Recent Progress in Risk Consideration and Issues on Developing Risk Informed Regulations in Japan

Author(s):  
Akihide Hidaka

The Nuclear Safety Commission (NSC), Japan set up the taskforce on introduction of risk informed regulation (RIR) into nuclear safety regulations in April 2004. Since then the taskforce (Chairperson: Prof. Genki Yagawa, Toyo university) has reviewed the status of risk considerations at related organizations and discussed the issues for developing RIR in Japan. Recently, the taskforce prepared the interim report on the review results and discussions, and NSC approved it in December 2005. The report described that the risk consideration in related organizations in Japan has made progress in line mostly with the NSC’s basic policy for introduction of RIR expressed in 2003. However, the following topics were identified as important issues for further promotion of RIR introduction: policy for utilization of risk information considering Japanese features, usage of safety goals and performance objectives in RIR, decision-making process using risk information, pilot program, PSA quality, improvement of safety examination guidelines considering risk information, utilization of risk information in nuclear fuel cycle facilities and risk communication.

Author(s):  
Akihide Hidaka

Based on the basic policy for introduction of Risk Informed Regulation (RIR) expressed by the Nuclear Safety Commission (NSC) of Japan in 2003, NSC set up the taskforce in April 2004 to take an initiative for coordinated collaboration of related organizations for developing scheme of RIR. Since then the taskforce has reviewed the efforts of related organizations and discussed the issues on further utilization of risk information in Japan. According to the final report prepared by the taskforce in September 2007, the risk consideration in related organizations has made a progress in line mostly with the NSC’s basic policy. For example, the regulatory guide for seismic design was revised in 2006 including combination of deterministic and probabilistic approaches. The regulatory body will start a new inspection system in 2008 that considers the risk informed safety classification of structures, systems and components. However, the followings were identified as important issues in the future: i) promotion of advanced and preliminary trials, ii) comprehensive applications using PSA results for both of the representative and individual plants, iii) preparation of acceptance guidelines for safety and performance goals in risk informed decision making, iv) improvement of PSA quality, v) revision of regulatory guides considering risk information, vi) comprehensive evaluation and promotion by NSC for further utilization of risk information, vii) enhancement of infrastructure such as PSA experts and database, viii) promotion of safety research, ix) application to seismic design, x) Introduction of risk informed approaches into nuclear fuel cycle facilities, and xi) promotion of risk communication, etc.


Author(s):  
Sungkook Park ◽  
David Sands ◽  
Carlos Alejaldre

The ITER project is basically an engineering and construction project in order to build the ITER machine which is a scientific experimental fusion device. The seven members of the project have all created legal entities called Domestic Agencies to provide in-kind contributions to the ITER Organization (IO) for the supply of components which are manufactured by their suppliers. According to ITER agreement and due to nuclear safety involved in the fusion process, the project requires a license from the French Nuclear Safety Authority. One of nuclear safety regulations is the French Quality Order. The IO has established a Quality Assurance Program for the construction of the ITER machine to meet the requirements of the Order and to ensure that ITER activities are performed to achieve the safety and performance objectives of the ITER machine. The requirements in the program shall be followed by all performers involved in the project not only the IO, but DAs and their suppliers and subcontractors. This paper represents the quality requirements from the Order, and roles and responsibilities between each performer involved in the project. The paper also shows the main characteristics of the ITER Quality Assurance Program ensuring that all activities performed for the project conform to established and documented requirements.


2012 ◽  
Vol 28 (2) ◽  
pp. 171-179 ◽  
Author(s):  
Philipp Mad ◽  
Sabine Geiger-Gritsch ◽  
Gerda Hinterreiter ◽  
Stefan Mathis-Edenhofer ◽  
Claudia Wild

Objectives: A new decision-making process was set up by the Austrian Ministry of Health to regulate coverage of new proposed Extra Medical Services (EMS; German: Medizinische Einzel-Leistung [MEL]) in 2008. As part of the annual decision-making process an independent academic institution (LBI-HTA) is evaluating relevant evidence on these new technologies and provides HTAs, including evidence-based recommendations for decision makers.Methods: About ten EMS assessments are performed annually by the LBI-HTA simultaneously between January and March. Each peer-reviewed report consists of a systematic literature review and critical appraisal of evidence using the GRADE methodology. The generation of numerous reports of good quality standards within the short timeframe is achieved by a standardized workflow with predefined assignment of tasks for all participants.Results: In total, the LBI-HTA performed twenty-five EMS assessments on thirty-three different interventions in the last three years. Coverage was recommended with limitation for eleven (33%) interventions, and not recommended for twenty-two (66%) interventions. The federal health commission decided on acceptance or preliminary acceptance of coverage in seven (22%) cases, rejection in eighteen (55%) cases and changed the status to “subject to approval” in seven (24%) cases.Conclusions: Pre-coverage assessment of new hospital interventions was implemented successfully in Austria. It has proved to be a useful tool to support decision makers with objective evidence when deciding whether or not to reimburse medical services.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Washington T. Samukange ◽  
Verena Kluempers ◽  
Manvi Porwal ◽  
Linda Mudyiwenyama ◽  
Khamusi Mutoti ◽  
...  

Abstract Background Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries. Methods We piloted the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed. Results The countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44 % (range: 7.5 % - 70 %). The lowest average performance scores were for the arrangement for effective organisation and coordination (35 %) and human resources (35 %) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50 % and 60 %, respectively). We identified clusters of best-implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources. Conclusions Implementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in the implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs.


Author(s):  
Yusuke Masuda ◽  
Yukihiro Iguchi ◽  
Satoru Kawasaki ◽  
Masami Kato

In Japan, 4 nuclear power stations are under decommissioning and some nuclear fuel cycle facilities are expected to be decommissioned in the future. On the other hand, the safety regulation of decommissioning of nuclear facilities was changed by amending act in 2005. An approval system after review process of decommissioning plan was adopted and applied to the power stations above. In this situation, based on the experiences of the new regulatory system, the system should be well established and moreover, it should be improved and enhanced in the future. Nuclear Industry and Safety Agency (NISA) is in charge of regulation of commercial nuclear facilities in Japan and decommissioning of them is included. Japan Nuclear Energy Safety Organization (JNES) is in charge of technical supports for NISA as a TSO (Technical Support Organization) also in this field. As for decommissioning, based on regulatory needs, JNES has been continuing research activities from October 2003, when JNES has been established. Considering the “Prioritized Nuclear Safety Research Plan (August 2009)” of the Nuclear Safety Commission of Japan and the situation of operators faculties, “Regulatory Support Research Plan between FY 2010–2014” was established in November 2009, which shows the present regulatory needs and a research program. This program consists of researches for 1. review process of decommissioning plan of power reactors, 2. review process of decommissioning plan of nuclear fuel cycle facilities, 3. termination of license at the end of decommissioning and 4. management of decommissioning waste. For the item 1, JNES studied safety assessment methods of dismantling, e.g. obtaining data and analysis of behavior of dust diffusion and risk assessment during decommissioning, which are useful findings for the review process. For the item 2, safety requirements for the decommissioning of nuclear fuel cycle facilities was compiled, which will be used in the future review. For the item 3, measuring method, release procedure and analysis code for the site release were studied for the establishment of the license termination process in the future. From FY 2010, based on the new plan, we have started the researches for the standardization of review process of decommissioning plan for power reactors and nuclear fuel cycle facilities, establishing the process and criteria of license termination and appropriate method of management of decommissioning waste based on the waste form confirmation process.


2011 ◽  
Vol 57 ◽  
pp. 26-38 ◽  
Author(s):  
Jonas Mackevičius ◽  
Dalia Daujotaitė

Veiklos auditas yra viena iš labai svarbių audito sistemos rūšių, tačiau audito literatūroje daugelis jo aspektų išnagrinėti nepakankamai. Veiklos audito praktinio taikymo patirtis Lietuvoje taip pat maža. Straipsnyje nagrinėjama veiklos audito reikšmė ir sąvokos apibūdinimas įvairių užsienio ir Lietuvos autorių darbuose. Pasiūlytas veiklos audito apibrėžimas (įvertinus šiuolaikinės ekonomikos dinamiškumą ir sudėtingumą), atitinkantis šiandieninės globalios rinkos sąlygas. Ištirta veiklos audito vieta audito sistemoje. Išnagrinėtas veiklos audito procesas.Pagrindiniai žodžiai: veiklos auditas, tikrinimas ir vertinimas, audito sistema, veiklos audito procesas.Performance Audit: Tool of Performance Testing and EvaluationJonas Mackevičius, Dalia Daujotaitė SummaryThe phenomenon of the performance audit could be assessed as a response to new developments in economy and the new management and governance models stimulating to seek a further improvement in the governance and enhancement of the accountability and responsibility of different levels of government. The findings and results of the insights formulated within the research lead to the conclusion that performance audit is representative of the modern version of audit and constitutes a challenge to the conventional administration, imposing a requirement for new knowledge and its innovative application. Performance audit may be perceived as a source of a timely, reliable and objective information on the management and performance processes showing the status of management and shaping the decision-making process."> 


Author(s):  
Barbara Vezzoni ◽  
Giuseppe Forasassi

This work focuses on the definition of a suitable methodology to compare different nuclear energy options, with particular attention to strategies able to minimize nuclear wastes. In order to set possible transition scenarios from actual GEN-II reactors, the energy demand and the nuclear energy share up to 2050 have been evaluated by means of data available in the international literature. To compare the different options, major indicators of energy-electricity sector have been analyzed. With particular attention to nuclear energy social acceptability the major indicators investigated are the inventory and the radiotoxicity vs. time of residual wastes. In order to reach a final equilibrium situation, transition scenarios, where GEN-III (e.g. EPR) and GEN-IV new reactors (as lead cooled fast ones), have been analyzed. As cases study Spain and France scenarios have been considered.


Author(s):  
J. C. Kuijper

The PUMA project, a Specific Targeted Research Project (STREP) of the European Union EURATOM 6th Framework Program, is mainly aimed at providing additional key elements for the utilisation and transmutation of plutonium and minor actinides (neptunium and americium) in contemporary and future (high temperature) gas-cooled reactor design, which are promising tools for improving the sustainability of the nuclear fuel cycle. PUMA would also contribute to the reduction of Pu and MA stockpiles and to the development of safe and sustainable reactors for CO2-free energy generation. The project runs from September 1, 2006 until August 31, 2009. PUMA also contributes to technological goals of the Generation IV International Forum. It contributes to developing and maintaining the competence in reactor technology in the EU and addresses European stakeholders on key issues for the future of nuclear energy in the EU. An overview is presented of the status of the project at mid-term.


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