• Journal of the Korean Society of Marine Environment & Safety
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• v.3 no.1
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• pp.51-71
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• 1997

As passenger ship accidents so frequently have occurred, crisis consciousness is highly aroused in Korean society. Although bombastic policy guidlines were suggested in accordance with every passenger ship accident, there remains a still high possibility of such an accident reoccurring because passenger ship accidents occur from the perspective of non-compliance. The research objective of this study is to government's safety regulatory policies. Data for the analysis was collected from literature review. A Case study related to passenger ship accident is adopted for the analysis. The research methods utilized in this study consist of extensive quantitative analysis of 138 passenger ship accidents which had happened over last 10 years from 1984 to 1993 in Korea and a qualitative analysis of the passenger ship accident of the Seohae Ferry in October 1993. The results of the quantitive analysis on the 138 passenger ship accidents are as follows; Seeing the accidents yearly, the accidents which occurred by policy non-compliance are still exist, only somewhat reduced as years gone by. Seeing the accidents from the perspective of types of accident, fire accidents and death and injury accidents had more non-compliance factors than contact accidents and one-side collision accidents, etc. had. Seeing the accidents from the perspectives of types of passenger ship, large ships like car ferries and general passenger ship accidents had more non-compliance factors than any other kinds of ships had. Seeing the accidents from the perspectives of tons of passenger ships, large ships weighing more than 1, 000 tons and small ships weighing less than 50tons contained a lots of non-compliance factors. The results of the qualitative analysis of the passenger ship accident of the Seohae Ferry in Octovber 1993 are as follows; From the viewpoint of the human factor, there were non-compliance to the recruiting of required number of qualified crew members and non-compliance to the rule which prohibited them from leaving port in bad weather and high wave conditions. From the viewpoint of the ship factor, there were defects in the ship. So we might say that there was non-compliance which was aroused from the lacks of technical skills. From the viewpoint of the administrative factor, there were many non-compliance factors such as sailor education, shipping management, rescue, safety equipment. From the viewpoint of the passenger factor, there were passengers' threats which compelled the crews to leave the port under bad weather conditions. In conclusion, the principal non-compliances factors are passenger ship company did not follow safety rules such as shipping the permitted number of passengers, loading permitted tons of freight and fastening freights properly and recruiting required number of qualified crew. In order to reduce accidents, firstly we should find out the causes which play key roles in passenger ship companies' non-compliance to the government's safety regulations. Secondly we should tackle the causes.

• Proceedings of the Korean Institute of Navigation and Port Research Conference
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• 1995.04a
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• pp.59-64
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• 1995

The impediment in enhancing the ship safety and combating vessel-source marine pollution depends on the combination of the immediate and mediate factors. The former is mainly caused by human errors and failure in compliance with the international convention standards in operation of compliance with the international convention standards in operation of vessel. The latter by the attitudes and activities of some of the flay states taking little responsibilities with appropriate seriousness in policing their fleets due to the lack of implementing capability of adminstrations. So long as there exists a large size of variation in implementing capability of administration between flag states a globally remarked progress cannot expect to be made in assuring the ship safety and preventing the vessel-source pollution Therefore a new regulatory regime is suggested to be adopted by IMO to maintain high standard flag state adminstrations by recommending standard paradigm to member states so that the development of a implementing culture is encouraged and supported.

• Journal of Korean Society for Quality Management
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• v.34 no.1
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• pp.54-72
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• 2006

In recent years, the widespread application of quality management and measurement reliability has put increasing emphasis on procedures for periodic instrument calibration. By optimizing calibration intervals, unnecessary calibrations can be minimized, thereby reducing costs. Moreover, optimizing intervals will improve compliance with regulatory directives while ensuring maximal compliance with reliability targets. In this paper, we present Calibration Interval Analysis Program developed using several establishment methodologies of calibration interval for measurement quality and reliability improvement. Also, we perform calibration interval analysis for some measurement instruments and analyse its results.

• Journal of Aerospace System Engineering
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• v.5 no.1
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• pp.17-23
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• 2011

Since the time, cost and lack of regulatory information and guidance, one of the largest regulatory obstacles for an airframe manufacturer of polymer based advanced composite materials in certified aircraft applications, is to generate design allowables that will satisfy Airworthiness Regulations. In the past two decades, the design allowables used in military aircraft had been generated and applied in Korea, however the qualification of composite materials used in certifying airframe structure was not accomplished for design and demonstration of compliance to applicable airworthiness regulation. It is the intend of this paper that provide the basis of composite material qualification for small aircraft certification to the airworthiness regulation.

• Journal of Legislation Research
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• no.53
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• pp.213-267
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• 2017

Regulatory barrier is considered most challenging out of all FinTech barriers, which many technology innovators have always experienced. Even though technological solutions promise customers accessibility to more cost-effective and secured financial services, it is quite challenging to create regulatory environment that enables innovation FinTech industry. Especially, a common challenge FinTech innovators and business face is regulatory uncertainty and confusion rather than any particular regulation. Since many FinTech models are continuously introducing new innovative ways in providing financial services, significant confusion could be raised in applying principles of existing law and regulations. In addition, it is uncertain whether or not applying complex regulatory compliance model intended for large financial institutions to small start-ups is appropriate since most existing regulations and rules are established and introduced without considering innovative tools such as mobile instruments, e-trade, and internet. Therefore, new mechanism to access to regulatory information in a more cost-effective, quick and immediate way should be created. Regulators, technological innovators, and financial customers should cooperate each other to find out appropriate solutions for those issues. Many regulators are introducing regulatory sandbox which provides service providers with opportunities to test their innovations, during the test, providing regulators with enough time to understand risks of innovations. However, regulatory sandbox is not a panacea for all challenges to FinTech innovations. Therefore, regulators should make comprehensive and multidimensional efforts including regulatory sandbox in supporting FinTech ecosystem.

• Proceedings of the Korea Contents Association Conference
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• 2010.05a
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• pp.345-346
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• 2010

기업은 개인정보의 보호를 위해 다양한 방안들을 마련해 이러한 규제를 준수하며 내부에 관리중인 개인정보에 대해 보안을 강화하기 위해 빠르게 보안 솔루션을 도입하고 있다. 이에 수많은 데이터들이 저장되어 사용되고 있는 DBMS 측면에서 이러한 규제를 준수하는 동시에 효과적으로 데이터 보안을 확보하기 위한 방안을 암호화, 접근제어, 감사로 구분하여 각각의 대한 구현방법 및 해당 솔루션들을 비교하여 이를 통해 최적의 데이터 보안 방안을 모색할 수 있도록 한다.

• Journal of Science and Technology Studies
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• v.11 no.2
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• pp.31-66
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• 2011

The main issue in Korean debates over genetically modified (GM) foods have been government's responsibility to guarantee consumers' right-to-know and make informed choice. Counter-experts' critique over the current regulatory processes based upon substantial equivalence have not been widely publicized. Through interviews and textual analysis, this paper explored three groups' performances in Korean GM food controversies-regulatory scientists, civil society organizations, and counter-experts. Analytic focus was made upon how each of the groups interact with current GM food regulations. While making conflicts with regulatory scientists and their 'discourse of compliance with global standards,' counter-experts were excluded from regulatory processes. This article suggests that the processes and contexts in which counter-experts failed to form strong alliance with other groups need to be examined in order to further understand the specific contours of Korean GM food controversies.

• The Journal of Fisheries Business Administration
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• v.49 no.4
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• pp.99-108
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• 2018

Maintaining a certain level of fisheries production is due to the increase in aquaculture production. In recent years, aquaculture plays an important role in fishery production in Korea. Nevertheless, aquaculture should be carefully managed by regulations because it also causes environmental load which can threat sustainability of aquaculture. For this reason, Korean government has regulated density of culturing facilities with the Fisheries Law and its adjective decrees. The regulatory compliance of fisheries businesses is very low because the criteria for the regulation of the density were not enacted with scientific research. Thus, this research was aimed to obtain scientific criteria for the regulation of oyster aquaculture in Jaran Bay with economic assessment. For this research, we collected the data necessary for the assessment on five investigation points in the bay for two years. With the data, simulation for the growth rate of oyster was performed and the result showed that at least 25.5% of facilities should be reduced. Also, it was revealed that removing 2 long lines would be most beneficial. The NPV of the best measurement was 35,120,300 won and IRR was 11.7%. With this research, the government will gain more accurate regulatory compliance due to the scientific approach. Moreover, fisheries businesses in oyster aquaculture can obtain flexibility to cope with market fluctuation.

• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• Korean Journal of Clinical Pharmacy
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• v.26 no.1
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.