• Proceedings of the KIEE Conference
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• 2006.07b
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• pp.1095-1096
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• 2006

Configuration management plays a key role in systems engineering process for any project from earlier stage of development. It consists of five major activities, ie., configuration management planing, configuration identification, configuration control, configuration status accounting and configuration verification and audit, and is essential to control system design development and operation throughout entire life cycle of the system development. And it is directly associated with other part of systems engineering management, ie., technical data management which provides traceability of important decisions and changes during development. In this paper, we describe how to apply CASE(Computer-aided Systems Engineering) tool-Cradle for the configuration management to achieve effectiveness of City Train Standard Specification Management process.

• Proceedings of the Safety Management and Science Conference
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• 2003.11a
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• pp.315-321
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• 2003

Under WTO we are confronted with the upcoming of the infinite competition and the opening of education market. In order to meet such new changes, more and more university in education industry participate in the certification of ISO 14000. This paper presents an effective approach to obtain the ISO 14001 environmental management system, summarized as follows: First, the top manager should understand the environmental problems and motivate all personnels. Second, a systematized environmental management system should be constructed in accord with actual circumstances of firms, and should be improved continuously by means of effective operation, internal audit and management review. Third, an environmental policy should be published, the environmental programs should be established following an environmental objective, target and they should be monitored regularly.

• Journal of Radiopharmaceuticals and Molecular Probes
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• v.1 no.2
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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.

• Proceedings of the KSR Conference
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• 2008.11b
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• pp.1570-1594
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• 2008

Nowadays there are lots of changes in the domestic railroad industries because of the reorganization in the industries, operation of KTX and expansion of city train in local areas. To cope with these changes effectively, domestic & abroad safety guideline and regulation were investigated and reviewed by railroad safety technical development project. Based on this project, domestic rolling stock safety regulation was established in the July and December on 2005. It's been a 3 years after 2005 and to confirm whether there are some problems to applicate the regulation in the field like korail, the necessity of reviewing the regulation gains force. In this study, to improve the field application in rolling stock safety regulation, we investigated the results of integrated railroad audit system and internal safety regulation system in a train operator and also collected the opinions from train manufacturer. Then through the result of investigation and collection of the opinions, we proposed the amendment to the rolling stock safety regulation.

• The Korean Journal of Archival Studies
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• no.25
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• pp.3-46
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• 2010

Digital records management is one whole system in which many social and technical elements are interacting. To maintain the trustworthiness, the repository needs periodical audit and certification. Thus, individual electronic records management agency needs toolkit that can be used to self-evaluate their trustworthiness continuously, and self-assess their atmosphere and system to recognize deficiencies. The purpose of this study is development of self-certification toolkit for repositories, which synthesized and analysed such four international standard and best practices as OAIS Reference Model(ISO 14721), TRAC, DRAMBORA, and the assessment report conducted and published by TNA/UKDA, as well as MoRe2 and current national laws and standards. As this paper describes and demonstrate the development process and the framework of this self-certification toolkit, other electronic records management agencies could follow the process and develop their own toolkit reflecting their situation, and utilize the self-assessment results in-house. As a result of this research, 12 areas for assessment were set, which include (organizational) operation management, classification system and master data management, acquisition, registration and description, storage and preservation, disposal, services, providing finding aids, system management, access control and security, monitoring/audit trail/statistics, and risk management. In each 12 area, the process map or functional charts were drawn and business functions were analyzed, and 54 'evaluation criteria', consisted of main business functional unit in each area were drawn. Under each 'evaluation criteria', 208 'specific evaluation criteria', which supposed to be implementable, measurable, and provable for self-evaluation in each area, were drawn. The audit and certification toolkit developed by this research could be used by digital repositories to conduct periodical self-assessment of the organization, which would be used to supplement any found deficiencies and be used to reflect the organizational development strategy.

• The Journal of KAIRB
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• v.2 no.2
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• Journal of the Society of Disaster Information
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• v.14 no.3
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• pp.334-342
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• 2018

Purpose: The purpose of this study is to examine and improve the issues related to National Safety Inspection currently operation and reform the system for response to various disasters. Method: For the completion, this study established theoretical background using materials related to National Safety Inspection and identified the issues using the open statistical data for National Safety Inspection to suggest the improvement plans. Results: National Safety Inspection has been operating a complete large-scale inspection on risk factors in cooperation with the central government, local governments, and citizens since 2015 to remove various disaster factors neglected in people's daily lives. Operation of National Safety Inspection had positive influence in preventing major disasters. However, inefficient activity is pointed out due to issues related to cooperation with other institutes, limitation for citizen's positional role, and superficial inspection. Conclution: To solve this issue, this study proposed strengthening of communication activity with disaster institutes, strengthening of efficiency through citizen participation by type, and actualization of checklist used in National Safety Inspection.

• The Journal of the Korea Contents Association
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• v.17 no.1
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• pp.436-443
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• 2017

This research aims to inquiry the present state of online game industry and related laws and investigate the nature and feature of the web-board game policy through the case of web-board game operation in China. We reviewed China local literature of online mobile game industry and inspected foreign entry, copyright protection, safety audit, distribution, and shop in China laws related to online game. We examined the game operation of the most famous 'Bianfeng' game company among China web-board game and considered how the charge and exchange for game money is made at issue. The result was revealed that money exchange was made in twilight zone neither legal nor illegal due to dual feature of China law. It is an ambiguous judgment that did not take a strong prohibition. However, we found that minium regulation was gone just in case social trouble happened. The result of this research will expect to help Korea regulation authorities and game company that have plans to enter China market the guideline for game operation policy.

• Convergence Security Journal
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• v.22 no.4
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• pp.99-107
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• 2022

The use of smart home appliances and Internet of Things (IoT) devices is growing, enabling new interactions and automation in the home. This technology relies heavily on mobile services which leaves it vulnerable to the increasing threat of hacking, identity theft, information leakage, serious infringement of personal privacy, abnormal access, and erroneous operation. Confirming or proving such security breaches have occurred is also currently insufficient. Furthermore, due to the restricted nature of IoT devices, such as their specifications and operating environments, it is difficult to provide the same level of internet security as personal computers. Therefore, to increase the security on smart home IoT devices, attention is needed on (1) preventing hacking and user authority theft; (2) disabling abnormal manipulation; and (3) strengthening audit records for device operation. In response to this, we present a plan to build a cloud security authentication platform which features security authentication management functionality between mobile terminals and IoT devices.

• Journal of Korean Society on Water Environment
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• v.36 no.6
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• pp.546-558
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• 2020

While industrialization has provided in abundance, the pollution it creates has caused untold damage to the environment, increasing the frequency and severity of natural disasters through changes in global climate patterns. The World Risk Forum's (WEF) World Risk Report presented the results of a survey of experts from around the world detailing the most influential risk factors over the next decade. Notably, the failure to respond to climate change ranked first and the global water crisis third. The extreme drought in the western Chungnam province was unexpected in 2016. At the time, the water level of Boryeong Dam was drastically decreased due to receiving less than half the average recorded rainfall in the region that year. The Boryeong Dam diversion pipeline has the capacity to solve the water shortage problem between these two regions by providing water from Geumgang to the western part of Chungnam, including Boryeong City. Current weather trends suggest drought is likely to continue in western Chungnam, which uses the Boryeong Dam as an intake source. This makes it necessary to operate Boryeong Dam diversion pipeline in an efficient and effective manner. SWAT is a watershed scale model developed to predict the impact of land management practices on water. The SWAT model was used in this study to evaluate the adequacy of the Boryeong Dam diversion pipeline operational plan by comparing it to present Boryeong Dam diversion pipeline operation. By investigating the number of days required to reach each reservoir stage, we determined that the number of days required to reach the boundary stage was less than that of the current operation. This determination accounts for the caveats that the Boryeong Dam waterway was not operated and only one pump will be operated from October to May of next year. As our results suggest, the most stable operation scenario is to operate two pumps at all times. This can be accomplished by operating two pumps from the caution stage to increase the number of pumps whenever the stage is raised. In addition to the stable operation of the Boryeong Dam pipeline, policy considerations are required with regard to imposing a water use charge on users of the Boryeong Dam region.