• 대한약학회:학술대회논문집
• /
• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
• /
• pp.40-41
• /
• 2003

The present topic in pharmaceutical industry is to establish Quality Assurance System for medicinal product Therefore, the most important and urgent subject to be solved in the field of the manufacturing industry is to establish, implement and maintain the control system for ensuring uniformity of medicinal product. In case of solid dosage forms for internal use, its quality was controlled by disintegration test, etc but at present bioavailability could be predicted with dissolution test and so the assurance of its uniformity should be prerequistie to preserve suitable dissolution of the manufactured medicinal product. (omitted)

• International Journal of Computer Science & Network Security
• /
• 제22권12호
• /
• pp.146-152
• /
• 2022

The National Agency for Quality Assurance in Higher Education plays a crucial role in education in Ukraine, as an independent entity creates and ensures quality standards of higher education, which allow to properly implement the educational policy of the state, develop the economy and society as a whole. The purpose of the article: to reveal the crucial role of the National Agency for Quality Assurance in Higher Education to create quality management of higher education institutions, to show its mechanism as an independent entity that creates and ensures quality standards of higher education. and society as a whole. The mission of the National Agency for Quality Assurance in Higher Education is to become a catalyst for positive changes in higher education and the formation of a culture of its quality. The strategic goals of the National Agency are implemented in three main areas: the quality of educational services, recognition of the quality of scientific results, ensuring the systemic impact of the National Agency. The National Agency for Quality Assurance in Higher Education exercises various powers, which can be divided into: regulatory, analytical, accreditation, control, communication. The effectiveness of the work of the National Agency for Quality Assurance in Higher Education for 2020 has been proved. The results of a survey conducted by 183 higher education institutions of Ukraine conducted by the National Agency for Quality Assurance in Higher Education are shown. Emphasis was placed on the development of "Recommendations of the National Agency for Quality Assurance in Higher Education regarding the introduction of an internal quality assurance system." The international activity and international recognition of the National Agency for Quality Assurance in Higher Education are shown.

• 품질경영학회지
• /
• 제51권2호
• /
• pp.155-170
• /
• 2023

Purpose: Nowadays, the risk assessment system is widely used in many industrial and public areas to reduce the possible risks. The system is used to determine the priorities of the government quality assurance works in Defense Agency for Technology and Quality. However, as the risk assessment system is used for other purposes, there are some items that need improvement, and in this study, we propose improvement plans by benchmarking the risk assessment systems of other institutions. Methods: In this paper, first, the procedures of risk assessment system used in many industrial sites were reviewed, and how each institution specialized and applied the system. Afterwards, by benchmarking various risk assessment systems, an improvement plan on how to operate the risk assessment system in the case of government quality assurance for centrally procured military supplies was presented, and practical application cases were presented to prove the usefulness of the improvement plan. Results: The proposed risk assessment system differs from the existing system in five major aspects. First, inputs, outputs, and key performance indicators were specified from the systematic point of view. Second, risk analysis was analyzed in four dimensions: probability of occurrence, impact, detection difficulty. Third, risk mitigation measures were classified, control, transfer, and sharing. Fourth, the risk mitigation measures were realized through document verification, product verification, process verification, and quality system evaluation. Finally, risk mitigation measures were implemented and the effectiveness of the risk mitigation measures was evaluated through effectiveness evaluation. Conclusions: In order for the risk assessment procedure proposed in this study to be applied to actual work, it is necessary to obtain the consent of the person involved in the work due to the increased time for risk identification and preparation of the government quality assurance log, and a change in the information system that performs the actual work is required. Therefore, the authors of this study plan to actively perform internal seminar presentations and work improvement suggestions to apply these research outputs to actual work.

• International Journal of Computer Science & Network Security
• /
• 제21권12호
• /
• pp.45-52
• /
• 2021

The article proves the relevance of developing conceptual frameworks for managing the quality assurance of logistics activities in the context of socio-economic interaction of their participants. It is established that the fundamental difference of the logistic approach in management from traditional approaches is the allocation of a single management function of previously separated, disparate material flows, as well as economic, technological, information integration of chain links into a single system capable of effective management of these flows. It is substantiated that the functioning of the enterprise as a logistics system can be represented in the form of a triad of logistics components, namely: supply logistics, production logistics, sales logistics. Management of quality assurance processes of logistics activities in the context of socio-economic interaction of their participants is a functional component of the entire logistics system due to the quality of work and interaction of all participants in the implementation of certain activities. The quality of logistics activities will affect the level of economic potential, rationalization and optimization of all logistics flows. It is proved that the management of quality assurance processes of logistics activities in the context of socio-economic interaction of their participants involves the following main areas: the introduction of a quality system of logistics processes; development and implementation of the general strategy of quality improvement at the enterprise; internal integration; controlling. Management of quality assurance processes of logistics activities in the context of socio-economic interaction of its participants requires compliance with the following requirements: systematic and comprehensive management of all flow processes; coordination of criteria and indicators for assessing the effectiveness of the entire logistics system; dissemination of the use and application of information technology; ensuring partnerships and close interaction of all participants in sales networks.

• 대한기관윤리심의기구협의회지
• /
• 제6권2호
• /
• pp.48-55
• /
• 2024

Purpose: The purpose of this study is to introduce the Institutional Review Board (IRB) member-based internal audit method performed at A University Hospital, a secondary medical institution, and to identify the differences in audit results according to the characteristics of each auditor and the factors affecting the internal audit results. Furthermore, we will find out what needs to be improved in the internal audits to achieve Quality assurance (QA) objectives for human subject research conducted in medical institutions. Methods: The auditors were divided into group A (IRB member belonging to institution A) and group B (clinical trial QA administrator belonging to other institutions) and independently inspected the 2 studies using the same internal audit checklist (consisting of 11 domains, 130 items), and the differences in the internal inspection checklists written by each auditor were compared and analyzed. Results: In the case of audit for the study 1, the number of missing checklists is 1 for group A and 0 for group B, and the number of the matters to be pointed out is 1 for group A and 12 for group B. In the case of audit for the study 2, the number of missing checklists is 2 for both A and B, and the number of points is 5 for A and 4 for B. The differences in the internal audit results written by each auditor that the authors verified are summarized as follows. First, there were more comments from group B auditor than from group A auditor. Second, the results may vary because each auditor has different criteria for evaluating the appropriateness of an item. Third, there are cases where the questions on the checklist are vague or the definition is not clear, so they have the same opinion but check it with different answers. Fourth, if the auditors make a mistake when filling out the checklist, it causes to led to different the results. Conclusion: We propose the following items that should be improved in order to conduct consistent and efficient internal audits. First, it is necessary to test the tool in order to carry out reliable and consistent internal audits. Second, it is necessary to complete specialized training related to internal audit before conducting internal audit. Third, before notifying the audit results, it is necessary to have a procedure or a final review system to check whether the audit contents are appropriate. Fourth, Institutional support is needed to recruit specialized personnel for internal audits.

• International Journal of Computer Science & Network Security
• /
• 제23권11호
• /
• pp.142-148
• /
• 2023

The National Agency for Quality Assurance in Higher Education plays a crucial role in education in Ukraine, as an independent entity creates and ensures quality standards of higher education, which allow to properly implement the educational policy of the state, develop the economy and society as a whole.The purpose of the article: to reveal the crucial role of the National Agency for Quality Assurance in Higher Education to create quality management of higher education institutions, to show its mechanism as an independent entity that creates and ensures quality standards of higher education. and society as a whole. The mission of the National Agency for Quality Assurance in Higher Education is to become a catalyst for positive changes in higher education and the formation of a culture of its quality. The strategic goals of the National Agency are implemented in three main areas: the quality of educational services, recognition of the quality of scientific results, ensuring the systemic impact of the National Agency. The National Agency for Quality Assurance in Higher Education exercises various powers, which can be divided into: regulatory, analytical, accreditation, control, communication.The effectiveness of the work of the National Agency for Quality Assurance in Higher Education for 2020 has been proved. The results of a survey conducted by 183 higher education institutions of Ukraine conducted by the National Agency for Quality Assurance in Higher Education are shown. Emphasis was placed on the development of "Recommendations of the National Agency for Quality Assurance in Higher Education regarding the introduction of an internal quality assurance system." The international activity and international recognition of the National Agency for Quality Assurance in Higher Education are shown.

• 산업경영시스템학회지
• /
• 제21권45호
• /
• pp.215-224
• /
• 1998

Nowadays most companies are required to acquire the quality assurance system from domestic or foreign Certification Institute. However, There are many problems in interpreting the requirements and procedures. This study presents an effective operation scheme by addressing the inherent limits of the system, potential problems in operation, relationship with internal standardization of the company, and the functions of Quality Management that lack or are not considered enough in the ISO 9000 series.

• International Journal of Computer Science & Network Security
• /
• 제22권11호
• /
• pp.324-330
• /
• 2022

The United Kingdom is known for the quality of its qualifications. There is a strict quality system with reputable bodies responsible for ensuring that high quality standards are met. In order for new qualifications to be accredited, they must meet all the requirements set out in the regulations for the quality and informatization of Education. The crucial role of the Agency for Quality Assurance of Higher Education (QAA) in the UK for creating high-quality management of higher education institutions is revealed, the influence of informatization tools on its effective mechanism as an independent entity is shown, and positive experience for the educational sector is highlighted. While the universities themselves are responsible for reviewing educational programs at the subject level, the QAA review focuses on verifying internal quality assurance, as well as systems and improvement strategies. The QAA uses a peer review process in which teams mostly consist of academic staff from other institutions to assess the quality of the institution's education. In Scotland, the team also includes an international reviewer. The student is also a member of the Scottish teams. In the UK, attention is paid to providing a cohort of experienced reviewers who can conduct high-quality monitoring and help with advice on improving education. All reviewers must complete training and have permission to participate in the review of educational programs. There are selected committees that are members of the QAA council, each of which is headed by a member of the Council or an independent person approved by the Council. Attention is drawn to the main areas of the QAA's work in the framework of environmental, social and corporate governance.

• The Journal of Asian Finance, Economics and Business
• /
• 제7권12호
• /
• pp.845-852
• /
• 2020

The study aims to investigate the implementation of the internal quality assurance system (IQAS) on HEIs performance, mediated by financial management accountability. The commitment from foundation leadership on financial management accountability and their implications for HEIs' performance is also carefully examined. This study employs samples of 108 respondents from the leadership of private HEIs under Region IV Service Institutions. The purposive sampling, as a part of non-probability sampling was chosen as the sampling technique. Statistical data analysis conducted by use the structural equation model to test the hypothesis. The results reveal that the implementation of IQAS does not influence the financial management accountability, but it has an essential role on HEIs' performance. Moreover, foundation leadership's commitment has a significant positive effect on financial management accountability and HEIs' performance. Financial management accountability also has a significant positive effect on HEIs' performance. Financial management becomes important because the entire activities of HEIs should end with financial reporting. Therefore, financial and non-financial aspects are two interrelated and complementary aspects in the accreditation process. The findings of this study suggest that that performance measurement is very crucial as a part of the efforts to meet the general accountability requirement for organizations, particularly in HEIs.

• 한국의료질향상학회지
• /
• 제18권1호
• /
• pp.71-78
• /
• 2012

Background : The objective of this study was to examine the effect of management system for the appropriate prophylactic use of antibiotics in surgical patients at a tertiary hospital from 2007 to 2010. Methods : We collected clinical data of three different surgical procedures(colectomy, heart surgery, hysterectomy) for three months of 2007 and 2010, respectively. The number of total cases was 245(137, 54, 54) in 2007, 240(133, 42, 65) in 2010. We measured the rate of use of inappropriate prophylactic antibiotics, administration within 1 hour prior to the incision and the antibiotics prescription days after surgery. To evaluate the effectiveness of the management system, the results of the two groups(Group1=2007, Group2=2010) were compared by t-test, chi-square test or Fisher's exact test. Result : The rate of Aminoglycoside uses decreased drastically from 11.4% to 0.8%(P<.001). The selection of 3rd/4th Cephalosporin dropped from 11.8% to 5.8%(P=.020). The combination of antibiotics decreased from 27.8% to 11.7%(P<.001). The antibiotic prescription rate on discharge declined from 11.8% to 2.5%(P<.001) and the number of antibiotics prescription days after surgery was shortened from 4.2 days to 2.3 days(P<.001). No significant difference in the rate of administration within 1 hour between two groups was found. Through 3-year management, 5 out of 6 measures were significantly improved(except the administration within 1 hour). The rate of surgical site infection decreased from 2.4% to 1.3%(P=.504). Conclusion : The findings demonstrate that the management system for the prophylactic use of antibiotics in surgical patients was effective in decreasing the rate of surgical site infection during 3 years.