• 제목/요약/키워드: Quality assurance/quality control

검색결과 323건 처리시간 0.023초

군수품 정부품보활동계획에 FMEA 분석결과의 적용방안 및 적용결과의 고찰 (A Study on the Applicability of FMEA and it's Results for Hand Grenade in Government Quality Assurance Planning)

  • 이영우;권인규
    • 한국산학기술학회논문지
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    • 제17권2호
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    • pp.252-258
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    • 2016
  • 군수품 품질보증을 위한 정부품보활동계획 수립의 기반이 되는 위험식별(Risk Identification)은 품질보증활동의 근간이 되는 업무로서, 위험을 구체적으로 파악하여 반영하는 활동이다. 그러나, 현재의 위험도평가 방법은 규격서 등에 명시된 제품에 대한 기능요구조건을 위주로 작성함에 따라 제조프로세스 측면에서의 위험식별 및 반영이 부족할 우려가 있으며, 또한 품보원의 개인적인 판단 즉 과거 경험, 노하우 등 정성적인 판단으로 결정할 우려가 있기 때문에 위험식별의 객관성과 전문성의 보완을 위해 정량적인 자료에 의한 판단 기준이 필요하게 되었다. 이러한 문제점에 대한 해결방안으로 FMEA 결과를 위험식별의 결과로 활용하는 방안을 강구하였다. FMEA는 현 제조공정을 기준으로 잠재적 고장형태를 분석하고 고장에 대한 영향 분석을 수행하므로 FMEA의 분석결과를 반영하여 위험식별을 하게 되면, 더욱 공정하고 객관적으로 정부품보활동 계획이 도출될 것으로 예상되었다. 본 논문에서는 양산단계 위험식별 업무를 강화시킬 수 있는 방안으로 세열수류탄에 대한 FMEA 수행내용과 이를 토대로 군수품 품보활동계획수립에 대한 적용방안을 모색하는데 그 작성 목적이 있다.

의약품 제조공정에서의 전사적 품질혁신을 위한 공정분석기술 개발 (Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes)

  • 신상문;박경진;최용선;이상길;최광진;권병수
    • Journal of Pharmaceutical Investigation
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    • 제37권6호
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    • pp.329-338
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    • 2007
  • The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

International Harmonization of Regulatory Quality Control and Quality Assurance of Drug

  • Kang, Chan-Soon
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.28-28
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    • 2003
  • After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)

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개방형BIM환경에서의 룰기반 초고층건축물 피난법규 검토모듈 개발 (Development of Rule-based Checking Modules for the Evacuation Regulations of Super-tall Buildings in Open BIM Environments)

  • 김인한;최중식;조근하
    • 한국CDE학회논문집
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    • 제18권2호
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    • pp.83-92
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    • 2013
  • IFC based open BIM has internationally developed as a solution for interoperability problem among different software applications. Despite much interest and effort, the open BIM technologies are rarely introduced to the construction industry and need more technical development for a practical application as well. This research aims to develop automated code checking modules for quality assurance process of BIM data. The research have analyzed domestic regulations focusing on super-tall buildings and developed open BIM-based code checking modules for the evacuation regulations. The modules are able to validate evacuation regulations such as installation of emergency elevator and fire safety zone. The authors expect to improve the process of BIM quality assurance and enhance the quality of BIM data by this research on automated checking system.

종합통제센터의 서비스품질이 항공사 직원의 직무몰입에 미치는 영향 (The Effect of Operational Control Center's Service Quality on Airline Staff's Job Engagement)

  • 김효중
    • 한국항공운항학회지
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    • 제28권1호
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    • pp.14-21
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    • 2020
  • Here I investigate what effects Operational Control Center(OCC)'s service quality may have on airline staff's job engagement. My analysis reveals that airline OCC's service quality has a meaningful effect on airline staff's service satisfaction, and that service satisfaction mediates a meaningful effect on staff's job engagement. It was suggested that improving OCC's service quality leads to higher staff's job engagement. Accordingly, I suggest methods of improving OCC's service quality. I find that the importance of contributing factors on OCC's service quality are as follows, in order of most to least important: professionalism, assurance, empathy, reliability, organizational culture, and responsiveness. The results of this study are relevant not only for airlines but also for government agencies such as the National Emergency Management Agency, the Korea Forest Service, the National Police Agency and the Korea Coast Guard that operate aircraft and must ensure aviation safety.

Classroom lecture monitoring case study

  • Baik, Jai-Wook;Yang, Geun-Dae
    • Journal of the Korean Data and Information Science Society
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    • 제19권4호
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    • pp.1191-1200
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    • 2008
  • Recently classroom monitoring is becoming important since the lecture is being held in the classroom and academic institutions are interested in the quality assurance. Some institutions have adopted ISO 9000 systems and constructed monitoring system through measurement, analysis and improvement. In this study quality assurance problems in academic institutions and the requirements of ISO 9001:2000 will be briefly discussed. Next we will investigate how to monitor the lecture in the classroom(in-class) using statistical process control techniques such as control charts. Then case study will be given to illustrate the technique to use appropriate statistics. Finally how to monitor the learning process during in-class and after-class will be proposed.

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Deming prize and malcolm baldrige national quality award

  • Ryu, Seewon;Jo, Hongkyu;Heo, Jaeho
    • 한국경영과학회:학술대회논문집
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    • 대한산업공학회/한국경영과학회 1995년도 춘계공동학술대회논문집; 전남대학교; 28-29 Apr. 1995
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    • pp.827-844
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    • 1995
  • Total Quality Management (TQM) is the aggregated management philosophy for quality including production, operation, human resource, leadership, marketing, and etc. TQM is the advanced concept and philosophy rather than traditional "Quality Control" or "Quality Assurance". Nowadays, downstream costs has been increased, that made cost accountants' attention to costs of quality. Many countries have developed their own quality awards system in order to improve overall national quality level. The Deming Prize of Japan and Malcolm Baldrige National Quality Award (MBNQA) of United States are two representatives of quality prizes. We compared the two awards by means of their history, objective, coverage, and judging criteria. Deming Prize has a longer history than MBNQA. Deming Prize selects five winners a year, while MBNQA has two or three areas. The biggest difference is judgement criteria. The Deming Prizes focuses on statistical control which is a traditional quality control method, while MBNQA concentrates on modem business concept such as customer satisfaction. The suggestions to these awards are: evaluate more on information of quality; evaluate more on inter-functional relationship between quality control function and other link more financial success.e financial success.

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KASS 통합운영국 소프트웨어 품질 보증을 위한 소프트웨어 품질 모델 및 메트릭 적용방안 (Application of Software Quality Model and Metric for Software Product Assurance for KASS Control Station)

  • 김연실;이은성
    • 한국항행학회논문지
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    • 제24권1호
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    • pp.28-36
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    • 2020
  • KASS(Korea Augmentation Satellite System)는 국토교통부에서 2014년부터 개발 중인 한국형 위성항법보강시스템이다. KASS는 항공기 안전에 영향을 미칠수 있는 항공용 시스템이기 때문에 KASS의 각 소프트웨어는 안전성 분석을 통해 할당된 DO-178B의 소프트웨어 레벨에 따라 개발이 수행된다. KASS의 하위시스템인 통합운영국의 경우 일부 소프트웨어를 제외하고는 DO-178B 레벨E를 할당 받았으며 DO-178B 레벨E 소프트웨어의 경우 제품 보증을 위해 ECSS-Q-ST-80C 카테고리 D를 준수하여 개발하도록 하고 있다. 본 논문에서는 ECSS-Q-ST-80C를 만족하기 위해 ECSS-E-ST-40C, ECSS-Q-HB-80-04A를 분석하여 KASS 통합운영국 소프트웨어의 제품 보증을 위한 소프트웨어 생명 주기 별 활동 및 소프트웨어 품질 모델, 메트릭을 제안한다.

Factors Affecting Quality of Internal Control: A Case Study of Listed Banks in Vietnam

  • TRAN, Quoc Thinh;NGUYEN, Khanh Tuan;LE, Xuan Thuy
    • The Journal of Asian Finance, Economics and Business
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    • 제8권5호
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    • pp.375-380
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    • 2021
  • Internal control is important for monitoring operations of organizations. In order to achieve the quality of internal control, organizations need to recognize different perspectives in which the components of internal control play a decisive role. Internal control is a process designed by the manager and it is applied within the organization to provide reasonable assurance of the reliability of financial information and to comply with policies, procedures, rules, regulations and laws. The article uses the ordinary least squares method and the seven-point Likert scale to test the variables affecting the quality of internal control in 18 Vietnamese listed banks. The article surveyed 179 leaders of listed banks. The results show that there are three variables out of a total of five variables that positively affect the quality of internal control, including the control environment, control activities, and monitoring. Accordingly, the managers of Vietnamese listed banks need to pay attention to building a corporate culture environment, improve the quality of control activities, and periodically and regularly conduct the monitoring. It contributes to improving the quality of internal control and is also an opportunity to increase economic benefits for Vietnamese listed banks in the context of international economic integration.

군수품 고객만족지수 개발 연구 (Development of Military Customer Satisfaction Index)

  • 박성현;김용섭;홍현의;박봉균
    • 품질경영학회지
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    • 제32권2호
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    • pp.212-231
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    • 2004
  • It is very important to produce military goods for customers, and a customer satisfaction index should be developed for quality control of military goods. Seoul National University and Defense Quality Assurance Agency jointly developed MCSI (Military Customer Satisfaction Index). In this paper the model of MCSI is explained, and the sampling design and survey method is introduced. Also a preliminary test was undertaken, and its result is briefly explained.