• Title/Summary/Keyword: Audit Plan

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Safety-critical 소프트웨어 V&V 지침서 개발 방법론

  • 김장열;이장수;권기춘
    • 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.

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A Study for Human-Error Prevention of Chemical Plant Safety Accident (Chemical 공장 안전사고의 Human-Error 방지에 대한 연구)

  • 윤용구;홍성만;박범
    • Journal of the Korea Safety Management & Science
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    • v.6 no.2
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    • pp.1-9
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    • 2004
  • The chemical factory deals with dangerous element and more advance, human-error analyzes and becomes effective research for the country and region. This paper analysis the form of work-miss on human-error according to a safety accident for domestic chemical factory from 1999-2002. It include the present contents and raise issues human knowledge, behavior, judgment, sensibility as an important counter plan that makes the safety solution of work miss. For the point of view of human knowledge, it takes color standard for works to be effective in work place. For behavior, the test has been for risk Point of work place and infra worker movement, also the workers performed professional work as classify according to work. For judgement, the valuation sheet is reflected to minimize the human-error and the 3rd supervisor does a cross-check audit beforehand. For sensibility, it is applicable for human relations, information, communication by program to the consciousness and an attitude of worker-supervisor.

A Basic Study on the Railway Safety Management Based on Risk Assessment Approach (위험도 평가기법을 적용한 철도시스템의 안전관리)

  • Kim Sang Am;Wang Jong Bae;Kwak Sang Log;Lee Dong Ha
    • Proceedings of the KSR Conference
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    • 2003.10b
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    • pp.223-228
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    • 2003
  • Risk Management does not mean accepting a risk but having a good grasp of, eliminating and controling the exact causes of known hazards. Good safety management plan or system for the safety of any systems need to include the procedures about standing safety goals, related technical information, time schedule, audit programs, etc at least. In this paper the summeries on general risk assessment techniques and the examples of risk assessment system and railway risk management strategies used in UK, Australia and Canada are introduced, and applicable establishment procedures for domestic railway industries are proposed.

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A Study on the Priority Making of Human Error Prevention Business Using AHP (계층화분석기법(AHP)을 이용한 철도 인적오류 예방 사업의 우선순위 분석 연구)

  • Han, Kee-Youl;Back, You-Seoung
    • Journal of the Korea Safety Management & Science
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    • v.14 no.3
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    • pp.111-117
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    • 2012
  • In this paper to prevent human errors analyzed the causes of railway accidents and human error in last 5 years(2007~2011). The 2nd Railway Comprehensive Safety Plan currently being implemented in the safety business for prevention of human error. The accidents are often resulted from multiple causes with hardware failure and human errors. And prevention of human error associated with the implementation details of the priority projects, 14 projects were selected by draw. Then Analytic Hierarchy Process(AHP) methodology was used to select what projects were effective to human error.

In-Situ Diagnosis of Vapor-Compressed Chiller Performance for Energy Saving

  • Shin Younggy;Kim Youngil;Moon Guee-Won;Choi Seok-Weon
    • Journal of Mechanical Science and Technology
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    • v.19 no.8
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    • pp.1670-1681
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    • 2005
  • In-situ diagnosis of chiller performance is an essential step for energy saving business. The main purpose of the in-situ diagnosis is to predict the performance of a target chiller. Many models based on thermodynamics have been proposed for the purpose. However, they have to be modified from chiller to chiller and require profound knowledge of thermodynamics and heat transfer. This study focuses on developing an easy-to-use diagnostic technique that is based on adaptive neuro-fuzzy inference system (ANFIS). The effect of sample data distribution on training the ANFIS is investigated. It is found that the data sampling over 10 days during summer results in a reliable ANFIS whose performance prediction error is within measurement errors. The reliable ANFIS makes it possible to prepare an energy audit and suggest an energy saving plan based on the diagnosed chilled water supply system.

Alcohol Use Disorder, Stress, Mental Health and Suicide among Seoul Citizens (서울시 지역주민의 알코올장애와 스트레스, 정신건강 및 자살)

  • Sohn, Ae-Ree;Legaspi, Sherme Villasurda;Hong, In-Ok;Kim, Tae-Kyung;Ryu, Eun-Jung;Oh, Gyung-Jae
    • Korean Journal of Health Education and Promotion
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    • v.26 no.4
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    • pp.71-81
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    • 2009
  • Objectives: This study furthers the currents understanding of alcohol use disorders, stress, mental health status and suicide among Seoul citizens. This study is to identify differences according to socio-demographic variables and variables which affect stress, mental status and suicide for developing mental health programs. Methods: The study subjects using cluster-stratified sampling method were 1234 adults over 19 years old from 17 dong, S-Ku in Seoul City. A cross-sectional study with face-to-face interview was used to collect data. A questionnaire measuring socio-demographic variables, Symptom Checklist-90-Revised (SCL-90-R) and psychosocial wellbeing index-short form (PWI-SF) was utilized. Results: Three findings in this study were discussed: (1) The prevalence of problem drinking and alcohol dependence and AUDIT score were significantly higher among male, younger age, and high level of education and income; (2) AUDIT score were related with stress, all 9 symptoms of SCL-R and suicide plan; (3) Problem drinkers were more likely to have 2.5 times of anxiety, 3.0 times of hostility, and 2.4 times psychoticism than non alcohol problem drinkers. Alcohol dependence drinkers were more likely to have 1.9 times of high risk group of stress, 4.1 times of obsessive-compulsive, 4.7 times of anxiety, 5.5 times of hostility, and 2.3 times psychoticism than non alcohol dependence drinkers. Conclusion: The findings suggest that the future intervention of Mental Health programs should be carefully designed and tailored by socio-demographic variables.

An Empirical Analysis on ISO 9001:2015 Transition Audits (ISO 9001:2015 전환심사의 실증적 분석)

  • Park, Dong Joon;Yoon, Min;Kang, Byung Hwan;Kim, Ho Gyun
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.41 no.4
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    • pp.70-80
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    • 2018
  • The International Organization for Standardization (ISO) published ISO 9001 Quality Management System (QMS)-Requirements in 1987 and has revised four times since then. ISO 9001:2015 is the latest edition. This latest edition has two most noticeable changes. The first major change of new edition focuses on performance with an emphasis on Risk-Based Thinking (RBT) to enhance the process approach. The new edition consists of ten clauses whose first three clauses are largely same as older edition but risks are clearly stated and stressed in last seven clauses, emphasizing on Plan-Do-Check-Act cycle at all levels in the organization. The second major change is that the new edition has the same overall structure as other ISO management system standards known as High Level Structure (HLS) with Annex SL. The companies obtained the certificate of new ISO 9001:2015 QMS by September 15, 2018 in order to maintain as an ISO QMS registered firm. In this article we collected transition audit data from more than 100 companies that registered ISO 9001:2015 QMS for recent three years. We performed a statistical analysis to disclose the relationships between the characteristics of companies and the minor nonconformities found in ISO 9001:2015 requirements during transition audit processes. We also aim to interpret the findings and deduce the implications of the statistical results.

A Case Study on the Risk Management for the Long-term Preservation Business Activities Related to Electronic Records (전자기록 장기보존 위험관리 사례)

  • Yim, Jin-Hee
    • The Korean Journal of Archival Studies
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    • no.39
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    • pp.3-43
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    • 2014
  • This paper showed results of the risk management project in detail which was conducted by National Archives of Korea(NAK) in 2010. In the project NAK examined its long-term preservation business of electronic records using DRAMBORA(Digital Repository Audit Method Based on Risk Assessment). NAK has defined 44 different risk elements related to its business activities, assessed and classified them into several grades according to the severity calculated by risk probability score and risk potential impact score, and developed precise management plans for two of the most serious risks. This paper introduced the management plan for one of them. The risk was numbered with NR04 and described by 'Loss of integrity of records information'. This paper explained mitigation strategies, contingency organization, disaster control responsibilities, and personal mission cards for the NR04. This paper planned to give comprehensive understandings to Records Management Organizations about the risk management approaches as an effective way for business management through the case study.

The Study on the dweller's Expressions of Apartment Facility Management in accordance with Built Year (준공연수에 따른 공동주택 관리에 대한 주민인식 비교분석)

  • Choi, Yeol;Ha, Kyu Yang;Kim, Jong-Gyeong
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.31 no.1D
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    • pp.149-155
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    • 2011
  • The aim of this study is to grasp how the dwellers of apartment cognize the real condition of the management such as general control of janitor office or management of maintenance, environment, account and imposing price of management. The analysed results of recognition are as following. First, as the dwellers judged that the janitors are incapable to control dispute among the households, it needs to develop the ability to cope with the demand of control dispute by various curriculum. There should be more strict management of parking lot for the handicapped. Second, it needs to establish the plan to improve maintenance of the rest facility. Third, as dwellers thought the management expenses not to be made public clearly, it needs to use various way, not only by neighborhood meeting but also information system such as establishing web page or E-mail notice for better announcement of the settled matters such as management expenses. Forth, the audit result of management expenses and the measures conducted after audit should be reported widely, contract of construction work services needs to be publicized by neighborhood meeting or other information system.

Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • 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.

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