• 한국임상약학회지
• /
• 제31권1호
• /
• pp.53-60
• /
• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• 한국안전학회지
• /
• 제29권1호
• /
• pp.86-92
• /
• 2014

This paper provides an integrated view on human and system interaction in advanced and automated systems, which adopting computerized multi-functional artifacts and complicated organizations, such as nuclear power plants, chemical plants, steel and semi-conduct manufacturing system. As current systems have advanced with various automated equipments but human operators from various organizations are involved in the systems, system safety still remains uncertain. Especially, a human operator plays an important role at the time of critical conditions that can lead to catastrophic accidents. The knowledge on human error helps a risk manager as well as a designer to create and control a more credible system. Several human error theories were reviewed and adopted for forming the integrated perspective: gulf of execution and evaluation; risk homeostasis; the ironies of automation; trust in automation; design affordance; distributed cognition; situation awareness; and plan delegation theory. The integrated perspective embraces human error theories within three levels of human-system interactions such as affordance level, psychological logic level and trust level. This paper argued that risk management process should dealt with human errors by providing (1) reasoning improvement; (2) support to situation awareness of operators; and (3) continuous monitoring on harmonization of human system interaction. This approach may help people to understand risk of human-system interaction failure characteristics and their countermeasures.

• 대한안전경영과학회지
• /
• 제3권3호
• /
• pp.175-190
• /
• 2001

We propose, a new process capability index $C_{psk}$(WV) applying the weighted variance control charting method for non-normally distributed. The main idea of the weighted variance method(WVM) is to divide a skewed or asymmetric distribution into two normal distributions from its mean to create two new distributions which have the same mean but different standard deviations. In this paper we propose an example, a distributions generated from the Johnson family of distributions, to demonstrate how the weighted variance-based process capability indices perform in comparison with another two non-normal methods, namely the Clements and the Wright methods. This example shows that the weighted valiance-based indices are more consistent than the other two methods in terms of sensitivity to departure to the process mean/median from the target value for non-normal processes. Second method show using the percentage nonconforming by the Pearson, Johnson and Burr systems. This example shows a little difference between the Pearson system and Burr system, but Johnson system underestimated than the two systems for process capability.

• 항공우주시스템공학회지
• /
• 제11권3호
• /
• pp.31-38
• /
• 2017

항공 산업의 소비 수요가 증가함에 따라 국내에서 수행할 수 있는 인증체계 및 비행시험 운영에 필요한 연구가 요구된다. 이에 따라 본 논문에서는 국내 민항기 KC-100, 군용기 T-50 사례와 국외 FAA(Federal Aviation Administration), CAAC(Civil Aviation Administration of China) 기관의 비행시험 관련 문건을 바탕으로 개발 및 개조 중에 있는 항공기에 대한 성능검증, 시험평가 및 안전성 인증을 위한 비행시험 운영 절차와 안전 관리 프로그램 개발 연구를 수행하였다. 또한 항공기 비행시험 절차에 적용할 수 있는 FTSC(Flight Test Safety Committee)의 모범사례(Best Practices)를 조사 분석하였다.

• 한국재난정보학회 논문집
• /
• 제18권3호
• /
• pp.520-531
• /
• 2022

연구목적: 본 연구는 수소충전소의 위험성 평가를 바탕으로, 운영주의 주요 관심 사항인 수익성과 경영 위험성을 고찰함으로써 경영안전성 강화를 위한 방안을 찾고자 한다. 연구방법: 위험성 평가를 수소충전소의 설치단계부터 시간의 흐름에 따라 '수용 가능한 위험성'과 '허용 가능한 위험성'으로 구분하여 기존의 연구결과와 비교, 분석하였다. 연구결과: 수소충전소 설치단계에 실행하는 위험성 평가는 현재 기존의 연구가 적절하게 적용되고 있었다. 그러나 운영단계에서 발생 가능한 위험을 찾을 수 있었다. 즉 경영위험성에 대한 평가도 필요함을 도출하였다. 그리고 이를 통해 수소충전소의 안전성이 강화됨을 확인했다. 결론: 수소충전소 설치단계에 선행되는 위험성평가는 '수용 가능한 위험성' 평가로 모두 유의미한 결과가 도출되어 적절하게 활용되고 있다. 그러나 운영주는 운영단계에서 발생 가능한 위험, 즉 '허용 가능한 위험성' 평가와 대응방안 마련이 필요하다. 따라서 보다 안전한 수소충전소 구축과 운영을 위하여 경영위험성 평가 항목 추가를 제안한다.

• 건설안전기술
• /
• 통권36호
• /
• pp.73-81
• /
• 2006

Construction fall accidents have been investigated by many researchers. Construction workers are prone to fall when elevations of the construction site is high. And falls are the most fatal accidents: it can be directly linked to the death. Construction fall accidents might be reduced by predetermining several areas which are highly probable to have fall accidents and by controlling such areas until the completion of the building construction. In this paper, a fall prevention system is suggested which can identify the areas where the focus on fall protection is perhaps most needed from the process characteristics. Main methodologies for this research are summarized as follows: 1. A data base on elements and types of falls is constructed from the data analysis of last 10 years fall accidents history. 2. Guideline is derived by identifying the highly probable areas of fall accidents with respect to the specific construction process. 3. Developed system is verified by applying the system to construction sites. 4. Finally a fall prevention system is suggested by utilizing the fall accidents data.

• 한국신뢰성학회지:신뢰성응용연구
• /
• 제15권1호
• /
• pp.27-32
• /
• 2015

Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.

• 한국보육지원학회지
• /
• 제19권5호
• /
• pp.65-79
• /
• 2023

Objective: The purpose of this study was to identify the importance and performance of the evaluation indicators of the childcare center evaluation system among childcare center staff and to find ways to improve the evaluation indicators of the childcare center evaluation system. Methods: A survey was conducted among 296 directors and teachers of childcare centers located in Busan and Gyeongnam. The collected data were analyzed using a paired sample t-test and an IPA analysis with SPSS 23.0 and Excel 2010. Results: There was a difference between the perceived importance and performance of childcare staff for the overall evaluation indicators, and significant differences were found in all areas and nine evaluation indicators except for "childcare environment and operation management". According to the IPA analysis, Health and Safety fell into quadrant 1, Staff into quadrant 2, and Child Care Process, Interaction, Child Care Environment, and Operations into quadrant 3. This distribution resulted in 6 indicators in quadrant 1, 4 in quadrant 2, 7 in quadrant 3, and 1 in quadrant 4. Conclusion/Implications: This study provides essential data for exploring ways to enhance the evaluation indicators of the childcare center evaluation system, with the goal of improving the quality of childcare services. Additionally, it offers policy implications.

• Nuclear Engineering and Technology
• /
• 제39권2호
• /
• pp.149-160
• /
• 2007

The IAEA launched the International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO) and developed the INPRO Methodology to provide guidelines and to assess the characteristics of a future innovative nuclear energy system in areas such as safety, economics, waste management, and proliferation resistance. The proliferation resistance area of the INPRO Methodology is reviewed here, and modifications for further improvements are proposed. The evaluation metrics including the evaluation parameters, evaluation scales and acceptance limits are developed for a practical application of the methodology to assess the proliferation resistance. The proliferation resistant characteristics of the DUPIC fuel cycle are assessed by applying the modified INPRO Methodology based on the developed evaluation metrics and acceptance criteria. The evaluation procedure and the metrics can be utilized as a reference for an evaluation of the proliferation resistance of a future innovative nuclear energy system.

• 대한안전경영과학회지
• /
• 제13권3호
• /
• pp.63-69
• /
• 2011

As environmental protection is becoming more and more important, green production has become a key issue for almost every manufacturer and will determine a manufacturer can be sustainable in the long term. Therefore a performance evaluation system for green suppliers is necessary to determine the suitability of suppliers to cooperate with the company. While the works on the evaluation and/or selection of suppliers are abundant, those that concern environmental issues are rather limited. The objective of this study is to construct a combined model based on fuzzy analytic hierarchy process (FAHP) and balanced scorecard (ESC) for evaluating green suppliers in the manufacturing industry. The ESC concept is applied to define the hierarchy with four major perspectives (i.e. financial, customer, internal business process, and learning and growth), and performance indicators are selected for each perspective. FAHP is then proposed in order to tolerate vagueness and ambiguity of information. Finally, FAHP is finally constructed to facilitate the solving process. With the proposed model, manufacturers can have a better understanding of the capabilities that a green supplier must possess and can evaluate and select the most suitable green supplier for cooperation.