• Nuclear Engineering and Technology
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• 제50권7호
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• pp.997-1005
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• 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.

• 한국전자통신학회논문지
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• 제12권5호
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• pp.725-730
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• 2017

원전의 안전 유지를 위한 계측제어계통에 일반적인 IT 자원을 활용하는 사례가 증가하고 있다. 이에 따라 기존 IT 자원이 갖는 잠정적인 보안 취약점으로 인해 원전 사이버 보안 침해 사고가 발생할 수 있으며, 원전의 가동 중단뿐만 아니라 국가적 재난에 이르는 심각한 사고를 야기할 수 있다는 문제가 제기되고 있다. 국내 원자력 규제기관에서는 이에 대응하기 위해 원전 사이버 보안 규제지침을 개발하고 규제 대상 및 범위를 확대시키고 있지만, 원전의 일반적인 보안 문제뿐만 아니라 원전 취약점에 특화된 공격에도 대응할 수 있는 방안이 필요하다. 이에 본 논문에서는 R.G.5.71에서 규정하고 있는 내용 중 취약점 점검과 관련된 42개 항목을 선별하여 5가지의 유형으로 분류 분석하였다. 제안된 분석 내용을 바탕으로 취약점 점검 도구를 개발한다면 원전 사이버 보안 취약점 점검 효율성을 향상시킬 수 있을 것으로 판단된다.

• 무역학회지
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• 제47권5호
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• pp.95-113
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• 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.

• 품질경영학회지
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• 제50권4호
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• pp.717-734
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• 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.

• 대한인간공학회지
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• 제35권4호
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• pp.263-275
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• 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
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• 제56권2호
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• pp.426-436
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• 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
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• 제11권2호
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• pp.43-47
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• 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.

• 비파괴검사학회지
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• 제30권4호
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• pp.380-385
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• 2010

국내 가동중 원자력발전소는 KEPIC MI 또는 ASME Code Sec. XI 등의 기술기준에 따라 가동중검사를 수행하며, 이를 통해 주요 기기 및 배관의 건전성을 확인하고 있다. 하지만, 원전 설계단계에서 고려되지 못한 다양한 손상기구에 대해서는 별도의 강화 검사프로그램을 통해 건전성을 확인하고 있다. 이러한 강화 검사프로그램에 대한 요건은 규제기관에서 개발하거나, 발전사업자가 자발적으로 규정을 마련하는 경우가 있으며, 사업자가 개발한 검사프로그램에 대해서는 규제기관의 심사과정을 거쳐 적합성 여부를 확인하고 있다. 본 논문에서는 원자력발전소 설계단계에서부터 반영된 기술기준 KEPIC 또는 ASME Code에 따른 가동중검사 외에, 발전소 손상경험 등을 반영하여 강화된 검사프로그램을 중점적으로 고찰하고, 비파괴검사 관련 요건을 검토하였다.

• 한국압력기기공학회 논문집
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• 제14권2호
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• pp.49-58
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• 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.

• 방사성폐기물학회지
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• 제4권4호
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• pp.401-409
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• 2006

우리나라를 포함한 일본 및 미국과 독일, 영국, 프랑스 등 유럽국가의 원자력발전소 해체에 관한 규제제도 조사를 수행하였다. 각국의 해체에 관한 규제제도에 관하여 규제정책, 법규, 인허가 절차, 검사, 대중참여 등의 항목별로 비교분석을 수행하였다. 향후 본 조사결과는 국내의 가동 원자력발전소의 폐로 및 해체에 대비한 국내 제도 개선방향 수립에 참조자료로서 활용될 예정이다.