• Proceedings of the Korean Nuclear Society Conference
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• 1997.05a
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• pp.233-238
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• 1997

본 논문에서는 Safety-critical 소프트웨어를 위한 V'||'&'||'V 지침서(guideline) 개발 방법론을 제시한다. 즉, 기존의 산업계 표준인 IEEE Std-1012, IEEE Std-1059에서 논의되고 있는 개념을 근간으로 "독립성(independence)", "소프트웨어 안전성 분석(software safety analysis)", "COTS 평가(evaluation) 기준", "다른 보증(assurance) 조직들간의 관련성(relationship)" 등의 필수 안전 항목들을 추가하여 원전 안전성 시스템(NPP safety system)을 위한 V'||'&'||'V 지침서 개발 방법론을 제시하였다 제시된 방법론에는 V'||'&'||'V 지침서의 범위(scope), 승인기준(acceptance criteria) 부분인 지침서 프레임(guideline framework), V'||'&'||'V activities 및 methods 부분인 타스크(task) entrance 및 exit 기준(criteria), 리뷰 및 감사(review and audit), 테스팅 그리고 V'||'&'||'V material의 QA 레코드(records) 및 형상관리, 소프트웨어 검증 및 확인 계획서(Software Verification and Validation Plan : SVVP) 생성 등의 내용을 기술하고, Safety-critical 소프트웨어 V'||'&'||'V 방법론도 함께 제시하였다.

• International conference on construction engineering and project management
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• 2020.12a
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• pp.243-248
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• 2020

In addition to a range of H&S documentation, a range of actions, beliefs, interventions, practices, and states are important in terms of achieving optimum construction H&S. Conclusions include that H&S documentation facilitates and assists planning, organising, leading, controlling, and coordinating H&S. Furthermore, current H&S documentation: is inappropriate in that it can be complex, generic, lengthy, onerous, repetitive (duplicative), and vague; engenders dubious practices; generally, 'does not add the potential value'; shifts the focus from the physical process, and could be improved. Recommendations include: industry associations should review their 'audit system' to interrogate the allocation of points; H&S documents must reflect the intention of the requirement; the synergy between H&S documentation, and actions, interventions, and practices should be investigated, digested, and focused upon, and 'audits', or rather inspections, should focus more on the physical process, actions, interventions, and practices, than documentation.

• The Journal of KAIRB
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• v.2 no.2
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of the Korean Society of Marine Environment & Safety
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• v.23 no.7
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• pp.783-790
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• 2017

An acceptable proximity assessment collision probability is widely considered to be less than $10^{-4}$ in maritime traffic safety audit schemes. In the 1970s, Fujii, Macduff and colleagues introduced various models for collision probability of aberrancy in the community. Although existing studies ensured acceptable proximity collision probability, around $10^{-4}$, they were constrained by assumptions. A lack of support for the proximity probability criterion has been investigated in this study for practical use. The appropriate proximity probability for different size vessels in both straight and curved lanes has been analyzed based on GICOMS data. As a result, reasonable proximity collision probabilities were determined for various vessel traffic conditions. Accordingly, necessary improvements in the maritime traffic system have been suggested in consideration for various maritime traffic situations and conditions.

• Journal of Food Hygiene and Safety
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• v.14 no.1
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• pp.104-114
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• 1999

This study was conducted to find out the proper ways of implementation of Hazard Analysis Critical Control Point (HACCP) concepts applicable to the current Korean food inspection system. The following recommendations are based on an in-depth review of the Canadian Food Safety Enhancement Program (FSEP), which is one of the leading HACCP programs adapted to the food industry. Since 1997, the HACCP system has been voluntarily applied to meat processing plants in Korea in accordance with the Food Protection Law. But the guidelines are obscure and inadequate to expand to the diversity of food plants, and are therefore only applied to a limited number of plants of small scale enterprise. For these reasons, it is necessary to prepare an enhanced food safety control program focused not only on the HACCP plants but also on the non-HACCP plants. The national program should be the fundamental framework of a food safety control policy enforced by all the relevant authorities. The Prerequiste Program of Canadian Food Inspection Agency and Sanitation Standard Operating Procedures (SSOP) of FSIS are good example programs for the non-HACCP plants. These programs, which are a major part of the HACCP system, could easily be adapted to the Korean food industry. To improve the current HACCP implementation guideline, it is necessary to develop a detailed implementation manual, generic HACCP model, training program, and an audit program.

• Journal of the Society of Disaster Information
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• v.8 no.3
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• pp.310-318
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• 2012

Actual condition by items based on the level of execution of Construction Company certified by Construction Safety and Health Management Systems (KOSHA 18001) was investigated, analyzed and evaluated reflecting various opinions fincluding safety experts, top management, audit experts, and construction engineers. Currently, the maintenance is being managed through internal audit after the safety and health management system has been certified, but it is difficult to identify the degree of continuous improvement. In order to present the standards to see the level of quantified system, this study was conducted. The purpose of this study is to present the system maturity evaluation tool to be used to reduce occupational accidents through proper establishment and continuous improvement of national health and safety management system. Results of this study are summarized through identification of current condition of implementation of KOSHA 18001 system, development of maturity measurement tool and verification as follows: First, priority of implementation for activities of headquarters and on-site was determined by importance of activities such as the risk assessment, safety and health accident prevention activities, performance assessment and monitoring, resource management and support, and management review and improvement in order. In addition, the expert group presented that association with continuous improvement activities could establish the system by presenting strengths, weaknesses and improvement subjects of system.

• International Commerce and Information Review
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• v.11 no.3
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• pp.239-262
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• 2009

This study shed light on the status of Korean Kimchi industry in overseas markets and presented methods for promoting Kimchi industry of Gwangju Jeonnam metropolitan city and stimulating the export of Kimchi produced in Gwangju Jeonnam, a city that has come to the fore as the center of Kimchi industry, which aimed to explore the ways of ratcheting up competitiveness of Kimchi industry in the global market as Kimchi has become more likely to be globalized amid the recent "Korea Trend" boom and the growing consumption of fermented food. Therefore, methods for promoting Kimchi industry and stimulating the export of Kimchi should be explored to ensure the promotion of Kimchi industry and the stimulation of the export of Kimchi, ultimately restoring the status of Korea as the home of Kimchi, in consideration of the great spillover effect on the regional economy, through a series of measures such as the clusterization of Kimchi industry, expansion of cultural experience projects related to Kimchi for the globalization and the increased consumption of Kimchi, government support to increase Kimchi companies in size and achieve the modernization of Kimchi companies, introduction of Kimchi KS audit system and quality certification system, development of new product targeting global market and making Kimchi a high-end product, expansion of export, support of export market diversification, assurance of safety and price competitiveness of Kimchi, differentiated production and marketing strategy by means of technological research, and others.

• Management & Information Systems Review
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• v.6
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• pp.137-162
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• 2001

Our business conglomerates are sharing their fates economically because of mutual debt warranty among their own affiliates and excessive financial loans. For this reason, it is inevitably restrictive to obtain the whole information on such conglomerates by individual and consolidated financial statements. To solve this problem, the system of combined financial statement was introduced through modifications of the Act of the outside audit of corporations in 1988. As a result, 15 out of this nation's 30 major business conglomerates prepared and submitted their own combined financial statements. In this paper, all financial statements are grouped into financial and non-financial parts, based on characteristics of business control and combined financial statement. Then the business size, financial rate and internal transactions for each of the conglomerates are analyzed, based on which problems of the combined financial statement as announced publicly are clarified. For the system, this study suggests improvement points such as a sufficient publication of any possible situations and interest coordination caused between the date of business settlement and that of preparing combined financial statements by applying principles of sharing to the evaluation of valuable instrument papers for investment and by determining the amount, 5% accounting for the total amount of debt warranty, foreign exchange assets and debts.

• The Journal of the Korea Contents Association
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• v.11 no.2
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• pp.397-407
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• 2011

The Open Position System is a new personnel management system started in korea, 1999.Open Position System have purpose to use outstanding talents and to expertise from both public and private sector. Korean government adapted open position system in order to use the right man in the right place. And Korean government incresae application of Open Position System. But, in spite of strong good point of Open Position System, We have limitation to apply Open Position System in police organization, generally. Because police have unique characteristics compare with other public organization. There is constant controversy concerning unique characteristics of police organization. Now, Korean police adopt Open Position System in few division: Chiep of Driver's License Agency, Director General for Audit and Inspection of Nation police Agency, Chiep of police hospital. Therefore, this study explore, extention possibility of Open Position System in Korean police.