• Nuclear Engineering and Technology
• /
• v.50 no.7
• /
• pp.997-1005
• /
• 2018

The regulatory periodic safety inspection system is one of the most important methods for confirming the safety of nuclear power plants and the defense in depth in nuclear safety is the most important basic means for accident prevention and mitigation. Recently, a new regulatory technology based on risk-informed and safety performance has been developed and used in advanced countries. However, since the domestic periodic inspection system is being used in the same way over 30 years, it is necessary to know how the inspection contributes to the safety confirmation of the nuclear power plants. In this study, the domestic periodic inspection system currently in use was analyzed from the perspective of defense in depth in nuclear safety. In addition, the analysis results were compared to the U.S. NRC's safety inspection system to obtain consistency and lessons in this study. As a result of analysis, the NRC's safety inspections were distributed almost evenly at the all levels of defense in depth, while in the case of domestic inspection, they were heavily focused on the level 1 of defense in depth. Therefore, it appeared urgent to improve the inspection system to strengthen the other levels of defense in depth in nuclear safety.

• The Journal of the Korea institute of electronic communication sciences
• /
• v.12 no.5
• /
• pp.725-730
• /
• 2017

The use of general IT resources in the Instrumentation and Control system(I&C) for the safety of Nuclear Power Plants(NPPs) is increasing. As a result, potential security vulnerabilities of existing IT resources may cause cyber attack to NPPs, which may cause serious consequences not only to shutdown of NPPs but also to national disasters. In order to respond to this, domestic nuclear regulatory agencies are developing guidelines for regulating nuclear cyber security regulations and expanding the range of regulatory targets. However, it is necessary to take measures to cope with not only general security problems of NPPs but also attacks specific to NPPs. In this paper, we select 42 items related to the vulnerability inspection in the contents defined in R.G.5.71 and classify it into 5 types. If the vulnerability inspection tool is developed based on the proposed analysis, it will be possible to improve the inspection efficiency of the cyber security vulnerability of the NPPs.

• Korea Trade Review
• /
• v.47 no.5
• /
• pp.95-113
• /
• 2022

Tariffs on pharmaceuticals are generally low, but the time-consuming and costly licensing procedures of importing countries may act as barriers to trade. Accordingly, in terms of improving export competitiveness through cost reduction of exporting countries and improving public health for importing countries, international regulatory collaboration is effective for both countries. However, little is known about the impact of cross-border cooperation in pharmaceutical regulation on international trade. This study empirically analyzed the effect of cross-border regulatory collaboration on pharmaceutical trade using the gravity model. It was confirmed that the regulatory collaboration measures had a trade promotion effect in all drugs(HS29+HS30), finished drugs (HS30), and vaccines (HS300220). This study is meaningful in that it empirically analyzed with the consideration of the reference pharmacopoeia, safety and effectiveness in addition to the GMP inspection used in the previous study.

• Journal of Korean Society for Quality Management
• /
• v.50 no.4
• /
• pp.717-734
• /
• 2022

Purpose: The purpose of this study is to effectively detect violations that occur simultaneously against Good Manufacturing Practice, which were concealed by drug manufacturers. Methods: In this study, we present an analysis framework for analyzing regulatory violation patterns using Association Rule Mining (ARM), Text Mining, and t-distributed Stochastic Neighbor Embedding (t-SNE) to increase the effectiveness of on-site inspection. Results: A number of simultaneous violation patterns was discovered by applying Association Rule Mining to FDA's inspection data collected from October 2008 to February 2022. Among them there were 'concurrent violation patterns' derived from similar regulatory ranges of two or more regulations. These patterns do not help to predict violations that simultaneously appear but belong to different regulations. Those unnecessary patterns were excluded by applying t-SNE based on text-mining. Conclusion: Our proposed approach enables the recognition of simultaneous violation patterns during the on-site inspection. It is expected to decrease the detection time by increasing the likelihood of finding intentionally concealed violations.

• Journal of the Ergonomics Society of Korea
• /
• v.35 no.4
• /
• pp.263-275
• /
• 2016

Objective: This paper introduces the regulatory oversight approaches and issues to consider in the course of safety culture oversight model development in the nuclear field. Common understanding on regulatory oversight and present practices of international communities are briefly reviewed. The nuclear safety culture oversight model of Korea is explained focusing on the development of safety culture definition and components, and their basic meanings. Oversight components are identified to represent the multiple human and organizational elements which can affect and reinforce elements of defense in depth system for nuclear safety. Result of validation study on safety culture components is briefly introduced too. Finally, the results of the application of the model are presented to show its effectiveness and feasibility. Background: The oversight of nuclear licensee's safety culture has been an important regulatory issue in the international community of nuclear safety regulation. Concurrent with the significant events that started to occur in the early 2000s and that had implications about safety culture of the operating organizations, it has been natural for regulators to pay attention to appropriate methods and even philosophy for intervening the licensee's safety culture. Although safety culture has been emphasized for last 30 years as a prerequisite to ensure high level of nuclear safety, it has not been of regulatory scope and has a unique dilemma between external oversight and the voluntary nature of culture. Safety culture oversight is a new regulatory challenge that needs to be approached taking into consideration of the uncontrollable aspects of cultural changes and the impacts on licensee's safety culture. Although researchers and industrial practitioners still struggle with measuring, evaluating, managing and changing safety culture, it was recognized that efforts to observe and influence licensees' safety culture should not be delayed. Method: Safety culture components which regulatory oversight will have to focus on are developed by benchmarking the concept of physical barriers and introducing the defense in depth philosophy into organizational system. Therefore, this paper begins with review of international regulatory oversight approaches and issues associated with the regulatory oversight of safety culture, followed by the development of oversight model. The validity of the model was verified by statistical analysis with the survey result obtained from survey administration to NPP employees in Korea. The developed safety culture oversight model and components were used in the "safety culture inspection" activities of the Korean regulatory body. Results: The developed safety culture model was confirmed to be valid in terms of content, construct and criterion validity. And the actual applicability in the nuclear operating organization was verified after series of pilot "safety culture inspection" activities. Conclusion: The application of the nuclear safety culture oversight model to operating organization of NPPs showed promising results for regulatory tools required for the organizations to improve their safety culture. Application: The developed oversight model and components might be used in the inspection activities and regulatory oversight of NPP operating organization's safety culture.

• Nuclear Engineering and Technology
• /
• v.56 no.2
• /
• pp.426-436
• /
• 2024

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards. In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

• Corrosion Science and Technology
• /
• v.11 no.2
• /
• pp.43-47
• /
• 2012

Recently, regulatory bodies quite often encourage to adopt risk-based inspection (RBI) and management programs because they can enhance safety simultaneously with deregulation in Korea. RBI is an integrated methodology that factors risk into inspection and maintenance decision making. This paper describes an example of how to use known risk assessment codes (API 580, API 581 BRD) to address such safety analysis requirements for risk management in the refining industry. Specifically, this paper reports the methodology and the results of implementation to the Crude Distillation Unit(CDU) plant of refinery units using the $KGS-RBI^{TM}$ program, developed by the Korea Gas Safety Corporation in reference of API Codes and ASME PC (Post Construction) with a suitable consideration of Korean situation. The results of the risk and reliability assessment using $KGS-RBI^{TM}$ program are useful in determining whether the detected defects are tolerable or required to be repaired. The subsequent decisions are to manage the future inspection, repair and maintenance planning in the risk reduction control.

• Journal of the Korean Society for Nondestructive Testing
• /
• v.30 no.4
• /
• pp.380-385
• /
• 2010

The integrity of components and piping of operating nuclear power plants has been identified by in-service inspection(ISI) requirements and activities commensurate with standards and codes such as KEPIC MI or ASME Code Section XI. However, the other various degradation mechanisms not considered during design stage of nuclear power plants have been checked by enhanced ISI. The requirements of enhanced ISI have been voluntarily developed by the industry itself or strickly issued by regulatory body. Even though the requirements were developed by the industry, they should be reviewed by regulatory body for their application in nuclear power plants. The enhanced ISI activities and requirements of non-destructive examination(NDE) which reflect the degradation issues in nuclear power industry will be primarily discussed in this paper.

• Transactions of the Korean Society of Pressure Vessels and Piping
• /
• v.14 no.2
• /
• pp.49-58
• /
• 2018

The regulatory periodic inspection program (PSI) conducted at every overhaul period is the most important process for confirming the safety of nuclear power plants. The PSI for operating nuclear power plants in Korea mainly consist of component level performance check that had been developed based on deterministic approach putting the same degree of importance to all the inspection items. This inspection methodology is likely to be effective for preoperational inspection. However, once the plant is put into service, the PSI must be focused on whether to minimize the risk of accident using defense-in-depth concept and risk insight. The incorporation of defense-in-depth concept and risk insight into the deterministic based safety inspection has not been well studied so far. In this study, two track approaches are proposed to make sure that core damage be avoided: one is to secure success path and the other to block the failure path in a specific event tree of PSA. The investigation shows how to select safety important components and how to set up inspection group to ensure that core damage would not occur for a given initiating event, which results in strengthening defense-in-depth level 3.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
• /
• v.4 no.4
• /
• pp.401-409
• /
• 2006

Regulatory systems for decommissioning of nuclear power plants in several countries, such as Japan, United States of America, Germany, United Kingdom, France, and Republic of Korea, are surveyed. In the survey, regulatory policies, legislations, licensing process, inspection and public involvements for decommissioning are identified and compared. Afterwards, the survey results will be utilized as a reference to establish the improvement directions of domestic regulatory system.