participant contact. Rationale for CHW involvement in research was due to local connections/acceptance, existing knowledge/skills, communication ability, and access to participants. Barriers to CHW involvement in research included competing demands on CHWs, recruitment and training difficulties, problems about research rigor and issues with proper data collection. Involving CHWs in occupational health and safety research has potential for improving inclusion of diverse, vulnerable and geographically isolated populations. Further research is needed to assess the challenges and opportunities of involving CHWs in this research and to develop evidence-based training strategies to teach CHWs to be lay-health researchers.

  15. A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

    Energy Technology Data Exchange (ETDEWEB)

    Park, Sunghyun; Kim, Namyeong; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of)

    2015-10-15

    In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant.

  16. A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

    International Nuclear Information System (INIS)

    Park, Sunghyun; Kim, Namyeong; Jae, Moosung

    2015-01-01

    In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant

  17. Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

    Science.gov (United States)

    Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; De Maeyer, J H; Stanghellini, V

    2012-04-01

    The nonselective 5-HT(4) receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT(4) agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006-2008 and DDW 2008-2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT(4) agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT(4) agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT(1) receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT(4) agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT(4) agonists with no hERG or 5-HT(1) affinity (renzapride, clebopride, mosapride). 5-HT(4) agonists for GI disorders differ in chemical structure and selectivity for 5-HT(4) receptors. Selectivity for 5-HT(4) over non-5-HT(4) receptors may influence the agent's safety and overall risk-benefit profile. Based on available evidence, highly selective 5-HT(4) agonists may offer improved safety to treat patients with impaired GI motility. © 2012 Blackwell Publishing Ltd.

  18. Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

    Science.gov (United States)

    Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

    2012-01-01

    Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

  19. "Assessing the methodological quality of systematic reviews in radiation oncology: A systematic review".

    Science.gov (United States)

    Hasan, Haroon; Muhammed, Taaha; Yu, Jennifer; Taguchi, Kelsi; Samargandi, Osama A; Howard, A Fuchsia; Lo, Andrea C; Olson, Robert; Goddard, Karen

    2017-10-01

    The objective of our study was to evaluate the methodological quality of systematic reviews and meta-analyses in Radiation Oncology. A systematic literature search was conducted for all eligible systematic reviews and meta-analyses in Radiation Oncology from 1966 to 2015. Methodological characteristics were abstracted from all works that satisfied the inclusion criteria and quality was assessed using the critical appraisal tool, AMSTAR. Regression analyses were performed to determine factors associated with a higher score of quality. Following exclusion based on a priori criteria, 410 studies (157 systematic reviews and 253 meta-analyses) satisfied the inclusion criteria. Meta-analyses were found to be of fair to good quality while systematic reviews were found to be of less than fair quality. Factors associated with higher scores of quality in the multivariable analysis were including primary studies consisting of randomized control trials, performing a meta-analysis, and applying a recommended guideline related to establishing a systematic review protocol and/or reporting. Systematic reviews and meta-analyses may introduce a high risk of bias if applied to inform decision-making based on AMSTAR. We recommend that decision-makers in Radiation Oncology scrutinize the methodological quality of systematic reviews and meta-analyses prior to assessing their utility to inform evidence-based medicine and researchers adhere to methodological standards outlined in validated guidelines when embarking on a systematic review. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. The Cosmetic Ingredient Review Program-Expert Safety Assessments of Cosmetic Ingredients in an Open Forum.

    Science.gov (United States)

    Boyer, Ivan J; Bergfeld, Wilma F; Heldreth, Bart; Fiume, Monice M; Gill, Lillian J

    The Cosmetic Ingredient Review (CIR) is a nonprofit program to assess the safety of ingredients in personal care products in an open, unbiased, and expert manner. Cosmetic Ingredient Review was established in 1976 by the Personal Care Products Council (PCPC), with the support of the US Food and Drug Administration (USFDA) and the Consumer Federation of America (CFA). Cosmetic Ingredient Review remains the only scientific program in the world committed to the systematic, independent review of cosmetic ingredient safety in a public forum. Cosmetic Ingredient Review operates in accordance with procedures modeled after the USFDA process for reviewing over-the-counter drugs. Nine voting panel members are distinguished, such as medical professionals, scientists, and professors. Three nonvoting liaisons are designated by the USFDA, CFA, and PCPC to represent government, consumer, and industry, respectively. The annual rate of completing safety assessments accelerated from about 100 to more than 400 ingredients by implementing grouping and read-across strategies and other approaches. As of March 2017, CIR had reviewed 4,740 individual cosmetic ingredients, including 4,611 determined to be safe as used or safe with qualifications, 12 determined to be unsafe, and 117 ingredients for which the information is insufficient to determine safety. Examples of especially challenging safety assessments and issues are presented here, including botanicals. Cosmetic Ingredient Review continues to strengthen its program with the ongoing cooperation of the USFDA, CFA, the cosmetics industry, and everyone else interested in contributing to the process.

  1. Complementary safety assessments - Report by the French Nuclear Safety Authority

    International Nuclear Information System (INIS)

    2011-12-01

    As an immediate consequence of the Fukushima accident, the French Authority of Nuclear Safety (ASN) launched a campaign of on-site inspections and asked operators (mainly EDF, AREVA and CEA) to make complementary assessments of the safety of the nuclear facilities they manage. The approach defined by ASN for the complementary safety assessments (CSA) is to study the behaviour of nuclear facilities in severe accidents situations caused by an off-site natural hazard according to accident scenarios exceeding the current baseline safety requirements. This approach can be broken into 2 phases: first conformity to current design and secondly an approach to the beyond design-basis scenarios built around the principle of defence in depth. 38 inspections were performed on issues linked to the causes of the Fukushima crisis. It appears that some sites have to reinforce the robustness of the heat sink. The CSA confirmed that the processes put into place at EDF to detect non-conformities were satisfactory. The complementary safety assessments demonstrated that the current seismic margins on the EDF nuclear reactors are satisfactory. With regard to flooding, the complementary safety assessments show that the complete reassessment carried out following the flooding of the Le Blayais nuclear power plant in 1999 offers the installations a high level of protection against the risk of flooding. Concerning the loss of electrical power supplies and the loss of cooling systems, the analysis of EDF's CSA reports showed that certain heat sink and electrical power supply loss scenarios can, if nothing is done, lead to core melt in just a few hours in the most unfavourable circumstances. As for nuclear facilities that are not power or experimental reactors, some difficulties have appeared to implement the CSA approach that was initially devised for reactors. Generally speaking, ASN considers that the safety of nuclear facilities must be made more robust to improbable risks which are not

  2. Development and applications of a safety assessment system for promoting safety culture in nuclear power plants

    International Nuclear Information System (INIS)

    Takano, Ken-ichi; Hasegawa, Naoko; Hirose, Ayako; Hayase, Ken-ichi

    2004-01-01

    For past five years, CRIEPI has been continuing efforts to develop and make applications of a 'safety assessment system' which enable to measure the safety level of organization. This report describe about frame of the system, assessment results and its reliability, and relation between labor accident rate in the site and total safety index (TSI), which can be obtained by the principal factors analysis. The safety assessment in this report is based on questionnaire survey of employee. The format and concrete questionnaires were developed using existing literatures including organizational assessment tools. The tailored questionnaire format involved 124 questionnaire items. The assessment results could be considered as a well indicator of the safety level of organization, safety management, and safety awareness of employee. (author)

  3. Safety culture' is integrating 'human' into risk assessment

    International Nuclear Information System (INIS)

    Sugimoto, Taiji

    2014-01-01

    Significance of Fukushima nuclear power accident requested reconsideration of safety standards, of which we had usually no doubt. Risk assessment standard (JIS B 9702), Which was used for repetition of database preparation and cumulative assessment, defined allowable risk and residual risk. However, work site and immediate assessment was indispensable beside such assessment so as to ensure safety. Risk of casualties was absolutely not acceptable in principle and judgments to approve allowable risk needed accountability, which was reminded by safety culture proposed by IAEA and also identified by investigation of organizational cause of Columbia accident. Actor of safety culture would be organization and individual, and mainly individual. Realization of safety culture was conducted by personnel having moral consciousness and firm sense of mission in the course of jobs and working daily with sweat pouring. Safety engineering/technology should have framework integrating human as such totality. (T. Tanaka)

  4. The awareness of employees in safety culture through the improved nuclear safety culture evaluation method

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Ga; Sung, Chan Ho; Jung, Yeon Sub [KHNP Central Research Institute, Daejeon (Korea, Republic of)

    2012-10-15

    After the Chernobyl nuclear accident in 1986, nuclear safety culture terminology was at first introduced emphasizing the importance of employees' attitude and organizational safety. The concept of safety culture was spread by INSAG 4 published in 1991. From that time, IAEA had provided the service of ASCOT for the safety culture assessment. However, many people still are thinking that safety culture is abstract and is not clear. It is why the systematic and reliable assessment methodology was not developed. Assessing safety culture is to identify what is the basic assumption for any organization to accept unconsciously. Therefore, it is very difficult to reach a meaningful conclusion by a superficial investigation alone. KHNP had been doing the safety culture assessment which was based on ASCOT methodology every 2 years. And this result had contributed to improving safety culture. But this result could not represent the level of organization's safety culture due to the limitation of method. So, KHNP has improved the safety culture method by benchmarking the over sea assessment techniques in 2011. The effectiveness of this improved methodology was validated through a pilot assessment. In this paper, the level of employees' safety culture awareness was analyzed by the improved method and reviewed what is necessary for the completeness and objectivity of the nuclear safety culture assessment methodology.

  5. The awareness of employees in safety culture through the improved nuclear safety culture evaluation method

    International Nuclear Information System (INIS)

    Kim, Young Ga; Sung, Chan Ho; Jung, Yeon Sub

    2012-01-01

    After the Chernobyl nuclear accident in 1986, nuclear safety culture terminology was at first introduced emphasizing the importance of employees' attitude and organizational safety. The concept of safety culture was spread by INSAG 4 published in 1991. From that time, IAEA had provided the service of ASCOT for the safety culture assessment. However, many people still are thinking that safety culture is abstract and is not clear. It is why the systematic and reliable assessment methodology was not developed. Assessing safety culture is to identify what is the basic assumption for any organization to accept unconsciously. Therefore, it is very difficult to reach a meaningful conclusion by a superficial investigation alone. KHNP had been doing the safety culture assessment which was based on ASCOT methodology every 2 years. And this result had contributed to improving safety culture. But this result could not represent the level of organization's safety culture due to the limitation of method. So, KHNP has improved the safety culture method by benchmarking the over sea assessment techniques in 2011. The effectiveness of this improved methodology was validated through a pilot assessment. In this paper, the level of employees' safety culture awareness was analyzed by the improved method and reviewed what is necessary for the completeness and objectivity of the nuclear safety culture assessment methodology

  6. Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

    Directory of Open Access Journals (Sweden)

    Matricciani Lisa

    2011-12-01

    Full Text Available Abstract Background Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. Methods The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science was undertaken (6/1/11. The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. Results The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. Conclusions This review indicates that there is good evidence (Level II to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of

  7. Uncertainty analysis in safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Lemos, Francisco Luiz de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN), Belo Horizonte, MG (Brazil); Sullivan, Terry [Brookhaven National Lab., Upton, NY (United States)

    1997-12-31

    Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author) 13 refs.; e-mail: lemos at bnl.gov; sulliva1 at bnl.gov

  8. Efficacy and safety of regenerative cell therapy for pulmonary arterial hypertension in animal models: a preclinical systematic review protocol.

    Science.gov (United States)

    Suen, Colin M; Zhai, Alex; Lalu, Manoj M; Welsh, Christopher; Levac, Brendan M; Fergusson, Dean; McIntyre, Lauralyn; Stewart, Duncan J

    2016-05-25

    Pulmonary arterial hypertension (PAH) is a rare disease (15 cases per million) that is characterized by widespread loss of the pulmonary microcirculation and elevated pulmonary vascular resistance leading to pathological right ventricular remodeling and ultimately right heart failure. Regenerative cell therapies (i.e., therapies involving cells with stem or progenitor-like properties) could potentially restore the effective lung microcirculation and provide a curative therapy for PAH. Preclinical evidence suggests that regenerative cell therapy using endothelial progenitor cells or mesenchymal stem cells may be beneficial in the treatment of PAH. These findings have led to the completion of a small number of human clinical trials, albeit with modest effect compared to animal studies. The objective of this systematic review is to compare the efficacy and safety of regenerative cell therapies in preclinical models of PAH as well as assess study quality to inform future clinical studies. We will include preclinical studies of PAH in which a regenerative cell type was administered and outcomes compared to a disease control. The primary outcome will be pulmonary hemodynamics as assessed by measurement of right ventricular systolic pressure and/or mean pulmonary arterial pressure. Secondary outcomes will include mortality, survival, right ventricular remodeling, pulmonary vascular resistance, cardiac output, cardiac index, pulmonary acceleration time, tricuspid annular systolic excursion, and right ventricular wall thickness. Electronic searches of MEDLINE and EMBASE databases will be constructed and reviewed by the Peer Review of Electronic Search Strategies (PRESS) process. Search results will be screened independently in duplicate. Data from eligible studies will be extracted, pooled, and analyzed using random effects models. Risk of bias will be assessed using the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool, and

  9. Safety assessment of foods derived from genetically modified crops

    NARCIS (Netherlands)

    Kleter, G.A.; Kuiper, H.A.

    2003-01-01

    The pre-market safety assessment of foods derived from genetically modified crops is carried out according to the consensus approach of "substantial equivalence", in other words: the comparative safety assessment. Currently, the safety assessment of genetically modified foods is harmonized at the

  10. National Waste Repository Novi Han operational safety analysis report. Safety assessment methodology

    International Nuclear Information System (INIS)

    2003-01-01

    The scope of the safety assessment (SA), presented includes: waste management functions (acceptance, conditioning, storage, disposal), inventory (current and expected in the future), hazards (radiological and non-radiological) and normal and accidental modes. The stages in the development of the SA are: criteria selection, information collection, safety analysis and safety assessment documentation. After the review the facilities functions and the national and international requirements, the criteria for safety level assessment are set. As a result from the 2nd stage actual parameters of the facility, necessary for safety analysis are obtained.The methodology is selected on the base of the comparability of the results with the results of previous safety assessments and existing standards and requirements. The procedure and requirements for scenarios selection are described. A radiological hazard categorisation of the facilities is presented. Qualitative hazards and operability analysis is applied. The resulting list of events are subjected to procedure for prioritization by method of 'criticality analysis', so the estimation of the risk is given for each event. The events that fall into category of risk on the boundary of acceptability or are unacceptable are subjected to the next steps of the analysis. As a result the lists with scenarios for PSA and possible design scenarios are established. PSA logical modeling and quantitative calculations of accident sequences are presented

  11. Safety of Running Two Rooms: A Systematic Review and Meta-Analysis of Overlapping Neurosurgical Procedures.

    Science.gov (United States)

    Self, D Mitchell; Ilyas, Adeel; Stetler, William R

    2018-04-27

    Overlapping surgery, a long-standing practice within academic neurosurgery centers nationwide, has recently come under scrutiny from the government and media as potentially harmful to patients. Therefore, the objective of this systematic review and meta-analysis is to determine the safety of overlapping neurosurgical procedures. The authors performed a systematic review and meta-analysis in accordance with PRISMA guidelines. A review of PubMed and Medline databases was undertaken with the search phrase "overlapping surgery AND neurosurgery AND outcomes." Data regarding patient demographics, type of neurosurgical procedure, and outcomes and complications were extracted from each study. The principle summary measure was odds ratio (OR) of the association of overlapping versus non-overlapping surgery with outcomes. The literature search yielded a total of 36 studies, of which 5 studies met inclusion criteria and were included in this study. These studies included a total of 25,764 patients undergoing neurosurgical procedures. Overlapping surgery was associated with an increased likelihood of being discharged home (OR = 1.32; 95% CI 1.20 to 1.44; P < 0.001) and a reduced 30-day unexpected return to the operating room (OR = 0.79; 95% CI 0.72 to 0.87; P < 0.001). Overlapping surgery did not significantly affect OR of length of surgery, 30-day mortality, or 30-day readmission. Overlapping neurosurgical procedures were not associated with worse patient outcomes. Additional, prospective studies are needed to further assess the safety overlapping procedures. Copyright © 2018. Published by Elsevier Inc.

  12. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review.

    Science.gov (United States)

    Hall, Louise H; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O'Connor, Daryl B

    2016-01-01

    To determine whether there is an association between healthcare professionals' wellbeing and burnout, with patient safety. Systematic research review. PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. This review illustrates the need for healthcare organisations to consider improving employees' mental health as well as creating safer work environments when planning interventions to improve patient safety. PROSPERO registration number: CRD42015023340.

  13. Research on advanced system safety assessment procedures (II)

    International Nuclear Information System (INIS)

    Suzuki, Kazuhiko; Shimada, Yukiyasu

    1999-03-01

    HAZOP (Hazard and operability study) is a systematic technique, which requires the involvement of an experienced, interdisciplinary team of engineers, to identify hazards or operability problems throughout an entire facility by brainstorming. Though HAZOP is recognized as the useful safety assessment method, it requires a labor-intensive and time-consuming process. So recently computer-aided HAZOP has been proposed. The research report in 1998 (PNC PJ1612 98-001) presented prototype system, which carries out HAZOP and FT synthesis, by making use of proposed method. Relationships between states of input and output variables, internal and external events of each component are represented using decision tables, and the system is implemented by C++. In this study, the causalities of plant component malfunctions are described as component malfunction basic model and are stored in the computer. Thus, we have developed safety evaluation support system by considering the fault propagation path. Component malfunction basic model is made based on the information on the causalities between the abnormal state and each malfunction in components. This component malfunction basic model provides the common frame to describe abnormal situation in components. By using this basic model, not only state malfunction of component but also the consequence to external circumstance is assessed. G2, which is an excellent object-oriented developer tool in GUI (Graphical User Interface), is used as a tool for developing the system. By using the graphical editor in the system, the user can carry out HAZOP easily. We have applied this system to the Nuclear Reprocessing Facilities to demonstrate the utilities of developing system. (author)

  14. Tolerability of risk, safety assessment principles and their implications for probabilistic safety analysis

    International Nuclear Information System (INIS)

    Ewing, D.J.F.; Campbell, J.F.

    1994-01-01

    This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)

  15. A Systematic Approach to Programmatic Assessment

    Science.gov (United States)

    Moffit, Dani M.; Mansell, Jamie L.; Russ, Anne C.

    2016-01-01

    Context: Accrediting bodies and universities increasingly require evidence of student learning within courses and programs. Within athletic training, programmatic assessment has been a source of angst for program directors. While there are many ways to assess educational programs, this article introduces 1 systematic approach. Objective: This…

  16. The radiation safety self-assessment program of Ontario Hydro

    International Nuclear Information System (INIS)

    Armitage, G.; Chase, W.J.

    1987-01-01

    Ontario Hydro has developed a self-assessment program to ensure that high quality in its radiation safety program is maintained. The self-assessment program has three major components: routine ongoing assessment, accident/incident investigation, and detailed assessments of particular radiation safety subsystems or of the total radiation safety program. The operation of each of these components is described

  17. Probabilistic safety assessment for seismic events

    International Nuclear Information System (INIS)

    1993-10-01

    This Technical Document on Probabilistic Safety Assessment for Seismic Events is mainly associated with the Safety Practice on Treatment of External Hazards in PSA and discusses in detail one specific external hazard, i.e. earthquakes

  18. Safety analysis and risk assessment handbook

    International Nuclear Information System (INIS)

    Peterson, V.L.; Colwell, R.G.; Dickey, R.L.

    1997-01-01

    This Safety Analysis and Risk Assessment Handbook (SARAH) provides guidance to the safety analyst at the Rocky Flats Environmental Technology Site (RFETS) in the preparation of safety analyses and risk assessments. Although the older guidance (the Rocky Flats Risk Assessment Guide) continues to be used for updating the Final Safety Analysis Reports developed in the mid-1980s, this new guidance is used with all new authorization basis documents. With the mission change at RFETS came the need to establish new authorization basis documents for its facilities, whose functions had changed. The methodology and databases for performing the evaluations that support the new authorization basis documents had to be standardized, to avoid the use of different approaches and/or databases for similar accidents in different facilities. This handbook presents this new standardized approach. The handbook begins with a discussion of the requirements of the different types of authorization basis documents and how to choose the one appropriate for the facility to be evaluated. It then walks the analyst through the process of identifying all the potential hazards in the facility, classifying them, and choosing the ones that need to be analyzed further. It then discusses the methods for evaluating accident initiation and progression and covers the basic steps in a safety analysis, including consequence and frequency binning and risk ranking. The handbook lays out standardized approaches for determining the source terms of the various accidents (including airborne release fractions, leakpath factors, etc.), the atmospheric dispersion factors appropriate for Rocky Flats, and the methods for radiological and chemical consequence assessments. The radiological assessments use a radiological open-quotes templateclose quotes, a spreadsheet that incorporates the standard values of parameters, whereas the chemical assessments use the standard codes ARCHIE and ALOHA

  19. Living probabilistic safety assessment (LPSA)

    International Nuclear Information System (INIS)

    1999-08-01

    Over the past few years many nuclear power plant organizations have performed probabilistic safety assessments (PSAs) to identify and understand key plant vulnerabilities. As a result of the availability of these PSA studies, there is a desire to use them to enhance plant safety and to operate the nuclear stations in the most efficient manner. PSA is an effective tool for this purpose as it assists plant management to target resources where the largest benefit to plant safety can be obtained. However, any PSA which is to be used in this way must have a credible and defensible basis. Thus, it is very important to have a high quality 'living PSA' accepted by the plant and the regulator. With this background in mind, the IAEA has prepared this report on Living Probabilistic Safety Assessment (LPSA) which addresses the updating, documentation, quality assurance, and management and organizational requirements for LPSA. Deficiencies in the areas addressed in this report would seriously reduce the adequacy of the LPSA as a tool to support decision making at NPPs. This report was reviewed by a working group during a Technical Committee Meeting on PSA Applications to Improve NPP Safety held in Madrid, Spain, from 23 to 27 February 1998

  20. Probabilistic safety assessment in nuclear power plant management

    International Nuclear Information System (INIS)

    Holloway, N.J.

    1989-06-01

    Probabilistic Safety Assessment (PSA) techniques have been widely used over the past few years to assist in understanding how engineered systems respond to abnormal conditions, particularly during a severe accident. The use of PSAs in the design and operation of such systems thus contributes to the safety of nuclear power plants. Probabilistic safety assessments can be maintained to provide a continuous up-to-date assessment (Living PSA), supporting the management of plant operations and modifications

  1. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review.

    Science.gov (United States)

    Marasinghe, Keshini Madara

    2015-05-12

    Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians' judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature, further research on implementation and

  2. The necessity of periodic fire safety review

    International Nuclear Information System (INIS)

    Mowrer, D.S.

    1998-01-01

    Effective fire safety requires the coordinated integration of many diverse elements. Clear fire safety objectives are defined by plant management and/or regulatory authorities. Extensive and time-consuming systematic analyses are performed. Fire safety features (both active and passive) are installed and maintained, and administrative programs are established and implemented to achieve the defined objectives. Personnel are rigorously trained. Given the time, effort and monetary resources expended to achieve a specific level of fire safety, conducting periodic assessments to verify that the specified level of fire safety has been achieved and is maintained is a matter of common sense. Periodic fire safety reviews and assessment play an essential role in assuring continual nuclear safety in the world's power plants

  3. Types of safety assessments of near surface repository for radioactive waste

    International Nuclear Information System (INIS)

    Mateeva, M.

    2004-01-01

    The purpose of this article is to presents the classification of different types safety assessments of near surface repository for low and intermediate level radioactive waste substantiated with results of safety assessments generated in Bulgaria. The different approach of safety assessments applied for old existing repository as well as for site selection for construction new repository is outlined. The regulatory requirements in Bulgaria define three main types of assessments: Safety assessment; Technical substation of repository safety; Assessment of repository influence on environment that is in form of report prepared from the Ministry of environment and waters on the base of results obtained in two first types of assessments. Additionally first type is subdivided in three categories - preliminary safety assessment, safety assessment and post closure safety assessment, which are generated using deterministic approach. The technical substation of repository safety is generated using probabilistic approach. Safety assessment results that are presented here are based on evaluation of existing old repository type 'Radon' in Novi Han and real site selection procedure for new near surface repository for low and intermediate level radioactive waste from nuclear power station in Kozloduy. The important role of safety assessment for improvement the repository safety as well as for repository licensing, correct site selection and right choice of engineer barriers and repository design is discussed using generated results. (author)

  4. Data used for safety assessment of reprocessing facilities

    International Nuclear Information System (INIS)

    Nomura, Yasushi; Suzuki, Atsuyuki; Kanagawa, Akira

    1990-08-01

    For safety assessment of a reprocessing facility, it is important to know performance of radioactive materials in their accidental release and transfer. Accordingly, it is necessary to collect and prepare data for use in analyses for their performance. In JAERI, experiments such as for data acquisition, for source-term evaluation and for radioactive material transfer, are now planned to be performed. Prior to these experiments, it is decided to investigate data in use for accidental safety assessment of reprocessing plants and their based experimental data, thus to make it possible to recommend reasonable values for safety analysis parameters by evaluating the investigated results, to select the experimental items, to edit a safety assessment handbook and so on. In this line of objectives, JAERI rewarded a two-year contract of investigation to Nuclear Safety Research Association, to make a working group under a special committee on data investigation for reprocessing facility safety assessment. This report is a collection of results reviewed and checked by the working group. The contents consist of two parts, one for investigation and review of data used for safety assessment of domestic or oversea reprocessing facilities, and the other for investigation, review and evaluation of ANSI recommended American standard data reported by E. Walker together with their based experimental data resorting to the original referred reports. (author)

  5. Safety functions and safety function indicators - key elements in SKB'S methodology for assessing long-term safety of a KBS-3 repository

    International Nuclear Information System (INIS)

    Hedin, A.

    2008-01-01

    The application of so called safety function indicators in SKB safety assessment of a KBS-3 repository for spent nuclear fuel is presented. Isolation and retardation are the two main safety functions of the KBS-3 concept. In order to quantitatively evaluate safety on a sub-system level, these functions need to be differentiated, associated with quantitative measures and, where possible, with quantitative criteria relating to the fulfillment of the safety functions. A safety function is defined as a role through which a repository component contributes to safety. A safety function indicator is a measurable or calculable property of a repository component that allows quantitative evaluation of a safety function. A safety function indicator criterion is a quantitative limit such that if the criterion is fulfilled, the corresponding safety function is upheld. The safety functions and their associated indicators and criteria developed for the KBS-3 repository are primarily related to the isolating potential and to physical states of the canister and the clay buffer surrounding the canister. They are thus not directly related to release rates of radionuclides. The paper also describes how the concepts introduced i) aid in focussing the assessment on critical, safety related issues, ii) provide a framework for the accounting of safety throughout the different time frames of the assessment and iii) provide key information in the selection of scenarios for the safety assessment. (author)

  6. Safety and reliability assessment

    International Nuclear Information System (INIS)

    1979-01-01

    This report contains the papers delivered at the course on safety and reliability assessment held at the CSIR Conference Centre, Scientia, Pretoria. The following topics were discussed: safety standards; licensing; biological effects of radiation; what is a PWR; safety principles in the design of a nuclear reactor; radio-release analysis; quality assurance; the staffing, organisation and training for a nuclear power plant project; event trees, fault trees and probability; Automatic Protective Systems; sources of failure-rate data; interpretation of failure data; synthesis and reliability; quantification of human error in man-machine systems; dispersion of noxious substances through the atmosphere; criticality aspects of enrichment and recovery plants; and risk and hazard analysis. Extensive examples are given as well as case studies

  7. Safety assessment as basis for the decision making process

    International Nuclear Information System (INIS)

    Ilie, P.; Didita, L.; Danchiv, A.

    2005-01-01

    This paper deals with the safety assessment for a new near surface repository, particularly for the early stage of repository development using ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) safety assessment methodology. In this stage of the repository life cycle the main purpose of the safety assessment is to demonstrate that the plant is capable to be constructed and operated safely. The paper is based on development of the ASAM (Application of the Safety Assessment Methodologies for Near-Surface Disposal Facilities) Decision Support Subgroup of the Common Aspects Working Group. The implications of decision making for the application of the ISAM methodology on post-closure safety assessment are analysed. Some important elements of the decision-making process with impact on key components of the ISAM process are described. Following the development of Decision Support Subgroup of the ASAM Common Aspects Working Group the proposed change of ISAM methodology is analysed. This approach puts all activities in a decision context where the first iteration of the safety assessment is based on the existing state of knowledge and the initial engineering design. Confidence in the process is accomplished through the direct inclusion of all decision makers and stakeholders in the formulation of decisions, the definition of the state of knowledge, and decision making activities. The decision process is developed in context of undertaking assessments with little site-specific information, this situation is specifically for new planned repository. Limited site-specific information can result in a high degree of uncertainty, therefore it is important first of all to identify the sources of uncertainty arising from the limited nature of the site-specific information and then to apply appropriate approaches to manage the uncertainties and to determine whether the uncertainties are important to the overall safety of the disposal facility

  8. Assessment of safety culture at INPP

    International Nuclear Information System (INIS)

    Lesin, S.

    2002-01-01

    Safety Culture covers all main directions of plant activities and the plant departments involved through integration into the INPP Quality Assurance System. Safety Culture is represented by three components. The first is the clear INPP Safety and Quality Assurance Policy. Based on the Policy INPP is safely operated and managers' actions firstly aim at safety assurance. The second component is based on personal responsibility for safety and attitude of each employee of the plant. The third component is based on commitment to safety and competence of managers and employees of the plant. This component links the first two to ensure efficient management of safety at the plant. The above mentioned components including the elements which may significantly affect Safety Culture are also presented in the attachment. The concept of such model implies understanding of effect of different factors on the level of Safety Culture in the organization. In order to continuously correct safety problems, self-assessment of the Safety Culture level is performed at regular intervals. (author)

  9. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Louise H Hall

    Full Text Available To determine whether there is an association between healthcare professionals' wellbeing and burnout, with patient safety.Systematic research review.PsychInfo (1806 to July 2015, Medline (1946 to July 2015, Embase (1947 to July 2015 and Scopus (1823 to July 2015 were searched, along with reference lists of eligible articles.Quantitative, empirical studies that included i either a measure of wellbeing or burnout, and ii patient safety, in healthcare staff populations.Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all subscales of the burnout measures employed, and patient safety.Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed.This review illustrates the need for healthcare organisations to consider improving employees' mental health as well as creating safer work environments when planning interventions to improve patient safety.PROSPERO registration number: CRD42015023340.

  10. Safety assessment for radioactive waste disposal facility

    International Nuclear Information System (INIS)

    Thanaletchumy Karuppiah; Mohd Abdul Wahab Yusof; Nik Marzuki Nik Ibrahim; Nurul Wahida Ahmad Khairuddin

    2008-08-01

    Safety assessments are used to evaluate the performance of a radioactive waste disposal facility and its impact on human health and the environment. This paper presents the overall information and methodology to carry out the safety assessment for a long term performance of a disposal system. A case study was also conducted to gain hands-on experience in the development and justification of scenarios, the formulation and implementation of models and the analysis of results. AMBER code using compartmental modeling approach was used to represent the migration and fate of contaminants in this training. This safety assessment is purely illustrative and it serves as a starting point for each development stage of a disposal facility. This assessment ultimately becomes more detail and specific as the facility evolves. (Author)

  11. Integrating teamwork, clinician occupational well-being and patient safety - development of a conceptual framework based on a systematic review.

    Science.gov (United States)

    Welp, Annalena; Manser, Tanja

    2016-07-19

    There is growing evidence that teamwork in hospitals is related to both patient outcomes and clinician occupational well-being. Furthermore, clinician well-being is associated with patient safety. Despite considerable research activity, few studies include all three concepts, and their interrelations have not yet been investigated systematically. To advance our understanding of these potentially complex interrelations we propose an integrative framework taking into account current evidence and research gaps identified in a systematic review. We conducted a literature search in six major databases (Medline, PsycArticles, PsycInfo, Psyndex, ScienceDirect, and Web of Knowledge). Inclusion criteria were: peer reviewed papers published between January 2000 and June 2015 investigating a statistical relationship between at least two of the three concepts; teamwork, patient safety, and clinician occupational well-being in hospital settings, including practicing nurses and physicians. We assessed methodological quality using a standardized rating system and qualitatively appraised and extracted relevant data, such as instruments, analyses and outcomes. The 98 studies included in this review were highly diverse regarding quality, methodology and outcomes. We found support for the existence of independent associations between teamwork, clinician occupational well-being and patient safety. However, we identified several conceptual and methodological limitations. The main barrier to advancing our understanding of the causal relationships between teamwork, clinician well-being and patient safety is the lack of an integrative, theory-based, and methodologically thorough approach investigating the three concepts simultaneously and longitudinally. Based on psychological theory and our findings, we developed an integrative framework that addresses these limitations and proposes mechanisms by which these concepts might be linked. Knowledge about the mechanisms underlying the

  12. Tools for 'safety netting' in common paediatric illnesses: A systematic review in emergency care

    NARCIS (Netherlands)

    E. De Vos-Kerkhof (Evelien); D.H.F. Geurts (Dorien); M. Wiggers (Mariska); H.A. Moll (Henriëtte); R. Oostenbrink (Rianne)

    2016-01-01

    textabstractContext Follow-up strategies after emergency department (ED) discharge, alias safety netting, is often based on the gut feeling of the attending physician. Objective To systematically identify evaluated safetynetting strategies after ED discharge and to describe determinants of

  13. Pharmacologic treatment in pediatric functional abdominal pain disorders: a systematic review

    NARCIS (Netherlands)

    Korterink, Judith J.; Rutten, Juliette M. T. M.; Venmans, Leonie; Benninga, Marc A.; Tabbers, Merit M.

    2015-01-01

    To systematically review literature assessing efficacy and safety of pharmacologic treatments in children with abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). MEDLINE and Cochrane Database were searched for systematic reviews and randomized controlled trials investigating

  14. Preliminary safety assessment of the WIPP facility

    International Nuclear Information System (INIS)

    Balestri, R.J.; Torres, B.W.; Pahwa, S.B.; Brannen, J.P.

    1979-01-01

    This paper summarizes the efforts to perform a safety assessment of the Waste Isolation Pilot Plant (WIPP) facility being proposed for southeastern New Mexico. This preliminary safety assessment is limited to a consequence assessment in terms of the dose to a maximally exposed individual as a result of introducing the radionuclides into the biosphere. The extremely low doses to the organs as a result of the liquid breach scenarios are contrasted with the background radiation

  15. LNG Safety Assessment Evaluation Methods

    Energy Technology Data Exchange (ETDEWEB)

    Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Angela Christine [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-05-01

    Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods were evaluated for their potential applicability for use in the LNG railroad application. After reviewing the documents included in this report, as well as others not included because of repetition, the Department of Energy (DOE) Hydrogen Safety Plan Checklist is most suitable to be adapted to the LNG railroad application. This report was developed to survey industries related to rail transportation for methodologies and tools that can be used by the FRA to review and evaluate safety assessments submitted by the railroad industry as a part of their implementation plans for liquefied or compressed natural gas storage ( on-board or tender) and engine fueling delivery systems. The main sections of this report provide an overview of various methods found during this survey. In most cases, the reference document is quoted directly. The final section provides discussion and a recommendation for the most appropriate methodology that will allow efficient and consistent evaluations to be made. The DOE Hydrogen Safety Plan Checklist was then revised to adapt it as a methodology for the Federal Railroad Administration’s use in evaluating safety plans submitted by the railroad industry.

  16. Promoting and assessment of safety culture within regulatory body

    International Nuclear Information System (INIS)

    Awasthi, Sumit; Bhattacharya, D.; Koley, J.; Krishnamurthy, P.R.

    2015-01-01

    Regulators have an important role to play in assisting organizations under their jurisdiction to develop positive safety cultures. It is therefore essential for the regulator to have a robust safety culture as an inherent strategy and communication of this strategy to the organizations it supervises. Atomic Energy Regulatory Board (AERB) emphasizes every utility to institute a good safety culture during various stages of a NPP. The regulatory requirement for establishing organisational safety culture within utility at different stages are delineated in the various AERB safety codes which are presented in the paper. Although the review and assessment of the safety culture is a part of AERB’s continual safety supervision through existing review mechanism, AERB do not use any specific indicators for safety culture assessment. However, establishing and nurturing a good safety culture within AERB helps in encouraging the utility to institute the same. At the induction level AERB provides training to its staffs for regulatory orientation which include a specific course on safety culture. Subsequently, the junior staffs are mentored by seniors while involving them in various regulatory processes and putting them as observers during regulatory decision making process. Further, AERB established a formal procedure for assessing and improving safety culture within its staff as a management system process. The paper describes as a case study the above safety culture assessment process established within AERB

  17. Probabilistic safety assessment for research reactors

    International Nuclear Information System (INIS)

    1986-12-01

    Increasing interest in using Probabilistic Safety Assessment (PSA) methods for research reactor safety is being observed in many countries throughout the world. This is mainly because of the great ability of this approach in achieving safe and reliable operation of research reactors. There is also a need to assist developing countries to apply Probabilistic Safety Assessment to existing nuclear facilities which are simpler and therefore less complicated to analyse than a large Nuclear Power Plant. It may be important, therefore, to develop PSA for research reactors. This might also help to better understand the safety characteristics of the reactor and to base any backfitting on a cost-benefit analysis which would ensure that only necessary changes are made. This document touches on all the key aspects of PSA but placed greater emphasis on so-called systems analysis aspects rather than the in-plant or ex-plant consequences

  18. Safety assessment of radioactive wastes storage 'Mironova Gora'

    International Nuclear Information System (INIS)

    Serbryakov, B.; Karamushka, V.; Ostroborodov, V.

    2000-01-01

    A project of transforming the radioactive wastes storage 'Mironova Gora' is under development. A safety assessment of this storage facility was performed to gain assurance on the design decision. The assessment, which was based on the safety assessment methods developed for radioactive wastes repositories, is presented in this paper. (author)

  19. Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

    International Nuclear Information System (INIS)

    Oh, Kyemin; Kang, Myoung-suk; Heo, Gyunyoung; Kim, Hyoung-chan

    2014-01-01

    Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

  20. Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Kyemin; Kang, Myoung-suk [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Heo, Gyunyoung, E-mail: gheo@khu.ac.kr [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Kim, Hyoung-chan [National Fusion Research Institute, Daejeon-si 305-333 (Korea, Republic of)

    2014-10-15

    Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

  1. Evaluating the safety and immunogenicity of yellow fever vaccines: a systematic review

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas Department of Family Medicine, G012 Health Sciences Center, University of Calgary Medical School, Calgary, AB, Canada Purpose: To review the safety and immunogenicity of yellow fever vaccines. Literature search: The Cochrane Library (including the Cochrane CENTRAL Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and the NHS Database of Abstracts of Reviews of Effects; MEDLINE; EMBASE; BIOSIS Previews; Global Health; CAB Abstracts; and the Lilacs Database of Latin American and Caribbean literature were searched for individual studies and systematic reviews through January 1, 2015. Results: Six yellow fever vaccines are currently produced, and they are effective against all seven yellow fever virus strains. There is a 99.2% homology of the genome sequences of the six current vaccines. Four systematic reviews identified very small numbers of serious adverse events. A systematic review (updated of all published cases identified 133 serious adverse events that met the Brighton Collaboration criteria: 32 anaphylactic, 42 neurologic (one death, 57 viscerotropic (25 deaths, and two of both neurologic and viscerotropic SAEs. The Sanofi Pasteur Global Pharmacovigilance database reported 276 million doses of Stamaril™ distributed worldwide and identified 12 reports of yellow fever vaccine-associated viscerotropic disease (YEL-AVD, 24 of yellow fever vaccine-associated neurologic disease (YEL-AND, and 33 reports of anaphylaxis (many already published. The Biomanguinhos manufacturer's database reported 110 million doses distributed worldwide between 1999 and 2009, and the rate of YEL-AND was estimated at 0.084/100,000 doses distributed and YEL-AVD at 0.02/100,000 doses distributed. Conclusion: Reports of serious adverse events are mostly from travelers from developed countries, and there is likely serious underreporting for developing countries. On the basis of the published reports, the yellow fever vaccines are

  2. Self-assessment of operational safety for nuclear power plants

    International Nuclear Information System (INIS)

    1999-12-01

    Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and the safety culture as a whole. Although the primary beneficiaries of the self-assessment process are the plant and operating organization, the results of the self-assessments are also used, for example, to increase the confidence of the regulator in the safe operation of an installation, and could be used to assist in meeting obligations under the Convention on Nuclear Safety. Such considerations influence the form of assessment, as well as the type and detail of the results. The concepts developed in this report present the basic approach to self-assessment, taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject. This report will be used in IAEA sponsored workshops and seminars on operational safety that include the topic of self-assessment

  3. The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review.

    Science.gov (United States)

    Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

    2015-05-20

    To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. A systematic review. Embase, Ovid Medline and PsycINFO databases. Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  4. Analysis of truncation limit in probabilistic safety assessment

    International Nuclear Information System (INIS)

    Cepin, Marko

    2005-01-01

    A truncation limit defines the boundaries of what is considered in the probabilistic safety assessment and what is neglected. The truncation limit that is the focus here is the truncation limit on the size of the minimal cut set contribution at which to cut off. A new method was developed, which defines truncation limit in probabilistic safety assessment. The method specifies truncation limits with more stringency than presenting existing documents dealing with truncation criteria in probabilistic safety assessment do. The results of this paper indicate that the truncation limits for more complex probabilistic safety assessments, which consist of larger number of basic events, should be more severe than presently recommended in existing documents if more accuracy is desired. The truncation limits defined by the new method reduce the relative errors of importance measures and produce more accurate results for probabilistic safety assessment applications. The reduced relative errors of importance measures can prevent situations, where the acceptability of change of equipment under investigation according to RG 1.174 would be shifted from region, where changes can be accepted, to region, where changes cannot be accepted, if the results would be calculated with smaller truncation limit

  5. Systematic Review of Kinship Care Effects on Safety, Permanency, and Well-Being Outcomes

    Science.gov (United States)

    Winokur, Marc A.; Holtan, Amy; Batchelder, Keri E.

    2018-01-01

    Objective: Children in out-of-home placements typically display more educational, behavioral, and psychological problems than do their peers. This systematic review evaluated the effect of kinship care placement compared to foster care placement on the safety, permanency, and well-being of children removed from the home for maltreatment. Methods:…

  6. Development of Safety Assessment Information System (SAIS)

    International Nuclear Information System (INIS)

    Park, Byung Shik; Lee, Kyung Jin; Lee, Byung Chul; Song, Tae Young; Lee, Chang Ho

    2007-01-01

    Many reports and documents about nuclear power plant safety analysis like a Periodic Safe Review (PSR), Periodic Safety Analysis (PSA) and Severe Accident Management Guideline (SAMG) come to be drawn up from KHNP. Since these are not arranged easy to look up, the systematic arrangement of data was necessary. The solution against hereupon is to store database, and it was developed with the name, SAIS, by FNC Tech. Co. together with NETEC KHNP. In this web program it is easy to manage (registration, search and statistics) data. And the authorized user can approach this system. This was developed, and was verified under the development environment of; - Web Server : Apache 2.2.5 - Program Language : PHP 5.2 - DBMS : Oracle 10g

  7. Development of Safety Assessment Information System (SAIS)

    Energy Technology Data Exchange (ETDEWEB)

    Park, Byung Shik; Lee, Kyung Jin; Lee, Byung Chul [FNC Tech. Co. Ltd. SNU, Seoul (Korea, Republic of); Song, Tae Young; Lee, Chang Ho [KHNP, Daejeon (Korea, Republic of)

    2007-10-15

    Many reports and documents about nuclear power plant safety analysis like a Periodic Safe Review (PSR), Periodic Safety Analysis (PSA) and Severe Accident Management Guideline (SAMG) come to be drawn up from KHNP. Since these are not arranged easy to look up, the systematic arrangement of data was necessary. The solution against hereupon is to store database, and it was developed with the name, SAIS, by FNC Tech. Co. together with NETEC KHNP. In this web program it is easy to manage (registration, search and statistics) data. And the authorized user can approach this system. This was developed, and was verified under the development environment of; - Web Server : Apache 2.2.5 - Program Language : PHP 5.2 - DBMS : Oracle 10g.

  8. Risk assessment of safety violations for coal mines

    Energy Technology Data Exchange (ETDEWEB)

    Megan Orsulaka; Vladislav Kecojevicb; Larry Graysona; Antonio Nietoa [Pennsylvania State University, University Park, PA (United States). Dept of Energy and Mineral Engineering

    2010-09-15

    This article presents an application of a risk assessment approach in characterising the risks associated with safety violations in underground bituminous mines in Pennsylvania using the Mine Safety and Health Administration (MSHA) citation database. The MSHA database on citations provides an opportunity to assess risks in mines through scrutiny of violations of mandatory safety standards. In this study, quantitative risk assessment is performed, which allows determination of the frequency of occurrence of safety violations (through associated citations) as well as the consequences of them in terms of penalty assessments. Focus is on establishing risk matrices on citation experiences of mines, which can give early indication of emerging potentially serious problems. The resulting frequency, consequence and risk rankings present valuable tools for prioritising resource allocations, determining control strategies, and could potentially contribute to more proactive prevention of incidents and injuries.

  9. Healthcare professionals’ views of feedback on patient safety culture assessment.

    OpenAIRE

    Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.

    2016-01-01

    Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the feedback of a patient safety culture assessment. Methods: Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a web...

  10. Safety assessment of research reactors and preparation of the safety analysis report

    International Nuclear Information System (INIS)

    1994-01-01

    This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors

  11. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... of these changes in risk factors on accident occurrence cannot be predicted. On the whole, the research that has been reported so far regarding road safety effects of porous asphalt is inconclusive. The studies are not of high quality and the findings are inconsistent.......This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...

  12. Safety Assessment of Polyether Lanolins as Used in Cosmetics.

    Science.gov (United States)

    Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan; Heldreth, Bart

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

  13. Probabilistic safety assessment as a standpoint for decision making

    International Nuclear Information System (INIS)

    Cepin, M.

    2001-01-01

    This paper focuses on the role of probabilistic safety assessment in decision-making. The prerequisites for use of the results of probabilistic safety assessment and the criteria for the decision-making based on probabilistic safety assessment are discussed. The decision-making process is described. It provides a risk evaluation of impact of the issue under investigation. Selected examples are discussed, which highlight the described process. (authors)

  14. Safety factors for neutron fluences in NPP safety assessment

    International Nuclear Information System (INIS)

    Demekhin, V.L.; Bukanov, V.N.; Il'kovich, V.V.; Pugach, A.M.

    2016-01-01

    In accordance with global practice and a number of existing regulations, the use of conservative approach is required for the calculations related to nuclear safety assessment of NPP. It implies the need to consider the determination of neutron fluence errors that is rather complicated. It is proposed to carry out the consideration by the way of multiplying the neutron fluences obtained with transport calculations by safety factors. The safety factor values are calculated by the developed technique based on the theory of errors, features of the neutron transport calculation code and the results obtained with the code. It is shown that the safety factor value is equal 1.18 with the confidence level of not less than 0.95 for the majority of VVER-1000 reactor places where neutron fluences are determined by MCPV code, and its maximum value is 1.25

  15. Efficacy and safety of histamine-2 receptor antagonists

    NARCIS (Netherlands)

    van der Pol, Rachel; Langendam, Miranda; Benninga, Marc; van Wijk, Michiel; Tabbers, Merit

    2014-01-01

    Histamine-2 receptor antagonists (H2RAs) are frequently used in the treatment of gastroesophageal reflux disease (GERD) in children; however, their efficacy and safety is questionable. To systematically review the literature to assess the efficacy and safety of H2RAs in pediatric GERD. PubMed,

  16. Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

    Science.gov (United States)

    Haslberger, Alexander G

    2006-05-03

    Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

  17. Ensuring the quality of occupational safety risk assessment.

    Science.gov (United States)

    Pinto, Abel; Ribeiro, Rita A; Nunes, Isabel L

    2013-03-01

    In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in-depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: "What constitutes a good occupational safety risk assessment?" The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites. © 2012 Society for Risk Analysis.

  18. SAFETY ASSESSMENT AND LIABILITY REGULATIONS IN THE CONTEXT OF GENETICALLY MODIFIED FOOD IN THE BRICS COUNTRIES

    Directory of Open Access Journals (Sweden)

    Sh. K. Balashanmugam

    2018-01-01

    Full Text Available International trade of food products is expected to increase rapidly with the widespread introduction of genetically modified (GM food. There will be greater participation of developing countries based on investment as well as research and development. Investment in research and development and commercial production of GM crops is high in Asia, particularly in India and China, but also in Latin American countries, such as Brazil, and on the African continent, especially in South Africa. Despite the merits, the introduction of GM foods in the world market has continued to raise public concerns touching upon health, legal, social, ethical and environmental issues. Especially, the issue of contamination is considered asignificant threat at many stages of development of GM food. Transboundary aspects and certain aspects of the components of the food safety system such as safety assessment, liability and redress are still not completely addressed. The present study is the systematic review of the extent of the development of legislation and institutional mechanisms in relation to safety assessment and liability mechanisms for regulating the emerging GM foods in the developing countries of BRICS. Additionally, the comparison of the components of national food safety systems of Brazil, Russia, India, China and South Africa reveals differences in policy and regulation in relation to GM food.

  19. Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

    International Nuclear Information System (INIS)

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-01-01

    The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design

  20. Exploiting data from safety investigations and processes to assess performance of safety management aspects

    NARCIS (Netherlands)

    Karanikas, Nektarios

    2016-01-01

    This paper presents an alternative way to use records from safety investigations as a means to support the evaluation of safety management (SM) aspects. Datasets from safety investigation reports and progress records of an aviation organization were analyzed with the scope of assessing safety

  1. NPP Krsko periodic safety review. Safety assessment and analyses

    International Nuclear Information System (INIS)

    Basic, I.; Spiler, J.; Thaulez, F.

    2002-01-01

    Definition of a PSR (Periodic Safety Review) project is a comprehensive safety review of a plant after ten years of operation. The objective is a verification by means of a comprehensive review using current methods that the plant remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. The overall goals of the NEK PSR Program are defined in compliance with the basic role of a PSR and the current practice typical for most of the countries in EU. This practice is described in the related guides and good practice documents issued by international organizations. The overall goals of the NEK PSR are formulated as follows: to demonstrate that the plant is as safe as originally intended; to evaluate the actual plant status with respect to aging and wear-out identifying any structures, systems or components that could limit the life of the plant in the foreseeable future, and to identify appropriate corrective actions, where needed; to compare current level of safety in the light of modern standards and knowledge, and to identify where improvements would be beneficial for minimizing deviations at justifiable costs. The Krsko PSR will address the following safety factors: Operational Experience, Safety Assessment, EQ and Aging Management, Safety Culture, Emergency Planning, Environmental Impact and Radioactive Waste.(author)

  2. Safety assessment of a lithium target

    International Nuclear Information System (INIS)

    Burgazzi, Luciano; Roberta, Ferri; Barbara, Giannone

    2006-01-01

    This paper addresses the safety assessment of the lithium target of the International Fusion Materials Irradiation Facility (IFMIF) through evaluating the most important risk factors related to system operation and verifying the fulfillment of the safety criteria. The hazard assessment is based on using a well-structured Failure Mode and Effect Analysis (FMEA) procedure by detailing on a component-by-component basis all the possible failure modes and identifying their effects on the plant. Additionally, a systems analysis, applying the fault tree technique, is performed in order to evaluate, from a probabilistic standpoint, all the relevant and possible failures of each component required for safe system operation and assessing the unavailability of the lithium target system. The last task includes the thermal-hydraulic transient analysis of the target lithium loop, including operational and accident transients. A lithium target loop model is developed, using the RELAP5/Mod3.2 thermal-hydraulic code, which has been modified to include specific features of IFMIF itself. The main conclusions are that target safety is fulfilled, the hazards associated with lithium operation are confined within the IFMIF security boundaries, the environmental impact is negligible, and the plant responds to the simulated transients by being able to reach steady conditions in a safety situation

  3. Environment, safety and health progress assessment manual

    International Nuclear Information System (INIS)

    1992-12-01

    On June 27, 1989, the Secretary of Energy announced a 1O-Point Initiative to strengthen environment,safety, and health (ES ampersand H) programs, and waste management activities at involved conducting DOE production, research, and testing facilities. One of the points independent Tiger Team Assessments of DOE operating facilities. The Office of Special Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This volume contains appendices to the Environment, Safety and Health Progress Assessment Manual

  4. The role of natural analogues in safety assessment and acceptability

    International Nuclear Information System (INIS)

    Papp, Toenis

    1987-01-01

    The safety assessment must evaluate the level of safety for a repository, the confidence that can be placed on the assessment and how well the repository can meet the acceptance criteria of the society. Many of the processes and phenomena that govern the long term performance of a deep geologic repository for radioactive waste also take place in nature. To investigate these natural analogues and try to validate the models on which the safety assessment are based is a main task in the effort to build of confidence in the safety assessments. The assessment of the safety of a repository can, however, not only be based on good models. The possible role of natural analogues or natural evidence in other parts of the safety assessment is discussed. Specially with regard to - the need to demonstrate that all relevant processes have been taken into account, and that the important ones have been validated to an acceptable level for relevant parameters spans, -the definition and analysis of external scenarios for the safety assessment and for the claim that all reasonable scenarios have been addressed, - the public confidence in the long-term relevance of the acceptance criteria. (author)

  5. Safety assessment of HLW geological disposal system

    International Nuclear Information System (INIS)

    Naito, Morimasa

    2006-01-01

    In accordance with the Japanese nuclear program, the liquid waste with a high level of radioactivity arising from reprocessing is solidified in a stable glass matrix (vitrification) in stainless steel fabrication containers. The vitrified waste is referred to as high-level radioactive waste (HLW), and is characterized by very high initial radioactivity which, even though it decreases with time, presents a potential long-term risk. It is therefore necessary to thoroughly manage HLW from human and his environment. After vitrification, HLW is stored for a period of 30 to 50 years to allow cooling, and finally disposed of in a stable geological environment at depths greater than 300 m below surface. The deep underground environment, in general, is considered to be stable over geological timescales compared with surface environment. By selecting an appropriate disposal site, therefore, it is considered to be feasible to isolate the waste in the repository from man and his environment until such time as radioactivity levels have decayed to insignificance. The concept of geological disposal in Japan is similar to that in other countries, being based on a multibarrier system which combines the natural geological environment with engineered barriers. It should be noted that geological disposal concept is based on a passive safety system that does not require any institutional control for assuring long term environmental safety. To demonstrate feasibility of safe HLW repository concept in Japan, following technical steps are essential. Selection of a geological environment which is sufficiently stable for disposal (site selection). Design and installation of the engineered barrier system in a stable geological environment (engineering measures). Confirmation of the safety of the constructed geological disposal system (safety assessment). For site selection, particular consideration is given to the long-term stability of the geological environment taking into account the fact

  6. Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

    International Nuclear Information System (INIS)

    Armstrong, D.L.

    1994-08-01

    This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment

  7. Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Armstrong, D.L.

    1994-08-01

    This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment.

  8. RSAS: a Reactor Safety Assessment System

    International Nuclear Information System (INIS)

    Sebo, D.E.; Dixon, B.W.; Bray, M.A.

    1985-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (NRC). RSAS is being developed for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system generates situation assessments for the NRC Reactor Safety Team based on a limited number of plant parameters, known operator actions, and plant status data. The RSAS rule base currently covers one reactor type. The extension of the rule base to other reactor types is also discussed

  9. History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms.

    Science.gov (United States)

    Constable, A; Jonas, D; Cockburn, A; Davi, A; Edwards, G; Hepburn, P; Herouet-Guicheney, C; Knowles, M; Moseley, B; Oberdörfer, R; Samuels, F

    2007-12-01

    Very few traditional foods that are consumed have been subjected to systematic toxicological and nutritional assessment, yet because of their long history and customary preparation and use and absence of evidence of harm, they are generally regarded as safe to eat. This 'history of safe use' of traditional foods forms the benchmark for the comparative safety assessment of novel foods, and of foods derived from genetically modified organisms. However, the concept is hard to define, since it relates to an existing body of information which describes the safety profile of a food, rather than a precise checklist of criteria. The term should be regarded as a working concept used to assist the safety assessment of a food product. Important factors in establishing a history of safe use include: the period over which the traditional food has been consumed; the way in which it has been prepared and used and at what intake levels; its composition and the results of animal studies and observations from human exposure. This paper is aimed to assist food safety professionals in the safety evaluation and regulation of novel foods and foods derived from genetically modified organisms, by describing the practical application and use of the concept of 'history of safe use'.

  10. Safety assessment and detection methods of genetically modified organisms.

    Science.gov (United States)

    Xu, Rong; Zheng, Zhe; Jiao, Guanglian

    2014-01-01

    Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

  11. Guidelines for Self-assessment of Research Reactor Safety

    International Nuclear Information System (INIS)

    2018-01-01

    Self-assessment is an organization’s internal process to review its current status, processes and performance against predefined criteria and thereby to provide key elements for the organization’s continual development and improvement. Self-assessment helps the organization to think through what it is expected to do, how it is performing in relation to these expectations, and what it needs to do to improve performance, fulfil the expectations and achieve better compliance with the predefined criteria. This publication provides guidelines for a research reactor operating organization to perform a self-assessment of the safety management and the safety of the facility and to identify gaps between the current situation and the IAEA safety requirements for research reactors. These guidelines also provide a methodology for Member States, regulatory bodies and operating organizations to perform a self-assessment of their application of the provisions of the Code of Conduct on the Safety of Research Reactors. This publication also addresses planning, implementation and follow-up of actions to enhance safety and strengthen application of the Code. The guidelines are applicable to all types of research reactor and critical and subcritical assemblies, at all stages in their lifetimes, and to States, regulatory bodies and operating organizations throughout all phases of research reactor programmes. Research reactor operating organizations can use these guidelines at any time to support self-assessments conducted in accordance with the organization’s integrated management system. These guidelines also serve as a tool for an organization to prepare to receive an IAEA Integrated Safety Assessment of Research Reactors (INSARR) mission. An important result of this is the opportunity for an operating organization to identify focus areas and make safety improvements in advance of an INSARR mission, thereby increasing the effectiveness of the mission and efficiency of the

  12. Advanced korean industrial safety and health policy with risk assessment.

    Science.gov (United States)

    Kwon, Hyuckmyun; Cho, Jae Hyun; Moon, Il; Choi, Jaewook; Park, Dooyong; Lee, Youngsoon

    2010-09-01

    This article describes a systematic roadmap master plan for advanced industrial safety and health policy in Korea, with an emphasis on. Since Korean industries had first emergence of industrial safety and health policy in 1953, enormous efforts have been made on upgrading the relevant laws in order to reflect real situation of industrial work environment in accordance with rapid changes of Korean and global business over three decades. Nevertheless, current policy has major defects; too much techniques-based articles, diverged contents in less organization, combined enforcement and punishments and finally enforcing regulations full of commands and control. These deficiencies have make it difficult to accommodate changes of social, industrial and employment environment in customized fashion. The approach to the solution must be generic at the level of paradigm-shift rather than local modifications and enhancement. The basic idea is to establish a new system integrated with a risk assessment scheme, which encourages employers to apply to their work environment under comprehensive responsibility. The risk assessment scheme is designed to enable to inspect employers' compliances afterwards. A project comprises four yearly phases based on applying zones; initially designating and operating a specified risk zone, gradually expanding the special zones during a period of 3 years (2010-2012) and the final zone expanded to entire nation. In each phase, the intermediate version of the system is updated through a process of precise and unbiased validation in terms of its operability, feasibility and sustainability with building relevant infrastructures as needed.

  13. Safety Culture Assessment at Regulatory Body - PNRA Experience of Implementing IAEA Methodology for Safety Culture Self Assessment

    International Nuclear Information System (INIS)

    Bhatti, S.A.N.; Arshad, N.

    2016-01-01

    The prevalence of a good safety culture is equally important for all kind of organizations involved in nuclear business including operating organizations, designers, regulator, etc., and this should be reflected through all the processes and activities of these organizations. The need for inculcating safety culture into regulatory processes and practices is gradually increasing since the major accident at Fukushima. Accordingly, several international fora in last few years repeatedly highlighted the importance of prevalence of safety culture in regulatory bodies as well. The utilisation of concept of safety culture always remained applicable in regulatory activities of PNRA in the form of core values. After the Fukushima accident, PNRA considered it important to check the extent of utilisation of safety culture concept in organizational activities and decided to conduct its “Safety Culture Self-Assessment (SCSA)” for presenting itself as a role model in-order to endorse the fact that safety culture at regulatory authority plays an important role to influence safety culture at licenced facilities.

  14. ASCOT guidelines revised 1996 edition. Guidelines for organizational self-assessment of safety culture and for reviews by the assessment of safety culture in organizations team

    International Nuclear Information System (INIS)

    1996-01-01

    In order to properly assess safety culture, it is necessary to consider the contribution of all organizations which have an impact on it. Therefore, while assessing the safety culture in an operating organization it is necessary to address at least its interfaces with the local regulatory agency, utility corporate headquarters and supporting organizations. These guidelines are primarily intended for use by any organization wishing to conduct a self-assessment of safety culture. They should also serve as a basis for conducting an international peer review of the organization's self-assessment carried out by an ASCOT (Assessment of Safety Culture in Organizations Team) mission

  15. Assessing Technical Competence in Surgical Trainees: A Systematic Review.

    Science.gov (United States)

    Szasz, Peter; Louridas, Marisa; Harris, Kenneth A; Aggarwal, Rajesh; Grantcharov, Teodor P

    2015-06-01

    To systematically examine the literature describing the methods by which technical competence is assessed in surgical trainees. The last decade has witnessed an evolution away from time-based surgical education. In response, governing bodies worldwide have implemented competency-based education paradigms. The definition of competence, however, remains elusive, and the impact of these education initiatives in terms of assessment methods remains unclear. A systematic review examining the methods by which technical competence is assessed was conducted by searching MEDLINE, EMBASE, PsychINFO, and the Cochrane database of systematic reviews. Abstracts of retrieved studies were reviewed and those meeting inclusion criteria were selected for full review. Data were retrieved in a systematic manner, the validity and reliability of the assessment methods was evaluated, and quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation classification. Of the 6814 studies identified, 85 studies involving 2369 surgical residents were included in this review. The methods used to assess technical competence were categorized into 5 groups; Likert scales (37), benchmarks (31), binary outcomes (11), novel tools (4), and surrogate outcomes (2). Their validity and reliability were mostly previously established. The overall Grading of Recommendations Assessment, Development and Evaluation for randomized controlled trials was high and low for the observational studies. The definition of technical competence continues to be debated within the medical literature. The methods used to evaluate technical competence predominantly include instruments that were originally created to assess technical skill. Very few studies identify standard setting approaches that differentiate competent versus noncompetent performers; subsequently, this has been identified as an area with great research potential.

  16. Application of fuzzy set theory for safety culture and safety management assessment of Kartini research reactor

    International Nuclear Information System (INIS)

    Syarip; Hauptmanns, U.

    2000-01-01

    The safety culture status of nuclear power plant is usually assessed through interview and/or discussions with personnel and management in plant, and an assessment of the pertinent documentation. The approach for safety culture assessment described in IAEA Safety Series, make uses of a questionnaire composed of questions which require 'Yes' or 'No' as an answer. Hence, it is basically a check-list approach which is quite common for safety assessments in industry. Such a procedure ignores the fact that the expert answering the question usually has knowledge which goes far beyond a mere binary answer. Additionally, many situations cannot readily be described in such restricted terms. Therefore, it was developed a checklist consisting of questions which are formulated such that they require more than a simple 'yes' or 'no' as an answer. This allows one to exploit the expert knowledge of the analyst appropriately by asking him to qualify the degree of compliance of each of the topics examined. The method presented has proved useful in assessing the safety culture and quality of safety management of the research reactor. The safety culture status and the quality of safety management of Kartini research reactor is rated as 'average'. The method is also flexible and allows one to add questions to existing areas or to introduce new areas covering related topics

  17. The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

    Science.gov (United States)

    de Luca, Katie E; Fang, Sheng Hung; Ong, Justin; Shin, Ki-Soo; Woods, Samuel; Tuchin, Peter J

    2017-09-01

    The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required. Copyright © 2017. Published by Elsevier Inc.

  18. Criticality safety evaluations - a open-quotes stalking horseclose quotes for integrated safety assessment

    International Nuclear Information System (INIS)

    Williams, R.A.

    1995-01-01

    The Columbia Fuel Fabrication Facility of the Westinghouse Commercial Nuclear Fuel Division manufactures low-enriched uranium fuel and associated components for use in commercial pressurized water power reactors. To support development of a comprehensive integrated safety assessment (ISA) for the facility, as well as to address increasing U.S. Nuclear Regulatory Commission (NRC) expectations regarding such a facility's criticality safety assessments, a project is under way to complete criticality safety evaluations (CSEs) of all plant systems used in processing nuclear materials. Each CSE is made up of seven sections, prepared by a multidisciplinary team of process engineers, systems engineers, safety engineers, maintenance representatives, and operators. This paper provides a cursory outline of the type of information presented in a CSE

  19. IRSN-ANCCLI partnership. Work session on Complementary safety assessments - November 2011

    International Nuclear Information System (INIS)

    Lachaume, Jean-Luc; Lheureux, Yves; Sene, Monique; Sene, Raymond; Jorel, Martial; Lavarenne, Caroline; Rousseau, Jean-Marie; Rebour, Vincent; Baumont, David; Dupuy, Patricia

    2011-11-01

    After an overview by the ASN of complementary safety assessments and an assessment of 'post-Fukushima' inspections of basic nuclear installations, the contributions (Power Point presentations) of this seminar proposed: the opinion of the Gravelines CLI (local information commission) on the Gravelines complementary safety assessment report, an analysis and discussion by the GSIEN on reports of complementary assessment of safety of nuclear installations with respect to the Fukushima accident, an analysis by the IRSN of complementary safety assessments performed by operators, the IRSN approach to analyze complementary safety assessments, reports on installation conditions, external flooding and seismic hazard, 'meltdown prevention' aspects in the management of accidental situations in EDF reactors

  20. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis: A systematic literature review.

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; Morales, José M García Ruiz de; Herreras, Jose M; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-10-01

    To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients.

  1. A Preliminary Study on the Measures to Assess the Organizational Safety: The Cultural Impact on Human Error Potential

    International Nuclear Information System (INIS)

    Lee, Yong Hee; Lee, Yong Hee

    2011-01-01

    The Fukushima I nuclear accident following the Tohoku earthquake and tsunami on 11 March 2011 occurred after twelve years had passed since the JCO accident which was caused as a result of an error made by JCO employees. These accidents, along with the Chernobyl accident, associated with characteristic problems of various organizations caused severe social and economic disruptions and have had significant environmental and health impact. The cultural problems with human errors occur for various reasons, and different actions are needed to prevent different errors. Unfortunately, much of the research on organization and human error has shown widely various or different results which call for different approaches. In other words, we have to find more practical solutions from various researches for nuclear safety and lead a systematic approach to organizational deficiency causing human error. This paper reviews Hofstede's criteria, IAEA safety culture, safety areas of periodic safety review (PSR), teamwork and performance, and an evaluation of HANARO safety culture to verify the measures used to assess the organizational safety

  2. A Preliminary Study on the Measures to Assess the Organizational Safety: The Cultural Impact on Human Error Potential

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Hee; Lee, Yong Hee [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2011-10-15

    The Fukushima I nuclear accident following the Tohoku earthquake and tsunami on 11 March 2011 occurred after twelve years had passed since the JCO accident which was caused as a result of an error made by JCO employees. These accidents, along with the Chernobyl accident, associated with characteristic problems of various organizations caused severe social and economic disruptions and have had significant environmental and health impact. The cultural problems with human errors occur for various reasons, and different actions are needed to prevent different errors. Unfortunately, much of the research on organization and human error has shown widely various or different results which call for different approaches. In other words, we have to find more practical solutions from various researches for nuclear safety and lead a systematic approach to organizational deficiency causing human error. This paper reviews Hofstede's criteria, IAEA safety culture, safety areas of periodic safety review (PSR), teamwork and performance, and an evaluation of HANARO safety culture to verify the measures used to assess the organizational safety

  3. Initial development of a practical safety audit tool to assess fleet safety management practices.

    Science.gov (United States)

    Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

    2012-07-01

    Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Animal-Free Chemical Safety Assessment

    Directory of Open Access Journals (Sweden)

    George D Loizou

    2016-07-01

    Full Text Available The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, nonmedical world of mobile (wireless devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced imaging which offers the increasingly realistic prospect of personalized medicine. Described as a potential seismic shift from the current healthcare model to a wellness paradigm that is predictive, preventative, personalized and participatory, this change is based on the development of increasingly sophisticated biosensors which can track and measure key biochemical variables in people. Additional key drivers in this shift are metabolomic and proteomic signatures, which are increasingly being reported as pre-symptomatic, diagnostic and prognostic of toxicity and disease. These advancements also have profound implications for toxicological evaluation and safety assessment of pharmaceuticals and environmental chemicals. An approach based primarily on human in vivo and high-throughput in vitro human cell-line data is a distinct possibility. This would transform current chemical safety assessment practise which operates in a human data poor to a human data rich environment. This could also lead to a seismic shift from the current animal-based to an animal-free chemical safety assessment paradigm.

  5. Additional safety assessments. Report by the Nuclear Safety Authority - December 2011

    International Nuclear Information System (INIS)

    2011-12-01

    The first part of this voluminous report proposes an assessment of targeted audits performed in French nuclear installations (water pressurized reactors on the one hand, laboratories, factories and waste and dismantling installations on the other hand) on issues related to the Fukushima accident. The examined issues were the protection against flooding and against earthquake, and the loss of electricity supplies and of cooling sources. The second part addresses the additional safety assessments of the reactors and the European resistance tests: presentation of the French electronuclear stock, earthquake, flooding and natural hazards (installation sizing, safety margin assessment), loss of electricity supplies and cooling systems, management of severe accidents, subcontracting conditions. The third part addresses the same issues for nuclear installations other than nuclear power reactors

  6. Preliminary investigation on reliability assessment of passive safety system

    International Nuclear Information System (INIS)

    Huang Changfan; Kuang Bo

    2012-01-01

    The reliability evaluation of passive safety system plays an important part in probabilistic safety assessment (PSA) of nuclear power plant applying passive safety design, which depends quantitatively on reliabilities of passive safety system. According to the object of reliability assessment of passive safety system, relevant parameters are identified. Then passive system behavior during accident scenarios are studied. A practical example of this method is given for the case of reliability assessment of AP1000 passive heat removal system in loss of normal feedwater accident. Key and design parameters of PRHRS are identified and functional failure criteria are established. Parameter combinations acquired by Latin hyper~ cube sampling (LHS) in possible parametric ranges are input and calculations of uncertainty propagation through RELAP5/MOD3 code are carried out. Based on the calculations, sensitivity assessment on PRHRS functional criteria and reliability evaluation of the system are presented, which might provide further PSA with PRHR system reliability. (authors)

  7. Systematic Suicide Risk Assessment for Patients With Schizophrenia

    DEFF Research Database (Denmark)

    Pedersen, Charlotte Gjørup; Wallenstein Jensen, Signe Olrik; Gradus, Jaimie

    2013-01-01

    Objectives: Systematic suicide risk assessment is recommended for patients with schizophrenia; however, little is known about the implementation of suicide risk assessment in routine clinical practice. The study aimed to determine the use of systematic suicide risk assessment at discharge...... and predictors of suicide attempt among hospitalized patients with schizophrenia in Denmark. Methods: A one-year follow-up study was conducted of 9,745 patients with schizophrenia who were discharged from psychiatric wards and registered in a national population-based schizophrenia registry between 2005 and 2009....... Results: The proportion of patients receiving suicide risk assessment at discharge from a psychiatric ward increased from 72% (95% confidence interval [CI]=71%-74%) in 2005, when the national monitoring began, to 89% (CI.89%-90%) in 2009. Within one year after discharge, 1% of all registered patients had...

  8. Probabilistic safety assessment of the Fugen NPS

    International Nuclear Information System (INIS)

    Sotsu, Masutake; Iguchi, Yukihiro; Mizuno, Kouichi; Sato, Shinichirou; Shimizu, Miwako

    1999-01-01

    We performed a probabilistic safety assessment (PSA) on the Fugen NPS. The main topic of assessment was internal factors. We assessment core damage frequency (level 1 PSA) and containment damage frequency (level 2 PSA) during rated operation, and core damage frequency during shutdown (PSA during shutdowns). Our assessment showed that the core damage frequency of Fugen is well below the IAEA criteria for existing plants, that the conditional containment damage during shutdown is almost the target value of 0.1, and that the core damage frequency during shutdown is almost the same as that assessed during operation. These results confirm that the Fugen plant maintains a sufficient safety margin during shutdowns for regular inspections and for refueling. We developed and verified the effectiveness of an accident management plan incorporating the results of the assessment. (author)

  9. Spatial abilities and anatomy knowledge assessment: A systematic review.

    Science.gov (United States)

    Langlois, Jean; Bellemare, Christian; Toulouse, Josée; Wells, George A

    2017-06-01

    Anatomy knowledge has been found to include both spatial and non-spatial components. However, no systematic evaluation of studies relating spatial abilities and anatomy knowledge has been undertaken. The objective of this study was to conduct a systematic review of the relationship between spatial abilities test and anatomy knowledge assessment. A literature search was done up to March 20, 2014 in Scopus and in several databases on the OvidSP and EBSCOhost platforms. Of the 556 citations obtained, 38 articles were identified and fully reviewed yielding 21 eligible articles and their quality were formally assessed. Non-significant relationships were found between spatial abilities test and anatomy knowledge assessment using essays and non-spatial multiple-choice questions. Significant relationships were observed between spatial abilities test and anatomy knowledge assessment using practical examination, three-dimensional synthesis from two-dimensional views, drawing of views, and cross-sections. Relationships between spatial abilities test and anatomy knowledge assessment using spatial multiple-choice questions were unclear. The results of this systematic review provide evidence for spatial and non-spatial methods of anatomy knowledge assessment. Anat Sci Educ 10: 235-241. © 2016 American Association of Anatomists. © 2016 American Association of Anatomists.

  10. Safety standards for near surface disposal and the safety case and supporting safety assessment for demonstrating compliance with the standards

    International Nuclear Information System (INIS)

    Metcalf, P.

    2003-01-01

    The report presents the safety standards for near surface disposal (ICRP guidance and IAEA standards) and the safety case and supporting safety assessment for demonstrating compliance with the standards. Special attention is paid to the recommendations for disposal of long-lived solid radioactive waste. The requirements are based on the principle for the same level of protection of future individuals as for the current generation. Two types of exposure are considered: human intrusion and natural processes and protection measures are discussed. Safety requirements for near surface disposal are discussed including requirements for protection of human health and environment, requirements or safety assessments, waste acceptance and requirements etc

  11. Failure rate data for fusion safety and risk assessment

    International Nuclear Information System (INIS)

    Cadwallader, L.C.

    1993-01-01

    The Fusion Safety Program (FSP) at the Idaho National Engineering Laboratory (INEL) conducts safety research in materials, chemical reactions, safety analysis, risk assessment, and in component research and development to support existing magnetic fusion experiments and also to promote safety in the design of future experiments. One of the areas of safety research is applying probabilistic risk assessment (PRA) methods to fusion experiments. To apply PRA, we need a fusion-relevant radiological dose code and a component failure rate data base. This paper describes the FSP effort to develop a failure rate data base for fusion-specific components

  12. Fusion blanket inherent safety assessment

    International Nuclear Information System (INIS)

    Sze, D.K.; Jung, J.; Cheng, E.T.

    1986-01-01

    Fusion has significant potential safety advantages. There is a strong incentive for designing fusion plants to ensure that inherent safety will be achieved. Accordingly, both the Tokamak Power Systems Studies and MINIMARS have identified inherent safety as a design goal. A necessary condition is for the blanket to maintain its configuration and integrity under all credible accident conditions. A main problem is caused by afterheat removal in an accident condition. In this regard, it is highly desirable to achieve the required level of protection of the plant capital investment and limitation of radioactivity release by systems that rely only on inherent properties of matter (e.g., thermal conductivity, specific heat, etc.) and without the use of active safety equipment. This paper assesses the conditions under which inherent safety is feasible. Three types of accident conditions are evaluated for two blankets. The blankets evaluated are a self cooled vanadium/lithium blanket and a self-cooled vanadium/Flibe blanket. The accident conditions evaluated are: (1) loss-of-flow accident; (2) loss-of-coolant accident (LOCA); and (3) partial loss-of-coolant accident

  13. Mathematical Safety Assessment Approaches for Thermal Power Plants

    Directory of Open Access Journals (Sweden)

    Zong-Xiao Yang

    2014-01-01

    Full Text Available How to use system analysis methods to identify the hazards in the industrialized process, working environment, and production management for complex industrial processes, such as thermal power plants, is one of the challenges in the systems engineering. A mathematical system safety assessment model is proposed for thermal power plants in this paper by integrating fuzzy analytical hierarchy process, set pair analysis, and system functionality analysis. In the basis of those, the key factors influencing the thermal power plant safety are analyzed. The influence factors are determined based on fuzzy analytical hierarchy process. The connection degree among the factors is obtained by set pair analysis. The system safety preponderant function is constructed through system functionality analysis for inherence properties and nonlinear influence. The decision analysis system is developed by using active server page technology, web resource integration, and cross-platform capabilities for applications to the industrialized process. The availability of proposed safety assessment approach is verified by using an actual thermal power plant, which has improved the enforceability and predictability in enterprise safety assessment.

  14. Progress in the development of methodology for fusion safety systems studies

    International Nuclear Information System (INIS)

    Ho, S.K.; Cambi, G.; Ciattaglia, S.; Fujii-e, Y.; Seki, Y.

    1994-01-01

    The development of fusion safety systems-study methodology, including the aspects of schematic classification of overall fusion safety system, qualitative assessment of fusion system for identification of critical accident scenarios, quantitative analysis of accident consequences and risk for safety design evaluation, and system-level analysis of accident consequences and risk for design optimization, by a consortium of international efforts is presented. The potential application of this methodology into reactor design studies will facilitate the systematic assessment of safety performance of reactor designs and enhance the impacts of safety considerations on the selection of design configurations

  15. Buffer and backfill process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrik (comp.)

    2006-09-15

    This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling.

  16. Buffer and backfill process report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Sellin, Patrik

    2006-09-01

    This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling

  17. Effectiveness and safety of atomoxetine for ADHD in population between 6 and 19 years: a systematic review

    Directory of Open Access Journals (Sweden)

    José Calleja

    2012-09-01

    Full Text Available Introduction: Attention deficit hyperactivity disorder (ADHD is generally treated with pharmacological interventions such as psychostimulants. The most used widely used one is methylphenidate followed by atomoxetine. Purpose: To identify, synthesize and evaluate the best available evidence on the effectiveness and safety of atomoxetine in ADHD treatment in the 6-19 year-old population. Methods: A systematic review of intervention studies that evaluated effectiveness of atomoxetine compared with placebo and methylphenidate was conducted. Outcomes assessed were educational functioning, psychosocial functioning, quality of life and adverse effects. The search was done up to February 2012 in English and Spanish in the following databases: PubMed/MEDLINE, LILACS, Cochrane, DARE and National Guideline Clearinghouse. The articles were independently evaluated by two investigators. Results: Of the 108 studies found initially, 11 were included, among which five systematic reviews, one primary article and 5 clinical guidelines. Conclusions: Atomoxetine is recommended as a second option in ADHD and was found to be superior to placebo. Its use is recommended when methylphenidate fails or comorbidities are present.

  18. A Computer Program for Assessing Nuclear Safety Culture Impact

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

    2014-10-15

    Through several accidents of NPP including the Fukushima Daiichi in 2011 and Chernobyl accidents in 1986, a lack of safety culture was pointed out as one of the root cause of these accidents. Due to its latent influences on safety performance, safety culture has become an important issue in safety researches. Most of the researches describe how to evaluate the state of the safety culture of the organization. However, they did not include a possibility that the accident occurs due to the lack of safety culture. Because of that, a methodology for evaluating the impact of the safety culture on NPP's safety is required. In this study, the methodology for assessing safety culture impact is suggested and a computer program is developed for its application. SCII model which is the new methodology for assessing safety culture impact quantitatively by using PSA model. The computer program is developed for its application. This program visualizes the SCIs and the SCIIs. It might contribute to comparing the level of the safety culture among NPPs as well as improving the management safety of NPP.

  19. Healthcare professionals? views on feedback of a patient safety culture assessment

    OpenAIRE

    Zwijnenberg, Nicolien C.; Hendriks, Michelle; Hoogervorst-Schilp, Janneke; Wagner, Cordula

    2016-01-01

    Background By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals? views on the feedback of a patient safety culture assessment. Methods Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a websi...

  20. Review of the state of the art of human biomonitoring for chemical substances and its application to human exposure assessment for food safety

    DEFF Research Database (Denmark)

    Choi, Judy; Mørck, Thit Aarøe; Polcher, Alexandra

    2015-01-01

    Human biomonitoring (HBM) measures the levels of substances in body fluids and tissues. Many countries have conducted HBM studies, yet little is known about its application towards chemical risk assessment, particularly in relation to food safety. Therefore a literature search was performed...... in several databases and conference proceedings for 2002 – 2014. Definitions of HBM and biomarkers, HBM techniques and requirements, and the possible application to the different steps of risk assessment were described. The usefulness of HBM for exposure assessment of chemical substances from food source...... safety areas (namely exposure assessment), and for the implementation of a systematic PMM approach. But further work needs to be done to improve usability. Major deficits are the lack of HBM guidance values on a considerable number of substance groups, for which health based guidance values (HBGVs) have...

  1. Safety assessment of the liquid-fed ceramic melter process

    International Nuclear Information System (INIS)

    Buelt, J.L.; Partain, W.L.

    1980-08-01

    As part of its development program for the solidification of high-level nuclear waste, Pacific Northwest Laboratory assessed the safety issues for a complete liquid-fed ceramic melter (LFCM) process. The LFCM process, an adaption of commercial glass-making technology, is being developed to convert high-level liquid waste from the nuclear fuel cycle into glass. This safety assessment uncovered no unresolved or significant safety problems with the LFCM process. Although in this assessment the LFCM process was not directly compared with other solidification processes, the safety hazards of the LFCM process are comparable to those of other processes. The high processing temperatures of the glass in the LFCM pose no additional significant safety concerns, and the dispersible inventory of dried waste (calcine) is small. This safety assessment was based on the nuclear power waste flowsheet, since power waste is more radioactive than defense waste at the time of solidification, and all accident conditions for the power waste would have greater radiological consequences than those for defense waste. An exhaustive list of possible off-standard conditions and equipment failures was compiled. These accidents were then classified according to severity of consequence and type of accident. Radionuclide releases to the stack were calculated for each group of accidents using conservative assumptions regarding the retention and decontamination features of the process and facility. Two recommendations that should be considered by process designers are given in the safety assessment

  2. ENSI Approach to Oversight of Safety Culture

    International Nuclear Information System (INIS)

    Humbel Haag, Claudia

    2012-01-01

    Claudia Humbel Haag presented developments in ENSI approach to safety culture oversight. ENSI has developed a definition/understanding of Safety Culture and a concept of how to perform oversight of Safety Culture. ENSI defines safety culture in the following way: Safety Culture comprises the behaviour, world views (in the sense of conceptualisations of reality and explanation models), values (in the sense of aims and evaluation scales), and features of the physical environment (specifically, the nuclear power plant and the documents used) which are shared by many members of an organization, in as much as these are of significance to nuclear safety. A model of the accessibility of safety culture was presented ranging from the observable (external aspects of safety culture), to aspects that are accessible by asking questions, through to aspects that are not accessible (internal part of safety culture). ENSI considers observable aspects through the existing systematic safety assessment compliance program. Aspects that are observable by asking questions will be addressed by additional oversight activities outside the systematic assessment program. Aspects that are not accessible are addressed by helping the licensee to re-think its safety culture through proactive discussions on safety culture. Reports are issued to the licensee on assumptions and observations identified through the discussions. The conclusions of the presentation emphasised the importance of basing any interventions in this area on a solid understanding of the concept of safety culture. ENSI safety culture oversight principles were also described. These include licensee responsibility for safety, and the need for the regulator to critically review their own activities to ensure a positive influence on the licensee

  3. Safety assessment of novel foods and strategies to determine their safety in use

    International Nuclear Information System (INIS)

    Edwards, Gareth

    2005-01-01

    Safety assessment of novel foods requires a different approach to that traditionally used for the assessment of food chemicals. A case-by-case approach is needed which must be adapted to take account of the characteristics of the individual novel food. A thorough appraisal is required of the origin, production, compositional analysis, nutritional characteristics, any previous human exposure and the anticipated use of the food. The information should be compared with a traditional counterpart of the food if this is available. In some cases, a conclusion about the safety of the food may be reached on the basis of this information alone, whereas in other cases, it will help to identify any nutritional or toxicological testing that may be required to further investigate the safety of the food. The importance of nutritional evaluation cannot be over-emphasised. This is essential for the conduct of toxicological studies in order to avoid dietary imbalances, etc., that might lead to interpretation difficulties, but also in the context of its use as food and to assess the potential impact of the novel food on the human diet. The traditional approach used for chemicals, whereby an acceptable daily intake (ADI) is established with a large safety margin relative to the expected exposure, cannot be applied to foods. The assessment of safety in use should be based upon a thorough knowledge of the composition of the food, evidence from nutritional, toxicological and human studies, expected use of the food and its expected consumption. Safety equates to a reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption

  4. LANL Safety Conscious Work Environment (SCWE) Self-Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Hargis, Barbara C. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2014-01-29

    On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance provided by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.

  5. Quantitative risk assessment of digitalized safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Sung Min; Lee, Sang Hun; Kang, Hym Gook [KAIST, Daejeon (Korea, Republic of); Lee, Seung Jun [UNIST, Ulasn (Korea, Republic of)

    2016-05-15

    A report published by the U.S. National Research Council indicates that appropriate methods for assessing reliability are key to establishing the acceptability of digital instrumentation and control (I and C) systems in safety-critical plants such as NPPs. Since the release of this issue, the methodology for the probabilistic safety assessment (PSA) of digital I and C systems has been studied. However, there is still no widely accepted method. Kang and Sung found three critical factors for safety assessment of digital systems: detection coverage of fault-tolerant techniques, software reliability quantification, and network communication risk. In reality the various factors composing digitalized I and C systems are not independent of each other but rather closely connected. Thus, from a macro point of view, a method that can integrate risk factors with different characteristics needs to be considered together with the micro approaches to address the challenges facing each factor.

  6. Safety assessment of high consequence robotics system

    International Nuclear Information System (INIS)

    Robinson, D.G.; Atcitty, C.B.

    1996-01-01

    This paper outlines the use of a failure modes and effects analysis for the safety assessment of a robotic system being developed at Sandia National Laboratories. The robotic system, the weigh and leak check system, is to replace a manual process for weight and leakage of nuclear materials at the DOE Pantex facility. Failure modes and effects analyses were completed for the robotics process to ensure that safety goals for the systems have been met. Due to the flexible nature of the robot configuration, traditional failure modes and effects analysis (FMEA) were not applicable. In addition, the primary focus of safety assessments of robotics systems has been the protection of personnel in the immediate area. In this application, the safety analysis must account for the sensitivities of the payload as well as traditional issues. A unique variation on the classical FMEA was developed that permits an organized and quite effective tool to be used to assure that safety was adequately considered during the development of the robotic system. The fundamental aspects of the approach are outlined in the paper

  7. Incorporation of formal safety assessment and Bayesian network in navigational risk estimation of the Yangtze River

    International Nuclear Information System (INIS)

    Zhang, D.; Yan, X.P.; Yang, Z.L.; Wall, A.; Wang, J.

    2013-01-01

    Formal safety assessment (FSA), as a structured and systematic risk evaluation methodology, has been increasingly and broadly used in the shipping industry around the world. Concerns have been raised as to navigational safety of the Yangtze River, China's largest and the world's busiest inland waterway. Over the last few decades, the throughput of ships in the Yangtze River has increased rapidly due to the national development of the Middle and Western parts of China. Accidents such as collisions, groundings, contacts, oil-spills and fires occur repeatedly, often causing serious consequences. In order to improve the navigational safety in the Yangtze River, this paper estimates the navigational risk of the Yangtze River using the FSA concept and a Bayesian network (BN) technique. The navigational risk model is established by considering both probability and consequences of accidents with respect to a risk matrix method, followed by a scenario analysis to demonstrate the application of the proposed model

  8. Kozloduy nuclear power plant. Units 1-4. Status of safety assessment activities. Rev. 2

    International Nuclear Information System (INIS)

    1999-01-01

    This paper presents the results of the status of safety assessment activities carried out by the Kozloduy Nuclear Power Plant (KNPP) in order to evaluate the current status of the safety of its reactor units 1-4. The steam supply system of this units is based of the reactor WWER-440/ B-230, which is a PWR of Russian design developed according to the safety standards in force in USSR in late 60-s. Now a days 10 reactor units of this type are in operation in four NPPs. Despite of efforts of the different plants to implement safety improvements measures during first 10-15 years of operation of this type of reactor its major safety problems were not eliminated and were a subject of international concern. The systematic evaluation of the deficiencies of the original design of this type of reactors have been initiated by IAEA in the beginning of 1990 and brought to developing a comprehensive list of safety problems which required urgent implementation of safety measures in all plants. To solve this problems in 1991 KNPP initiated implementation of so called 'short term' safety improvement program, developed with the help of WANO under agreement with Bulgarian Nuclear Safety Authority (BNSA) and consortium RISKAUDIT. The program was based on a stage approach and was foreseen to be implemented by tree stages in very tight time schedule in order to achieve significant and rapid improvements of the level of safety in operation of the units. The Short Tenn Program was implemented between the years 1991 and 1997 thanks of the strong safety commitment of NEK and KNPP staff and the broad international cooperation and financial support. Important part of resources were supplied under PHARE program of CEC, EBRD grant agreement and EDF support. The plant current safety level analysis has been performed using IAEA analytical methodology according to 50-SG-O12 standard 'Periodic safety review of operational nuclear power plants'. The approach and criteria for acceptable safety level

  9. On a systematic perspective on risk for formal safety assessment (FSA)

    International Nuclear Information System (INIS)

    Montewka, Jakub; Goerlandt, Floris; Kujala, Pentti

    2014-01-01

    In the maritime domain, risk is evaluated within the framework of the Formal Safety Assessment (FSA), introduced by the International Maritime Organization in 2002. Although the FSA has become an internationally recognized and recommended method, the definition, which is adopted there, to describe the risk, seems to be too narrow to reflect the actual content of the FSA. Therefore this article discusses methodological requirements for the risk perspective, which is appropriate for risk management in the maritime domain with special attention to maritime transportation systems. A perspective that is proposed here considers risk as a set encompassing the following: a set of plausible scenarios leading to an accident, the likelihoods of unwanted events within the scenarios, the consequences of the events and description of uncertainty. All these elements are conditional upon the available knowledge (K) about the analyzed system and understanding (N) of the system behavior. Therefore, the quality of K and the level of N of a risk model should be reflected in the uncertainty description. For this purpose we introduce a qualitative scoring system, and we show its applicability on an exemplary risk model for a RoPax ship. - Highlights: • We present a risk perspective for the maritime domain. • A distinction between knowledge and understanding is made. • We describe risk as (Scenario, Consequences, Uncertainty/Knowledge, Understanding). • The perspective highlights the strength and weaknesses of a given risk analysis

  10. Research on fuzzy comprehensive assessment method of nuclear power plant safety culture

    International Nuclear Information System (INIS)

    Xiang Yuanyuan; Chen Xukun; Xu Rongbin

    2012-01-01

    Considering the traits of safety culture in nuclear plant, 38 safety culture assessment indexes are established from 4 aspects such as safety values, safety institution, safety behavior and safety sub- stances. Based on it, a comprehensive assessment method for nuclear power plant safety culture is constructed by using AHP (Analytic Hierarchy Process) approach and fuzzy mathematics. The comprehensive assessment method has the quality of high precision and high operability, which can support the decision making of safety culture development. (authors)

  11. Safety/security interface assessments at commercial nuclear power plants

    International Nuclear Information System (INIS)

    Byers, K.R.; Brown, P.J.; Norderhaug, L.R.

    1985-01-01

    The findings of the Haynes Task Force Committee (NUREG-0992) are used as the basis for defining safety/security assessment team activities at commercial nuclear power plants in NRC Region V. A safety/security interface assessment outline and the approach used for making the assessments are presented along with the composition of team members. As a result of observing simulated plant emergency conditions during scheduled emergency preparedness exercises, examining security and operational response procedures, and interviewing plant personnel, the team has identified instances where safety/security conflicts can occur

  12. Safety/security interface assessments at commercial nuclear power plants

    International Nuclear Information System (INIS)

    Byers, K.R.; Brown, P.J.; Norderhaug, L.R.

    1985-07-01

    The findings of the Haynes Task Force Committee (NUREG-0992) are used as the basis for defining safety/security assessment team activities at commercial nuclear power plants in NRC Region V. A safety/security interface assessment outline and the approach used for making the assessments are presented along with the composition of team members. As a result of observing simulated plant emergency conditions during scheduled emergency preparedness exercises, examining security and operational response procedures, and interviewing plant personnel, the team has identified instances where safety/security conflicts can occur. 2 refs

  13. Safety assessment for Generation IV nuclear systems

    International Nuclear Information System (INIS)

    Leahy, T.J.

    2012-01-01

    The Generation IV International Forum (GIF) Risk and Safety Working Group (RSWG) was created to develop an effective approach for the safety of Generation IV advanced nuclear energy systems. Recent RSWG work has focused on the definition of an integrated safety assessment methodology (ISAM) for evaluating the safety of Generation IV systems. ISAM is an integrated 'tool-kit' consisting of 5 analytical techniques that are available and matched to appropriate stages of Generation IV system concept development: 1) qualitative safety features review - QSR, 2) phenomena identification and ranking table - PIRT, 3) objective provision tree - OPT, 4) deterministic and phenomenological analyses - DPA, and 5) probabilistic safety analysis - PSA. The integrated methodology is intended to yield safety-related insights that help actively drive the evolving design throughout the technology development cycle, potentially resulting in enhanced safety, reduced costs, and shortened development time

  14. Nirex safety assessment research programme: 1987/88

    International Nuclear Information System (INIS)

    George, D.; Hodgkinson, D.P.

    1987-01-01

    The Nirex Safety Assessment Research programme's objective is to provide information for the radiological safety case for disposing low-level and intermediate-level radioactive wastes in underground repositories. The programme covers a wide range of experimental studies and mathematical modelling for the near and far field. It attempts to develop a quantitative understanding of events and processes which have an impact on the safety of radioactive waste disposal. (U.K.)

  15. Safety assessment requirements for onsite transfers of radioactive material

    International Nuclear Information System (INIS)

    Opperman, E.K.; Jackson, E.J.; Eggers, A.G.

    1992-05-01

    This document contains the requirements for developing a safety assessment document for an onsite package containing radioactive material. It also provides format and content guidance to establish uniformity in the safety assessment documentation and to ensure completeness of the information provided

  16. Geosphere process report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Skagius, Kristina

    2010-11-01

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  17. Geosphere process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))

    2010-11-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  18. Research on advanced system safety assessment procedures (4)

    International Nuclear Information System (INIS)

    Suzuki, Kazuhiko; Shimada, Yukiyasu

    2001-03-01

    The past research reports in the area of safety engineering proposed the Computer-aided HAZOP system to be applied to Nuclear Reprocessing Facilities. Automated HAZOP system has great advantage compared with human analysts in terms of accuracy of the results, and time required to conduct HAZOP studies. This report surveys the literature on risk assessment and safety design based on the concept of independent protection layers (IPLs). Furthermore, to improve HAZOP System, tool is proposed to construct the basic model and the internal state model. Such HAZOP system is applied to analyze two kinds of processes, where the ability of the proposed system is verified. In addition, risk assessment support system is proposed to integrate safety design environment and assessment result to be used by other plants as well as to enable the underline plant to use other plants' information. This technique can be implemented using web-based safety information systems. (author)

  19. Development of the JNC geological disposal technical information integration system subjected for repository design and safety assessment

    International Nuclear Information System (INIS)

    Ishihara, Yoshinao; Ito, Takashi; Kobayashi, Shigeki; Neyama, Atsushi

    2004-02-01

    On this work, system manufacture about disposal technology and safety assessment field was performed towards construction of the JNC Geological Disposal Technical Information Integration System which systematized three fields of technical information acquired in investigation (site characteristic investigation) of geology environmental conditions, disposal technology (design of deep repository), and performance/safety assessment. The technical information database managed focusing on the technical information concerning individual research of an examination, analysis, etc. and the parameter set database managed focusing on the set up data set used in case of comprehensive evaluation are examined. In order to support and promote share and use of the technical information registered and managed by the database, utility functions, such as a technical information registration function, technical information search/browse function, analysis support function, and visualization function, are considered, and the system realized in these functions is built. The built system is installed in the server of JNC, and the functional check examination is carried out. (author)

  20. Audit of data and code use in the SR-Can safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Hicks, T.W.; Baldwin, T.D. [Galson Sciences Ltd, 5 Grosvenor House, Melton R oad, Oakham, Rutland LE15 6AX (United Kingdom)

    2008-03-15

    Building on the findings of previous studies on data and code quality assurance (QA) in safety assessments, this report provides a review of data and code QA in the SR-Can safety assessment. The data quality audit aimed to check that the selection and use of data in the SR-Can safety assessment was appropriate, focusing on the data that underpin representations of and assumptions about canister, insert, buffer, and backfill behaviour. The SR-Can Data Report provided the initial focus for examining the traceability and reliability of data used in the safety assessment; the Data Report is one of the series of SR-Can safety assessment reports and, in this review, it was anticipated that it would provide the primary source of data on the canister, insert, buffer, and backfill. However, other safety assessment reports (the SR-Can Main Report, the Initial State Report, the Fuel and Canister Process Report, and the Buffer and Backfill Process Report) were found to provide key information on data used in the safety assessment. The quality audit of codes aimed to check that code use in the SR-Can safety assessment has been justified through a transparent and traceable process of code development and selection. The Model Summary Report provided the focus for reviewing the QA status of the codes used in the safety assessment. As well as highlighting a number of concerns regarding QA aspects of specific data sets, parameter values, and codes used in the SR-Can safety assessment (which are presented in the report), the review has led to several general observations on data and code QA that should be considered by SKB in the development and implementation of a QA system for the SR-Site safety assessment: - The SR-Site safety assessment and associated QA records should include information that demonstrates that a full QA system has been implemented in order to build confidence in the validity of the assessment. - The data and parameter values used directly in the safety

  1. Assessing safety culture using RADAR matrix

    International Nuclear Information System (INIS)

    Mariscal-Saldana, M. a.; Garcia-Herrero, S.; Toca-Otero, A.

    2009-01-01

    Santa Maria de Garona nuclear power plant, in collaboration with Burgos University, has proceeded to conduct a pilot project aimed at seeing the possibilities for the RADAR (Results, Approach, Development, Assessment and review) logic of EFQM model, as a tool for self evaluation of Safety Culture in a nuclear power plant. In the work it has sought evidences of Safety culture implanted in the plant, and identify strengths and areas for improvement regarding this Culture. the score obtained by analyzing these strengths and areas for improvements has served to prioritize actions implemented. The nuclear power plant has been submitted voluntarily to the mission SCART (Safety Culture Assessment Review Team), an international review being done for the first time in the world at a plant in operation and the team of experts led by International Agency of Atomic Energy (IAEA) has identified this project as a good practice, an innovative process implemented in the plant, that must be transmitted to other plants. (Author) 10 refs

  2. Developing IAM for Life Cycle Safety Assessment

    NARCIS (Netherlands)

    Toxopeus, Marten E.; Lutters, Diederick; Nee, Andrew Y.C.; Song, Bin; Ong, Soh-Khim

    2013-01-01

    This publication discusses aspects of the development of an impact assessment method (IAM) for safety. Compared to the many existing IAM’s for environmentally oriented LCA, this method should translate the impact of a product life cycle on the subject of safety. Moreover, the method should be

  3. Safety assessment of smoke flavouring primary products by the European Food Safety Authority

    NARCIS (Netherlands)

    Theobald, A.; Arcella, D.; Carere, A.; Croera, C.; Engel, K.H.; Gott, D.; Gurtler, R.; Meier, D.; Pratt, I.; Rietjens, I.M.C.M.; Simon, R.; Walker, R.

    2012-01-01

    This paper summarises the safety assessments of eleven smoke flavouring primary products evaluated by the European Food Safety Authority (EFSA). Data on chemical composition, content of polyaromatic hydrocarbons and results of genotoxicity tests and subchronic toxicity studies are presented and

  4. Fire safety assessment of tunnel structures

    DEFF Research Database (Denmark)

    Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco

    2011-01-01

    .g. structural and non structural, organizational, human behavior). This is even more truth for the fire safety design of such structures. Fire safety in tunnels is challenging because of the particular environment, bearing in mind also that a fire can occur in different phases of the tunnel’s lifecycle. Plans...... for upgrading fire safety provisions and tunnel management are also important for existing tunnels. In this study, following a brief introduction of issues regarding the above mentioned aspects, the structural performance of a steel rib for a tunnel infrastructure subject to fire is assessed by means...

  5. Advanced Korean Industrial Safety and Health Policy with Risk Assessment

    Directory of Open Access Journals (Sweden)

    Hyuckmyun Kwon

    2010-09-01

    Full Text Available This article describes a systematic roadmap master plan for advanced industrial safety and health policy in Korea, with an emphasis on. Since Korean industries had first emergence of industrial safety and health policy in 1953, enormous efforts have been made on upgrading the relevant laws in order to reflect real situation of industrial work environment in accordance with rapid changes of Korean and global business over three decades. Nevertheless, current policy has major defects; too much techniques-based articles, diverged contents in less organization, combined enforcement and punishments and finally enforcing regulations full of commands and control. These deficiencies have make it difficult to accommodate changes of social, industrial and employment environment in customized fashion. The approach to the solution must be generic at the level of paradigm- shift rather than local modifications and enhancement. The basic idea is to establish a new system integrated with a risk assessment scheme, which encourages employers to apply to their work environment under comprehensive responsibility. The risk assessment scheme is designed to enable to inspect employers’ compliances afterwards. A project comprises four yearly phases based on applying zones; initially designating and operating a specified risk zone, gradually expanding the special zones during a period of 3 years (2010-2012 and the final zone expanded to entire nation. In each phase, the intermediate version of the system is updated through a process of precise and unbiased validation in terms of its operability, feasibility and sustainability with building relevant infrastructures as needed.

  6. Safety classification of herbal medicines used among pregnant women in Asian countries: a systematic review.

    Science.gov (United States)

    Ahmed, Mansoor; Hwang, Jung Hye; Choi, Soojeung; Han, Dongwoon

    2017-11-14

    High prevalence of herbal medicines used in pregnancy and the lack of information on their safety is a public concern. Despite this, no significant research has been done regarding potential adverse effects of using herbal medicines during pregnancy, especially among developing Asian countries. Cross-sectional studies were searched up to year 2016 on PubMed/Medline and EMBASE, the data were extracted and quality of studies was assessed using the quality appraisal tool. The findings are reported in accordance to the PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Classification on safety of identified herbal medicines was done based on current scientific literature. This study included eight cross-sectional studies (2729 participants) from seven different Asian countries, of which 1283 (47.01%) women used one or more herbal medicines during pregnancy. Peppermint (22.8%), aniseed (14.7%), olibanum (12.9%), flixweed seed (12.2%) and ginger (11.5%) were the most frequently used herbal medicines. Out of the 33 identified herbal medicines, 13 were classified as safe to use, five as use with caution, eight were potentially harmful to use in pregnancy and information on seven herbal medicines was not available in the current literature. Several herbal medicines identified in this review were classified to be potentially harmful or the information regarding safety in pregnancy was missing. It is recommended that contraindicated herbal medicines should be avoided and other herbals should be taken under supervision of a qualified health care practitioner. The classification regarding safety of herbal medicines in pregnancy can be utilized to create awareness on prevention of adverse effects.

  7. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB and XDR-TB : systematic review and meta-analysis

    NARCIS (Netherlands)

    Sotgiu, Giovanni; Centis, Rosella; D'Ambrosio, Lia; Alffenaar, Jan-William C.; Anger, Holly A.; Caminero, Jose A.; Castiglia, Paolo; De Lorenzo, Saverio; Ferrara, Giovanni; Koh, Won-Jung; Schecter, Giesela F.; Shim, Tae S.; Singla, Rupak; Skrahina, Alena; Spanevello, Antonio; Udwadia, Zarir F.; Villar, Miquel; Zampogna, Elisabetta; Zellweger, Jean-Pierre; Zumla, Alimuddin; Migliori, Giovanni Battista

    2012-01-01

    Linezolid is used off-label to treat multidrug-resistant tuberculosis (MDR-TB) in absence of systematic evidence. We performed a systematic review and meta-analysis on efficacy, safety and tolerability of linezolid-containing regimes based on individual data analysis. 12 studies (11 countries from

  8. Embalse refurbishment - aging, safety assessment, and the path forward

    International Nuclear Information System (INIS)

    Sainz, R.; Fornero, D.; Diaz, G.; Gold, R.; Dam, R.; McCrea, L.

    2009-01-01

    The Embalse Nuclear Power Station has been engaged in Pre-refurbishment activities for two years. The primary focus has been on the first phase Pre-Project Condition Assessment Program (PCAP). This phase of the Refurbishment and Life Extension (RLE) project consists of all preparatory activities that are required to define the refurbishment scope and costs, and for input into the utility business case for the RLE project. As part of an overall Plant Life Management (PLiM) program, the following activities have been performed: 1. Systematic and rigorous condition assessments / life assessments (including Health Prognosis and Recommendations); 2. Assessment of design and safety analysis features at Embalse, relative to current technology and licensing practices; 3. Pre-Project activities related to: Retube, Steam Generator replacement, and Digital Control Computer (DCC) replacement. The program has been a joint effort of Embalse NPS-NASA, AECL, ANSALDO and several other support organizations. Details of the planned program were addressed previously in a paper presented at the 28th CNS Conference (2007), entitled 'Embalse Refurbishment - Pre-Project Condition Assessment Phase 1'. Since that time, significant progress has been made towards completing the assessment program and planning for the next steps. This paper presents the progress of Refurbishment and Life Extension (RLE) Program at Embalse Nuclear Power Station with specific emphasis on the PCAP efforts. This includes a discussion of the benefits and lessons learned from RLE project's perspective, and an overview of some key conclusions of the aging assessments. Finally, this paper outlines the path forward. It should be noted that results of assessments presented in this paper are very conservative. This is driven largely by the fact that there are currently uncertainties in equipment condition that can be addressed through the activities recommended as an outcome of these assessments. (author)

  9. Safety management system needs assessment.

    Science.gov (United States)

    2016-04-01

    The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

  10. Cutaneous lichen planus: A systematic review of treatments.

    Science.gov (United States)

    Fazel, Nasim

    2015-06-01

    Various treatment modalities are available for cutaneous lichen planus. Pubmed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database were searched for all the systematic reviews and randomized controlled trials related to cutaneous lichen planus. Two systematic reviews and nine relevant randomized controlled trials were identified. Acitretin, griseofulvin, hydroxychloroquine and narrow band ultraviolet B are demonstrated to be effective in the treatment of cutaneous lichen planus. Sulfasalazine is effective, but has an unfavorable safety profile. KH1060, a vitamin D analogue, is not beneficial in the management of cutaneous lichen planus. Evidence from large scale randomized trials demonstrating the safety and efficacy for many other treatment modalities used to treat cutaneous lichen planus is simply not available.

  11. Criticality safety evaluations - a {open_quotes}stalking horse{close_quotes} for integrated safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Williams, R.A. [Westinghouse Electric Corp., Columbia, SC (United States)

    1995-12-31

    The Columbia Fuel Fabrication Facility of the Westinghouse Commercial Nuclear Fuel Division manufactures low-enriched uranium fuel and associated components for use in commercial pressurized water power reactors. To support development of a comprehensive integrated safety assessment (ISA) for the facility, as well as to address increasing U.S. Nuclear Regulatory Commission (NRC) expectations regarding such a facility`s criticality safety assessments, a project is under way to complete criticality safety evaluations (CSEs) of all plant systems used in processing nuclear materials. Each CSE is made up of seven sections, prepared by a multidisciplinary team of process engineers, systems engineers, safety engineers, maintenance representatives, and operators. This paper provides a cursory outline of the type of information presented in a CSE.

  12. [Assessment of the MF59-adjuvanted pandemic influenza A/H1N1 vaccine. Systematic review of literature].

    Science.gov (United States)

    Ruiz-Aragón, J; Grande Tejada, A M; Márquez-Peláez, S; Molina Linde, J M; Yang, R

    2013-10-01

    To assess the efficacy and safety of MF59-adjuvanted pandemic influenza A/H1N1 vaccine in children. A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist. Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines. The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups. Copyright © 2012 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  13. Safety and security risk assessments--now demystified!

    Science.gov (United States)

    White, Donald E

    2011-01-01

    Safety/security risk assessments no longer need to spook nor baffle healthcare safety/security managers. This grid template provides at-at-glance quick lookup of the possible threats, the affected people and things, a priority ranking of these risks, and a workable solution for each risk. Using the standard document, spreadsheet, or graphics software already available on your computer, you can easily use a scientific method to produce professional looking risk assessments that get quickly understood by both senior managers and first responders alike!

  14. Evaluation of fire probabilistic safety assessment for a PWR plant

    International Nuclear Information System (INIS)

    Wu, C.H.; Lin, T.J.; Kao, T.M.

    2001-01-01

    The internal fire analysis of the level 1 power operation probability safety assessment (PSA) for Maanshan (PWR) Nuclear Power Plant (MNPP) was updated. The fire analysis adopted a scenario-based PSA approach to systematically evaluate fire and smoke hazards and their associated risk impact to MNPP. The result shows that the core damage frequency (CDF) due to fire is about six times lower than the previous one analyzed by the Atomic Energy Council (AEC), Republic of China in 1987. The plant model was modified to reflect the impact of human events and recovery actions during fire. Many tabulated EXCEL spread-sheets were used for evaluation of the fire risk. The fire-induced CDF for MNPP is found to be 2.1 E-6 per year in this study. The relative results of the fire analysis will provide the bases for further risk-informed fire protection evaluation in the near future. (author)

  15. Visualization of Safety Assessment Result Using GIS in SITES

    International Nuclear Information System (INIS)

    Yun, Bong-Yo; Park, Joo Wan; Park, Se-Moon; Kim, Chang-Lak

    2006-01-01

    Site Information and Total Environmental database management System (SITES) is an integrated program for overall data analysis, environmental monitoring, and safety analysis that are produced from the site investigation and environmental assessment of the relevant nuclear facility. SITES is composed of three main modules such as Site Environment Characterization database for Unified and Reliable Evaluation system (SECURE), Safety Assessment INTegration system (SAINT) and Site Useful Data Analysis and ALarm system (SUDAL). The visualization function of safety assessment and environmental monitoring results is designed. This paper is to introduce the visualization design method using Geographic Information System (GIS) for SITES

  16. A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

    Science.gov (United States)

    Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

    2017-09-01

    This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

  17. Additional safety assessment of ITER - Addition safety investigation of the INB ITER

    International Nuclear Information System (INIS)

    2012-01-01

    This assessment aims at re-assessing safety margins in the light of events which occurred in Fukushima Daiichi, i.e. extreme natural events challenging the safety of installations. After a presentation of some characteristics of the ITER installation (location, activities, buildings, premise detritiation systems, electric supply, handling means, radioactive materials, chemical products, nuclear risks, specific risks), the report addresses the installation robustness by identifying cliff-edge effect risks which can be related to a loss of confinement of radioactive materials, explosions, a significant increase of exposure level, a possible effect on water sheets, and so on. The next part addresses the various aspects related to a seismic risk: installation sizing (assessment methodology, seismic risk characterization in Cadarache), sizing protection measures, installation compliance, and margin assessment. External flooding is the next addressed risk: installation sizing with respect to this specific risk, protection measures, installation compliance, margin assessment, and studied additional measures. Other extreme natural phenomena are considered (meteorological conditions, earthquake and flood) which may have effects on other installations (dam, canal). Then, the report addresses technical risks like the loss of electric supplies and cooling systems, the way a crisis is managed in terms of technical and human means and organization in different typical accidental cases. Subcontracting practices are also discussed. A synthesis proposes an overview of this additional safety assessment and discusses the impact which could have additional measures which could be implemented

  18. Exposure data and risk indicators for safety performance assessment in Europe.

    Science.gov (United States)

    Papadimitriou, Eleonora; Yannis, George; Bijleveld, Frits; Cardoso, João L

    2013-11-01

    The objective of this paper is the analysis of the state-of-the-art in risk indicators and exposure data for safety performance assessment in Europe, in terms of data availability, collection methodologies and use. More specifically, the concepts of exposure and risk are explored, as well as the theoretical properties of various exposure measures used in road safety research (e.g. vehicle- and person-kilometres of travel, vehicle fleet, road length, driver population, time spent in traffic, etc.). Moreover, the existing methods for collecting disaggregate exposure data for risk estimates at national level are presented and assessed, including survey methods (e.g. travel surveys, traffic counts) and databases (e.g. national registers). A detailed analysis of the availability and quality of existing risk exposure data is also carried out. More specifically, the results of a questionnaire survey in the European countries are presented, with detailed information on exposure measures available, their possible disaggregations (i.e. variables and values), their conformity to standard definitions and the characteristics of their national collection methods. Finally, the potential of international risk comparisons is investigated, mainly through the International Data Files with exposure data (e.g. Eurostat, IRTAD, ECMT, UNECE, IRF, etc.). The results of this review confirm that comparing risk rates at international level may be a complex task, as the availability and quality of exposure estimates in European countries varies significantly. The lack of a common framework for the collection and exploitation of exposure data limits significantly the comparability of the national data. On the other hand, the International Data Files containing exposure data provide useful statistics and estimates in a systematic way and are currently the only sources allowing international comparisons of road safety performance under certain conditions. Copyright © 2013 Elsevier Ltd. All

  19. Swedish REGULATORY APPROACH TO SAFETY Assessment AND SEVERE ACCIDENT MANAGEMENT

    International Nuclear Information System (INIS)

    Frid, W.; Sandervaag, O.

    1997-01-01

    The Swedish regulatory approach to safety assessment and severe accident management is briefly described. The safety assessment program, which focuses on prevention of incidents and accidents, has three main components: periodic safety reviews, probabilistic safety analysis, and analysis of postulated disturbances and accident progression sequences. Management and man-technology-organisation issues, as well as inspections, play a key role in safety assessment. Basis for severe accident management were established by the Government decisions in 1981 and 1986. By the end of 1988, the severe accident mitigation systems and emergency operating procedures were implemented at all Swedish reactors. The severe accident research has continued after 1988 for further verification of the protection provided by the systems and reduction of remaining uncertainties in risk dominant phenomena

  20. Complementary assessment of the safety of French nuclear power plants

    International Nuclear Information System (INIS)

    Camarcat, N.; Pouget-Abadie, X.

    2011-01-01

    As an immediate consequence of the Fukushima accident the French nuclear safety Authority (ASN) asked EDF to perform a complementary safety assessment for each nuclear power plant dealing with 3 points: 1) the consequences of exceptional natural disasters, 2) the consequences of total loss of electrical power, and 3) the management of emergency situations. The safety margin has to be assessed considering 3 main points: first a review of the conformity to the initial safety requirements, secondly the resistance to events overdoing what the facility was designed to stand for, and the feasibility of any modification susceptible to improve the safety of the facility. This article details the specifications of such assessment, the methodology followed by EDF, the task organization and the time schedule. (A.C.)

  1. Towards Clinical Application of Neurotrophic Factors to the Auditory Nerve; Assessment of Safety and Efficacy by a Systematic Review of Neurotrophic Treatments in Humans

    Directory of Open Access Journals (Sweden)

    Aren Bezdjian

    2016-11-01

    Full Text Available Animal studies have evidenced protection of the auditory nerve by exogenous neurotrophic factors. In order to assess clinical applicability of neurotrophic treatment of the auditory nerve, the safety and efficacy of neurotrophic therapies in various human disorders were systematically reviewed. Outcomes of our literature search included disorder, neurotrophic factor, administration route, therapeutic outcome, and adverse event. From 2103 articles retrieved, 20 randomized controlled trials including 3974 patients were selected. Amyotrophic lateral sclerosis (53% was the most frequently reported indication for neurotrophic therapy followed by diabetic polyneuropathy (28%. Ciliary neurotrophic factor (50%, nerve growth factor (24% and insulin-like growth factor (21% were most often used. Injection site reaction was a frequently occurring adverse event (61% followed by asthenia (24% and gastrointestinal disturbances (20%. Eighteen out of 20 trials deemed neurotrophic therapy to be safe, and six out of 17 studies concluded the neurotrophic therapy to be effective. Positive outcomes were generally small or contradicted by other studies. Most non-neurodegenerative diseases treated by targeted deliveries of neurotrophic factors were considered safe and effective. Hence, since local delivery to the cochlea is feasible, translation from animal studies to human trials in treating auditory nerve degeneration seems promising.

  2. Assessment of safety regulation using an artificial society

    International Nuclear Information System (INIS)

    Furuta, Kazuo; Nagase, Masaya

    2005-01-01

    This study proposes using an artificial society to assess impacts of safety regulation on the society. The artificial society used in this study is a multi-agent system, which consists of many agents representing companies. The agents cannot survive unless they get profits by producing some products. Safety regulation functions as the business environment, which the agents will evolve to fit to. We modeled this process of survival and adaptation by the genetic algorithm. Using the proposed model, case simulations were performed to compare various regulation styles, and some interesting insights were obtained how regulation style influences behavior of the agents and then productivity and safety level of the industry. In conclusion, an effective method for assessment of safety regulation has been developed, and then several insights were shown in this study

  3. Integrated Deterministic-Probabilistic Safety Assessment Methodologies

    Energy Technology Data Exchange (ETDEWEB)

    Kudinov, P.; Vorobyev, Y.; Sanchez-Perea, M.; Queral, C.; Jimenez Varas, G.; Rebollo, M. J.; Mena, L.; Gomez-Magin, J.

    2014-02-01

    IDPSA (Integrated Deterministic-Probabilistic Safety Assessment) is a family of methods which use tightly coupled probabilistic and deterministic approaches to address respective sources of uncertainties, enabling Risk informed decision making in a consistent manner. The starting point of the IDPSA framework is that safety justification must be based on the coupling of deterministic (consequences) and probabilistic (frequency) considerations to address the mutual interactions between stochastic disturbances (e.g. failures of the equipment, human actions, stochastic physical phenomena) and deterministic response of the plant (i.e. transients). This paper gives a general overview of some IDPSA methods as well as some possible applications to PWR safety analyses. (Author)

  4. Human reliability in probabilistic safety assessments

    International Nuclear Information System (INIS)

    Nunez Mendez, J.

    1989-01-01

    Nowadays a growing interest in medioambiental aspects is detected in our country. It implies an assessment of the risk involved in the industrial processess and installations in order to determine if those are into the acceptable limits. In these safety assessments, among which PSA (Probabilistic Safety Assessments), can be pointed out the role played by the human being in the system is one of the more relevant subjects. (This relevance has been demostrated in the accidents happenned). However in Spain there aren't manuals specifically dedicated to asses the human contribution to risk in the frame of PSAs. This report aims to improve this situation providing: a) a theoretical background to help the reader in the understanding of the nature of the human error, b) a guide to carry out a Human Reliability Analysis and c) a selected overwiev of the techniques and methodologies currently applied in this area. (Author)

  5. Probabilistic assessment of NPP safety under aircraft impact

    International Nuclear Information System (INIS)

    Birbraer, A.N.; Roleder, A.J.; Arhipov, S.B.

    1999-01-01

    Methodology of probabilistic assessment of NPP safety under aircraft impact is described below. The assessment is made taking into account not only the fact of aircraft fall onto the NPP building, but another casual parameters too, namely an aircraft class, velocity and mass, as well as point and angle of its impact with the building structure. This analysis can permit to justify the decrease of the required structure strength and dynamic loads on the NPP equipment. It can also be especially useful when assessing the safety of existing NPP. (author)

  6. Nirex Safety Assessment Research Programme bibliography, 1990

    International Nuclear Information System (INIS)

    Cooper, M.J.

    1990-10-01

    This bibliography lists reports and papers written as part of the Nirex Safety Assessment Research Programme, which is concerned with disposal of low-level and intermediate-level waste (LLW and ILW) and associated radiological assessments. (author)

  7. Understanding and assessing safety culture

    International Nuclear Information System (INIS)

    Dalling, Ian

    1997-01-01

    The 'Dalling' integrated model of organisational performance is introduced and described. A principal element of this model is culture, which is dynamically contrasted with the five other interacting critical elements, which comprise: the management system, the knowledge base, corporate leadership, stakeholders and consciousness. All six of these principal driving elements significantly influence health, safety, environmental, security, or any other aspect of organisational performance. It is asserted that the elements of organisational performance must be clearly defined and understood if meaningful measurements are to be carried out and sustained progress made in improving the knowledge of organisational performance. AEA Technology's safety culture research programme is then described together with the application of a safety culture assessment tool to organisations in the nuclear, electricity, transport, and oil and gas industries, both within and outside of the United Kingdom. (author)

  8. Systematic assessment of environmental risk factors for bipolar disorder

    DEFF Research Database (Denmark)

    Bortolato, Beatrice; Köhler, Cristiano A.; Evangelou, Evangelos

    2017-01-01

    factors supported by high epidemiological credibility. Methods: We searched the Pubmed/MEDLINE, EMBASE and PsycInfo databases up to 7 October 2016 to identify systematic reviews and meta-analyses of observational studies that assessed associations between putative environmental risk factors and BD......Objectives: The pathophysiology of bipolar disorder is likely to involve both genetic and environmental risk factors. In our study, we aimed to perform a systematic search of environmental risk factors for BD. In addition, we assessed possible hints of bias in this literature, and identified risk...... met the inclusion criteria (seven meta-analyses and nine qualitative systematic reviews). Fifty-one unique environmental risk factors for BD were evaluated. Six meta-analyses investigated associations with a risk factor for BD. Only irritable bowel syndrome (IBS) emerged as a risk factor for BD...

  9. Efficacy and safety of miconazole for oral candidiasis: a systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, L-W; Fu, J-Y; Hua, H; Yan, Z-M

    2016-04-01

    The objective of this study is to assess the efficacy and safety of miconazole for treating oral candidiasis. Twelve electronic databases were searched for randomized controlled trials evaluating treatments for oral candidiasis and complemented by hand searching. The clinical and mycological outcomes, as well as adverse effects, were set as the primary outcome criteria. Seventeen trials were included in this review. Most studies were considered to have a high or moderate level of bias. Miconazole was more effective than nystatin for thrush. For HIV-infected patients, there was no significant difference in the efficacy between miconazole and other antifungals. For denture wearers, microwave therapy was significantly better than miconazole. No significant difference was found in the safety evaluation between miconazole and other treatments. The relapse rate of miconazole oral gel may be lower than that of other formulations. This systematic review and meta-analysis indicated that miconazole may be an optional choice for thrush. Microwave therapy could be an effective adjunct treatment for denture stomatitis. Miconazole oral gel may be more effective than other formulations with regard to long-term results. However, future studies that are adequately powered, large-scale, and well-designed are needed to provide higher-quality evidence for the management of oral candidiasis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. The use of probabilistic safety assessments for improving nuclear safety in Europe

    International Nuclear Information System (INIS)

    Birkhofer, A.

    1992-01-01

    The political changes in Europe broadened the scope of international nuclear safety matters considerably. The Western world started to receive reliable and increasingly detailed information on Eastern European nuclear technology and took note of a broad range of technical and administrative problems relevant for nuclear safety in these countries. Reunification made Germany a focus of information exchange on these matters. Here, cooperation with the former German Democratic Republic and with other Eastern European countries as well as safety analyses of Soviet-built nuclear power plants started rather early. Meanwhile, these activities are progressing toward all-European cooperation in the nuclear safety sector. This cooperation includes the use of probabilistic safety assessments (PSAs) addressing applications in both Western and Eastern Europe as well as the further development of this methodology in a converging Europe

  11. Risk assessment of safety data link and network communication in digital safety feature control system of nuclear power plant

    International Nuclear Information System (INIS)

    Lee, Sang Hun; Son, Kwang Seop; Jung, Wondea; Kang, Hyun Gook

    2017-01-01

    Highlights: • Safety data communication risk assessment framework and quantitative scheme were proposed. • Fault-tree model of ESFAS unavailability due to safety data communication failure was developed. • Safety data link and network risk were assessed based on various ESF-CCS design specifications. • The effect of fault-tolerant algorithm reliability of safety data network on ESFAS unavailability was assessed. - Abstract: As one of the safety-critical systems in nuclear power plants (NPPs), the Engineered Safety Feature-Component Control System (ESF-CCS) employs safety data link and network communication for the transmission of safety component actuation signals from the group controllers to loop controllers to effectively accommodate various safety-critical field controllers. Since data communication failure risk in the ESF-CCS has yet to be fully quantified, the ESF-CCS employing data communication systems have not been applied in NPPs. This study therefore developed a fault tree model to assess the data link and data network failure-induced unavailability of a system function used to generate an automated control signal for accident mitigation equipment. The current aim is to provide risk information regarding data communication failure in a digital safety feature control system in consideration of interconnection between controllers and the fault-tolerant algorithm implemented in the target system. Based on the developed fault tree model, case studies were performed to quantitatively assess the unavailability of ESF-CCS signal generation due to data link and network failure and its risk effect on safety signal generation failure. This study is expected to provide insight into the risk assessment of safety-critical data communication in a digitalized NPP instrumentation and control system.

  12. Human performance analysis in the frame of probabilistic safety assessment of research reactors

    International Nuclear Information System (INIS)

    Farcasiu, Mita; Nitoi, Mirela; Apostol, Minodora; Turcu, I.; Florescu, Gh.

    2005-01-01

    Full text: The analysis of operating experience has identified the importance of human performance in reliability and safety of research reactors. In Probabilistic Safety Assessment (PSA) of nuclear facilities, human performance analysis (HPA) is used in order to estimate human error contribution to the failure of system components or functions. HPA is a qualitative and quantitative analysis of human actions identified for error-likely situations or accident-prone situations. Qualitative analysis is used to identify all man-machine interfaces that can lead to an accident, types of human interactions which may mitigate or exacerbate the accident, types of human errors and performance shaping factors. Quantitative analysis is used to develop estimates of human error probability as effects of human performance in reliability and safety. The goal of this paper is to accomplish a HPA in the PSA frame for research reactors. Human error probabilities estimated as results of human actions analysis could be included in system event tree and/or system fault tree. The achieved sensitivity analyses determine human performance sensibility at systematically variations both for dependencies level between human actions and for operator stress level. The necessary information was obtained from operating experience of research reactor TRIGA from INR Pitesti. The required data were obtained from generic data bases. (authors)

  13. Savannah River Site K-Reactor Probabilistic Safety Assessment

    International Nuclear Information System (INIS)

    Brandyberry, M.D.; Bailey, R.T.; Baker, W.H.; Kearnaghan, D.P.; O'Kula, K.R.; Wittman, R.S.; Woody, N.D.; Amos, C.N.; Weingardt, J.J.

    1992-12-01

    This report gives the results of a Savannah River Site (SRS) K-Reactor Probabilistic Safety Assessment (PSA). Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide useful information to the U. S. Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other DOE programs in Heavy Water Reactor safety

  14. Car-to-Pedestrian Communication Safety System Based on the Vehicular Ad-Hoc Network Environment: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Peng Jing

    2017-10-01

    Full Text Available With the unparalleled growth of motor vehicles, traffic accident between pedestrians and vehicles is one of the most serious issues in the word-wild. Plenty of injuries and fatalities are caused by the traffic accidents and crashes. The connected vehicular ad hoc network as an emerging approach which has the potential to reduce and even avoid accidents have been focused on by many researchers. A large number of car-to-pedestrian communication safety systems based on the vehicular ad hoc network are researching and developing. However, to our limited knowledge, a systematic review about the car-to-pedestrian communication safety system based on the vehicular ad-hoc network has not be written. The purpose and goal of this review is to systematically evaluate and access the reliability of car-to-pedestrian communication safety system based on the vehicular ad-hoc network environment and provide some recommendations for the future works according to throwing some light on the previous literatures. A quality evaluation was developed through established items and instruments tailored to this review. Future works are needed to focus on developing a valid as well as effective communication safety system based on the vehicular ad hoc network to protect the vulnerable road users.

  15. Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

    Science.gov (United States)

    Guarro, Sergio B.

    2010-01-01

    This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

  16. A novel safety assessment strategy applied to non-selective extracts.

    Science.gov (United States)

    Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

    2015-06-01

    A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Suggestions on the Development of Safety Culture Assessment Method

    International Nuclear Information System (INIS)

    Choi, Young Sung; Choi, Kwang Sik; Kim, Woong Sik

    2006-01-01

    Several efforts have been made to assess safety culture of organization that operates nuclear power plants in Korea. The MOST and KINS played a major role to develop assessment methods and KHNP applied them to its NPPs. This paper explains the two methods developed by KINS briefly and presents the insights obtained from the two different applications. It concludes with some suggestions for safety culture assessment based on the insights

  18. Efficacy and safety of laxatives for chronic constipation in long-term care settings: A systematic review.

    Science.gov (United States)

    Alsalimy, N; Madi, L; Awaisu, A

    2018-06-09

    Constipation is a common disorder among long-term care (LTC) patients due to several factors. However, there are no systematic reviews investigating the use of laxatives for chronic constipation in LTC settings. This study aims to explore the safety and efficacy of laxatives in LTC patients. A systematic review of randomized controlled trials (RCTs) describing the efficacy and safety of laxatives for chronic constipation in LTC patients was conducted using the following databases and search engines: MEDLINE, Cochrane Database of Systematic Reviews, ScienceDirect, ProQuest and Google Scholar. Two of the investigators independently performed the searches, and the data were extracted using a standardized data abstraction tool. Seven RCTs involving 444 patients were included in the review. These studies included senna (with or without fibre, ie Plantago ovata), lactulose, sodium picosulphate, docusate sodium, docusate calcium, isotonic and hypotonic polyethylene glycol and Chinese herbal medicine. Senna and lactulose were the most studied laxatives in LTC patients, and senna was found to be superior to or as effective as other laxatives. Generally, the frequency and severity of adverse drug reactions (ADRs) were similar between the arms of the studies, and no serious ADRs were reported. Considering the short duration of the trials, the lack of trials including newer laxatives and the low quality of some of the included trials, the long-term efficacy and safety of these laxatives are not conclusive. There is a need to conduct more robust RCTs that include newer agents to evaluate long-term outcomes. © 2018 John Wiley & Sons Ltd.

  19. Methodology for the Systematic Assessment of the Regulatory Competence Needs (SARCoN) for Regulatory Bodies of Nuclear Installations

    International Nuclear Information System (INIS)

    2015-03-01

    A regulatory body’s competence is dependent, among other things, on the competence of its staff. A necessary, but not sufficient, condition for a regulatory body to be competent is that its staff can perform the tasks related to the functions of the regulatory body. In 2001, the IAEA published TECDOC 1254, Training the Staff of the Regulatory Body for Nuclear Facilities: A Competency Framework, which examines the manner in which the recognized regulatory functions of a nuclear regulatory body results in competence needs. Using the internationally recognized systematic approach to training, TECDOC 1254 provides a framework for regulatory bodies for managing training and developing, and maintaining the competence of its staff. It has been successfully used by many regulatory bodies all over the world, including States embarking on a nuclear power programme. The IAEA has also introduced a methodology and an assessment tool — Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) — which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2013, the IAEA published Safety Reports Series No. 79, Managing Regulatory Body Competence, which provides generic guidance based on IAEA safety requirements in the development of a competence management system within a regulatory body’s integrated management system. An appendix in the Safety Report deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an embarking State’s regulatory system. This publication provides guidance for the analysis of required and existing competences to identify those required by the regulatory body to perform its functions and therefore associated needs for acquiring competences. Hence, it is equally applicable to the needs of States embarking on nuclear power

  20. Safety assessment of primary system components at the USNRC

    Energy Technology Data Exchange (ETDEWEB)

    Serpan, C Z; Chen, C Y; Taboada, A

    1988-12-31

    This document deals with the safety assessment in nuclear reactor components at the USNRC. The USNRC regulations and requirements concerning nuclear reactor design and operations are presented, together with guides and standards which describe how the actions should be implemented. The safety assessment relies on fracture analysis and Non Destructive Examination (NDE). (TEC).

  1. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

    International Nuclear Information System (INIS)

    Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

    2008-12-01

    The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments that lie outside the

  2. Patient Safety and Quality Improvement in Otolaryngology Education: A Systematic Review.

    Science.gov (United States)

    Gettelfinger, John D; Paulk, P Barrett; Schmalbach, Cecelia E

    2017-06-01

    Objective The breadth and depth of patient safety/quality improvement (PS/QI) research dedicated to otolaryngology-head and neck surgery (OHNS) education remains unknown. This systematic review aims to define this scope and to identify knowledge gaps as well as potential areas of future study to improved PS/QI education and training in OHNS. Data Sources A computerized Ovid/Medline database search was conducted (January 1, 1965, to May 15, 2015). Similar computerized searches were conducted using Cochrane Database, PubMed, and Google Scholar. Review Methods The study protocol was developed a priori using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles were classified by year, subspecialty, Institute of Medicine (IOM) Crossing the Chasm categories, and World Health Organization (WHO) subclass. Results Computerized searches yielded 8743 eligible articles, 267 (3.4%) of which met otolaryngology PS/QI inclusion criteria; 51 (19%) were dedicated to resident/fellow education and training. Simulation studies (39%) and performance/competency evaluation (23.5%) were the most common focus. Most projects involved general otolaryngology (47%), rhinology (18%), and otology (16%). Classification by the IOM included effective care (45%), safety/effective care (41%), and effective and efficient care (7.8%). Most research fell into the WHO category of "identifying solutions" (61%). Conclusion Nineteen percent of OHNS PS/QI articles are dedicated to education, the majority of which are simulation and focus on effective care. Knowledges gaps for future research include facial plastics PS/QI and the WHO category of "studies translating evidence into safer care."

  3. Operational safety review programmes for nuclear power plants. Guidelines for assessment

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA has been offering the Operational Safety Review Team (OSART) programme to provide advice and assistance to Member States in enhancing the operational safety of nuclear power plants (NPPs). Simultaneously, the IAEA has encouraged self-assessment and review by Member States of their own nuclear power plants to continuously improve nuclear safety. Currently, some utilities have been implementing safety review programmes to independently review their own plants. Corporate or national operational safety review programmes may be compliance or performance based. Successful utilities have found that both techniques are necessary to provide assurance that (i) as a minimum the NPP meets specific corporate and legal requirements and (ii) management at the NPP is encouraged to pursue continuous improvement principles. These programmes can bring nuclear safety benefits to the plants and utilities. The IAEA has conducted two pilot missions to assess the effectiveness of the operational review programme. Based on these missions and on the experience gained during OSART missions, this document has been developed to provide guidance on and broaden national/corporate safety review programmes in Member States, and to assist in maximizing their benefits. These guidelines are intended primarily for the IAEA team to conduct assessment of a national/corporate safety review programme. However, this report may also be used by a country or utility to establish its own national/corporate safety review programme. The guidelines may likewise be used for self-assessment or for establishing a baseline when benchmarking other safety review programmes. This report consists of four parts. Section 2 addresses the planning and preparation of an IAEA assessment mission and Sections 3 and 4 deal with specific guidelines for conducting the assessment mission itself

  4. Systematic assessment of core assurance activities in a company specific food safety management system

    NARCIS (Netherlands)

    Luning, P.A.; Marcelis, W.J.; Rovira, J.; Spiegel, van der M.; Uyttendaele, M.; Jacxsens, L.

    2009-01-01

    The dynamic environment wherein agri-food companies operate and the high requirements on food safety force companies to critically judge and improve their food safety management system (FSMS) and its performance. The objective of this study was to develop a diagnostic instrument enabling a

  5. Flamanville 3 EPR, Safety Assessment and On-site Inspections

    International Nuclear Information System (INIS)

    Piedagnel, Corinne; Tarallo, Francois; Monnot, Bernard

    2011-01-01

    As a Technical Support Organisation of the French Safety Authority (ASN), the IRSN carries out the safety assessment of EPR project design and participates in the ASN inspections performed at the construction site and in factories. The design assessment consists in defining the safety functions which should be ensured by civil structures, evaluating the EPR Technical Code for Civil works (ETC-C) in which EdF has defined design criteria and construction rules, and carrying out a detailed assessment of a selection of safety-related structures. Those detailed assessments do not consist of a technical control but of an analysis whose objectives are to ensure that design and demonstrations are robust, in accordance with safety and regulatory rules. Most assessments led IRSN to ask EdF to provide additional justification sometimes involving significant modifications. In the light of those complementary justifications and modifications, IRSN concluded that assessments carried out on design studies were globally satisfactory. The participation of IRSN to the on-site inspections led by ASN is a part of the global control of the compliance of the reactor with its safety objectives. For that purpose IRSN has defined a methodology and an inspection program intended to ASN: based on safety functions associated with civil works (confinement and resistance to aggressions), the corresponding behaviour requirements are identified and linked to a list of main civil works elements. During the inspections, deviations to the project's technical specifications or to the rules of the art were pointed out by IRSN. Those deviations cover various items, such as concrete fabrication, concrete pouring methodology, lack of reinforcement in some structures, unadapted welding procedures of the containment leak-tight steel liner and unsatisfactory treatment of concreting joints. The analysis of those problems has revealed flaws in the organisation of the contractors teams together with an

  6. Prospects for probabilistic safety assessment

    International Nuclear Information System (INIS)

    Hirschberg, S.

    1992-01-01

    This article provides some reflections on future developments of Probabilistic Safety Assessment (PSA) in view of the present state of the art and evaluates current trends in the use of PSA for safety management. The main emphasis is on Level 1 PSA, although Level 2 aspects are also highlighted to some extent. As a starting point, the role of PSA is outlined from a historical perspective, demonstrating the rapid expansion of the uses of PSA. In this context the wide spectrum of PSA applications and the associated benefits to the users are in focus. It should be kept in mind, however, that PSA, in spite of its merits, is not a self-standing safety tool. It complements deterministic analysis and thus improves understanding and facilitating prioritization of safety issues. Significant progress in handling PSA limitations - such as reliability data, common-cause failures, human interactions, external events, accident progression, containment performance, and source-term issues - is described. This forms a background for expected future developments of PSA. Among the most important issues on the agenda for the future are PSA scope extensions, methodological improvements and computer code advancements, and full exploitation of the potential benefits of applications to operational safety management. Many PSA uses, if properly exercised, lead to safety improvements as well as major burden reductions. The article provides, in addition, International Atomic Energy Agency (IAEA) perspective on the topics covered, as reflected in the current PSA programs of the agency. 74 refs., 6 figs., 1 tab

  7. Training courses on integrated safety assessment modelling for waste repositories

    International Nuclear Information System (INIS)

    Mallants, D.

    2007-01-01

    Near-surface or deep repositories of radioactive waste are being developed and evaluated all over the world. Also, existing repositories for low- and intermediate-level waste often need to be re-evaluated to extend their license or to obtain permission for final closure. The evaluation encompasses both a technical feasibility as well as a safety analysis. The long term safety is usually demonstrated by means of performance or safety assessment. For this purpose computer models are used that calculate the migration of radionuclides from the conditioned radioactive waste, through engineered barriers to the environment (groundwater, surface water, and biosphere). Integrated safety assessment modelling addresses all relevant radionuclide pathways from source to receptor (man), using in combination various computer codes in which the most relevant physical, chemical, mechanical, or even microbiological processes are mathematically described. SCK-CEN organizes training courses in Integrated safety assessment modelling that are intended for individuals who have either a controlling or supervising role within the national radwaste agencies or regulating authorities, or for technical experts that carry out the actual post-closure safety assessment for an existing or new repository. Courses are organised by the Department of Waste and Disposal

  8. Human Reliability in Probabilistic Safety Assessments

    International Nuclear Information System (INIS)

    Nunez Mendez, J.

    1989-01-01

    Nowadays a growing interest in environmental aspects is detected in our country. It implies an assessment of the risk involved in the industrial processes and installations in order to determine if those are into the acceptable limits. In these safety assessments, among which PSA (Probabilistic Safety Assessments), can be pointed out the role played by the human being in the system is one of the more relevant subjects (This relevance has been demonstrated in the accidents happened) . However, in Spain there aren't manuals specifically dedicated to asses the human contribution to risk in the frame of PSAs. This report aims to improve this situation providing: a) a theoretical background to help the reader in the understanding of the nature of the human error, b) a quid to carry out a Human Reliability Analysis and c) a selected overview of the techniques and methodologies currently applied in this area. (Author) 20 refs

  9. Interim process report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Sellin, Patrick

    2004-08-01

    This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses

  10. Interim process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrick (ed.)

    2004-08-01

    This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses.

  11. Probabilistic safety assessment goals in Canada

    International Nuclear Information System (INIS)

    Snell, V.G.

    1986-01-01

    CANDU safety philosphy, both in design and in licensing, has always had a strong bias towards quantitative probabilistically-based goals derived from comparative safety. Formal probabilistic safety assessment began in Canada as a design tool. The influence of this carried over later on into the definition of the deterministic safety guidelines used in CANDU licensing. Design goals were further developed which extended the consequence/frequency spectrum of 'acceptable' events, from the two points defined by the deterministic single/dual failure analysis, to a line passing through lower and higher frequencies. Since these were design tools, a complete risk summation was not necessary, allowing a cutoff at low event frequencies while preserving the identification of the most significant safety-related events. These goals gave a logical framework for making decisions on implementing design changes proposed as a result of the Probabilistic Safety Analysis. Performing this analysis became a regulatory requirement, and the design goals remained the framework under which this was submitted. Recently, there have been initiatives to incorporate more detailed probabilistic safety goals into the regulatory process in Canada. These range from far-reaching safety optimization across society, to initiatives aimed at the nuclear industry only. The effectiveness of the latter is minor at very low and very high event frequencies; at medium frequencies, a justification against expenditures per life saved in other industries should be part of the goal setting

  12. Probabilistic Safety Assessment of Waste from PyroGreen Processes

    International Nuclear Information System (INIS)

    Ju, Hee Jae; Ham, In hye; Hwang, Il Soon

    2016-01-01

    The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.

  13. Probabilistic Safety Assessment of Waste from PyroGreen Processes

    Energy Technology Data Exchange (ETDEWEB)

    Ju, Hee Jae; Ham, In hye; Hwang, Il Soon [Seoul National University, Seoul (Korea, Republic of)

    2016-05-15

    The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.

  14. Electronuclear's safety culture assessment and enhancement program

    International Nuclear Information System (INIS)

    Selvatici, E.; Diaz-Francisco, J.M.; Diniz de Souza, V.

    2002-01-01

    The present paper describes the Eletronuclear's safety culture assessment and enhancement program. The program was launched by the company's top management one year after the creation of Eletronuclear in 1997, from the merging of two companies with different organizational cultures, the design and engineering company Nuclen and the nuclear directorate of the Utility Furnas, Operator of the Angra1 NPP. The program consisted of an assessment performed internally in 1999 with the support and advice of the IAEA. This assessment, performed with the help of a survey, pooled about 80% of the company's employees. The overall result of the assessment was that a satisfactory level of safety culture existed; however, a number of points with a considerable margin for improvement were also identified. These points were mostly related with behavioural matters such as motivation, stress in the workplace, view of mistakes, handling of conflicts, and last but not least a view by a considerable number of employees that a conflict between safety and production might exist. An Action Plan was established by the company managers to tackle these weak points. This Plan was issued as company guideline by the company's Directorate. The subsequent step was to detail and implement the different actions of the Plan, which is the phase that we are at present. In the detailing of the Action Plan, special care was taken to sum up efforts, avoiding duplication of work or competition with already existing programs. In this process it was identified that the company had a considerable number of initiatives directly related to organizational and safety culture improvement, already operational. These initiatives have been integrated in the detailed Action Plan. A new assessment, for checking the effectiveness of the undertaken actions, is planned for 2003. (author)

  15. Ignalina Safety Analysis Group

    International Nuclear Information System (INIS)

    Ushpuras, E.

    1995-01-01

    The article describes the fields of activities of Ignalina NPP Safety Analysis Group (ISAG) in the Lithuanian Energy Institute and overview the main achievements gained since the group establishment in 1992. The group is working under the following guidelines: in-depth analysis of the fundamental physical processes of RBMK-1500 reactors; collection, systematization and verification of the design and operational data; simulation and analysis of potential accident consequences; analysis of thermohydraulic and neutronic characteristics of the plant; provision of technical and scientific consultations to VATESI, Governmental authorities, and also international institutions, participating in various projects aiming at Ignalina NPP safety enhancement. The ISAG is performing broad scientific co-operation programs with both Eastern and Western scientific groups, supplying engineering assistance for Ignalina NPP. ISAG is also participating in the joint Lithuanian - Swedish - Russian project - Barselina, the first Probabilistic Safety Assessment (PSA) study of Ignalina NPP. The work is underway together with Maryland University (USA) for assessment of the accident confinement system for a range of breaks in the primary circuit. At present the ISAG personnel is also involved in the project under the grant from the Nuclear Safety Account, administered by the European Bank for reconstruction and development for the preparation and review of an in-depth safety assessment of the Ignalina plant

  16. Operating experience review for nuclear power plants in the Systematic Evaluation Program

    International Nuclear Information System (INIS)

    Mays, G.T.; Harrington, K.H.

    1982-01-01

    The Systematic Evaluation Program Branch (SEPB) of the Nuclear Regulatory Commission (NRC) is conducting the Systematic Evaluation Program (SEP) whose purpose is to determine the safety margins of the design and operation of the eleven oldest operating commercial nuclear power plants in the United States. This paper describes the methodology and results of the operational experience review portion of the SEP evaluation. SEPB will combine the results from these operational reviews with other safety topic evaluations to perform an integrated assessment of the SEP plants

  17. Development of a quality assurance safety assessment database for near surface radioactive waste disposal

    International Nuclear Information System (INIS)

    Park, J. W.; Kim, C. L.; Park, J. B.; Lee, E. Y.; Lee, Y. M.; Kang, C. H.; Zhou, W.; Kozak, M. W.

    2003-01-01

    A quality assurance safety assessment database, called QUARK (QUality Assurance program for Radioactive waste management in Korea), has been developed to manage both analysis information and parameter database for safety assessment of Low- and Intermediate-Level radioactive Waste (LILW) disposal facility in Korea. QUARK is such a tool that serves QA purposes for managing safety assessment information properly and securely. In QUARK, the information is organized and linked to maximize the integrity of information and traceability. QUARK provides guidance to conduct safety assessment analysis, from scenario generation to result analysis, and provides a window to inspect and trace previous safety assessment analysis and parameter values. QUARK also provides default database for safety assessment staff who construct input data files using SAGE(Safety Assessment Groundwater Evaluation), a safety assessment computer code

  18. Safety assessments for deep geological disposal of radioactive wastes

    International Nuclear Information System (INIS)

    Lyon, R.B.

    1984-01-01

    The objective of safety assessment for deep geological disposal of radioactive wastes is to evaluate how well the engineered barriers and geological setting inhibit radionuclide migration and prevent radiation dose to man. Safety assessment is influenced through interaction with the regulatory agencies, research groups, the public and the various levels of government. Under the auspices of the IAEA, a generic disposal system description has been developed to facilitate international exchange and comparison of data and results, and to enable development and comparison of performance for all components of the disposal system. It is generally accepted that a systems modelling approach is required and that safety assessment can be considered on two levels. At the systems level, all components of the system are taken into account to evaluate the risk to man. At the systems level, critical review and quality assurance on software provide the major validation techniques. Risk is a combination of dose estimate and probability of that dose. For analysis of the total system to be practical, the components are usually represented by simplified models. Recently, assessments have been taking uncertainties in the input data into account. At the detailed level, large-scale, complex computer programs model components of the system in sufficient detail that validation by comparison with field and laboratory measurements is possible. For example, three-dimensional fluid-flow, heat-transport and solute-transport computer programs have been used. Approaches to safety assessment are described, with illustrations from safety assessments performed in a number of countries. (author)

  19. New safety performance indicators for safety assessment of radioactive waste disposal facilities. Cuban experience

    International Nuclear Information System (INIS)

    Peralta Vital, J.L.; Castillo, R.G.; Olivera, J.

    2002-01-01

    The paper shows the Cuban experience on implementing geological disposal of radioactive waste and the necessity for identifying new safety performance indicators for the safety assessment (SA) of radioactive waste disposal facilities. The selected indicator was the concentration of natural radioactive elements (U, Ra, Th, K) in the Cuban geologic environment. We have carried out a group of investigations, which have allowed characterising the concentration for the whole Country, creating a wide database where this indicator is associated with the lithology. The main lithologies in Cuba are: the sedimentary rocks (70 percent of national occurrence), which are present in the three regions (limestone and lutite), and finally the igneous and metamorphic rocks. The results show the concentrations ranges of the natural radionuclides associated fundamentally to the variation in the lithology and geographical area of the Country. In Cuba, the higher concentration (ppm) of Uranium and Radium are referenced to the Central region associated to Skarn, while for Thorium (ppm) and Potassium (%), in the East region the concentration peaks in Tuffs have been found. The concentrations ranges obtained are preliminary, they characterise the behaviour of this parameter for the Cuban geology, but they do not represent limits for safety assessment purposes yet. Also other factors should be taken into account as the assessment context, time scales and others assumptions before establishing the final concentration limits for the natural radionuclides as a radiological and nuclear safety performance indicator complementary to dose and risk for safety assessment for radiological and nuclear facilities. (author)

  20. Safety Assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto

    International Nuclear Information System (INIS)

    Smith, P.; Neall, F.; Snellman, M.; Pastina, B.; Hjerpe, T.; Nordman, H.; Johnson, L.

    2007-12-01

    The KBS-3 method, based on multiple barriers, is the proposed spent fuel disposal method both in Sweden and Finland. KBS-3H and KBS-3V are the two design alternatives of the KBS-3 spent fuel disposal method. Posiva and SKB have conducted a joint research, demonstration and development (RD and D) programme in 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to the reference alternative KBS-3V. The overall objectives of the present phase covering the period 2004-2007 have been to demonstrate that the horizontal deposition alternative is technically feasible and to demonstrate that it fulfils the same long-term safety requirements as KBS-3V. The safety studies conducted as part of this programme include a safety assessment of a preliminary design of a KBS-3H repository for spent nuclear fuel located about 400 m underground at the Olkiluoto site, which is the proposed site for a spent fuel repository in Finland. This safety assessment is summarised in the present report. The scientific basis of the safety assessment includes around 30 years of scientific R and D and technical development in the Swedish and Finnish KBS-3V programmes. Much of this scientific basis is directly applicable to KBS-3H. This has allowed the KBS-3H safety studies to focus on those issues that are unique to this design alternative, identified in a systematic difference analysis of KBS-3H and KBS-3V. This difference analysis has shown that the key differences in the evolution and performance of KBS-3H and KBS-3V relate mainly to the engineered barrier system and to the impact of local variations in the rate of groundwater inflow on buffer saturation along the KBS-3H deposition drifts. No features or processes specific to KBS-3H have been identified that could lead to a loss or substantial degradation of the safety functions of the engineered barriers over a million year time frame. Radionuclide release from the repository near field in the event of

  1. The impact of telehealthcare on the quality and safety of care: a systematic overview.

    Directory of Open Access Journals (Sweden)

    Susannah McLean

    Full Text Available Telehealthcare involves the use of information and communication technologies to deliver healthcare at a distance and to support patient self-management through remote monitoring and personalised feedback. It is timely to scrutinise the evidence regarding the benefits, risks and costs of telehealthcare.Two reviewers searched for relevant systematic reviews published from January 1997 to November 2011 in: The Cochrane Library, MEDLINE, EMBASE, LILACS, IndMed and PakMed. Reviewers undertook independent quality assessment of studies using the Critical Appraisal Skills Programme (CASP tool for systematic reviews. 1,782 review articles were identified, from which 80 systematic reviews were selected for inclusion. These covered a range of telehealthcare models involving both synchronous (live and asynchronous (store-and-forward interactions between provider and patients. Many studies showed no differences in outcomes between telehealthcare and usual care. Several reviews highlighted the large number of short-term (<12 months feasibility studies with under 20 participants. Effects of telehealthcare on health service indicators were reported in several reviews, particularly reduced hospitalisations. The reported clinical effectiveness of telehealthcare interventions for patients with long-term conditions appeared to be greatest in those with more severe disease at high-risk of hospitalisation and death. The failure of many studies to adequately describe the intervention makes it difficult to disentangle the contributions of technological and human/organisational factors on the outcomes reported. Evidence on the cost-effectiveness of telehealthcare remains sparse. Patient safety considerations were absent from the evaluative telehealthcare literature.Policymakers and planners need to be aware that investment in telehealthcare will not inevitably yield clinical or economic benefits. It is likely that the greatest gains will be achieved for patients at

  2. EFFICIENT QUANTITATIVE RISK ASSESSMENT OF JUMP PROCESSES: IMPLICATIONS FOR FOOD SAFETY

    OpenAIRE

    Nganje, William E.

    1999-01-01

    This paper develops a dynamic framework for efficient quantitative risk assessment from the simplest general risk, combining three parameters (contamination, exposure, and dose response) in a Kataoka safety-first model and a Poisson probability representing the uncertainty effect or jump processes associated with food safety. Analysis indicates that incorporating jump processes in food safety risk assessment provides more efficient cost/risk tradeoffs. Nevertheless, increased margin of safety...

  3. Safety re-assessment of AECL test and research reactors

    International Nuclear Information System (INIS)

    Winfield, D.J.

    1990-01-01

    Atomic Energy of Canada Limited currently has four operating engineering test/research reactors of various sizes and ages; a new isotope-production reactor Maple-X10, under construction at Chalk River Nuclear Laboratories (CRNL), and a heating demonstration reactor, SDR, undergoing high-power commissioning at Whiteshell Nuclear Research Establishment (WNRE). The company is also performing design studies of small reactors for hot water and electricity production. The older reactors are ZED-2, PTR, NRX, and NRU; these range in age from 42 years (NRX) to 29 years (ZED-2). Since 1984, limited-scope safety re-assessments have been underway on three of these reactors (ZED-2, NRX AND NRU). ZED-2 and PTR are operated by the Reactor Physics Branch; all other reactors are operated by the respective site Reactor Operations Branches. For the older reactors the original safety reports produced were entirely deterministic in nature and based on the design-basis accident concept. The limited scope safety re-assessments for these older reactors, carried out over the past 5 years, have comprised both quantitative probabilistic safety-assessment techniques, such as event tree and fault analysis, and/or qualitative techniques, such as failure mode and effect analysis. The technique used for an individual assessment was dependent upon the specific scope required. This paper discusses the types of analyses carried out, specific insights/recommendations resulting from the analysis, and the plan for future analysis. In addition, during the last four years safety assessments have been carried out on the new isotope-, heat-, and electricity-producing reactors, as part of the safety design review, commissioning and licensing activities

  4. A Level 1+ Probabilistic Safety Assessment of the High Flux Australian Reactor. Vol 1

    International Nuclear Information System (INIS)

    1998-01-01

    The Department of Industry, Science and Tourism selected PLG, an EQE International Company, to systematically and independently evaluate the safety of the High Flux Australian Reactor (HIFAR), located at Lucas Heights, New South Wales. PLG performed a comprehensive probabilistic safety assessment (PSA) to quantify the risks posed by operation of HIFAR . The PSA identified possible accident scenarios, estimated their likelihood of occurrence, and assigned each scenario to a consequence category; i.e., end state. The accident scenarios developed included the possible release of radioactive material from irradiated nuclear fuel and of tritium releases from reactor coolant. The study team developed a recommended set of safety criteria against which the results of the PSA may be judged. HIFAR was found to exceed one of the two primary safety objectives and two of the five secondary safety objectives. Reactor coolant leaks, earthquakes, and coolant pump trips were the accident initiators that contributed most to scenarios that could result in fuel overheating. Scenarios initiated by earthquakes were the reason the frequency criterion for the one primary safety objective was exceeded. Overall, the plant safety status has been shown to be generally good with no evidence of major safety-related problems from its operation. One design deficiency associated with the emergency core cooling system was identified that should be corrected as soon as possible. Additionally, several analytical issues have been identified that should be investigated further. The results from these additional investigations should be used to determine whether additional plant and procedural changes are required, or if further evaluations of postulated severe accidents are warranted. Supporting information can be found in Appendix A for the seismic analysis and in the Appendix B for selected other external events

  5. A Level 1+ Probabilistic Safety Assessment of the High Flux Australian Reactor. Vol 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-01-01

    The Department of Industry, Science and Tourism selected PLG, an EQE International Company, to systematically and independently evaluate the safety of the High Flux Australian Reactor (HIFAR), located at Lucas Heights, New South Wales. PLG performed a comprehensive probabilistic safety assessment (PSA) to quantify the risks posed by operation of HIFAR . The PSA identified possible accident scenarios, estimated their likelihood of occurrence, and assigned each scenario to a consequence category; i.e., end state. The accident scenarios developed included the possible release of radioactive material from irradiated nuclear fuel and of tritium releases from reactor coolant. The study team developed a recommended set of safety criteria against which the results of the PSA may be judged. HIFAR was found to exceed one of the two primary safety objectives and two of the five secondary safety objectives. Reactor coolant leaks, earthquakes, and coolant pump trips were the accident initiators that contributed most to scenarios that could result in fuel overheating. Scenarios initiated by earthquakes were the reason the frequency criterion for the one primary safety objective was exceeded. Overall, the plant safety status has been shown to be generally good with no evidence of major safety-related problems from its operation. One design deficiency associated with the emergency core cooling system was identified that should be corrected as soon as possible. Additionally, several analytical issues have been identified that should be investigated further. The results from these additional investigations should be used to determine whether additional plant and procedural changes are required, or if further evaluations of postulated severe accidents are warranted. Supporting information can be found in Appendix A for the seismic analysis and in the Appendix B for selected other external events refs., 139 tabs., 85 figs. Prepared for Department of Industry, Science and Tourism

  6. Value-impact assessment of safety-related modifications

    International Nuclear Information System (INIS)

    Knowles, W.M.C.; Dinnie, K.S.; Gordon, C.W.

    1992-01-01

    Like other nuclear utilities, Ontario Hydro, as part of its risk management activities, continually assesses the safety of its nuclear operations. In addition, new regulatory requirements are being applied to the older nuclear power plants. Both of these result in proposed plant modifications designed to reduce the risk to the public. However, modifications to an operating plant can have serious economic effects, and the resources, both financial and personnel, required for the implementation of these modifications are limited. Thus, all potential benefits and effects of a proposed modification must be thoroughly investigated to judge whether the modification is beneficial. Ontario Hydro has begun to use comprehensive value-impact assessments, utilizing plant-specific probabilistic risk assessments (PRAs), as tools to provide an informed basis for judgments on the benefit of safety-related modifications. The results from value-impact assessments can also be used to prioritize the implementation of these modifications

  7. Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

    Science.gov (United States)

    Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

    2016-10-01

    This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

  8. Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

    OpenAIRE

    Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

    2012-01-01

    Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) an...

  9. Integrated safety assessment report: Integrated Safety Assessment Program: Millstone Nuclear Power Station, Unit 1 (Docket No. 50-245): Draft report

    International Nuclear Information System (INIS)

    1987-04-01

    The Integrated Safety Assessment Program (ISAP) was initiated in November 1984, by the US Nuclear Regulatory Commission to conduct integrated assessments for operating nuclear power reactors. The integrated assessment is conducted in a plant-specific basis to evaluate all licensing actions, licensee initiated plant improvements and selected unresolved generic/safety issues to establish implementation schedules for each item. In addition, procedures will be established to allow for a periodic updating of the schedules to account for licensing issues that arise in the future. This report documents the review of Millstone Nuclear Power Station, Unit No. 1, operated by Northeast Nuclear Energy Company (located in Waterford, Connecticut). Millstone Nuclear Power Station, Unit No. 1, is one of two plants being reviewed under the pilot program for ISAP. This report indicates how 85 topics selected for review were addressed. This report presents the staff's recommendations regarding the corrective actions to resolve the 85 topics and other actions to enhance plant safety. The report is being issued in draft form to obtain comments from the licensee, nuclear safety experts, and the Advisory Committee for Reactor Safeguards (ACRS). Once those comments have been resolved, the staff will present its positions, along with a long-term implementation schedule from the licensee, in the final version of this report

  10. Assessing progress in the development of safety culture

    International Nuclear Information System (INIS)

    Rotaru, Ioan; Ghita, Sorin

    1999-01-01

    The concept of safety culture was introduced by the International Nuclear Safety Advisory Group (INSAG) in the Summary Report on the Post-Accident Meeting on the Chernobyl Accident in 1986. The concept was further expanded in the 1988 INSAG-3 report, Basic Safety Principles for Nuclear Power Plants, and again in 1991 in the INSAG-4 report. Recognizing the increasing role that safety culture is expected to play in nuclear installations worldwide, the Convention on Nuclear Safety states the Contracting Parties' desire 'to promote an effective nuclear safety culture'. The concept of safety culture is defined in INSAG-4 as follows: Safety culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance. Safety culture is also an amalgamation of values, standards, morals and norms of acceptable behaviour. These are aimed at maintaining a self disciplined approach to the enhancement of safety beyond legislative and regulatory requirements. Therefore, the safety culture has to be inherent in the thoughts and actions of all the individuals at every level in an organization. The leadership provided by top management is crucial. Safety culture applies to conventional and personal safety as well as nuclear safety. All safety consideration are affected by common points of beliefs, attitudes, behaviour, and cultural differences, closely linked to a shared system of values and standards. The paper poses questions and tries to find answers relative to issues like: - how to assess progress; - specific organizational indicators of a progressive safety culture; - detection of incipient weaknesses in safety culture (organizational issues, employee issues, technology issues); - revitalizing a weakened safety culture; - overall assesment of safety culture; - general evaluation model. In conclusion, there is no consistent and

  11. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

    Energy Technology Data Exchange (ETDEWEB)

    Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

    2008-12-15

    The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments

  12. Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities

    International Nuclear Information System (INIS)

    Batandjieva, B.; Torres-Vidal, C.

    2002-01-01

    The International Atomic Energy Agency (IAEA) Coordinated research program ''Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities'' (ISAM) has developed improved safety assessment methodology for near surface disposal facilities. The program has been underway for three years and has included around 75 active participants from 40 countries. It has also provided examples for application to three safety cases--vault, Radon type and borehole radioactive waste disposal facilities. The program has served as an excellent forum for exchange of information and good practices on safety assessment approaches and methodologies used worldwide. It also provided an opportunity for reaching broad consensus on the safety assessment methodologies to be applied to near surface low and intermediate level waste repositories. The methodology has found widespread acceptance and the need for its application on real waste disposal facilities has been clearly identified. The ISAM was finalized by the end of 2000, working material documents are available and an IAEA report will be published in 2002 summarizing the work performed during the three years of the program. The outcome of the ISAM program provides a sound basis for moving forward to a new IAEA program, which will focus on practical application of the safety assessment methodologies to different purposes, such as licensing radioactive waste repositories, development of design concepts, upgrading existing facilities, reassessment of operating repositories, etc. The new program will also provide an opportunity for development of guidance on application of the methodology that will be of assistance to both safety assessors and regulators

  13. [Agricultural biotechnology safety assessment].

    Science.gov (United States)

    McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

    2015-01-01

    Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be

  14. The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature.

    Science.gov (United States)

    Derrick, Chase D; Shridharani, Sachin M; Broyles, Justin M

    2015-09-01

    In the past decade, the practice of body contouring using cryolipolysis has increased tremendously. While numerous anecdotal reports extol the efficacy of this product, the majority of these studies are small, retrospective case-series that lack control groups. The authors aim to systematically review available literature to better illustrate the efficacy and safety of this new procedure. A systematic literature review performed using MEDLINE, Embase, PubMed, and Cochrane databases identified all published studies evaluating cryolipolysis for body contouring. A total of 34 articles up to February 2015 were identified. Nineteen articles matched the selection criteria and were included in the analysis. Sixteen were evaluated in the final analysis. A total of 1445 patients had reportable data for analysis of the safety profile. Twelve patients (0.82%) reported complications with the most common being diminished sensation lasting greater than 4 weeks. An aggregate total of 295 patients had objective data for evaluation of tissue reduction. The mean time from procedure to objective outcome evaluation was 3.83 months. The mean reduction of subcutaneous tissue was 19.55% with respect to a designated control site. Selective cryolipolysis appears, at short-term follow-up, to reliably decrease subcutaneous tissue deposits. Reported complications are uncommon and appear to resolve without intervention. Future studies should aim to optimize patient selection and treatment characteristics while obtaining long-term follow-up data. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  15. Assessing propensity to learn from safety-related events

    NARCIS (Netherlands)

    Drupsteen, L.; Wybo, J.L.

    2015-01-01

    Most organisations aim to use experience from the past to improve safety, for instance through learning from safety-related incidents and accidents. Whether an organisation is able to learn successfully can however only be determined afterwards. So far, there are no proactive measures to assess

  16. Healthcare professionals’ views of feedback on patient safety culture assessment.

    NARCIS (Netherlands)

    Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.

    2016-01-01

    Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the

  17. Interim FEP report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) [Kemakta Konsult AB, Stockholm (Sweden)

    2004-08-01

    This report describes the work with identification and structuring of features, events and processes (FEPs) that has been carried out within the scope of the SR-Can safety assessment up to the time of the interim reporting of the project. The overall objective of the work is to develop a database of features, events and processes in a format that would facilitate both a systematic analysis of FEPs and documentation of the FEP analysis as well as facilitate revisions and updates to be made in connection with new safety assessments. This overall objective also includes the development of procedures for a systematic FEP analysis as well as to apply these procedures in order to arrive at an SR-Can version of the FEP database. The work started by implementing the content of the SR 97 Process report into a database format suitable for import and processing of FEP information from other sources. The SR 97 version of the database was systematically audited against the NEA database with Project FEPs, version 1.2. In addition, an earlier audit of the SR 97 process report against the interaction matrices developed for a deep repository of the KBS-3 type was revisited and updated. Relevant FEPs from the audit were sorted into three main categories in the SR-Can database i) FEPs related to the initial states of the repository system, ii) FEPs related to internal processes of the repository system, and iii) FEPs related to external impacts on the repository system. These groups of FEPs were further processed for making decisions on how to handle these FEPs in the assessment. Biosphere processes were not included in the SR 97 Process report and there is thus not the same basis for updating these descriptions as for the engineered barriers and the geosphere. All biosphere FEPs from the audit have therefore been compiled in a single category in the database, but remain to be further handled. FEPs were also categorised as irrelevant or as being related to methodology on a general

  18. Interim FEP report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Skagius, Kristina

    2004-08-01

    This report describes the work with identification and structuring of features, events and processes (FEPs) that has been carried out within the scope of the SR-Can safety assessment up to the time of the interim reporting of the project. The overall objective of the work is to develop a database of features, events and processes in a format that would facilitate both a systematic analysis of FEPs and documentation of the FEP analysis as well as facilitate revisions and updates to be made in connection with new safety assessments. This overall objective also includes the development of procedures for a systematic FEP analysis as well as to apply these procedures in order to arrive at an SR-Can version of the FEP database. The work started by implementing the content of the SR 97 Process report into a database format suitable for import and processing of FEP information from other sources. The SR 97 version of the database was systematically audited against the NEA database with Project FEPs, version 1.2. In addition, an earlier audit of the SR 97 process report against the interaction matrices developed for a deep repository of the KBS-3 type was revisited and updated. Relevant FEPs from the audit were sorted into three main categories in the SR-Can database i) FEPs related to the initial states of the repository system, ii) FEPs related to internal processes of the repository system, and iii) FEPs related to external impacts on the repository system. These groups of FEPs were further processed for making decisions on how to handle these FEPs in the assessment. Biosphere processes were not included in the SR 97 Process report and there is thus not the same basis for updating these descriptions as for the engineered barriers and the geosphere. All biosphere FEPs from the audit have therefore been compiled in a single category in the database, but remain to be further handled. FEPs were also categorised as irrelevant or as being related to methodology on a general

  19. Application of the Integrated Safety Assessment methodology to safety margins. Dynamic Event Trees, Damage Domains and Risk Assessment

    International Nuclear Information System (INIS)

    Ibánez, L.; Hortal, J.; Queral, C.; Gómez-Magán, J.; Sánchez-Perea, M.; Fernández, I.; Meléndez, E.; Expósito, A.; Izquierdo, J.M.; Gil, J.; Marrao, H.; Villalba-Jabonero, E.

    2016-01-01

    The Integrated Safety Assessment (ISA) methodology, developed by the Consejo de Seguridad Nuclear, has been applied to an analysis of Zion NPP for sequences with Loss of the Component Cooling Water System (CCWS). The ISA methodology proposal starts from the unfolding of the Dynamic Event Tree (DET). Results from this first step allow assessing the sequence delineation of standard Probabilistic Safety Analysis results. For some sequences of interest of the outlined DET, ISA then identifies the Damage Domain (DD). This is the region of uncertain times and/or parameters where a safety limit is exceeded, which indicates the occurrence of certain damage situation. This paper illustrates application of this concept obtained simulating sequences with MAAP and with TRACE. From information of simulation results of sequence transients belonging to the DD and the time-density probability distributions of the manual actions and of occurrence of stochastic phenomena, ISA integrates the dynamic reliability equations proposed to obtain the sequence contribution to the global Damage Exceedance Frequency (DEF). Reported results show a slight increase in the DEF for sequences investigated following a power uprate from 100% to 110%. This demonstrates the potential use of the method to help in the assessment of design modifications. - Highlights: • This paper illustrates an application of the ISA methodology to safety margins. • Dynamic Event Trees are useful tool for verifying the standard PSA Event Trees. • The ISA methodology takes into account the uncertainties in human action times. • The ISA methodology shows the Damage Exceedance Frequency increase in power uprates.

  20. Guidance on the safety assessment methodology for storage of radioactive waste

    International Nuclear Information System (INIS)

    Kinyanjui, M.N.

    2014-04-01

    This project on safety assessment on storage was carried out with the main objective of ensuring safety of human life and our environment. This is the fundamental principle of radiation protection. Safety assessment has been evaluated as a tool in the safety case in the pre-construction, operational and the post closure phase of storage. In particular the iterative process of evaluating and predicting safety scenarios at each stage of the process has proved to be prudent. It is important that this concept be adopted for this type of facility to ensure safety of mankind and the environment now and in the future.

  1. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

    Science.gov (United States)

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-12-15

    Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

  2. How effects on health equity are assessed in systematic reviews of interventions.

    Science.gov (United States)

    Welch, Vivian; Tugwell, Peter; Petticrew, Mark; de Montigny, Joanne; Ueffing, Erin; Kristjansson, Betsy; McGowan, Jessie; Benkhalti Jandu, Maria; Wells, George A; Brand, Kevin; Smylie, Janet

    2010-12-08

    Enhancing health equity has now achieved international political importance with endorsement from the World Health Assembly in 2009.  The failure of systematic reviews to consider effects on health equity is cited by decision-makers as a limitation to their ability to inform policy and program decisions.  To systematically review methods to assess effects on health equity in systematic reviews of effectiveness. We searched the following databases up to July 2 2010: MEDLINE, PsychINFO, the Cochrane Methodology Register, CINAHL, Education Resources Information Center, Education Abstracts, Criminal Justice Abstracts, Index to Legal Periodicals, PAIS International, Social Services Abstracts, Sociological Abstracts, Digital Dissertations and the Health Technology Assessment Database. We searched SCOPUS to identify articles that cited any of the included studies on October 7 2010. We included empirical studies of cohorts of systematic reviews that assessed methods for measuring effects on health inequalities. Data were extracted using a pre-tested form by two independent reviewers. Risk of bias was appraised for included studies according to the potential for bias in selection and detection of systematic reviews.  Thirty-four methodological studies were included.  The methods used by these included studies were: 1) Targeted approaches (n=22); 2) gap approaches (n=12) and gradient approach (n=1).  Gender or sex was assessed in eight out of 34 studies, socioeconomic status in ten studies, race/ethnicity in seven studies, age in seven studies, low and middle income countries in 14 studies, and two studies assessed multiple factors across health inequity may exist.Only three studies provided a definition of health equity. Four methodological approaches to assessing effects on health equity were identified: 1) descriptive assessment of reporting and analysis in systematic reviews (all 34 studies used a type of descriptive method); 2) descriptive assessment of reporting

  3. MAPLE-X10 reactor safety assessment

    International Nuclear Information System (INIS)

    Cotnam, K.D.; Lounsbury, R.I.; Gillespie, G.E.

    1990-01-01

    This paper reports on the safety assessment of the 10 MW MAPLE-X10 reactor which has involved a substantial component of PSA analysis to supplement deterministic analysis. Initiating events are identified through the use of a master logic diagram. The events are then examined through event sequence diagrams, at the concept design stage, followed by a set of reliability analyses that are coordinated with the event sequence diagrams. Improvements identified through the reliability analyses are incorporated into the design to ensure that safety objectives are attained

  4. Towards an occupational safety and health culture

    NARCIS (Netherlands)

    Zwetsloot, G.I.J.M.; Steijger, N.

    2014-01-01

    Occupational safety and health (OSH) is a highly regulated area that appears to be based on rational planning and logical management approaches, e.g. OSM Management Systems: employers and employees of organisations should be aware of OSH risks, assess these risks systematically, provide the

  5. Designing systematic conservation assessments that promote effective implementation: best practice from South Africa.

    Science.gov (United States)

    Knight, Andrew T; Driver, Amanda; Cowling, Richard M; Maze, Kristal; Desmet, Philip G; Lombard, Amanda T; Rouget, Mathieu; Botha, Mark A; Boshoff, Andre F; Castley, J Guy; Goodman, Peter S; Mackinnon, Kathy; Pierce, Shirley M; Sims-Castley, Rebecca; Stewart, Warrick I; von Hase, Amrei

    2006-06-01

    Systematic conservation assessment and conservation planning are two distinct fields of conservation science often confused as one and the same. Systematic conservation assessment is the technical, often computer-based, identification of priority areas for conservation. Conservation planning is composed of a systematic conservation assessment coupled with processes for development of an implementation strategy and stakeholder collaboration. The peer-reviewed conservation biology literature abounds with studies analyzing the performance of assessments (e.g., area-selection techniques). This information alone, however can never deliver effective conservation action; it informs conservation planning. Examples of how to translate systematic assessment outputs into knowledge and then use them for "doing" conservation are rare. South Africa has received generous international and domestic funding for regional conservation planning since the mid-1990s. We reviewed eight South African conservation planning processes and identified key ingredients of best practice for undertaking systematic conservation assessments in a way that facilitates implementing conservation action. These key ingredients include the design of conservation planning processes, skills for conservation assessment teams, collaboration with stakeholders, and interpretation and mainstreaming of products (e.g., maps) for stakeholders. Social learning institutions are critical to the successful operationalization of assessments within broader conservation planning processes and should include not only conservation planners but also diverse interest groups, including rural landowners, politicians, and government employees.

  6. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Simone de Souza Nascimento

    2013-01-01

    Full Text Available To assess the effects of medicinal plants (MPs or related natural products (RNPs on fibromyalgia (FM patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects.

  7. Intrusion resistant underground structure (IRUS) - safety assessment and licensing

    International Nuclear Information System (INIS)

    Lange, B. A.

    1997-01-01

    This paper describes the safety goals, human exposure scenarios and critical groups, the syvac-nsure performance assessment code, groundwater pathway safety results, and inadvertent human intrusion of the IRUS. 2 tabs

  8. Safety assessment of complex engineered and natural systems: radioactive waste disposal

    International Nuclear Information System (INIS)

    McNeish, J.A.; Vallikat, V.; Atkins, J.; Balady, M.A.

    1997-01-01

    Evaluation of deep, geologic disposal of nuclear waste requires the probabilistic safety assessment of a complex system from the coupling of various processes and sub-systems, parameter and model uncertainties, spatial and temporal variabilities, and the multiplicity of designs and scenarios. Both the engineered and natural system are included in the evaluation. Each system has aspects with considerable uncertainty both in important parameters and in overall conceptual models. The study represented herein provides a probabilistic safety assessment of a potential respository system for multiple engineered barrier system (EBS) design and conceptual model configurations (CRWMS M and O, 1996a) and considers the effects of uncertainty on the overall results. The assessment is based on data and process models available at the time of the study and doesnt necessarily represent the current safety evaluation. In fact, the percolation flux through the repository system is now expected to be higher than the estimate used for this study. The potential effects of higher percolation fluxes are currently under study. The safety of the system was assessed for both 10,000 and 1,000,000 years. Use of alternative conceptual models also produced major improvement in safety. For example, use of a more realistic engineered system release model produced improvement of over an order of magnitude in safety. Alternative measurement locations for the safety assessment produced substantial increases in safety, through the results are based on uncertain dilution factors in the transporting groundwater. (Author)

  9. Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis.

    Science.gov (United States)

    Cheng, Cai-Qi; Xu, Hao; Liu, Ling; Wang, Rui-Nan; Liu, Yu-Ting; Li, Jing; Zhou, Xi-Kun

    2016-04-01

    Pilocarpine has been used widely in the treatment of dry mouth and glaucoma. In this review, the authors assessed the efficacy and safety of pilocarpine for patients with head and neck cancer who have radiation-induced xerostomia. The authors conducted a systematic search including meta-analyses and randomized controlled trials in the following databases: MEDLINE, Embase, Cochrane Library, and Science Citation Index Expanded. The primary outcome was the severity of xerostomia (measured using visual analog scale [VAS] scores). Adverse events were other outcomes of interest. The authors performed meta-analyses where appropriate. The authors used the Cochrane Collaboration's tool for assessing risk of bias to assess the quality of the study. The authors identified 6 studies (including 752 patients in total). The results of a meta-analysis of 3 articles showed that pilocarpine was associated with a 12-point increase in VAS score (mean difference, 12.00; 95% confidence interval [CI], 1.93-22.08; P = .02) and higher rates of adverse events compared with placebo in terms of sweating (odds ratio [OR], 3.71; 95% CI, 2.34-5.86; P xerostomia in patients with head and neck cancer. However, the authors of this systematic review found the best available evidence in the meta-analysis in 3 studies, 1 of which showed no effect. The authors of this systematic review suggest that these patients take 5 milligrams of pilocarpine 3 times daily, and that there is need for further study. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  10. Methodology for Safety Assessment Applied to Predisposal Waste Management. Report of the Results of the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) 2004–2010)

    International Nuclear Information System (INIS)

    2015-12-01

    Report of the Results of the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) (2004–2010) The IAEA’s progamme on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) focused on approaches and mechanisms for application of safety assessment methodologies for the predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts, which have since been incorporated into IAEA Safety Standards Series No. GSG-3, Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste. In 2005, an initial specification was developed for the Safety Assessment Framework (SAFRAN) software tool to apply the SADRWMS flowcharts. In 2008, an in-depth application of the SAFRAN tool and the SADRWMS methodology was carried out on the predisposal management facilities of the Thailand Institute of Nuclear Technology Radioactive Waste Management Centre (TINT Facility). This publication summarizes the content and outcomes of the SADRWMS programme. The Chairman’s Report of the SADRWMS Project and the Report of the TINT test case are provided on the CD-ROM which accompanies this report

  11. Safety assessment of human and organizational factors in French fuel cycle facilities

    International Nuclear Information System (INIS)

    Menuet, Lise; Beauquier, Sophie

    2013-01-01

    According to the French law, each nuclear facility has to provide a safety demonstration every ten years. The assessment of this demonstration supports the decision of the French Safety Authority regarding the authorisation of operating for the ten years to come. In addition, transversal topics, which are linked with safety performance, such as safety management, management of competencies, maintenance's policy are periodically evaluated. One aspect of these assessments relates to Human and Organizational Factors (HOF) and their contribution to safety. Our communication will describe the assessment of the HOF-related part, performed by the Institute for Radioprotection and Nuclear Safety Institute (IRSN) the Technical Support Organisation of the French Safety Authority). It will focus on the methodological framework, the tools which are developed and used for assessing the integration of HOF in safety demonstration, and the main difficulties of this kind of assessment. Each situation will be illustrated by concrete examples coming from safety assessments concerning fuel cycle's plants: Areva's plants dedicated to uranium conversion, uranium enrichment, fuel manufacturing, spent fuel reprocessing, treatment facilities and CEA's laboratories dedicated to research and development and to interim spent fuel storage. The methodological framework for assessing HOF currently implements three main steps which will be precisely described: - checking that the nuclear plant has made an exhaustive analysis of the risks linked with HOF. Regarding to HOF, the Licensee safety demonstration is based on the description of the main human activities which are considered as hazardous regarding safety. These activities are accomplished with a human contribution and they require a safe realisation. - assessing the human, organisational and technical barriers that the nuclear plant have planed in order to make the operations safe, to avoid, prevent or detect an

  12. The Sport Concussion Assessment Tool: a systematic review.

    Science.gov (United States)

    Yengo-Kahn, Aaron M; Hale, Andrew T; Zalneraitis, Brian H; Zuckerman, Scott L; Sills, Allen K; Solomon, Gary S

    2016-04-01

    OBJECTIVE Over the last 2 decades, sport-related concussion (SRC) has garnered significant attention. Even with increased awareness and athlete education, sideline recognition and real-time diagnosis remain crucial. The need for an objective and standardized assessment of concussion led to the eventual development of the Sport Concussion Assessment Tool (SCAT) during the Second International Conference on Concussion in Sport in 2004, which is now in its third iteration (SCAT3). In an effort to update our understanding of the most well-known sideline concussion assessment, the authors conducted a systematic review of the SCAT and the evidence supporting its use to date. METHODS English-language titles and abstracts published between 1995 and October 2015 were searched systematically across 4 electronic databases and a review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines adapted for the review of a heterogeneous collection of study designs. Peer-reviewed journal articles were included if they reported quantitative data on any iteration of the SCAT, Standardized Assessment of Concussion (SAC), or modified Balance Error Scoring System (mBESS) data at baseline or following concussion in an exclusively athlete population with any portion older than 13 years of age. Studies that included nonathletes, only children less than 13 years old, exclusively BESS data, exclusively symptom scale data, or a non-SCAT-related assessment were excluded. RESULTS The database search process yielded 549 abstracts, and 105 full-text articles were reviewed with 36 meeting criteria for inclusion. Nineteen studies were associated with the SAC, 1 was associated with the mBESS exclusively, and 16 studies were associated with a full iteration of the SCAT. The majority of these studies (56%) were prospective cohort studies. Male football players were the most common athletes studied. An analysis of the studies focused on

  13. Safety assessment and licensing issues of low level radioactive waste disposal facilities in the United Kingdom

    Energy Technology Data Exchange (ETDEWEB)

    Fearnley, I. G. [British Nuclear Fuels Ltd., Sellafield (United Kingdom)

    1997-12-31

    More than 90% of radioactive waste generated in the United Kingdom is classified as low level and is disposed of in near surface repositories. BNFL owns and operates the principal facility for the disposal of this material at Drigg in West Cumbria. In order to fully optimise the use of the site and effectively manage this `national` resource a full understanding and assessment of the risks associated with the performance of the repository to safely contain the disposed waste must be achieved to support the application for the site authorization for disposal. This paper describes the approaches adopted by BNFL to reviewing these risks by the use of systematic Safety and Engineering Assessments supported in turn by experimental programmes and computations models. (author). 6 refs., 1 tab., 4 figs.

  14. Safety assessment and licensing issues of low level radioactive waste disposal facilities in the United Kingdom

    International Nuclear Information System (INIS)

    Fearnley, I. G.

    1997-01-01

    More than 90% of radioactive waste generated in the United Kingdom is classified as low level and is disposed of in near surface repositories. BNFL owns and operates the principal facility for the disposal of this material at Drigg in West Cumbria. In order to fully optimise the use of the site and effectively manage this 'national' resource a full understanding and assessment of the risks associated with the performance of the repository to safely contain the disposed waste must be achieved to support the application for the site authorization for disposal. This paper describes the approaches adopted by BNFL to reviewing these risks by the use of systematic Safety and Engineering Assessments supported in turn by experimental programmes and computations models. (author). 6 refs., 1 tab., 4 figs

  15. Economic aspects of risk assessment in chemical safety

    Energy Technology Data Exchange (ETDEWEB)

    Drummond, M F; Shannon, H S

    1986-05-01

    This paper considers how the economic aspects of risk assessment in chemical safety can be strengthened. Its main focus is on how economic appraisal techniques, such as cost-benefit and cost-effectiveness analysis, can be adapted to the requirements of the risk-assessment process. Following a discussion of the main methodological issues raised by the use of economic appraisal, illustrated by examples from the health and safety field, a number of practical issues are discussed. These include the consideration of the distribution of costs, effects and benefits, taking account of uncertainty, risk probabilities and public perception, making the appraisal techniques useful to the early stages of the risk-assessment process and structuring the appraisal to permit continuous feedback to the participants in the risk-assessment process. It is concluded that while the way of thinking embodied in economic appraisal is highly relevant to the consideration of choices in chemical safety, the application of these principles in formal analysis of risk reduction procedures presents a more mixed picture. The main suggestions for improvement in the analyses performed are the undertaking of sensitivity analyses of study results to changes in the key assumptions, the presentation of the distribution of costs and benefits by viewpoint, the comparison of health and safety measures in terms of their incremental cost per life-year (or quality-adjusted life-year) gained and the more frequent retrospective review and revision of the economic analyses that are undertaken.

  16. The role of probabilistic safety assessment in the design

    International Nuclear Information System (INIS)

    Green, A.; Ingham, E.L.

    1989-01-01

    The use of probabilistic safety assessment (PSA) for Heysham 2 and Torness marked a major change in the design approach to nuclear safety within the U.K. Design Safety Guidelines incorporating probabilistic safety targets required that design justification would necessitate explicit consideration of the consequence of accidents in relation to their frequency. The paper discusses these safety targets and their implications, the integration of PSA into the design process and an outline of the methodology. The influence of PSA on the design is discussed together with its role in the overall demonstration of reactor safety. (author)

  17. Procedures for conducting probabilistic safety assessment for non-reactor nuclear facilities

    International Nuclear Information System (INIS)

    2002-01-01

    A well performed and adequately documented safety assessment of a nuclear facility will serve as a basis to determine whether the facility complies with the safety objectives, principles and criteria as stipulated by the national regulatory body of the country where the facility is in operation. International experience shows that the practices and methodologies used to perform safety assessments and periodic safety re-assessment for non-reactor nuclear facilities differ significantly from county to country. Most developing countries do not have methods and guidance for safety assessment that are prescribed by the regulatory body. Typically the safety evaluation for the facility is based on a case by case assessment. Whilst conservative deterministic analyses are predominantly used as a licensing basis in many countries, recently probabilistic safety assessment (PSA) techniques have been applied as a useful complementary tool to support safety decision making. The main benefit of PSA is to provide insights into the safety aspects of facility design and operation. PSA points up the potential environmental impacts of postulated accidents, including the dominant risk contributors, and enables safety analysts to compare options for reducing risk. In order to advise on how to apply PSA methodology for the safety assessment of non-reactor nuclear facilities, the IAEA organized several consultants meetings, which led to the preparation of this TECDOC. This document is intended as guidance for the conduct of PSA in non-nuclear facilities. The main emphasis here is on the general procedural steps of a PSA that is specific for a non-reactor nuclear facility, rather than the details of the specific methods. The report is directed at technical staff managing or performing such probabilistic assessments and to promote a standardized framework, terminology and form of documentation for these PSAs. It is understood that the level of detail implied in the tasks presented in this

  18. Selected component failure rate values from fusion safety assessment tasks

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1998-09-01

    This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

  19. Selected Component Failure Rate Values from Fusion Safety Assessment Tasks

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, Lee Charles

    1998-09-01

    This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

  20. Selected component failure rate values from fusion safety assessment tasks

    International Nuclear Information System (INIS)

    Cadwallader, L.C.

    1998-01-01

    This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers

  1. Review of SKB's interim report of SR-Can: SKI's and SSI's evaluation of SKB's up-dated methodology for safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Dverstorp, Bjoern; Moberg, Leif; Wiebert, Anders; Xu Shulan [Swedish Radiation Protection Authority, Stockholm (Sweden); Stroemberg, Bo; Kautsky, Fritz; Lilja, Christina; Simic, Eva; Sundstroem, Benny; Toverud, Oeivind [Swedish Nuclear Power Inspectorate, Stockholm (Sweden)

    2005-07-01

    This report presents the findings of a review of the Swedish Nuclear Fuel and Waste Management Co.'s (SKB) interim report of the safety assessment SR-Can (SKB TR 04-11), conducted by the Swedish Radiation Protection Authority (SSI) and the Swedish Nuclear Power Inspectorate (SKI). SKB's interim report describes and exemplifies the safety assessment methodology that SKB plans to use in the oncoming licence applications for an encapsulation plant and a final repository for spent nuclear fuel. The authorities' review takes into account the findings of an international peer review of SKB's interim report. The authorities conclude that SKB has improved its safety assessment methodology in several aspects compared to earlier safety reports. Among other things the authorities commend SKB for giving a comprehensive account of relevant regulations and guidance, and for the systematic approach to identification and documentation of features, events and processes that need to be considered in the safety assessment. However, the authorities also conclude that important parts of SKB's method need to be further developed before they are mature enough to be used as a basis for a license application. The authorities' overall assessment is summarised in chapter 8 of this report.

  2. Learning from Aviation to Improve Safety in the Operating Room - a Systematic Literature Review

    Directory of Open Access Journals (Sweden)

    Linda S. G. L. Wauben

    2012-01-01

    Full Text Available Lessons learned from other high-risk industries could improve patient safety in the operating room (OR. This review describes similarities and differences between high-risk industries and describes current methods and solutions within a system approach to reduce errors in the OR. PubMed and Scopus databases were systematically searched for relevant articles written in the English language published between 2000 and 2011. In total, 25 articles were included, all within the medical domain focusing on the comparison between surgery and aviation. In order to improve safety in the OR, multiple interventions have to be implemented. Additionally, the healthcare organization has to become a ‘learning organization’ and the OR team has to become a team with shared responsibilities and flat hierarchies. Interpersonal and technical skills can be trained by means of simulation and can be supported by implementing team briefings, debriefings and cross-checks. However, further development and research is needed to prove if these solutions are useful, practical, and actually increase safety.

  3. Safety Assessment of Talc as Used in Cosmetics.

    Science.gov (United States)

    Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

  4. Bounding probabilistic safety assessment probabilities by reality

    International Nuclear Information System (INIS)

    Fragola, J.R.; Shooman, M.L.

    1991-01-01

    The investigation of the failure in systems where failure is a rare event makes the continual comparisons between the developed probabilities and empirical evidence difficult. The comparison of the predictions of rare event risk assessments with historical reality is essential to prevent probabilistic safety assessment (PSA) predictions from drifting into fantasy. One approach to performing such comparisons is to search out and assign probabilities to natural events which, while extremely rare, have a basis in the history of natural phenomena or human activities. For example the Segovian aqueduct and some of the Roman fortresses in Spain have existed for several millennia and in many cases show no physical signs of earthquake damage. This evidence could be used to bound the probability of earthquakes above a certain magnitude to less than 10 -3 per year. On the other hand, there is evidence that some repetitive actions can be performed with extremely low historical probabilities when operators are properly trained and motivated, and sufficient warning indicators are provided. The point is not that low probability estimates are impossible, but continual reassessment of the analysis assumptions, and a bounding of the analysis predictions by historical reality. This paper reviews the probabilistic predictions of PSA in this light, attempts to develop, in a general way, the limits which can be historically established and the consequent bounds that these limits place upon the predictions, and illustrates the methodology used in computing such limits. Further, the paper discusses the use of empirical evidence and the requirement for disciplined systematic approaches within the bounds of reality and the associated impact on PSA probabilistic estimates

  5. Environment, safety and health progress assessment manual

    International Nuclear Information System (INIS)

    1992-12-01

    On June 27, 1989, the Secretary of Energy announced a 10-Point Initiative to strengthen environment, safety, and health (ES ampersand H) programs, and waste management activities at DOE production, research, and testing facilities. One of the points involved conducting dent Tiger Team Assessments of DOE operating facilities. The Office of Special independent Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This manual documents the processes to be used to perform the ES ampersand H Progress Assessments. It was developed based upon the lessons learned from Tiger Team Assessments, the two pilot Progress Assessments, and Progress Assessments that have been completed. The manual will be updated periodically to reflect lessons learned or changes in policy

  6. On the fundamentals of nuclear reactor safety assessment. Inherent threats and their implications

    Energy Technology Data Exchange (ETDEWEB)

    Hyvaerinen, J. [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland). Nuclear Safety Dept.

    1996-12-01

    The thesis addresses some fundamental questions related to implementation and assessment of nuclear safety. The safety principles and assessment methods are described, followed by descriptions of selected novel technical challenges to nuclear safety. The novel challenges encompass a wide variety of technical issues, thus providing insights on the limitations of conventional safety assessment methods. Study of the limitations suggests means to improve nuclear reactor design criteria and safety assessment practices. The novel safety challenges discussed are (1) inherent boron dilution in PWRs, (2) metallic insulation performance with respect to total loss of emergency cooling systems in a loss-of-coolant accident, and (3) horizontal steam generator heat transfer performance at natural circulation conditions. (50 refs.).

  7. On the fundamentals of nuclear reactor safety assessment. Inherent threats and their implications

    International Nuclear Information System (INIS)

    Hyvaerinen, J.

    1996-12-01

    The thesis addresses some fundamental questions related to implementation and assessment of nuclear safety. The safety principles and assessment methods are described, followed by descriptions of selected novel technical challenges to nuclear safety. The novel challenges encompass a wide variety of technical issues, thus providing insights on the limitations of conventional safety assessment methods. Study of the limitations suggests means to improve nuclear reactor design criteria and safety assessment practices. The novel safety challenges discussed are (1) inherent boron dilution in PWRs, (2) metallic insulation performance with respect to total loss of emergency cooling systems in a loss-of-coolant accident, and (3) horizontal steam generator heat transfer performance at natural circulation conditions. (50 refs.)

  8. A systematic review of light-based home-use devices for hair removal and considerations on human safety

    DEFF Research Database (Denmark)

    Thaysen-Petersen, D; Bjerring, P; Dierickx, C

    2012-01-01

    To systematically review and evaluate the efficacy and human safety of currently available home-based optical hair removal devices. Methods A comprehensive Pub Med literature search was conducted which systematically identified publications of relevance. Prospective clinical trials were included whether controlled......, uncontrolled or randomized and with a sample size of at least 10 individuals. Results We identified a total of seven studies: one controlled (CT) and six uncontrolled trials (UCTs). No randomized controlled trials (RCT) were recognized. The best evidence was found for IPL (intense pulsed light) (three devices...

  9. Assessment of Safety Standards for Automotive Electronic Control Systems

    Science.gov (United States)

    2016-06-01

    This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

  10. Plasma-safety assessment model and safety analyses of ITER

    International Nuclear Information System (INIS)

    Honda, T.; Okazaki, T.; Bartels, H.-H.; Uckan, N.A.; Sugihara, M.; Seki, Y.

    2001-01-01

    A plasma-safety assessment model has been provided on the basis of the plasma physics database of the International Thermonuclear Experimental Reactor (ITER) to analyze events including plasma behavior. The model was implemented in a safety analysis code (SAFALY), which consists of a 0-D dynamic plasma model and a 1-D thermal behavior model of the in-vessel components. Unusual plasma events of ITER, e.g., overfueling, were calculated using the code and plasma burning is found to be self-bounded by operation limits or passively shut down due to impurity ingress from overheated divertor targets. Sudden transition of divertor plasma might lead to failure of the divertor target because of a sharp increase of the heat flux. However, the effects of the aggravating failure can be safely handled by the confinement boundaries. (author)

  11. Safety assessment for the above ground storage of Cadmium Safety and Control Rods at the Solid Waste Management Facility

    International Nuclear Information System (INIS)

    Shaw, K.W.

    1993-11-01

    The mission of the Savannah River Site is changing from radioisotope production to waste management and environmental restoration. As such, Reactor Engineering has recently developed a plan to transfer the safety and control rods from the C, K, L, and P reactor disassembly basin areas to the Transuranic (TRU) Waste Storage Pads for long-term, retrievable storage. The TRU pads are located within the Solid Waste Management Facilities at the Savannah River Site. An Unreviewed Safety Question (USQ) Safety Evaluation has been performed for the proposed disassembly basin operations phase of the Cadmium Safety and Control Rod Project. The USQ screening identified a required change to the authorization basis; however, the Proposed Activity does not involve a positive USQ Safety Evaluation. A Hazard Assessment for the Cadmium Safety and Control Rod Project determined that the above-ground storage of the cadmium rods results in no change in hazard level at the TRU pads. A Safety Assessment that specifically addresses the storage (at the TRU pads) phase of the Cadmium Safety and Control Rod Project has been performed. Results of the Safety Assessment support the conclusion that a positive USQ is not involved as a result of the Proposed Activity

  12. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  13. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  14. Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

    Energy Technology Data Exchange (ETDEWEB)

    Vovk, I.F.; Seitz, R.R.

    1995-12-31

    The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safety assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.

  15. Systematic Review on the Efficacy and Safety of Herbal Medicines for Vascular Dementia

    Directory of Open Access Journals (Sweden)

    Sui Cheung Man

    2012-01-01

    Full Text Available We present a systematic review of existing research that aims to assess the efficacy and safety of herbal medications (HM, as either monotherapy or adjunct to orthodox medications (OM, mainly comprised of cholinesterase inhibitors, for vascular dementia (VaD. We included 47 studies conducted in mainland China, each testing different HM. Of 43 HM monotherapy studies, 37 reported HM to be significantly better than OM or placebo; six reported similar efficacy between HM and OM. All four HM adjuvant studies reported significant efficacy. No major adverse events for HM were reported. Heterogeneity in diagnostic criteria, interventions and outcome measures hindered comprehensive data analysis. Studies suggested that HM can be a safe and effective treatment for VaD, either alone or in conjunction with OM. However, methodological flaws in the design of the studies limited the extent to which the results could be interpreted. Thirty most commonly used herbal constituents, including Rhizoma Chuanxiong (Chuanxiong in Chinese, Radix Polygoni Multiflori (Heshouwu in Chinese and Radix Astragali (Huangqi in Chinese. were ranked. Further multi-center trials with large sample sizes, high methodological quality and standardized HM ingredients are necessary for clinical recommendations to be made.

  16. Factor Analysis in Assessing the Research Methodology Quality of Systematic Reviews

    Directory of Open Access Journals (Sweden)

    Andrada Elena URDA-CÎMPEAN

    2011-12-01

    Full Text Available Introduction: Many high quality systematic reviews available from medical journals, data bases and other electronic sources differ in quality and provide different answers to the same question. The literature recommended the use of a checklist type approach, which exceeds many of the problems associated with measurements. Aim: This study proposes to identify in a checklist type approach the most commonly used factors (from a methodological point of view in assessing the quality of systematic reviews, and then mirror the actual stage of medical writing. We want to analyze the factors’ occurrence and / or their development in the text and in the abstract of systematic reviews published in 2011. Methods: The present study randomly selected only free full text systematic reviews published in 2011, systematic reviews found in Pubmed and in Cochrane Database. The most commonly used factors were identified in PRISMA statement and quality measurement tools. Results: The evaluated systematic reviews mentioned or developed several of the factors studied. Only 78% of the papers surveyed have used the correct IMRAD format and 59% of them have mentioned the sample size used. The correspondence between the content of the paper and its abstract is summarized in the proportion of 54.63% and 51.85% for the two sets of factors, and it can lead to scarce appreciation of the article provided that only abstracts are read. Conclusions: Researchers do not properly take into consideration scientific articles and assessment tools used for quality evaluation. They should place more value over methodological factors which help assess systematic review quality, while journals form the only party who can enforce quality standards in medical writing.

  17. Uncertainty in safety : new techniques for the assessment and optimisation of safety in process industry

    NARCIS (Netherlands)

    Rouvroye, J.L.; Nieuwenhuizen, J.K.; Brombacher, A.C.; Stavrianidis, P.; Spiker, R.Th.E.; Pyatt, D.W.

    1995-01-01

    At this moment there is no standardised method for the assessment for safety in the process industry. Many companies and institutes use qualitative techniques for safety analysis while other companies and institutes use quantitative techniques. The authors of this paper will compare different

  18. Safety and efficacy of fenproporex for obesity treatment: a systematic review

    OpenAIRE

    Paumgartten,Francisco José Roma; Pereira,Sabrina Schaaf Teixeira Costa; Oliveira,Ana Cecilia Amado Xavier de

    2016-01-01

    ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to trea...

  19. Nuclear utility self-assessment as viewed by the corporate nuclear safety committee

    International Nuclear Information System (INIS)

    Corcoran, W.R.

    1992-01-01

    This paper discusses how corporate nuclear safety committees use the principles of self-assessment to enhance nuclear power plant safety performance. Corporate nuclear safety committees function to advise the senior nuclear power executive on matters affecting nuclear safety. These committees are required by the administrative controls section of the plant technical specifications which are part of the final safety analysis report and the operating license. Committee membership includes senior utility executives, executives from sister utilities, utility senior technical experts, and outside consultants. Current corporate nuclear safety committees often have a finely tuned intuitive feel for self-assessment that they use to probe the underlying opportunities for quality and safety enhancements. The questions prompted by the self-assessment orientation enable the utility line organization members to gain better perspectives on the characteristics of the organizational systems that they manage and work in

  20. Quantitative reliability assessment for safety critical system software

    International Nuclear Information System (INIS)

    Chung, Dae Won; Kwon, Soon Man

    2005-01-01

    An essential issue in the replacement of the old analogue I and C to computer-based digital systems in nuclear power plants is the quantitative software reliability assessment. Software reliability models have been successfully applied to many industrial applications, but have the unfortunate drawback of requiring data from which one can formulate a model. Software which is developed for safety critical applications is frequently unable to produce such data for at least two reasons. First, the software is frequently one-of-a-kind, and second, it rarely fails. Safety critical software is normally expected to pass every unit test producing precious little failure data. The basic premise of the rare events approach is that well-tested software does not fail under normal routine and input signals, which means that failures must be triggered by unusual input data and computer states. The failure data found under the reasonable testing cases and testing time for these conditions should be considered for the quantitative reliability assessment. We will present the quantitative reliability assessment methodology of safety critical software for rare failure cases in this paper

  1. Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

    Science.gov (United States)

    Speijers, Gerrit; Bottex, Bernard; Dusemund, Birgit; Lugasi, Andrea; Tóth, Jaroslav; Amberg-Müller, Judith; Galli, Corrado L; Silano, Vittorio; Rietjens, Ivonne M C M

    2010-02-01

    This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

  2. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

    Science.gov (United States)

    Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

    2015-12-01

    Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher

  3. NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

    Science.gov (United States)

    Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

    2003-01-01

    The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

  4. Development of Safety Culture Assessment Strategy for Korean NPP

    International Nuclear Information System (INIS)

    Park, Jung Hwan; Kim, Jong Hyun

    2014-01-01

    This paper aims at developing the requirements for a method to evaluate the operational safety culture, evaluating currently available methods based on the requirements, and suggesting a method to evaluate and improve the operational safety culture for Korean nuclear power plants. This paper reviews the widely-used methods to assess safety culture for NPPs and their basis. Then, this paper develops the requirements for the method to evaluate operational safety culture for Korean NPPs. Based on these requirements, Korean Safety Culture Indicators (KSCI) and evaluation measures are also suggested. Finally this paper proposes the guidelines to develop improvements to safety culture from the evaluation results

  5. Development of Safety Culture Assessment Strategy for Korean NPP

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jung Hwan; Kim, Jong Hyun [KEPCO, Ulsan (Korea, Republic of)

    2014-08-15

    This paper aims at developing the requirements for a method to evaluate the operational safety culture, evaluating currently available methods based on the requirements, and suggesting a method to evaluate and improve the operational safety culture for Korean nuclear power plants. This paper reviews the widely-used methods to assess safety culture for NPPs and their basis. Then, this paper develops the requirements for the method to evaluate operational safety culture for Korean NPPs. Based on these requirements, Korean Safety Culture Indicators (KSCI) and evaluation measures are also suggested. Finally this paper proposes the guidelines to develop improvements to safety culture from the evaluation results.

  6. Institutionalization of safety re-assessment system for operating nuclear power plants

    International Nuclear Information System (INIS)

    Kim, H. J.; Cho, J. C.; Min, B. K.; Park, J. S.; Jung, H. D.; Oh, K. M.; Kim, W. K.; Lim, J. H.

    1999-01-01

    In this study, in-depth reviews of the foreign countries' experiences and practices in applications of the periodic safety review (PSR), backfitting and license renewal systems as well as the current status of nuclear power safety assurance programs and activities in Korea have been performed to investigate the necessity and feasibility of the application of the systems for the domestic operating nuclear power plants and to establish effective strategy and methodology for the institutionalization of a periodic safety re-assessment system appropriate to both the domestic and international nuclear power environments by incorporating the PSR with the backfitting and license renewal systems. For these purposes, the regulatory policy, fundamental principles and detailed requirements for the institutionalization of the safety re-assessment system and the effective measures for active implementation of the backfitting program have been developed and then a comparative study of benefits and shortcomings has been conducted for the three different models of the periodic safety re-assessment system incorporated with either the license renewal or life extension process, which have been considered as practicable ones in the domestic situation. The model chosen in this study as the most appropriate safety re-assessment system is the one that the re-assessments are performed at the interval of ten years throughout the service life of nuclear power plant and the ten-year license renewal or life extension after the expiration of design life can be permitted based on the regulatory review of the re-assessment results and follow-up measures. Finally, this paper has discussed on the details of the requirements, approach and procedures established for the institutionalization of the periodic safety re-assessment system chosen as the most appropriate one for domestic applications

  7. Comparative assessment of safety indicators for vehicle trajectories on the highway

    NARCIS (Netherlands)

    Mullakkal Babu, F.A.; Wang, M.; Farah, H.; van Arem, B.; Happee, R.

    2017-01-01

    Safety measurement and analysis have been a challenging and well-researched topic in transportation. Conventionally, surrogate safety measures have been used as safety indicators in simulation models for safety assessment, in control formulations for driver assistance systems, and in data analysis

  8. The quality of systematic reviews about interventions for refractive error can be improved: a review of systematic reviews.

    Science.gov (United States)

    Mayo-Wilson, Evan; Ng, Sueko Matsumura; Chuck, Roy S; Li, Tianjing

    2017-09-05

    Systematic reviews should inform American Academy of Ophthalmology (AAO) Preferred Practice Pattern® (PPP) guidelines. The quality of systematic reviews related to the forthcoming Preferred Practice Pattern® guideline (PPP) Refractive Errors & Refractive Surgery is unknown. We sought to identify reliable systematic reviews to assist the AAO Refractive Errors & Refractive Surgery PPP. Systematic reviews were eligible if they evaluated the effectiveness or safety of interventions included in the 2012 PPP Refractive Errors & Refractive Surgery. To identify potentially eligible systematic reviews, we searched the Cochrane Eyes and Vision United States Satellite database of systematic reviews. Two authors identified eligible reviews and abstracted information about the characteristics and quality of the reviews independently using the Systematic Review Data Repository. We classified systematic reviews as "reliable" when they (1) defined criteria for the selection of studies, (2) conducted comprehensive literature searches for eligible studies, (3) assessed the methodological quality (risk of bias) of the included studies, (4) used appropriate methods for meta-analyses (which we assessed only when meta-analyses were reported), (5) presented conclusions that were supported by the evidence provided in the review. We identified 124 systematic reviews related to refractive error; 39 met our eligibility criteria, of which we classified 11 to be reliable. Systematic reviews classified as unreliable did not define the criteria for selecting studies (5; 13%), did not assess methodological rigor (10; 26%), did not conduct comprehensive searches (17; 44%), or used inappropriate quantitative methods (3; 8%). The 11 reliable reviews were published between 2002 and 2016. They included 0 to 23 studies (median = 9) and analyzed 0 to 4696 participants (median = 666). Seven reliable reviews (64%) assessed surgical interventions. Most systematic reviews of interventions for

  9. Safety assessment of Novi Han radioactive waste repository - features, problems, results and perspectives

    International Nuclear Information System (INIS)

    Mateeva, M.

    2000-01-01

    This paper summarizes the work done and the achievements reached in the Novi Han radioactive waste repository safety assessment within the IAEA Model Project 'Increasing the safety of Novi Han radioactive waste repository BUL 4/005'. The overall safety assessment has a wide context, but the work reported here relates only to some details and results concerning the development and implementation of the appropriate methodology approach, model and computer code used for the calculations. Different steps and procedures are included for a better practical understanding of the obtained results during the safety assessment performance. The methodology approach is widely based on an international experience in safety analysis and implemented for evaluation computer code AMBER, which is one of the recommended from the safety assessments experts. (author)

  10. 76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

    Science.gov (United States)

    2011-12-01

    ... [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY... NHTSA's regulation on vehicle labeling of safety rating information to reflect the enhanced NCAP ratings... Traffic Safety Administration under the enhanced NCAP testing and rating program. * * * * * (e) * * * (4...

  11. Nurses' Views Highlight a Need for the Systematic Development of Patient Safety Culture in Forensic Psychiatry Nursing.

    Science.gov (United States)

    Kuosmanen, Anssi; Tiihonen, Jari; Repo-Tiihonen, Eila; Eronen, Markku; Turunen, Hannele

    2017-11-04

    Although forensic nurses work with the most challenging psychiatric patients and manifest a safety culture in their interactions with patients, there have been few studies on patient safety culture in forensic psychiatric nursing. The aim of this qualitative study was to describe nurses' views of patient safety culture in their working unit and daily hospital work in 2 forensic hospitals in Finland. Data were collected over a period of 1 month by inviting nurses to answer an open-ended question in an anonymous Web-based questionnaire. A qualitative inductive analysis was performed on nurses' (n = 72) written descriptions of patient safety culture in state-owned forensic hospitals where most Finnish forensic patients are treated. Six main themes were identified: "systematization of an open and trusting communication culture," "visible and close interaction between managers and staff," "nonpunitive responses to errors, learning and developing," "balancing staff and patient perspectives on safety culture," "operational safety guidelines," and "adequate human resources to ensure safety." The findings highlight the influence of the prevailing culture on safety behaviors and outcomes for both healthcare workers and patients. Additionally, they underline the importance of an open culture with open communication and protocols.

  12. Efficacy and safety of ginger in osteoarthritis patients

    DEFF Research Database (Denmark)

    Bartels, E M; Folmer, V N; Bliddal, Henning

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing ...

  13. Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-11-15

    . The standards are also applied by regulatory bodies and operators around the world to enhance safety in nuclear power generation and in nuclear applications in medicine, industry, agriculture and research. Safety is not an end in itself but a prerequisite for the purpose of the protection of people in all States and of the environment - now and in the future. The risks associated with ionizing radiation must be assessed and controlled without unduly limiting the contribution of nuclear energy to equitable and sustainable development. Governments, regulatory bodies and operators everywhere must ensure that nuclear material and radiation sources are used beneficially, safely and ethically. The IAEA safety standards are designed to facilitate this, and I encourage all Member States to make use of them.

  14. Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

    International Nuclear Information System (INIS)

    2011-01-01

    . The standards are also applied by regulatory bodies and operators around the world to enhance safety in nuclear power generation and in nuclear applications in medicine, industry, agriculture and research. Safety is not an end in itself but a prerequisite for the purpose of the protection of people in all States and of the environment - now and in the future. The risks associated with ionizing radiation must be assessed and controlled without unduly limiting the contribution of nuclear energy to equitable and sustainable development. Governments, regulatory bodies and operators everywhere must ensure that nuclear material and radiation sources are used beneficially, safely and ethically. The IAEA safety standards are designed to facilitate this, and I encourage all Member States to make use of them.

  15. Using systematic aging assessments to improve effectiveness of plant maintenance programs

    International Nuclear Information System (INIS)

    Watson, P.; Yang, J.X.; Dam, R.F.; Nickerson, J.H.

    2003-01-01

    Nuclear plant equipment aging assessment studies provided by AECL include life assessments, condition assessments or systematic assessments of maintenance. AECL has developed several tools to apply the results of aging assessment studies to improve the effectiveness of actual plant maintenance programs. The Systematic Assessment of Maintenance and the SYSTMS tool generate maintenance tasks for a system. The System Maintenance Datastore tool assesses the maintenance resources on a system basis, and can thus quantify the savings realized by optimizing the maintenance program. Long term trends in condition-based maintenance due to component aging can be predicted, and resource savings due to optimum timing of component replacement or general plant refurbishment can be quantified. The System based Adaptive Maintenance Process ensures the maintenance program is continually updated to reflect the latest plant equipment condition and maintenance strategy information. (author)

  16. Guidelines for the review research reactor safety. Reference document for IAEA Integrated Safety Assessment of Research Reactors (INSARR)

    International Nuclear Information System (INIS)

    1997-01-01

    In 1992, the IAEA published new safety standards for research reactors as part of the set of publications considered by its Research Reactor Safety Programme (RRSP). This set also includes publications giving guidance for all safety aspects related to the lifetime of a research reactor. In addition, the IAEA has also revised the Safety Standards for radiation protection. Consequently, it was considered advisable to revise the Integrated Safety Assessment of Research Reactors (INSARR) procedures to incorporate the new requirements and guidance as well as to extend the scope of the safety reviews to currently operating research reactors. The present report is the result of this revision. The purpose of this report is to give guidance on the preparation, execution, reporting and follow-up of safety review mission to research reactors as conducted by the IAEA under its INSARR missions safety service. However, it will also be of assistance to operators and regulators in conducting: (a) ad hoc safety assessments of research reactors to address individual issues such as ageing or safety culture; and (b) other types of safety reviews such as internal and peer reviews and regulatory inspections

  17. Smartphone apps for calculating insulin dose: a systematic assessment.

    Science.gov (United States)

    Huckvale, Kit; Adomaviciute, Samanta; Prieto, José Tomás; Leow, Melvin Khee-Shing; Car, Josip

    2015-05-06

    Medical apps are widely available, increasingly used by patients and clinicians, and are being actively promoted for use in routine care. However, there is little systematic evidence exploring possible risks associated with apps intended for patient use. Because self-medication errors are a recognized source of avoidable harm, apps that affect medication use, such as dose calculators, deserve particular scrutiny. We explored the accuracy and clinical suitability of apps for calculating medication doses, focusing on insulin calculators for patients with diabetes as a representative use for a prevalent long-term condition. We performed a systematic assessment of all English-language rapid/short-acting insulin dose calculators available for iOS and Android. Searches identified 46 calculators that performed simple mathematical operations using planned carbohydrate intake and measured blood glucose. While 59% (n = 27/46) of apps included a clinical disclaimer, only 30% (n = 14/46) documented the calculation formula. 91% (n = 42/46) lacked numeric input validation, 59% (n = 27/46) allowed calculation when one or more values were missing, 48% (n = 22/46) used ambiguous terminology, 9% (n = 4/46) did not use adequate numeric precision and 4% (n = 2/46) did not store parameters faithfully. 67% (n = 31/46) of apps carried a risk of inappropriate output dose recommendation that either violated basic clinical assumptions (48%, n = 22/46) or did not match a stated formula (14%, n = 3/21) or correctly update in response to changing user inputs (37%, n = 17/46). Only one app, for iOS, was issue-free according to our criteria. No significant differences were observed in issue prevalence by payment model or platform. The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more

  18. Data report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  19. Data report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  20. Psychometric model for safety culture assessment in nuclear research facilities

    Energy Technology Data Exchange (ETDEWEB)

    Nascimento, C.S. do, E-mail: claudio.souza@ctmsp.mar.mil.br [Centro Tecnológico da Marinha em São Paulo (CTMSP), Av. Professor Lineu Prestes 2468, 05508-000 São Paulo, SP (Brazil); Andrade, D.A., E-mail: delvonei@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil); Mesquita, R.N. de, E-mail: rnavarro@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil)

    2017-04-01

    Highlights: • A psychometric model to evaluate ‘safety climate’ at nuclear research facilities. • The model presented evidences of good psychometric qualities. • The model was applied to nuclear research facilities in Brazil. • Some ‘safety culture’ weaknesses were detected in the assessed organization. • A potential tool to develop safety management programs in nuclear facilities. - Abstract: A safe and reliable operation of nuclear power plants depends not only on technical performance, but also on the people and on the organization. Organizational factors have been recognized as the main causal mechanisms of accidents by research organizations through USA, Europe and Japan. Deficiencies related with these factors reveal weaknesses in the organization’s safety culture. A significant number of instruments to assess the safety culture based on psychometric models that evaluate safety climate through questionnaires, and which are based on reliability and validity evidences, have been published in health and ‘safety at work’ areas. However, there are few safety culture assessment instruments with these characteristics (reliability and validity) available on nuclear literature. Therefore, this work proposes an instrument to evaluate, with valid and reliable measures, the safety climate of nuclear research facilities. The instrument was developed based on methodological principles applied to research modeling and its psychometric properties were evaluated by a reliability analysis and validation of content, face and construct. The instrument was applied to an important nuclear research organization in Brazil. This organization comprises 4 research reactors and many nuclear laboratories. The survey results made possible a demographic characterization and the identification of some possible safety culture weaknesses and pointing out potential areas to be improved in the assessed organization. Good evidence of reliability with Cronbach's alpha

  1. Psychometric model for safety culture assessment in nuclear research facilities

    International Nuclear Information System (INIS)

    Nascimento, C.S. do; Andrade, D.A.; Mesquita, R.N. de

    2017-01-01

    Highlights: • A psychometric model to evaluate ‘safety climate’ at nuclear research facilities. • The model presented evidences of good psychometric qualities. • The model was applied to nuclear research facilities in Brazil. • Some ‘safety culture’ weaknesses were detected in the assessed organization. • A potential tool to develop safety management programs in nuclear facilities. - Abstract: A safe and reliable operation of nuclear power plants depends not only on technical performance, but also on the people and on the organization. Organizational factors have been recognized as the main causal mechanisms of accidents by research organizations through USA, Europe and Japan. Deficiencies related with these factors reveal weaknesses in the organization’s safety culture. A significant number of instruments to assess the safety culture based on psychometric models that evaluate safety climate through questionnaires, and which are based on reliability and validity evidences, have been published in health and ‘safety at work’ areas. However, there are few safety culture assessment instruments with these characteristics (reliability and validity) available on nuclear literature. Therefore, this work proposes an instrument to evaluate, with valid and reliable measures, the safety climate of nuclear research facilities. The instrument was developed based on methodological principles applied to research modeling and its psychometric properties were evaluated by a reliability analysis and validation of content, face and construct. The instrument was applied to an important nuclear research organization in Brazil. This organization comprises 4 research reactors and many nuclear laboratories. The survey results made possible a demographic characterization and the identification of some possible safety culture weaknesses and pointing out potential areas to be improved in the assessed organization. Good evidence of reliability with Cronbach's alpha

  2. 78 FR 14912 - International Aviation Safety Assessment (IASA) Program Change

    Science.gov (United States)

    2013-03-08

    ... Aviation Safety Assessment (IASA) Program Change AGENCY: Federal Aviation Administration (FAA), DOT. ACTION..., into the U.S., or codeshare with a U.S. air carrier, complies with international aviation safety... subject to that country's aviation safety oversight can serve the United States using its own aircraft or...

  3. Fuel and canister process report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Werme, Lars; Lilja, Christina

    2010-12-01

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  4. Fuel and canister process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Werme, Lars; Lilja, Christina (eds.)

    2010-12-15

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  5. Probabilistic safety assessment in radioactive waste disposal

    International Nuclear Information System (INIS)

    Robinson, P.C.

    1987-07-01

    Probabilistic safety assessment codes are now widely used in radioactive waste disposal assessments. This report gives an overview of the current state of the field. The relationship between the codes and the regulations covering radioactive waste disposal is discussed and the characteristics of current codes is described. The problems of verification and validation are considered. (author)

  6. Safety as a management concept in the air transport sector: A systematic literature review

    Directory of Open Access Journals (Sweden)

    Fernando Campa-Planas

    2017-01-01

    Full Text Available Purpose: The main purpose of the present study is to conduct a literature review of the contribution made by safety in air transport, based on the existing international academic literature in the field of the social sciences. It primarily attempts to examine and verify the relationship between safety-related concepts (co-occurrence, the link between the different authors (co-authorship and the corresponding citations (co-citations. Methodology: To achieve the established objectives, a systematic literature review (SLR has been conducted using the Scopus database between the years 1990 and 2016, identifying international academic papers related to the research topic of the present study. Findings: It has been verified, on the one hand, that safety in the air transport sector is a field of growing interest, as the number of papers has increased considerably in recent years, thus demonstrating the importance that this topic has acquired over time. On the other hand, however, it must be mentioned that the total quantity of papers related to the topic is low in terms of absolute numbers. The results of the co-occurrence analysis show that the most important aspect of safety is safety management, while the strongest link is between safety management and aircraft accidents, a fact that is foreseeable a priori.  Originality/value: The approach used allows a better view of the academic contribution made in relation to safety; this serves as the link among the different elements of the concept studied, and it demonstrates the growing interest in this area.

  7. Assessment of Electrical Safety Beliefs and Practices: A Case Study

    Directory of Open Access Journals (Sweden)

    S. Boubaker

    2017-12-01

    Full Text Available In this paper, the electrical safety beliefs and practices in Hail region, Saudi Arabia, have been assessed. Based on legislative recommendations and rules applied in Saudi Arabia, on official statistics regarding the electricity-caused accidents and on the analysis of more than 200 photos captured in Hail (related to electrical safety, a questionnaire composed of 36 questions (10 for the respondents information, 16 for the home safety culture and 10 for the electrical devices purchasing culture has been devised and distributed to residents. 228 responses have been collected and analyzed. Using a scale similar to the one adopted for a university student GPA calculation, the electrical safety level (ESL in Hail region has been found to be 0.76 (in a scale of 4 points which is a very low score and indicates a poor electrical safety culture. Several recommendations involving different competent authorities have been proposed. Future work will concern the assessment of safety in industrial companies in Hail region.

  8. Microbubbles combined with ultrasound therapy in ischemic stroke: A systematic review of in-vivo preclinical studies.

    Directory of Open Access Journals (Sweden)

    Laurent Auboire

    Full Text Available Microbubbles (MBs combined with ultrasound sonothrombolysis (STL appears to be an alternative therapeutic strategy for acute ischemic stroke (IS, but clinical results remain controversial.The aim of this systematic review is to identify the parameters tested; to assess evidence on the safety and efficacy on preclinical data on STL; and to assess the validity and publication bias.Pubmed® and Web of ScienceTM databases were systematically searched from January 1995 to April 2017 in French and English. We included studies evaluating STL on animal stroke model. This systematic review was conducted in accordance with the PRISMA guidelines. Data were extracted following a pre-defined schedule by two of the authors. The CAMARADES criteria were used for quality assessment. A narrative synthesis was conducted.Sixteen studies met the inclusion criteria. The result showed that ultrasound parameters and types of MBs were heterogeneous among studies. Numerous positive outcomes on efficacy were found, but only four studies demonstrated superiority of STL versus recombinant tissue-type plasminogen activator on clinical criteria. Data available on safety are limited.Quality assessment of the studies reviewed revealed a number of biases.Further in vivo studies are needed to demonstrate a better efficacy and safety of STL compared to currently approved therapeutic options.http://syrf.org.uk/protocols/.

  9. Safety assessment of emergency power systems for nuclear power plants

    International Nuclear Information System (INIS)

    1992-01-01

    This publication is intended to assist the safety assessor within a regulatory body, or one working as a consultant, in assessing the safety of a given design of the emergency power systems (EPS) for a nuclear power plant. The present publication refers closely to the NUSS Safety Guide 50-SG-D7 (Rev. 1), Emergency Power Systems at Nuclear Power Plants. It covers therefore exactly the same technical subject as that Safety Guide. In view of its objective, however, it attempts to help in the evaluation of possible technical solutions which are intended to fulfill the safety requirements. Section 2 clarifies the scope further by giving an outline of the assessment steps in the licensing process. After a general outline of the assessment process in relation to the licensing of a nuclear power plant, the publication is divided into two parts. First, all safety issues are presented in the form of questions that have to be answered in order for the assessor to be confident of a safe design. The second part presents the same topics in tabulated form, listing the required documentation which the assessor has to consult and those international and national technical standards pertinent to the topics. An extensive reference list provides information on standards. 1 tab

  10. Timing of Decompression in Patients With Acute Spinal Cord Injury: A Systematic Review

    OpenAIRE

    Wilson, Jefferson R.; Tetreault, Lindsay A.; Kwon, Brian K.; Arnold, Paul M.; Mroz, Thomas E.; Shaffrey, Christopher; Harrop, James S.; Chapman, Jens R.; Casha, Steve; Skelly, Andrea C.; Holmer, Haley K.; Brodt, Erika D.; Fehlings, Michael G.

    2017-01-01

    Study Design: Systematic review. Objective: To conduct a systematic review and synthesis of the literature to assess the comparative effectiveness, safety, and cost-effectiveness of early (≤24 hours) versus late decompression (>24 hours) in adults with acute spinal cord injury (SCI). Methods: A systematic search was conducted of Medline, EMBASE, the Cochrane Collaboration Library, and Google Scholar to identify studies published through November 6, 2014. Studies published in any language, in ...

  11. Reactor Safety Assessment System--A situation assessment aid for USNRC emergency response

    International Nuclear Information System (INIS)

    Bray, M.A.; Sebo, D.E.; Dixon, B.W.

    1985-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is intended for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system uses plant parameter data and status information from the power plant. It has a rule base that uses the parametric values, the known operator actions, and the time sequence information in the data to generate situation assessment conclusions for use by the NRC Reactor Safety Team. RSAS rules currently cover one specific reactor type and use setpoints specific to one power plant

  12. Reactor Safety Assessment System: a situation assessment aid for USNRC emergency response

    International Nuclear Information System (INIS)

    Bray, M.A.; Sebo, D.E.; Dixon, B.W.

    1985-04-01

    The Reactor Safety Assessment System is an expert system under development for the United States Nuclear Regulatory Commission (NRC). RSAS is intended for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system uses plant parameter data and status information from the power plant. It has a rule base which uses the parametric values, the known operator actions and the time sequence information in the data to generate situation assessment conclusions for use by the NRC Reactor Safety Team. RSAS rules currently cover one specific reactor type and use setpoints specific to one power plant. 5 figs

  13. Systematic reviews of adverse effects: framework for a structured approach

    Directory of Open Access Journals (Sweden)

    Herxheimer Andrew

    2007-07-01

    Full Text Available Abstract Background As every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favourable outcomes of an intervention, without also assessing the adverse effects, can mislead by introducing a bias favouring the intervention. Much of the current guidance on systematic reviews is directed towards the evaluation of effectiveness; but this differs in important ways from the methods used in assessing the safety and tolerability of an intervention. A detailed discussion of why, how and when to include adverse effects in a systematic review, is required. Methods This discussion paper, which presupposes a basic knowledge of systematic review methodology, was developed by consensus among experienced reviewers, members of the Adverse Effects Subgroup of The Cochrane Collaboration, and supplemented by a consultation of content experts in reviews methodology, as well as those working in drug safety. Results A logical framework for making decisions in reviews that incorporate adverse effects is provided. We explore situations where a comprehensive investigation of adverse effects is warranted and suggest strategies to identify practicable and clinically useful outcomes. The advantages and disadvantages of including observational and experimental study designs are reviewed. The consequences of including separate studies for intended and unintended effects are explained. Detailed advice is given on designing electronic searches for studies with adverse effects data. Reviewers of adverse effects are given general guidance on the assessment of study bias, data collection, analysis, presentation and the interpretation of harms in a systematic review. Conclusion Readers need to be able to recognize how strategic choices made in the review process determine what harms are found, and how the findings may affect

  14. [Safety assessment of foods derived from genetically modified plants].

    Science.gov (United States)

    Pöting, A; Schauzu, M

    2010-06-01

    The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

  15. The Fukushima Daiichi Accident. Technical Volume 2/5. Safety Assessment

    International Nuclear Information System (INIS)

    2015-08-01

    Technical Volume 1 of this report has described what happened during the accident at the Fukushima Daiichi nuclear power plant (NPP). This volume begins (Section 2.1) with a review of how the design basis of the site for external events was assessed initially and then reassessed over the life of the NPP. The section also describes the physical changes that were made to the units as a result. The remainder of the volume describes the treatment of beyond design basis events in the safety assessment of the site, the accident management provisions, the effectiveness of regulatory programmes, human and organizational factors and the safety culture, and the role of operating experience. Further background information is contained in three annexes included on the CD-ROM of this Technical Volume which describe analytical investigations of the accident along with information on topics such as system performance, defence in depth and severe accident phenomena. Section 2.2 provides an assessment of the systems that failed, resulting in a failure to maintain the fundamental safety functions in Units 1–3, which were in operation at the time of the tsunami and in which the reactor pressure vessels (RPV) and containment vessels failed. The section also describes Units 4-6, which were shut down at the time of the tsunami, and the site’s central spent fuel storage facility. Section 2.3 discusses the probabilistic and deterministic safety assessments of beyond design basis accidents (BDBAs) that had been performed for the plant and the insights from these assessments that had led to changes in the plant’s design. The section pays particular attention to the assessment of extreme natural hazards, such as the one which led to the total loss of AC power supply on the site. The additional loss of DC power supply in Units 1 and 2 played a key role in the progression of the accident because it impeded the diagnosis of plant conditions and made the operators unaware of the status of

  16. The role of hospital managers in quality and patient safety: a systematic review.

    Science.gov (United States)

    Parand, Anam; Dopson, Sue; Renz, Anna; Vincent, Charles

    2014-09-05

    To review the empirical literature to identify the activities, time spent and engagement of hospital managers in quality of care. A systematic review of the literature. A search was carried out on the databases MEDLINE, PSYCHINFO, EMBASE, HMIC. The search strategy covered three facets: management, quality of care and the hospital setting comprising medical subject headings and key terms. Reviewers screened 15,447 titles/abstracts and 423 full texts were checked against inclusion criteria. Data extraction and quality assessment were performed on 19 included articles. The majority of studies were set in the USA and investigated Board/senior level management. The most common research designs were interviews and surveys on the perceptions of managerial quality and safety practices. Managerial activities comprised strategy, culture and data-centred activities, such as driving improvement culture and promotion of quality, strategy/goal setting and providing feedback. Significant positive associations with quality included compensation attached to quality, using quality improvement measures and having a Board quality committee. However, there is an inconsistency and inadequate employment of these conditions and actions across the sample hospitals. There is some evidence that managers' time spent and work can influence quality and safety clinical outcomes, processes and performance. However, there is a dearth of empirical studies, further weakened by a lack of objective outcome measures and little examination of actual actions undertaken. We present a model to summarise the conditions and activities that affect quality performance. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. A systematic assessment of quality assurance-based food safety management system of Chinese edible oil manufacturer in view of context characteristics

    NARCIS (Netherlands)

    Ren, Yingxue; He, Zhen; Luning, Pieternel A.

    2016-01-01

    This study uses a framework of a food safety management system-diagnostic instrument (FSMS-DI), for the assessment of the context of a Chinese edible oil manufacture through the view of a case study, and an evaluation of the performance of the FSMS of a Chinese edible oil company. The study

  18. Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

    Science.gov (United States)

    Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

    2014-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

  19. Self-assessment of safety culture in nuclear installations. Highlights and good practices

    International Nuclear Information System (INIS)

    2002-11-01

    This report summarizes the findings of two IAEA Technical Committee Meetings on Safety Culture Self-Assessment Highlights and Good Practices. The meetings took place on 3-5 June 1998 and 23-25 October 2000 in Vienna, and involved an international cross-section of representatives who participated both in plenary discussions and working groups. The purpose of the meetings was to discuss the practical implications of evolutionary changes in the development of safety culture, and to share international experience, particularly on the methods used for the assessment of safety culture and good practices for its enhancement in an organization. The working groups were allocated specific topics for discussion, which included the following: organizational factors influencing the implementation of actions to improve safety culture; how to measure, effectively, progress in implementing solutions to safety culture problems; the symptoms of a weakening safety culture; the suitability of different methods for assessing safety culture; the achievement of sustainable improvements in safety culture using the results of assessment; the potential threats to the continuation of a strong safety culture in an organization from the many challenges facing the nuclear industry. The working groups, when appropriate, considered issues from both the utility's and the regulator's perspectives. This report will be of interest to all organizations who wish to assess and achieve a strong and sustainable safety culture. This includes not only nuclear power plants, but also other sectors of the nuclear industry such as uranium mines and mills, nuclear fuel fabrication facilities, nuclear waste repositories, research reactors, accelerators, radiography facilities, etc. The report specifically supplements other IAEA publications on this subject

  20. A 2-year study of patient safety competency assessment in 29 clinical laboratories.

    Science.gov (United States)

    Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

    2008-06-01

    Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

  1. State-of-the-art report on systematic approaches to safety management - Special Expert Group on Human and Organisational Factors (SEGHOF)

    International Nuclear Information System (INIS)

    Van den Berghe, Yves; Frischknecht, Albert; Gil, Benito; Martin, Anibal; McRobbie, Helen; Reiersen, Craig; Tasset, Daniel; Aastrand, Kaisa; Dahlgren-Persson, Kerstin; Pyy, Pekka; Mauny, Elisabeth

    2006-02-01

    identified areas where future work should be considered. One of the identified key needs was to gather and share information about current practices and approaches used by different countries. The findings of the workshop are reported separately in NEA/CSNI/R(2003)14. A questionnaire-based survey was subsequently prepared to investigate licensee methods and tools and regulatory expectations in SEGHOF member countries. Respondents were also asked to highlight research developments as well as current practices. The principal findings of the survey are summarised as follows: - There is a clear trend for regulatory bodies to develop regulatory requirements and guidelines on safety management. - There is a move towards developing integrated management systems in which safety, quality and business management are not perceived as separate activities to be managed in different ways. - A number of areas warranting further research and development in the area of safety management have been identified. SEGHOF concludes that the CSNI and CNRA should consider the following future activities to further refine the nuclear community's understanding of the key aspects of effective management and organisation of nuclear plants. This should enable good practices to be drawn out and shared internationally: - To update the CSNI/SEGHOF survey about systematic approaches to safety management at suitable intervals to provide a useful reference for workers in this area. - To produce a short publication comparing regulatory approaches to assessment of licensee approaches to safety management (including other industries than nuclear). - To exchange experience about regulatory oversight and licensee approaches in the area of safety culture. - To clarify competencies (including human and organizational factors) needed in the development, implementation and operation of Safety Management Systems as a part of Management Systems in general. - To identify successful practices for dealing with identified

  2. FEP report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  3. FEP report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  4. South African safety assessment framework for the pebble bed modular reactor - HTR2008-58192

    International Nuclear Information System (INIS)

    Joubert, J.; Kohtz, N.; Coe, I.

    2008-01-01

    It is planned to construct a first of a kind Pebble Bed Modular Reactor (PBMR) in South Africa. A need has been recognized to accompany the licensing process for the PBMR with independent safety assessments to ensure that the safety case submitted by the applicant complies with the licensing requirements of the NNR. At the HTR 2006 Conference, the framework and major challenges on safety assessment that the South African National Nuclear Regulator (NNR) faces in developing and applying appropriate strategies and tools were presented. This paper discusses the current status of the various NNR assessment activities and describes how this will be considered in the NNR Final Report on the PBMR Safety Case. The traditional safety assessment process has been adapted to take into account the developmental nature of the project. By performing safety assessments, the designer and applicant must ensure that the design as proposed for construction and as-built meets the safety requirements defined by the regulatory framework. The regulator performs independent safety assessments, including independent analyses in areas deemed safety significant and potentially safety significant. The developmental nature of the project also led to the identification of a series of regulatory assessment activities preceding the formal assessment of the safety case. Besides an assessment of the resolution of Key Licensing Issues which have been defined in an early stage of the project and are discussed in /l/, these activities comprise the participation in an SAR Early Intervention Process, the execution of a regulatory HAZOP and the development of a regulatory assessment specification for the formal assessment of the safety case. This paper briefly describes these activities and their current status. During the last two years, significant progress was made with the development or adjustment of tools for the independent analysis by the regulator of the steady state core design, of the transient

  5. Recent Trends In The Methods Of Safety Assessment Of Rad Waste Treatment And Disposal

    International Nuclear Information System (INIS)

    Mahmoud, N.S.

    2012-01-01

    Radioactive waste management system involves a huge variety of processes and activities. This includes; collection and segregation, pretreatment, treatment, conditioning, storage and finally disposal. To assure the safety of the different facility of each step in the waste management system, the operator should prepare a safety analysis report to be assessed by the national regulatory body. The content of the safety analysis report must include all data about the site, facility design, operational phase, waste materials, and safety assessment methodologies. Safety assessment methodologies are iterative processes involving site-specific, prospective modeling evaluations of the pre-operational, operational, and post-closure time in case of disposal facilities. The safety assessment focuses primarily on a decision about compliance with performance objectives, rather than the much more difficult problem of predicting actual radiological impacts on the public at far future times. The recent organization processes of the safety assessment are improved by the ISAM working group from IAEA for waste disposal site. These safety assessment methodologies have been modified within SADRWMS IAEA project for the establishment of safety methodologies for the pre-disposal facilities (treatment and storage facilities) and the disposal site.

  6. Safety assessment of genetically modified foods

    NARCIS (Netherlands)

    Kleter, G.A.; Noordam, M.Y.

    2016-01-01

    The cultivation of genetically modified (GM) crops has steadily increased since their introduction to the market in the mid-1990s. Before these crops can be grown and sold they have to obtain regulatory approval in many countries, the process of which includes a pre-market safety assessment. The

  7. Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

    DEFF Research Database (Denmark)

    Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.

    2010-01-01

    Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

  8. Quantitative safety assessment of air traffic control systems through system control capacity

    Science.gov (United States)

    Guo, Jingjing

    Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

  9. Safety assessment of discharge chute isolation barrier preparation and installation

    International Nuclear Information System (INIS)

    Meichle, R.H.

    1994-01-01

    This analysis examines activities associated with the installation of isolation barriers in the K Basins at the Hanford Reservation. This revision adds evaluation of barrier drops on stored fuel and basin floor, identifies fuel which will be moved and addresses criticality issues with sludge. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparisons of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions was made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classifications

  10. HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

    Energy Technology Data Exchange (ETDEWEB)

    EVANS, C B

    2004-12-21

    The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.

  11. Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

    Science.gov (United States)

    Co, Michael; Ng, Judy; Kwong, Ava

    2018-05-17

    Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

  12. Assessment of public safety around EDF facilities

    Energy Technology Data Exchange (ETDEWEB)

    Poupart, M. [Electricite de France, Paris (France)

    2004-09-01

    Electricite de France (EDF) recognizes that a dam's structural resistance and its capacity to withstand heavy flooding are 2 of the most significant safety aspects for hydroelectric power stations. However, in addition to dam failure, there are safety risks for the public who frequent the rivers up and down stream from the dam, as well as on property and the environment. A fatal accident which occurred in 1995 down river from EDF's Monteynard hydroelectric facility on the Drac River prompted the utility to take measures to improve control over this type of hazard. Collaboration with public authorities led to an action plan to educate the public about possible danger areas and to improve methods of reducing risks. Regulations regarding access to these areas were also studied along with ways of informing and warning the public. All the stretches of river directly above and below the power stations and dams were listed systematically and a qualitative analysis was carried out of any possible dangers. This led to changes in operating rules, technical instructions and power plant operating regulations. Certain areas are designated as prohibited areas, such as places subject to hazards caused by violent and unexpected water discharges. This paper outlined the Hydraulic Safety Significant Event (HSSE) classification which relates to an operational event related to water that is liable to affect human beings, the environment, water level or flow rate. 9 figs.

  13. Evaluation of safety assessment methodologies in Rocky Flats Risk Assessment Guide (1985) and Building 707 Final Safety Analysis Report (1987)

    International Nuclear Information System (INIS)

    Walsh, B.; Fisher, C.; Zigler, G.; Clark, R.A.

    1990-01-01

    FSARs. Rockwell International, as operating contractor at the Rocky Flats plant, conducted a safety analysis program during the 1980s. That effort resulted in Final Safety Analysis Reports (FSARs) for several buildings, one of them being the Building 707 Final Safety Analysis Report, June 87 (707FSAR) and a Plant Safety Analysis Report. Rocky Flats Risk Assessment Guide, March 1985 (RFRAG85) documents the methodologies that were used for those FSARs. Resources available for preparation of those Rocky Flats FSARs were very limited. After addressing the more pressing safety issues, some of which are described below, the present contractor (EG ampersand G) intends to conduct a program of upgrading the FSARs. This report presents the results of a review of the methodologies described in RFRAG85 and 707FSAR and contains suggestions that might be incorporated into the methodology for the FSAR upgrade effort

  14. Measurement properties of instruments assessing permanent functional impairment of the spine: a systematic review protocol

    Science.gov (United States)

    Trask, Catherine M; Boden, Catherine; Bath, Brenna; Hendrick, Paul; Clay, Lynne; Zeng, Xiaoke; Milosavljevic, Stephan

    2018-01-01

    Introduction Permanent functional impairment (PFI) of the spine is a rating system used by compensation authorities, such as workers compensation boards, to establish an appropriate level of financial compensation for persistent loss of function. Determination of PFI of the spine is commonly based on the assessment of spinal movement combined with other measures of physical and functional impairments; however, the reliability and validity of the measurement instruments used for these evaluations have yet to be established. The aim of this study is to systematically review and synthesise the literature concerning measurement properties of the various and different instruments used for assessing PFI of the spine. Methods Three conceptual groups of terms (1) PFI, (2) spinal disorder and (3) measurement properties will be combined to search Medline, EMBASE, CINAHL, Web of Science, Scopus, PEDro, OTSeeker and Health and Safety Science Abstracts. We will examine peer-reviewed, full-text articles over the full available date range. Two reviewers will independently screen citations (title, abstract and full text) and perform data extraction. Included studies will be appraised as to their methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments criteria. Findings will be summarised and presented descriptively, with meta-analysis pursued as appropriate. Ethics and dissemination This review will summarise the current level of evidence of measurement properties of instruments used for assessing PFI of the spine. Findings of this review may be applicable to clinicians, policy-makers, workers’ compensation boards, other insurers and health and safety organisations. The findings will likely provide a foundation and direction for future research priorities for assessing spinal PFI. PROSPERO registration number CRD42017060390. PMID:29374671

  15. Validity of instruments to assess students' travel and pedestrian safety

    Directory of Open Access Journals (Sweden)

    Baranowski Tom

    2010-05-01

    Full Text Available Abstract Background Safe Routes to School (SRTS programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI and intraclass correlations (ICC across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

  16. Assessment of safety of the nuclear installations of the world

    International Nuclear Information System (INIS)

    Thomas, B.A.; Pozniakov, N.; Banga, U.

    1992-01-01

    Incidents and accidents periodically remind us that preventive measures at nuclear installations are not fully reliable. Although sound design is widely recognized to be prerequisite for safe operation, it is not sufficient. An active management that compensates for the weak aspects of the installations design by redundant operational provisions, is the key factor to ensure safe operation. Safety of nuclear installations cannot be assessed on an emotional basis. Since 1986, accurate safety assessment techniques based on an integrated approach to operational safety have been made available by the ASSET services and are applicable to any industrial process dealing with nuclear materials. The ASSET methodology enables to eliminate in advance the Root Causes of the future accidents by introducing practical safety culture principles in the current managerial practices

  17. Safety assessment driving radioactive waste management solutions (SADRWMS Methodology) implemented in a software tool (SAFRAN)

    Energy Technology Data Exchange (ETDEWEB)

    Kinker, M., E-mail: M.Kinker@iaea.org [International Atomic Energy Agency (IAEA), Vienna (Austria); Avila, R.; Hofman, D., E-mail: rodolfo@facilia.se [FACILIA AB, Stockholm (Sweden); Jova Sed, L., E-mail: jovaluis@gmail.com [Centro Nacional de Seguridad Nuclear (CNSN), La Habana (Cuba); Ledroit, F., E-mail: frederic.ledroit@irsn.fr [IRSN PSN-EXP/SSRD/BTE, (France)

    2013-07-01

    In 2004, the International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts which could be used to improve the mechanisms for applying safety assessment methodologies to predisposal management of radioactive waste. These flowcharts have since been incorporated into DS284 (General Safety Guide on the Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste), and were also considered during the early development stages of the Safety Assessment Framework (SAFRAN) Tool. In 2009 the IAEA presented DS284 to the IAEA Waste Safety Standards Committee, during which it was proposed that the graded approach to safety case and safety assessment be illustrated through the development of Safety Reports for representative predisposal radioactive waste management facilities and activities. To oversee the development of these reports, it was agreed to establish the International Project on Complementary Safety Reports: Development and Application to Waste Management Facilities (CRAFT). The goal of the CRAFT project is to develop complementary reports by 2014, which the IAEA could then publish as IAEA Safety Reports. The present work describes how the DS284 methodology and SAFRAN Tool can be applied in the development and review of the safety case and safety assessment to a range of predisposal waste management facilities or activities within the Region. (author)

  18. Safety assessment driving radioactive waste management solutions (SADRWMS Methodology) implemented in a software tool (SAFRAN)

    International Nuclear Information System (INIS)

    Kinker, M.; Avila, R.; Hofman, D.; Jova Sed, L.; Ledroit, F.

    2013-01-01

    In 2004, the International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts which could be used to improve the mechanisms for applying safety assessment methodologies to predisposal management of radioactive waste. These flowcharts have since been incorporated into DS284 (General Safety Guide on the Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste), and were also considered during the early development stages of the Safety Assessment Framework (SAFRAN) Tool. In 2009 the IAEA presented DS284 to the IAEA Waste Safety Standards Committee, during which it was proposed that the graded approach to safety case and safety assessment be illustrated through the development of Safety Reports for representative predisposal radioactive waste management facilities and activities. To oversee the development of these reports, it was agreed to establish the International Project on Complementary Safety Reports: Development and Application to Waste Management Facilities (CRAFT). The goal of the CRAFT project is to develop complementary reports by 2014, which the IAEA could then publish as IAEA Safety Reports. The present work describes how the DS284 methodology and SAFRAN Tool can be applied in the development and review of the safety case and safety assessment to a range of predisposal waste management facilities or activities within the Region. (author)

  19. Conducting Systematic Outcome Assessment in Private Addictions Treatment Settings

    Directory of Open Access Journals (Sweden)

    Gerard J Connors

    2017-07-01

    Full Text Available Systematic outcome assessment is central to ascertaining the impact of treatment services and to informing future treatment initiatives. This project was designed to be conducted within the clinical operations of 4 private addictions treatment centers. A structured interview was used to assess patients’ alcohol and other drug use and related variables (on treatment entry and at 1, 3, and 6 months following treatment discharge. The primary outcomes were percentage of days abstinent (PDA from alcohol and drugs, PDA from alcohol, and PDA from other drugs. Collateral reports during follow-up also were gathered. A total of 280 patients (56% men across the 4 programs participated. Percentage of days abstinent for each outcome increased significantly from baseline to the 1-month follow-up assessment, and this change was maintained at the 3- and 6-month follow-up assessments. Collateral reports mirrored the patient follow-up reports. Secondary outcomes of patient ratings of urges/cravings, depression, anxiety, and general life functioning all indicated significant improvement from baseline over the course of the follow-up. The results suggest the feasibility of conducting systematic outcome assessment in freestanding private addictions treatment environments.

  20. Safety assessment of genetically modified crops

    International Nuclear Information System (INIS)

    Atherton, Keith T.

    2002-01-01

    The development of genetically modified (GM) crops has prompted widespread debate regarding both human safety and environmental issues. Food crops produced by modern biotechnology using recombinant techniques usually differ from their conventional counterparts only in respect of one or a few desirable genes, as opposed to the use of traditional breeding methods which mix thousands of genes and require considerable efforts to select acceptable and robust hybrid offspring. The difficulties of applying traditional toxicological testing and risk assessment procedures to whole foods are discussed along with the evaluation strategies that are used for these new food products to ensure the safety of these products for the consumer

  1. Assessing progress in the development of safety culture

    International Nuclear Information System (INIS)

    Rotaru, I.; Ghita, S.; Biro, L.

    2002-01-01

    This paper is focussed on the organizational culture and learning processes required for the implementation of all aspects of safety culture. There is no prescriptive formula for improving safety culture. However, some common characteristics and practices are emerging that can be adopted by organizations in order to make progress. The paper refers to some approaches that have been successful in a number of countries. The experience of the international nuclear industry in the development and improvement of safety culture could be extended and found useful in other nuclear activities, irrespective of scale. The examples given of specific practice cover a wide range of activities including analysis of events, the regulatory approach on safety culture, employee participation and safety performance measures. Many of these practices may be relevant to smaller organizations and could contribute to improving safety culture, whatever the size of the organization. The most effective approach is to pursue a range of practices that can be mutually supportive in the development of a progressive safety culture, supported by professional standards, organizational and management commitment. Some guidance is also given on the assessment of safety culture and on the detection of a weakening safety culture. Few suggestions for accelerating the safety culture development and improvement process are also provided. (author)

  2. Crane Safety Assessment Method Based on Entropy and Cumulative Prospect Theory

    Directory of Open Access Journals (Sweden)

    Aihua Li

    2017-01-01

    Full Text Available Assessing the safety status of cranes is an important problem. To overcome the inaccuracies and misjudgments in such assessments, this work describes a safety assessment method for cranes that combines entropy and cumulative prospect theory. Firstly, the proposed method transforms the set of evaluation indices into an evaluation vector. Secondly, a decision matrix is then constructed from the evaluation vectors and evaluation standards, and an entropy-based technique is applied to calculate the index weights. Thirdly, positive and negative prospect value matrices are established from reference points based on the positive and negative ideal solutions. Thus, this enables the crane safety grade to be determined according to the ranked comprehensive prospect values. Finally, the safety status of four general overhead traveling crane samples is evaluated to verify the rationality and feasibility of the proposed method. The results demonstrate that the method described in this paper can precisely and reasonably reflect the safety status of a crane.

  3. An approach for risk informed safety culture assessment for Canadian nuclear power stations

    International Nuclear Information System (INIS)

    Nelson, W.R.

    2010-01-01

    One of the most important components of effective safety and risk management for nuclear power stations is a healthy safety culture. DNV has developed an approach for risk informed safety culture assessment that combines two complementary paradigms for safety and risk management: loss prevention - for preventing and intervening in accidents; and critical function management - for achieving safety and performance goals. Combining these two paradigms makes it possible to provide more robust systems for safety management and to support a healthy safety culture. This approach is being applied to safety culture assessment in partnership with a Canadian nuclear utility. (author)

  4. Safety assessment of existing highway bridges and viaducts

    NARCIS (Netherlands)

    Maljaars, J.; Steenbergen, R.; Abspoel, L.; Kolstein, M.H.

    2012-01-01

    The assessment of the structural safety of existing br idges and viaducts becomes increasingly important in many countries owing to an increase in traffic loads. Most existing standards, however, are developed for the design of new structures. For this reason, an assessment method for determining

  5. A generalized framework for assessment of safety margins in nuclear power plants

    International Nuclear Information System (INIS)

    Gavrilas, M.; Youngblood, B.; Prelewicz, D.; Meyer, Jim

    2004-01-01

    The protection of public health and safety, and the environment from inadvertent releases of radioactive materials from nuclear power plants relies on the implementation of the defense-in-depth strategy. The term defense-in-depth evolved historically, and thus its application has not always been uniform. The use of the term in the context of the U.S. Nuclear Regulatory Commission (NRC) safety philosophy entails the reliance of a nuclear facility on successive compensatory measures in preventing accidents or mitigating damage caused by malfunctions, accidents, or naturally occurring events. The introduction of probabilistic risk analyses with NUREG-74/014 and subsequent evolution in risk assessment techniques, are leading to the implementation of risk informed regulation to ensure the safety of the public and the environment. Risk informed regulation minimizes the likelihood of overlooking potentially significant accident sequences while limiting unnecessary burdens imposed on licensees. The proposed framework merges fundamental elements of safety regulation: defense-in depth, safety margins and probabilistic risk. It formalizes the relationship between probabilistic risk assessment (PRA) methods and data, and deterministic analyses in a manner consistent with NRC's defense-in-depth philosophy. Succinctly put, the likelihood and consequences of accident scenarios are considered simultaneously and quantified by a plant safety metric. The integration of these fundamental elements into a practically applicable safety framework is consistent with the NRC policy statement on use of probabilistic risk assessment methods and the November 2002 Regulatory Guide on risk informed decisions on plant-specific changes to the licensing basis. Safety information resulting from the application of the framework supersedes traditional safety figures of merit. Safety quantifiers, referred herein as safety indices, expand on the qualifier outcomes that currently accompany fault tree

  6. Can systematic reviews inform GMO risk assessment and risk management?

    Directory of Open Access Journals (Sweden)

    Christian eKohl

    2015-08-01

    Full Text Available Systematic reviews represent powerful tools to identify, collect, synthesize and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a gold standard for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper we 1 consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO and 2 critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.

  7. Can Systematic Reviews Inform GMO Risk Assessment and Risk Management?

    Science.gov (United States)

    Kohl, Christian; Frampton, Geoff; Sweet, Jeremy; Spök, Armin; Haddaway, Neal Robert; Wilhelm, Ralf; Unger, Stefan; Schiemann, Joachim

    2015-01-01

    Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a "gold standard" for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.

  8. Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review.

    Science.gov (United States)

    Pereira, Luisa Santos; Müller, Vanessa Teixeira; da Mota Gomes, Marleide; Rotenberg, Alexander; Fregni, Felipe

    2016-04-01

    Approximately one-third of patients with epilepsy remain with pharmacologically intractable seizures. An emerging therapeutic modality for seizure suppression is repetitive transcranial magnetic stimulation (rTMS). Despite being considered a safe technique, rTMS carries the risk of inducing seizures, among other milder adverse events, and thus, its safety in the population with epilepsy should be continuously assessed. We performed an updated systematic review on the safety and tolerability of rTMS in patients with epilepsy, similar to a previous report published in 2007 (Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007; 10 (4): 521-8), and estimated the risk of seizures and other adverse events during or shortly after rTMS application. We searched the literature for reports of rTMS being applied on patients with epilepsy, with no time or language restrictions, and obtained studies published from January 1990 to August 2015. A total of 46 publications were identified, of which 16 were new studies published after the previous safety review of 2007. We noted the total number of subjects with epilepsy undergoing rTMS, medication usage, incidence of adverse events, and rTMS protocol parameters: frequency, intensity, total number of stimuli, train duration, intertrain intervals, coil type, and stimulation site. Our main data analysis included separate calculations for crude per subject risk of seizure and other adverse events, as well as risk per 1000 stimuli. We also performed an exploratory, secondary analysis on the risk of seizure and other adverse events according to the type of coil used (figure-of-8 or circular), stimulation frequency (≤ 1 Hz or > 1 Hz), pulse intensity in terms of motor threshold (stimulator output for speech arrest, clinically arising from the region of

  9. Development of a New Safety Culture Assessment Method for Nuclear Power Plants (NPPs) (A study to suggest a new safety culture assessment method in nuclear power plants)

    International Nuclear Information System (INIS)

    Han, Sang Min; Seong, Poong Hyun

    2014-01-01

    This study is conducted to suggest a new safety culture assessment method in nuclear power plants. Criteria with various existing safety culture analysis methods are united, and reliability analysis methods are applied. The concept of the most representative methods, Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA), are adopted to assess safety culture. Through this application, it is expected that the suggested method will bring results with convenience and objectiveness

  10. Development of a New Safety Culture Assessment Method for Nuclear Power Plants (NPPs) (A study to suggest a new safety culture assessment method in nuclear power plants)

    Energy Technology Data Exchange (ETDEWEB)

    Han, Sang Min; Seong, Poong Hyun [KAIST, Daejeon (Korea, Republic of)

    2014-08-15

    This study is conducted to suggest a new safety culture assessment method in nuclear power plants. Criteria with various existing safety culture analysis methods are united, and reliability analysis methods are applied. The concept of the most representative methods, Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA), are adopted to assess safety culture. Through this application, it is expected that the suggested method will bring results with convenience and objectiveness.

  11. Overview of the ISAM safety assessment methodology

    International Nuclear Information System (INIS)

    Simeonov, G.

    2003-01-01

    The ISAM safety assessment methodology consists of the following key components: specification of the assessment context description of the disposal system development and justification of scenarios formulation and implementation of models running of computer codes and analysis and presentation of results. Common issues run through two or more of these assessment components, including: use of methodological and computer tools, collation and use of data, need to address various sources of uncertainty, building of confidence in the individual components, as well as the overall assessment. The importance of the iterative nature of the assessment should be recognised

  12. Building quality into performance and safety assessment software

    International Nuclear Information System (INIS)

    Wojciechowski, L.C.

    2011-01-01

    Quality assurance is integrated throughout the development lifecycle for performance and safety assessment software. The software used in the performance and safety assessment of a Canadian deep geological repository (DGR) follows the CSA quality assurance standard CSA-N286.7 [1], Quality Assurance of Analytical, Scientific and Design Computer Programs for Nuclear Power Plants. Quality assurance activities in this standard include tasks such as verification and inspection; however, much more is involved in producing a quality software computer program. The types of errors found with different verification methods are described. The integrated quality process ensures that defects are found and corrected as early as possible. (author)

  13. Safety assessment input for site selection - the Swedish example - 59031

    International Nuclear Information System (INIS)

    Andersson, Johan

    2012-01-01

    Svensk Kaernbraenslehantering AB (SKB) has performed comprehensive investigations of two candidate sites for a final repository for Sweden's spent nuclear fuel. In March 2011 SKB decided to submit licence applications for a final repository at Forsmark. Before selection, SKB stated that the site that offers the best prospects for achieving long-term safety in practice would be selected. Based on experiences previous safety assessments, a number of issues related to long-term safety need to be considered in the context of site comparison. The factors include sensitivity to climate change such as periods of permafrost and glaciations, rock mechanics evolution including the potential for thermally induced spalling and sensitivity to potential future earthquakes, current and future groundwater flow, evolution of groundwater composition and proximity to mineral resources. Each of these factors related to long-term safety for the two candidate sites is assessed in a comparative analysis of site characteristics. The assessment also considers differences in biosphere conditions and in the confidence of the site descriptions. The comparison is concluded by an assessment on how the identified differences would affect the estimated radiological risk from a repository located at either of the sites. The assessment concludes that there are a number of safety related site characteristics for which the analyses do not show any decisive differences in terms of implications on safety, between the sites Forsmark and Laxemar. However, the frequency of water conducting fractures at repository depth is much smaller at Forsmark than at Laxemar. This difference, in turn, affects the future stability of the current favourable groundwater composition, which combined with the much higher flows at Laxemar would, for the current repository design, lead to a breach in the safety functions for the buffer and the canister for many more deposition positions at Laxemar than at Forsmark. Thereby

  14. Human reliability analysis methods for probabilistic safety assessment

    International Nuclear Information System (INIS)

    Pyy, P.

    2000-11-01

    Human reliability analysis (HRA) of a probabilistic safety assessment (PSA) includes identifying human actions from safety point of view, modelling the most important of them in PSA models, and assessing their probabilities. As manifested by many incidents and studies, human actions may have both positive and negative effect on safety and economy. Human reliability analysis is one of the areas of probabilistic safety assessment (PSA) that has direct applications outside the nuclear industry. The thesis focuses upon developments in human reliability analysis methods and data. The aim is to support PSA by extending the applicability of HRA. The thesis consists of six publications and a summary. The summary includes general considerations and a discussion about human actions in the nuclear power plant (NPP) environment. A condensed discussion about the results of the attached publications is then given, including new development in methods and data. At the end of the summary part, the contribution of the publications to good practice in HRA is presented. In the publications, studies based on the collection of data on maintenance-related failures, simulator runs and expert judgement are presented in order to extend the human reliability analysis database. Furthermore, methodological frameworks are presented to perform a comprehensive HRA, including shutdown conditions, to study reliability of decision making, and to study the effects of wrong human actions. In the last publication, an interdisciplinary approach to analysing human decision making is presented. The publications also include practical applications of the presented methodological frameworks. (orig.)

  15. The use of ketamine in ECT anaesthesia: A systematic review and critical commentary on efficacy, cognitive, safety and seizure outcomes.

    Science.gov (United States)

    Gálvez, Verònica; McGuirk, Lucy; Loo, Colleen K

    2017-09-01

    This review will discuss ECT efficacy and cognitive outcomes when using ketamine as an ECT anaesthetic compared to other anaesthetics, taking into account important moderator variables that have often not been considered to date. It will also include information on safety and other ECT outcomes (seizure threshold and quality). A systematic search through MEDLINE, PubMed, PsychINFO, Cochrane Databases and reference lists from retrieved articles was performed. Search terms were: "ketamine" and "Electroconvulsive Therapy", from 1995 to September 2016. Meta-analyses, randomised controlled trials, open-label and retrospective studies published in English of depressed samples receiving ECT with ketamine anaesthesia were included (n = 24). Studies were heterogeneous in the clinical populations included and ECT treatment and anaesthetic methods. Frequently, studies did not report on ECT factors (i.e., pulse-width, treatment schedule). Findings regarding efficacy were mixed. Tolerance from repeated use may explain why several studies found that ketamine enhanced efficacy early in the ECT course but not at the end. The majority of studies did not comprehensively examine cognition and adverse effects were not systematically studied. Only a minority of the studies reported on seizure threshold and expression. The routine use of ketamine anaesthesia for ECT in clinical settings cannot yet be recommended based on published data. Larger randomised controlled trials, taking into account moderator variables, specifically reporting on ECT parameters and systematically assessing outcomes are encouraged.

  16. Initialization of Safety Assessment Process for the Croatian Radioactive Waste repository on Trgovska gora

    International Nuclear Information System (INIS)

    Lokner, V.; Levanat, I.; Subasic, D.

    2000-01-01

    An iterative process of safety assessment, presently focusing on the site-specific evaluation of the post-closure phase for the prospective LILW repository on Trgovska gora in Croatia, has recently been initiated. The primary aim of the first assessment iterations is to provide the experts involved, the regulators and the general public with a reasonable assurance that the applicable long term performance and safety objectives can be met. Another goal is to develop a sufficient understanding of the system behavior to support decisions about the site investigation, the facility design, the waste acceptance criteria and the closure conditions. In this initial phase, the safety assessment is structured in a manner following closely methodology of the ISAM. The International Programme for Improving Long Term Safety Assessment Methodologies for Near Surface Radioactive Waste Disposal Facilities the IAEA coordinated research program started in 1997. Results of the safety assessment first iteration will be organized and presented in the form of a preliminary safety analysis report (PSAR), expected to be completed in the second part of the year 2000. As the first report on the initiated safety assessment activities, the PSAR will describe the concept and aims of the assessment process. Particular emphasis will be placed on description of the key elements of a safety assessment approach by: a) defining the assessment context; b) providing description of the disposal system; c) developing and justifying assessment scenarios; d) formulating and implementing models; and e) interpreting the scoping calculations. (author)

  17. Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

    International Nuclear Information System (INIS)

    Kwon, Kee-Choon; Lee, Jang-Soo; Jee, Eunkyoung

    2016-01-01

    Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents

  18. Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee-Choon; Lee, Jang-Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Jee, Eunkyoung [KAIST, Daejeon (Korea, Republic of)

    2016-10-15

    Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents.

  19. Periodic safety reviews of nuclear power plants

    International Nuclear Information System (INIS)

    Toth, Csilla

    2009-01-01

    Operational nuclear power plants (NPPs) are generally subject to routine reviews of plant operation and special safety reviews following operational events. In addition, many Member States of the International Atomic Energy Agency (IAEA) have initiated systematic safety reassessment, termed periodic safety review (PSR), to assess the cumulative effects of plant ageing and plant modifications, operating experience, technical developments, site specific, organizational and human aspects. These reviews include assessments of plant design and operation against current safety standards and practices. PSRs are considered an effective way of obtaining an overall view of actual plant safety, to determine reasonable and practical modifications that should be made in order to maintain a high level of safety throughout the plant's operating lifetime. PSRs can be used as a means to identify time limiting features of the plant. The trend is to use PSR as a condition for deciding whether to continue operation of the plant beyond the originally established design lifetime and for assessing the status of the plant for long term operation. To assist Member States in the implementation of PSR, the IAEA develops safety standards, technical documents and provides different services: training courses, workshops, technical meetings and safety review missions for the independent assessment of the PSR at NPPs, including the requirements for PSR, the review process and the PSR final reports. This paper describes the PSR's objectives, scopes, methods and the relationship of PSR with other plant safety related activities and recent experiences of Member States in implementation of PSRs at NPPs. (author)

  20. Climate and climate-related issues for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Naeslund, Jens-Ove

    2006-11-01

    The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the behaviour of a