• 대한약침학회지
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• 제24권2호
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• pp.59-67
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• 2021

Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

• Safety and Health at Work
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• 제1권1호
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• pp.1-10
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• 2010

The Finnish risk assessment practice is based on the Occupational Safety and Health (OSH) Act aiming to improve working conditions in order maintain the employees' work ability, and to prevent occupational accidents and diseases. In practice there are hundreds of risk assessment methods in use. A simple method is used in small and medium sized enterprises and more complex risk evaluation methods in larger work places. Does the risk management function in the work places in Finland? According to our experience something more is needed. That is, understanding of common and company related benefits of risk management. The wider conclusion is that commitment for risk assessment in Finland is high enough. However, in those enterprises where OSH management was at an acceptable level or above it, there were also more varied and more successfully accomplished actions to remove or reduce the risks than in enterprises, where OSH management was in lower level. In risk assessment it is important to process active technical prevention and exact communication, increase work place attraction and increase job satisfaction and motivation. Investments in OSH are also good business. Low absenteeism due to illness or accidents increases directly the production results by improved quality and quantity of the product. In general Finnish studies have consistently shown that the return of an invested euro is three to seven-old. In national level, according to our calculations the savings could be even 20% of our gross national product.

• 한국기록관리학회지
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• 제10권2호
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• pp.171-192
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• 2010

본 연구는 현재 국제표준화기구(ISO)의 TC46/SC11에서 제정을 준비하고 있는 기록경영시스템(MSR) 표준의 개념과 주요 내용을 소개하고 그에 대한 우리나라 기록관리 분야에 대한 시사점과 개선 과제를 제안하였다. MSR은 ISO 9001과 같은 경영시스템 형식으로 제정되며, 실무지침의 내용은 ISO 15489를 크게 벗어나지 않으면서 기록관리가 조직의 경영과 정책, 시스템 구축 전략과 결합되도록 해 준다. 중앙 행정기관 중심으로 진행되는 현행 우리나라 기록관리 제도의 한계점과 최근 제기된 기록전문직의 전문성 논란에 대해 MSR은 적절한 대안을 제시해 줄 수 있다.

• 성인간호학회지
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• 제21권6호
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• pp.570-579
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• 2009

Purpose: The aim of this research was to determine knowledge and management of tracheal tube cuffs among nurses of ICU. Methods: This descriptive survey recruited 150 nurses working at 8 different adult ICUs within 2 tertiary hospitals in Seoul. A survey questionnaire was developed to measure cuff management. The internal reliability of the tool was examined by Cronbach's ${\alpha}$. Descriptive statistics and multiple regressions were used to analyze data. Results: Among the 150 nurses, 94.0% replied that they would measure the pressure themselves. With regard to nurses' knowledge about tracheal tube cuffs, only 6% answered that they knew 'the appropriate cuff pressure'. The existence of a measuring device (p < .001), a guideline (p < .001), the level of knowledge on its related complications(p = .003), and clinical experience (p < .001) together accounted for 35.0% of the total variation in cuff management. They pointed out that the lack of time and the lack of education were major barriers to appropriate management; whereas education update was the most imperative factor for good management. Conclusion: ICU nurses have inappropriate knowledge and practice in cuff management. Therefore continuing education is necessary for better practice of tracheal tube cuff management.

• 한국방사선학회논문지
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• 제7권6호
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• pp.397-402
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• 2013

우리나라 약사법과 외국의 방사성의약품 제조관리기준 가이드라인을 참고하여 방사성의약품 제조관리기준 제정 시 고려해야할 사항들에 대해 의견을 제시하였다. 의약품은 안전성, 유효성과 더불어 제품의 균일성이 검증되어야 한다. 따라서 방사성의약품의 특성을 충분히 고려한 합리적인 제조관리기준을 제정하면 방사성의약품 관리의 효율성을 증대시키고 국민건강 증진에 기여할 수 있을 것으로 기대된다.

• 품질경영학회지
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• 제46권2호
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• 품질경영학회지
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• 제50권3호
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• pp.503-515
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• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• 대한영양사협회학술지
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• 제7권1호
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• pp.28-37
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• 2001

The purpose of this study was to evaluate the status of sanitary management based on HACCP. The surveys which were on various aspects of general characteristics, food handling practice, personal sanitation, equipment sanitation, and equipment possession were carried out using questionnaires for 146 business and industry foodservice operations in Taegu and Kyungpook areas. The results of this study were summarized as follows. Forty-nine percent of surveyed foodservice operations was in Taegu, 51% in Kyungpook and 69.2% in direct foodservice operations and 28.1% in contracted foodservice operations. Seventy-eight percent of foodservice operations replied that they have done only basic sanitary management, while 13% surveyed stated that they were implementing HACCP. Food handling practice and personal sanitation were significantly better in Kyungpook area than in Taegu. Significantly high levels in food handling practice, personal sanitation, equipment sanitation, and equipment possession were seen in foodservice operations which had more than 1,000 meal served than those which had less than 1,000 meals served. According to the results of food handling practice, in items of food-temperature measurement during receiving, cooking, holding after cooking, and reheating, foodservice operations showed very low scores below the average. All foodservice operations presented good scores in the parts of personal and equipment sanitation. In equipment possession, sterilizing systems were generally not enough, dishwasher and sterilizing facilities of contracted foodservice operation showed significantly high scores. Therefore, the business and industry foodservice operations will have to pay special attention to temperature management in the foodservice production process as the first step to implement of HACCP.

• 한국직업건강간호학회지
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• 제25권3호
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• pp.177-187
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• 2016

Purpose: This cross-sectional descriptive study was to explore the relationship among practice environment, organizational justice, and job satisfaction of male nurses. Methods: Subjects were 115 male nurses who were the member of the Korean man nurses association, and they were asked to complete self-administration questionnaires via internet site for this survey which included nurse's practice environment, organizational justice, and job satisfaction. Collected data were analyzed using SPSS/WIN version 21.0 software. Results: The mean scores of the nurse's practice environment, organizational justice, and job satisfaction were 2.9, 3.0, 3.1 out of 5 Likert scale respectively. The job satisfaction was positively correlated with the nurse's practice environment (r=.70, p<.001) and organizational justice (r=.78, p<.001). The job satisfaction was affected by procedure-related justice, interpersonal justice, adequacy of staffing and resources in nursing work environment, compensation justice, and good healthy status. These variables explained 68.6% of male nurse's job satisfaction. Conclusion: This finding suggest that suitable organization management for male nurses are necessary through improvement of practice environment and organizational justice in hospital.

• 대한안전경영과학회:학술대회논문집
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• 대한안전경영과학회 2007년도 추계학술대회
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• pp.299-303
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• 2007

This paper deals with conformity assessments requirements for accreditation and certification bodies. This study also introduces conformity guidances of product certification and code of good practice. This paper presents general requirements for accreditation, recognition and registration bodies of environmental quality system and product certification.