• Proceedings of the PSK Conference
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• 2003.10a
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• Journal of Korean Society for Quality Management
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• v.41 no.4
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• pp.725-735
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• 2013

Purpose: The purpose of this study is to propose an Integrated Safety Evaluation Process (ISEP) that can enhances the safety aspect of the safety-critical system. This process utilizes the advantages of the iterative Systems Engineering process combined with the safety assessment process that is commonly and well defined in many standards and/or guidelines for railway, aerospace, and other safety-critical systems. Methods: The proposed process model is based on the predefined system lifecycle, in each phase of which the appropriate safety assessment activities and the safety data are identified. The interfaces between Systems Engineering process and the safety assessment process are identified before the two processes are integrated. For the integration, the elements at lower level of Systems Engineering process are combined with the relevant elements of safety assessment process. This combined process model is represented as Enhanced Functional Flow Block Diagram (EFFBD) by using CORE(R) that is commercial modelling tool. Results: The proposed model is applied to the lifecycle and management process of the United States aircraft system. The US aircraft systems engineering process are composed of twelve key elements, among which the requirements management, functional analysis, and Synthesis processes are considered for examplenary application of the proposed process. To synchronize the Systems Engineering process and the safety assessment process, the Systems Engineering milestones are utilized, where the US aircraft system has thirteen milestones. Taking into account of the nine steps in the maturity level, the integrated process models are proposed in some phases of lifecycle. The flows of processes are simulated using CORE(R), confirming the flows are timelined without any conflict between the Systems Engineering process and the safety assessment process. Conclusion: ISEP allows the timeline analysis for identifying activity and data flows. Also, the use of CORE(R) is shown to be effective in the management and change of process data, which helps for the ISEP to apply for the development of safety critical system. In this study, only the first few phases of lifecyle are considered, however, the implementation through operation phases can be revised by combining the elements of safety activities regarding those phases.

• Journal of the Korean Society of Safety
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• v.18 no.4
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• pp.148-154
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• 2003

There are now the plating process that have many hazardous factor cause of the using numerous noxious chemical and bad working environments. The purpose of the study is to make a selection of suitable safety evaluation method that can analyze and righteously find with numerous hazardous factor of the plating process. And another purpose is to systematically adjust the risk of plating process by comprehension of the role of process, equipment, and source material. Therefore, these studies are carried out in the following three investigations of this report. The first research understands the injurious human health and environment by analyzing hazardous material based on the MSDS. To evaluate the safety of process and compartment, the second research is proposed the security secure counterproposal by using the FMEA and the HAZOP. The final research is devoted to systematically analyze the hazard by applying for reasonable guide word and doing the HAZOP for hazardous factor in specific process.

• Journal of the Korea Safety Management & Science
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• v.9 no.4
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• pp.49-56
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• 2007

It is known that human factors account for 80 percent of all railway accidents. To reduce human errors must be the most efficient shortcut to railway safety. For public transportation employees like railway, the more delicate safety management should be executed in individual level. However, there are rarely efforts to improve safety performance of workers who are the subject operating the railway system. This paper develops a hierarchy model to evaluate the human safety performance in railway industry. To evaluate the model, AHP (Analytic Hierarchy Process) methodology is adopted. The hierarchy model is composed of four levels which are objective, two criteria, specific factors of criteria, and rating scales. In addition, since employees for evaluation are over 10, the pairwise comparisons for rating scales are carried out by the absolute measurement. We explore the applicability of AHP to the performance evaluation of railway safety workers by an example and also investigate the changes of alternatives that are railway employees according to the changes of human characteristic which is one of criteria.

• Journal of the Korea Safety Management & Science
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• v.7 no.4
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• pp.27-38
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• 2005

In manufacturing industry of the modem industrial society, people increasingly become concerned the awareness of safety increasingly although they have regarded production the most important factor. Even though, as people make efforts on accident preventions, the number of accidents is decreasing, fatal major industry accidents are rather thanincreasing so that the number of deaths has not decreased. Under these conditions, there is an attempt to introduce and perform the process safety management system as a means for keeping from major industry accidents. However, it leaves to be desired on the methods of measuring process safety in the general manufacturing industry, while it is available to do that in the chemistry industry. Therefore, in this paper, we analysis processes of manufacturing industry in safety point of view and suggest the technique efficiently measuring and managing each process. Proposed the technique shows that the specification on safety determines AHP weight through the managers of firms and each process is suggested by using normalized matrix.

• Journal of the Korea Safety Management & Science
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• v.9 no.2
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• pp.195-214
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• 2007

The purpose of this study is to explore the applicability of AHP(Analytic Hierarchy Process) to select more productive projects among various proposed projects in a particular company. To achieve this research objective, the characteristics of project evaluation and selection are first reviewed with respect to when, where, and how the decision is made. Then the theoretical basis of the AHP is briefly reviewed along with its mathematical underpinnings to construct the framework of project evaluation and selection. To be more specific, the evaluation and selection criteria were reorganized in the AHP-based framework to make the process of project evaluation and selection more productive. Project evaluation and selection is one of the most important activities for the most companies to be more advantageous in the market. Despite the importance of decision making process of project selection, not many of how to choose the best project were suggested as the reliable project selection methods in the industries. It may be because it involves various activities related to conflict resolution among different evaluation criteria, high uncertainties of market, and the unclear tradeoff among various project objectives. Furthermore, the decision, once made at this point, tends to be irrevocable until the whole process turns out to be a complete success or failure. As the result, the AHP method showed better financial performance rather than the traditional method in a case study.

• Proceedings of the Safety Management and Science Conference
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• 2013.04a
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• pp.271-284
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• 2013

최근 현대 무기체계는 최첨단 기술로 인한 무기체계 개발 속도 증가와 획득환경의 다변화와 더불어 이에 대한 위험도 동시에 증가하고 있다. 이에 따라 미국방부는 무기체계의 수명주기를 고려하여 시험평가를 지속 적용토록 강조하고 있다. 따라서 기존의 무기체계 시험평가 프로세스에서 다루는 시스템 설계에 대한 단계별 안전 활동의 강화의 필요성 역시 강조되고 있다. 그 중에서도 무기체계 개발의 핵심 활동에 해당하는 체계개발 단계는 양산에 들어가기 전의 최종 활동으로서 제대로 수행되어야만 초기에 의도한 무기체계 개발의 목적을 달성할 수 있을 것이다. 본 논문에서는 시스템 안전성 요소를 고려한 시험평가 프로세스의 개선사항 도출과 모델링을 통해 무기체계 시스템인 무기체계를 대상으로 적용 및 조정 구축에 대한 내용을 기술하고 있다. 본 연구의 결과를 토대로 향후 시험평가 기간의 단축 및 비용 절감과 데이터의 관리 및 추적 기능을 개선함으로써 무기체계 개발 후의 안전사고 발생 가능성을 줄일 수 있을 것으로 기대된다.

• Journal of the Korea Safety Management & Science
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• v.25 no.3
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• pp.55-62
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• 2023

Public institutions have a responsibility to ensure the safety of their employees and the public. One way to do this is to implement a systematic safety inspection system based on risk assessments and continuous improvements. This study developed a systematic safety inspection system for public institutions that are ordered construction projects. The proposed system in this study consists of a three-step process: (1) developing safety grade evaluation tables, (2) preparing and conducting safety inspections, and (3) evaluating and improving safety management grades. The first step is to develop safety grade evaluation tables by analysis and diagnosis of the construction site's work type, disaster statistics, and related laws. The second step is to conduct safety inspections using the developed evaluation tables. The third step is to determine the safety management grade based on the results of the safety inspection, and to improve risk factors found during the safety evaluation. The proposed system was implemented in highway construction projects carried out by public institutions. The results showed that the proposed system has two major effects: (1) reducing accident-related deaths and injuries, (2) improving safety management levels by continuous evaluation and improvement. The proposed system can be utilized in construction projects ordered by public institutions to improve the level of occupational safety and health.

• Journal of the Korean Society for Railway
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• v.10 no.4
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• pp.438-443
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• 2007

This paper proposes an integrated SE process for the development of railway systems with safety assessment included. Although the safety assessment process must be performed with SE process properly with good coordination, the interfaces between the two processes have not been clear. Thus, in many of safety critical system developments in Korea, it is difficult to assess safety in proper development phase. The process model proposed in this paper is based on both the concept of system life cycle and the repetitive use of SE process. In each of development phases, appropriate safety assessment methods are described. Also the evaluation of the integrated system incorporating safety factors is described. The resultant process model is expressed by the Enhanced Functional Flow Block Diagram (EFFBD) using a CASE tool. The model also allows timeline analysis for identifying activity flow and data flow, resulting in the effective management of process. In conclusion, the integrated process enable both the SE process and safety assessment process to cooperate with each other from early development phase throughout the whole system life cycle.

• KSCE Journal of Civil and Environmental Engineering Research
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• v.39 no.1
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• pp.105-114
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• 2019

Recently, the paradigm of road policy has been focused on user safety. Recently, the number of road facility improvement project has been continuously increased but the economic feasibility (B/C ratio) is insufficient. Therefore, it is necessary to select a reasonable road improvement project through accurate and objective analysis of the road safety evaluation. In this study, to develop a new road safety evaluation method, data were collected based on the current road safety evaluation method for 75 routes including national roads and provincial ones. Based on the collected data, problems were analyzed and utilized as the basic factors of the new road safety evaluation method. Therefore, in this study, traffic accidents were reflected as a general evaluation item by weighing to solve these problems, and the evaluation items were added from experiences and ideas of the local public officials. For each evaluation item, a reasonable weight was determined through AHP (Analytic Hierarchy Process) questionnaire evaluation with highway experts. In addition, the safety index was determined based on the evaluation criteria for each evaluation item. The criteria for evaluating the danger zone are determined by the overall safety index. Finally, the criteria for selection of road improvement projects based on the overall risk level were derived.