WorldWideScience

Sample records for premarket safety assessment

  1. 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.

  2. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-10-04

    ... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...

  3. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-03-21

    ... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...

  4. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-07-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...

  5. 78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-06-12

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  6. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-08-19

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...

  7. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-06-02

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...

  8. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-06-24

    ... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...

  9. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

    Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

  10. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  11. Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Kazuo Iijima

    Full Text Available Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention. However, to our knowledge, no studies have compared the effectiveness and the safety between the pre- and postmarketing settings. In this study, we aimed to investigate the importance of the postmarketing data analysis using clinical data.Studies on capsule endoscopy with rich clinical data in both pre- and postmarketing settings were selected for the analysis. For effectiveness, clinical studies published before October 10, 2015 comparing capsule endoscopy and conventional flexible endoscopy measuring the detection ratio of obscure gastrointestinal bleeding were selected (premarketing: 4 studies and postmarketing: 8 studies from PubMed (MEDLINE, Cochrane Library, EMBASE and Web of Science. Among the 12 studies, 5 were blinded and 7 were non-blinded. A time series meta-analysis was conducted. Effectiveness (odds ratio decreased in the postmarketing setting (premarketing: 5.19 [95% confidence interval: 3.07-8.76] vs. postmarketing: 1.48 [0.81-2.69]. The change in odds ratio was caused by the increase in the detection ratio with flexible endoscopy as the control group. The efficacy of capsule endoscopy did not change between pre- and postmarketing settings. Heterogeneity (I2 increased in the postmarketing setting because of one study. For safety, in terms of endoscope retention in the body, data from the approval summary and adverse event reports were analyzed. The incidence of retention decreased in the postmarketing setting (premarketing: 0.75% vs postmarketing: 0.095%. The introduction of the new patency capsule for checking the patency of the digestive tract might contribute to the decrease.Effectiveness and safety could change in the postmarketing setting. Therefore, time series meta-analyses could be useful to continuously monitor the

  12. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  13. 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

  14. 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

  15. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Science.gov (United States)

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

  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. 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

  18. 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.

  19. 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

  20. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  1. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  2. 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

  3. 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

  4. 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

  5. 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

  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. Analysis of longitudinal laboratory data in the presence of common selection mechanisms: a view toward greater emphasis on pre-marketing pharmaceutical safety.

    Science.gov (United States)

    Schildcrout, Jonathan S; Jenkins, Cathy A; Ostroff, Jack H; Gillen, Daniel L; Harrell, Frank E; Trost, Donald C

    2008-05-30

    Pharmaceutical safety has received substantial attention in the recent past; however, longitudinal clinical laboratory data routinely collected during clinical trials to derive safety profiles are often used ineffectively. For example, these data are frequently summarized by comparing proportions (between treatment arms) of participants who cross pre-specified threshold values at some time during follow-up. This research is intended, in part, to encourage more effective utilization of these data by avoiding unnecessary dichotomization of continuous data, acknowledging and making use of the longitudinal follow-up, and combining data from multiple clinical trials. However, appropriate analyses require careful consideration of a number of challenges (e.g. selection, comparability of study populations, etc.). We discuss estimation strategies based on estimating equations and maximum likelihood for analyses in the presence of three response history-dependent selection mechanisms: dropout, follow-up frequency, and treatment discontinuation. In addition, because clinical trials' participants usually represent non-random samples from target populations, we describe two sensitivity analysis approaches. All discussions are motivated by an analysis that aims to characterize the dynamic relationship between concentrations of a liver enzyme (alanine aminotransferase) and three distinct doses (no drug, low dose, and high dose) of an nk-1 antagonist across four Phase II clinical trials.

  8. [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

  9. 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)

  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. Safety Assessment of Probiotics

    Science.gov (United States)

    Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

    Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

  12. 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)

  13. Assessment of criticality safety

    International Nuclear Information System (INIS)

    Lloyd, R.C.; Heaberlin, S.W.; Clayton, E.D.; Carter, R.D.

    1979-01-01

    A study was made of 100 violations of criticality safety specifications reported over a 10-y period in the operations of fuel reprocessing plants. The seriousness of each rule violation was evaluated by assigning it a severity index value. The underlying causes or reasons, for the violations were identified. A criticality event tree was constructed using the parameters, causes, and reasons found in the analysis of the infractions. The event tree provides a means for visualizing the paths to an accidental criticality. Some 65% of the violations were caused by misinterpretation on the part of the operator, being attributed to a lack of clarity in the specification and insufficient training; 33% were attributed to lack of care, whereas only 2% were caused by mechanical failure. A fault tree was constructed by assembling the events that could contribute to an accident. With suitable data on the probabilities of contributing events, the probability of the accident's occurrence can be forecast. Estimated probabilities for criticality were made, based on the limited data available, that in this case indicate a minimum time span of 244 y of plant operation per accident ranging up to approx. 3000 y subject to the various underlying assumptions made. Some general suggestions for improvement are formulated based on the cases studied. Although conclusions for other plants may differ in detail, the general method of analysis and the fault tree logic should prove applicable. 4 figures, 8 tables

  14. 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

  15. 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

  16. 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)

  17. 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

  18. 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

  19. 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...

  20. 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

  1. 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

  2. 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.

  3. 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)

  4. 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

  5. Framework of nuclear safety and safety assessment

    International Nuclear Information System (INIS)

    Furuta, Kazuo

    2007-01-01

    Since enormous energy is released by nuclear chain reaction mainly as a form of radiation, a great potential risk accompanies utilization of nuclear energy. Safety has been continuously a critical issue therefore from the very beginning of its development. Though the framework of nuclear safety that has been established at an early developmental stage of nuclear engineering is still valid, more comprehensive approaches are required having experienced several events such as Three Mile Island, Chernobyl, and JCO. This article gives a brief view of the most basic principles how nuclear safety is achieved, which were introduced and sophisticated in nuclear engineering but applicable also to other engineering domains in general. (author)

  6. Confidence building in safety assessment

    International Nuclear Information System (INIS)

    Osthols, E.

    1999-01-01

    Engineered disposal systems are necessary to isolate radioactive waste from humans and the environment. It is essential to have access to basic thermochemical data relevant to varying geological environments for the radioactive elements involved. The OECD/NEA Thermochemical Data Base project (TDB) aims to make widely available basic thermochemical data of the type needed for safety assessment of nuclear storage facilities. The history and the present status of the project are presented. (K.A.)

  7. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

    Science.gov (United States)

    2013-03-04

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

  8. 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

  9. Aging in probabilistic safety assessment

    International Nuclear Information System (INIS)

    Jordan Cizelj, R.; Kozuh, M.

    1995-01-01

    Aging is a phenomenon, which is influencing on unavailability of all components of the plant. The influence of aging on Probabilistic Safety Assessment calculations was estimated for Electrical Power Supply System. The average increase of system unavailability due to aging of system components was estimated and components were prioritized regarding their influence on change of system unavailability and relative increase of their unavailability due to aging. After the analysis of some numerical results, the recommendation for a detailed research of aging phenomena and its influence on system availability is given. (author)

  10. Waste isolation safety assessment program

    International Nuclear Information System (INIS)

    Brandstetter, A.; Harwell, M.A.

    1979-05-01

    Associated with commercial nuclear power production in the United States is the generation of potentially hazardous radioactive wastes. The Department of Energy (DOE), through the National Waste Terminal Storage (NWTS) Program, is seeking to develop nuclear waste isolation systems in geologic formations that will preclude contact with the biosphere of waste radionuclides in concentrations which are sufficient to cause deleterious impact on humans or their environments. Comprehensive analyses of specific isolation systems are needed to assess the expectations of meeting that objective. The Waste Isolation Safety Assessment Program (WISAP) has been established at the Pacific Northwest Laboratory (operated by Battelle Memorial Institute) for developing the capability of making those analyses. Among the analyses required for isolation system evaluation is the detailed assessment of the post-closure performance of nuclear waste repositories in geologic formations. This assessment is essential, since it is concerned with aspects of the nuclear power program which previously have not been addressed. Specifically, the nature of the isolation systems (e.g., involving breach scenarios and transport through the geosphere), and the time-scales necessary for isolation, dictate the development, demonstration and application of novel assessment capabilities. The assessment methodology needs to be thorough, flexible, objective, and scientifically defensible. Further, the data utilized must be accurate, documented, reproducible, and based on sound scientific principles

  11. Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

    Science.gov (United States)

    Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

    2014-11-01

    The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

  12. Probabilistic safety assessment - regulatory perspective

    International Nuclear Information System (INIS)

    Solanki, R.B.; Paul, U.K.; Hajra, P.; Agarwal, S.K.

    2002-01-01

    Full text: Nuclear power plants (NPPs) have been designed, constructed and operated mainly based on deterministic safety analysis philosophy. In this approach, a substantial amount of safety margin is incorporated in the design and operational requirements. Additional margin is incorporated by applying the highest quality engineering codes, standards and practices, and the concept of defence-in-depth in design and operating procedures, by including conservative assumptions and acceptance criteria in plant response analysis of postulated initiating events (PIEs). However, as the probabilistic approach has been improved and refined over the years, it is possible for the designer, operator and regulator to get a more detailed and realistic picture of the safety importance of plant design features, operating procedures and operational practices by using probabilistic safety assessment (PSA) along with the deterministic methodology. At present, many countries including USA, UK and France are using PSA insights in their decision making along with deterministic basis. India has also made substantial progress in the development of methods for carrying out PSA. However, consensus on the use of PSA in regulatory decision-making has not been achieved yet. This paper emphasises on the requirements (e.g.,level of details, key modelling assumptions, data, modelling aspects, success criteria, sensitivity and uncertainty analysis) for improving the quality and consistency in performance and use of PSA that can facilitate meaningful use of the PSA insights in the regulatory decision-making in India. This paper also provides relevant information on international scenario and various application areas of PSA along with progress made in India. The PSA perspective presented in this paper may help in achieving consensus on the use of PSA for regulatory / utility decision-making in design and operation of NPPs

  13. 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

  14. 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

  15. 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)

  16. 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)

  17. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

  18. Radiological safety and risk assessment

    International Nuclear Information System (INIS)

    Hunter, P.H.; Barg, D.C.; Baird, R.D.; Card, D.H.; de Souza, F.; Elder, J.; Felthauser, K.; Jensen, C.; Winkler, V.

    1982-02-01

    A brief radiological safety and risk assessment of a nuclear power generation center with an adjacent on-site waste disposal facility at a specific site in the State of Utah is presented. The assessment was conducted to assist in determining the feasibility and practicality of developing a nuclear energy center (NEC) in Utah consisting of nine 1250 MWe nuclear pressurized water reactor (PWR) electrical generating units arranged in 3 clusters of 3 units each known as triads. The site selected for this conceptual study is in the Horse Bench area about 15 miles directly south of the town of Green River, Utah. The radiological issues included direct radiation exposures to on-site workers and the off-site population, release of radioactive material, and effects of these releases for both normal operations and accidental occurrences. The basic finding of this study is that the concept of an NEC in the Green River area, specifically at the Horse Bench site, is radiologically feasible

  19. 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)

  20. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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

  7. 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

  8. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  9. 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)

  10. 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)

  11. 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

  12. 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

  13. 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

  14. Food and feed safety assessment

    NARCIS (Netherlands)

    Kuiper, H.A.; Paoletti, Claudia

    2015-01-01

    The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the

  15. Assessment of basic safety issues

    International Nuclear Information System (INIS)

    Queniart, D.

    1996-01-01

    Work on the French-German common safety approach for future nuclear power plants continued in 1994 to allow for more detailed discussion of some major issues, taking into account the options provided by the industry for the EPR (European Pressurized water Reactor) project, as described in the document entitled 'Conceptual Safety Features Review File'. Seven meetings of a GPR/RSK advisory experts subgroup, six GPR/RSK plenary sessions and six meetings of the safety authorities (DFD) dealt with the following topics: design of the systems and use of probabilistic approaches, application of a 'break preclusion' approach to the main primary pipings, protection against external hazards (aircraft crashes, explosions, earthquakes), provisions with respect to accidents involving core melt and to containment design, radiological consequences of reference accidents and accidents involving core melt at low pressure. The important aspects of the joint policy are recalled in the presentation. The whole set of GPR/RSK recommendations were agreed by the French and German safety authorities during the DFD meetings of 1994 and early 1995. The utilities decided to begin the basic design phase in February, 1995. Work is now continuing to develop the common French-German approach for future nuclear power plants, in the same way as before. In 1995, this mainly covers the design of the containment and of the systems, but also new issues such as the protection against secondary side overpressurization, radiological protection of workers and radioactive wastes. (J.S.). 3 figs., 1 tab

  16. 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.

  17. 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)

  18. 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

  19. 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

  20. 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)

  1. Assessment of elementary school safety restraint programs.

    Science.gov (United States)

    1985-06-01

    The purpose of this research was to identify elementary school (K-6) safety belt : education programs in use in the United States, to review their development, and : to make administrative and impact assessments of their use in selected States. : Six...

  2. The Benefits of the 3T3 NRU Test in the Safety Assessment of Cosmetics: Long-Term Experience from Pre-Marketing Testing in the Czech Republic.

    Czech Academy of Sciences Publication Activity Database

    Jírová, D.; Kejlová, K.; Brabec, Marek; Bendová, H.; Kolářová, H.

    2003-01-01

    Roč. 174, č. 5-6 (2003), s. 791-796 ISSN 0887-2333 Source of funding: V - iné verejné zdroje Keywords : cytotoxicity * 3T3 NRU assay * irritation * nonparametric statistical model Subject RIV: BB - Applied Statistics, Operational Research Impact factor: 1.642, year: 2003

  3. Review of the regulation and safety assessment of food substances in various countries and jurisdictions

    Science.gov (United States)

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

  4. 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)

  5. 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)

  6. 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

  7. 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...

  8. 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)

  9. 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.

  10. Engineering safety assessment. An introduction

    International Nuclear Information System (INIS)

    Thomson, J.R.

    1987-01-01

    There have been several major industrial accidents in recent years, notably the Chernobyl reactor accident, the Bhopal disaster and the Mexico City gas explosions. It is essential that engineers should understand the natures of the hazards and risks of industrial plant. This book is intended to give an introduction to this subject. Determining the risks associated with hazardous plant such as a chemical plant or a nuclear power station requires knowledge of the probability of a given accident, as well as knowledge of the likely consequences in terms of human lives or damaged property. In this book, the author explains these two main themes in assessing overall risk. He introduces basic probability theory, the assessment of systems reliabilities and structural reliabilities, and the means used to estimate the consequences of hypothetical major accidents. In particular, the methodologies for estimating the consequences of accidental explosion and accidents involving the release of airborne toxic materials (including chemical toxins, carcinogens, and radioactive materials) are explained. A final chapter explores the difficult question of 'acceptable' risk, and how much can justifiably be spent on risk reduction. Intended for use by final year students of chemical, mechanical or nuclear engineering, this book will also be suitable for postgraduate students and practising engineers and scientists whose work involves them in risk assessment. (author)

  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 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)

  13. 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

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Model uncertainty in safety assessment

    International Nuclear Information System (INIS)

    Pulkkinen, U.; Huovinen, T.

    1996-01-01

    The uncertainty analyses are an essential part of any risk assessment. Usually the uncertainties of reliability model parameter values are described by probability distributions and the uncertainty is propagated through the whole risk model. In addition to the parameter uncertainties, the assumptions behind the risk models may be based on insufficient experimental observations and the models themselves may not be exact descriptions of the phenomena under analysis. The description and quantification of this type of uncertainty, model uncertainty, is the topic of this report. The model uncertainty is characterized and some approaches to model and quantify it are discussed. The emphasis is on so called mixture models, which have been applied in PSAs. Some of the possible disadvantages of the mixture model are addressed. In addition to quantitative analyses, also qualitative analysis is discussed shortly. To illustrate the models, two simple case studies on failure intensity and human error modeling are described. In both examples, the analysis is based on simple mixture models, which are observed to apply in PSA analyses. (orig.) (36 refs., 6 figs., 2 tabs.)

  1. Model uncertainty in safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Pulkkinen, U; Huovinen, T [VTT Automation, Espoo (Finland). Industrial Automation

    1996-01-01

    The uncertainty analyses are an essential part of any risk assessment. Usually the uncertainties of reliability model parameter values are described by probability distributions and the uncertainty is propagated through the whole risk model. In addition to the parameter uncertainties, the assumptions behind the risk models may be based on insufficient experimental observations and the models themselves may not be exact descriptions of the phenomena under analysis. The description and quantification of this type of uncertainty, model uncertainty, is the topic of this report. The model uncertainty is characterized and some approaches to model and quantify it are discussed. The emphasis is on so called mixture models, which have been applied in PSAs. Some of the possible disadvantages of the mixture model are addressed. In addition to quantitative analyses, also qualitative analysis is discussed shortly. To illustrate the models, two simple case studies on failure intensity and human error modeling are described. In both examples, the analysis is based on simple mixture models, which are observed to apply in PSA analyses. (orig.) (36 refs., 6 figs., 2 tabs.).

  2. Probabilistic safety assessment for food irradiation facility

    International Nuclear Information System (INIS)

    Solanki, R.B.; Prasad, M.; Sonawane, A.U.; Gupta, S.K.

    2012-01-01

    Highlights: ► Different considerations are required in PSA for Non-Reactor Nuclear Facilities. ► We carried out PSA for food irradiation facility as a part of safety evaluation. ► The results indicate that the fatal exposure risk is below the ‘acceptable risk’. ► Adequate operator training and observing good safety culture would reduce the risk. - Abstract: Probabilistic safety assessment (PSA) is widely used for safety evaluation of Nuclear Power Plants (NPPs) worldwide. The approaches and methodologies are matured and general consensus exists on using these approaches in PSA applications. However, PSA applications for safety evaluation for non-reactor facilities are limited. Due to differences in the processes in nuclear reactor facilities and non-reactor facilities, the considerations are different in application of PSA to these facilities. The food irradiation facilities utilize gamma irradiation sources, X-ray machines and electron accelerators for the purpose of radiation processing of variety of food items. This is categorized as Non-Reactor Nuclear Facility. In this paper, the application of PSA to safety evaluation of food irradiation facility is presented considering the ‘fatality due to radiation overexposure’ as a risk measure. The results indicate that the frequency of the fatal exposure is below the numerical acceptance guidance for the risk to the individual. Further, it is found that the overall risk to the over exposure can be reduced by providing the adequate operator training and observing good safety culture.

  3. 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)

  4. 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

  5. Safety assessment of plant food supplements (PFS)

    NARCIS (Netherlands)

    Berg, van den S.J.P.L.; Serra-Majem, L.; Coppens, P.; Rietjens, I.

    2011-01-01

    Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more

  6. Safety assessment for Dragon fuel element production

    International Nuclear Information System (INIS)

    Price, M.S.T.

    1963-11-01

    This report shall be the Safety Assessment covering the manufacture of the First Charge of Fuel and Fuel Elements for the Dragon Reactor Experiment. It is issued in two parts, of which Part I is descriptive and Part II gives the Hazards Analysis, the Operating Limitations, the Standing Orders and the Emergency Drill. (author)

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). A manufacturer or supplier may withdraw an FCN without prejudice to a...

  14. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Science.gov (United States)

    2013-08-28

    ...] The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers... availability of the draft guidance entitled ``The Applicability of Good Laboratory Practice in Premarket Device... applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of...

  15. 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)

  16. 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

  17. Probabilistic assessment of nuclear safety and safeguards

    International Nuclear Information System (INIS)

    Higson, D.J.

    1987-01-01

    Nuclear reactor accidents and diversions of materials from the nuclear fuel cycle are perceived by many people as particularly serious threats to society. Probabilistic assessment is a rational approach to the evaluation of both threats, and may provide a basis for decisions on appropriate actions to control them. Probabilistic method have become standard tools used in the analysis of safety, but there are disagreements on the criteria to be applied when assessing the results of analysis. Probabilistic analysis and assessment of the effectiveness of nuclear material safeguards are still at an early stage of development. (author)

  18. Using driving simulators to assess driving safety.

    Science.gov (United States)

    Boyle, Linda Ng; Lee, John D

    2010-05-01

    Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

  19. Ultraviolet safety assessments of insect light traps.

    Science.gov (United States)

    Sliney, David H; Gilbert, David W; Lyon, Terry

    2016-01-01

    Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

  20. 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)

  1. 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)

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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

  8. 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

  9. Management of safety, safety culture and self assessment

    International Nuclear Information System (INIS)

    Carnino, A.

    2000-01-01

    Safety management is the term used for the measures required to ensure that an acceptable level of safety is maintained throughout the life of an installation, including decommissioning. The safety culture concept and its implementation are described in part one of the paper. The principles of safety are now quite well known and are implemented worldwide. It leads to a situation where harmonization is being achieved as indicated by the entry into force of the Convention on Nuclear Safety. To go beyond the present nuclear safety levels, management of safety and safety culture will be the means for achieving progress. Recent events which took place in major nuclear power countries have shown the importance of the management and the consequences on safety. At the same time, electricity deregulation is coming and will impact on safety through reductions in staffing and in operation and maintenance cost at nuclear installations. Management of safety as well as its control and monitoring by the safety authorities become a key to the future of nuclear energy.(author)

  10. 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...

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

    International Nuclear Information System (INIS)

    2004-01-01

    This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

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

    International Nuclear Information System (INIS)

    2005-01-01

    This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

  13. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should...

  14. Retained gas sampler interim safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Pasamehmetoglu, K.O.; Miller, W.O.; Unal, C.; Fujita, R.K.

    1995-01-13

    This safety assessment addresses the proposed action to install, operate, and remove a Retained Gas Sampler (RGS) in Tank 101-SY at Hanford. Purpose of the RGS is to help characterize the gas species retained in the tank waste; the information will be used to refine models that predict the gas-producing behavior of the waste tank. The RGS will take samples of the tank from top to bottom; these samples will be analyzed for gas constituents. The proposed action is required as part of an evaluation of mitigation concepts for eliminating episodic gas releases that result in high hydrogen concentrations in the tank dome space.

  15. Safety assessment of outdoor live fire range

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1989-05-01

    The following Safety Assessment (SA) pertains to the outdoor live fire range facility (LFR). The purpose of this facility is to supplement the indoor LFR. In particular it provides capacity for exercises that would be inappropriate on the indoor range. This SA examines the risks that are attendant to the training on the outdoor LFR. The outdoor LFR used by EG&G Mound is privately owned. It is identified as the Miami Valley Shooting Grounds. Mondays are leased for the exclusive use of EG&G Mound.

  16. Retained gas sampler interim safety assessment

    International Nuclear Information System (INIS)

    Pasamehmetoglu, K.O.; Miller, W.O.; Unal, C.; Fujita, R.K.

    1995-01-01

    This safety assessment addresses the proposed action to install, operate, and remove a Retained Gas Sampler (RGS) in Tank 101-SY at Hanford. Purpose of the RGS is to help characterize the gas species retained in the tank waste; the information will be used to refine models that predict the gas-producing behavior of the waste tank. The RGS will take samples of the tank from top to bottom; these samples will be analyzed for gas constituents. The proposed action is required as part of an evaluation of mitigation concepts for eliminating episodic gas releases that result in high hydrogen concentrations in the tank dome space

  17. The waste isolation safety assessment programme

    International Nuclear Information System (INIS)

    Brandstetter, A.; Harwell, M.A.

    1980-01-01

    Associated with commercial nuclear power production in the USA is the generation of potentially hazardous radioactive wastes. The Department of Energy (DOE), through the National Waste Terminal Storage (NWTS) Programme, is seeking to develop nuclear waste isolation systems in geologic formations that will preclude contact with the biosphere of waste radionuclides in concentrations which are sufficient to cause deleterious impact on humans or their environments. Comprehensive analyses of specific isolation systems are needed to assess the expectations of meeting that objective. The Waste Isolation Safety Assessment Programme (WISAP) has been established at the Pacific Northwest Laboratory (operated by Battelle Memorial Institute) for developing the capability of making those analyses. Among the analyses required for isolation system evaluation is the detailed assessment of the post-closure performance of nuclear waste repositories in geologic formations. This assessment is essential, since it is concerned with aspects of the nuclear power programme which previously have not been addressed. Specifically, the nature of the isolation systems (e.g. involving breach scenarios and transport through the geosphere), and the time-scales necessary for isolation, dictate the development, demonstration and application of novel assessment capabilities. The assessment methodology needs to be thorough, flexible, objective, and scientifically defensible. Further, the data utilized must be accurate, documented, reproducible, and based on sound scientific principles. (author)

  18. 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

  19. Assessment of radiation safety in well logging

    International Nuclear Information System (INIS)

    Alles, A.; Pérez, Y.; Duménigo, C.

    2015-01-01

    Radiation safety assessments required by current regulations are a means to verify compliance with the requirements. Different methods have been used for this purpose. In the paper the results of applying the method of risk matrices, applied for the first time in the practice of well logging are exposed. For each initiating event frequency of occurrence, the severity of its consequences and the probability of failure of the barriers identified were evaluated. Starting from these assumptions, the risk associated is determined for each of the identified accident sequences, using for this the SEVRRA code 'Risk Assessment System', originally designed for use in radiotherapy. As an result sequences increased risk associated with the practice of well logging were identified, which is the starting point for the further implementation of a coherent program of dose optimization in practice. [es

  20. Nirex Safety Assessment Research Programme bibliography, 1988

    International Nuclear Information System (INIS)

    Cooper, M.J.

    1988-05-01

    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. All work referred to has been funded, or partly funded, by UK Nirex Limited, previously known as the Nuclear Industry Radioactive Waste Executive (NIREX). The bibliography has been divided into two sections, a List of Publications in roughly chronological order and an Author Index. The topics involved include near-field and far-field studies. The near-field includes the waste, its immobilising medium, its container, the engineered structure in which the containers are emplaced, and the immediately adjacent geological formation disturbed by the construction of the repository. The far-field is the undisturbed geological formation between the near-field and the biosphere. (author)

  1. 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

  2. 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.

  3. 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

  4. 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

  5. Probabilistic safety assessment activities at Ignalina NPP

    International Nuclear Information System (INIS)

    Bagdonas, A.

    1999-01-01

    The Barselina Project was initiated in the summer 1991. The project was a multilateral co-operation between Lithuania, Russia and Sweden up until phase 3, and phase 4 has been performed as a bilateral between Lithuania and Sweden. The long-range objective is to establish common perspectives and unified bases for assessment of severe accident risks and needs for remedial measures for the RBMK reactors. During phase 3, from 1993 to 1994, a full scope Probabilistic Safety Analysis (PSA) model of the Ignalina Nuclear Power Plant unit 2 was developed to identify possible safety improvement of risk importance. The probabilistic methodology was applied on a plant specific basis for a channel type reactor of RBMK design. During phase 4, from 1994 to 1996, the PSA was further developed, taking into account plant changes, improved modelling methods and extended plant information concerning dependencies (area events, dynamic effects, electrical and signal dependencies). The model reflected the plant status before the outage 1996. During phase 4+, 1998 to 1999 the PSA model was upgraded taking into account the newest plant modifications. The new PSA model of CPS/AZRT was developed. Modelling was based on the Single Failure Analysis

  6. 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

  7. 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 - ...

  8. 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

  9. 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

  10. Nirex Safety Assessment Research Programme bibliography, 1987

    International Nuclear Information System (INIS)

    Cooper, M.J.; Hodgkinson, D.P.

    1987-06-01

    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). All work referred to has been funded, or partly funded, by UK Nirex Limited, previously known as the Nuclear Industry Radioactive Waste Executive (NIREX). The bibliography has been divided into two sections, a List of Publications in roughly chronological order and an Author Index. The topics involved include near-field and far-field studies. The near-field includes the waste, its immobilising medium, its container, the engineered structure in which the containers are emplaced, and the immediately adjacent geological formation disturbed by the construction of the repository. The far-field is the undisturbed geological formation between the near-field and the biosphere. (author)

  11. 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

  12. 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)

  13. Complementary safety assessment assessment of nuclear facilities - Tricastin facility - AREVA

    International Nuclear Information System (INIS)

    2011-01-01

    This complementary safety assessment analyses the robustness of the Areva part of the Tricastin nuclear site to extreme situations such as those that led to the Fukushima accident. This study includes the following facilities: Areva NC Pierrelatte, EURODIF production, Comurhex Pierrelatte, Georges Besse II plant and Socatri. Robustness is the ability for the plant to withstand events beyond which the plant was designed. Robustness is linked to safety margins but also to the situations leading to a sudden deterioration of the accidental sequence. Moreover, safety is not only a matter of design or engineered systems but also a matter of organizing: task organization (including subcontracting) as well as the setting of emergency plans or the inventory of nuclear materials are taken into consideration in this assessment. This report is divided into 10 main chapters: 1) the feedback experience of the Fukushima accident; 2) description of the site and its surroundings; 3) featuring of the site's activities and installations; 4) accidental sequences; 5) protection from earthquakes; 6) protection from floods; 7) protection from other extreme natural disasters; 8) the loss of electrical power and of the heat sink; 9) the management of severe accidents; and 10) subcontracting policy. This analysis has identified 5 main measures to be taken to limit the risks linked to natural disasters: -) continuing the program for replacing the current conversion plant and the enrichment plant; -) renewing the storage of hydrofluoric acid at the de-fluorination workshop; -) assessing the seismic behaviour of some parts of the de-fluorination workshop and of the fluorine fabrication workshop; -) improving the availability of warning and information means in case of emergency; and -) improving the means to mitigate accidental gaseous releases. (A.C.)

  14. Safety Assessment in Installation of Precast Concrete

    Directory of Open Access Journals (Sweden)

    Yashrri S.N.

    2014-03-01

    Full Text Available This study was carried out to identify the safety aspects and the level of safety during the installation process in construction sites. A questionnaire survey and interviews were done to provide data on safety requirements in precast concrete construction. All of the interviews and the research questionnaire survey were conducted among contractors that are registered as class 1 to class 7 with the Construction Industry Development Board (CIDB and class A to class G with Pusat Khidmat Kontraktor (PKK in Penang. Returned questionnaires were analysed with the use of simple percentages and the Likert Scale analysis method to identify safety aspects of precast construction. The results indicate that the safety aspect implemented by companies involved in the precast construction process is at a good level in the safety aspect during bracing, propping, welding and grouting processes and at a very good level of safety in general aspects and safety aspects during lifting processes.

  15. ASSESSMENT OF FOOD SAFETY PRACTICES AMONG CASSAVA ...

    African Journals Online (AJOL)

    Philips Olusola

    public policies on food safety management. ... in the contemporary world and a significant factor in the reduction of productivity. There is some .... adduced to the views of the majority who considered food safety practices a big ..... Contingency.

  16. 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

  17. 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.

  18. 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)

  19. Nirex safety assessment research programme bibliography, 1991

    International Nuclear Information System (INIS)

    Cooper, M.J.

    1991-09-01

    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. The bibliography has been divided into two sections, a list of Publications in roughly chronological order and an Author Index. The topics involved include near-field and far-field studies. The near-field includes the waste package, filling or sealing materials, and those parts of the host medium whose characteristics have been or could be altered by the repository or its content. The far-field is the rock formation outside the repository, including the surrounding strata, at a distance from the waste disposal site such that, for modelling purposes, the site may be considered as a single entity, and the effects of individual waste packages are indistinguishable in the effects of the whole. The far-field includes also the biosphere, into which radionuclides from the waste could conceivably migrate in the future. (author)

  20. The Nirex safety assessment research programme

    International Nuclear Information System (INIS)

    Cooper, M.J.

    1988-07-01

    This report describes progress on the Nirex Safety Assessment Research Programme in 1987/88. The programme is concerned with research into the disposal of low-level waste (LLW) and intermediate-level waste (ILW) into underground repositories. At the beginning of 1987/88 a range of techniques for measuring and modelling far-field phenomena were being applied to near-surface disposal of low-level waste in clay. However, during the year the far-field studies were redirected to consider generic geological materials of interest for deep disposal of low and intermediate-level waste, which is now the preferred option in the UK. A substantial part of the programme is concerned with the effectiveness of near-field barriers to water-borne leakage of radionuclides from cementitious repositories. Considerable progress has been made in quantifying this and laying the foundations for robust and reliable radiological assessments to be made with appropriate models. New projects have also been initiated to study the evolution and migration of gases from an underground repository and to consider the contribution of the biosphere to the retardation of radionuclides. (author)

  1. 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.

  2. 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/

  3. 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/

  4. 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)

  5. 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)

  6. 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

  7. [Patient safety in antibiotics administration: Risk assessment].

    Science.gov (United States)

    Maqueda Palau, M; Pérez Juan, E

    To determine the level of risk in the preparation and administration of antibiotics frequently used in the Intensive Care Unit using a risk matrix. A study was conducted using situation analysis and literature review of databases, protocols and good practice guidelines on intravenous therapy, drugs, and their administration routes. The most used antibiotics in the ICU registered in the ENVIN-HELICS program from 1 April to 30 June 2015 were selected. In this period, 257 patients received antimicrobial treatment and 26 antibiotics were evaluated. Variables studied: A risk assessment of each antibiotic using the scale Risk Assessment Tool, of the National Patient Safety Agency, as well as pH, osmolarity, type of catheter recommended for administration, and compatibility and incompatibility with other antibiotics studied. Almost two-thirds (65.3%) of antibiotics had more than 3 risk factors (represented by a yellow stripe), with the remaining 34.7% of antibiotics having between 0 and 2 risk factors (represented by a green stripe). There were no antibiotics with 6 or more risk factors (represented by a red stripe). Most drugs needed reconstitution, additional dilution, and the use of part of the vial to administer the prescribed dose. More than half of the antibiotics studied had a moderate risk level; thus measures should be adopted in order to reduce it. The risk matrix is a useful tool for the assessment and detection of weaknesses associated with the preparation and administration of intravenous antibiotics. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Safety assessment of the BELENE NPP

    International Nuclear Information System (INIS)

    Bruna, G.B.

    2010-01-01

    The most important outcome of the RISKAUDIT’s review of the BELENE’s ISAR was that the design of the plant is in general conformity with the applied requirements, the Bulgarian regulation and the international practice.No substantial design flaws have been identified and no major issues are found as missing. However, the ISAR should be significantly improved before issuing the construction permit. RISKAUDIT asked for elaboration of a revised version of the ISAR, in which all the recommendations, the requests for information as well the questions should be comprehensively addressed, and explicitly referenced to facilitate their assessment. The satisfactory accomplishment of this duty has been considered. The considered as a as prerequisite for the issuance of the construction permit, 2.The REV 2 of the ISAR have been issued at the beginning of this year, BNRA and RISKAUDIT signed on a new collaboration under the above-mentioned Contract, which has the following main objectives:a. Assessing the implementation of the above-mentioned recommendations, b.Verifying and integrating the answers provided to the questions,c.Performing additional in-depth analysis aimed at completing and finalizing the previous investigations as well as addressing some complementary relevant safety issues.3.The inception meeting of this Contract is planed June 17 –18 in Sofia. Details on the planning have to be defined, but, tentatively, the assessment activity should be completed by the end of current year and the accompanying in-depth analysis at the latest at the beginnings of 2011. 4.4.The issuance of those Reports is an important technical support., The support to to the process for granting the construction permit

  9. 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

  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. 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.

  12. 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...

  13. 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

  14. 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...

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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)

  20. Plant assessment system and safety culture

    International Nuclear Information System (INIS)

    Chun, Chuyoung

    1996-01-01

    The government, upon these events, keenly felt the necessity for developing the safety culture which was already forwarded in nuclear industries and started taking actions to propagate it to all parts of society. The government established a social safety director position under the Prime Minister's jurisdiction and also established a Safety Culture Promotion Headquarters in which 7 ministries and other organizations, such as Korea Economic Council, Federation of Korea Trade Union and Women's Federation Council were participating. In accordance with the government's strong will to enhance the safety consciousness of people, safety campaigns are being developed voluntarily in the private sector. The formation of non-governmental organizations, such as People's Central Council of Safety Culture Promotion, shows a good example of such movement

  1. 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

  2. ITER plasma safety interface models and assessments

    International Nuclear Information System (INIS)

    Uckan, N.A.; Bartels, H-W.; Honda, T.; Amano, T.; Boucher, D.; Post, D.; Wesley, J.

    1996-01-01

    Physics models and requirements to be used as a basis for safety analysis studies are developed and physics results motivated by safety considerations are presented for the ITER design. Physics specifications are provided for enveloping plasma dynamic events for Category I (operational event), Category II (likely event), and Category III (unlikely event). A safety analysis code SAFALY has been developed to investigate plasma anomaly events. The plasma response to ex-vessel component failure and machine response to plasma transients are considered

  3. Assessing verticalization effects on urban safety perception

    OpenAIRE

    Lourenço, Ricardo Barros

    2017-01-01

    We describe an experiment with the modeling of urban verticalization effects on perceived safety scores as obtained with computer vision on Google Streetview data for New York City. Preliminary results suggests that for smaller buildings (between one and seven floors), perceived safety increases with building height, but that for high-rise buildings, perceived safety decreases with increased height. We also determined that while height contributing for this relation, other zonal aspects also ...

  4. Risk measures in living probabilistic safety assessment

    International Nuclear Information System (INIS)

    Holmberg, J.; Niemelae, I.

    1993-05-01

    The main objectives of the study are: to define risk measures and suggested uses of them in various living PSA applications for the operational safety management and to describe specific model features required for living PSA applications. The report is based on three case studies performed within the Nordic research project Safety Evaluation by Use of Living PSA and Safety Indicators. (48 refs., 11 figs., 17 tabs.)

  5. 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.

  6. 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

  7. Tree Simulation Techniques for Integrated Safety Assessment

    International Nuclear Information System (INIS)

    Melendez Asensio, E.; Izquierdo Rocha, J.M.; Sanchez Perez, M.; Hortal Reymundo, J.; Perez Mulas, A.

    1999-01-01

    techniques are: (a) An unifying theory that should (i) establish the relationship among different approaches and, in particular, be able to demonstrate the standard safety assessment approach as a particular case, (ii) identify implicit assumptions in present practice and (iii) establish a sound scientific reference for an ideal treatment in order to judge the relative importance of implicit and explicit assumptions. In addition, the theoretical developments help to identify the type of applications where the new developments will be a necessary requirement. (b) The capability for simulation of trees. By this we mean the techniques required to be able to efficiently simulate all branches. Historically algorithms able to do this were already implemented in earlier pioneering work for discrete number of branches while stochastic branching requires Montecarlo techniques. (c) The capability to incorporate new types of branching, particularly operator actions. This paper shortly reviews these aspects and justifies in that frame our particular development, denoted here as Integrated Safety Assessment methodology. In this method, the dynamics of the event is followed by transient simulation in tree form, building a Setpoint or Deterministic Dynamic Event Tree (DDET). When a setpoint that should trigger the actuation of a protection is crossed, the tree is opened in branches corresponding to different functioning states of the protection device and each branch followed by the engineering simulator. One of these states is the nominal state, which, in the PSAs, is Associated to the success criterion of the system

  8. 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)

  9. Key issues on safety design basis selection and safety assessment

    International Nuclear Information System (INIS)

    An, S.; Togo, Y.

    1976-01-01

    In current fast reactor design in Japan, four design accident conditions and four design seismic conditions are adopted as the design base classifications. These are classified by the considerations on both likelihood of occurrence and the severeness of the consequences. There are several major problem areas in safety design consideration such as core accident problems which include fuel sodium interaction, fuel failure propagation and residual decay heat removal, and decay heat removal systems problems which is more or less the problem of selection of appropriate system and of assurance of high reliability of the system. In view of licensing, two kinds of accidents are postulated in evaluating the adequacy of a reactor site. The one is the ''major accident'' which is the accident to give most severe radiation hazard to the public from technical point of view. The other is the ''hypothetical accident'', induced public accident of which is severer than that of major accident. While the concept of the former is rather unique to Japanese licensing, the latter is almost equivalent to design base hypothetical accident of the US practice. In this paper, design bases selections, key safety issues and some of the licensing considerations in Japan are described

  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. Radionuclide transport report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This document compiles radionuclide transport calculations of a KBS-3 repository for the safety assessment SR-Site. The SR-Site assessment supports the licence application for a final repository at Forsmark, Sweden

  12. 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

  13. 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).

  14. 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

  15. Patient safety culture assessment in oman.

    Science.gov (United States)

    Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S S; Al-Adawi, Samir

    2014-07-01

    To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included 'organizational learning and continuous improvement' while conversely, 'non-punitive response to errors' was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman.

  16. Patient Safety Culture Assessment in Oman

    Science.gov (United States)

    Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S.S.; Al-Adawi, Samir

    2014-01-01

    Objective To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. Methods This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. Results The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included ‘organizational learning and continuous improvement’ while conversely, ‘non-punitive response to errors’ was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). Conclusion This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman. PMID:25170407

  17. MAPLE research reactor safety uncertainty assessment methodology

    International Nuclear Information System (INIS)

    Sills, H.E.; Duffey, R.B.; Andres, T.H.

    1999-01-01

    The MAPLE (multipurpose Applied Physics Lattice Experiment) reactor is a low pressure, low temperature, open-tank-in pool type research reactor that operates at a power level of 5 to 35 MW. MAPLE is designed for ease of operation, maintenance, and to meet today's most demanding requirements for safety and licensing. The emphasis is on the use of passive safety systems and environmentally qualified components. Key safety features include two independent and diverse shutdown systems, two parallel and independent cooling loops, fail safe operation, and a building design that incorporates the concepts of primary containment supported by secondary confinement

  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. An Integrated Safety Assessment Methodology for Generation IV Nuclear Systems

    International Nuclear Information System (INIS)

    Leahy, Timothy J.

    2010-01-01

    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. Early work of the RSWG focused on defining a safety philosophy founded on lessons learned from current and prior generations of nuclear technologies, and on identifying technology characteristics that may help achieve Generation IV safety goals. More recent RSWG work has focused on the definition of an integrated safety assessment methodology for evaluating the safety of Generation IV systems. The methodology, tentatively called ISAM, is an integrated 'toolkit' consisting of analytical techniques that are available and matched to appropriate stages of Generation IV system concept development. 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.

  20. The probability safety assessment impact on the BR2 refurbishment

    International Nuclear Information System (INIS)

    Pouleur, Yvan

    1995-01-01

    The probabilistic safety assessment (PSA) study has proven its worth by establishing a sensitive safety screening of the reactor. It has focused engineering forces to technically improve safety systems and to measure the influence of functional modifications. In the future, the project will be developed in a living way, to reinforce the present structure along with continuous safety monitoring of the reactor and to develop engineers and operators safety skills. This paper presents the PSA impact on the BR2 (Belgian Reactor Two) refurbishment. (author)

  1. 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)

  2. 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)

  3. 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

  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. Ultraviolet safety assessments of insect light traps

    OpenAIRE

    Sliney, David H.; Gilbert, David W.; Lyon, Terry

    2016-01-01

    ABSTRACT Near-ultraviolet (UV-A: 315?400?nm), ?black-light,? electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV ?Black-light? ILTs were measured at...

  6. 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

  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. 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

  9. 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.)

  10. 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

  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. 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

  13. 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

  14. 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

  15. Seismic and tsunami safety margin assessment

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    Nuclear Regulation Authority is going to establish new seismic and tsunami safety guidelines to increase the safety of NPPs. The main purpose of this research is testing structures/components important to safety and tsunami resistant structures/components, and evaluating the capacity of them against earthquake and tsunami. Those capacity data will be utilized for the seismic and tsunami back-fit review based on the new seismic and tsunami safety guidelines. The summary of the program in 2012 is as follows. 1. Component seismic capacity test and quantitative seismic capacity evaluation. PWR emergency diesel generator partial-model seismic capacity tests have been conducted and quantitative seismic capacities have been evaluated. 2. Seismic capacity evaluation of switching-station electric equipment. Existing seismic test data investigation, specification survey and seismic response analyses have been conducted. 3. Tsunami capacity evaluation of anti-inundation measure facilities. Tsunami pressure test have been conducted utilizing a small breakwater model and evaluated basic characteristics of tsunami pressure against seawall structure. (author)

  16. Safety assessment in primary Mycobacterium tuberculosis smear ...

    African Journals Online (AJOL)

    Introduction Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is transmitted mainly through aerosolization of infected sputum which puts laboratory workers at risk in spite of the laboratory workersf risk of infection being at 3 to 9 times higher than the general public. Laboratory safety should therefore be ...

  17. Seismic and tsunami safety margin assessment

    International Nuclear Information System (INIS)

    2013-01-01

    Nuclear Regulation Authority is going to establish new seismic and tsunami safety guidelines to increase the safety of NPPs. The main purpose of this research is testing structures/components important to safety and tsunami resistant structures/components, and evaluating the capacity of them against earthquake and tsunami. Those capacity data will be utilized for the seismic and tsunami back-fit review based on the new seismic and tsunami safety guidelines. The summary of the program in 2012 is as follows. 1. Component seismic capacity test and quantitative seismic capacity evaluation. PWR emergency diesel generator partial-model seismic capacity tests have been conducted and quantitative seismic capacities have been evaluated. 2. Seismic capacity evaluation of switching-station electric equipment. Existing seismic test data investigation, specification survey and seismic response analyses have been conducted. 3. Tsunami capacity evaluation of anti-inundation measure facilities. Tsunami pressure test have been conducted utilizing a small breakwater model and evaluated basic characteristics of tsunami pressure against seawall structure. (author)

  18. 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

  19. 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.)

  20. 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)

  1. 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)

  2. 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

  3. 76 FR 45453 - New Car Assessment Program (NCAP); Safety Labeling

    Science.gov (United States)

    2011-07-29

    ... Testing F. Consumer Survey and Label Research G. Other Issues 1. Legend for Star Ratings 2. Overall... consumers to consider and assess the relative safety of vehicles before deciding which new vehicle they want..., and prominent fashion, and that the safety rating area of the Monroney label meet minimum size...

  4. Assessing the safety of the road network : a simple method.

    NARCIS (Netherlands)

    Janssen, S.T.M.C.

    1993-01-01

    Research by the SWOV Institute for Road Safety Research in The Netherlands assessing the safety of the Dutch road network is presented. In The Netherlands urban and rural roads and motorways are used roughly equally, however accident rates vary greatly. These are discussed in this paper. Tables show

  5. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  6. 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

  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. 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

  9. Safety Assessment of Radioactive waste Repositories

    International Nuclear Information System (INIS)

    1991-01-01

    It is planned to dispose of high-level radioactive wastes in deep geological formations. To access the long-term safety of radioactive waste disposal systems, mathematical models are used to describe groundwater flow, chemistry and potential radionuclide migration through these formations. Establishing the validity of such models is important in order to obtain the necessary confidence in the safety of the disposal method. The papers in these proceedings of the GEOVAL'90 Symposium describe the current state of knowledge on the validation of geosphere flow and transport models. This symposium, divided into five sessions, contains 65 technical papers: session 1 - Necessity of validation. Session 2 - Progress in validation of flow and transport models in orystalline rock, unsaturated media, salt media or clay. Session 3 - Progress in validation of geochemical models. Session 4 - Progress in validation of coupled thermo-hydro-mechanical effects. Session 5 - Validation strategy

  10. 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

  11. 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

  12. 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.

  13. 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)

  14. Re-assessment of safety and ageing

    International Nuclear Information System (INIS)

    Boudot, R.; Dallery, D.; Delmas, J.; Balley, J.; Acalet, R.; Bignan, G.; Mergui, C.; Mazoyer, R.; Maegey, M.; Laigneau, P.

    2007-01-01

    The first article presents the research program led conjointly by Cea, EDF and Areva to face ageing of nuclear power plants. 3 axis have been defined: 1) the damaging processes in equipment, 2) the damaging processes in concrete structures, and 3) inspection and monitoring techniques. In the context of the preparation of the third decennial safety review of its 900 MWe PWR units, EDF was asked by the Nuclear Authority (ANS) to write up documentation (DAPE) whose purpose is to show that the aging processes are mastered and adequately handled in the unit concerned and that the carrying on of reactor operation for the next 10 years will not degrade its safety standard. The second article presents the specific purposes of the second (VD2) and third (VD3) decennial safety reviews. The last article deals with the renovation work planned on the Masurca research reactor. Masurca installation is dedicated to the setting of neutron experiments necessary for the validation of neutron calculations in fast neutron spectra configurations. The reactor upgrade will concern: -) the power system, -) the instrumentation and control of the reactor, -) the ventilation of the reactor building, -) the seismic reinforcement of an auxiliary building, -) fire protection, and -) radiation monitoring. (A.C.)

  15. Safety Assessment - Swedish Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Kjellstroem, B. [Luleaa Univ. of Technology (Sweden)

    1996-12-31

    After the reactor accident at Three Mile Island, the Swedish nuclear power plants were equipped with filtered venting of the containment. Several types of accidents can be identified where the filtered venting has no effect on the radioactive release. The probability for such accidents is hopefully very small. It is not possible however to estimate the probability accurately. Experiences gained in the last years, which have been documented in official reports from the Nuclear Power Inspectorate indicate that the probability for core melt accidents in Swedish reactors can be significantly larger than estimated earlier. A probability up to one in a thousand operating years can not be excluded. There are so far no indications that aging of the plants has contributed to an increased accident risk. Maintaining the safety level with aging nuclear power plants can however be expected to be increasingly difficult. It is concluded that the 12 Swedish plants remain a major threat for severe radioactive pollution of the Swedish environment despite measures taken since 1980 to improve their safety. Closing of the nuclear power plants is the only possibility to eliminate this threat. It is recommended that until this is done, quantitative safety goals, same for all Swedish plants, shall be defined and strictly enforced. It is also recommended that utilities distributing misleading information about nuclear power risks shall have their operating license withdrawn. 37 refs.

  16. Modern Aspects of Safety Assessment of Foodstuff

    Directory of Open Access Journals (Sweden)

    Tetiana Chorna

    2018-04-01

    Full Text Available Food safety is one of the decisive components of the economic security of each state and is determined by the ability of the country to control effectively the production and import of safe and high-quality food on the generally accepted principles of the world. This sphere of activity in human society has extremely important humanitarian, social, economic and political aspects. The food raw materials and food products quality and safety control is currently the most relevant analytical task. It is more important than environmental pollution, according to some data, more than 70 % of harmful pollutants in the human body gets through food, 20% of water and 10 % of the air. Technogenic pollution of the environment through soil, water and air gets directly into the food. However, food products are contaminated with natural harmful substances that appear in improper storage, in violation of technologies, food processing and processing charts. The article is devoted to the main factors analysis influencing the safety of food products and the improvement of instrumental methods for the study of quality aromatic products (for example, coffee.

  17. Safety Assessment - Swedish Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kjellstroem, B.

    1996-01-01

    After the reactor accident at Three Mile Island, the Swedish nuclear power plants were equipped with filtered venting of the containment. Several types of accidents can be identified where the filtered venting has no effect on the radioactive release. The probability for such accidents is hopefully very small. It is not possible however to estimate the probability accurately. Experiences gained in the last years, which have been documented in official reports from the Nuclear Power Inspectorate indicate that the probability for core melt accidents in Swedish reactors can be significantly larger than estimated earlier. A probability up to one in a thousand operating years can not be excluded. There are so far no indications that aging of the plants has contributed to an increased accident risk. Maintaining the safety level with aging nuclear power plants can however be expected to be increasingly difficult. It is concluded that the 12 Swedish plants remain a major threat for severe radioactive pollution of the Swedish environment despite measures taken since 1980 to improve their safety. Closing of the nuclear power plants is the only possibility to eliminate this threat. It is recommended that until this is done, quantitative safety goals, same for all Swedish plants, shall be defined and strictly enforced. It is also recommended that utilities distributing misleading information about nuclear power risks shall have their operating license withdrawn. 37 refs

  18. 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.

  19. 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.

  20. Use of agent based simulation for traffic safety assessment

    CSIR Research Space (South Africa)

    Conradie, Dirk CU

    2008-07-01

    Full Text Available This paper describes the development of an agent based Computational Building Simulation (CBS) tool, termed KRONOS that is being used to work on advanced research questions such as traffic safety assessment and user behaviour in buildings...

  1. NANoREG framework for the safety assessment of nanomaterials

    OpenAIRE

    Gottardo, Stefania; Alessandrelli, Maria; Amenta, Valeria; Atluri, Rambabu; Barberio, Grazia; Bekker, Cindy; Bergonzo, Philippe; Bleeker, Eric; Booth, Andy; Borges, Teresa; Buttol, Patrizia; Carlander, David; Castelli, Stefano; Chevillard, Sylvie

    2017-01-01

    The NANoREG framework addresses the need to ease the nanomaterials safety assessment in the REACH Regulation context. It offers forward-looking strategies: Safe-by-Design, a Nanospecific Prioritisation and Risk Assessment, and Life Cycle Assessment. It is intended for scientific experts, regulatory authorities and industry.

  2. 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

  3. 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.

  4. 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.

  5. A probabilistic safety assessment PEER review: Case study on the use of probabilistic safety assessment for safety decisions

    International Nuclear Information System (INIS)

    1989-10-01

    The purpose of this case study is to illustrate, using an actual example, the organizing and carrying out of an independent peer review of a draft full-scope (level 3) probabilistic safety assessment. The specific findings of the peer review are of less importance than the approach taken, the interaction between sponsor and study team, and the technical and administrative issues that can arise during a peer review. This case study will examine the following issues: how the scope of the peer review was established, based on how it was to be used by the review sponsoring body; how the level of effort was determined, and what this determination meant for the technical quality of the review; how the team of peer reviewers was selected; how the review itself was carried out; what findings were made; what was done with these findings by both the review sponsoring body and the PSA analysis team. 9 refs, 2 figs, 1 tab

  6. 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)

  7. 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.

  8. 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

  9. AP1000 Containment Design and Safety Assessment

    International Nuclear Information System (INIS)

    Wright, Richard F.; Ofstun, Richard P.; Bachere, Sebastien

    2002-01-01

    The AP1000 is an up-rated version of the AP600 passive plant design that recently received final design certification from the US NRC. Like AP600, the AP1000 is a two-loop, pressurized water reactor featuring passive core cooling and passive containment safety systems. One key safety feature of the AP1000 is the passive containment cooling system which maintains containment integrity in the event of a design basis accident. This system utilizes a high strength, steel containment vessel inside a concrete shield building. In the event of a pipe break inside containment, a high pressure signal actuates valves which allow water to drain from a storage tank atop the shield building. Water is applied to the top of the containment shell, and evaporates, thereby removing heat. An air flow path is formed between the shield building and the containment to aid in the evaporation and is exhausted through a chimney at the top of the shield building. Extensive testing and analysis of this system was performed as part of the AP600 design certification process. The AP1000 containment has been designed to provide increased safety margin despite the increased reactor power. The containment volume was increased to accommodate the larger steam generators, and to provide increased margin for containment pressure response to design basis events. The containment design pressure was increased from AP600 by increasing the shell thickness and by utilizing high strength steel. The passive containment cooling system water capacity has been increased and the water application rate has been scaled to the higher decay heat level. The net result is higher margins to the containment design pressure limit than were calculated for AP600 for all design basis events. (authors)

  10. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Science.gov (United States)

    2013-03-25

    ... requiring this device to meet the statute's premarket approval requirements and the benefits to the public... requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from... consider exercising enforcement discretion for devices lawfully distributed before the requirement to have...

  11. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

  12. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug... requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform... wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption...

  13. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Science.gov (United States)

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...

  14. 21 CFR 864.3 - Effective dates of requirement for premarket approval.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Effective dates of requirement for premarket approval. 864.3 Section 864.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES General Provisions § 864.3 Effective...

  15. Guidelines for pressure vessel safety assessment

    Science.gov (United States)

    Yukawa, S.

    1990-04-01

    A technical overview and information on metallic pressure containment vessels and tanks is given. The intent is to provide Occupational Safety and Health Administration (OSHA) personnel and other persons with information to assist in the evaluation of the safety of operating pressure vessels and low pressure storage tanks. The scope is limited to general industrial application vessels and tanks constructed of carbon or low alloy steels and used at temperatures between -75 and 315 C (-100 and 600 F). Information on design codes, materials, fabrication processes, inspection and testing applicable to the vessels and tanks are presented. The majority of the vessels and tanks are made to the rules and requirements of ASME Code Section VIII or API Standard 620. The causes of deterioration and damage in operation are described and methods and capabilities of detecting serious damage and cracking are discussed. Guidelines and recommendations formulated by various groups to inspect for the damages being found and to mitigate the causes and effects of the problems are presented.

  16. 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.

  17. 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)

  18. 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)

  19. 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)

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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)

  5. Assessment of the factors with significant influence on safety culture

    International Nuclear Information System (INIS)

    Farcasiu, M.; Nitoi, M.

    2013-01-01

    In this paper, a qualitative and a quantitative evaluation of the factors with significant impact on safety culture were performed. These techniques were established and applied in accordance with IAEA standards. In order to show the applicability and opportunity of the methodology a specific case study was prepared: safety culture evaluation for INR Pitesti. The qualitative evaluation was performed using specific developed questionnaires. Through analysis of the completed questionnaires was established the development stage of safety culture at INR. The quantitative evaluation was performed using a guide to rate the influence factors. For each factor was identified the influence (negative or positive) and ranking score was estimated using scoring criteria. The results have emphasized safety culture stages. The paper demonstrates the fact that using both quantitative and qualitative assessment techniques, a practical value of the safety culture concept is given. (authors)

  6. 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

  7. Risk assessment and safety regulations in offshore oil and gas ...

    African Journals Online (AJOL)

    Risk management of which risk assessment is part, and safety regulations are common in the offshore oil and gas industry management system. The process of conducting risk assessment is mostly a challenge for operational personnel assigned to perform this function. The most significant problem is the decision to use ...

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. Results of the CANDU 3 probabilistic safety assessment

    International Nuclear Information System (INIS)

    Jaitly, R.K.

    1995-01-01

    The purpose of the Conceptual Probabilistic Safety Assessment (PSA) of the CANDU 3 reactor was to provide safety assistance in the early stages of design to ensure that the design included adequate redundancy and functional separation of the mitigating systems; the final design should therefore give better results, particularly after modifications involving control, electrical power, instrument air, and service water. The initial PSA gave a total CANDU 3 core damage frequency of 7.8 x 10 -6 /year. 4 refs., 1 fig

  15. HANFORD SAFETY ANALYSIS and RISK ASSESSMENT HANDBOOK (SARAH)

    International Nuclear Information System (INIS)

    EVANS, C.B.

    2004-01-01

    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 and 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

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. [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.

  8. 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

  9. 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

  10. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    Science.gov (United States)

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  11. 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)

  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

    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

  13. 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

  14. 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.

  15. A proposal of safety indicators aggregation to assess the safety management effectiveness of nuclear power plants

    International Nuclear Information System (INIS)

    Carvalho, Jose Antonio B.; Saldanha, Pedro L.C.; Melo, Paulo F.F. Frutuoso e

    2009-01-01

    Safety management has changed with the evolution of management methods, named Quality Systems, moving from Quality Control, where the focus was the product, passing through Quality Assurance, which takes care of the whole manufacturing process and reaching the Total Quality Management, where policies and goals are established. Nowadays, there is a trend towards Management Systems, which integrate all different aspects related to the management of an organization (safety, environment, security, quality, costs and, etc), but it is necessary to have features to establish and assure that safety overrides the remaining aspects. The most usual way to reach this goal is to establish a policy where safety is a priority, but its implementation and the assessment of its effectiveness are no so simple. Nuclear power plants usually have over a hundred safety indicators in many processes dedicated to prevent and detect problems, although a lot of them do not evaluate these indicators in an integrated manner or point out degradation trends of organizational aspects, which can affect the plant safety. This work develops an aggregation of proactive and reactive safety indicators in order to evaluate the effectiveness of nuclear power plant safety management and to detect, at early stages, signs of process degradation or activities used to establish, maintain and assure safety conditions. The aggregation integrates indicators of the usual processes and is based on the manner the management activities have been developed in the last decades, that is: Planning, Doing, Checking and Acting - known as PDCA cycle - plus a fifth element related to the capability of those who perform safety activities. The proposed aggregation is in accordance to Brazilian standards and international recommendations and constitutes a friendly link between the top management level and the daily aspects of the organization. (author)

  16. A proposal of safety indicators aggregation to assess the safety management effectiveness of nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Carvalho, Jose Antonio B.; Saldanha, Pedro L.C. [Comissao Nacional de Energia Nuclear (CNEN), Rio de Janeiro, RJ (Brazil). Coordenacao-Geral de Reatores e Ciclo Combustivel], e-mail: jantonio@cnen.gov.br, e-mail: saldanha@cnen.gov.br; Melo, Paulo F.F. Frutuoso e [Coordenacao dos Programas de Pos-graduacao de Engenharia (COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia Nuclear], e-mail: frutuoso@con.ufrj.br

    2009-07-01

    Safety management has changed with the evolution of management methods, named Quality Systems, moving from Quality Control, where the focus was the product, passing through Quality Assurance, which takes care of the whole manufacturing process and reaching the Total Quality Management, where policies and goals are established. Nowadays, there is a trend towards Management Systems, which integrate all different aspects related to the management of an organization (safety, environment, security, quality, costs and, etc), but it is necessary to have features to establish and assure that safety overrides the remaining aspects. The most usual way to reach this goal is to establish a policy where safety is a priority, but its implementation and the assessment of its effectiveness are no so simple. Nuclear power plants usually have over a hundred safety indicators in many processes dedicated to prevent and detect problems, although a lot of them do not evaluate these indicators in an integrated manner or point out degradation trends of organizational aspects, which can affect the plant safety. This work develops an aggregation of proactive and reactive safety indicators in order to evaluate the effectiveness of nuclear power plant safety management and to detect, at early stages, signs of process degradation or activities used to establish, maintain and assure safety conditions. The aggregation integrates indicators of the usual processes and is based on the manner the management activities have been developed in the last decades, that is: Planning, Doing, Checking and Acting - known as PDCA cycle - plus a fifth element related to the capability of those who perform safety activities. The proposed aggregation is in accordance to Brazilian standards and international recommendations and constitutes a friendly link between the top management level and the daily aspects of the organization. (author)

  17. Technical Issues and Proposes on the Legislation of Probabilistic Safety Assessment in Periodic Safety Review

    International Nuclear Information System (INIS)

    Hwang, Seok-Won; Jeon, Ho-Jun; Na, Jang-Hwan

    2015-01-01

    Korean Nuclear Power Plants have performed a comprehensive safety assessment reflecting design and procedure changes and using the latest technology every 10 years. In Korea, safety factors of PSR are revised to 14 by revision of IAEA Safety Guidelines in 2003. In the revised safety guidelines, safety analysis field was subdivided into deterministic safety analysis, PSA (Probabilistic safety analysis), and hazard analysis. The purpose to examine PSA as a safety factor on PSR is to make sure that PSA results and assumptions reflect the latest state of NPPs, validate the level of computer codes and analytical models, and evaluate the adequacy of PSA instructions. In addition, its purpose is to derive the plant design change, operating experience of other plants and safety enhancement items as well. In Korea, PSA is introduced as a new factor. Thus, the overall guideline development and long-term implementation strategy are needed. Today in Korea, full-power PSA model revision and low-power and shutdown (LPSD) PSA model development is being performed as a part of the post Fukushima action items for operating plants. The scope of the full-power PSA is internal/external level 1, 2 PSA. But in case of fire PSA, the scope is level 1 PSA using new method, NUREG/CR-6850. In case of LPSD PSA, level 1 PSA for all operating plants, and level 2 PSA for 2 demonstration plants are under development. The result of the LPSD PSA will be used as major input data for plant specific SAMG (Severe Accident Management Guideline). The scope of PSA currently being developed in Korea cannot fulfill 'All Mode, All Scope' requirements recommended in the IAEA Safety Guidelines. Besides the legislation of PSA, step-by-step development strategy for non-performed scopes such as level 3 PSA and new fire PSA is one of the urgent issues in Korea. This paper suggests technical issues and development strategies for each PSA technical elements.

  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. 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)

  20. 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!

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Probabilistic safety assessment (Cernavoda). Experience and strategies

    International Nuclear Information System (INIS)

    Mircea, Mariana

    2000-01-01

    An IAEA project named 'Support for PSA related activities for Cernavoda NPP' was agreed at the beginning of 2000. The objectives were: upgrading of capability and framework to perform deterministic analyses as support for PSA (accident analyses and severe accident analyses); upgrading of capability and framework to extend the scope of PSA model for Cernavoda NPP to include internal and external hazards (internal fire, internal flooding, earthquake); upgrading of capability and framework to perform the Level 2 PSA for Cernavoda NPP. valuation was done for the status of the development of the seismic PSA, fire PSA and flooding PSA. For seismic PSA it was concluded by IAEA experts that this work needs adequate human and financial resources. Decision was taken to coordinate this project from Cernavoda but using specialists from external institutions. A Fire Hazard Assessment-FHA is in progress for Unit 1. First stage, regarding the methodology, was reviewed by IAEA experts in November 1999. In present, work is done for Reactor and Service Buildings. Work on flooding PSA was not started yet. To extend the PSA scope: Capability will be extended to develop the seismic PSA, fire PSA, flooding PSA (procurement of supplementary computer codes and specialist training); the extension of PSA scope to include internal and external hazards will continue after the completion of deterministic studies and is expected that the effective inclusion in the PSA model will start at the end of 2002

  6. A Framework for Assessment of Aviation Safety Technology Portfolios

    Science.gov (United States)

    Jones, Sharon M.; Reveley, Mary S.

    2014-01-01

    The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

  7. 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

  8. 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.

  9. 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.

  10. Safety assessment of geologic repositories for nuclear waste

    International Nuclear Information System (INIS)

    Bartlett, J.W.; Burkholder, H.C.; Winegardner, W.K.

    1977-01-01

    Consideration of geologic isolation for final disposition of radioactive wastes has led to the need for evaluation of the safety of the concept. Such evaluations require consideration of factors not encountered in conventional risk analysis: consequences at times and places far removed from the repository site; indirect, complex, and alternative pathways between the waste and the point of potential consequences; a highly limited data base; and limited opportunity for experimental verification of results. R and D programs to provide technical safety evaluations are under way. Three methods are being considered for the probabilistic aspects of the evaluations: fault tree analysis, repository simulation analysis, and system stability analysis. Nuclide transport models, currently in a relatively advanced state of development, are used to evaluate consequences of postulated loss of geologic isolation. This paper outlines the safety assessment methods, unique features of the assessment problem that affect selection of methods and reliability of results, and available results. It also discusses potential directions for future work

  11. 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.

  12. Safety assessment for the underground disposal of radioactive wastes

    International Nuclear Information System (INIS)

    1981-01-01

    This document is addressed to authorities and specialists responsible for or involved in planning, performing and reviewing safety assessments of underground radioactive waste repositories. It introduces and discusses in a general manner approaches and areas to be considered in making such safety assessments; its emphasis is on repositories for long-lived radioactive wastes in deep geological formations. It is hoped that this document will contribute to providing a base for a common understanding among the authorities and specialists concerned with the numerous studies involving a variety of scientific disciplines. While providing guidance, the document is also intended to stimulate further international discussion on this subject. It is the intention of the IAEA to develop more specific reports providing examples for the application of safety analyses for underground waste disposal

  13. Cyber Security Risk Assessment for the KNICS Safety Systems

    International Nuclear Information System (INIS)

    Lee, C. K.; Park, G. Y.; Lee, Y. J.; Choi, J. G.; Kim, D. H.; Lee, D. Y.; Kwon, K. C.

    2008-01-01

    In the Korea Nuclear I and C Systems Development (KNICS) project the platforms for plant protection systems are developed, which function as a reactor shutdown, actuation of engineered safety features and a control of the related equipment. Those are fully digitalized through the use of safety-grade programmable logic controllers (PLCs) and communication networks. In 2006 the Regulatory Guide 1.152 (Rev. 02) was published by the U.S. NRC and it describes the application of a cyber security to the safety systems in the Nuclear Power Plant (NPP). Therefore it is required that the new requirements are incorporated into the developed platforms to apply to NPP, and a cyber security risk assessment is performed. The results of the assessment were input for establishing the cyber security policies and planning the work breakdown to incorporate them

  14. Safety assessment for the underground disposal of radioactive wastes

    Energy Technology Data Exchange (ETDEWEB)

    1981-01-01

    This document is addressed to authorities and specialists responsible for or involved in planning, performing and reviewing safety assessments of underground radioactive waste repositories. It introduces and discusses in a general manner approaches and areas to be considered in making such safety assessments; its emphasis is on repositories for long-lived radioactive wastes in deep geological formations. It is hoped that this document will contribute to providing a base for a common understanding among the authorities and specialists concerned with the numerous studies involving a variety of scientific disciplines. While providing guidance, the document is also intended to stimulate further international discussion on this subject. It is the intention of the IAEA to develop more specific reports providing examples for the application of safety analyses for underground waste disposal.

  15. 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

  16. Current issues and perspectives in food safety and risk assessment.

    Science.gov (United States)

    Eisenbrand, G

    2015-12-01

    In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

  17. 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

  18. Microbial safety assessment of recreation water at Lake Nabugabo ...

    African Journals Online (AJOL)

    EJIRO

    Key words: Lake Nabugabo, microbial safety assessment, recreation water, water quality. ... the environment is favourable for growth (Jaiani et al., ... Swimming and bathing in inland waters are recognized .... in India. This can be attributed to variation in number of recreational users and the frequency of use of the various.

  19. Nuclear data for radiation damage assessment and related safety aspects

    International Nuclear Information System (INIS)

    Kocherov, N.P.

    1989-12-01

    The IAEA Advisory Group Meeting on Nuclear Data for Radiation Damage Assessment and Related Safety Aspects was held at the IAEA Headquarters in Vienna, 19-22 September 1989. This report contains the conclusions and recommendations of this meeting. The papers which the participants prepared for and presented at the meeting will be published as an IAEA Technical Document. (author)

  20. Safety assessment standards for modern plants in the UK

    International Nuclear Information System (INIS)

    Harbison, S.A.; Hannaford, J.

    1993-01-01

    The NII has revised its safety assessment principles (SAPs). This paper discusses the revised SAPs and their links with international standards. It considers the licensing of foreign designs of plant - a matter under active consideration in the UK -and discusses how the SAPs and the licensing process cater for that possibility. (author)

  1. Assessing the Food Safety Knowledge of University of Maine Students

    Science.gov (United States)

    Ferk, Chelsea C.; Calder, Beth L.; Camire, Mary Ellen

    2016-01-01

    Foodborne illness is a global public health issue. Young adults may work in foodservice while they are university students, and their habits may later shape the practices and well-being of their children. The objective of this study was to establish baseline data and assess the food safety knowledge of 18- to 26-year-old Univ. of Maine students.…

  2. 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.

  3. 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.

  4. Waste isolation safety assessment program. Summary of FY-77 progress

    International Nuclear Information System (INIS)

    Burkholder, H.C.; Greenborg, J.; Stottlemyre, J.A.; Bradley, D.J.; Raymond, J.R.; Serne, R.J.

    1977-11-01

    Objective is to provide long-term safety information for the National Waste Terminal Storage Program. Work in FY 77 supported the development of the generic assessment method (release scenario analysis, release consequence analysis) and of the generic data base (waste form release rate data, radionuclide geochemical interaction data)

  5. 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

  6. Safety assessment of indoor live fire range, May 1989

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1989-05-01

    The following Safety Assessment (SA) pertains to the indoor live fire range (LFR) at EG&G Mound Applied Technology plant. The purpose of the indoor LFR is to conduct training with live ammunition for all designated personnel. The SA examines the risks that are attendant to the operation of an indoor LFR for this purpose.

  7. Probabilistic Safety Assessment Of It TRIGA Mark-II Reactor

    International Nuclear Information System (INIS)

    Ergun, E; Kadiroglu, O.S.

    1999-01-01

    The probabilistic safety assessment for Istanbul Technical University (ITU) TRIGA Mark-II reactor is performed. Qualitative analysis, which includes fault and event trees and quantitative analysis which includes the collection of data for basic events, determination of minimal cut sets, calculation of quantitative values of top events, sensitivity analysis and importance measures, uncertainty analysis and radiation release from fuel elements are considered

  8. Nuclear Criticality Safety Assessment for Tank 38H Salt Dissolution

    International Nuclear Information System (INIS)

    Davis, P.L.

    1996-01-01

    This assessment report of sample results of the accumulating insoluble solids from Tank 38H demonstrates that an inherent subcritical condition for nuclear criticality safety exists during saltcake dissolution. This report also defines criteria for future sampling of Tank 38H for continued verification of the inherent subcritical condition as saltcake dissolution proceeds

  9. Comparative safety assessment of plant-derived foods

    NARCIS (Netherlands)

    Kok, E.J.; Keijer, J.; Kleter, G.A.; Kuiper, H.A.

    2008-01-01

    The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting

  10. Method for quantitative assessment of nuclear safety computer codes

    International Nuclear Information System (INIS)

    Dearien, J.A.; Davis, C.B.; Matthews, L.J.

    1979-01-01

    A procedure has been developed for the quantitative assessment of nuclear safety computer codes and tested by comparison of RELAP4/MOD6 predictions with results from two Semiscale tests. This paper describes the developed procedure, the application of the procedure to the Semiscale tests, and the results obtained from the comparison

  11. Safety assessment of the Area 6 Decontamination Pad and Laundry

    International Nuclear Information System (INIS)

    Chilton, M.W.; Orcutt, J.A.

    1984-10-01

    The Safety Assessment of the Area 6 Decontamination Pad and Laundry, prepared in accordance with DOE Order 5481.1A, identifies and evaluates potential radiation and chemical hazards to personnel, and impacts on the environment. Site and facility characteristics, as well as routine and nonroutine operations are discussed. Hypothetical incidents and accidents are described and evaluated. 3 figures, 1 table

  12. 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.

  13. Learning Safety Assessment from Accidents in a University Environment

    OpenAIRE

    Jensen, Niels; Jørgensen, Sten Bay

    2013-01-01

    This contribution describes how a chemical engineering department started learning from accidents during experimental work and ended up implementing an industrially inspired system for risk assessment of new and existing experimental setups as well as a system for assessing potential risk from the chemicals used in the experimental work. These experiences have led to recent developments which focus increasingly on the a theoretical basis for modeling and reasoning on safety as well as operati...

  14. 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

  15. Upgrading the safety assessment of exported nuclear power plants

    International Nuclear Information System (INIS)

    Rosen, M.

    1978-01-01

    An examination of the safety aspects of exported nuclear power plants demonstrates that additional and somewhat special considerations exist for these plants, and thus that some new approaches may be required to insure their safety. In view of the generally small regulatory staffs of importing countries, suggestions are given for measures which should be taken by the various organizations involved in the export and import of nuclear power facilities to raise the level of the very essential safety assessment. These include the upgrading of the 'export edition' of the traditionally supplied safety documentation by use of a Supplementary Information Report, written specifically for the needs of a smaller and/or less technically qualified staff, which highlights the differences that exist between the facility to be constructed and the supposedly similar reference plant of the supplier country; by improvement of supporting safety documentation to allow for adequate understanding of significant safety parameters; and by attention to the needs of smaller countries in the critical Operating Regulations (Technical Specifications for Operation). Consideration is also given to upgrading the regulatory effort and to the obligations of principal organizations involved with exported nuclear plants, including national and international, for insuring the importing countries' technical readiness and the adequacy of the regulatory effort. Special attention is directed towards the project contract as a means of implementing programmes to achieve these goals. (author)

  16. Assessment of safety culture in the Iranian nuclear installations

    International Nuclear Information System (INIS)

    Farahani, H.F.; Davilu, H.; Sepanloo, K.

    2005-01-01

    The deficient safety culture (S.C) is the center of safety issues of nuclear industry. To benefit from the advantages of nuclear technology and considering the fact of potential hazards of accidents in nuclear installations it is essential to view safety as the highest priority. S.C is an amalgamation of values, standards, morals and norms of acceptable behavior. Organizations having effective S.C show constant commitment to safety as a top level priority. Furthermore, the personnel of a nuclear facility shall recognize the safety significance of their tasks. Many people even those who work in the field of safety do not have a correct understanding of what S.C looks like in practical sense. In this study, by conducting a survey according to IAEA-TECDOC-1329 in some nuclear facilities, the S.C within the Iranian nuclear facilities is assessed. The human and organizational factors in Tehran Research Reactor are evaluated using a questionnaire method with active participation of the reactor operators. The results sho w that the operators are pretty aware of the subject. Also it has been identified some areas of improvement. (authors)

  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. Concrete structures. Contribution to the safety assessment of existing structures

    Directory of Open Access Journals (Sweden)

    D. COUTO

    Full Text Available The safety evaluation of an existing concrete structure differs from the design of new structures. The partial safety factors for actions and resistances adopted in the design phase consider uncertainties and inaccuracies related to the building processes of structures, variability of materials strength and numerical approximations of the calculation and design processes. However, when analyzing a finished structure, a large number of unknown factors during the design stage are already defined and can be measured, which justifies a change in the increasing factors of the actions or reduction factors of resistances. Therefore, it is understood that safety assessment in existing structures is more complex than introducing security when designing a new structure, because it requires inspection, testing, analysis and careful diagnose. Strong knowledge and security concepts in structural engineering are needed, as well as knowledge about the materials of construction employed, in order to identify, control and properly consider the variability of actions and resistances in the structure. With the intention of discussing this topic considered complex and diffuse, this paper presents an introduction to the safety of concrete structures, a synthesis of the recommended procedures by Brazilian standards and another codes, associated with the topic, as well a realistic example of the safety assessment of an existing structure.

  19. Safety assessment methodology for waste repositories in deep geological formations

    International Nuclear Information System (INIS)

    Chapuis, A.M.; Lewi, J.; Pradel, J.; Queniart, D.; Raimbault, P.; Assouline, M.

    1986-06-01

    The long term safety of a nuclear waste repository relies on the evaluation of the doses which could be transferred to man in the future. This implies a detailed knowledge of the medium where the waste will be confined, the identification of the basic phenomena which govern the migration of the radionuclides and the investigation of all possible scenarios that may affect the integrity of the barriers between the waste and the biosphere. Inside the Institute of protection and nuclear safety of the French Atomic Energy Commission (CEA/IPSN), the Department of the Safety Analysis (DAS) is currently developing a methodology for assessing the safety of future geological waste repositories, and is in charge of the modelling development, while the Department of Technical Protection (DPT) is in charge of the geological experimental studies. Both aspects of this program are presented. The methodology for risk assessment stresses the needs for coordination between data acquisition and model development which should result in the obtention of an efficient tool for safety evaluation. Progress needs to be made in source and geosphere modelling. Much more sophisticated models could be used than the ones which is described; however sensitivity analysis will determine the level of sophistication which is necessary to implement. Participation to international validation programs are also very important for gaining confidence in the approaches which have been chosen

  20. Method of operator safety assessment for underground mobile mining equipment

    Science.gov (United States)

    Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

    2018-01-01

    The paper presents a method of assessing the safety of operators of mobile mining equipment (MME), which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM). As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

  1. Method of operator safety assessment for underground mobile mining equipment

    Directory of Open Access Journals (Sweden)

    Działak Paulina

    2018-01-01

    Full Text Available The paper presents a method of assessing the safety of operators of mobile mining equipment (MME, which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM. As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

  2. Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

    Science.gov (United States)

    Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

    2018-03-01

    Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

  3. Environment, Safety and Health Progress Assessment of the Hanford Site

    International Nuclear Information System (INIS)

    1992-05-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety and Health (ES ampersand H) Progress Assessment of the Hanford Site, in Richland, Washington. The assessment, which was conducted from May 11 through May 22, 1992, included a selective-review of the ES ampersand H management systems and programs of the responsible DOE Headquarters Program Offices the DOE Richland Field Office, and the site contractors. The ES ampersand H Progress Assessments are part of the Secretary of Energy's continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. The purpose of the Hanford Site ES ampersand H Progress Assessment is to provide the Secretary with an independent assessment of the adequacy and effectiveness of the DOE and contractor management structures, resources, and systems to address ES ampersand H problems and requirements. They are not intended to be comprehensive compliance assessments of ES ampersand H activities. The point of reference for assessing programs at the Hanford Site was, for the most part, the Tiger Team Assessment of the Hanford Site, which was conducted from May 21 through July 18, 1990. A summary of issues and progress in the areas of environment, safety and health, and management is included

  4. 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

  5. Validity of instruments to assess students' travel and pedestrian safety.

    Science.gov (United States)

    Mendoza, Jason A; Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

    2010-05-18

    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. 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. The SRTS travel survey had high test-retest reliability (kappa = 0.97, n = 96, p < 0.001) and convergent validity (kappa = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p = < 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

  6. 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.

  7. 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)

  8. Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

    Science.gov (United States)

    Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

    2014-02-01

    To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

  9. Statistical analysis applied to safety culture self-assessment

    International Nuclear Information System (INIS)

    Macedo Soares, P.P.

    2002-01-01

    Interviews and opinion surveys are instruments used to assess the safety culture in an organization as part of the Safety Culture Enhancement Programme. Specific statistical tools are used to analyse the survey results. This paper presents an example of an opinion survey with the corresponding application of the statistical analysis and the conclusions obtained. Survey validation, Frequency statistics, Kolmogorov-Smirnov non-parametric test, Student (T-test) and ANOVA means comparison tests and LSD post-hoc multiple comparison test, are discussed. (author)

  10. Results of the CANDU 3 probabilistic safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Jaitly, R K [Atomic Energy of Canada Ltd., Saskatoon, SK (Canada)

    1996-12-31

    The purpose of the Conceptual Probabilistic Safety Assessment (PSA) of the CANDU 3 reactor was to provide safety assistance in the early stages of design to ensure that the design included adequate redundancy and functional separation of the mitigating systems; the final design should therefore give better results, particularly after modifications involving control, electrical power, instrument air, and service water. The initial PSA gave a total CANDU 3 core damage frequency of 7.8 x 10{sup -6}/year. 4 refs., 1 fig.

  11. Safety assessment of a robotic system handling nuclear material

    International Nuclear Information System (INIS)

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

    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 at the Department of Energy facility at Pantex by which nuclear material is inspected for weight and leakage. Failure Modes and Effects Analyses were completed for the robotics process to ensure that safety goals for the system had been meet. These analyses showed that the risks to people and the internal and external environment were acceptable

  12. 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.)

  13. Aspects of safety assessments for package with additional equipment components

    International Nuclear Information System (INIS)

    Reiche, I.; Boerst, F.M.; Krietsch, T.

    2004-01-01

    Many paragraphs in TS-R-1 contain the terms ''package'' or ''packaging''. These terms are defined in TS-R-1 paras 230 and 231 and explained in TS-G-1.1 paras 230.1 - 230.6. The importance of a consistent understanding of these definitions has been shown by recent discussions during the assessment of applications for package design approval. There was disagreement, if equipment components attached to the container body during transport, e.g. a transport frame, should be considered part of the package and taken into account in the safety assessment for the package. Discussions were also caused by the way inner design components are treated in the safety assessment of the package. This paper summarises the regulatory requirements to such additional equipment components and presents the way of their inclusion into the package design approval process in Germany

  14. HSE assessment of explosion risk analysis in offshore safety cases

    Energy Technology Data Exchange (ETDEWEB)

    Brighton, P.W.M.; Fearnley, P.J.; Brearley, I.G. [Health and Safety Executive, Bootle (United Kingdom). Offshore Safety Div.

    1995-12-31

    In the past two years HSE has assessed around 250 Safety Cases for offshore oil and gas installations, building up a unique overview of the current state of the art on fire and explosion risk assessment. This paper reviews the explosion risk methods employed, focusing on the aspects causing most difficulty for assessment and acceptance of Safety Cases. Prediction of overpressures in offshore explosions has been intensively researched in recent years but the justification of the means of prevention, control and mitigation of explosions often depends on much additional analysis of the frequency and damage potential of explosions. This involves a number of factors, the five usually considered being: leak sizes; gas dispersion; ignition probabilities; the frequency distribution of explosion strength; and the prediction of explosion damage. Sources of major uncertainty in these factors and their implications for practical risk management decisions are discussed. (author)

  15. 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

  16. Concept of risk: risk assessment and nuclear safety

    International Nuclear Information System (INIS)

    Thompson, P.B.

    1980-01-01

    The dissertation is a critical examination of risk assessment and its role in public policy. Nuclear power safety safety issues are selected as the primary source of illustrations and examples. The dissertation examines how risk assessment studies develop a concept of risk which becomes decisive for policy choices. Risk-assessment techniques are interpreted as instruments which secure an evaluation of risk which, in turn, figures prominently in technical reports on nuclear power. The philosophical critique is mounted on two levels. First, an epistemological critique surveys distinctions between the technical concept of risk and more familiar senses of risk. The critique shows that utilization of risk assessment re-structures the concept of risk. The technical concept is contrasted to the function of risk within a decision-maker's conceptual agenda and hierarchy of values. Second, an ethical critique exposes the value commitments of risk assessment recommendations. Although some of these values might be defended for policy decisions, the technical character of risk assessment obfuscates normative issues. Risk assessment is shown to be a form of factual enquiry which, nonetheless, represents a commitment to a specific selection of ethical and social values. Risk assessment should not be interpreted as a primary guide to decision unless the specific values incorporated into its concept of risk are stated explicitly and justified philosophically. Such a statement would allow value questions which have been sublimated by the factual tone of the analytic techniques to be debated on clear, social and ethical grounds

  17. Interim main report of the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Hedin, Allan [and others

    2004-08-01

    This document is an interim report on the safety assessment SR-Can (SR in the acronym stands for Safety Report and Can is short for canister). The final SR-Can report will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of the present interim report is to demonstrate the methodology for safety assessment so that it can be reviewed before it is used in a license application. The assessment relates to the KBS-3 disposal concept in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at approximately 500 m depth in saturated, granitic rock. Preliminary data from the Forsmark site, presently being investigated by SKB as one of the candidate for a KBS-3 repository are used to some extent as examples. However, the collected data are yet too sparse to allow an evaluation of safety for this site. An important aim of this report is to demonstrate the proper handling of requirements on the safety assessment in applicable regulations. Therefore, regulations issued by the Swedish Nuclear Power Inspectorate and the Swedish Radiation Protection Authority are duplicated in an Appendix. The principal acceptance criterion requires that 'the annual risk of harmful effects after closure does not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk'. 'Harmful effects' refer to cancer and hereditary effects. Following the introductory chapter 1, this report outlines the methodology for the SR-Can assessment in chapter 2, and presents in chapters 3, 4 and 5 the initial state of the system and the plans and methods for handling external influences and internal processes, respectively. Function indicators are introduced in chapter 6 and a preliminary evaluation of these is given in chapter 7. The material presented in the first seven chapters is utilised in the scenario selection in chapter 8

  18. Interim main report of the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Hedin, Allan (ed.) [and others

    2004-08-01

    This document is an interim report on the safety assessment SR-Can (SR in the acronym stands for Safety Report and Can is short for canister). The final SR-Can report will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of the present interim report is to demonstrate the methodology for safety assessment so that it can be reviewed before it is used in a license application. The assessment relates to the KBS-3 disposal concept in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at approximately 500 m depth in saturated, granitic rock. Preliminary data from the Forsmark site, presently being investigated by SKB as one of the candidate for a KBS-3 repository are used to some extent as examples. However, the collected data are yet too sparse to allow an evaluation of safety for this site. An important aim of this report is to demonstrate the proper handling of requirements on the safety assessment in applicable regulations. Therefore, regulations issued by the Swedish Nuclear Power Inspectorate and the Swedish Radiation Protection Authority are duplicated in an Appendix. The principal acceptance criterion requires that 'the annual risk of harmful effects after closure does not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk'. 'Harmful effects' refer to cancer and hereditary effects. Following the introductory chapter 1, this report outlines the methodology for the SR-Can assessment in chapter 2, and presents in chapters 3, 4 and 5 the initial state of the system and the plans and methods for handling external influences and internal processes, respectively. Function indicators are introduced in chapter 6 and a preliminary evaluation of these is given in chapter 7. The material presented in the first seven chapters is utilised in the scenario selection

  19. Interim main report of the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Hedin, Allan

    2004-08-01

    This document is an interim report on the safety assessment SR-Can (SR in the acronym stands for Safety Report and Can is short for canister). The final SR-Can report will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of the present interim report is to demonstrate the methodology for safety assessment so that it can be reviewed before it is used in a license application. The assessment relates to the KBS-3 disposal concept in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at approximately 500 m depth in saturated, granitic rock. Preliminary data from the Forsmark site, presently being investigated by SKB as one of the candidate for a KBS-3 repository are used to some extent as examples. However, the collected data are yet too sparse to allow an evaluation of safety for this site. An important aim of this report is to demonstrate the proper handling of requirements on the safety assessment in applicable regulations. Therefore, regulations issued by the Swedish Nuclear Power Inspectorate and the Swedish Radiation Protection Authority are duplicated in an Appendix. The principal acceptance criterion requires that 'the annual risk of harmful effects after closure does not exceed 10 -6 for a representative individual in the group exposed to the greatest risk'. 'Harmful effects' refer to cancer and hereditary effects. Following the introductory chapter 1, this report outlines the methodology for the SR-Can assessment in chapter 2, and presents in chapters 3, 4 and 5 the initial state of the system and the plans and methods for handling external influences and internal processes, respectively. Function indicators are introduced in chapter 6 and a preliminary evaluation of these is given in chapter 7. The material presented in the first seven chapters is utilised in the scenario selection in chapter 8. Hydrogeological

  20. 21 CFR 190.6 - Requirement for premarket notification.

    Science.gov (United States)

    2010-04-01

    ... that has not been present in the food supply as an article used for food in a form in which the food... (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any citation to published articles that is...

  1. Model summary report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik

    2006-10-15

    This document is the model summary report for the safety assessment SR-Can. In the report, the quality assurance measures conducted for the assessment codes are presented together with the chosen methodology. In the safety assessment SR-Can, a number of different computer codes are used. In order to better understand how these codes are related Assessment Model Flowcharts, AMFs, have been produced within the project. From these, it is possible to identify the different modelling tasks and consequently also the different computer codes used. A large number of different computer codes are used in the assessment of which some are commercial while others are developed especially for the current assessment project. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined: It must be demonstrated that the code is suitable for its purpose; It must be demonstrated that the code has been properly used; and, It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. Although the requirements are identical for all codes, the measures used to show that the requirements are fulfilled will be different for different codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented and it is shown how the requirements are met.

  2. Model summary report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Vahlund, Fredrik

    2006-10-01

    This document is the model summary report for the safety assessment SR-Can. In the report, the quality assurance measures conducted for the assessment codes are presented together with the chosen methodology. In the safety assessment SR-Can, a number of different computer codes are used. In order to better understand how these codes are related Assessment Model Flowcharts, AMFs, have been produced within the project. From these, it is possible to identify the different modelling tasks and consequently also the different computer codes used. A large number of different computer codes are used in the assessment of which some are commercial while others are developed especially for the current assessment project. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined: It must be demonstrated that the code is suitable for its purpose; It must be demonstrated that the code has been properly used; and, It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. Although the requirements are identical for all codes, the measures used to show that the requirements are fulfilled will be different for different codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented and it is shown how the requirements are met

  3. A comparison of integrated safety analysis and probabilistic risk assessment

    International Nuclear Information System (INIS)

    Damon, Dennis R.; Mattern, Kevin S.

    2013-01-01

    The U.S. Nuclear Regulatory Commission conducted a comparison of two standard tools for risk informing the regulatory process, namely, the Probabilistic Risk Assessment (PRA) and the Integrated Safety Analysis (ISA). PRA is a calculation of risk metrics, such as Large Early Release Frequency (LERF), and has been used to assess the safety of all commercial power reactors. ISA is an analysis required for fuel cycle facilities (FCFs) licensed to possess potentially critical quantities of special nuclear material. A PRA is usually more detailed and uses more refined models and data than an ISA, in order to obtain reasonable quantitative estimates of risk. PRA is considered fully quantitative, while most ISAs are typically only partially quantitative. The extension of PRA methodology to augment or supplant ISAs in FCFs has long been considered. However, fuel cycle facilities have a wide variety of possible accident consequences, rather than a few surrogates like LERF or core damage as used for reactors. It has been noted that a fuel cycle PRA could be used to better focus attention on the most risk-significant structures, systems, components, and operator actions. ISA and PRA both identify accident sequences; however, their treatment is quite different. ISA's identify accidents that lead to high or intermediate consequences, as defined in 10 Code of Federal Regulations (CFR) 70, and develop a set of Items Relied on For Safety (IROFS) to assure adherence to performance criteria. PRAs identify potential accident scenarios and estimate their frequency and consequences to obtain risk metrics. It is acceptable for ISAs to provide bounding evaluations of accident consequences and likelihoods in order to establish acceptable safety; but PRA applications usually require a reasonable quantitative estimate, and often obtain metrics of uncertainty. This paper provides the background, features, and methodology associated with the PRA and ISA. The differences between the

  4. Integrated safety assessment report, Haddam Neck Plant (Docket No. 50-213): Integrated Safety Assessment Program: Draft report

    International Nuclear Information System (INIS)

    1987-07-01

    The integrated assessment is conducted on 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. Procedures allow for a periodic updating of the schedules to account for licensing issues that arise in the future. The Haddam Neck Plant is one of two plants being reviewed under the pilot program. This report indicates how 82 topics selected for review were addressed, and presents the staff's recommendations regarding the corrective actions to resolve the 82 topics and other actions to enhance plant safety. 135 refs., 4 figs., 5 tabs

  5. Development and Application of Level 2 Probabilistic Safety Assessment for Nuclear Power Plants. Specific Safety Guide

    International Nuclear Information System (INIS)

    2010-01-01

    The objective of this Safety Guide is to provide recommendations for meeting the IAEA safety requirements in performing or managing a level 2 probabilistic safety assessment (PSA) project for a nuclear power plant; thus it complements the Safety Guide on level 1 PSA. One of the aims of this Safety Guide is to promote a standard framework, standard terms and a standard set of documents for level 2 PSAs to facilitate regulatory and external peer review of their results. It describes all elements of the level 2 PSA that need to be carried out if the starting point is a fully comprehensive level 1 PSA. Contents: 1. Introduction; 2. PSA project management and organization; 3. Identification of design aspects important to severe accidents and acquisition of information; 4. Interface with level 1 PSA: Grouping of sequences; 5. Accident progression and containment analysis; 6. Source terms for severe accidents; 7. Documentation of the analysis: Presentation and interpretation of results; 8. Use and applications of the PSA; Annex I: Example of a typical schedule for a level 2 PSA; Annex II: Computer codes for simulation of severe accidents; Annex III: Sample outline of documentation for a level 2 PSA study.

  6. The achievement and assessment of safety in systems containing software

    International Nuclear Information System (INIS)

    Ball, A.; Dale, C.J.; Butterfield, M.H.

    1986-01-01

    In order to establish confidence in the safe operation of a reactor protection system, there is a need to establish, as far as it is possible, that: (i) the algorithms used are correct; (ii) the system is a correct implementation of the algorithms; and (iii) the hardware is sufficiently reliable. This paper concentrates principally on the second of these, as it applies to the software aspect of the more accurate and complex trip functions to be performed by modern reactor protection systems. In order to engineer safety into software, there is a need to use a development strategy which will stand a high chance of achieving a correct implementation of the trip algorithms. This paper describes three broad methodologies by which it is possible to enhance the integrity of software: fault avoidance, fault tolerance and fault removal. Fault avoidance is concerned with making the software as fault free as possible by appropriate choice of specification, design and implementation methods. A fault tolerant strategy may be advisable in many safety critical applications, in order to guard against residual faults present in the software of the installed system. Fault detection and removal techniques are used to remove as many faults as possible of those introduced during software development. The paper also discusses safety and reliability assessment as it applies to software, outlining the various approaches available. Finally, there is an outline of a research project underway in the UKAEA which is intended to assess methods for developing and testing safety and protection systems involving software. (author)

  7. The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

    Science.gov (United States)

    Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

    2018-05-04

    Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

  8. Radiation safety assessment and development of environmental radiation monitoring technology

    CERN Document Server

    Choi, B H; Kim, S G

    2002-01-01

    The Periodic Safety Review(PSR) of the existing nuclear power plants is required every ten years according to the recently revised atomic energy acts. The PSR of Kori unit 1 and Wolsong unit 1 that have been operating more than ten years is ongoing to comply the regulations. This research project started to develop the techniques necessary for the PSR. The project developed the following four techniques at the first stage for the environmental assessment of the existing plants. 1) Establishment of the assessment technology for contamination and accumulation trends of radionuclides, 2) alarm point setting of environmental radiation monitoring system, 3) Development of Radiation Safety Evaluation Factor for Korean NPP, and 4) the evaluation of radiation monitoring system performance and set-up of alarm/warn set point. A dynamic compartment model to derive a relationship between the release rates of gas phase radionuclides and the concentrations in the environmental samples. The model was validated by comparing ...

  9. Potential of acoustic monitoring for safety assessment of primary system

    International Nuclear Information System (INIS)

    Olma, B.J.

    1997-01-01

    Safety assessment of the primary system and its components with respect to their mechanical integrity is increasingly supported by acoustic signature analysis during power operation of the plants. Acoustic signals of Loose Parts Monitoring System sensors are continuously monitored by dedicated digital systems for signal bursts associated with metallic impacts. Several years of ISTec/GRS experience and the practical use of its digital systems MEDEA and RAMSES have shown that acoustic monitoring is very successful for detecting component failures at an early stage. Advanced powerful tools for classification and acoustic evaluation of burst signals have recently been realized. The paper presents diagnosis experiences of BWR's and PWR's safety assessment. (author). 7 refs, 8 figs

  10. Assessment of safety engineering of circuits with dc micromotors

    Energy Technology Data Exchange (ETDEWEB)

    Pavlyuchenko, L.A.; Starchuk, S.E.

    1986-01-01

    Presents an assessment of safety engineering in d.c. micromotors operating as part of actuating devices in mining equipment. These micromotors should have RO (especially explosion proof) protection. The safety engineering should be assessed with an intermittent fault in the power line. Equations are given for calculation of the equivalent inductance of the micromotor circuit with an intermittent power line fault. If the circuit is not intrinsically safe, a diode in the forward direction is recommended for connection in series with the micromotor. If the power line is not intrinsically safe, a diode shunt is recommended. Comparative data for power sources (IBP) and micromotors (DPM, DPR, with permanent magnets) are given in tables. 4 refs.

  11. The DYLAM approach to systems safety and reliability assessment

    International Nuclear Information System (INIS)

    Amendola, A.

    1988-01-01

    A survey of the principal features and applications of DYLAM (Dynamic Logical Analytical Methodology) is presented, whose basic principles can be summarized as follows: after a particular modelling of the component states, computerized heuristical procedures generate stochastic configurations of the system, whereas the resulting physical processes are simultaneously simulated to give account of the possible interactions between physics and states and, on the other hand, to search for system dangerous configurations and related probabilities. The association of probabilistic techniques for describing the states with physical equations for describing the process results in a very powerful tool for safety and reliability assessment of systems potentially subjected to dangerous incidental transients. A comprehensive picture of DYLAM capability for manifold applications can be obtained by the review of the study cases analyzed (LMFBR core accident, systems reliability assessment, accident simulation, man-machine interaction analysis, chemical reactors safety, etc.)

  12. The safety assessment of radioactive material transpotation at sea

    International Nuclear Information System (INIS)

    Satoh, K.; Ozaki, S.; Watabe, N.; Fukuda, S.; Iida, T.; Miyao, S.; Noguchi, K.; Nakajima, K.

    1989-01-01

    Large quantities of low level wastes are prepared for transportation by special use vessels from each power plant to the storage facility at Rokkasho-mura in Aomori Prefecture. Large quantities of reprocessed wastes are also planned for return by similar vessels to the same place from France and the UK. In this paper the authors describe the safety assessment in hypothetical accident conditions during such mass transportation at sea. Although the possibilities of the sinking of the special use vessels as shown in figure 1 are considered to be very low on account of their double-hull structure, it is necessary to estimate the radiological risks of the transportation in order to obtain public acceptance. In this study, the following procedure is taken: (i) assumption of accident; (ii) establishment of safety assessment procedure; (iii) determination of source terms; (iv) diffusion calculation of radionuclide; (v) estimation of radiation exposure of the public

  13. A study on safety assessment methodology for a vitrification plant

    Energy Technology Data Exchange (ETDEWEB)

    Seo, Y. C.; Lee, G. S.; Choi, Y. C.; Kim, G. H. [Yonsei Univ., Seoul (Korea, Republic of)

    2002-03-15

    In this study, the technical and regulatory status of radioactive waste vitrification technologies in foreign and domestic plants is investigated and analyzed, and then significant factors are suggested which must be contained in the final technical guideline or standard for the safety assessment of vitrification plants. Also, the methods to estimate the stability of vitrified waste forms are suggested with property analysis of them. The contents and scope of the study are summarized as follows : survey of the status on radioactive waste vitrification technologies in foreign and domestic plants, survey of the characterization methodology for radioactive waste form, analysis of stability for vitrified waste forms, survey and analysis of technical standards and regulations concerned with them in foreign and domestic plants, suggestion of significant factors for the safety assessment of vitrification plants, submission of regulated technical standard on radioactive waste vitrification plats.

  14. Ageing management by probabilistic safety assessment (PSA) methods

    International Nuclear Information System (INIS)

    Das, M.; Bhawal, R.N.; Maiti, S.C.

    1994-01-01

    The process and safety system of a nuclear power plant must achieve the reliability/availability target throughout the plant life or for extended plant life. It is therefore necessary to assess the trend of component or system ageing and to take preventive measures so that ageing effect can be counter balanced. In this paper a mathematical model has been established to predict ageing effect and to find out time dependent inspection or test interval to upgrade the system availability. (author). 5 figs

  15. Safety assessment of UP3-A reprocessing plant

    International Nuclear Information System (INIS)

    Mercier, J.P.; Guezenec, J.Y.; Poirier, M.C.

    1992-02-01

    This presentation describes how the safety assessment was made of UP3-A plant of the La Hague establishment for the building permit and operating license within the context of French nuclear regulations and the national debate on the need for reprocessing. Other factors discussed are how the public was involved, how the regulations were improved in the process and what the different stages of commissioning consisted of. (author)

  16. Probabilistic safety assessment of the nuclear facilities in Cuba

    International Nuclear Information System (INIS)

    Rivero O, J.J.; Salomon L, J.

    1991-01-01

    During 1986-1990 basis were established for further developing probabilistic safety assessment (PSA) of Juragua NPP. A team work was consolidated and carried out the preliminary studies of the small break LOCA initiating event. A significant achievement was the creation of the ANCON code, which allows the evaluation of complex fault trees in personal computers, and has been applied in PSA modelling, and specialist qualification. The paper describes the main results and future activities in this field. (author)

  17. Assessment of the nuclear installation's safety significant events

    International Nuclear Information System (INIS)

    Vidican, D.

    2005-01-01

    This document tries to establish, based on the available documentation, the main steps in development of Assessment of the Events in Nuclear Installations. It takes into account: selection of the safety significant occurrences, establishing the direct cause and contributors as well as the root cause and contributors. Also, the document presents the necessary corrective actions and generic lessons to be learned from the event. The document is based especially on IAEA - ASSET guidelines and DOE root cause analysis Guidance. (author)

  18. Safety analysis, risk assessment, and risk acceptance criteria

    International Nuclear Information System (INIS)

    Jamali, K.

    1997-01-01

    This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities and that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, 'ensuring' plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is 'safe.' Use of RACs requires quantitative estimates of consequence frequency and magnitude

  19. Safety assessment of silica and zinc oxide nanoparticles

    OpenAIRE

    An, Seong Soo A; Kim, Meyoung-Kon

    2014-01-01

    Seong Soo A An,1 Meyoung-Kon Kim2 1Department of Bionanotechnology, Gachon Medical Research Institute, Gachon University, Seongnam, Gyeonggi, Korea; 2Department of Biochemistry and Molecular Biology, Korea University Medical School and College, Seoul, KoreaThe current volume is a special issue focusing on a safety assessment of nanoparticles, from their physicochemical properties to government regulations. It features twenty-five papers, discussing general issues with the possible harmfulness...

  20. CP-50 calibration facility radiological safety assessment document

    International Nuclear Information System (INIS)

    Chilton, M.W.; Hill, R.L.; Eubank, B.F.

    1980-03-01

    The CP-50 Calibration Facility Radiological Safety Assessment document, prepared at the request of the Nevada Operations Office of the US Department of Energy to satisfy provisions of ERDA Manual Chapter 0531, presents design features, systems controls, and procedures used in the operation of the calibration facility. Site and facility characteristics and routine and non-routine operations, including hypothetical incidents or accidents are discussed and design factors, source control systems, and radiation monitoring considerations are described

  1. Food and feed safety assessment: the importance of proper sampling.

    Science.gov (United States)

    Kuiper, Harry A; Paoletti, Claudia

    2015-01-01

    The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

  2. 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

  3. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

    Science.gov (United States)

    Morton, Laura Dill; Spindeldreher, Sebastian; Kiessling, Andrea; Allenspach, Roy; Hey, Adam; Muller, Patrick Y; Frings, Werner; Sims, Jennifer

    2010-01-01

    Most therapeutic monoclonal antibodies (mAbs) licensed for human use or in clinical development are indicated for treatment of patients with cancer and inflammatory/autoimmune disease and as such, are designed to directly interact with the immune system. A major hurdle for the development and early clinical investigation of many of these immunomodulatory mAbs is their inherent risk for adverse immune-mediated drug reactions in humans such as infusion reactions, cytokine storms, immunosuppression and autoimmunity. A thorough understanding of the immunopharmacology of a mAb in humans and animals is required to both anticipate the clinical risk of adverse immunotoxicological events and to select a safe starting dose for first-in-human (FIH) clinical studies. This review summarizes the most common adverse immunotoxicological events occurring in humans with immunomodulatory mAbs and outlines non-clinical strategies to define their immunopharmacology and assess their immunotoxic potential, as well as reduce the risk of immunotoxicity through rational mAb design. Tests to assess the relative risk of mAb candidates for cytokine release syndrome, innate immune system (dendritic cell) activation and immunogenicity in humans are also described. The importance of selecting a relevant and sensitive toxicity species for human safety assessment in which the immunopharmacology of the mAb is similar to that expected in humans is highlighted, as is the importance of understanding the limitations of the species selected for human safety assessment and supplementation of in vivo safety assessment with appropriate in vitro human assays. A tiered approach to assess effects on immune status, immune function and risk of infection and cancer, governed by the mechanism of action and structural features of the mAb, is described. Finally, the use of immunopharmacology and immunotoxicity data in determining a minimum anticipated biologic effect Level (MABEL) and in the selection of safe human

  4. 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

  5. Learning Safety Assessment from Accidents in a University Environment

    DEFF Research Database (Denmark)

    Jensen, Niels; Jørgensen, Sten Bay

    2013-01-01

    This contribution describes how a chemical engineering department started learning from accidents during experimental work and ended up implementing an industrially inspired system for risk assessment of new and existing experimental setups as well as a system for assessing potential risk from...... the chemicals used in the experimental work. These experiences have led to recent developments which focus increasingly on the a theoretical basis for modeling and reasoning on safety as well as operational aspects within a common framework. Presently this framework is being extended with barrier concepts both...

  6. Reliability assessment for safety critical systems by statistical random testing

    International Nuclear Information System (INIS)

    Mills, S.E.

    1995-11-01

    In this report we present an overview of reliability assessment for software and focus on some basic aspects of assessing reliability for safety critical systems by statistical random testing. We also discuss possible deviations from some essential assumptions on which the general methodology is based. These deviations appear quite likely in practical applications. We present and discuss possible remedies and adjustments and then undertake applying this methodology to a portion of the SDS1 software. We also indicate shortcomings of the methodology and possible avenues to address to follow to address these problems. (author). 128 refs., 11 tabs., 31 figs

  7. Reliability assessment for safety critical systems by statistical random testing

    Energy Technology Data Exchange (ETDEWEB)

    Mills, S E [Carleton Univ., Ottawa, ON (Canada). Statistical Consulting Centre

    1995-11-01

    In this report we present an overview of reliability assessment for software and focus on some basic aspects of assessing reliability for safety critical systems by statistical random testing. We also discuss possible deviations from some essential assumptions on which the general methodology is based. These deviations appear quite likely in practical applications. We present and discuss possible remedies and adjustments and then undertake applying this methodology to a portion of the SDS1 software. We also indicate shortcomings of the methodology and possible avenues to address to follow to address these problems. (author). 128 refs., 11 tabs., 31 figs.

  8. Preliminary safety assessment and preliminary safety report for the treated radwaste store, Winfrith

    International Nuclear Information System (INIS)

    Staples, A.T.

    1992-06-01

    It is the purpose of this assessment to define the categorisation of the Treated Radwaste Store, TRS, B55 at the Winfrith Technology Centre. Its further purpose is to cover all relevant sections required for a Preliminary Safety Report (PSR) encompassing the TRS and the integral Quality Assessment Unit (QUA). The TRS is designed for the interim storage of intermediate level radioactive wastes. All waste material stored in the TRS will be contained within 500 litre stainless steel drums acceptable to NIREX. It is proposed that the TRS will receive 500 litre stainless steel NIREX drums containing either irradiated DRAGON fuel or encapsulated sludge waste. (author)

  9. 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.)

  10. Computer codes for level 1 probabilistic safety assessment

    International Nuclear Information System (INIS)

    1990-06-01

    Probabilistic Safety Assessment (PSA) entails several laborious tasks suitable for computer codes assistance. This guide identifies these tasks, presents guidelines for selecting and utilizing computer codes in the conduct of the PSA tasks and for the use of PSA results in safety management and provides information on available codes suggested or applied in performing PSA in nuclear power plants. The guidance is intended for use by nuclear power plant system engineers, safety and operating personnel, and regulators. Large efforts are made today to provide PC-based software systems and PSA processed information in a way to enable their use as a safety management tool by the nuclear power plant overall management. Guidelines on the characteristics of software needed for management to prepare a software that meets their specific needs are also provided. Most of these computer codes are also applicable for PSA of other industrial facilities. The scope of this document is limited to computer codes used for the treatment of internal events. It does not address other codes available mainly for the analysis of external events (e.g. seismic analysis) flood and fire analysis. Codes discussed in the document are those used for probabilistic rather than for phenomenological modelling. It should be also appreciated that these guidelines are not intended to lead the user to selection of one specific code. They provide simply criteria for the selection. Refs and tabs

  11. Progress of IRSN R&D on ITER Safety Assessment

    Science.gov (United States)

    Van Dorsselaere, J. P.; Perrault, D.; Barrachin, M.; Bentaib, A.; Gensdarmes, F.; Haeck, W.; Pouvreau, S.; Salat, E.; Seropian, C.; Vendel, J.

    2012-08-01

    The French "Institut de Radioprotection et de Sûreté Nucléaire" (IRSN), in support to the French "Autorité de Sûreté Nucléaire", is analysing the safety of ITER fusion installation on the basis of the ITER operator's safety file. IRSN set up a multi-year R&D program in 2007 to support this safety assessment process. Priority has been given to four technical issues and the main outcomes of the work done in 2010 and 2011 are summarized in this paper: for simulation of accident scenarios in the vacuum vessel, adaptation of the ASTEC system code; for risk of explosion of gas-dust mixtures in the vacuum vessel, adaptation of the TONUS-CFD code for gas distribution, development of DUST code for dust transport, and preparation of IRSN experiments on gas inerting, dust mobilization, and hydrogen-dust mixtures explosion; for evaluation of the efficiency of the detritiation systems, thermo-chemical calculations of tritium speciation during transport in the gas phase and preparation of future experiments to evaluate the most influent factors on detritiation; for material neutron activation, adaptation of the VESTA Monte Carlo depletion code. The first results of these tasks have been used in 2011 for the analysis of the ITER safety file. In the near future, this R&D global programme may be reoriented to account for the feedback of the latter analysis or for new knowledge.

  12. 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

  13. Safety assessment for the passive system of the nuclear power plants (NPPs) using safety margin estimation

    International Nuclear Information System (INIS)

    Woo, Tae-Ho; Lee, Un-Chul

    2010-01-01

    The probabilistic safety assessment (PSA) for gas-cooled nuclear power plants has been investigated where the operational data are deficient, because there is not any commercial gas-cooled nuclear power plant. Therefore, it is necessary to use the statistical data for the basic event constructions. Several estimations for the safety margin are introduced for the quantification of the failure frequency in the basic event, which is made by the concept of the impact and affordability. Trend of probability of failure (TPF) and fuzzy converter (FC) are introduced using the safety margin, which shows the simplified and easy configurations for the event characteristics. The mass flow rate in the natural circulation is studied for the modeling. The potential energy in the gravity, the temperature and pressure in the heat conduction, and the heat transfer rate in the internal stored energy are also investigated. The values in the probability set are compared with those of the fuzzy set modeling. Non-linearity of the safety margin is expressed by the fuzziness of the membership function. This artificial intelligence analysis of the fuzzy set could enhance the reliability of the system comparing to the probabilistic analysis.

  14. Model summary report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Vahlund, Fredrik; Zetterstroem Evins, Lena; Lindgren, Maria

    2010-12-01

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  15. Model summary report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik; Zetterstroem Evins, Lena (Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden)); Lindgren, Maria (Kemakta Konsult AB, Stockholm (Sweden))

    2010-12-15

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  16. 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

  17. An approach for assessing ALWR passive safety system reliability

    International Nuclear Information System (INIS)

    Hake, T.M.

    1991-01-01

    Many of the advanced light water reactor (ALWR) concepts proposed for the next generation of nuclear power plants rely on passive rather than active systems to perform safety functions. Despite the reduced redundancy of the passive systems as compared to active systems in current plants, the assertion is that the overall safety of the plant is enhanced due to the much higher expected reliability of the passive systems. In order to investigate this assertion, a study is being conducted at Sandia National Laboratories to evaluate the reliability of ALWR passive safety features in the context of probabilistic risk assessment (PRA). The purpose of this paper is to provide a brief overview of the approach to this study. The quantification of passive system reliability is not as straightforward as for active systems, due to the lack of operating experience, and to the greater uncertainty in the governing physical phenomena. Thus, the adequacy of current methods for evaluating system reliability must be assessed, and alternatives proposed if necessary. For this study, the Westinghouse Advanced Passive 600 MWe reactor (AP600) was chosen as the advanced reactor for analysis, because of the availability of AP600 design information. This study compares the reliability of AP600 emergency cooling system with that of corresponding systems in a current generation reactor

  18. Development and assessment of best estimate integrated safety analysis code

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Bub Dong; Lee, Young Jin; Hwang, Moon Kyu (and others)

    2007-03-15

    Improvement of the integrated safety analysis code MARS3.0 has been carried out and a multi-D safety analysis application system has been established. Iterative matrix solver and parallel processing algorithm have been introduced, and a LINUX version has been generated to enable MARS to run in cluster PCs. MARS variables and sub-routines have been reformed and modularised to simplify code maintenance. Model uncertainty analyses have been performed for THTF, FLECHT, NEPTUN, and LOFT experiments as well as APR1400 plant. Participations in international cooperation research projects such as OECD BEMUSE, SETH, PKL, BFBT, and TMI-2 have been actively pursued as part of code assessment efforts. The assessment, evaluation and experimental data obtained through international cooperation projects have been registered and maintained in the T/H Databank. Multi-D analyses of APR1400 LBLOCA, DVI Break, SLB, and SGTR have been carried out as a part of application efforts in multi-D safety analysis. GUI based 3D input generator has been developed for user convenience. Operation of the MARS Users Group (MUG) was continued and through MUG, the technology has been transferred to 24 organisations. A set of 4 volumes of user manuals has been compiled and the correction reports for the code errors reported during MARS development have been published.

  19. 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

  20. Development and assessment of best estimate integrated safety analysis code

    International Nuclear Information System (INIS)

    Chung, Bub Dong; Lee, Young Jin; Hwang, Moon Kyu

    2007-03-01

    Improvement of the integrated safety analysis code MARS3.0 has been carried out and a multi-D safety analysis application system has been established. Iterative matrix solver and parallel processing algorithm have been introduced, and a LINUX version has been generated to enable MARS to run in cluster PCs. MARS variables and sub-routines have been reformed and modularised to simplify code maintenance. Model uncertainty analyses have been performed for THTF, FLECHT, NEPTUN, and LOFT experiments as well as APR1400 plant. Participations in international cooperation research projects such as OECD BEMUSE, SETH, PKL, BFBT, and TMI-2 have been actively pursued as part of code assessment efforts. The assessment, evaluation and experimental data obtained through international cooperation projects have been registered and maintained in the T/H Databank. Multi-D analyses of APR1400 LBLOCA, DVI Break, SLB, and SGTR have been carried out as a part of application efforts in multi-D safety analysis. GUI based 3D input generator has been developed for user convenience. Operation of the MARS Users Group (MUG) was continued and through MUG, the technology has been transferred to 24 organisations. A set of 4 volumes of user manuals has been compiled and the correction reports for the code errors reported during MARS development have been published

  1. Knowledge representation in safety assessment: improving transparency and traceability

    Energy Technology Data Exchange (ETDEWEB)

    Lemos, F.L. de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil); Sullivan, T. [Brookhaven National Laboratory (BNL), Upton, NY (United States); Ross, T. [University of New Mexico (UNM), Albuquerque, NM (United States); Guimaraes, L.N.F. [Instituto de Estudos Avancados (IEAv/CTA), Sao Jose dos Campos, SP (Brazil)

    2011-07-01

    Transparency and traceability are key factors for confidence building, acceptability, and quality enhancement of the safety assessment, and safety case for a radioactive waste disposal facility. In order to facilitate analysis and promote discussions, all of the information used to make decisions should be readily available to stake holders. The information should convey a good understanding of the intermediate decisions processes, allowing examination of alternatives and 'what if questions'. In an ideal situation all stake holders, including scientists and the public, should be able to follow the path of a certain parameter, from the beginning where it was defined, its assumptions and uncertainties, throughout the calculations until the final results of the safety assessment. One of the main challenges, to achieving such a transparency and traceability, is that stake holders are a very diverse audience, with very different backgrounds. This could require preparation of various versions of the same documentation, which would be impractical. While the linguistic information is of crucial importance to understanding the reasoning, it is very difficult to convey the supporting conditions, and consequent uncertainties for the selection of parameters values. Even scientists involved in the process can become confused due to the overwhelming amount of information that is used to support parameter value selection. The amount of details makes it difficult to track the decisions, which lead to the selection of a certain parameter, throughout the calculations. This paper presents a methodology to represent the linguistic information used in the safety assessment in terms of mathematical expressions by using the fuzzy sets and fuzzy logic tools. This methodology aims to help information to be readily available while keeping, as much as possible, the original meaning of the linguistic expressions and, consequently, to be available at any time as a quick reference

  2. Knowledge representation in safety assessment: improving transparency and traceability

    International Nuclear Information System (INIS)

    Lemos, F.L. de; Sullivan, T.; Ross, T.; Guimaraes, L.N.F.

    2011-01-01

    Transparency and traceability are key factors for confidence building, acceptability, and quality enhancement of the safety assessment, and safety case for a radioactive waste disposal facility. In order to facilitate analysis and promote discussions, all of the information used to make decisions should be readily available to stake holders. The information should convey a good understanding of the intermediate decisions processes, allowing examination of alternatives and 'what if questions'. In an ideal situation all stake holders, including scientists and the public, should be able to follow the path of a certain parameter, from the beginning where it was defined, its assumptions and uncertainties, throughout the calculations until the final results of the safety assessment. One of the main challenges, to achieving such a transparency and traceability, is that stake holders are a very diverse audience, with very different backgrounds. This could require preparation of various versions of the same documentation, which would be impractical. While the linguistic information is of crucial importance to understanding the reasoning, it is very difficult to convey the supporting conditions, and consequent uncertainties for the selection of parameters values. Even scientists involved in the process can become confused due to the overwhelming amount of information that is used to support parameter value selection. The amount of details makes it difficult to track the decisions, which lead to the selection of a certain parameter, throughout the calculations. This paper presents a methodology to represent the linguistic information used in the safety assessment in terms of mathematical expressions by using the fuzzy sets and fuzzy logic tools. This methodology aims to help information to be readily available while keeping, as much as possible, the original meaning of the linguistic expressions and, consequently, to be available at any time as a quick reference. This would

  3. 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

  4. Geosphere process report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Skagius, Kristina

    2006-09-01

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. 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, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground

  5. Geosphere process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina [Kemakta Konsult AB, Stockholm (SE)] (ed.)

    2006-09-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. 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, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground

  6. 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)

  7. Integrated deterministic and probabilistic safety assessment: Concepts, challenges, research directions

    International Nuclear Information System (INIS)

    Zio, Enrico

    2014-01-01

    Highlights: • IDPSA contributes to robust risk-informed decision making in nuclear safety. • IDPSA considers time-dependent interactions among component failures and system process. • Also, IDPSA considers time-dependent interactions among control and operator actions. • Computational efficiency by advanced Monte Carlo and meta-modelling simulations. • Efficient post-processing of IDPSA output by clustering and data mining. - Abstract: Integrated deterministic and probabilistic safety assessment (IDPSA) is conceived as a way to analyze the evolution of accident scenarios in complex dynamic systems, like nuclear, aerospace and process ones, accounting for the mutual interactions between the failure and recovery of system components, the evolving physical processes, the control and operator actions, the software and firmware. In spite of the potential offered by IDPSA, several challenges need to be effectively addressed for its development and practical deployment. In this paper, we give an overview of these and discuss the related implications in terms of research perspectives

  8. The Nordic safety program on accident consequence assessment

    International Nuclear Information System (INIS)

    Tveten, U.

    1988-01-01

    One important part of Nordic cooperation is partially funded by the Nordic Council of Ministers, namely the work performed within the Nordic Safety Program (often referred to as the NKA projects). NKA is the Nordic abbreviation of the Nordic Liaison Committee on Atomic Energy. One program area in the present four-year period is concerned with problems related to reactor accident consequence assessment, and contains almost twenty projects covering a wide range of subjects. The author is program coordinator for this program area. The program will be completed in 1989. The program was strongly influenced by Chernobyl, and a number of new projects were included in the program in 1986. Involved in the program are these Nordic institutions: Riso National Laboratory (Denmark). Technical Research Centre of Finland. Finnish Centre for Radiation and Nuclear Safety. Finnish Meteorological Institute. Institute for Energy Technology (Norway). Agricultural University of Norway. Meteorological Institute of Norway. Studsvik Energiteknik AB (Sweden). National Defence Research Laboratory (Sweden)

  9. Safety assessment for genetically modified sweet pepper and tomato

    International Nuclear Information System (INIS)

    Chen Zhangliang; Gu Hongya; Li Yi; Su Yilan; Wu Ping; Jiang Zhicheng; Ming Xiaotian; Tian Jinhua; Pan Naisui; Qu Lijia

    2003-01-01

    The coat protein (CP) gene of cucumber mosaic virus (CMV) was cloned from a Chinese CMV isolate, the CaMV promoter and NOS terminator added and the gene construct was transformed into both sweet pepper and tomato plants to confer resistance to CMV. Safety assessments of these genetically modified (GM) plants were conducted. It was found that these two GM products showed no genotoxicity either in vitro or in vivo by the micronucleus test, sperm aberration test and Ames test. Animal feeding studies showed no significant differences in growth, body weight gain, food consumption, hematology, blood biochemical indices, organ weights and histopathology between rats or mice of either sex fed with either GM sweet pepper or tomato diets compared with those with non-GM diets. These results demonstrate that the CMV-resistant sweet pepper and tomato are comparable to the non-GM counterparts in terms of food safety

  10. Nanotechnology in food science: Functionality, applicability, and safety assessment

    Directory of Open Access Journals (Sweden)

    Xiaojia He

    2016-10-01

    Full Text Available Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted.

  11. The Nirex safety assessment research programme for 1987/88

    International Nuclear Information System (INIS)

    Cooper, M.J.; Tasker, P.W.

    1987-10-01

    This report outlines the work of the Nirex Safety Assessment Research Programme during the period 1st April 1987 to 31st March 1988. The research programme has the specific objective of providing the information requirements of the post-emplacement radiological safety case for the disposal of low-level and intermediate-level radioactive waste in underground repositories. For convenience the programme has been divided into seven areas: physical containment, near-field radionuclide chemistry, evolution of the near-field aqueous environment, mass transfer in the geosphere, the biosphere, gas evolution and migration, and integrated studies. The near-field includes the waste, its immobilising medium, its container, the engineered structure in which the container is emplaced and the immediately adjacent geological formation disturbed by the construction of the repository. (author)

  12. Integrated deterministic and probabilistic safety assessment: Concepts, challenges, research directions

    Energy Technology Data Exchange (ETDEWEB)

    Zio, Enrico, E-mail: enrico.zio@ecp.fr [Ecole Centrale Paris and Supelec, Chair on System Science and the Energetic Challenge, European Foundation for New Energy – Electricite de France (EDF), Grande Voie des Vignes, 92295 Chatenay-Malabry Cedex (France); Dipartimento di Energia, Politecnico di Milano, Via Ponzio 34/3, 20133 Milano (Italy)

    2014-12-15

    Highlights: • IDPSA contributes to robust risk-informed decision making in nuclear safety. • IDPSA considers time-dependent interactions among component failures and system process. • Also, IDPSA considers time-dependent interactions among control and operator actions. • Computational efficiency by advanced Monte Carlo and meta-modelling simulations. • Efficient post-processing of IDPSA output by clustering and data mining. - Abstract: Integrated deterministic and probabilistic safety assessment (IDPSA) is conceived as a way to analyze the evolution of accident scenarios in complex dynamic systems, like nuclear, aerospace and process ones, accounting for the mutual interactions between the failure and recovery of system components, the evolving physical processes, the control and operator actions, the software and firmware. In spite of the potential offered by IDPSA, several challenges need to be effectively addressed for its development and practical deployment. In this paper, we give an overview of these and discuss the related implications in terms of research perspectives.

  13. Safety assessment of silica and zinc oxide nanoparticles

    Directory of Open Access Journals (Sweden)

    An SSA

    2014-12-01

    Full Text Available Seong Soo A An,1 Meyoung-Kon Kim2 1Department of Bionanotechnology, Gachon Medical Research Institute, Gachon University, Seongnam, Gyeonggi, Korea; 2Department of Biochemistry and Molecular Biology, Korea University Medical School and College, Seoul, KoreaThe current volume is a special issue focusing on a safety assessment of nanoparticles, from their physicochemical properties to government regulations. It features twenty-five papers, discussing general issues with the possible harmfulness of two different types of nanoparticles (NPs; silica (SiO2 and zinc oxide (ZnO. Six papers describe detailed analyses from 90-day repeated administrations of NPs, and finally there is a series of technical reports, formatted by the National Toxicology Program (NTP, dealing with safety issues regarding international cooperation with the OECD (Organisation for Economic Co-operation and Development Working Party on Manufactured Nanomaterials (WPMN.

  14. Biosphere models for safety assessment of radioactive waste disposal

    International Nuclear Information System (INIS)

    Proehl, G.; Olyslaegers, G.; Zeevaert, T.; Kanyar, B.; Bergstroem, U.; Hallberg, B.; Mobbs, S.; Chen, Q.; Kowe, R.

    2004-01-01

    The aim of the BioMoSA project has been to contribute in the confidence building of biosphere models, for application in performance assessments of radioactive waste disposal. The detailed objectives of this project are: development and test of practical biosphere models for application in long-term safety studies of radioactive waste disposal to different European locations, identification of features, events and processes that need to be modelled on a site-specific rather than on a generic base, comparison of the results and quantification of the variability of site-specific models developed according to the reference biosphere methodology, development of a generic biosphere tool for application in long term safety studies, comparison of results from site-specific models to those from generic one, Identification of possibilities and limitations for the application of the generic biosphere model. (orig.)

  15. Nanotechnology in food science: Functionality, applicability, and safety assessment.

    Science.gov (United States)

    He, Xiaojia; Hwang, Huey-Min

    2016-10-01

    Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted. Copyright © 2016. Published by Elsevier B.V.

  16. German data for risk based fire safety assessment

    International Nuclear Information System (INIS)

    Roewekamp, M.; Berg, H.P.

    1998-01-01

    Different types of data are necessary to perform risk based fire safety assessments and, in particular, to quantify the fire event tree considering the plant specific conditions. Data on fire barriers, fire detection and extinguishing, including also data on secondary effects of a fire, have to be used for quantifying the potential hazard and damage states. The existing German database on fires in nuclear power plants (NPPs) is very small. Therefore, in general generic data, mainly from US databases, are used for risk based safety assessments. Due to several differences in the plant design and conditions generic data can only be used as conservative assumptions. World-wide existing generic data on personnel failures in case of fire fighting have only to be adapted to the plant specific conditions inside the NPP to be investigated. In contrary, unavailabilities of fire barrier elements may differ strongly depending on different standards, testing requirements, etc. In addition, the operational behaviour of active fire protection equipment may vary depending on type and manufacturer. The necessity for more detailed and for additional plant specific data was the main reason for generating updated German data on the operational behaviour of active fire protection equipment/features in NPPs to support risk based fire safety analyses being recommended to be carried out as an additional tool to deterministic fire hazard analyses in the frame of safety reviews. The results of these investigations revealed a broader and more realistic database for technical reliability of active fire protection means, but improvements as well as collection of further data are still necessary. (author)

  17. 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.

  18. 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...

  19. Safety Assessment in the AREVA Group: Operating Experience from a Self-Assessment Tool

    International Nuclear Information System (INIS)

    Coye de Brunélis, T.; Mignot, E.; Sidaner, J.-F.

    2016-01-01

    The expression “safety culture” first appeared following analysis of the Chernobyl accident in 1986. It was first defined in INSAG-4 (International Nuclear Safety Advisory Group safety series) in 1991. Other events have occurred in nuclear facilities and during transportation since Chernobyl: Tokai Mura in 1999, Roissy Transport in 2002, Davis Besse in 2002, Thorp in 2005. These events show that the initial approach was too simplistic. Based on this observation, the definition of safety culture was supplemented by including concepts of cultural value (associated with the country and the company) and human and organizational factors, and was integrated in that form with the emergence and implementation of integrated management systems (IMS). Today, the concept of nuclear safety culture covers a wide set of factors such as safety, quality, corporate culture, defined processes and policies, organizations and related resources. Any assessment of people’s safety culture, particularly people directly involved in facility operations, is thus part of a comprehensive policy and contributes to a de facto demonstration of the priority which management assigns to safety.

  20. Application of probabilistic safety assessment for Macedonian electric power system

    International Nuclear Information System (INIS)

    Kancev, D.; Causevski, A.; Cepin, M.; Volkanovski, A.

    2007-01-01

    Due to the complex and integrated nature of a power system, failures in any part of the system can cause interruptions, which range from inconveniencing a small number of local residents to a major and widespread catastrophic disruption of supply known as blackout. The objective of the paper is to show that the methods and tools of probabilistic safety assessment are applicable for assessment and improvement of real power systems. The method used in this paper is developed based on the fault tree analysis and is adapted for the power system reliability analysis. A particular power system i.e. the Macedonian power system is the object of the analysis. The results show that the method is suitable for application of real systems. The reliability of Macedonian power system assumed as the static system is assessed. The components, which can significantly impact the power system are identified and analysed in more details. (author)

  1. Hybrid probabilistic and possibilistic safety assessment. Methodology and application

    International Nuclear Information System (INIS)

    Kato, Kazuyuki; Amano, Osamu; Ueda, Hiroyoshi; Ikeda, Takao; Yoshida, Hideji; Takase, Hiroyasu

    2002-01-01

    This paper presents a unified methodology to handle variability and ignorance by using probabilistic and possibilistic techniques respectively. The methodology has been applied to the safety assessment of geological disposal of high-level radioactive waste. Uncertainties associated with scenarios, models and parameters were defined in terms of fuzzy membership functions derived through a series of interviews to the experts, while variability was formulated by means of probability density functions (pdfs) based on available data sets. The exercise demonstrated the applicability of the new methodology and, in particular, its advantage in quantifying uncertainties based on expert opinion and in providing information on the dependence of assessment results on the level of conservatism. In addition, it was shown that sensitivity analysis can identify key parameters contributing to uncertainties associated with results of the overall assessment. The information mentioned above can be utilized to support decision-making and to guide the process of disposal system development and optimization of protection against potential exposure. (author)

  2. Project SAFE. Update of the SFR-1 safety assessment. Phase 1. Appendix A5: Radionuclide transport

    International Nuclear Information System (INIS)

    Moreno, L.

    1998-01-01

    A critical revision of the previous safety assessments made by SKB on the Final Repository for Radioactive Operational Waste, SFR is presented. The review of the Deepened Safety Assessment is also discussed. Based on this critical revision improvements are suggested. Hydrology, formation of complexes, and long-term behaviour of the barriers are some of the aspects where the safety assessment could be improved

  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. 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)

  5. 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)

  6. 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

  7. Considerations in the safety assessment of sealed nuclear facilities

    International Nuclear Information System (INIS)

    1991-06-01

    This report is a part of the International Atomic Energy Agency's radioactive waste management programme, whose objective is to provide assistance to Member States in developing guidance for identifying safe alternatives for isolating radioactive waste from man and his environment. This report attempts to integrate information from the previous reports on decommissioning of nuclear facilities, mitigation of accidents at such facilities, and performance assessment of disposal systems to provide useful advice and qualitative guidance to those responsible for performance and safety assessments of sealed nuclear facilities by giving an overview of possible approaches and techniques for such assessments. In this context, the establishment of requirements and rules governing the radiological safety of personnel, the general public, and the environment for sealing and post-sealing activities will enable the choice of the most appropriated approach and help to promote consistency in both decommissioning and waste management standards. The near-field effects discussed in this document include gas generation, interactions of the groundwater and the residual water with other components of the system, thermal, thermo-mechanical, radiation effects and chemical and geochemical reactions. 59 refs, figs and tabs

  8. 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.

  9. Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

    Science.gov (United States)

    Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

    2010-09-01

    We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires

  10. Assessing community child passenger safety efforts in three Northwest Tribes.

    Science.gov (United States)

    Smith, M L; Berger, L R

    2002-12-01

    To identify strengths and weaknesses in community based child passenger safety programs by developing a scoring instrument and conducting observations of child restraint use in three Native American communities. The three communities are autonomous Tribal reservations in the Pacific Northwest. Their per capita incomes and rates of unemployment are comparable. In each community, 100 children under 5 years old were observed for car seat use. A six item community assessment tool (100 points maximum) awarded points for such items as the type (primary or secondary) and enforcement of child restraint laws; availability of car seats from distribution programs; extent of educational programs; and access to data on vehicle injuries. For children from birth to 4 years, the car seat use rate ranged from 12%-21%. Rates for infants (71%-80%) far exceeded rates for 1-4 year old children (5%-14%). Community scores ranged from 0 to 31.5 points. There was no correlation between scores and observed car seat use. One reason was the total lack of enforcement of restraint laws. A community assessment tool can highlight weaknesses in child passenger efforts. Linking such a tool with an objective measure of impact can be applied to other injury problems, such as fire safety or domestic violence. The very process of creating and implementing a community assessment can enhance agency collaboration and publicize evidence based "best practices" for injury prevention. Further study is needed to address methodologic issues and to examine crash and medical data in relation to community child passenger safety scores.

  11. Uncertainty estimation in nuclear power plant probabilistic safety assessment

    International Nuclear Information System (INIS)

    Guarro, S.B.; Cummings, G.E.

    1989-01-01

    Probabilistic Risk Assessment (PRA) was introduced in the nuclear industry and the nuclear regulatory process in 1975 with the publication of the Reactor Safety Study by the U.S. Nuclear Regulatory Commission. Almost fifteen years later, the state-of-the-art in this field has been expanded and sharpened in many areas, and about thirty-five plant-specific PRAs (Probabilistic Risk Assessments) have been performed by the nuclear utility companies or by the U.S. Nuclear Regulatory commission. Among the areas where the most evident progress has been made in PRA and PSA (Probabilistic Safety Assessment, as these studies are more commonly referred to in the international community outside the U.S.) is the development of a consistent framework for the identification of sources of uncertainty and the estimation of their magnitude as it impacts various risk measures. Techniques to propagate uncertainty in reliability data through the risk models and display its effect on the top level risk estimates were developed in the early PRAs. The Seismic Safety Margin Research Program (SSMRP) study was the first major risk study to develop an approach to deal explicitly with uncertainty in risk estimates introduced not only by uncertainty in component reliability data, but by the incomplete state of knowledge of the assessor(s) with regard to basic phenomena that may trigger and drive a severe accident. More recently NUREG-1150, another major study of reactor risk sponsored by the NRC, has expanded risk uncertainty estimation and analysis into the realm of model uncertainty related to the relatively poorly known post-core-melt phenomena which determine the behavior of the molten core and of the rector containment structures

  12. Safety assessments using surveillance programmes and data base

    International Nuclear Information System (INIS)

    Njo, D.H.

    1998-01-01

    As a result of the popularity of the Agencies report 'Neutron Irradiation Embrittlement of Reactor Pressure Vessel Steels' of 1975, it was decided that another report on this broad subject would be of use. In this report, background and contemporary views on specially identified areas of the subject are considered as self-contained chapters, written by experts. Chapter 12 presents some aspects on safety assessments of RPV materials during the life of a NPP, using surveillance programmes and data bases. Specific criteria for the usefulness of data bases are developed

  13. Methodology of safety assessment for radioactive waste disposal

    International Nuclear Information System (INIS)

    Matsuzuru, Hideo; Kimura, Hideo

    1991-01-01

    The Japan Atomic Energy Research Institute (JAERI) is conducting an extensive R and D program to develop a safety assessment methodology to evaluate environmental consequences associated with geological disposal of a high-level radioactive waste, and also to elucidate a generic feasibility of the geological disposal in Japan. The paper describes the current R and D activities in the JAERI to develop an interim version of the methodology based on a normal evolution scenario, and also to validate models used in the methodology. (author)

  14. Assessing systemwide occupational health and safety risks of energy technologies

    International Nuclear Information System (INIS)

    Rowe, M.D.

    1982-01-01

    Input-output modelling is now being used to assess systemwide occupational and public health and safety risks of energy technologies. Some of the advantages and disadvantages of this method are presented and some of its important limitations are discussed. Its primary advantage is that it provides a standard method with which to compare technologies on a consistent basis without extensive economic analysis. Among the disadvantages are limited range of applicability, limited spectrum of health impacts, and inability to identify unusual health impacts unique to a new technology. (author)

  15. Probabilistic safety assessment for Hanford high-level waste tanks

    International Nuclear Information System (INIS)

    MacFarlane, D.R.; Stack, D.S.; Kindinger, J.P.; Deremer, R.K.

    1995-01-01

    This paper gives results from the first comprehensive level-3 probabilistic safety assessment (PSA), including consideration of external events, for the Hanford tank farm (HTF). This work was sponsored by the U.S. Department of Energy/Environmental Restoration and Waste Management Division (DOE/EM). At the HTF, there are 177 underground tanks in 18 separate tank farms containing accumulated liquid/sludge/saltcake radioactive wastes from 50 yr of weapons materials production activities. The total waste volume is ∼60 million gal, containing ∼200 million Ci of radioactivity

  16. Dependencies, human interactions and uncertainties in probabilistic safety assessment

    International Nuclear Information System (INIS)

    Hirschberg, S.

    1990-01-01

    In the context of Probabilistic Safety Assessment (PSA), three areas were investigated in a 4-year Nordic programme: dependencies with special emphasis on common cause failures, human interactions and uncertainty aspects. The approach was centered around comparative analyses in form of Benchmark/Reference Studies and retrospective reviews. Weak points in available PSAs were identified and recommendations were made aiming at improving consistency of the PSAs. The sensitivity of PSA-results to basic assumptions was demonstrated and the sensitivity to data assignment and to choices of methods for analysis of selected topics was investigated. (author)

  17. An approach for assessing ALWR passive safety system reliability

    International Nuclear Information System (INIS)

    Hake, T.M.

    1991-01-01

    Many advanced light water reactor designs incorporate passive rather than active safety features for front-line accident response. A method for evaluating the reliability of these passive systems in the context of probabilistic risk assessment has been developed at Sandia National Laboratories. This method addresses both the component (e.g. valve) failure aspect of passive system failure, and uncertainties in system success criteria arising from uncertainties in the system's underlying physical processes. These processes provide the system's driving force; examples are natural circulation and gravity-induced injection. This paper describes the method, and provides some preliminary results of application of the approach to the Westinghouse AP600 design

  18. Validation study of safety assessment model for radioactive waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Munakata, Masahiro; Takeda, Seiji; Kimura, Hideo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    The JAERI-AECL collaboration research program has been conducted to validate a groundwater flow and radionuclide transport models for safety assessment. JAERI have developed a geostatistical model for radionuclide transport through a heterogeneous geological media and verify using experimental results of field tracer tests. The simulated tracer plumes explain favorably the experimental tracer plumes. A regional groundwater flow and transport model using site-scale parameter obtained from tracer tests have been verified by comparing simulation results with observation ones of natural environmental tracer. (author)

  19. Safety assessment document for the dynamic test complex (Building 836)

    International Nuclear Information System (INIS)

    Odell, B.N.; Pfeifer, H.E.

    1981-01-01

    A safety assessment was performed to determine if potential accidents at the 836 Complex at Site 300 could present undue hazards to the general public, personnel at Site 300, or have an adverse effect on the environment. The credible accidents that might have an effect on these facilities or have off-site consequences were considered. These were earthquake, extreme wind (including missiles), lightning, flood, criticality, high explosive (H) detonation that disperses uranium and beryllium, spontaneous oxidation of plutonium, explosions due to finely divided particles, and a fire

  20. Defining initiating events for purposes of probabilistic safety assessment

    International Nuclear Information System (INIS)

    1993-09-01

    This document is primarily directed towards technical staff involved in the performance or review of plant specific Probabilistic Safety Assessment (PSA). It highlights different approaches and provides typical examples useful for defining the Initiating Events (IE). The document also includes the generic initiating event database, containing about 300 records taken from about 30 plant specific PSAs. In addition to its usefulness during the actual performance of a PSA, the generic IE database is of the utmost importance for peer reviews of PSAs, such as the IAEA's International Peer Review Service (IPERS) where reference to studies on similar NPPs is needed. 60 refs, figs and tabs

  1. Safety assessment document for the dynamic test complex (Building 836)

    Energy Technology Data Exchange (ETDEWEB)

    Odell, B.N.; Pfeifer, H.E.

    1981-11-24

    A safety assessment was performed to determine if potential accidents at the 836 Complex at Site 300 could present undue hazards to the general public, personnel at Site 300, or have an adverse effect on the environment. The credible accidents that might have an effect on these facilities or have off-site consequences were considered. These were earthquake, extreme wind (including missiles), lightning, flood, criticality, high explosive (H) detonation that disperses uranium and beryllium, spontaneous oxidation of plutonium, explosions due to finely divided particles, and a fire.

  2. Probabilistic safety assessment past, present and future. An IAEA perspective

    International Nuclear Information System (INIS)

    Lederman, L.; Niehaus, F.; Tomic, B.

    1996-01-01

    Despite the high level of development that probabilistic safety assessment (PSA) methods have reached, a number of issues place constraints on its use in supporting decision making on safety matters. A recent publication of the International Nuclear Safety Advisory Group (INSAG) represents an important step in reaching international consensus on the use of PSA. PSA is ''strongly encouraged'' by INSAG; however, it is noted that ''PSA methodology is not sufficiently mature for its present status to be frozen''. The main aspects of the report are discussed in this paper. The paper next discusses three main categories of PSA application, namely the adequacy of design and procedures, optimization of operational activities and regulatory applications. For each of the applications, the objectives, specific modelling requirements and the prospects for implementation are presented. Consistent with its statutory functions, an important aspect of the work of the IAEA is to reach international consensus on the possibilities of and limitations on the use of PSA methods. Whereas past efforts have been concentrated on promotion and assistance to perform Level 1 PSAs, work is now extending with emphasis on PSA applications, Level 2 and Level 3 analysis, external events and shutdown risks. The main elements of IAEA's PSA Programme are discussed. Finally some challenges related to the use of PSA in the backfitting of nuclear power plants in Eastern Europe and countries of the former USSR are addressed. (orig.)

  3. An assessment of food hygiene and safety at farmers' markets.

    Science.gov (United States)

    Worsfold, D; Worsfold, P M; Griffith, C J

    2004-04-01

    Farmers' markets are becoming a more significant part of the food-retailing sector. A survey of farmers' markets was conducted to assess aspects of food hygiene and safety. The views of the public using the markets were also examined. The range of farm products was wide and the methods utilised varied. The markets were usually temporary outdoor events with few facilities. Traders had received elementary food hygiene training and rated their hygiene standards highly. Less than half had risk management procedures in place, most did not perceive their produce as high-risk. They believed consumers to be mainly interested in food quality and to regard food safety issues highly. Consumers shopped at the markets because of the quality of the products sold. Their overall satisfaction with the markets was high and they raised no concerns about food safety. Given the restricted facilities at farmers' markets and the early phase of implementation of hygiene management systems by market traders, it may be precautionary to restrict the sale of farm products at farmers markets to those that are regarded as low-risk.

  4. A reliability assessment methodology for the VHTR passive safety system

    International Nuclear Information System (INIS)

    Lee, Hyungsuk; Jae, Moosung

    2014-01-01

    The passive safety system of a VHTR (Very High Temperature Reactor), which has recently attracted worldwide attention, is currently being considered for the design of safety improvements for the next generation of nuclear power plants in Korea. The functionality of the passive system does not rely on an external source of an electrical support system, but on the intelligent use of natural phenomena. Its function involves an ultimate heat sink for a passive secondary auxiliary cooling system, especially during a station blackout such as the case of the Fukushima Daiichi reactor accidents. However, it is not easy to quantitatively evaluate the reliability of passive safety for the purpose of risk analysis, considering the existing active system failure since the classical reliability assessment method cannot be applied. Therefore, we present a new methodology to quantify the reliability based on reliability physics models. This evaluation framework is then applied to of the conceptually designed VHTR in Korea. The Response Surface Method (RSM) is also utilized for evaluating the uncertainty of the maximum temperature of nuclear fuel. The proposed method could contribute to evaluating accident sequence frequency and designing new innovative nuclear systems, such as the reactor cavity cooling system (RCCS) in VHTR to be designed and constructed in Korea.

  5. Probabilistic safety assessment of Narora Atomic Power Project

    International Nuclear Information System (INIS)

    Babar, A.K.; Saraf, R.K.; Kakodkar, A.; Sanyasi Rao, V.V.S.

    1989-01-01

    Various safety studies on Pressurised Water and Boiling Water reactors have been conducted. However, a detailed report on probabilistic safety assessment (PSA) of PHWRs is not available. PSA level I results of the standardised 235 MWe PHWR under construction at Narora are presented herein. Fault Tree analysis of various initiating events (IEs), safety systems has been completed. Event Tree analysis has been performed for all the dominating IEs to identify the accident sequences and a list of the dominating accident sequences is included. Analysis has been carried out using Monte Carlo simulation to propagate the uncertanities in failure rate data. Further uncertainty analysis is extended to obtain distributions for the accident sequences and core damage frequency. Some noteworthy results of the study apart from the various design modifications incorporated during the design phase are: (i) The accident sequences resulting from station blackout are dominant contributors to the core damage frequency. (ii) Class-IV transients, small break LOCA are significant IEs. Main steam line break is likely to induce steam generator tube ruptures. (iii) Moderator circulation, fire fighting system, secondary steam relief are relatively important in core damage frequency reductions. (iv) Under accidental situations human errors are likely to be asociated with valving in shutdown cooling and fire fighting systems. (author). 14 tabs., 14 figs., 15 refs

  6. Safety and risk assessment of ceramide 3 in cosmetic products.

    Science.gov (United States)

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

    Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Assessment of IAEA safety series no. 75-INSAG-3 - ''basic safety principles for nuclear power plants''

    International Nuclear Information System (INIS)

    1989-01-01

    The International Atomic Energy Agency Safety Series No. 75-INSAG--3, 'Basic Safety Principles for Nuclear Power Plants' is reviewed in the light of the Advisory Committee on Nuclear Safety reports ACNS--2, 'Safety Objectives for Nuclear Activities in Canada', and ACNS--4, 'Recommended General Safety Requirements for Nuclear Power Plants'. The INSAG safety objectives are consistent with the safety objectives stated in ACNS--2 but are less general, applying only to nuclear power plants. The INSAG safety principles are, in general, consistent with the requirements stated in ACNS--4 but put more emphasis on 'safety culture'. They give little attention to reactor plant effluents, waste management, or decommissioning. (fig., 5 refs.)

  8. First safety assessment objectives and content of the 2001 report

    International Nuclear Information System (INIS)

    Franco, Michel de

    2002-01-01

    Michel de Franco (ANDRA, France) described plans to report its first safety assessment of facility designs for disposal of high and intermediate level waste and spent fuel. This assessment will be the forerunner of a more detailed assessment that is required to be presented to the French government in 2005 and is intended to facilitate the formalization and testing of the assessment methodology intended to be used in the 2005 assessment report. The report will include information about the waste inventory, the materials used for the engineered barriers and current understanding of the geology and surface environment at the Bure site in eastern France. It will also describe the preliminary design concepts and the phenomena defining the evolution of the repository in different time frames as well as presenting the results of the initial performance assessment of the repository. The report will also include an analysis of the implications of the requirement for reversibility, taken to mean that each repository development step can be reversed

  9. Safety assessment of OPG's used fuel for dry storage

    International Nuclear Information System (INIS)

    Roman, H.; Khan, A.

    2005-01-01

    'Full text:' Ontario Power Generation (OPG) operates the Pickering Waste Management Facility (PWMF) and Western Waste Management Facility (WWMF) where OPG has been storing 10-year or older used fuel in the Dry Storage Containers (DSCs) since 1996 and 2003 respectively. The construction licence for the Darlington Used Fuel Dry Storage Facility (DUFDSF) was obtained in August 2004. Safety assessment of the used fuel for dry storage is required to support each request for regulatory approval to construct and operate a dry storage facility. The objective of the safety assessment is to assess the used fuel performance under normal operation and postulated credible accident scenarios. A reference used fuel bundle is defined based on the operating history and data on fuel discharged from the reactors of the specific nuclear generating station. The characteristics of the reference used fuel bundle are used to calculate the nuclide inventory, source term and decay heat used for the assessment. When assessing malfunctions and accidents, postulated external and internal events are considered. Consideration is also given to the design basis accidents of the specific nuclear generating station that could affect the used fuel under dry storage. For those events deemed credible (i.e. probability > 10 -7 ), a bounding fuel failure consequence is predicted. Given the chemical characteristics of the radionuclides in used fuel, the design of the CANDU fuel and the conditions inside the DSC, in the event that a used fuel bundle should become damaged during used fuel dry storage operations, the only significant radionuclides species that are volatile are krypton-85 and tritium. Release of these radionuclides is considered in calculating public and worker doses. (author)

  10. Seismic safety margin assessment program (Annual safety research report, JFY 2010)

    International Nuclear Information System (INIS)

    Suzuki, Kenichi; Iijima, Toru; Inagaki, Masakatsu; Taoka, Hideto; Hidaka, Shinjiro

    2011-01-01

    Seismic capacity test data, analysis method and evaluation code provided by Seismic Safety Margin Assessment Program have been utilized for the support of seismic back-check evaluation of existing plants. The summary of the program in 2010 is as follows. 1. Component seismic capacity test and quantitative seismic capacity evaluation. Many seismic capacity tests of various snubbers were conducted and quantitative seismic capacities were evaluated. One of the emergency diesel generator partial-model seismic capacity tests was conducted and quantitative seismic capacity was evaluated. Some of the analytical evaluations of piping-system seismic capacities were conducted. 2. Analysis method for minute evaluation of component seismic response. The difference of seismic response of large components such as primary containment vessel and reactor pressure vessel when they were coupled with 3-dimensional FEM building model or 1-dimensional lumped mass building model, was quantitatively evaluated. 3. Evaluation code for quantitative evaluation of seismic safety margin of systems, structures and components. As the example, quantitative evaluation of seismic safety margin of systems, structures and components were conducted for the reference plant. (author)

  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. 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

  14. 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)

  15. Safety level assessment in the production environment using Fuzzy logic

    Directory of Open Access Journals (Sweden)

    2012-05-01

    Conclusion: The application of the proposed method can reveal which safety items and factors are most important in improving workers safety, and therefore decide where to concentrate resources in order to improve the safety of the work environment.

  16. Risk assessment for safety laboratories in Politeknik Negeri Medan

    Science.gov (United States)

    Viyata Sundawa, Bakti; Hutajulu, Elferida; Sirait, Regina; Banurea, Waldemar; Indrayadi; Mulyadi, Sangap

    2017-09-01

    International Labour Organization (ILO) estimated 2.34 million people die each year because accidents and diseases in workplace. It also impact to economic losses in some countries. It need to do safety and healthy in working environment especially in laboratory. Identification of potential hazards and risks must be done in Telecommunication Laboratory Politeknik Negeri Medan. Therefore, this study was assessed 5 of potential hazards and risks in our laboratory by Likert Scale. This object was divided into 2 assessment namely likelihood of hazards and severity of consequences. Collecting data is taken from questionnaire who involved 100 students at random academic level. The result showed The highest score is chemical hazards 73.2% in likelihood of hazards and electrical hazards 85% in severity of consequences. This condition is classified as “high” state. Big attention must be given to “high” state because it can help us to determine mitigate action.

  17. Corrosion calculations report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q eq , is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 10 6 years. Several processes give corrosion depths less than 100 μm, but no process give corrosion depths larger than a few millimetres

  18. Corrosion calculations report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q{sub eq}, is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 106 years. Several processes give corrosion depths less than 100 mum, but no process give corrosion depths larger than a few

  19. Genetically Modified Foods: Promises, Challenges and Safety Assessments

    Directory of Open Access Journals (Sweden)

    Manouchehr Dadgarnejad

    2017-09-01

    Full Text Available Background and Objective: Application of genetically modified organisms in the agriculture sector and food industry began since last years of 20th century. Since then this technology has become a central part of the broader public controversy about the advantages and safety of these products. This article has tried to review aspects of these types of organisms and foods.Results and Conclusion: Genetically modified technology has potential to overcome agricultural problems, such as biotic and abiotic issues by enhancing pests and herbicides resistance, drought tolerance, fast ripening, and finally enhancing yield and nutritional quality. Besides these revolutionary advantages, during the last decades some potential human, animal and environmental risks have been taken in account for these organisms or foods. However, no scientific evidence exists adequately about their harmful human or animal effects, and also, some new scientific and management methodologies (new technologies and regulations have been developed to mitigate the environmental risks. Some challenges such as pest adaptation are being solved by refuge technology, gene pyramiding and insertion of best-coupled primers through the known conditions reducing unintended outcomes including silencing, activation or rearrangement of non-target genome pieces. However, it does not mean that no harmful effect will happen in the future. Therefore, it is required that before release of any genetically modified crop, all requested risk assessments be performed, and then post release monitoring be done to follow the possible gene flow and prevent any potential disastrous contaminations to the food chain. Finally, it could be concluded that the safe usage of this technology, by considering all nationally and internationally accepted environmental and health safety assessment protocols, can help us to use advantages of this technology in agriculture, medicine and industry. However, more safety

  20. 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.

  1. Safety assessment for Area 5 radioactive-waste-management site

    International Nuclear Information System (INIS)

    Hunter, P.H.; Card, D.H.; Horton, K.

    1982-09-01

    The Area 5 Radioactive Waste Management Safety Assessment Document contains evaluations of site characteristics, facilities, and operating practices that contribute to the safe handling, storage, and disposal of low-level radioactive wastes at the Nevada Test Site. Physical geography, cultural factors, climate and meteorology, geology, hydrology (with emphasis on radionuclide migration), ecology, natural phenomena, and natural resources are discussed and determined to be suitable for effective containment of radionuclides. A separate section considers facilities and operating practices such as monitoring, storage/disposal criteria, site maintenance, equipment, and support. The section also considers the transportation and waste handling requirements supporting the new Greater Confinement Disposal Facility (GCDF), GCDF demonstration project, and other requirements for the safe handling, storage, and disposal of low-level radioactive wastes. Finally, the document provides an analysis of releases and an assessment of the near-term operational impacts and dose commitments to operating personnel and the general public from normal operations and anticipated accidental occurrences. The conclusion of this report is that the Area 5 Radioactive Waste Management Site is suitable for low-level radioactive waste handling, storage, and disposal. Also, the new GCDF demonstration project will not affect the overall safety of the Area 5 Radioactive Waste Management Site

  2. Probabilistic safety assessment of nuclear power plants: a monograph

    International Nuclear Information System (INIS)

    Solanki, R.B.; Prasad, Mahendra

    2007-11-01

    This monograph on probabilistic safety assessment (PSA) is addressed to the wide community of professionals engaged in the nuclear industry and concerned with the safety issues of nuclear power plants (NPPs). While the monograph describes PSA of NPPs, the principles described in this monograph can be extended to other facilities like spent fuel storage, fuel reprocessing plants and non-nuclear facilities like chemical plants, refineries etc. as applicable. The methodology for risk assessment in chemical plants or refineries is generally known as quantitative risk analysis (QRA). The fundamental difference between NPP and chemical plant is that in NPPs the hazardous material (fuel and fission products) are contained at a single location (i.e. inside containment), whereas in a chemical plant and reprocessing plants, the hazardous material is present simultaneously at many places, like pipelines, reaction towers, storage tanks, etc. Also unlike PSA, QRA does not deal with levels; it uses an integrated approach combining all the levels. The monograph covers the areas of broad interest in the field of PSA such as historical perspective, fundamentals of PSA, strengths and weaknesses of PSA, applications of PSA, role of PSA in the regulatory decision making and issues for advancement of PSA

  3. 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.

  4. 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.

  5. Mathematical simulation for safety assessment of nuclear waste repositories

    International Nuclear Information System (INIS)

    Brandstetter, A.; Raymond, J.R.; Benson, G.L.

    1979-01-01

    Mathematical models are being developed as part of the Waste Isolation Safety Assessment Program (WISAP) for assessing the post-closure safety of nuclear waste storage in geologic formations. The objective of this program is to develop the methods and data necessary to determine potential events that might disrupt the integrity of a waste repository and provide pathways for radionuclides to reach the bioshpere, primarily through groundwater transport. Four categories of mathematical models are being developed to assist in the analysis of potential release scenarios and consequences: (1) release scenario analysis models; (2) groundwater flow models; (3) contaminant transport models; and (4) radiation dose models. The development of the release scenario models is in a preliminary stage; the last three categories of models are fully operational. The release scenario models determine the bounds of potential future hydrogeologic changes, including potentially disruptive events. The groundwater flow and contaminant transport models compute the flowpaths, travel times, and concentrations of radionuclides that might migrate from a repository in the event of a breach and potentially reach the biosphere. The dose models compute the radiation doses to future populations. Reference site analyses are in progress to test the models for application to different geologies, including salt domes, bedded salt, and basalt

  6. 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.

  7. Safety assessment of Department of Energy nuclear reactors

    International Nuclear Information System (INIS)

    1981-03-01

    One of the first tasks of the NFPQT Committee was to determine which DOE reactors would be assessed. The Committee determined that in view of the limited time available to conduct the assessment, 13 DOE reactors were of such size (physical, power or fission product inventory) to warrant review. This determination was approved by the Under Secretary. A decision was also made in the cases of three weapons material production reactors, C, K and P, to concentrate on the K reactor only, since all three are of the same basic design, have the same operating features, are all at the same site, and are all operated by the same contractor. The assessment was accomplished in the following ways: reviewing the results of assessments conducted by the DOE organizations with reactor safety responsibilities, which were undertaken in compliance with the request of the various program directors; reviewing selected documents that were requested by the Committee and assembled at DOE Headquarters; interviewing DOE Headquarters and Field Office personnel; and conducting on-site reviews of four reactors located at four different sites. The four reactors for on-site reviews were: Advanced Test Reactor (ATR); K Production Reactor; High Flux Beam Reactor (HFBR); and High Flux Isotope Reactor (HFIR). Specific findings and recommendations from the assessment are presented

  8. New Car Assessment Program (NCAP) - 5 Star Safety Ratings

    Data.gov (United States)

    Department of Transportation — NCAP rates vehicles to determine crash worthiness and rollover safety. The safety ratings are gathered during controlled crash and rollover tests conducted at NHTSA...

  9. 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

  10. Risk-informed approaches to assess ecological safety of facilities with radioactive waste

    International Nuclear Information System (INIS)

    Vashchenko, V.N.; Zlochevskij, V.V.; Skalozubov, V.I.

    2011-01-01

    Ingenious risk-informed methods to assess ecological safety of facilities with radioactive waste are proposed in the paper. Probabilistic norms on lethal outcomes and reliability of safety barriers are used as safety criteria. Based on the probability measures, it is established that ecological safety conditions are met for the standard criterion of lethal outcomes

  11. Assessment of the long-term safety for SFR

    Energy Technology Data Exchange (ETDEWEB)

    Greis Dahlberg, Christina; Vahlund, Frederik [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)

    2015-07-01

    During operation and decommissioning of the Swedish nuclear facilities, radioactive waste is generated that must be disposed of. Besides waste from the nuclear facilities, some waste derives from other activities such as industry, research, medical care, etc. Short-lived low- and intermediate-level waste from these activities is disposed of in the final repository for short-lived radioactive waste, SFR, in Forsmark. The facility, which has been in operation since 1988, is owned and operated by Svensk Karnbranslehantering AB, SKB. The existing facility has neither sufficient space nor a license to receive decommissioning waste. SFR must therefore be extended so that shortlived low- and intermediate-level decommissioning waste from the nuclear facilities can also be received. The need for additional capacity has been accentuated by the closure of two reactors in Barseback. These reactors cannot be dismantled until the SFR facility has been extended. The existing repository is built to receive, and after closure serve as a passive repository for, low- and intermediate-level radioactive waste. The disposal rooms are situated in the bedrock beneath the sea floor, covered by about 60 metres of rock. The repository has been designed so that it can be abandoned after closure without requiring further measures to maintain its function. The extension of SFR, is done at the -120 m level immediately adjacent to, and within the same depth range as, the existing facility. The basic function of the existing SFR and of the extended one will be the same. However, a clear difference is the design of the tunnel and the rock vault that are required to permit transport and storage of whole reactor pressure vessels. The application for a license to build this extension includes an assessment of the long-term safety (post-closure safety) of the facility. The safety assessment also contains an updated assessment of the long-term safety of the existing facility. The safety assessment for

  12. 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.

  13. 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

  14. Planning report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-06-01

    This document is a planning report for SKB's next assessment of long-term safety for a KBS 3 repository. The assessment, SR-Can, is to be finished by the end of 2005 and will be used for SKB's application to build an Encapsulation plant for spent nuclear fuel. Apart from outlining the methodology, the report discusses the handling in SR-Can of a number of important issues regarding the near field, the geosphere, the biosphere, the climatic evolution etc. The Swedish nuclear safety and radiation protection authorities have recently issued regulations concerning the final disposal of nuclear waste. The principal compliance criterion states that the annual risk of harmful effects must not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk. There are also a number of requirements on methodological aspects of the safety assessment as well as on the contents of a safety report. The regulations are reproduced in an Appendix to this report. The primary safety function of the KBS 3 system is to completely isolate the spent nuclear fuel within copper canisters over the entire assessment period, which will be one million years in SR-Can. Should a canister be damaged, the secondary safety function is to retard any releases from the canisters. The main steps of the assessment are the following: 1. Qualitative system description, FEP processing: This step consists of defining a system boundary and of describing the system on a format suitable for the safety assessment. Databases of relevant features, events and processes influencing long-term safety are structured and used as one starting point for the assessment. 2. Initial state descriptions. 3. Process descriptions: In this step all identified processes within the system boundary involved in the long-term evolution of the system are described in detail. 4. Description of boundary conditions: This step is a broad description of the evolution of the boundaries of the system

  15. Planning report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    2003-06-01

    This document is a planning report for SKB's next assessment of long-term safety for a KBS 3 repository. The assessment, SR-Can, is to be finished by the end of 2005 and will be used for SKB's application to build an Encapsulation plant for spent nuclear fuel. Apart from outlining the methodology, the report discusses the handling in SR-Can of a number of important issues regarding the near field, the geosphere, the biosphere, the climatic evolution etc. The Swedish nuclear safety and radiation protection authorities have recently issued regulations concerning the final disposal of nuclear waste. The principal compliance criterion states that the annual risk of harmful effects must not exceed 10 -6 for a representative individual in the group exposed to the greatest risk. There are also a number of requirements on methodological aspects of the safety assessment as well as on the contents of a safety report. The regulations are reproduced in an Appendix to this report. The primary safety function of the KBS 3 system is to completely isolate the spent nuclear fuel within copper canisters over the entire assessment period, which will be one million years in SR-Can. Should a canister be damaged, the secondary safety function is to retard any releases from the canisters. The main steps of the assessment are the following: 1. Qualitative system description, FEP processing: This step consists of defining a system boundary and of describing the system on a format suitable for the safety assessment. Databases of relevant features, events and processes influencing long-term safety are structured and used as one starting point for the assessment. 2. Initial state descriptions. 3. Process descriptions: In this step all identified processes within the system boundary involved in the long-term evolution of the system are described in detail. 4. Description of boundary conditions: This step is a broad description of the evolution of the boundaries of the system, focussing mainly

  16. 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...

  17. The Safety Assessment of Long term Interim Storage at Sellafield

    International Nuclear Information System (INIS)

    Buchan, Andrew B.

    2014-01-01

    The Sellafield site comprises a wide range of nuclear facilities, including operating facilities associated with the Magnox reprocessing programme, the Thermal Oxide Reprocessing Plant (THORP) and a range of waste treatment plants. The operational life of some of the site facilities currently extends to 2120, requiring the retrieval, treatment, consolidation and safe extended storage of a variety of radioactive materials. Sellafield has utilised its existing safety assessment processes to inform and prioritise studies into beyond design basis events and resilience evaluation required following Fukushima by UK regulators and industry bodies such as WANO. There are significant differences between NPPs, for which the ENSREG 'stress tests' were originally intended, and the Sellafield site which is instead centered around two reprocessing facilities (Magnox and THORP), with a supporting infrastructure of waste processing and storage facilities, coupled with a legacy of high hazard older facilities. In the former case the consequences of a catastrophic failure are promptly realised, leading to significant problems such as fuel failure / meltdown in AGRs and LWRs respectively in the event of complete loss of cooling. At Sellafield, the processes are carried out at comparatively low temperatures and pressures with relatively low rates of change following any loss of cooling. Instead the consequences of catastrophic failure at Sellafield are more directly related to the very large inventories of radioactive materials, including high level liquid wastes and unprocessed fuels, present in specific plants and to the condition of the ageing assets, holding legacy wastes. The paper will consider how a number of analysis techniques have been used to establish a safety case for fault and accident conditions, i.e. design basis analysis (DBA), probabilistic safety analysis (PSA) and severe accident analysis (SAA) DBA is focused on the key safety measures for those initiating faults

  18. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  19. 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

  20. Complementary Safety Assessments for Research Reactors for the French Nuclear Safety Authority

    International Nuclear Information System (INIS)

    Kassiotis, Christophe; Rigaud, Antoine; Evrard, Lydie

    2013-01-01

    The 'Autorite de surete nucleaire' (ASN) requested licensees to undertake stress tests, called complementary safety assessments (CSA), of their installations on May 5th 2011, following the accident that occurred in Japan on March 11th 2011. Their mission consisted in providing feedback on the consequences of potential extreme events. In this process, all the French facilities were divided into three categories of decreasing priority, depending on two main factors: on the one hand, their vulnerability to the various phenomena that led to the Fukushima accident, and on the other hand, the amount of radioactive elements that would be dispersed in the event of a failure of the safety functions. On the 79 high-priority facilities, only five of them are research or experimental reactors (including two currently shutdown or in decommissioning) and their operators (the 'Comissariat a l'energie atomique et aux energies alternatives' (CEA) and the 'Institut Laue Langevin') submitted their reports to the ASN on September 15 th 2011. Concerning the lower-priority facilities, including three other facilities (two research reactors operated by the CEA and a facility operated by ITER Organization) the deadline was September 15 th 2012. Finally, the remaining facilities were not asked to submit a report yet, but they will have to do it later, mainly on the occasion of their next periodic safety review. The analyses of the cliff-edge effects, that may occur in extreme situations (exceptional scale event, combination of several disasters...), led to the definition of a hardened safety core concept by the 'Institut de radioprotection et de surete nucleaire' (IRSN). This hardened safety core of structures, equipment and organizational measures must ensure the ultimate protection of the concerned facilities in extreme situations : it is designed to prevent severe accidents (or curb their progression), limit large scale releases for extreme accidents, and enables the operating teams to

  1. Food Safety Practices Assessment Tool: An Innovative Way to Test Food Safety Skills among Individuals with Special Needs

    Science.gov (United States)

    Carbone, Elena T.; Scarpati, Stanley E.; Pivarnik, Lori F.

    2013-01-01

    This article describes an innovative assessment tool designed to evaluate the effectiveness of a food safety skills curriculum for learners receiving special education services. As schools respond to the increased demand for training students with special needs about food safety, the need for effective curricula and tools is also increasing. A…

  2. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Science.gov (United States)

    2013-03-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)] Pulse Oximeters--Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  3. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.

    Science.gov (United States)

    2016-01-05

    The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.

  4. 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

  5. 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

  6. Development of a safety case editor with assessment features

    NARCIS (Netherlands)

    Luo, Y.; Li, Z.; van den Brand, M.G.J.

    2016-01-01

    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 are represented in plain text, but the structure of safety cases might become ambiguous and unclear. To address this, the

  7. Safety climate and self-reported injury: assessing the mediating role of employee safety control.

    Science.gov (United States)

    Huang, Yueng-Hsiang; Ho, Michael; Smith, Gordon S; Chen, Peter Y

    2006-05-01

    To further reduce injuries in the workplace, companies have begun focusing on organizational factors which may contribute to workplace safety. Safety climate is an organizational factor commonly cited as a predictor of injury occurrence. Characterized by the shared perceptions of employees, safety climate can be viewed as a snapshot of the prevailing state of safety in the organization at a discrete point in time. However, few studies have elaborated plausible mechanisms through which safety climate likely influences injury occurrence. A mediating model is proposed to link safety climate (i.e., management commitment to safety, return-to-work policies, post-injury administration, and safety training) with self-reported injury through employees' perceived control on safety. Factorial evidence substantiated that management commitment to safety, return-to-work policies, post-injury administration, and safety training are important dimensions of safety climate. In addition, the data support that safety climate is a critical factor predicting the history of a self-reported occupational injury, and that employee safety control mediates the relationship between safety climate and occupational injury. These findings highlight the importance of incorporating organizational factors and workers' characteristics in efforts to improve organizational safety performance.

  8. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    ... placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire...

  9. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-01-07

    ..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability.... Glucose Monitoring System (TGMS). P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \\TM\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc...

  10. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-03-16

    ...-2011-M-0746 Pluromed, Inc........ LEGOO September 28, 2011. P090024, FDA-2011-M-0737 Siemens Healthcare...). P110022, FDA-2011-M-0786 Roche Diagnostics ELECSYS anti-HBC IGM October 26, 2011. Corp. immunoassay and....... November 14, 2011. H090002, FDA-2011-M-0848 BSD Medical Corp..... BSD-2000 November 18, 2011. hyperthermia...

  11. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-06-14

    ... Paclitaxel- February 22, 2012. Corp. Eluting Coronary Stent System (Monorail and Over- The-Wire Delivery...] February 22, 2012. Corp. Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery.... Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Delivery Systems). P110023, FDA-2012-M...

  12. Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

    Science.gov (United States)

    Serabian, M A; Pilaro, A M

    1999-01-01

    Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity

  13. Application of Safety Maturity Model and 4P-4C Model in Safety Culture Assessment

    International Nuclear Information System (INIS)

    Choi, K. S.; Lee, Y. E.; Ha, J. T.; Chang, H. S.; Kam, S. C.

    2010-01-01

    Korean government and utility have made efforts to enhance the nuclear safety culture and the development of quantitative index of safety culture was promoted for past several years. Quantitative index of safety culture and the past efforts to understand safety culture need insight into the concept of culture. This paper aims to apply new method of measuring nuclear safety culture through the review of approaches of evaluating safety culture in non-nuclear industries. Scoring table has been developed based on new models and example of result of interviews evaluating the nuclear safety culture is also shown

  14. Contributions to safety assessment of the radioactive waste disposal facilities

    International Nuclear Information System (INIS)

    Ilie, Petre; Didita, Liana; Ionescu, Alice; Deaconu, Viorel

    2003-01-01

    The paper presents the progress in the frame of the safety assessments related to the potential near-surface Romanian National Repository, as well as to the geological repository in salt rock for CANDU spent fuel. The safety assessment of the near-surface repository follows the ISAM methodology. The repository design consists of a vault, in which the wastes resulted from the operation and decommissioning of the CANDU reactor from Cernavoda Nuclear Power Plant (CNPP) are disposed off. The repository is located nearby the CNPP. A layered unsaturated zone overlying a variable thickness confined aquifer, which consists of barremian limestones, characterizes the site. The interface with biosphere is considered to be the Danube-Black Sea Channel. The paper summarizes the results of the post-closure safety assessment for the design scenario and the prediction of the radionuclide release in the liquid phase. As to the final disposal of the CANDU spent fuel from the CNPP, we assumed that the repository is built in a salt dome. Romania has important salt formations, some of them being potentially suitable for hosting a repository. Up to now there are no detailed characterization studies of such formations in Romania, from the point of view of the suitability as a repository site. Therefore, generic data for hydrogeological characterization of the site have been used, coming from the Gorleben site in Germany. The spent fuel containers are disposed off in galleries, somewhere 500 m bellow the cap rock of the salt dome. The temporal loading scheme of the repository is based on a sequential filing of the disposal fields, with a delay of 10 years between filling of two neighbouring disposal areas. The disposal fields are accessed via a shaft. After filling of a disposal gallery, the remaining space is backfilled with salt powder and the gallery is sealed with compacted salt bricks. The access galleries are also backfilled and sealed. Only the reference scenario is considered, in

  15. Initial state report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Pers, Karin (ed.) [Kemakta Konsult AB, Stockholm (Sweden)

    2006-10-15

    A comprehensive description of the initial state of the engineered parts of the repository system is one of the main bases for the safety assessment. There is no obvious definition of the time of the initial state. For the engineered part of their repository system, the time of deposition is a natural starting point and the initial state in SR-Can is, therefore, defined as the state at the time of deposition for the engineered barrier system. The initial state of the engineered parts of the repository system is largely obtained from the design specifications of the repository, including allowed tolerances or allowance for deviations. Also the manufacturing, excavation and control methods have to be described in order to adequately discuss and handle hypothetical initial states outside the allowed limits in the design specifications. It should also be noted that many parts of the repository system are as yet not finally designed, there can be many changes in the future. The design and technical solutions presented here are representative of the current stage of development. The repository system is based on the KBS-3 method, in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at 400-700 m depth in saturated granitic rock. The facility design comprises rock caverns, tunnels, deposition positions etc. Deposition tunnels are linked by tunnels for transport and communication and shafts for ventilation. One ramp and five shafts connect the surface facility to the underground repository. The ramp is used for heavy and bulky transports and the shafts are for utility systems and for transport of excavated rock, backfill and staff. For the purposes of the safety assessment, the engineered parts of the repository system have been sub-divided into a number of components or sub-systems. These are: The fuel, (also including cavities in the canister since strong interactions between the two occur if the

  16. Initial state report for the safety assessment SR-Can

    International Nuclear Information System (INIS)

    Pers, Karin

    2006-10-01

    A comprehensive description of the initial state of the engineered parts of the repository system is one of the main bases for the safety assessment. There is no obvious definition of the time of the initial state. For the engineered part of their repository system, the time of deposition is a natural starting point and the initial state in SR-Can is, therefore, defined as the state at the time of deposition for the engineered barrier system. The initial state of the engineered parts of the repository system is largely obtained from the design specifications of the repository, including allowed tolerances or allowance for deviations. Also the manufacturing, excavation and control methods have to be described in order to adequately discuss and handle hypothetical initial states outside the allowed limits in the design specifications. It should also be noted that many parts of the repository system are as yet not finally designed, there can be many changes in the future. The design and technical solutions presented here are representative of the current stage of development. The repository system is based on the KBS-3 method, in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at 400-700 m depth in saturated granitic rock. The facility design comprises rock caverns, tunnels, deposition positions etc. Deposition tunnels are linked by tunnels for transport and communication and shafts for ventilation. One ramp and five shafts connect the surface facility to the underground repository. The ramp is used for heavy and bulky transports and the shafts are for utility systems and for transport of excavated rock, backfill and staff. For the purposes of the safety assessment, the engineered parts of the repository system have been sub-divided into a number of components or sub-systems. These are: The fuel, (also including cavities in the canister since strong interactions between the two occur if the

  17. Health, Safety and Environmental Risk Assessment in Laboratory Sites

    Directory of Open Access Journals (Sweden)

    2012-05-01

    Full Text Available Introduction: ”Exposing to danger” or in other words, “risk” is a process which is led to an uncertain result in every field. Project risks are uncertain contingent events or situations that if they occur will have positive or negative effects on project’s objectives. Todays, research and educational process and more complicated and the professional risk management become much more difficult, as a result. .Material and Method: In this research, the health and safety issues have been studied and analyzed using ISO 14121 and the environmental issues by EMEA to determine the risk level separately for research laboratories and to prioritize corrective measure in each field (school. .Result: The finding in this study showed that from all the main risks within the rage of 38-86 percent have been decreased. Moreover average of the risk level for the health, safety and environment cases showed a significant decrease (Pvalue<0.0001 by implement controlling and protective countermeasures compariy to the priority state without any measures. . Conclusion: The risk assessment with hazards control strategy based on ISO 14121 is a compatible method in laboratory site as universities and other reasearch sites.

  18. Probability safety assessment of LOOP accident to molten salt reactor

    International Nuclear Information System (INIS)

    Mei Mudan; Shao Shiwei; Yu Zhizhen; Chen Kun; Zuo Jiaxu

    2013-01-01

    Background: Loss of offsite power (LOOP) is a possible accident to any type of reactor, and this accident can reflect the main idea of reactor safety design. Therefore, it is very important to conduct a study on probabilistic safety assessment (PSA) of the molten salt reactor that is under LOOP circumstance. Purpose: The aim is to calculate the release frequency of molten salt radioactive material to the core caused by LOOP, and find out the biggest contributor to causing the radioactive release frequency. Methods: We carried out the PSA analysis of the LOOP using the PSA process risk spectrum, and assumed that the primary circuit had no valve and equipment reliability data based on the existing mature power plant equipment reliability data. Results: Through the PSA analysis, we got the accident sequences of the release of radioactive material to the core caused by LOOP and its frequency. The results show that the release frequency of molten salt radioactive material to the core caused by LOOP is about 2×10 -11 /(reactor ·year), which is far below that of the AP1000 LOOP. In addition, through the quantitative analysis, we obtained the point estimation and interval estimation of uncertainty analysis, and found that the biggest contributor to cause the release frequency of radioactive material to the core is the reactor cavity cooling function failure. Conclusion: This study provides effective help for the design and improvement of the following molten salt reactor system. (authors)

  19. Adapting a reactor safety assessment system for specific plants

    International Nuclear Information System (INIS)

    Ballard, T.L.; Cordes, G.A.

    1991-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system being developed by the Idaho National Engineering Laboratory, the University of Maryland (UofM) and US Nuclear Regulatory Commission (NRC) for use in the NRC Operations center. RSAS is designed to help the Reactor Safety Team monitor and project core status during an emergency at a licensed nuclear power plant. Analysis uses a hierarchical plant model based on equipment availability and automatically input parametric plant information. There are 3 families of designs of pressurized water reactors and 75 plants using modified versions of the basic design. In order to make an RSAS model for each power plant, a generic model for a given plant type is used with differences being specified by plant specific files. Graphical displays of this knowledge are flexible enough to handle any plant configuration. A variety of tools have been implemented to make it easy to modify a design to fit a given plant while minimizing chance for error. 3 refs., 4 figs

  20. Qualitative uncertainty analysis in probabilistic safety assessment context

    International Nuclear Information System (INIS)

    Apostol, M.; Constantin, M; Turcu, I.

    2007-01-01

    In Probabilistic Safety Assessment (PSA) context, an uncertainty analysis is performed either to estimate the uncertainty in the final results (the risk to public health and safety) or to estimate the uncertainty in some intermediate quantities (the core damage frequency, the radionuclide release frequency or fatality frequency). The identification and evaluation of uncertainty are important tasks because they afford credit to the results and help in the decision-making process. Uncertainty analysis can be performed qualitatively or quantitatively. This paper performs a preliminary qualitative uncertainty analysis, by identification of major uncertainty in PSA level 1- level 2 interface and in the other two major procedural steps of a level 2 PSA i.e. the analysis of accident progression and of the containment and analysis of source term for severe accidents. One should mention that a level 2 PSA for a Nuclear Power Plant (NPP) involves the evaluation and quantification of the mechanisms, amount and probabilities of subsequent radioactive material releases from the containment. According to NUREG 1150, an important task in source term analysis is fission products transport analysis. The uncertainties related to the isotopes distribution in CANDU NPP primary circuit and isotopes' masses transferred in the containment, using SOPHAEROS module from ASTEC computer code will be also presented. (authors)