• 한국식생활문화학회지
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• 제11권2호
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• pp.235-242
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• 1996

Sanitary management practices from 8 packaged meals (Dosirak) manufacturing establishments were surveyd during production and distribution and their microbiological quality of dosirak items marketed in CVS were analyzed. Correlation coefficients were calculated to deternine significant relationships between sanitary management practices and microbiological quality of packaged meals. The results of self evaluation on sanitary management practices indicated 'doing practice well' in personnel and equipment sanitation management but time-temperature control management were practiced satisfactorily only about 55% as compared with the managerial standard guidelines. Significant relationships between the status of actual sanitary management practices and microbiological quality of Dosirak items were not found, but general status of microbiological quality of Dosirak items revealed positive relationship with the size of operational structure and the status of time-temperature control management practices.

• 대한방사성의약품학회지
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• 제1권2호
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• pp.98-103
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• 2015

Good manufacturing Practice (GMP) regulation for diagnostic and therapeutic radiopharmaceuticals was prepared at 2014. The mandatory GMP regulation becomes effective on $1^{st}$, July 2015,with two years of grace periods. Korean radiopharmaceuticals GMP regulation was consisted of quality management, personnel, premise and facility, documentation, production, quality control and self-audit and they have a very similar structure to European Union and PIC/S GMP regulation. Here, we describe detailed description of GMP regulation each part and application to radiopharmaceuticals production. And we also compare Korea, Japan and USA radiopharmaceuticals GMP regulation. GMP is a method to maintain quality of radiopharmaceuticals in daily production and it must be embedded on the manufacturing operation and management.

• Nuclear Medicine and Molecular Imaging
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• 제42권4호
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• pp.314-322
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• 2008

목적: 전국의 의료기관에 설치된 감마카메라의 정도관리 실태를 체계적으로 조사하여 감마카메라 성능유지를 위하여 정도관리가 적절한 방법으로 수행되고 있는지 파악하고자 하였다. 이를 위하여 보유 장비 현황, 시행하고 있는 정도관리 성능평가 항목, 그리고 주기적 정도관리 현황을 조사 분석하고, 각 병원의 정도관리 능력을 파악하기 위하여 인력 현황, 교육, 정도관리 실무 수행 정도 등을 조사 분석하였다. 방법: 2003년 3월 1일부터 11월 30일까지 국내 감마카메라를 보유 중인 병원의 핵의학과나 핵의학 검사실에 설문지를 발송하고 응답을 받았다. 감마카메라 정도관리 실태 수집은 보유 중인 감마카메라의 수량, 제작사, 제원, 의료 인력의 실태, 정도관리 시행 항목과 주기, 팬텀 등 감마카메라 성능평가용 기기 보유 실태, 성능평가 수행 실태론 설문지를 작성한 후 우편, 전화 조사를 하고 필요한 경우 실사를 하여 취합하고 통계처리를 하였다. 결과: 감마카메라를 보유하고 있는 92군데의 의료기관 중 응답을 받은 기관은 78 군데로 응답율은 84.7%이었다. 1인 이하의 전문의에 의해서 운영되는 검사실이 72%으로 대부분을 차지하고 있었고, 물리화학자를 보유하지 못한 병원이 94%이었다. 감마카메라 담당 의료기사가 3인 이하로 운영되는 검사실이 71%로서 성능평가와 정도관리 프로그램을 시행하는데 인력 부족이 심각한 것을 알 수 있었다. 2대 이하의 감마카메라를 보유한 병원이 72%이었다. 장균일도치 실시여부는 매일 실시하는 곳이 32.1%, 매주 실시하는 기관이 21.8%, 매달 실시하는 곳이 24.4%이었으나, 실시하지 않는 곳도 4군데로 5.1%를 차지하고 있었다. COR의 실시주기를 보면 NEMA 권고안 대로 매주하는 곳이 5.1%이었다. 정도관리 수행 정도가 우수한 검사실은 7군데(8.9%), 양호한 검사실은 17 군데(21.8%), 보통인 검사실 44 군데 (29.5%), 불량인 검사실은 10 군데 (34.6%)로 나타났다. 결론: 국내 핵의학 검사실의 시설, 인력, 및 장비 등이 매우 부족한 환경에 있어서 감마카메라의 정도관리가 원활하게 이루어지고 있지 않은 것을 확인할 수 있었다. 이 번 조사로써 열악한 환경 하에 있는 국내 의료기관에 대한 감마카메라 성능평가와 정도관리를 보다 잘 수행하기 위하여 각 관련 당사자들의 적극적인 인식 전환과 정도관리 지침서의 필요성을 제기하고 보완책들에 대하여 주의를 환기시키는 계기가 되었다고 보여진다. 국외의 사례들을 조사한 결과 감마카메라의 성능평가와 정도관리에는 정부주도보다는 민간 기구가 주축이 되어서 정도관리를 권고하고 시행하는 예들이 대부분이었다. 국내외의 감마카메라 성능평가와 정도관리에 대한 사례를 참조하여 정도관리의 체계화에 대한 대안을 제시할 필요가 있다.

• 한국식품조리과학회지
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• 제8권2호
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• pp.137-145
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• 1992

A computer-assisted microbiological quality assurance program was developed based on HACCP data obtained from a 500 bed general hospital by assessing time and temperature conditions and microbiological qualities of six categories of menu items according to the process of food product flow. The purpose of the study was to develop a computer-assisted microbiological quality assurance program in order to simplify the assessment procedures and to provide a maximum assurance to foodservice personnel and the public. A 16-Bit personnel computer compatible with IBM-PC/AT was used. The data base files and processing programs were created using dBASE III plus packages. The contents of the computerized system are summarized as knows: 1. When the input program for hazard analysis runs, a series of questions are asked to determine hazards and assess their severity and risks. Critical control points and monitoring methods for CCPs are identified and saved in Master file. 2. Output and search programs for hazard analysis are composed of 6 categories of recipe data file list, code identification list, and HACCP identification of the specific menu item. 3. When the user selects a specific category of recipe from 6 categories presented on the screen and runs data file list, a series of menu item list, CCP list, monitoring methods list are generated. When the code search program runs, menu names, ingredients, amounts and a series of codes are generated. 4. When the user types in a menu item and an identification code, critical control points and monitoring methods are generated for each menu item.

• 설비공학논문집
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• 제25권1호
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• pp.7-13
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• 2013

Bio Clean Room(BCR) and pharmaceutical product manufacturing facilities require careful assessment of many factors, including HVAC, controls, room finishes, process equipment, room operations, and utilities. Flow of equipment, personnel, and product must also be considered along with system flexibility, redundancy, and maintenance shutdown strategies. It is important to involve designers, operators, commissioning staff, quality control, maintenance, constructors, validation personnel, and the production representative during the conceptual stage of design. Critical variables for room environment and types of controls vary greatly with the clean space's intended purpose. It is particularly important to determine critical parameters with quality assurance to set limits and safety factors for temperature, humidity, room pressure, and other control requirements. In this paper, oxygen cluster ion equipment was utilized in order to enhance the indoor air quality and to prevent the airborne infection of ward in hospital. Moreover, the performance test of the equipment was also performed in order to develop the optimal sterilization system of BCR using the equipment.

• 대한예방한의학회지
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• 제4권2호
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• pp.193-204
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• 2000

In this study, advanced model for quality control of oriental medicine and methods for practice was suggested through literature inspection, analysis of foreign system such as China and Japan, survey analysis on the current system, quality analysis of randomly selected oriental medicine samples, and intensive discussions among oriental medicine specialists 1. The quality of oriental medicine should be consistently controlled by Ministry of Health and Welfare form its cultivation or import to its circulation process to final consumer 2. All oriental medicines should be circulated as standardized goods which should be marked by lot numbers. The packing material and Packing size should be liberalized. The qualify should be differentialized though free competition among makers. 3. Realistic standards for pesticide, heavy metal and decolorant should be established though long-term monitoring process according to each oriental medicine's origin, therapeutic part, cultivation area, harvesting time, and cultivation method. 4. Ministry of Health and Welfare should educate oriental medicine's quality control personnel regularly or on demand, and establish specialist pool. Ministry of Health and Welfare should also establish oriental medicine information system to provide informations about quality of domestic or foreign oriental medicinal raw materials. 5. The government should provide information about foreign of oriental medicine market to importers. Quality of imported oriental medicine should be inspected before its customs clearance, and all imported oriental medicine should be circulated by standardized oriental medicine makers. 6. Oriental medicine's pharmacopoeia should be Published to provide quality standard of oriental medicine and improve it.

• 제어로봇시스템학회:학술대회논문집
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• 제어로봇시스템학회 1997년도 한국자동제어학술회의논문집; 한국전력공사 서울연수원; 17-18 Oct. 1997
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• pp.1884-1887
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• 1997

The increasing concern over radiation exposure in the nuclear industry has fostered agrressive efforts to reduce the levels of radiation exposure. One area of the effot to reduce the radiation exposure is the development of a remote radiation monitoring system. Remote radiation monitoring can serve many benificaial functions reduce exposure to radiation by plant personnel, impruve the quality of the data that is collected and recognize the radiation environment easily. Radiation mapping system gives a good information that represents radiation level distribution. The system we have developed consists of a data acquistion parts, mobile robot and remote control parts. Data acquisition parts consist of radiation detection module and vision acquistion module which collect radiation data, visiion data and distance information. In remote control parts, the acquision data are processed and displayed. We have constructed radiation mapping image by overlaying the vision and radiation data. The radiation mapping techniques for displaying the results of the survey in an easily comprehendable form will facilitate a better understanding of the radiation environment in the facility. This system can reduce workers radiation exposure and aid to help work plan, so it has significant benifits in cost and safety.

• 한국항해학회지
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• 제9권1호
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• pp.83-93
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• 1985

Sea casulties involving tankers, compared with those incurred by other type of vessels, have become particularly threatening to port State in terms of environmental as well as property damages. As a result, most of developed countries including the U.S.A. and Japan have shown a strong interest in implementing the policy of the Port State Control more rigorously in an attempt to protect themselves from irreparable damages caused by sea casualties involving large vessels. In this paper, the problems associated with the implementation of the Port State Control are analysed and then following recommendations and suggestions are made: ⅰ) The flag nation is urged to improve the quality of personnel associated with the operation of a ship. ⅱ) A closer cooperation between developing nations operating vessels and developed nations adopting the Port State Control is required for a successful implementation of this policy. ⅲ) Port states are advised to give a special attention to vessels carrying hazardous cargoes.

• 한국건설관리학회:학술대회논문집
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• 한국건설관리학회 2008년도 정기학술발표대회 논문집
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• pp.819-823
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• 2008

현재 국내의 건설공사 품질관리, 안전관리, 환경관리는 각각의 법령을 기반으로 고유특성에 맞게 발전되어와 통합을 위한 기반이 형성되어 있지 못하다. 즉, 인력에서는 품질관리자와 안전관리자를 법적 배치인력으로 정하고 있으나, 환경관리자는 법적 배치인력이 아니다. 또한 품질관리계획은 KS A ISO 9001 규격의 모든 요구사항이 반영되어 PDCA(계획-실행-체크-조치) 시스템으로 업무를 수행하도록 되어 있으나, 안전관리계획 및 유해 위험방지계획은 KOSHA 18001 규격 요구사항 중 4항 실행(D) 및 운영에만 치중되어 P(계획), C(체크) 및 A(조치) 시스템이 제대로 반영되어 있지 못하다. 더욱이 환경관리계획은 수립기준조차 마련되어 있지 못한 실정이다. 이에 건설공사 품질 안전 환경 통합관리 기준을 마련함에 앞서 해외의 건설공사 운영사례를 조사하여 국내 적용가능성을 검토하고자 하며 본고에서는 싱가폴의 건설공사 운영사례를 살펴보기로 한다.

• 유통과학연구
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• 제13권8호
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• pp.27-40
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• 2015

Purpose - Total Quality Management (TQM) has received significant attention and interest from a large number of organizations around the world in various industries. These organizations have tried to embody TQM concepts in areas such as engineering and product design, marketing, R&D, procurement, production, personnel, and product inspection. Research design, data, and methodology - This study presents an overview of the fundamentals of TQM and an in depth review of the obstacles to the successful implementation of TQM. Results - In order to control the cost of manufacturing, the tracking of the cost of quality (COQ) allows companies to capture the actual overall cost incurred in producing a unit of product or service. The study explores the reasons why companies track the COQ and ways to address it. Conclusions - Based on the results, COQ is one of the key performance indicators for making more accurate strategic decisions as well as a critical aspect of TQM. The study also presents a few popular quality improvement tools that have been widely used in organizations successfully implementing TQM.