Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

Science.gov (United States)

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

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)

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

Development of safety assessment method for human intrusion scenario in Japan. Part 1. Drilling scenario database for safety assessment of geological disposal (Contract research)

International Nuclear Information System (INIS)

Nagasawa, Hirokazu; Takeda, Seiji; Kimura, Hideo; Sasaki, Toshihisa

2010-11-01

In deep geological disposal or intermediate depth disposal, human intrusion, i.e. accidental excavation or drilling into the disposal site, may make a direct or an indirect effect on the disposal system. Safety assessment method for the human intrusion scenario, that is, the evaluation code of radiological effect from the human intrusion and the data to examine the reduction of the probability of the human intrusion occurring, is essential for the future safety regulation. Assuming that drilling action into the disposal site leads to the human proximity to the radioactive waste or the damage to the barrier system (drilling scenario), we have collected both the data on borehole drilling implemented in Japan and information on actual situation of drilling activities. Based on the data and information, we provide concrete exposure scenarios associated with borehole drilling in the vicinity of the repository and model for estimating the frequency on borehole reaching the depth of repository. The frequency is characterized with the relation to objective of excavation, geographical features, and region in Japan etc. We have developed an assembly of the information mentioned above as database, including the model parameters used in the code to assess radiation dose for drilling scenario. (author)

How to evaluate the effectiveness of safety assessment in the area of human factors?

International Nuclear Information System (INIS)

Rolina, G.; Moisdon, J.C.; Jeffroy, F.

2007-01-01

The Three Mile Island nuclear reactor accident in 1979 led to a new approach regarding safety that includes a better consideration of man and his activities. A few years later, with the set up of a group of specialists at Electricite de France and at the Institute for Radiological Protection and Nuclear Safety, a new player appeared at France's nuclear safety organisation: the assessment expert specialising in human factors (HF). The improvement of man-machine interfaces was one of the first projects undertaken by the HF experts, the majority of whom specialise in ergonomics. A review of the literature and analysis of the archives, revealed that the specialists' scope of investigation has since increased; so that organisation is also the subject of HF assessment. However, this area is not one of consensual or established knowledge; neither researchers nor specialists can agree on a model of safe organisation. What then can we say about effectiveness of HF assessment? How can we define the criteria of effectiveness of a safety assessment production system in this area? The question is the subject of original research based on collaboration between the scientific management centre (CGS) of the Ecole des Mines in Paris and the section for the study of human factors (SEFH) at IRSN. To address this question, the CGS team monitors some assessments to which SEFH contributes. In other words, it attends different meetings on framing, technical instruction, reporting, taking notes and collecting related documents (minutes of meetings,...). It carries out additional interviews with different parties involved in assessment in order to ascertain their point of view. A sample of five assessments was defined to cover a varied number of situations encountered by the team of HF experts. The type of facility, the operator and the subject concerned are some of the variables integrated for this choice

Development of a quantitative safety assessment method for nuclear I and C systems including human operators

International Nuclear Information System (INIS)

Kim, Man Cheol

2004-02-01

Conventional PSA (probabilistic safety analysis) is performed in the framework of event tree analysis and fault tree analysis. In conventional PSA, I and C systems and human operators are assumed to be independent for simplicity. But, the dependency of human operators on I and C systems and the dependency of I and C systems on human operators are gradually recognized to be significant. I believe that it is time to consider the interdependency between I and C systems and human operators in the framework of PSA. But, unfortunately it seems that we do not have appropriate methods for incorporating the interdependency between I and C systems and human operators in the framework of Pasa. Conventional human reliability analysis (HRA) methods are not developed to consider the interdependecy, and the modeling of the interdependency using conventional event tree analysis and fault tree analysis seem to be, event though is does not seem to be impossible, quite complex. To incorporate the interdependency between I and C systems and human operators, we need a new method for HRA and a new method for modeling the I and C systems, man-machine interface (MMI), and human operators for quantitative safety assessment. As a new method for modeling the I and C systems, MMI and human operators, I develop a new system reliability analysis method, reliability graph with general gates (RGGG), which can substitute conventional fault tree analysis. RGGG is an intuitive and easy-to-use method for system reliability analysis, while as powerful as conventional fault tree analysis. To demonstrate the usefulness of the RGGG method, it is applied to the reliability analysis of Digital Plant Protection System (DPPS), which is the actual plant protection system of Ulchin 5 and 6 nuclear power plants located in Republic of Korea. The latest version of the fault tree for DPPS, which is developed by the Integrated Safety Assessment team in Korea Atomic Energy Research Institute (KAERI), consists of 64

Elements of a regulatory strategy for the consideration of future human actions in safety assessments

International Nuclear Information System (INIS)

Wilmot, R.D.; Wickham, S.M.; Galson, D.A.

1999-09-01

The objective of this report is to discuss issues that should be considered in the development of a regulatory strategy for assessing future human actions in any forthcoming license application for a deep repository for spent fuel in Sweden and for sites of other repositories. The report comprises an outline of key issues concerning the treatment of future human actions in safety assessment, reviews of regulatory developments, recent safety assessments and supporting studies, and international initiatives on the treatment of future human actions in safety assessment, and the principal elements of a regulatory strategy. Performance assessments (PAs) are generally accepted as providing illustrations of system performance under given sets of assumptions. The results of PAs are clearer and easier to understand if certain large uncertainties are accounted for by determining performance under several different sets of assumptions or scenarios, each of which defines a possible evolution of the disposal system. A number of assumptions can be made that would restrict the scope of an assessment without reducing the credibility of the corresponding safety case. Reducing speculation about technological development, by assuming that the techniques used in future human activities are similar to those currently in use in the region or at similar sites, will simplify the assessment. A distinction is generally made between inadvertent and intentional intrusion, with intentional activities excluded because society cannot protect future populations from their own actions if they understand the potential consequences. A division of human activities into 'recent and ongoing' and 'future' activities considers not only the timing of the activities but also the degree of control or influence that can be imposed on them. Recent and ongoing human activities are those that affect an area beyond the immediate vicinity of the disposal facility and which neither the proponent nor the regulator

A computational method for probabilistic safety assessment of I and C systems and human operators in nuclear power plants

International Nuclear Information System (INIS)

Kim, Man Cheol; Seong, Poong Hyun

2006-01-01

To make probabilistic safety assessment (PSA) more realistic, the improvements of human reliability analysis (HRA) are essential. But, current HRA methods have many limitations including the lack of considerations on the interdependency between instrumentation and control (I and C) systems and human operators, and lack of theoretical basis for situation assessment of human operators. To overcome these limitations, we propose a new method for the quantitative safety assessment of I and C systems and human operators. The proposed method is developed based on the computational models for the knowledge-driven monitoring and the situation assessment of human operators, with the consideration of the interdependency between I and C systems and human operators. The application of the proposed method to an example situation demonstrates that the quantitative description by the proposed method for a probable scenario well matches with the qualitative description of the scenario. It is also demonstrated that the proposed method can probabilistically consider all possible scenarios and the proposed method can be used to quantitatively evaluate the effects of various context factor on the safety of nuclear power plants. In our opinion, the proposed method can be used as the basis for the development of advanced HRA methods

Human reliability analysis for probabilistic safety assessments - review of methods and issues

International Nuclear Information System (INIS)

Srinivas, G.; Guptan, Rajee; Malhotra, P.K.; Ghadge, S.G.; Chandra, Umesh

2011-01-01

It is well known that the two major events in World Nuclear Power Plant Operating history, namely the Three Mile Island and Chernobyl, were Human failure events. Subsequent to these two events, several significant changes have been incorporated in Plant Design, Control Room Design and Operator Training to reduce the possibility of Human errors during plant transients. Still, human error contribution to Risk in Nuclear Power Plant operations has been a topic of continued attention for research, development and analysis. Probabilistic Safety Assessments attempt to capture all potential human errors with a scientifically computed failure probability, through Human Reliability Analysis. Several methods are followed by different countries to quantify the Human error probability. This paper reviews the various popular methods being followed, critically examines them with reference to their criticisms and brings out issues for future research. (author)

Elements of a regulatory strategy for the consideration of future human actions in safety assessments

Energy Technology Data Exchange (ETDEWEB)

Wilmot, R.D.; Wickham, S.M.; Galson, D.A. [Galson Sciences Ltd, Oakham (United Kingdom)

1999-09-01

The objective of this report is to discuss issues that should be considered in the development of a regulatory strategy for assessing future human actions in any forthcoming license application for a deep repository for spent fuel in Sweden and for sites of other repositories. The report comprises an outline of key issues concerning the treatment of future human actions in safety assessment, reviews of regulatory developments, recent safety assessments and supporting studies, and international initiatives on the treatment of future human actions in safety assessment, and the principal elements of a regulatory strategy. Performance assessments (PAs) are generally accepted as providing illustrations of system performance under given sets of assumptions. The results of PAs are clearer and easier tounderstand if certain large uncertainties are accounted for by determining performance under several different sets of assumptions or scenarios, each of which defines a possible evolution of the disposal system. A number of assumptions can be made that would restrict the scope of an assessment without reducing the credibility of the corresponding safety case. Reducing speculation about technological development, by assuming that the techniques used in future human activities are similar to those currently in use in the region or at similar sites, will simplify the assessment. A distinction is generally made between inadvertent and intentional intrusion, with intentional activities excluded because society cannot protect future populations from their own actions if they understand the potential consequences. A division of human activities into 'recent and ongoing' and 'future' activities considers not only the timing of the activities but also the degree of control or influence that can be imposed on them. Recent and ongoing human activities are those that affect an area beyond the immediate vicinity of the disposal facility and which neither the proponent

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.

Human factors in nuclear safety oversight

International Nuclear Information System (INIS)

Taylor, K.

1989-01-01

The mission of the nuclear safety oversight function at the Savannah River Plant is to enhance the process and nuclear safety of site facilities. One of the major goals surrounding this mission is the reduction of human error. It is for this reason that several human factors engineers are assigned to the Operations assessment Group of the Facility Safety Evaluation Section (FSES). The initial task of the human factors contingent was the design and implementation of a site wide root cause analysis program. The intent of this system is to determine the most prevalent sources of human error in facility operations and to assist in determining where the limited human factors resources should be focused. In this paper the strategy used to educate the organization about the field of human factors is described. Creating an awareness of the importance of human factors engineering in all facets of design, operation, and maintenance is considered to be an important step in reducing the rate of human error

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

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

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

International Nuclear Information System (INIS)

Lee, Yong Hee; Lee, Yong Hee

2011-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2011-10-15

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

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

The human factors and the safety of experimentation reactors

International Nuclear Information System (INIS)

Jeffroy, F.; Delaporte-Normier, M.L.

2007-01-01

Inside IRSN (Institute for Radiological protection and Nuclear Safety), the mission of the Human Factors Group is to assess the way operators of nuclear installations take into account the risks related to human activities. In the last few years, IRSN has been involved in the safety analysis of different installations where Cea develops research programs, in particular experimental reactors. The first part of this article presents the methodology used by IRSN to evaluate how operators take into account risks related to human activities. This methodology is made up of 4 steps: 1) the identification of the human activities that convey a risk for the installation nuclear safety (safety-sensitive activities), for instance in the case of the Masurca reactor, it has been shown that errors made during the manufacturing of fuel tubes can lead to a criticality accident; 2) listing all the dispositions or arrangements taken to make human safety-sensitive activities more reliable; 3) checking the efficiency of such dispositions or arrangements; and 4) assessing the ability of the operators to generate the adequate dispositions or arrangements. The second part highlights the necessity to develop inside these research installations an organisation that facilitates cooperation between experimenters and operators

Safety Metrics for Human-Computer Controlled Systems

Science.gov (United States)

Leveson, Nancy G; Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems.This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

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

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

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

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.

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

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)

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

DEFF Research Database (Denmark)

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

2015-01-01

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

A study on the dependency evaluation for multiple human actions in human reliability analysis of probabilistic safety assessment

International Nuclear Information System (INIS)

Kang, D. I.; Yang, J. E.; Jung, W. D.; Sung, T. Y.; Park, J. H.; Lee, Y. H.; Hwang, M. J.; Kim, K. Y.; Jin, Y. H.; Kim, S. C.

1997-02-01

This report describes the study results on the method of the dependency evaluation and the modeling, and the limited value of human error probability (HEP) for multiple human actions in accident sequences of probabilistic safety assessment (PSA). THERP and Parry's method, which have been generally used in dependency evaluation of human reliability analysis (HRA), are introduced and their limitations are discussed. New dependency evaluation method in HRA is established to make up for the weak points of THERP and Parry's methods. The limited value of HEP is also established based on the review of several HRA related documents. This report describes the definition, the type, the evaluation method, and the evaluation example of dependency to help the reader's understanding. It is expected that this study results will give a guidance to HRA analysts in dependency evaluation of multiple human actions and enable PSA analysts to understand HRA in detail. (author). 23 refs., 3 tabs., 2 figs

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...

Contents of a regulatory strategy for assessing future human actions in the safety evaluation of a repository for spent fuels

International Nuclear Information System (INIS)

Wilmot, R.D.; Wickham, S.M.; Galson, D.A.

2001-08-01

The objective of this report is to discuss issues that should be considered in the development of a regulatory strategy for assessing future human actions in any forthcoming license application for a deep repository for spent fuel in Sweden and for sites of other repositories. The report comprises an outline of key issues concerning the treatment of future human actions in safety assessment, reviews of regulatory developments, recent safety assessments and supporting studies, and international initiatives on the treatment of future human actions in safety assessment, and the principal elements of a regulatory strategy. Performance assessments (PAs) are generally accepted as providing illustrations of system performance under given sets of assumptions. The results of PAs are clearer and easier to understand if certain large uncertainties are accounted for by determining performance under several different sets of assumptions or scenarios, each of which defines a possible evolution of the disposal system. A number of assumptions can be made that would restrict the scope of an assessment without reducing the credibility of the corresponding safety case. Reducing speculation about technological development, by assuming that the techniques used in future human activities are similar to those currently in use in the region or at similar sites, will simplify the assessment. A distinction is generally made between inadvertent and intentional intrusion, with intentional activities excluded because society cannot protect future populations from their own actions if they understand the potential consequences. A division of human activities into 'recent and ongoing' and 'future' activities considers not only the timing of the activities but also the degree of control or influence that can be imposed on them. Recent and ongoing human activities are those that affect an area beyond the immediate vicinity of the disposal facility and which neither the proponent nor the regulator

Representation of human behaviour in probabilistic safety analysis

International Nuclear Information System (INIS)

Whittingham, R.B.

1991-01-01

This paper provides an overview of the representation of human behaviour in probabilistic safety assessment. Human performance problems which may result in errors leading to accidents are considered in terms of methods of identification using task analysis, screening analysis of critical errors, representation and quantification of human errors in fault trees and event trees and error reduction measures. (author) figs., tabs., 43 refs

Human reliability assessment and probabilistic risk assessment

International Nuclear Information System (INIS)

Embrey, D.E.; Lucas, D.A.

1989-01-01

Human reliability assessment (HRA) is used within Probabilistic Risk Assessment (PRA) to identify the human errors (both omission and commission) which have a significant effect on the overall safety of the system and to quantify the probability of their occurrence. There exist a variey of HRA techniques and the selection of an appropriate one is often difficult. This paper reviews a number of available HRA techniques and discusses their strengths and weaknesses. The techniques reviewed include: decompositional methods, time-reliability curves and systematic expert judgement techniques. (orig.)

The definition of commonly agreed stylized human intrusion scenarios for use in the long term safety assessments of radioactive waste disposal systems

International Nuclear Information System (INIS)

Carboneras, P.

2002-01-01

Recent international advice on the treatment of human intrusion in relation to the safety of radioactive waste repositories is reviewed. The outstanding issues which need to be resolved in order to establish an agreed international approach to assessing the consequences and judging the impact of human intrusion are summarized. Finally, a way forward towards an internationally agreed assessment approach is proposed. (author)

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)

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.

Development of a procedure for qualitative and quantitative evaluation of human factors as a part of probabilistic safety assessments of nuclear power plants. Part A

International Nuclear Information System (INIS)

Richei, A.

1998-01-01

The objective of this project is the development of a procedure for the qualitative and quantitative evaluation of human factors in the probabilistic safety assessment for nuclear power plants. The Human Error Rate Assessment and Optimizing System (HEROS) is introduced. The evaluation of a task with HEROS is realized in the three evaluation levels, i.e. 'Management Structure', 'Working Environment' and 'Man-Machine-Interface'. The developed expert system uses the fuzzy set theory for an assessment. For the evaluation of cognitive tasks evaluation criteria are derived also. The validation of the procedure is based on three examples, reflecting the common practice of probabilistic safety assessments and including problems, which cannot, respectively - only insufficiently - be evaluated with the established human risk analysis procedures. HERO applications give plausible and comprehensible results. (orig.) [de

Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union

Directory of Open Access Journals (Sweden)

Theodor Brodmann

2017-09-01

Full Text Available Novel microbes are either newly isolated genera and species from natural sources or bacterial strains derived from existing bacteria. Novel microbes are gaining increasing attention for the general aims to preserve and modify foods and to modulate gut microbiota. The use of novel microbes to improve health outcomes is of particular interest because growing evidence points to the importance of gut microbiota in human health. As well, some recently isolated microorganisms have promise for use as probiotics, although in-depth assessment of their safety is necessary. Recent examples of microorganisms calling for more detailed evaluation include Bacteroides xylanisolvens, Akkermansia muciniphila, fructophilic lactic acid bacteria (FLAB, and Faecalibacterium prausnitzii. This paper discusses each candidate's safety evaluation for novel food or novel food ingredient approval according to European Union (EU regulations. The factors evaluated include their beneficial properties, antibiotic resistance profiling, history of safe use (if available, publication of the genomic sequence, toxicological studies in agreement with novel food regulations, and the qualified presumptions of safety. Sufficient evidences have made possible to support and authorize the use of heat-inactivated B. xylanisolvens in the European Union. In the case of A. muciniphila, the discussion focuses on earlier safety studies and the strain's suitability. FLAB are also subjected to standard safety assessments, which, along with their proximity to lactic acid bacteria generally considered to be safe, may lead to novel food authorization in the future. Further research with F. prausnitzii will increase knowledge about its safety and probiotic properties and may lead to its future use as novel food. Upcoming changes in EUU Regulation 2015/2283 on novel food will facilitate the authorization of future novel products and might increase the presence of novel microbes in the food market.

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.

Guidance on the safety assessment methodology for storage of radioactive waste

International Nuclear Information System (INIS)

Kinyanjui, M.N.

2014-04-01

This project on safety assessment on storage was carried out with the main objective of ensuring safety of human life and our environment. This is the fundamental principle of radiation protection. Safety assessment has been evaluated as a tool in the safety case in the pre-construction, operational and the post closure phase of storage. In particular the iterative process of evaluating and predicting safety scenarios at each stage of the process has proved to be prudent. It is important that this concept be adopted for this type of facility to ensure safety of mankind and the environment now and in the future.

Safety assessment of menaquinone-7 for use in human nutrition

Directory of Open Access Journals (Sweden)

Basavaias Ravishankar

2015-03-01

Full Text Available Vitamin K occurs widely in foods and has been shown to have a beneficial effect on the cardiovascular system, as well as anticancer, anti-inflammatory, and antiosteoporosis properties. A previous study indicates that long-chain menaquinone-7 may be more bioavailable than vitamin K and short-chain menaquinones. In the present study, acute, subacute toxicity and genotoxicity assays were carried out to evaluate the safety of oral menaquinone-7 in albino Wistar rats. Oral administration of menaquinone-7, at a concentration of 2000 mg/kg, did not cause toxic symptoms in either male or female rats. A subacute toxicity study also proved the safety and tolerance of prolonged treatment (for 90 days with menaquinone-7 in rats, as evidenced by biochemical, hematological, and urine parameters as well as by histopathological analysis. Genotoxicity and mutagenicity studies were performed by comet, micronucleus, and Ames tests on Salmonella typhimurium strains, which showed cellular safety and nonmutagenicity of menaquinone-7. The results indicate the safety of menaquinone-7 for human consumption.

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

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

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

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

Human Factors and Safety Culture in Maritime Safety (revised

Directory of Open Access Journals (Sweden)

Heinz Peter Berg

2013-09-01

Full Text Available As in every industry at risk, the human and organizational factors constitute the main stakes for maritime safety. Furthermore, several events at sea have been used to develop appropriate risk models. The investigation on maritime accidents is, nowadays, a very important tool to identify the problems related to human factor and can support accident prevention and the improvement of maritime safety. Part of this investigation should in future also be near misses. Operation of ships is full of regulations, instructions and guidelines also addressing human factors and safety culture to enhance safety. However, even though the roots of a safety culture have been established, there are still serious barriers to the breakthrough of the safety management. One of the most common deficiencies in the case of maritime transport is the respective monitoring and documentation usually lacking of adequacy and excellence. Nonetheless, the maritime area can be exemplified from other industries where activities are ongoing to foster and enhance safety culture.

Human and organization factors: engineering operating safety into offshore structures

International Nuclear Information System (INIS)

Bea, Robert G.

1998-01-01

History indicates clearly that the safety of offshore structures is determined primarily by the humans and organizations responsible for these structures during their design, construction, operation, maintenance, and decommissioning. If the safety of offshore structures is to be preserved and improved, then attention of engineers should focus on to how to improve the reliability of the offshore structure 'system,' including the people that come into contact with the structure during its life-cycle. This article reviews and discusss concepts and engineering approaches that can be used in such efforts. Two specific human factor issues are addressed: (1) real-time management of safety during operations, and (2) development of a Safety Management Assessment System to help improve the safety of offshore structures

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

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)

Human Resources Readiness as TSO for Deterministic Safety Analysis on the First NPP in Indonesia

International Nuclear Information System (INIS)

Sony Tjahyani, D. T.

2010-01-01

In government regulation no. 43 year 2006 it is mentioned that preliminary safety analysis report and final safety analysis report are one of requirements which should be applied in construction and operation licensing for commercial power reactor (NPPs). The purpose of safety analysis report is to confirm the adequacy and efficiency of provisions within the defence in depth of nuclear reactor. Deterministic analysis is used on the safety analysis report. One of the TSO task is to evaluate this report based on request of operator or regulatory body. This paper discusses about human resources readiness as TSO for deterministic safety analysis on the first NPP in Indonesia. The assessment is done by comparing the analysis step on SS-23 and SS-30 with human resources status of BATAN currently. The assessment results showed that human resources for deterministic safety analysis are ready as TSO especially to review preliminary safety analysis report and to revise final safety analysis report in licensing on the first NPP in Indonesia. Otherwise, to prepare the safety analysis report is still needed many competency human resources. (author)

Assessing the effects of human action on the safety of geologic disposal: the U.S. regulatory experience

International Nuclear Information System (INIS)

Schultheisz, D.

2010-01-01

There is general agreement that geologic disposal of long-lived radioactive waste provides the greatest degree of isolation from the biosphere, and hence the greatest protection for humans, over the extended time frames during which the waste presents a hazard. Geologic disposal has an additional advantage in that it does not rely on active institutional controls to maintain and protect the facility, but is instead intended to operate passively even if all knowledge of the facility is lost. Thus, geologic disposal does not rely on the questionable assumption that governmental or other responsible institutions can be maintained in perpetuity; this, however, also raises the possibility that some future human action could be taken that disrupts the repository and compromises its ability to isolate the radioactive material. It is clear, therefore, that some evaluation of this possibility must be included in the overall safety case for the facility. The nature and extent of the analysis, as well as the relative importance it is assigned within the safety case, is less clear. The U.S. Environmental Protection Agency (EPA) has applied two very different approaches to the analysis of human intrusion scenarios at geologic disposal facilities. For the Waste Isolation Pilot Plant (WIPP) in New Mexico, which accepts transuranic radioactive waste from government defence activities, realistic drilling and mining scenarios are analyzed as part of the safety assessment addressing the natural (undisturbed) evolution of the repository. (40 CFR 194.32 and 194.33) For the proposed repository for spent nuclear fuel and high-level radioactive waste at Yucca Mountain, Nevada, however, a specified stylised drilling scenario is analyzed separately from the safety assessment for the undisturbed evolution of the disposal system. (40 CFR 197.25 ) What is the basis for these different approaches? How can they both be 'right'? The answer lies in the details of the two facilities, specifically

Human factors in safety and business management.

Science.gov (United States)

Vogt, Joachim; Leonhardt, Jorg; Koper, Birgit; Pennig, Stefan

2010-02-01

Human factors in safety is concerned with all those factors that influence people and their behaviour in safety-critical situations. In aviation these are, for example, environmental factors in the cockpit, organisational factors such as shift work, human characteristics such as ability and motivation of staff. Careful consideration of human factors is necessary to improve health and safety at work by optimising the interaction of humans with their technical and social (team, supervisor) work environment. This provides considerable benefits for business by increasing efficiency and by preventing incidents/accidents. The aim of this paper is to suggest management tools for this purpose. Management tools such as balanced scorecards (BSC) are widespread instruments and also well known in aviation organisations. Only a few aviation organisations utilise management tools for human factors although they are the most important conditions in the safety management systems of aviation organisations. One reason for this is that human factors are difficult to measure and therefore also difficult to manage. Studies in other domains, such as workplace health promotion, indicate that BSC-based tools are useful for human factor management. Their mission is to develop a set of indicators that are sensitive to organisational performance and help identify driving forces as well as bottlenecks. Another tool presented in this paper is the Human Resources Performance Model (HPM). HPM facilitates the integrative assessment of human factors programmes on the basis of a systematic performance analysis of the whole system. Cause-effect relationships between system elements are defined in process models in a first step and validated empirically in a second step. Thus, a specific representation of the performance processes is developed, which ranges from individual behaviour to system performance. HPM is more analytic than BSC-based tools because HPM also asks why a certain factor is

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.)

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)

合成洗涤剂的人体安全性风险评估和控制%Human safety risk assessment and management of synthetic detergent

Institute of Scientific and Technical Information of China (English)

杨利川; 郑翔龙

2011-01-01

合成洗涤剂对人体的安全性一直是消费者关注的问题。结合欧洲家用清洁产品HERA（Human＆Environmental Risk Assessment）安全性评估报告的内容,从合成洗涤剂产品组分的安全性角度,对洗涤产品组份安全性评估的主要内容和使用安全性风险评估的方法进行了详细论述,说明洗涤剂的人体安全性风险是可以被控制的。%The human safety of synthetic detergent are always much concerned by consumer.Based on the content of Human Environmental Risk Assessment on ingredients of European household cleaning products,this paper from the components of synthetic detergent safety point of view,discussed the content of the safety assessment and the methods of risk assessment about the components of synthetic detergent in detail.The results showed that the human safety risks of synthetic detergents can be controlled.

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

A quantitative assessment of organizational factors affecting safety using a system dynamics model

International Nuclear Information System (INIS)

Yoo, J. K.; Yoon, T. S.

2003-01-01

The purpose of this study is to develop a system dynamics model for the assessment of organizational and human factors in the nuclear power plant safety. Previous studies are classified into two major approaches. One is the engineering approach such as ergonomics and Probabilistic Safety Assessment (PSA). The other is socio-psychology one. Both have contributed to find organizational and human factors and increased nuclear safety However, since these approaches assume that the relationship among factors is independent they do not explain the interactions between factors or variables in NPP's. To overcome these restrictions, a system dynamics model, which can show causal relations between factors and quantify organizational and human factors, has been developed. Operating variables such as degree of leadership, adjustment of number of employee, and workload in each department, users can simulate various situations in nuclear power plants in the organization side. Through simulation, user can get an insight to improve safety in plants and to find managerial tools in the organization and human side

Operational human performance reliability assessment (OHPRA)

International Nuclear Information System (INIS)

Haas, P.M.; Swanson, P.J.; Connelly, E.M.

1993-01-01

Operational Human Performance Reliability Assessment (OHPRA) is an approach for assessing human performance that is being developed in response to demands from modern process industries for practical and effective tools to assess and improve human performance, and therefore overall system performance and safety. The single most distinguishing feature of the approach is that is defines human performance in open-quotes operationalclose quotes terms. OHPRA is focused not on generation of human error probabilities, but on practical analysis of human performance to aid management in (1) identifying open-quotes fixableclose quotes problems and (2) providing input on the importance and nature of potential improvements. Development of the model in progress uses a unique approach for eliciting expert strategies for assessing performance. A PC-based model incorporating this expertise is planned. A preliminary version of the approach has already been used successfully to identify practical human performance problems in reactor and chemical process plant operations

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

National plan to enhance aviation safety through human factors improvements

Science.gov (United States)

Foushee, Clay

1990-01-01

The purpose of this section of the plan is to establish a development and implementation strategy plan for improving safety and efficiency in the Air Traffic Control (ATC) system. These improvements will be achieved through the proper applications of human factors considerations to the present and future systems. The program will have four basic goals: (1) prepare for the future system through proper hiring and training; (2) develop a controller work station team concept (managing human errors); (3) understand and address the human factors implications of negative system results; and (4) define the proper division of responsibilities and interactions between the human and the machine in ATC systems. This plan addresses six program elements which together address the overall purpose. The six program elements are: (1) determine principles of human-centered automation that will enhance aviation safety and the efficiency of the air traffic controller; (2) provide new and/or enhanced methods and techniques to measure, assess, and improve human performance in the ATC environment; (3) determine system needs and methods for information transfer between and within controller teams and between controller teams and the cockpit; (4) determine how new controller work station technology can optimally be applied and integrated to enhance safety and efficiency; (5) assess training needs and develop improved techniques and strategies for selection, training, and evaluation of controllers; and (6) develop standards, methods, and procedures for the certification and validation of human engineering in the design, testing, and implementation of any hardware or software system element which affects information flow to or from the human.

Human factor in the problem of Russian nuclear industry safety

International Nuclear Information System (INIS)

Abramova, V.

2002-01-01

The approach to human factor definition, considered in the paper, consists of recognition of as many as possible factors for developing a complete list of factors, which have influence on mistakes or successful work of NPP personnel. Safety culture is considered as the main factor. The enhancement in nuclear power industry includes an optimization of organizational structures and development of personnel safety attitudes. The organizational factors, as possible root causes for human errors, need to be identified, assessed and improved. The organizational activities taken in Russia are presented

Assessment of the long-term safety of repositories. Scientific basis

International Nuclear Information System (INIS)

Noseck, Ulrich; Becker, Dirk; Fahrenholz, Christine

2008-12-01

The project contributed to increase the scientific knowledge on the long-term safety assessment and the safety cases of a radioactive waste repository. International guidelines and more recent safety cases from other countries were evaluated. The feasibility study of the three safety indicators ''individual dose rate'', ''radiotoxicity concentration in the biosphere water'' and ''radiotoxicity flux from the geosphere'' showed that due to the independently derived corresponding reference values these indicators describe three different safety statements. The combination of the three values can give a stronger argument for the safety of the repository system. Another important methodological aspect of the safety cases is the definition and selection of scenarios, one of these the human intrusion scenario. Various human intrusion scenarios are considered in the different nations, which differ significantly with respect to type and time scale, the exposition type and exposition pathway. Further progress has been achieved in how to treat human intrusion scenarios in a German post-closure safety case. Another port of the project dealt with the impact of specific geochemical processes on the long-term safety of the repository. The impact of climate changes on the long-term safety of a radioactive waste repository in rock salt was investigated with respect to processes in the overburden and the biosphere where highest impact is expected. Sofa simplified models and only discrete climate estates have been considered

Fall Protection Characteristics of Safety Belts and Human Impact Tolerance.

Science.gov (United States)

Hino, Yasumichi; Ohdo, Katsutoshi; Takahashi, Hiroki

2014-08-23

Many fatal accidents due to falls from heights have occurred at construction sites not only in Japan but also in other countries. This study aims to determine the fall prevention performance of two types of safety belts: a body belt 1) , which has been used for more than 40 yr in the Japanese construction industry as a general type of safety equipment for fall accident prevention, and a full harness 2, 3) , which has been used in many other countries. To determine human tolerance for impact trauma, this study discusses features of safety belts with reference 4-9) to relevant studies in the medical science, automobile crash safety, and aircrew safety. For this purpose, simple drop tests were carried out in a virtual workplace to measure impact load, head acceleration, and posture in the experiments, the Hybrid-III pedestrian model 10) was used as a human dummy. Hybrid-III is typically employed in official automobile crash tests (New Car Assessment Program: NCAP) and is currently recognized as a model that faithfully reproduces dynamic responses. Experimental results shows that safety performance strongly depends on both the variety of safety belts used and the shock absorbers attached onto lanyards. These findings indicate that fall prevention equipment, such as safety belts, lanyards, and shock absorbers, must be improved to reduce impact injuries to the human head and body during falls.

The balance between safety and productivity and its relationship with human factors and safety awareness and communication in aircraft manufacturing

NARCIS (Netherlands)

Karanikas, N.; Melis, Damien Jose; Kourousis, Kyriakos

2017-01-01

Background: This paper presents the findings of a pilot research survey which assessed the degree of balance between safety and productivity, and its relationship with awareness and communication of human factors and safety rules in the aircraft manufacturing environment. Methods: The study was

A quantitative assessment of organizational factors affecting safety using a system dynamics model

Energy Technology Data Exchange (ETDEWEB)

Yoo, J. K. [Systemix Company, Seoul (Korea, Republic of); Yoon, T. S. [Korea Electric Power Research Institute (Korea, Republic of)

2003-07-01

The purpose of this study is to develop a system dynamics model for the assessment of organizational and human factors in the nuclear power plant safety. Previous studies are classified into two major approaches. One is the engineering approach such as ergonomics and Probabilistic Safety Assessment (PSA). The other is socio-psychology one. Both have contributed to find organizational and human factors and increased nuclear safety However, since these approaches assume that the relationship among factors is independent they do not explain the interactions between factors or variables in NPP's. To overcome these restrictions, a system dynamics model, which can show causal relations between factors and quantify organizational and human factors, has been developed. Operating variables such as degree of leadership, adjustment of number of employee, and workload in each department, users can simulate various situations in nuclear power plants in the organization side. Through simulation, user can get an insight to improve safety in plants and to find managerial tools in the organization and human side.

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

Improving Safety through Human Factors Engineering.

Science.gov (United States)

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

Human actions in the pre-operational probabilistic safety analysis of Juragua Nuclear Power Plant

International Nuclear Information System (INIS)

Ferro, R.

1995-01-01

Human error is one of the main contributors to the biggest industrial disasters that the world has suffered in the last years. Safety probabilistic analysis techniques allow to consider, in the some study, the contribution of a facility's mechanical and human components safety, this guaranteeing a move integral assessment of these two factors although the PSA study of Juragua Nuclear Power Plant is carried out at a preoperational stage which causes important information limitations fos assessment of human reliability some considerations and suppositions in order to conduct treatment of human actions this stage were adopted. The present work describes the projected targets, approach applied and results obtained from the lakes of human reliability of this study

Basic Safety Considerations for Nuclear Power Plant Dealing with External Human Induced Events

Energy Technology Data Exchange (ETDEWEB)

Salem, W., E-mail: wafaasalem21@yahoo.com [Nuclear and Radiological Regulatory Authority (Egypt)

2014-10-15

Facilities and human activities in the region in which a nuclear power plant is located may under some conditions affect its safety. The potential sources of human induced events external to the plant should be identified and the severity of the possible resulting hazard phenomena should be evaluated to derive the appropriate design bases for the plant. They should also be monitored and periodically assessed over the lifetime of the plant to ensure that consistency with the design assumptions is maintained. External human induced events that could affect safety should be investigated in the site evaluation stage for every nuclear power plant site. The region is required to be examined for facilities and human activities that have the potential, under certain conditions, to endanger the nuclear power plant over its entire lifetime. Each relevant potential source is required to be identified and assessed to determine the potential interactions with personnel and plant items important to safety. (author)

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

Extended biosphere dataset for safety assessment of radioactive waste geological disposal

International Nuclear Information System (INIS)

Kato, Tomoko; Suzuki, Yuji

2007-01-01

JAEA has an on-going programme of research and development relating to the safety assessment of the deep geological disposal systems of high-level radioactive waste (HLW) and transuranic waste (TRU). In the safety assessment of HLW and TRU disposal systems, biosphere assessment is necessary to estimate future radiological impacts on human beings (e.g. radiation dose). In order to estimate radiation dose, consideration needs to be given to the biosphere into which future releases of radionuclides might occur and to the associated future human behaviour. The data of some biosphere parameters needed to be updated by appropriate data sources for generic and site-specific biosphere assessment to improve reliability for the biosphere assessment, because some data published in the 1980's or the early 90's were found to be inappropriate for the recent biosphere assessment. Therefore, data of the significant parameters (especially for element-dependent) were set up on the basis of recent information, to update the generic biosphere dataset. (author)

The Fukushima Daiichi Accident. Technical Volume 2/5. Safety Assessment

International Nuclear Information System (INIS)

2015-08-01

Technical Volume 1 of this report has described what happened during the accident at the Fukushima Daiichi nuclear power plant (NPP). This volume begins (Section 2.1) with a review of how the design basis of the site for external events was assessed initially and then reassessed over the life of the NPP. The section also describes the physical changes that were made to the units as a result. The remainder of the volume describes the treatment of beyond design basis events in the safety assessment of the site, the accident management provisions, the effectiveness of regulatory programmes, human and organizational factors and the safety culture, and the role of operating experience. Further background information is contained in three annexes included on the CD-ROM of this Technical Volume which describe analytical investigations of the accident along with information on topics such as system performance, defence in depth and severe accident phenomena. Section 2.2 provides an assessment of the systems that failed, resulting in a failure to maintain the fundamental safety functions in Units 1–3, which were in operation at the time of the tsunami and in which the reactor pressure vessels (RPV) and containment vessels failed. The section also describes Units 4-6, which were shut down at the time of the tsunami, and the site’s central spent fuel storage facility. Section 2.3 discusses the probabilistic and deterministic safety assessments of beyond design basis accidents (BDBAs) that had been performed for the plant and the insights from these assessments that had led to changes in the plant’s design. The section pays particular attention to the assessment of extreme natural hazards, such as the one which led to the total loss of AC power supply on the site. The additional loss of DC power supply in Units 1 and 2 played a key role in the progression of the accident because it impeded the diagnosis of plant conditions and made the operators unaware of the status of

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

Safety assessment of personal care products/cosmetics and their ingredients

International Nuclear Information System (INIS)

Nohynek, Gerhard J.; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-01-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO 2 and ZnO in sunscreens. However

Safety assessment of personal care products/cosmetics and their ingredients.

Science.gov (United States)

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

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

International Nuclear Information System (INIS)

Mateeva, M.

2003-01-01

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

Development of β-lactoglobulin-specific chimeric human IgEκ monoclonal antibodies for in vitro safety assessment of whey hydrolysates.

Science.gov (United States)

Knipping, Karen; Simons, Peter J; Buelens-Sleumer, Laura S; Cox, Linda; den Hartog, Marcel; de Jong, Niels; Teshima, Reiko; Garssen, Johan; Boon, Louis; Knippels, Léon M J

2014-01-01

Cow's milk-derived whey hydrolysates are nutritional substitutes for allergic infants. Safety or residual allergenicity assessment of these whey hydrolysates is crucial. Currently, rat basophilic leukemia RBL-2H3 cells expressing the human IgE receptor α-chain (huFcεRIα-RBL-2H3), sensitized with serum IgE from cow's milk allergic children, are being employed to assess in vitro residual allergenicity of these whey hydrolysates. However, limited availability and inter-lot variation of these allergic sera impede standardization of whey hydrolysate safety testing in degranulation assays. An oligoclonal pool of chimeric human (chu)IgE antibodies against bovine β-lactoglobulin (a major allergen in whey) was generated to increase sensitivity, specificity, and reproducibility of existing degranulation assays. Mice were immunized with bovine β-lactoglobulin, and subsequently the variable domains of dissimilar anti-β-lactoglobulin mouse IgG antibodies were cloned and sequenced. Six chimeric antibodies were generated comprising mouse variable domains and human constant IgE/κ domains. After sensitization with this pool of anti-β-lactoglobulin chuIgEs, huFcεRIα-expressing RBL-2H3 cells demonstrated degranulation upon cross-linking with whey, native 18 kDa β-lactoglobulin, and 5-10 kDa whey hydrolysates, whereas a 3 kDa whey hydrolysate and cow's milk powder (mainly casein) showed no degranulation. In parallel, allergic serum IgEs were less sensitive. In addition, our pool anti-β-lactoglobulin chuIgEs recognized multiple allergenic immunodominant regions on β-lactoglobulin, which were also recognized by serum IgEs from cow's milk allergic children. Usage of our 'unlimited' source and well-defined pool of β-lactoglobulin-specific recombinant chuIgEs to sensitize huFcεRIα on RBL-2H3 cells showed to be a relevant and sensitive alternative for serum IgEs from cow's milk allergic patients to assess safety of whey-based non-allergic hydrolyzed formula.

The role of engineering judgement, safety culture, and organizational factors in risk assessment

International Nuclear Information System (INIS)

Muzumdar, Ajit; Professor, Visiting

1996-01-01

This paper reviews the role of engineering judgement, safety culture, and organizational factors in risk assessment by examining the reasons for human-based error. The need for more emphasis on producing engineers with good engineering judgement is described. The progress in quantifying the role of safety culture and organizational factors in risk assessment studies is summarized

A quantitative assessment of organizational factors affecting safety using system dynamics model

Energy Technology Data Exchange (ETDEWEB)

Yu, Jae Kook; Ahn, Nam Sung [Korea Electric Power Research Institute, Taejon (Korea, Republic of); Jae, Moo Sung [Hanyang Univ., Seoul (Korea, Republic of)

2004-02-01

The purpose of this study is to develop a system dynamics model for the assessment of the organizational and human factors in a nuclear power plant which contribute to nuclear safety. Previous studies can be classified into two major approaches. One is the engineering approach using tools such as ergonomics and Probability Safety Assessment (PSA). The other is the socio-psychology approach. Both have contributed to find organizational and human factors and to present guidelines to lessen human error in plants. However, since these approaches assume that the relationship among factors is independent they do not explain the interactions among the factors or variables in nuclear power plants. To overcome these restrictions, a system dynamics model, which can show cause and effect relationships among factors and quantify the organizational and human factors, has been developed. Handling variables such as the degree of leadership, the number of employees, and workload in each department, users can simulate various situations in nuclear power plant organization. Through simulation, users can get insights to improve safety in plants and to find managerial tools in both organizational and human factors.

A quantitative assessment of organizational factors affecting safety using system dynamics model

International Nuclear Information System (INIS)

Yu, Jae Kook; Ahn, Nam Sung; Jae, Moo Sung

2004-01-01

The purpose of this study is to develop a system dynamics model for the assessment of the organizational and human factors in a nuclear power plant which contribute to nuclear safety. Previous studies can be classified into two major approaches. One is the engineering approach using tools such as ergonomics and Probability Safety Assessment (PSA). The other is the socio-psychology approach. Both have contributed to find organizational and human factors and to present guidelines to lessen human error in plants. However, since these approaches assume that the relationship among factors is independent they do not explain the interactions among the factors or variables in nuclear power plants. To overcome these restrictions, a system dynamics model, which can show cause and effect relationships among factors and quantify the organizational and human factors, has been developed. Handling variables such as the degree of leadership, the number of employees, and workload in each department, users can simulate various situations in nuclear power plant organization. Through simulation, users can get insights to improve safety in plants and to find managerial tools in both organizational and human factors

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

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)

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

Innovative Modelling Approach of Safety Culture Assessment in Nuclear Power Plant

International Nuclear Information System (INIS)

Ahn, N.

2016-01-01

A culture is commonly defined as the shared set of norms and values that govern appropriate individual behavior. Safety culture is the subset of organizational culture that reflects the general attitude and approaches to safety and risk management. While safety is sometimes narrowly defined in terms of human death and injury, we use a more inclusive definition that also considers mission loss as a safety problem and is thus applicable to nuclear power plants and missions. The recent accident reports and investigations of the nuclear power plant mission failures (i.e., TMI, Chernobyl, and Fukushima) point to safety cultural problems in nuclear power plants. Many assessment approaches have been developed by organizations such as IAEA and INPO based on the assessment of parameters at separate levels — individuals, groups, and organizations.

Human factors evaluation of man-machine interface for periodic safety review of nuclear power plants

International Nuclear Information System (INIS)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang; Hwang, In Koo; Lee, Hyun Cheol; Jang, Tong Il; Ku, Jin Young; Kim, Soo Jin

2004-12-01

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Nuclear Power Plants(NPPs). As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area

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

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)

Nanotechnology and health safety--toxicity and risk assessments of nanostructured materials on human health.

Science.gov (United States)

Singh, Surya; Nalwa, Hari Singh

2007-09-01

The field of nanotechnology has recently emerged as the most commercially viable technology of this century because of its wide-ranging applications in our daily lives. Man-made nanostructured materials such as fullerenes, nanoparticles, nanopowders, nanotubes, nanowires, nanorods, nanofibers, quantum dots, dendrimers, nanoclusters, nanocrystals, and nanocomposites are globally produced in large quantities due to their wide potential applications, e.g., in skincare and consumer products, healthcare, electronics, photonics, biotechnology, engineering products, pharmaceuticals, drug delivery, and agriculture. Human exposure to these nanostructured materials is inevitable, as they can enter the body through the lungs or other organs via food, drink, and medicine and affect different organs and tissues such as the brain, liver, kidney, heart, colon, spleen, bone, blood, etc., and may cause cytotoxic effects, e.g., deformation and inhibition of cell growth leading to various diseases in humans and animals. Since a very wide variety of nanostructured materials exits, their interactions with biological systems and toxicity largely depend upon their properties, such as size, concentration, solubility, chemical and biological properties, and stability. The toxicity of nanostructured materials could be reduced by chemical approaches such by surface treatment, functionalization, and composite formation. This review summarizes the sources of various nanostructured materials and their human exposure, biocompatibility in relation to potential toxicological effects, risk assessment, and safety evaluation on human and animal health as well as on the environment.

Safety assessment of starch-based personal care products: Nanocapsules and pickering emulsions.

Science.gov (United States)

Marto, J; Pinto, P; Fitas, M; Gonçalves, L M; Almeida, A J; Ribeiro, H M

2018-03-01

The safety profile of the ingredients used in topical dosage forms and its evaluation is an issue of utmost importance. A suitable equilibrium between safety and efficacy is crucial before promoting a dermatological product. The aim of this work was to assess the safety and biological effects of starch-based vehicles (St-BV) used in such products. The hazard, exposure and dose-response assessment were used to characterize the risk of each ingredient. The EpiSkin™ assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the St-BV was studied using biophysical measurements in human volunteers during 28 days, showing that all ingredients and their combinations were safe for the consumer. Tissue viability determined using the EpiSkin™ testing reached values between 84.0 ± 5.0% and 98.0 ± 8.6% after application of St-BV, which were considered as non-irritant to the skin. These observations were confirmed by the in vivo studies where the St-BV did not induce any sensitization on the volunteers, being safe for human use. Moreover, St-BV increased skin hydration and microcirculation, emerging as an attractive alternative to chemical raw materials. Copyright © 2018 Elsevier Inc. All rights reserved.

A methodology for a quantitative assessment of safety culture in NPPs based on Bayesian networks

International Nuclear Information System (INIS)

Kim, Young Gab; Lee, Seung Min; Seong, Poong Hyun

2017-01-01

Highlights: • A safety culture framework and a quantitative methodology to assess safety culture were proposed. • The relation among Norm system, Safety Management System and worker's awareness was established. • Safety culture probability at NPPs was updated by collecting actual organizational data. • Vulnerable areas and the relationship between safety culture and human error were confirmed. - Abstract: For a long time, safety has been recognized as a top priority in high-reliability industries such as aviation and nuclear power plants (NPPs). Establishing a safety culture requires a number of actions to enhance safety, one of which is changing the safety culture awareness of workers. The concept of safety culture in the nuclear power domain was established in the International Atomic Energy Agency (IAEA) safety series, wherein the importance of employee attitudes for maintaining organizational safety was emphasized. Safety culture assessment is a critical step in the process of enhancing safety culture. In this respect, assessment is focused on measuring the level of safety culture in an organization, and improving any weakness in the organization. However, many continue to think that the concept of safety culture is abstract and unclear. In addition, the results of safety culture assessments are mostly subjective and qualitative. Given the current situation, this paper suggests a quantitative methodology for safety culture assessments based on a Bayesian network. A proposed safety culture framework for NPPs would include the following: (1) a norm system, (2) a safety management system, (3) safety culture awareness of worker, and (4) Worker behavior. The level of safety culture awareness of workers at NPPs was reasoned through the proposed methodology. Then, areas of the organization that were vulnerable in terms of safety culture were derived by analyzing observational evidence. We also confirmed that the frequency of events involving human error

Standardization of domestic human reliability analysis and experience of human reliability analysis in probabilistic safety assessment for NPPs under design

International Nuclear Information System (INIS)

Kang, D. I.; Jung, W. D.

2002-01-01

This paper introduces the background and development activities of domestic standardization of procedure and method for Human Reliability Analysis (HRA) to avoid the intervention of subjectivity by HRA analyst in Probabilistic Safety Assessment (PSA) as possible, and the review of the HRA results for domestic nuclear power plants under design studied by Korea Atomic Energy Research Institute. We identify the HRA methods used for PSA for domestic NPPs and discuss the subjectivity of HRA analyst shown in performing a HRA. Also, we introduce the PSA guidelines published in USA and review the HRA results based on them. We propose the system of a standard procedure and method for HRA to be developed

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.

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

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.

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.

Self assessment of safety culture in HANARO using the code of conduct on the safety of research reactor by IAEA

International Nuclear Information System (INIS)

Lim, I.C.; Hwang, S.Y.; Woo, J.S.; Lee, M.; Jun, B.J.

2003-01-01

Full text: The safety culture in HANARO was self-assessed in accordance with the Code of Conduct on the Safety of Research Reactor drafted by IAEA. From 2002, IAEA has worked on the development of the Code of Conduct to achieve and maintain high level of nuclear safety in research reactors worldwide through the enhancement of national measures and international co-operation including, where appropriate, safety related technical cooperation. It defines the role of the state, the role of the regulatory body, the role of the operating organization and the role of the IAEA. As for the role of operating organization, the code specifies general requirements in assessment and verification of safety, financial and human resources, quality assurance, human factors, radiation protection and emergency preparedness. It also defines the role of operating organization for safety of research reactor in siting, design, operation, maintenance, modification and utilization as well. All of these items are the subjects for safety culture implementation, which means the Code could be a guideline for an operating organization to assess its safety culture. The self-assessment of safety culture in HANARO was made by using the sections of the Code describing the role of the operating organization for safety of research reactor. The major assessment items and the practices in HANARO for each items are as follow: The SAR of HANARO was reviewed by the regulatory body before the construction and the fuel loading of HANARO. Major design modifications and new installation of utilization facility needs the approval from regulatory body and safety assessment is a requirement for the approval. The Tech. Spec. for HANARO Operation specifies the analysis, surveillance, testing and inspection for HANARO operation. The reactor operation is mainly supported by the government and partly by nuclear R and D fund. The education and training of operation staff are one of major tasks of operating organization

Biosphere modeling for safety assessment to high-level radioactive waste geological disposal. Application of reference biosphere methodology to safety assesment of geological disposal

International Nuclear Information System (INIS)

Baba, Tomoko; Ishihara, Yoshinao; Ishiguro, Katsuhiko; Suzuki, Yuji; Naito, Morimasa

2000-01-01

In the safety assessment of a high-level radioactive waste disposal system, it is required to estimate future radiological impacts on human beings. Consideration of living habits and the human environment in the future involves a large degree of uncertainty. To avoid endless speculation aimed at reducing such uncertainty, an approach is applied for identifying and justifying a 'reference biosphere' for use in safety assessment in Japan. considering a wide range of Japanese geological environments, saline specific reference biospheres' were developed using an approach consistent with the BIOMOVS II reference biosphere methodology. (author)

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)

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)

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)

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)

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)

Human error data collection as a precursor to the development of a human reliability assessment capability in air traffic management

International Nuclear Information System (INIS)

Kirwan, Barry; Gibson, W. Huw; Hickling, Brian

2008-01-01

Quantified risk and safety assessments are now required for safety cases for European air traffic management (ATM) services. Since ATM is highly human-dependent for its safety, this suggests a need for formal human reliability assessment (HRA), as carried out in other industries such as nuclear power. Since the fundamental aspect of HRA is human error data, in the form of human error probabilities (HEPs), it was decided to take a first step towards development of an ATM HRA approach by deriving some HEPs in an ATM context. This paper reports a study, which collected HEPs via analysing the results of a real-time simulation involving air traffic controllers (ATCOs) and pilots, with a focus on communication errors. This study did indeed derive HEPs that were found to be concordant with other known communication human error data. This is a first step, and shows promise for HRA in ATM, since HEPs have been derived which could be used in safety assessments, although these HEPs are for only one (albeit critical) aspect of ATCOs' tasks (communications). The paper discusses options and potential ways forward for the development of a full HRA capability in ATM

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

NARCIS (Netherlands)

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

2016-01-01

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

Review of probabilistic safety assessments: insights and recommendations regarding further developments

International Nuclear Information System (INIS)

Spitzer, C.

1996-01-01

Probabilistic Safety Assessments (PSAs) performed by utilities in the framework of Periodic Safety Reviews for German nuclear power plants are reviewed by TUeV Suedwest. Insights gained and recommendations concerning the necessity and focus of further developments and applications according to practical requests for the performance and assessment of PSAs within regulatory procedures are presented in this paper. Further on, recommendations are made in order to ensure the validity of the results of PSAs necessary in order to achieve the goals thereof. Beside some general points of view the emphasis of the paper is on methodological aspects with respect to evaluation methods and assessment of common cause failures as well as human reliability assessment

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

Probabilistic safety assessment of Tehran Research Reactor using systems analysis programs for hands-on integrated reliability evaluations

International Nuclear Information System (INIS)

Hosseini, M.H.; Nematollahi, M.R.; Sepanloo, K.

2004-01-01

Probabilistic safety assessment application is found to be a practical tool for research reactor safety due to intense involvement of human interactions in an experimental facility. In this document the application of the probabilistic safety assessment to the Tehran Research Reactor is presented. The level 1 practicabilities safety assessment application involved: Familiarization with the plant, selection of accident initiators, mitigating functions and system definitions, event tree constructions and quantifications, fault tree constructions and quantification, human reliability, component failure data base development and dependent failure analysis. Each of the steps of the analysis given above is discussed with highlights from the selected results. Quantification of the constructed models is done using systems analysis programs for hands-on integrated reliability evaluations software

Human-system safety methods for development of advanced air traffic management systems

International Nuclear Information System (INIS)

Nelson, William R.

1999-01-01

The Idaho National Engineering and Environmental Laboratory (INEEL) is supporting the National Aeronautics and Space Administration in the development of advanced air traffic management (ATM) systems as part of the Advanced Air Transportation Technologies program. As part of this program INEEL conducted a survey of human-system safety methods that have been applied to complex technical systems, to identify lessons learned from these applications and provide recommendations for the development of advanced ATM systems. The domains that were surveyed included offshore oil and gas, commercial nuclear power, commercial aviation, and military. The survey showed that widely different approaches are used in these industries, and that the methods used range from very high-level, qualitative approaches to very detailed quantitative methods such as human reliability analysis (HRA) and probabilistic safety assessment (PSA). In addition, the industries varied widely in how effectively they incorporate human-system safety assessment in the design, development, and testing of complex technical systems. In spite of the lack of uniformity in the approaches and methods used, it was found that methods are available that can be combined and adapted to support the development of advanced air traffic management systems (author) (ml)

Human factors questionnaire as a tool for risk assessment

International Nuclear Information System (INIS)

Santos, Isaac J.A.L.; Grecco, Claudio H.S.; Carvalho, Paulo V.R.; Mol, Antonio C.A.; Oliveira, Mauro V.; Augusto, Silas C.

2009-01-01

The human factors engineering (HFE) as a discipline, and as a process, seeks to discover and to apply knowledge about human capabilities and limitations to system and equipment design, ensuring that the system design, human tasks and work environment are compatible with the sensory, perceptual, cognitive and physical attributes of the personnel who operates systems and equipment. Risk significance considers the magnitude of the consequences (loss of life, material damage, environmental degradation) and the frequency of occurrence of a particular adverse event. The questionnaire design was based on the following definitions: the score and the classification of the nuclear safety risk. The principal benefit of applying an approach based on the risk significance in the development of the questionnaire is to ensure the identification and evaluation of the features of the projects, related to human factors, which affect the nuclear safety risk, the human actions and the safety of the nuclear plant systems. The human factors questionnaire developed in this study will provide valuable support for risk assessment, making possible the identification of design problems that can influence the evaluation of the nuclear safety risk. (author)

Importance of human factors on nuclear installations safety

International Nuclear Information System (INIS)

Caruso, G.J.

1990-01-01

Actually, installations safety and, in particular the nuclear installations infer a strong incidence in human factors related to the design and operation of such installations. In general, the experience aims to that the most important accidents have happened as result of the components' failures combination and human failures in the operation of safety systems. Human factors in the nuclear installations may be divided into two areas: economy and human reliability. Human factors treatments for the safety evaluation of the nuclear installations allow to diagnose the weak points of man-machine interaction. (Author) [es

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

International Nuclear Information System (INIS)

Beyerle, Andrea; Nolte, Marc W.; Solomon, Cristina; Herzog, Eva; Dickneite, Gerhard

2014-01-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

Energy Technology Data Exchange (ETDEWEB)

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Nolte, Marc W. [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Solomon, Cristina [CSL Behring GmbH, Medical Affairs, Marburg (Germany); Department of Anaesthesiology, Perioperative Medicine and General Intensive Care, Paracelsus Medical University, Salzburg (Austria); Herzog, Eva; Dickneite, Gerhard [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany)

2014-10-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

[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

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.

Human Factors Evaluation of Procedures for Periodic Safety Review of Yonggwang Unit no. 1, 2

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang (and others)

2006-01-15

This report describes the results of human factors assessment on the plant operating procedures as part of Periodic Safety Review(PSR) of Yonggwang Nuclear Power Plant Unit no. 1, 2. The suitability of item and appropriateness of format and structure in the key operating procedures of nuclear power plants were investigated by the review of plant operating experiences and procedure documents, field survey, and experimental assessment on some part of procedures. A checklist was used to perform this assessment and record the review results. The reviewed procedures include EOP(Emergency Operating Procedures), GOP(General Operating Procedures), AOP(Abnormal Operating Procedures), and management procedures of some technical departments. As results of the assessments, any significant problem challenging the safety was not found on the human factors in the operating procedures. However, several small items to be changed and improved were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on the operating procedure.

Some Challenges in the Design of Human-Automation Interaction for Safety-Critical Systems

Science.gov (United States)

Feary, Michael S.; Roth, Emilie

2014-01-01

Increasing amounts of automation are being introduced to safety-critical domains. While the introduction of automation has led to an overall increase in reliability and improved safety, it has also introduced a class of failure modes, and new challenges in risk assessment for the new systems, particularly in the assessment of rare events resulting from complex inter-related factors. Designing successful human-automation systems is challenging, and the challenges go beyond good interface development (e.g., Roth, Malin, & Schreckenghost 1997; Christoffersen & Woods, 2002). Human-automation design is particularly challenging when the underlying automation technology generates behavior that is difficult for the user to anticipate or understand. These challenges have been recognized in several safety-critical domains, and have resulted in increased efforts to develop training, procedures, regulations and guidance material (CAST, 2008, IAEA, 2001, FAA, 2013, ICAO, 2012). This paper points to the continuing need for new methods to describe and characterize the operational environment within which new automation concepts are being presented. We will describe challenges to the successful development and evaluation of human-automation systems in safety-critical domains, and describe some approaches that could be used to address these challenges. We will draw from experience with the aviation, spaceflight and nuclear power domains.

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)

Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

International Nuclear Information System (INIS)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang

2006-01-01

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area

Human Factors Evaluation of Man-Machine Interface for Periodic Safety Review of Yonggwang Unit no. 1, 2

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Hee; Lee, Jung Woon; Park, Jae Chang (and others)

2006-01-15

This report describes the research results of human factors assessment on the MMI(Man Machine Interface) equipment as part of Periodic Safety Review(PSR) of Yonggwang Unit no. 1, 2. As MMI is a key factor among human factors to be reviewed in PSR, we reviewed the MMI components of nuclear power plants in aspect of human factors engineering. The availability, suitability, and effectiveness of the MMI devices were chosen to be reviewed. The MMI devices were investigated through the review of design documents related to the MMI, survey of control panels, evaluation of experts, and experimental assessment. Checklists were used to perform this assessment and record the review results. The items mentioned by the expert comments to review in detail in relation with task procedures were tested by experiments with operators' participation. For some questionable issues arisen during this MMI review, operator workload and possibility of errors in operator actions were analysed. The reviewed MMI devices contain MCR(Main Control Room), SPDS(Safety Parameter Display System), RSP(Remote Shutdown Panel), and the selected LCBs(Local Control Boards) importantly related to safety. As results of the assessments, any significant problem challenging the safety was not found on human factors in the MMI devices. However, several small items to be changed and improved in suitability of MMI devices were discovered. An action plan is recommended to accommodate the suggestions and review comments. It will enhance the plant safety on MMI area.

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)

Human and organizational biases affecting the management of safety

Energy Technology Data Exchange (ETDEWEB)

Reiman, Teemu, E-mail: teemu.reiman@vtt.fi [VTT, Espoo (Finland); Rollenhagen, Carl [KTH, Stockholm (Sweden)

2011-10-15

Management of safety is always based on underlying models or theories of organization, human behavior and system safety. The aim of the article is to review and describe a set of potential biases in these models and theories. We will outline human and organizational biases that have an effect on the management of safety in four thematic areas: beliefs about human behavior, beliefs about organizations, beliefs about information and safety models. At worst, biases in these areas can lead to an approach where people are treated as isolated and independent actors who make (bad) decisions in a social vacuum and who pose a threat to safety. Such an approach aims at building barriers and constraints to human behavior and neglects the measures aiming at providing prerequisites and organizational conditions for people to work effectively. This reductionist view of safety management can also lead to too drastic a strong separation of so-called human factors from technical issues, undermining the holistic view of system safety. Human behavior needs to be understood in the context of people attempting (together) to make sense of themselves and their environment, and act based on perpetually incomplete information while relying on social conventions, affordances provided by the environment and the available cognitive heuristics. In addition, a move toward a positive view of the human contribution to safety is needed. Systemic safety management requires an increased understanding of various normal organizational phenomena - in this paper discussed from the point of view of biases - coupled with a systemic safety culture that encourages and endorses a holistic view of the workings and challenges of the socio-technical system in question. - Highlights: > Biases in safety management approaches are reviewed and described. > Four thematic areas are covered: human behavior, organizations, information, safety models. > The biases influence how safety management is defined, executed

Human and organizational biases affecting the management of safety

International Nuclear Information System (INIS)

Reiman, Teemu; Rollenhagen, Carl

2011-01-01

Management of safety is always based on underlying models or theories of organization, human behavior and system safety. The aim of the article is to review and describe a set of potential biases in these models and theories. We will outline human and organizational biases that have an effect on the management of safety in four thematic areas: beliefs about human behavior, beliefs about organizations, beliefs about information and safety models. At worst, biases in these areas can lead to an approach where people are treated as isolated and independent actors who make (bad) decisions in a social vacuum and who pose a threat to safety. Such an approach aims at building barriers and constraints to human behavior and neglects the measures aiming at providing prerequisites and organizational conditions for people to work effectively. This reductionist view of safety management can also lead to too drastic a strong separation of so-called human factors from technical issues, undermining the holistic view of system safety. Human behavior needs to be understood in the context of people attempting (together) to make sense of themselves and their environment, and act based on perpetually incomplete information while relying on social conventions, affordances provided by the environment and the available cognitive heuristics. In addition, a move toward a positive view of the human contribution to safety is needed. Systemic safety management requires an increased understanding of various normal organizational phenomena - in this paper discussed from the point of view of biases - coupled with a systemic safety culture that encourages and endorses a holistic view of the workings and challenges of the socio-technical system in question. - Highlights: → Biases in safety management approaches are reviewed and described. → Four thematic areas are covered: human behavior, organizations, information, safety models. → The biases influence how safety management is defined

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)

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)

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

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.

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

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy

International Nuclear Information System (INIS)

Giardina, M; Castiglia, F; Tomarchio, E

2014-01-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events. (paper)

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

scope of the quantitative safety assessment. These arguments include: Support from natural and anthropogenic analogues for both key process understanding and total system performance. Comparison of the methodology and results with the earlier TILA-99 and SR-Can safety assessments, as well as other international safety assessments, to ensure completeness, consistency and reasonableness of the present assessment. Use of safety indicators other than dose and activity to avoid uncertainties in future human lifestyles and also in geological processes on very long timescales. Consideration of the calculation results from a wider perspective to consider significance of their impact compared to other risks

Problems of probabilistic safety assessment after Fukushima Daiichi nuclear power plant accident

International Nuclear Information System (INIS)

Sugiyama, Naoki

2011-01-01

Probabilistic safety assessment (PSA) methodology to assure nuclear safety is had great expectations of lessons learned from Fukushima Daiichi nuclear power plant (NPP) accident and on the other hand this accident made actualized technical problems of PSA. Effectiveness of current PSA methodology for risk assessment was confirmed by comparing the accident development with accident scenario of PSA and equipment failure rate. From a viewpoint of nuclear safety objective and defense in depth approach of IAEA, technical problems of PSA were (1) extension of PSA for spent fuel pool and waste disposal system as well as level 3PSA for broader environmental contamination and (2) overlapping of accident scenario of plural unit site, balance of high quality plant management and preceding negation, treatment of uncertainty of external events, severe accident measure and human reliability analysis and reflection of disaster prevention capability to level 3PSA. In order to upgrade PSA technology, six proposals were described for nuclear safety and defense in depth, comprehensive evaluation scope and catch-up of latest technology, necessity of strategic preparation of PSA standard, human resources fostering and risk communication. (T. Tanaka)

Safety and performance indicators for the assessment of long-term safety of deep geological disposal of radioactive waste

International Nuclear Information System (INIS)

Hugi, M.; Schneider, J.W.; Dorp, F. van; Zuidema, P.

2005-01-01

The evaluation of the ability to isolate radioactive waste and the assessment of the long-term safety of a deep geological repository is usually done in terms of the calculated dose and/or risk for an average individual of the population which is potentially most affected by the potential impacts of the repository. At present, various countries and international organisations are developing so-called complementary indicators to supplement such calculations. These indicators are called ''safety indicators'' if they refer to the safety of the whole repository system; if they address the isolation capability of individual system components or the whole system from a more technical perspective, they are called ''performance indicators''. The need for complementary indicators follows from the long time frames which characterise the safety assessment of a geological repository, and the corresponding uncertainty of the calculated radiation dose. The main reason for these uncertainties is associated with the uncertain long-term prognosis of the surface environment and the related human behaviour. (orig.)

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)

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.

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

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

Safety assessment on the human intrusion scenarios of near surface disposal facility for low and very low level radioactive waste

Energy Technology Data Exchange (ETDEWEB)

Hong, Sung Wook; Park, Jin Baek [Korea Radioactive Waste Agency, Daejeon (Korea, Republic of); Park, Sang Ho [Chungnam National University, Daejeon (Korea, Republic of)

2016-03-15

The second-stage near surface disposal facility for low and very low level radioactive waste's permanent disposal is to be built. During the institutional control period, the inadvertent intrusion of the general public is limited. But after the institutional control period, the access to the general public is not restricted. Therefore human who has purpose of residence and resource exploration can intrude the disposal facility. In this case, radioactive effects to the intruder should be limited within regulatory dose limits. This study conducted the safety assessment of human intrusion on the second-stage surface disposal facility through drilling and post drilling scenario. Results of drilling and post drilling scenario were satisfied with regulatory dose limits. The result showed that post-drilling scenario was more significant than drilling scenario. According to the human intrusion time and behavior after the closure of the facility, dominant radionuclide contributing to the intruder was different. Sensitivity analyses on the parameters about the human behavior were also satisfied with regulatory dose limits. Especially, manual redistribution factor was the most sensitive parameter on exposure dose. A loading plan of spent filter waste and dry active waste was more effective than a loading plan of spent filter waste and other wastes for the radiological point of view. These results can be expected to provide both robustness and defense in depth for the development of safety case further.

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.

The role of human intrusion in the dutch safety study

International Nuclear Information System (INIS)

Prij, J.; Weers, A.W.v.; Glasbergen, P.; Slot, A.F.M.

1989-01-01

In the Netherlands the OPLA research program in which a large number of possible disposal concepts for radioactive waste is investigated has been carried out recently. The disposal concepts concern three different waste strategies, two disposal techiques and three different types of salt formations. In the OPLA program the post-closure safety of the disposal concepts has been investigated. The paper reviews the role of the human intrusion in this safety study. The hydrological consequences of human activities in the underground are discussed and it has been demonstrated that these effects could be taken into account during the groundwater transport calculations. Four different scenario's for human intrusion in the repository have been studied to obtain an indication of the radiological effects. The results show that extremely high doses may result if, after several hundred years, human beings come into direct contact with highly active waste. For the final assessment the probability that the doses will be received should be calculated. This should be done in a subsequent research

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

The current status of exposure-driven approaches for chemical safety assessment: A cross-sector perspective.

Science.gov (United States)

Sewell, Fiona; Aggarwal, Manoj; Bachler, Gerald; Broadmeadow, Alan; Gellatly, Nichola; Moore, Emma; Robinson, Sally; Rooseboom, Martijn; Stevens, Alexander; Terry, Claire; Burden, Natalie

2017-08-15

For the purposes of chemical safety assessment, the value of using non-animal (in silico and in vitro) approaches and generating mechanistic information on toxic effects is being increasingly recognised. For sectors where in vivo toxicity tests continue to be a regulatory requirement, there has been a parallel focus on how to refine studies (i.e. reduce suffering and improve animal welfare) and increase the value that in vivo data adds to the safety assessment process, as well as where to reduce animal numbers where possible. A key element necessary to ensure the transition towards successfully utilising both non-animal and refined safety testing is the better understanding of chemical exposure. This includes approaches such as measuring chemical concentrations within cell-based assays and during in vivo studies, understanding how predicted human exposures relate to levels tested, and using existing information on human exposures to aid in toxicity study design. Such approaches promise to increase the human relevance of safety assessment, and shift the focus from hazard-driven to risk-driven strategies similar to those used in the pharmaceutical sectors. Human exposure-based safety assessment offers scientific and 3Rs benefits across all sectors marketing chemical or medicinal products. The UK's National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) convened an expert working group of scientists across the agrochemical, industrial chemical and pharmaceutical industries plus a contract research organisation (CRO) to discuss the current status of the utilisation of exposure-driven approaches, and the challenges and potential next steps for wider uptake and acceptance. This paper summarises these discussions, highlights the challenges - particularly those identified by industry - and proposes initial steps for moving the field forward. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

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.

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

that lie outside the scope of the quantitative safety assessment. These arguments include: Support from natural and anthropogenic analogues for both key process understanding and total system performance. Comparison of the methodology and results with the earlier TILA-99 and SR-Can safety assessments, as well as other international safety assessments, to ensure completeness, consistency and reasonableness of the present assessment. Use of safety indicators other than dose and activity to avoid uncertainties in future human lifestyles and also in geological processes on very long timescales. Consideration of the calculation results from a wider perspective to consider significance of their impact compared to other risks

Safety of human papillomavirus vaccines: a review.

Science.gov (United States)

Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

2015-05-01

Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

Human factors assessments of D and D technologies

International Nuclear Information System (INIS)

Carpenter, C.P.; Evans, T.T.; McCabe, B.

2000-01-01

On April 2, 1997, the US Secretary of Energy directed the US Assistant Secretary of Environmental Management and of Safety and Health to require field input of appropriate data to ensure that safety and health considerations were properly addressed in the Accelerating Cleanup: Focus on 2006 Plan. The US Department of Energy (DOE) field managers have committed to the Secretary that they will fully implement integrated safety management systems (ISMSs) at their respective sites by the end of fiscal year 1999. The Secretary has further directed that headquarters safety and health guidance be developed to support consistent and comprehensive project baseline summaries from the field. The Secretary has committed to institutionalizing ISMS as an integral component of the way the DOE conducts its business. The Defense Nuclear Facilities Safety Board continues to oversee and closely monitor the DOE's commitment to the safety and health of its workers. The DOE is committed to a management system approach to ensure that work is performed in a manner that protects the worker, public, and environment. The Deactivation and Decommissioning Focus Area (DDFA) is actively addressing the need to incorporate environmental safety and health (ES and H) considerations in developing technologies. The DDFA is partnered with the Operating Engineers National Hazmat Program (OENHP) to evaluate the ES and H considerations of the innovative and improved decontamination and decommissioning technologies. Part of the implementation of the ES and H work practices in the field is through a cooperative agreement between the National Energy Technology Laboratory (NETL) and the OENHP. The objective of this program is to establish an International Environmental Technology and Training Center to conduct human factors assessments and protocols on environmental technologies. The intent of the human factors assessments is to enhance the effectiveness and efficiency of the technologies and to enhance

Human and Organisational Safety Barriers in the Oil & Gas Industry

International Nuclear Information System (INIS)

Nystad, E.; Szőke, I.

2016-01-01

The oil & gas industry is a safety-critical industry where errors or accidents may potentially have severe consequences. Offshore oil & gas installations are complex technical systems constructed to pump hydrocarbons from below the seabed, process them and pipe them to onshore refineries. Hydrocarbon leaks may lead to major accidents or have negative environmental impacts. The industry must therefore have a strong focus on safety. Safety barriers are devices put into place to prevent or reduce the effects of unwanted incidents. Technical barriers are one type of safety barrier, e.g., blow-out preventers to prevent uncontrolled release of hydrocarbons from a well. Human operators may also have an important function in maintaining safety. These human operators are part of a larger organisation consisting of different roles and responsibilities and with different mechanisms for ensuring safety. This paper will present two research projects from the Norwegian oil & gas industry that look at the role of humans and organisations as safety barriers. The first project used questionnaire data to investigate the use of mindful safety practices (safety-promoting work practices intended to prevent or interrupt unwanted events) and what contextual factors may affect employees’ willingness to use these safety practices. Among the findings was that employees’ willingness to use mindful safety practices was affected more by factors on a group level than factors at an individual or organisational level, and that the factors may differ depending on what is the object of a practice—the employee or other persons. It was also suggested that employees’ willingness to use mindful safety practices could be an indicator used in the assessment of the safety level on oil & gas installations. The second project is related to organisational safety barriers against major accidents. This project was based on a review of recent incidents in the Norwegian oil & gas industry, as well as

Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

Science.gov (United States)

Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

2015-01-01

Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

Safety assessment of genetically modified rice expressing human serum albumin from urine metabonomics and fecal bacterial profile.

Science.gov (United States)

Qi, Xiaozhe; Chen, Siyuan; Sheng, Yao; Guo, Mingzhang; Liu, Yifei; He, Xiaoyun; Huang, Kunlun; Xu, Wentao

2015-02-01

The genetically modified (GM) rice expressing human serum albumin (HSA) is used for non-food purposes; however, its food safety assessment should be conducted due to the probability of accidental mixture with conventional food. In this research, Sprague Dawley rats were fed diets containing 50% (wt/wt) GM rice expressing HSA or non-GM rice for 90 days. Urine metabolites were detected by (1)H NMR to examine the changes of the metabolites in the dynamic process of metabolism. Fecal bacterial profiles were detected by denaturing gradient gel electrophoresis to reflect intestinal health. Additionally, short chain fatty acids and fecal enzymes were investigated. The results showed that compared with rats fed the non-GM rice, some significant differences were observed in rats fed with the GM rice; however, these changes were not significantly different from the control diet group. Additionally, the gut microbiota was associated with blood indexes and urine metabolites. In conclusion, the GM rice diet is as safe as the traditional daily diet. Furthermore, urine metabonomics and fecal bacterial profiles provide a non-invasive food safety assessment rat model for genetically modified crops that are used for non-food/feed purposes. Fecal bacterial profiles have the potential for predicting the change of blood indexes in future. Copyright © 2014 Elsevier Ltd. All rights reserved.

1981 NRC/BNL/IEEE standards workshop on human factors and nuclear safety. The man-machine interface and human reliability: an assessment and projection

International Nuclear Information System (INIS)

Hall, R.E.; Fragola, J.R.; Luckas, W.J. Jr.

1981-09-01

The role of the human in the safety of nuclear power plant operations was addressed in a meeting held in Myrtle Beach, SC in August 1981. Presentation were made on Control Room reviews, safety parameter display systems, the integration of human factors in the entire design process, and the use of automated control features. A need was shown for the development of a taxonomy or model to structure future data gathering and the need for models and data to address the issue of cognitive behavior. The primary effect of this behavior on risk was identified. Discussion sessions on the human impact on reliability, and control room design and evaluation were included

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)

Efficacy and Safety of Human Retinal Progenitor Cells

Science.gov (United States)

Semo, Ma'ayan; Haamedi, Nasrin; Stevanato, Lara; Carter, David; Brooke, Gary; Young, Michael; Coffey, Peter; Sinden, John; Patel, Sara; Vugler, Anthony

2016-01-01

Purpose We assessed the long-term efficacy and safety of human retinal progenitor cells (hRPC) using established rodent models. Methods Efficacy of hRPC was tested initially in Royal College of Surgeons (RCS) dystrophic rats immunosuppressed with cyclosporine/dexamethasone. Due to adverse effects of dexamethasone, this drug was omitted from a subsequent dose-ranging study, where different hRPC doses were tested for their ability to preserve visual function (measured by optokinetic head tracking) and retinal structure in RCS rats at 3 to 6 months after grafting. Safety of hRPC was assessed by subretinal transplantation into wild type (WT) rats and NIH-III nude mice, with analysis at 3 to 6 and 9 months after grafting, respectively. Results The optimal dose of hRPC for preserving visual function/retinal structure in dystrophic rats was 50,000 to 100,000 cells. Human retinal progenitor cells integrated/survived in dystrophic and WT rat retina up to 6 months after grafting and expressed nestin, vimentin, GFAP, and βIII tubulin. Vision and retinal structure remained normal in WT rats injected with hRPC and there was no evidence of tumors. A comparison between dexamethasone-treated and untreated dystrophic rats at 3 months after grafting revealed an unexpected reduction in the baseline visual acuity of dexamethasone-treated animals. Conclusions Human retinal progenitor cells appear safe and efficacious in the preclinical models used here. Translational Relevance Human retinal progenitor cells could be deployed during early stages of retinal degeneration or in regions of intact retina, without adverse effects on visual function. The ability of dexamethasone to reduce baseline visual acuity in RCS dystrophic rats has important implications for the interpretation of preclinical and clinical cell transplant studies. PMID:27486556

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

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

International Nuclear Information System (INIS)

Samaddar, Sujit; Hibino, Kenta; Coman, Ovidiu

2014-01-01

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

Collection and classification of human reliability data for use in probabilistic safety assessments. Final report of a co-ordinated research programme 1995-1998

International Nuclear Information System (INIS)

1998-10-01

One of the most important lessons from abnormal events in NPPs is that they often result from incorrect human action. The awareness of the importance of human factors and human reliability has increased significantly over 10-15 years primarily owing to the fact that some major incidents (nuclear or non-nuclear) have had significant human error contributions. Each of these incidents have revealed different types of human errors, some of which were not generally recognized prior to the incident. The analysis of these events led to wide recognition of the fact that more information about human actions and errors is needed to improve the safety and operation of nuclear power plants. At the same time, the need or proper human reliability data was recognised in view of probabilistic safety assessment (PSA). No PSA study can be regarded as complete and accurate without adequate incorporation of human reliability analysis (HRA). In order to support incorporation of human reliability data into PSA the IAEA established a coordinated research programme with the objective to develop a common data base structure for human errors that might have important contributions to risk in different types of reactors. This report is a product of four years of coordinated research and describes the data collection and classification schemes currently in use in Member States as well as an outlook into future, discussing what types of data might be needed to support the new improved HRA methods which are currently under development

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

Science.gov (United States)

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

2004-07-01

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

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

General safety considerations

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-09-01

This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

General safety considerations

International Nuclear Information System (INIS)

2001-01-01

This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness

General safety considerations

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-09-01

This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

General safety considerations

International Nuclear Information System (INIS)

1998-01-01

This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness

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

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

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

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

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)

Environment, Safety and Health progress assessment of the Idaho National Engineering Laboratory (INEL)

International Nuclear Information System (INIS)

1993-08-01

The ES ampersand H Progress Assessments are part of the Department's continuous improvement process throughout DOE and its contractor organizations. The purpose of the INEL ES ampersand H Progress Assessment is to provide the Department with concise independent information on the following: (1) change in culture and attitude related to ES ampersand H activities; (2) progress and effectiveness of the ES ampersand H corrective actions resulting from previous Tiger Team Assessments; (3) adequacy and effectiveness of the ES ampersand H self-assessment programs of the DOE line organizations and the site management and operating contractor; and (4) effectiveness of DOE and contractor management structures, resources, and systems to effectively address ES ampersand H problems. It is not intended that this Progress Assessment be a comprehensive compliance assessments of ES ampersand H activities. The points of reference for assessing programs at the INEL were, for the most part, the 1991 INEL Tiger Team Assessment, the INEL Corrective Action Plan, and recent appraisals and self-assessments of INEL. Horizontal and vertical reviews of the following programmatic areas were conducted: Management: Corrective action program; self-assessment; oversight; directives, policies, and procedures; human resources management; and planning, budgeting, and resource allocation. Environment: Air quality management, surface water management, groundwater protection, and environmental radiation. Safety and Health: Construction safety, worker safety and OSHA, maintenance, packaging and transportation, site/facility safety review, and industrial hygiene

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.

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)

Biosphere modelling for the safety assessment of high-level radioactive waste disposal in the Japanese H12 assessment

International Nuclear Information System (INIS)

Kato, Tomoko; Suzuki, Yuji; Ishiguro, Katsuhiko; Naito, Morimasa; Ishiguro, Katsuhiko; Ikeda, Takao; Little, Richard H.; Smith, Graham M.

2002-01-01

JNC has an on-going programme of research and development relating to the safety assessment of the deep geological disposal system of high-level radioactive waste (HLW). In the safety assessment of a HLW disposal system, it is often necessary to estimate future radiological impacts on human beings (e.g. radiation dose). In order to estimate dose, consideration needs to be given to the surface environment (biosphere) into which future releases of radionuclides might occur and to the associated future human behaviour. However, for a deep repository, such releases might not occur for many thousands of years after disposal. Over such timescales, it is not possible to predict with any certainty how the biosphere and human behaviour will evolve. To avoid endless speculation aimed at reducing such uncertainty, the reference biosphere le concept has been developed for use in the safety assessment of HLW disposal. The Reference Biospheres Methodology was originally developed by the BIOMOVS II Reference Biospheres Working Group and subsequently enhanced within Theme 1 of the BIOMASS programme. As the aim of the H12 assessment with a hypothetical HLW disposal system was to demonstrate the technical feasibility and reliability of the Japanese disposal concept for a range of geological and surface environments, some assessment specific reference biospheres were developed for the biosphere modelling in the H12 assessment using an approach consistent with the BIOMOVS II/BIOMASS approach. They have been used to derive factors to convert the radionuclide flux from a geosphere to a biosphere into a dose. The influx to dose conversion factor also have been derived for a range of different geosphere-biosphere interfaces (well, river and marine) and potential exposure groups (farming, freshwater-fishing and marine-fishing). This paper summarises the approach used for the derivation of the influx to dose conversion factor also for the range of geosphere-biosphere interfaces and

An Empirical Analysis of Human Performance and Nuclear Safety Culture

International Nuclear Information System (INIS)

Jeffrey Joe; Larry G. Blackwood

2006-01-01

The purpose of this analysis, which was conducted for the US Nuclear Regulatory Commission (NRC), was to test whether an empirical connection exists between human performance and nuclear power plant safety culture. This was accomplished through analyzing the relationship between a measure of human performance and a plant's Safety Conscious Work Environment (SCWE). SCWE is an important component of safety culture the NRC has developed, but it is not synonymous with it. SCWE is an environment in which employees are encouraged to raise safety concerns both to their own management and to the NRC without fear of harassment, intimidation, retaliation, or discrimination. Because the relationship between human performance and allegations is intuitively reciprocal and both relationship directions need exploration, two series of analyses were performed. First, human performance data could be indicative of safety culture, so regression analyses were performed using human performance data to predict SCWE. It also is likely that safety culture contributes to human performance issues at a plant, so a second set of regressions were performed using allegations to predict HFIS results

A review of the probabilistic safety assessment application to the TR-2 research reactor

International Nuclear Information System (INIS)

Goektepe, G.; Adalioglu, U.; Anac, H.; Sevdik, B.; Menteseoglu, S.

2001-01-01

A review of the Probabilistic Safety Assessment (PSA) to the TR-2 Research Reactor is presented. The level 1 PSA application involved: selection of accident initiators, mitigating functions and system definitions, event tree constructions and quantification, fault tree constructions and quantification, human reliability, component failure data base development, dependent failure analysis. Each of the steps of the analysis given above is reviewed briefly with highlights from the selected results. PSA application is found to be a practical tool for research reactor safety due to intense involvement of human interactions in an experimental facility. Insights gained from the application of PSA methodology to the TR-2 research reactor led to a significant safety review of the system

Modifications of Probabilistic Safety Assessment-1 Nuclear Power Plant Dukovany based upon new version of Emergency Operating Procedures

International Nuclear Information System (INIS)

Aldorf, R.

1997-01-01

In the frame of 'living Probabilistic Safety Assessment-1 Nuclear Power Plant Dukovany Project' being performed by Nuclear Research Institute Rez during 1997 is planned to reflect on Probabilistic Safety Assessment-1 basis on impact of Emergency Response Guidelines (as one particular event from the list of other modifications) on Plant Safety. Following highlights help to orient the reader in main general aspects, findings and issues of the work that currently continues on. Older results of Probabilistic Safety Assessment-1 Nuclear Power Plant Dukovany have revealed that human behaviour during accident progression scenarios represent one of the most important aspects in plant safety. Current effort of Nuclear Power Plants Dukovany (Czech Republic) and Bohunice (Slovak Republic) is focussed on development of qualitatively new symptom-based Emergency Operating Procedures called Emergency Response Guidelines Supplier - Westinghouse Energy Systems Europe, Brussels works in cooperation with teams of specialist from both Nuclear Power Plants. In the frame of 'living Probabilistic Safety Assessment-1 Nuclear Power Plant Dukovany Project' being performed by Nuclear Research Institute Rez during 1997 is planned to prove on Probabilistic Safety Assessment -1 basis an expected - positive impact of Emergency Response Guidelines on Plant Safety, Since this contract is currently still in progress, it is possible to release only preliminary conclusions and observations. Emergency Response Guidelines compare to original Emergency Operating Procedures substantially reduce uncertainty of general human behaviour during plant response to an accident process. It is possible to conclude that from the current scope Probabilistic Safety Assessment Dukovany point of view (until core damage), Emergency Response Guidelines represent adequately wide basis for mitigating any initiating event

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

Probabilistic safety analysis and human reliability analysis. Proceedings. Working material

International Nuclear Information System (INIS)

1996-01-01

An international meeting on Probabilistic Safety Assessment (PSA) and Human Reliability Analysis (HRA) was jointly organized by Electricite de France - Research and Development (EDF DER) and SRI International in co-ordination with the International Atomic Energy Agency. The meeting was held in Paris 21-23 November 1994. A group of international and French specialists in PSA and HRA participated at the meeting and discussed the state of the art and current trends in the following six topics: PSA Methodology; PSA Applications; From PSA to Dependability; Incident Analysis; Safety Indicators; Human Reliability. For each topic a background paper was prepared by EDF/DER and reviewed by the international group of specialists who attended the meeting. The results of this meeting provide a comprehensive overview of the most important questions related to the readiness of PSA for specific uses and areas where further research and development is required. Refs, figs, tabs

Probabilistic safety analysis and human reliability analysis. Proceedings. Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-12-31

An international meeting on Probabilistic Safety Assessment (PSA) and Human Reliability Analysis (HRA) was jointly organized by Electricite de France - Research and Development (EDF DER) and SRI International in co-ordination with the International Atomic Energy Agency. The meeting was held in Paris 21-23 November 1994. A group of international and French specialists in PSA and HRA participated at the meeting and discussed the state of the art and current trends in the following six topics: PSA Methodology; PSA Applications; From PSA to Dependability; Incident Analysis; Safety Indicators; Human Reliability. For each topic a background paper was prepared by EDF/DER and reviewed by the international group of specialists who attended the meeting. The results of this meeting provide a comprehensive overview of the most important questions related to the readiness of PSA for specific uses and areas where further research and development is required. Refs, figs, tabs.

General safety aspects

International Nuclear Information System (INIS)

1998-01-01

In this part next aspects are described: (1) Priority to safety; (2) Financial and human resources;; (3) Human factor; (4) Operator's quality assurance system; (5) Safety assessment and Verification; (6) Radiation protection and (7) Emergency preparedness

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

International Nuclear Information System (INIS)

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

2013-01-01

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

Contrasting safety assessments of a runway incursion scenario: Event sequence analysis versus multi-agent dynamic risk modelling

International Nuclear Information System (INIS)

Stroeve, Sybert H.; Blom, Henk A.P.; Bakker, G.J.

2013-01-01

In the safety literature it has been argued, that in a complex socio-technical system safety cannot be well analysed by event sequence based approaches, but requires to capture the complex interactions and performance variability of the socio-technical system. In order to evaluate the quantitative and practical consequences of these arguments, this study compares two approaches to assess accident risk of an example safety critical sociotechnical system. It contrasts an event sequence based assessment with a multi-agent dynamic risk model (MA-DRM) based assessment, both of which are performed for a particular runway incursion scenario. The event sequence analysis uses the well-known event tree modelling formalism and the MA-DRM based approach combines agent based modelling, hybrid Petri nets and rare event Monte Carlo simulation. The comparison addresses qualitative and quantitative differences in the methods, attained risk levels, and in the prime factors influencing the safety of the operation. The assessments show considerable differences in the accident risk implications of the performance of human operators and technical systems in the runway incursion scenario. In contrast with the event sequence based results, the MA-DRM based results show that the accident risk is not manifest from the performance of and relations between individual human operators and technical systems. Instead, the safety risk emerges from the totality of the performance and interactions in the agent based model of the safety critical operation considered, which coincides very well with the argumentation in the safety literature.

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

A Model-based Framework for Risk Assessment in Human-Computer Controlled Systems

Science.gov (United States)

Hatanaka, Iwao

2000-01-01

The rapid growth of computer technology and innovation has played a significant role in the rise of computer automation of human tasks in modem production systems across all industries. Although the rationale for automation has been to eliminate "human error" or to relieve humans from manual repetitive tasks, various computer-related hazards and accidents have emerged as a direct result of increased system complexity attributed to computer automation. The risk assessment techniques utilized for electromechanical systems are not suitable for today's software-intensive systems or complex human-computer controlled systems. This thesis will propose a new systemic model-based framework for analyzing risk in safety-critical systems where both computers and humans are controlling safety-critical functions. A new systems accident model will be developed based upon modem systems theory and human cognitive processes to better characterize system accidents, the role of human operators, and the influence of software in its direct control of significant system functions. Better risk assessments will then be achievable through the application of this new framework to complex human-computer controlled systems.

Making the link between radiological assessment, nuclear safety assessment and environmental impact assessment, as applied to unloading of the Lepse spent fuel storage vessel

International Nuclear Information System (INIS)

Smith, Graham M.; Sneve, Malgorzata K.; Markarov, Valentine G.

2000-01-01

Planning and optimisation of radioactive waste management operations is a complicated task involving scientific, technical and social issues. There are many factors which have to be balanced, involving trade-offs such as those between safety now and long term safety; between protection of human health and protection of the environment as a whole; between protection of workers and protection of the public; and between mitigation of risks of major accidents and mitigation of routine low-level but certain to occur risks. Managing the spent fuel currently stored on the Lepse vessel in Murmansk offers as big a challenge as any other in this context. The Russian Federation state regulatory process imposes strict requirements on operators to demonstrate adequate safety, environmental and human health protection. Practically, however, there is little experience in Russia or elsewhere on how to combine all the issues referred to above within an overall assessment that leads to informed decision making. The paper will describe the components of assessment work being considered within the context of the regulatory planning of Lepse unloading operations. The scope will focus on radiation protection issues but also include non-radioactive pollution risks and other safety issues have to be taken into account if a truly optimal allocation and application of resources is to be made. Consideration will be given to radiation worker dose and other health risk assessments for routine operations, safety assessments of special operations such as spent fuel handling; and the radiological and other environmental and human health impacts of planned releases of effluents to the biosphere. The need to identify and collate particular relevant information will discussed and the links between the different components of the overall assessment will be identified with a view to improving the overall effectiveness of the assessment process. The problem of combining all the information coherently

Towards understanding work-as-done in air traffic management safety assessment and design

International Nuclear Information System (INIS)

Woltjer, Rogier; Pinska-Chauvin, Ella; Laursen, Tom; Josefsson, Billy

2015-01-01

This paper describes the approach taken and the results to develop guidance, to include Resilience Engineering principles in methodology for safety assessment of functional changes, in Air Traffic Management (ATM). It summarizes the process of deriving resilience principles for ATM, originating from Resilience Engineering concepts and transposed into ATM operations. These principles are the foundation for guidance material incorporating Resilience Engineering (RE) concepts into safety assessment methodology. The guidance material provides a method using workshops generating qualitative descriptions of RE principles applied to ATM services of everyday work, as done currently and as envisioned after introduction of a new technology or way of working. The guidance material has been proposed as part of the safety assessment methodology of SESAR (Single European Sky ATM Research), and as stand-alone guidance for ATM design processes. The methodology was validated via a test case on the i4D/CTA (Controlled Time of Arrival) concept. Operational examples from the application of the developed guidance to the i4D/CTA concept are provided. Initial evaluation of the guidance suggests that the methodology (1) provides a narrative, vocabulary and documentation means of project discussions on resilience; (2) brings the discussions of safety and resilience closer to operational practice; (3) facilitates a broader systemic and integrative perspective on operational, management, business, safety, environmental, and human performance aspects; and (4) can extend the vocabulary of safety assessment to include the description of emergent properties, to better support functional changes in ATM. - Highlights: • Guidance material for safety assessment based on systemic thinking is proposed. • It operationalizes Resilience Engineering principles in Air Traffic Management, including a case study. • It enables description of expected changes in work-as-done when introducing a new

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

The role of human performance in the safety complex plants' operation

International Nuclear Information System (INIS)

Preda, Irina Aida; Lazar, Roxana Elena; Croitoru, Cornelia

1999-01-01

According to statistics, about 20-30% from the failures occurred in the plants are caused directly or indirectly by human errors. Furthermore, it was established that 10-15% of the global failures are related with the human errors. These are mainly due to the wrong actions, maintenance errors, and misinterpretation of instruments. The human performance is influenced by: professional ability, complexity and danger to the plant experience in the working place, level of skills, events in personal and/or professional life, discipline, social ambience, somatic health. The human performances' assessment in the probabilistic safety assessment offers the possibility of evaluation of human contribution to the events sequences outcome. Not all the human errors have impact on the system. A human error may be recovered before the unwanted consequences had been occurred on system. This paper presents the possibilities to use the probabilistic method (event tree, fault tree) to identify the solutions for human reliability improved in order to minimize the risk in industrial plants' operation. Also, the human error types and their causes are defined and the 'decision tree method' as technique in our analysis for human reliability assessment is presented. The exemplification of human error analysis method was achieved based on operation data for Valcea Heavy Water Pilot Plant. As initiating event for the accident state 'the steam supply interruption' event has been considered. The human errors' contribution was analysed for the accident sequence with the worst consequences. (authors)

Self-assessment of human performance errors in nuclear operations

International Nuclear Information System (INIS)

Chambliss, K.V.

1996-01-01

One of the most important approaches to improving nuclear safety is to have an effective self-assessment process in place, whose cornerstone is the identification and improvement of human performance errors. Experience has shown that significant events usually have had precursors of human performance errors. If these precursors are left uncorrected or not understood, the symptoms recur and result in unanticipated events of greater safety significance. The Institute of Nuclear Power Operations (INPO) has been championing the cause of promoting excellence in human performance in the nuclear industry. INPO's report, open-quotes Excellence in Human Performance,close quotes emphasizes the importance of several factors that play a role in human performance. They include individual, supervisory, and organizational behaviors; real-time feedback that results in specific behavior to produce safe and reliable performance; and proactive measures that remove obstacles from excellent human performance. Zack Pate, chief executive officer and president of INPO, in his report, open-quotes The Control Room,close quotes provides an excellent discussion of serious events in the nuclear industry since 1994 and compares them with the results from a recent study by the National Transportation Safety Board of airline accidents in the 12-yr period from 1978 to 1990 to draw some common themes that relate to human performance issues in the control room

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)

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

Hazard Identification and Risk Assessment in Water Treatment Plant considering Environmental Health and Safety Practice

Directory of Open Access Journals (Sweden)

Falakh Fajrul

2018-01-01

Full Text Available Water Treatment Plant (WTP is an important infrastructure to ensure human health and the environment. In its development, aspects of environmental safety and health are of concern. This paper case study was conducted at the Water Treatment Plant Company in Semarang, Central Java, Indonesia. Hazard identification and risk assessment is one part of the occupational safety and health program at the risk management stage. The purpose of this study was to identify potential hazards using hazard identification methods and risk assessment methods. Risk assessment is done using criteria of severity and probability of accident. The results obtained from this risk assessment are 22 potential hazards present in the water purification process. Extreme categories that exist in the risk assessment are leakage of chlorine and industrial fires. Chlorine and fire leakage gets the highest value because its impact threatens many things, such as industrial disasters that could endanger human life and the environment. Control measures undertaken to avoid potential hazards are to apply the use of personal protective equipment, but management will also be better managed in accordance with hazard control hazards, occupational safety and health programs such as issuing work permits, emergency response training is required, Very useful in overcoming potential hazards that have been determined.

Hazard Identification and Risk Assessment in Water Treatment Plant considering Environmental Health and Safety Practice

Science.gov (United States)

Falakh, Fajrul; Setiani, Onny

2018-02-01

Water Treatment Plant (WTP) is an important infrastructure to ensure human health and the environment. In its development, aspects of environmental safety and health are of concern. This paper case study was conducted at the Water Treatment Plant Company in Semarang, Central Java, Indonesia. Hazard identification and risk assessment is one part of the occupational safety and health program at the risk management stage. The purpose of this study was to identify potential hazards using hazard identification methods and risk assessment methods. Risk assessment is done using criteria of severity and probability of accident. The results obtained from this risk assessment are 22 potential hazards present in the water purification process. Extreme categories that exist in the risk assessment are leakage of chlorine and industrial fires. Chlorine and fire leakage gets the highest value because its impact threatens many things, such as industrial disasters that could endanger human life and the environment. Control measures undertaken to avoid potential hazards are to apply the use of personal protective equipment, but management will also be better managed in accordance with hazard control hazards, occupational safety and health programs such as issuing work permits, emergency response training is required, Very useful in overcoming potential hazards that have been determined.

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

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.

Modelling human interactions in the assessment of man-made hazards

International Nuclear Information System (INIS)

Nitoi, M.; Farcasiu, M.; Apostol, M.

2016-01-01

The human reliability assessment tools are not currently capable to model adequately the human ability to adapt, to innovate and to manage under extreme situations. The paper presents the results obtained by ICN PSA team in the frame of FP7 Advanced Safety Assessment Methodologies: extended PSA (ASAMPSA_E) project regarding the investigation of conducting HRA in human-made hazards. The paper proposes to use a 4-steps methodology for the assessment of human interactions in the external events (Definition and modelling of human interactions; Quantification of human failure events; Recovery analysis; Review). The most relevant factors with respect to HRA for man-made hazards (response execution complexity; existence of procedures with respect to the scenario in question; time available for action; timing of cues; accessibility of equipment; harsh environmental conditions) are presented and discussed thoroughly. The challenges identified in relation to man-made hazards HRA are highlighted. (authors)

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

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)

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

DEFF Research Database (Denmark)

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

2015-01-01

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

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

SafetyNet. Human factors safety training on the Internet

DEFF Research Database (Denmark)

Hauland, G.; Pedrali, M.

2002-01-01

This report describes user requirements to an Internet based distance learning system of human factors training, i.e. the SafetyNet prototype, within the aviation (pilots and air traffic control), maritime and medical domains. User requirements totraining have been elicited through 19 semi...

76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

Science.gov (United States)

2011-06-16

...: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety Administration... the Control Room Management/Human Factors regulations in order to realize the safety benefits sooner... FR 5536). By this amendment to the Control Room Management/Human Factors (CRM) rule, an operator must...

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

Human reliability. Is probabilistic human reliability assessment possible?

International Nuclear Information System (INIS)

Mosneron Dupin, F.

1996-01-01

The possibility of carrying out Probabilistic Human Reliability Assessments (PHRA) is often doubted. Basing ourselves on the experience Electricite de France (EDF) has acquired in Probabilistic Safety Assessments for nuclear power plants, we show why the uncertainty of PHRA is very high. We then specify the limits of generic data and models for PHRA: very important factors are often poorly taken into account. To account for them, you need to have proper understanding of the actual context in which operators work. This demands surveys on the field (power plant and simulator) all of which must be carried out with behaviours science skills. The idea of estimating the probabilities of operator failure must not be abandoned, but probabilities must be given less importance, for they are only approximate indications. The qualitative aspects of PHRA should be given greater value (analysis process and qualitative insights). That is why the description (illustrated by case histories) of the main mechanisms of human behaviour, and of their manifestations in the nuclear power plant context (in terms of habits, attitudes, and informal methods and organization in particular) should be an important part of PHRA handbooks. These handbooks should also insist more on methods for gathering information on the actual context of the work of operators. Under these conditions, the PHRA should be possible and even desirable as a process for systematic analysis and assessment of human intervention. (author). 24 refs, 2 figs, 1 tab

Human reliability. Is probabilistic human reliability assessment possible?

Energy Technology Data Exchange (ETDEWEB)

Mosneron Dupin, F

1997-12-31

The possibility of carrying out Probabilistic Human Reliability Assessments (PHRA) is often doubted. Basing ourselves on the experience Electricite de France (EDF) has acquired in Probabilistic Safety Assessments for nuclear power plants, we show why the uncertainty of PHRA is very high. We then specify the limits of generic data and models for PHRA: very important factors are often poorly taken into account. To account for them, you need to have proper understanding of the actual context in which operators work. This demands surveys on the field (power plant and simulator) all of which must be carried out with behaviours science skills. The idea of estimating the probabilities of operator failure must not be abandoned, but probabilities must be given less importance, for they are only approximate indications. The qualitative aspects of PHRA should be given greater value (analysis process and qualitative insights). That is why the description (illustrated by case histories) of the main mechanisms of human behaviour, and of their manifestations in the nuclear power plant context (in terms of habits, attitudes, and informal methods and organization in particular) should be an important part of PHRA handbooks. These handbooks should also insist more on methods for gathering information on the actual context of the work of operators. Under these conditions, the PHRA should be possible and even desirable as a process for systematic analysis and assessment of human intervention. (author). 24 refs, 2 figs, 1 tab.

Assessment of modern methods of human factor reliability analysis in PSA studies

International Nuclear Information System (INIS)

Holy, J.

2001-12-01

The report is structured as follows: Classical terms and objects (Probabilistic safety assessment as a framework for human reliability assessment; Human failure within the PSA model; Basic types of operator failure modelled in a PSA study and analyzed by HRA methods; Qualitative analysis of human reliability; Quantitative analysis of human reliability used; Process of analysis of nuclear reactor operator reliability in a PSA study); New terms and objects (Analysis of dependences; Errors of omission; Errors of commission; Error forcing context); and Overview and brief assessment of human reliability analysis (Basic characteristics of the methods; Assets and drawbacks of the use of each of HRA method; History and prospects of the use of the methods). (P.A.)

Low- and Intermediate Level Radioactive Waste Disposal Environmental and Safety Assessment Activities in Slovenia

International Nuclear Information System (INIS)

Marc, D.; Loose, A.; Urbanc, J.

1998-01-01

The protection of the environment is one of the main concerns in the management of radioactive waste, especially in repository planning. In different stages of repository lifetime the environmental assessment has different functions: it can be used as a decision making process and as a planning, communication and management tool. Safety assessment as a procedure for evaluating the performance of a disposal system, and its potential radiological impact on human health and environment, is also required. Following the international recommendations and Slovene legislation, a presentation is given of the role and importance of the environmental and safety assessment activities in the early stages following concept development and site selection for a low- and intermediate level radioactive waste (LILW) repository in Slovenia. As a case study, a short overview is also given of the preliminary safety assessment that has been carried out in the analysis of possibilities for long-lived LILW disposal in Slovenia. (author)

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2004-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2000-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2001-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2002-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

1999-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

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

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

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

DEFF Research Database (Denmark)

Konig, A.; Cockburn, A.; Crewel, R. W. R.

2004-01-01

of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use......This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group I of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics...... (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex...

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)

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)

Nuclear safety regulation on nuclear safety equipment activities in relation to human and organizational factors

International Nuclear Information System (INIS)

Li Tianshu

2013-01-01

Based on years of knowledge in nuclear safety supervision and experience of investigating and dealing with violation events in repair welding of DFHM, this paper analyzes major faults in manufacturing and maintaining activities of nuclear safety equipment in relation to human and organizational factors. It could be deducted that human and organizational factors has definitely become key features in the development of nuclear energy and technology. Some feasible measures to reinforce supervision on nuclear safety equipment activities have also been proposed. (author)

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)

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

Safety assessment methodologies and their application in development of near surface waste disposal facilities - the ASAM project

International Nuclear Information System (INIS)

Metcalf, P.

2003-01-01

The scope of ASAM project covers near surface disposal facilities for all types of low and intermediate level wastes with emphasis of the post-closure safety assessment.The objectives are to explore practical application to a range of disposal facilities for a number of purposes e.g. development of design concepts, safety re-assessment, upgrading safety and to develop practical approaches to assist regulators, operators and other experts in review of safety assessment. The task of the Co-ordination Group are: reassessment of existing facilities - use of safety assessment in decision making on selection of options (volunteer site Hungary); disused sealed sources - evaluation of disposability of disused sealed sources in near surface facilities (volunteer site Saratov, Russia); mining and minerals processing waste - evaluation of long-term safety (volunteer site pmc S. Africa). An agreement on the scope and objectives of the project are reached and the further consideration, such as human intrusion/institutional control/security; waste from oil/gas industry; very low level waste; categorization of sealed sources coordinated with other IAEA activities are outlined

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

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

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

Outcomes of an international initiative for harmonization of low power and shutdown probabilistic safety assessment

Directory of Open Access Journals (Sweden)

Manna Giustino

2010-01-01

Full Text Available Many probabilistic safety assessment studies completed to the date have demonstrated that the risk dealing with low power and shutdown operation of nuclear power plants is often comparable with the risk of at-power operation, and the main contributors to the low power and shutdown risk often deal with human factors. Since the beginning of the nuclear power generation, human performance has been a very important factor in all phases of the plant lifecycle: design, commissioning, operation, maintenance, surveillance, modification, decommissioning and dismantling. The importance of this aspect has been confirmed by recent operating experience. This paper provides the insights and conclusions of a workshop organized in 2007 by the IAEA and the Joint Research Centre of the European Commission, on Harmonization of low power and shutdown probabilistic safety assessment for WWER nuclear power plants. The major objective of the workshop was to provide a comparison of the approaches and the results of human reliability analyses and gain insights in the enhanced handling of human factors.

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

Modeling and Analysis on Radiological Safety Assessment of Low- and Intermediate Level Radioactive Waste Repository

Energy Technology Data Exchange (ETDEWEB)

Lee, Youn Myoung; Jung, Jong Tae; Kang, Chul Hyung (and others)

2008-04-15

Modeling study and analysis for technical support for the safety and performance assessment of the low- and intermediate level (LILW) repository partially needed for radiological environmental impact reporting which is essential for the licenses for construction and operation of LILW has been fulfilled. Throughout this study such essential area for technical support for safety and performance assessment of the LILW repository and its licensing as gas generation and migration in and around the repository, risk analysis and environmental impact during transportation of LILW, biosphere modeling and assessment for the flux-to-dose conversion factors for human exposure as well as regional and global groundwater modeling and analysis has been carried out.

Modeling and Analysis on Radiological Safety Assessment of Low- and Intermediate Level Radioactive Waste Repository

International Nuclear Information System (INIS)

Lee, Youn Myoung; Jung, Jong Tae; Kang, Chul Hyung

2008-04-01

Modeling study and analysis for technical support for the safety and performance assessment of the low- and intermediate level (LILW) repository partially needed for radiological environmental impact reporting which is essential for the licenses for construction and operation of LILW has been fulfilled. Throughout this study such essential area for technical support for safety and performance assessment of the LILW repository and its licensing as gas generation and migration in and around the repository, risk analysis and environmental impact during transportation of LILW, biosphere modeling and assessment for the flux-to-dose conversion factors for human exposure as well as regional and global groundwater modeling and analysis has been carried out

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)

In prospect: role of safety assessment and risk regulation

International Nuclear Information System (INIS)

Novegno, A.; Askulaj, Eh.

1987-01-01

Problems of accident prevention in industry and power engineering are considered for the sake of environment and human health protection. Investigations into comparison of power system risks are conducted; based on the data obtained a possibility to control the risk has appeared. The IAEA provides an active assistance in realization of a program of coordinated investigations on the risk assessment using the cost-benefit method. For each NPP investigation into all types of its effect on the environment (risk for personnel and population under normal radioactivity releases and in case of accidents), is conducted. Two approaches to calculating the impacts of accidents at NPPs-'determination' one, based on the designed accident and safety probability evaluation exist. Regional approach appears to be the best one when solving the problems of risk control. Attention is paid to a joint project of the IAEA-UNO and WHO related to risk assessment and control for human health and environment protection at power and other complex commercial systems

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)

Human Factors engineering criteria and design for the Hanford Waste Vitrification Plant preliminary safety analysis report

International Nuclear Information System (INIS)

Wise, J.A.; Schur, A.; Stitzel, J.C.L.

1993-09-01

This report provides a rationale and systematic methodology for bringing Human Factors into the safety design and operations of the Hanford Waste Vitrification Plant (HWVP). Human Factors focuses on how people perform work with tools and machine systems in designed settings. When the design of machine systems and settings take into account the capabilities and limitations of the individuals who use them, human performance can be enhanced while protecting against susceptibility to human error. The inclusion of Human Factors in the safety design of the HWVP is an essential ingredient to safe operation of the facility. The HWVP is a new construction, nonreactor nuclear facility designed to process radioactive wastes held in underground storage tanks into glass logs for permanent disposal. Its design and mission offer new opposites for implementing Human Factors while requiring some means for ensuring that the Human Factors assessments are sound, comprehensive, and appropriately directed

Geosphere process report for the safety assessment SR-Can

International Nuclear Information System (INIS)

Skagius, Kristina

2006-09-01

design reports for each site. Factors related to external conditions are handled in the categories 'climate related issues', 'large-scale geological processes and effects' and 'future human actions'. The handling of climate related issues is described in the SR-Can Climate report, whereas the few external, large-scale geosphere processes are addressed here in the Geosphere process report. The treatment of future human actions in SR-Can is described in the SR-Can FHA report. The identification of relevant processes is based on earlier assessments and FEP screening. All identified processes within the system boundary relevant to the long-term evolution of the system are described in dedicated Process reports, i.e. this report and process reports for the fuel and canister and for the buffer and backfill. For each process, its general characteristics, the time frame in which it is important, the other processes to which it is coupled and how the process is handled in the safety assessment are documented, Definition of safety functions, function indicators and function indicator criteria. This step consists of an account of the safety functions of the system and of how they can be evaluated by means of a set of function indicators that are, in principle, measurable or calculable properties of the system. Criteria for the safety function indicators are provided. The Process reports are important references for this step. A FEP chart is developed, showing how FEPs are related to the function indicators. Data to be used in the quantification of repository evolution and in dose calculations are selected using a structured procedure. Also, a template for discussion of input data uncertainties has been developed and applied. A reference evolution, providing a description of a plausible evolution of the repository system, is defined and analysed. The isolating potential of the system over time is analysed in a first step, yielding a description of the general system evolution and an

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

design reports for each site. Factors related to external conditions are handled in the categories 'climate related issues', 'large-scale geological processes and effects' and 'future human actions'. The handling of climate related issues is described in the SR-Can Climate report, whereas the few external, large-scale geosphere processes are addressed here in the Geosphere process report. The treatment of future human actions in SR-Can is described in the SR-Can FHA report. The identification of relevant processes is based on earlier assessments and FEP screening. All identified processes within the system boundary relevant to the long-term evolution of the system are described in dedicated Process reports, i.e. this report and process reports for the fuel and canister and for the buffer and backfill. For each process, its general characteristics, the time frame in which it is important, the other processes to which it is coupled and how the process is handled in the safety assessment are documented, Definition of safety functions, function indicators and function indicator criteria. This step consists of an account of the safety functions of the system and of how they can be evaluated by means of a set of function indicators that are, in principle, measurable or calculable properties of the system. Criteria for the safety function indicators are provided. The Process reports are important references for this step. A FEP chart is developed, showing how FEPs are related to the function indicators. Data to be used in the quantification of repository evolution and in dose calculations are selected using a structured procedure. Also, a template for discussion of input data uncertainties has been developed and applied. A reference evolution, providing a description of a plausible evolution of the repository system, is defined and analysed. The isolating potential of the system over time is analysed in a first step, yielding a description of the

Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials.

Science.gov (United States)

Veyrand, Julien; Marin-Kuan, Maricel; Bezencon, Claudine; Frank, Nancy; Guérin, Violaine; Koster, Sander; Latado, Hélia; Mollergues, Julie; Patin, Amaury; Piguet, Dominique; Serrant, Patrick; Varela, Jesus; Schilter, Benoît

2017-10-01

Food contact materials (FCM) contain chemicals which can migrate into food and result in human exposure. Although it is mandatory to ensure that migration does not endanger human health, there is still no consensus on how to pragmatically assess the safety of FCM since traditional approaches would require extensive toxicological and analytical testing which are expensive and time consuming. Recently, the combination of bioassays, analytical chemistry and risk assessment has been promoted as a new paradigm to identify toxicologically relevant molecules and address safety issues. However, there has been debate on the actual value of bioassays in that framework. In the present work, a FCM anticipated to release the endocrine active chemical 4-nonyphenol (4NP) was used as a model. In a migration study, the leaching of 4NP was confirmed by LC-MS/MS and GC-MS. This was correlated with an increase in both estrogenic and anti-androgenic activities as measured with bioassays. A standard risk assessment indicated that according to the food intake scenario applied, the level of 4NP measured was lower, close or slightly above the acceptable daily intake. Altogether these results show that bioassays could reveal the presence of an endocrine active chemical in a real-case FCM migration study. The levels reported were relevant for safety assessment. In addition, this work also highlighted that bioactivity measured in migrate does not necessarily represent a safety issue. In conclusion, together with analytics, bioassays contribute to identify toxicologically relevant molecules leaching from FCM and enable improved safety assessment.

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)

Human systemic exposure to [¹⁴C]-paraphenylenediamine-containing oxidative hair dyes: Absorption, kinetics, metabolism, excretion and safety assessment.

Science.gov (United States)

Nohynek, Gerhard J; Skare, Julie A; Meuling, Wim J A; Wehmeyer, Kenneth R; de Bie, Albertus Th H J; Vaes, Wouter H J; Dufour, Eric K; Fautz, Rolf; Steiling, Winfried; Bramante, Mario; Toutain, Herve

2015-07-01

Systemic exposure was measured in humans after hair dyeing with oxidative hair dyes containing 2.0% (A) or 1.0% (B) [(14)C]-p-phenylenediamine (PPD). Hair was dyed, rinsed, dried, clipped and shaved; blood and urine samples were collected for 48 hours after application. [(14)C] was measured in all materials, rinsing water, hair, plasma, urine and skin strips. Plasma and urine were also analysed by HLPC/MS/MS for PPD and its metabolites (B). Total mean recovery of radioactivity was 94.30% (A) or 96.21% (B). Mean plasma Cmax values were 132.6 or 97.4 ng [(14)C]-PPDeq/mL, mean AUC(0-∞) values 1415 or 966 ng [(14)C]-PPDeq/mL*hr in studies A or B, respectively. Urinary excretion of [(14)C] mainly occurred within 24 hrs after hair colouring with a total excretion of 0.72 or 0.88% of applied radioactivity in studies A or B, respectively. Only N,N'-diacetylated-PPD was detected in plasma and the urine. A TK-based human safety assessment estimated margins of safety of 23.3- or 65-fold relative to respective plasma AUC or Cmax values in rats at the NOAEL of a toxicity study. Overall, hair dyes containing PPD are unlikely to pose a health risk since they are used intermittently and systemic exposure is limited to the detoxified metabolite N,N'-diacetyl-PPD. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

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)

Nuclear power and probabilistic safety assessment (PSA): past through future applications

Science.gov (United States)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

Thermal reactor safety

International Nuclear Information System (INIS)

1980-06-01

Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport

Thermal reactor safety

Energy Technology Data Exchange (ETDEWEB)

1980-06-01

Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

The human component in the safety of complex systems

International Nuclear Information System (INIS)

Wahlstroem, B.

1986-02-01

The safety of nuclear power and other complex processes requires that human actions are carried though on time and without error. Investigations indicate that human errors are the main or an important contributing cause in more than half of the incidents which occur. This makes it important to try understand the mechanisms behind the human errors and to investigate possibilities for decreasing their likelihood. The present report presents an overview of the Nordic cooperation in the field of human factors in nuclear safety, under the LIT-programme carried out 1981-1985. The work was divided into six different projects in the following fields: human reliability in test and maintenance work; safety oriented organizations and company structures; design of information and control systems; new approaches for information presentation; experimental validation of man-machine interfaces; planning and evaluation of operator training. The research topics were selected from the findings of an earlier phase of the Nordic cooperation. The results are described in more detail in separate reports

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

Science.gov (United States)

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

The consideration of the humane factor is essential in safety systems

International Nuclear Information System (INIS)

Parisot, F.

2010-01-01

In most risk analysis we consider that the staff fit perfectly the tasks to do in terms of training and competence but in fact a lot of factors intervene like the level of stress of the operator, the time available to identify the trouble or to take a decision, the relevance of the procedures, or the level of coordination and communication between the members of the staff. Different methods exist to assess the human factor, most have been designed to be used in the nuclear sector for instance: THERP (Technique for Human Error Rate Prediction) or OATS (Operation Action Tree) or SHARP (Systematic Human Action Reliability Procedure). These methods apply as early as the design stage of the engineered safety systems. Virtual reality has entered these methods because it allows operators to learn by making errors since errors in virtual reality have no consequences. Learning by making errors is an efficient method to get the operator used to accidental situations and as a consequence to reduce his level of stress. Some methods incorporate human elements into system safety analysis through the definition of performance shaping factors that describe the behaviour of operators in terms of physical and psychological abilities. (A.C.)

Assessment and promotion of safety culture in medical practices using sources of ionizing radiation. The Cuban experience

International Nuclear Information System (INIS)

Ferro Fernandez, Ruben; Guillen Campos, Alba; Arnau Fernandez, Alma

2008-01-01

Full text: The lessons learned from several radiological accidents in medical and industrial practices using sources of ionization radiation show that a fragile safety culture in the organizations and the human error were the most important contributors to such events. The high contribution of human factors to safety of radiotherapy treatment process have been also revealed by the results of a recent study on Probabilistic Safety Assessment to this process conducted in the framework of the Extra budgetary Programme on Nuclear and Radiological Safety in Iberian-America. Nevertheless non considerable efforts are appreciated around the world to investigate and develop methods and techniques to assess and promote a strong safety culture in those practices as it has been happening in other sectors like nuclear power, chemical, commercial aviation and oil industry. The Cuban Nuclear Regulatory Authority has in course a National Program for Promoting and Assessment of Safety Culture in organizations using sources of ionizing radiation. As part of this program, during the 2007 year, a pilot study with this purpose was carried out Two Radiotherapy and Nuclear Medicine Units were selected for this pilot study, where managers and specialists were interviewed, a safety culture survey was executed and a final report was prepared with several recommendations to be taking account by Regulator for designing its regulatory strategy on safety culture for medical practices and by users to increase their safety culture level. This paper describes the methodology used to organize, prepare, execute and report the results, findings and recommendations of this kind of review, the benefits and main difficulties encountered during this effort and the perspective and suggestions that, in opinion of the authors of this paper, are important to take into account in the field of radiological safety culture in the near future. (author)

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

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.

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

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

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

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)

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

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

Sensitivity of risk parameters to human errors in reactor safety study for a PWR

International Nuclear Information System (INIS)

Samanta, P.K.; Hall, R.E.; Swoboda, A.L.

1981-01-01

Sensitivities of the risk parameters, emergency safety system unavailabilities, accident sequence probabilities, release category probabilities and core melt probability were investigated for changes in the human error rates within the general methodological framework of the Reactor Safety Study (RSS) for a Pressurized Water Reactor (PWR). Impact of individual human errors were assessed both in terms of their structural importance to core melt and reliability importance on core melt probability. The Human Error Sensitivity Assessment of a PWR (HESAP) computer code was written for the purpose of this study. The code employed point estimate approach and ignored the smoothing technique applied in RSS. It computed the point estimates for the system unavailabilities from the median values of the component failure rates and proceeded in terms of point values to obtain the point estimates for the accident sequence probabilities, core melt probability, and release category probabilities. The sensitivity measure used was the ratio of the top event probability before and after the perturbation of the constituent events. Core melt probability per reactor year showed significant increase with the increase in the human error rates, but did not show similar decrease with the decrease in the human error rates due to the dominance of the hardware failures. When the Minimum Human Error Rate (M.H.E.R.) used is increased to 10 -3 , the base case human error rates start sensitivity to human errors. This effort now allows the evaluation of new error rate data along with proposed changes in the man machine interface

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

MedWatch Safety Alerts for Human Medical Products

Data.gov (United States)

U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

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

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

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.

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...

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

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Nuclear power safety economics

International Nuclear Information System (INIS)

Legasov, V.A.; Demin, V.F.; Shevelev, Ya.V.

1984-01-01

The existing conceptual and methodical basis for the decision-making process insuring safety of the nuclear power and other (industrial and non-industrial) human activities is critically analyzed. Necessity of development a generalized economic safety analysis method (GESAM) is shown. Its purpose is justifying safety measures. Problems of GESAM development are considered including the problem of costing human risk. A number of suggestions on solving them are given. Using the discounting procedure in the assessment of risk or detriment caused by harmful impact on human health is substantiated. Examples of analyzing some safety systems in the nuclear power and other spheres of human activity are given

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.

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)

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

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)

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

The Safety of Melatonin in Humans

DEFF Research Database (Denmark)

Andersen, Lars Peter Holst; Gögenür, Ismayil; Rosenberg, Jacob

2016-01-01

Exogenous melatonin has been investigated as treatment for a number of medical and surgical diseases, demonstrating encouraging results. The aim of this review was to present and evaluate the literature concerning the possible adverse effects and safety of exogenous melatonin in humans. Furthermore...... been reported. No studies have indicated that exogenous melatonin should induce any serious adverse effects. Similarly, randomized clinical studies indicate that long-term melatonin treatment causes only mild adverse effects comparable to placebo. Long-term safety of melatonin in children...

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.

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

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

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)

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

Leadership and Management for Safety. General Safety Requirements

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factor, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations (registrants and licensees) and other organizations concerned with facilities and activities that give rise to radiation risks

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

Large Scale System Safety Integration for Human Rated Space Vehicles

Science.gov (United States)

Massie, Michael J.

2005-12-01

Since the 1960s man has searched for ways to establish a human presence in space. Unfortunately, the development and operation of human spaceflight vehicles carry significant safety risks that are not always well understood. As a result, the countries with human space programs have felt the pain of loss of lives in the attempt to develop human space travel systems. Integrated System Safety is a process developed through years of experience (since before Apollo and Soyuz) as a way to assess risks involved in space travel and prevent such losses. The intent of Integrated System Safety is to take a look at an entire program and put together all the pieces in such a way that the risks can be identified, understood and dispositioned by program management. This process has many inherent challenges and they need to be explored, understood and addressed.In order to prepare truly integrated analysis safety professionals must gain a level of technical understanding of all of the project's pieces and how they interact. Next, they must find a way to present the analysis so the customer can understand the risks and make decisions about managing them. However, every organization in a large-scale project can have different ideas about what is or is not a hazard, what is or is not an appropriate hazard control, and what is or is not adequate hazard control verification. NASA provides some direction on these topics, but interpretations of those instructions can vary widely.Even more challenging is the fact that every individual/organization involved in a project has different levels of risk tolerance. When the discrete hazard controls of the contracts and agreements cannot be met, additional risk must be accepted. However, when one has left the arena of compliance with the known rules, there can be no longer be specific ground rules on which to base a decision as to what is acceptable and what is not. The integrator must find common grounds between all parties to achieve

Light water reactor sequence timing: its significance to probabilistic safety assessment modeling

International Nuclear Information System (INIS)

Bley, D.C.; Buttemer, D.R.; Stetkar, J.W.

1988-01-01

This paper examines event sequence timing in light water reactor plants from the viewpoint of probabilistic safety assessment (PSA). The analytical basis for the ideas presented here come primarily from the authors' work in support of more than 20 PSA studies over the past several years. Timing effects are important for establishing success criteria for support and safety system response and for identifying the time available for operator recovery actions. The principal results of this paper are as follows: 1. Analysis of event sequence timing is necessary for meaningful probabilistic safety assessment - both the success criteria for systems performance and the probability of recovery are tightly linked to sequence timing. 2. Simple engineering analyses based on first principles are often sufficient to provide adequate resolution of the time available for recovery of PSA scenarios. Only those parameters that influence sequence timing and its variability and uncertainty need be examined. 3. Time available for recovery is the basic criterion for evaluation of human performance, whether time is an explicit parameter of the operator actions analysis or not. (author)

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)

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

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.

Development of a procedure for qualitative and quantitative evaluation of human factors as a part of probabilistic safety assessments of nuclear power plants. Part B. Technical documentation

International Nuclear Information System (INIS)

Richei, A.

1998-01-01

As international studies have shown, accidents in plants are increasingly caused by combinations of technical failures and human errors. Therefore careful investigations of man-machine-interactions to determine human reliability are gaining importance worldwide. Regarding nuclear power plants such investigations are usually carried out within the scope of probabilistic safety assessments. A great number of procedures to evaluate human factors has been developed up to now. However, none of them is able to take into account the whole spectrum of requirements - as for instance transferability of date to other plants, analysis of weak points, and evaluation of cognitive tasks - for a complete and reliable probabilistic safety assessment. Based on an advanced model for a man-machine-system, the Human Error Rate Assessment and Optimizing System (HEROS) and a corresponding expert system of the same name are introduced. This expert system enables the quantification of human error probabilities for plant operator actions on the one hand and is also capable of providing quantitative statements regarding the optimization of man-machine-system in terms of human error probability minimization on the other one. Three relevant evaluation levels, i.e. 'Management Structure', 'Working Environment' and 'Man-Machine-Interface', are derived from a model of the man-machine-system. Linguistic variables are assigned to all performance shaping factors at these levels. These variables are used to establish a rule-based expert system. The knowledge bases of this system are represented by rules. Processing of these rules is carried out by means of the fuzzy set theory, after provision of relevant data for a particular personal action to be evaluated. This procedure enables a simple and effective use of ergonomic studies as the relevant database, which is also transferable to other plants with any design. The expert system consist in total of 16 rule bases in which all ascertainable and

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

Assessment of reliability and validity of a new safety culture questionnaire

Directory of Open Access Journals (Sweden)

A.A. Farshad

2010-04-01

Full Text Available Background and aims   As a Development of Industrial process, human, environment, equipment, material and validity of system has been exposed to hazardous conditions. Regards of 32.3 percent of occupations in industries, this study focused on risk assessment of foundry unit by energy trace and barrier analysis (ETBA method and presented approaches to control of accident.     Methods   the recent study is as a case study one to risk assessment in a foundry unit in Qazvin industrial city in1387. In this study risks were founded by ETBA method and evaluated by MILSTD- 882B. Data were collected by direct observations, interview with workers and supervisor and engineers, walking-talking through method, documents investigation of operational processors, preventive maintenances, equipment technical properties, accidental and medical documents. Finally ETBA worksheets completed.     Results   totally 154 risks has been found. 40 from total are been unacceptable risk, 68 unfavorable and also 46 acceptable but with remediation action. Casting workshop had risks more than other workshops (with 74 identified risks.Potential and heat energies were founded as most   hazardous energies, with respectively 51 and 38 risk cases.     Conclusion   This study recommended to be done actions for identification and control risk, such as: safety training, occupation training, preventive maintenance, contract safety, safety  communication and safety audit group.  

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.

Human factors and systems engineering approach to patient safety for radiotherapy.

Science.gov (United States)

Rivera, A Joy; Karsh, Ben-Tzion

2008-01-01

The traditional approach to solving patient safety problems in healthcare is to blame the last person to touch the patient. But since the publication of To Err is Human, the call has been instead to use human factors and systems engineering methods and principles to solve patient safety problems. However, an understanding of the human factors and systems engineering is lacking, and confusion remains about what it means to apply their principles. This paper provides a primer on them and their applications to patient safety.

Human Factors and Systems Engineering Approach to Patient Safety for Radiotherapy

International Nuclear Information System (INIS)

Rivera, A. Joy; Karsh, Ben-Tzion

2008-01-01

The traditional approach to solving patient safety problems in healthcare is to blame the last person to touch the patient. But since the publication of To Err is Human, the call has been instead to use human factors and systems engineering methods and principles to solve patient safety problems. However, an understanding of the human factors and systems engineering is lacking, and confusion remains about what it means to apply their principles. This paper provides a primer on them and their applications to patient safety

Safety assessment of consumption of glabrous canary seed (Phalaris canariensis L.) in rats.

Science.gov (United States)

Magnuson, B A; Patterson, C A; Hucl, P; Newkirk, R W; Ram, J I; Classen, H L

2014-01-01

Canary seed is a nutrient-rich cereal grain; however, it has not been used in human food in part due to concerns regarding safety of consumption. Glabrous or hairless canary seed has potential human food use as trichomes are absent. The objective of the oral feeding studies reported here was to assess the safety of yellow and brown glabrous canary seed cultivars as human cereal foods. The first study was a 90-day rat oral toxicity study, which compared the effects of diets containing 50% of either brown dehulled glabrous, brown hulled glabrous, or brown hulled pubescent (hairy) hulled canary seed to a diet containing 50% wheat. No significant adverse effects were observed. In a 28-day and a 90-day study rats were fed yellow or brown glabrous canary seed groats in the AIN-76 diet at concentrations levels of 2.5%, 5% and 10%. The NOAELs in 90-day study were 5.15 g/kg/d and 5.23 g/kg/d for yellow and brown canary seed groats. Consumption of canary seed was associated with reduced incidence and severity of liver lipidosis as compared to controls. The combined results of these studies clearly demonstrate the safety of consumption of glabrous canary seed, and support its use as a human cereal grain. Copyright © 2013 Elsevier Ltd. All rights reserved.

NASA Human System Risk Assessment Process

Science.gov (United States)

Francisco, D.; Romero, E.

2016-01-01

two-page assessment representing the state of knowledge/evidence of that risk, available risk mitigations, traceability to the Space Flight Human System Standards (SFHSS) and program requirements, and future work required. These data then can drive coordinated budgets across the Human Research Program, the International Space Station, Crew Health and Safety and Advanced Exploration System budgets to provide the most economical and timely mitigations. The risk assessments were completed for the 6 DRMs and serve as the baseline for which subsequent research and technology development and crew health care portfolios can be assessed. The HSRB reviews each risk at least annually or when new evidence/information is available that adds to the body of evidence. The current status of each risk can be reported to program management for operations, budget reviews and general oversight of the human system risk management program.

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

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.

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

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

Development of advanced methods and related software for human reliability evaluation within probabilistic safety analyses

International Nuclear Information System (INIS)

Kosmowski, K.T.; Mertens, J.; Degen, G.; Reer, B.

1994-06-01

Human Reliability Analysis (HRA) is an important part of Probabilistic Safety Analysis (PSA). The first part of this report consists of an overview of types of human behaviour and human error including the effect of significant performance shaping factors on human reliability. Particularly with regard to safety assessments for nuclear power plants a lot of HRA methods have been developed. The most important of these methods are presented and discussed in the report, together with techniques for incorporating HRA into PSA and with models of operator cognitive behaviour. Based on existing HRA methods the concept of a software system is described. For the development of this system the utilization of modern programming tools is proposed; the essential goal is the effective application of HRA methods. A possible integration of computeraided HRA within PSA is discussed. The features of Expert System Technology and examples of applications (PSA, HRA) are presented in four appendices. (orig.) [de

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

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

Human Capital Questionnaire: Assessment of European nurses' perceptions as indicators of human capital quality.

Science.gov (United States)

Yepes-Baldó, Montserrat; Romeo, Marina; Berger, Rita

2013-06-01

Healthcare accreditation models generally include indicators related to healthcare employees' perceptions (e.g. satisfaction, career development, and health safety). During the accreditation process, organizations are asked to demonstrate the methods with which assessments are made. However, none of the models provide standardized systems for the assessment of employees. In this study, we analyzed the psychometric properties of an instrument for the assessment of nurses' perceptions as indicators of human capital quality in healthcare organizations. The Human Capital Questionnaire was applied to a sample of 902 nurses in four European countries (Spain, Portugal, Poland, and the UK). Exploratory factor analysis identified six factors: satisfaction with leadership, identification and commitment, satisfaction with participation, staff well-being, career development opportunities, and motivation. The results showed the validity and reliability of the questionnaire, which when applied to healthcare organizations, provide a better understanding of nurses' perceptions, and is a parsimonious instrument for assessment and organizational accreditation. From a practical point of view, improving the quality of human capital, by analyzing nurses and other healthcare employees' perceptions, is related to workforce empowerment. © 2012 Wiley Publishing Asia Pty Ltd.

Reference biospheres for the long term safety assessment of radioactive waste disposal facilities

International Nuclear Information System (INIS)

Crossland, I.G.; Torres, C.

2002-01-01

Regulatory guidance on the safety assessment of radioactive waste disposals usually requires the consequences of any radionuclide releases to be considered in terms of their potential impact on human health. This requires consideration of the prevailing biosphere and the habits of the potentially exposed humans within it. However, it could take many thousands of years for migrating radionuclides to reach the surface environment. In these circumstances, an assessment model that was based on the present-day biosphere could be inappropriate while future biospheres would be unpredictable. These and other considerations suggest that a standardised, or reference biosphere, approach may be useful. Theme 1 of the IAEA BIOMASS project was established to develop the concept of reference biospheres into a practical system that can be applied to the assessment of the long term safety of geological disposal facilities for radioactive waste. The technical phase of the project lasted for four years until November 2000 and brought together disparate interests from many countries including waste disposal agencies, regulators and technical experts. Building on the experience from earlier BIOMOVS projects, a methodology was constructed for the logical and defensible construction of mathematical biosphere models that can be used in the total system performance assessment of radioactive waste disposal. The methodology was then further developed through the creation of a series of BIOMASS Example Reference Biospheres ('Examples'). These are stylised biosphere models that, in addition to illustrating the methodology, are intended to be useful assessment tools in their own right. (author)

Safety assessment of decyl glucoside and other alkyl glucosides as used in cosmetics.

Science.gov (United States)

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

2013-01-01

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 19 alkyl glucosides as used in cosmetics and concluded that these ingredients are safe in the present practices of use and concentration when formulated to be nonirritating. Most of these ingredients function as surfactants in cosmetics, but some have additional functions as skin-conditioning agents, hair-conditioning agents, or emulsion stabilizers. The Panel reviewed the available animal and clinical data on these ingredients. Since glucoside hydrolases in human skin are likely to break down these ingredients to release their respective fatty acids and glucose, the Panel also reviewed CIR reports on the safety of fatty alcohols and were able to extrapolate data from those previous reports to support safety.

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.

Biosafety assessment of probiotics used for human consumption: recommendations from the EU-PROSAFE project

NARCIS (Netherlands)

Vankerckhoven, V.; Huys, G.; Vancanneyt, M.; Vael, C.; Klare, I.; Romond, M.B.; Entenza, J.M.; Moreillon, P.; Wind, R.D.; Knol, J.; Wiertz, E.; Pot, B.; Vaughan, E.E.; Kahlmeter, G.; Goossens, H.

2008-01-01

On June 26-27, 2006, 60 academic and industry scientists gathered during the PROSAFE workshop to discuss recommendations on taxonomy, antibiotic resistance, in vitro assessment of virulence and in vivo assessment of safety of probiotics used for human consumption. For identification of lactic acid

Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.

Science.gov (United States)

Zhang, Wei; Kong, Yujia; Jiang, Zhiwei; Li, Chanjuan; Wang, Ling; Xia, Jielai

2016-04-02

Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, double-blinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P < 0.0001), except local pain and pruritus. More severe adverse reactions were observed after the initial injection than after the booster injection. Serious cold or respiratory tract infections (RTI) were observed more often in children aged 6-36 months than in older children. Only the severity of local swelling was associated with body mass index. Children with throat discomfort before injection had a higher risk of serious cold or RTI. These results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile.

A development of the Human Factors Assessment Guide for the Study of Erroneous Human Behaviors in Nuclear Power Plants

International Nuclear Information System (INIS)

Oh, Yeon Ju; Lee, Yong Hee; Jang, Tong Il; Kim, Sa Kil

2014-01-01

The aim of this paper is to describe a human factors assessment guide for the study of the erroneous characteristic of operators in nuclear power plants (NPPs). We think there are still remaining the human factors issues such as an uneasy emotion, fatigue and stress, varying mental workload situation by digital environment, and various new type of unsafe response to digital interface for better decisions, although introducing an advanced main control room. These human factors issues may not be resolved through the current human reliability assessment which evaluates the total probability of a human error occurring throughout the completion of a specific task. This paper provides an assessment guide for the human factors issues a set of experimental methodology, and presents an assessment case of measurement and analysis especially from neuro physiology approach. It would be the most objective psycho-physiological research technique on human performance for a qualitative analysis considering the safety aspects. This paper can be trial to experimental assessment of erroneous behaviors and their influencing factors, and it can be used as an index for recognition and a method to apply human factors engineering V and V, which is required as a mandatory element of human factor engineering program plan for a NPP design

A development of the Human Factors Assessment Guide for the Study of Erroneous Human Behaviors in Nuclear Power Plants

Energy Technology Data Exchange (ETDEWEB)

Oh, Yeon Ju; Lee, Yong Hee; Jang, Tong Il; Kim, Sa Kil [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2014-08-15

The aim of this paper is to describe a human factors assessment guide for the study of the erroneous characteristic of operators in nuclear power plants (NPPs). We think there are still remaining the human factors issues such as an uneasy emotion, fatigue and stress, varying mental workload situation by digital environment, and various new type of unsafe response to digital interface for better decisions, although introducing an advanced main control room. These human factors issues may not be resolved through the current human reliability assessment which evaluates the total probability of a human error occurring throughout the completion of a specific task. This paper provides an assessment guide for the human factors issues a set of experimental methodology, and presents an assessment case of measurement and analysis especially from neuro physiology approach. It would be the most objective psycho-physiological research technique on human performance for a qualitative analysis considering the safety aspects. This paper can be trial to experimental assessment of erroneous behaviors and their influencing factors, and it can be used as an index for recognition and a method to apply human factors engineering V and V, which is required as a mandatory element of human factor engineering program plan for a NPP design.

Modelling of safety barriers including human and organisational factors to improve process safety

DEFF Research Database (Denmark)

Markert, Frank; Duijm, Nijs Jan; Thommesen, Jacob

2013-01-01

It is believed that traditional safety management needs to be improved on the aspect of preparedness for coping with expected and unexpected deviations, avoiding an overly optimistic reliance on safety systems. Remembering recent major accidents, such as the Deep Water Horizon, the Texas City....... A valuable approach is the inclusion of human and organisational factors into the simulation of the reliability of the technical system using event trees and fault trees and the concept of safety barriers. This has been demonstrated e.g. in the former European research project ARAMIS (Accidental Risk...

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

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)

Research on the development of advanced system safety assessment procedures (1)

International Nuclear Information System (INIS)

Suzuki, Kazuhiko

2002-02-01

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, counter measures information related to abnormal situation in plants are added to knowledge base in the system. As the result the HAZOP system can give appropriate measures information to protect accidents to uses. Such HAZOP system is applied to analyze the processes, where the ability of the proposed system is verified. (author)

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)

Development Of Dynamic Probabilistic Safety Assessment: The Accident Dynamic Simulator (ADS) Tool

International Nuclear Information System (INIS)

Chang, Y.H.; Mosleh, A.; Dang, V.N.

2003-01-01

The development of a dynamic methodology for Probabilistic Safety Assessment (PSA) addresses the complex interactions between the behaviour of technical systems and personnel response in the evolution of accident scenarios. This paper introduces the discrete dynamic event tree, a framework for dynamic PSA, and its implementation in the Accident Dynamic Simulator (ADS) tool. Dynamic event tree tools generate and quantify accident scenarios through coupled simulation models of the plant physical processes, its automatic systems, the equipment reliability, and the human response. The current research on the framework, the ADS tool, and on Human Reliability Analysis issues within dynamic PSA, is discussed. (author)

Development Of Dynamic Probabilistic Safety Assessment: The Accident Dynamic Simulator (ADS) Tool

Energy Technology Data Exchange (ETDEWEB)

Chang, Y.H.; Mosleh, A.; Dang, V.N

2003-03-01

The development of a dynamic methodology for Probabilistic Safety Assessment (PSA) addresses the complex interactions between the behaviour of technical systems and personnel response in the evolution of accident scenarios. This paper introduces the discrete dynamic event tree, a framework for dynamic PSA, and its implementation in the Accident Dynamic Simulator (ADS) tool. Dynamic event tree tools generate and quantify accident scenarios through coupled simulation models of the plant physical processes, its automatic systems, the equipment reliability, and the human response. The current research on the framework, the ADS tool, and on Human Reliability Analysis issues within dynamic PSA, is discussed. (author)

Assessment of compliance of Employees and Management to Occupational Health & Safety Act in the Department of Public Safety in the North West Province / Neo Patricia Seleka

OpenAIRE

2011-01-01

The study was designed to determine the worker assessment of compliance to OHS act in the department of Public safety. One hundred and two (102) employees were selected randomly using table of random numbers from different directorates such as Human resources, Finance, Road safety, Crime prevention and Traffic management. Data were collected using a structured questionnaire which was made of personal characteristics and sections on level of compliance with OHS act, workers' ...

International assessment of application of the Code of Conduct on the Safety of Research Reactors

Energy Technology Data Exchange (ETDEWEB)

Shokr, A.M. [Atomic Energy Authority, Abouzabal (Egypt). Egypt Second Research Reactor

2015-11-15

The self-assessments performed by thirty-eight countries on application of the Code of Conduct on the Safety of Research Reactors were analyzed and discussed. The results of this analysis were used to identify areas of satisfactory application of the Code and area needing improvements, and therefore require more attention worldwide. The results showed improvement in application of the Code provisions; notably in aging management, regulatory supervision, and consideration of human factors. However, there is a continuing need for further improvement in these areas, as well as in operational radiation protection, emergency preparedness and decommissioning planning. Additionally, increased attention needs to be given to periodic safety reviews, evaluation of site-specific hazards, and assessment of extreme external events. The results showed consistency with the feedback from other sources of information on generic safety issues for research reactors.

International assessment of application of the Code of Conduct on the Safety of Research Reactors

International Nuclear Information System (INIS)

Shokr, A.M.

2015-01-01

The self-assessments performed by thirty-eight countries on application of the Code of Conduct on the Safety of Research Reactors were analyzed and discussed. The results of this analysis were used to identify areas of satisfactory application of the Code and area needing improvements, and therefore require more attention worldwide. The results showed improvement in application of the Code provisions; notably in aging management, regulatory supervision, and consideration of human factors. However, there is a continuing need for further improvement in these areas, as well as in operational radiation protection, emergency preparedness and decommissioning planning. Additionally, increased attention needs to be given to periodic safety reviews, evaluation of site-specific hazards, and assessment of extreme external events. The results showed consistency with the feedback from other sources of information on generic safety issues for research reactors.

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

Suggestions for an improved HRA method for use in Probabilistic Safety Assessment

International Nuclear Information System (INIS)

Parry, Gareth W.

1995-01-01

This paper discusses why an improved Human Reliability Analysis (HRA) approach for use in Probabilistic Safety Assessments (PSAs) is needed, and proposes a set of requirements on the improved HRA method. The constraints imposed by the need to embed the approach into the PSA methodology are discussed. One approach to laying the foundation for an improved method, using models from the cognitive psychology and behavioral science disciplines, is outlined

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

Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

Science.gov (United States)

Luxhoj, James T.

2003-01-01

Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

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.

Patient safety - the role of human factors and systems engineering.

Science.gov (United States)

Carayon, Pascale; Wood, Kenneth E

2010-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety.

Patient Safety: The Role of Human Factors and Systems Engineering

Science.gov (United States)

Carayon, Pascale; Wood, Kenneth E.

2011-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety. PMID:20543237

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

Energy Technology Data Exchange (ETDEWEB)

Sellin, Patrik (comp.)

2006-09-15

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

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

International Nuclear Information System (INIS)

Sellin, Patrik

2006-09-01

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

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.

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...

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

Human Factor Modelling in the Risk Assessment of Port Manoeuvers

Directory of Open Access Journals (Sweden)

Teresa Abramowicz-Gerigk

2015-09-01

Full Text Available The documentation of human factor influence on the scenario development in maritime accidents compared with expert methods is commonly used as a basis in the process of setting up safety regulations and instructions. The new accidents and near misses show the necessity for further studies in determining the human factor influence on both risk acceptance criteria and development of risk control options for the manoeuvers in restricted waters. The paper presents the model of human error probability proposed for the assessment of ship masters and marine pilots' error decision and its influence on the risk of port manoeuvres.

Safety of modifications at nuclear power plants - the role of minor modifications and human and organisational factors

International Nuclear Information System (INIS)

2005-01-01

Operating experience repeatedly shows that changes and modifications at nuclear power plants (NPPs) may lead to safety significant events. At the same time, modifications are necessary to ensure a safe and economic functioning of the NPPs. To ensure safety in all plant configurations it is important that modification processes are given proper attention both by the utilities and the regulators. The operability, maintainability and testability of every modification should be thoroughly assessed from different points of view to ensure that no safety problems are introduced. The OECD/NEA Committee on Safety of Nuclear Installations (CSNI) has recently addressed the issue of modifications by organising a 'Workshop on Modifications at Nuclear Power Plants Operating Experience, Safety Significance and Role of Human Factors'. This workshop was undertaken as a joint effort of the Working Group on Operating Experience (WGOE) and the Special Experts Group on Human and Organisational Factors (SEGHOF), and it was held at the OECD Headquarters in Paris on October 6 to 8, 2003. The initiative to organise the workshop was taken by the WGOE and the SEGHOF based on findings from events and incidents due to modifications at nuclear power plants in the world and weaknesses experienced in modification processes. During the workshop, the WGOE focused on the theme of 'Minor Modifications and their Safety Significance', while the SEGHOF focused on the topic 'Human and Organisational Factors in NPP Modifications'. This report is based on material collected before the workshop, the workshop proceedings, discussions of the group of experts responsible for the arrangement of the workshop, and additional material collected by a consultant. The workshop was preceded by extensive preparations, which included collection of national surveys in response to questionnaires on modifications at the NPPs. Not all of these surveys were available at the workshop, but their findings have now been included

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.

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.

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

A human error taxonomy for analysing healthcare incident reports: assessing reporting culture and its effects on safety perfomance

DEFF Research Database (Denmark)

Itoh, Kenji; Omata, N.; Andersen, Henning Boje

2009-01-01

The present paper reports on a human error taxonomy system developed for healthcare risk management and on its application to evaluating safety performance and reporting culture. The taxonomy comprises dimensions for classifying errors, for performance-shaping factors, and for the maturity...

Some international perspectives on legislation for the management of human-induced safety risks

Directory of Open Access Journals (Sweden)

Alfonso Niemand

2016-01-01

Full Text Available Legislation that governs the health and safety of communities near major-hazard installations in South Africa is largely based on existing legislation that had been developed in the United Kingdom and other European Union countries. The latter was developed as a consequence of several major human-induced technological disasters in Europe. The history of the evolution of health-and-safety legislation for the protection of vulnerable communities in European Union (EU countries, France, Malaysia and the USA is explored through a literature survey. A concise comparison is drawn between EU countries, the USA and South Africa to obtain an exploratory view of whether current South-African legislation represents an optimum model for the protection of the health-and-safety of workers and communities near major-hazard installations. The authors come to the conclusion that South-African legislation needs revision as was done in the UK in 2011. Specific areas in the legislation that need revision are an overlap between occupational health and safety and environmental legislation, appropriate land-use planning for the protection of communities near major-hazard installations, the inclusion of vulnerability studies and the refinement of appropriate decision-making instruments such as risk assessment. This article is the first in a series that forms part of a broader study aimed at the development of an optimised model for the regulatory management of human-induced health and safety risks associated with hazardous installations in South Africa.