• Journal of Pharmacopuncture
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• v.24 no.2
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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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• v.1 no.1
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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.

• Journal of Korean Society of Archives and Records Management
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• v.10 no.2
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• pp.171-192
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• 2010

In this study, the concepts and main ideas of the 'Management System for Records(MSR)' standards which is being prepared by ISO(TC46/SC11) are explained. And the implications and prospects of MSR standards are suggested for the development of records management practice in Korea. The MSR has the same frame with the ISO 9001(QA system) and its main procedures are consistent with ISO 15489. Its methodology of record management can help organizations to integrate their records management with their own management and system development strategies. The MSR can provide good solutions to improve the national archiving policy and to solve the current argument about the professionalism of record managers.

• Korean Journal of Adult Nursing
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• v.21 no.6
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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.

• Journal of the Korean Society of Radiology
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• v.7 no.6
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• pp.397-402
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• 2013

This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

• Journal of Korean Society for Quality Management
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• v.46 no.2
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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.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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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.

• Journal of the Korean Dietetic Association
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• v.7 no.1
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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.

• Korean Journal of Occupational Health Nursing
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• v.25 no.3
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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.

• Proceedings of the Safety Management and Science Conference
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• 2007.11a
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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.