• Title/Summary/Keyword: Safety Assessment Regulations

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Flight Test Safety Risk Assessment and Mitigation (비행시험 안전 리스크 평가 및 완화 연구)

  • Kim, Mu-Geun;Yoo, Beong-Seon;Han, Jeongho;Kang, Ja-Young
    • Journal of Advanced Navigation Technology
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    • v.22 no.6
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    • pp.537-544
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    • 2018
  • A national comprehensive aviation test center is being constructed for the purpose of flight tests for development and modification of aircraft or flight inspections for the development of navaids. Flight testing is a high-risk task, so strict risk management processes are required prior to operation. In addition, since the flight test center is subject to the airdrome regulations under the current law, the introduction of the safety management system will enhance safety as usual in ordinary airports. The establishment of a safety management system based on ICAO criteria is an optimal means of ensuring safe and effective operation of the test center and may mitigate the risks that may arise during flight testing. This paper focuses on risk assessment and mitigation required for safety management at the flight test center. We conducted risk assessments on the flight hazards identified in the previous study. Then the high risk group of hazards were selected and risk mitigation techniques such as avoidance, reduction, acceptance, and control were applied.

The Current Status and Acceptance of Traditional Medicine of East Asia in the UK

  • Lee, Hai Woong
    • Journal of Society of Preventive Korean Medicine
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    • v.20 no.2
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    • pp.87-95
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    • 2016
  • Objectives : Traditional medicine(TM) of East Asia has been taking its status as part of complementary and alternative medicine(CAM) in the UK. However, the efficacy and safety issues make it hard to be accepted in the healthcare system. The aim of the research is to find out the current status of TM of East Asia in the UK and to discuss some issues around its acceptance as formal healthcare method. Methods : Articles, books and regulations related to the acceptance of TM of East Asia were analysed and the internet websites were visited such as Westlaw UK for legal materials, government websites for formal documents, and some UK-based associations. Keyword searches were followed and the essential parts from the articles and documents were generalised for the analysis and discussion. Results : Issues over TM of East Asia include identity as medicine, efficacy and safety, and the statutory regulation can be a measure for the acceptance. Osteopathy and chiropractic therapies came under statutory regulation among the CAM in the UK. Conclusions : TM of East Asia could be under the statutory regulation in the near future. Efficacy and safety issues are the challenging barrier. However, the approach from the viewpoint of TM of East Asia is necessary for development and good practice. The simplified registration procedure for traditional herbal medicinal product in EU can be the model. Education, evaluation, assessment and managing quality of practice are essential for the standard care and formal regulation.

The Optimization of Passenger Seat Belt Design for Female Passenger (여성 승객을 고려한 동승자석 안전벨트의 설계 최적화)

  • Kim, Yun-Bae;Kim, Hyung-Jun;Han, Jae-Nyung;Kim, Hyung-Il;Chae, Soo-Won
    • Transactions of the Korean Society of Automotive Engineers
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    • v.20 no.4
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    • pp.10-15
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    • 2012
  • The design of automobile occupant seat belt system has been studied by using MADYMO. Based on the FMVSS 208 (Federal Motor Vehicle Safety Standards 208) and the USNCAP (United States New Car Assessment Program) regulations, seat belt design parameters were chosen for the design improvement to the 5th percentile female dummy: limit force of load limiter, time to fire of shoulder belt, inlet length of shoulder belt, inlet length of lap belt. The design of experiment method was employed to optimize the design parameters of passenger seat belt. Range of injury probability due to the change of H-point position was estimated by the simulation.

Analysis on Field Professionals' Assessment of Alternative Fire Escape Methods in Apartment Building (공동주택 대안적 화재 피난방식에 대한 건설전문가 평가조사)

  • Lee, Myung Sik;Lee, So Young
    • KIEAE Journal
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    • v.9 no.5
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    • pp.21-28
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    • 2009
  • In apartment buildings, casualties, especially fatalities have occurred in balcony areas in fires if residents fail to escape to the main entrance. Potential consequences of a particular infrequent event should be considered. In attempting to design apartment buildings for fire safety, alternative escape methods such as vertical penetration could be considered. The purpose of this study is to investigate present building regulations regarding apartment buildings and examine pros and cons of the current escape method and alternative escape methods. Focus group interview was conducted to discuss problems of fire escape methods. In addition, questionnaires were distributed to field professionals working in architecture, construction and related industries. Among 500 questionnaires distributed, 192 questionnaires were collected. Usable 162 questionnaires were analyzed using SPSS 15. Regarding alternative fire escape methods, several concerns were mentioned. Safety, privacy, security, effectiveness of escape, water proof problems were raised. Based on the opinions, vertical penetration between apartment unit appeared more safe, secure, effective than horizontal penetration. However, both methods have its own pros and cons under specific contexts. Alternative escape methods need be considered for a selective options for residents in case of fire.

A Study on Risk Classification of Small Plant for Safe Management of Hazardous Chemicals (유해화학물질 안전관리를 위한 중소사업장의 위험도 분류에 관한 연구)

  • Lee, Hyo-Eun;Kim, Min-Gyu;Lee, Bong-Woo
    • Journal of the Korean Society of Industry Convergence
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    • v.24 no.5
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    • pp.609-615
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    • 2021
  • Chemical accidents can happen anywhere in the world. To prevent chemical accidents, Korea introduced the Chemicals Control Act. However, Small and medium-sized businesses do not meet these regulations. Accordingly, the Ministry of Environment is providing a chemical safety management support project for Small and medium-sized businesses. However, there are many small and medium-sized businesses, and businesses that need support need priority. In this study, the risk of the plants was classified into hig h, medium, and low risk based on four methods. As a result, out of 90 plants subject to the study, high risk was 30% and medium risk was 70%. The industries with the high risk were chemical products manufacturing and paint manufacturing. The plating and printing industries showed relatively medium risk. This risk classification has the advantage that it can obtain intuitive and quick results. These studies can be used as basic data for chemical safety management of local governments and Ministry of Environment.

A Study on Damage Analysis Safety Distance Setting for LPG BLEVE (LPG BLEVE 피해분석 및 안전거리 설정에 관한 연구)

  • Kim, Jonghyuk;Lee, Byeongwoo;Kim, Jungwook;Jung, Seungho
    • Journal of the Korean Society of Safety
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    • v.35 no.6
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    • pp.25-31
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    • 2020
  • Boiling Liquid Expanding Vapor Explosion(BLEVE) can cause not only economic damage to the plant but also serious casualties. LPG accidents account for 89.6 percent of all accidents caused by gas leaks in Korea over the past nine years, while casualties from accidents also account for 73 percent of all accidents, according to statistics from the Korea Gas Safety Corporation. In addition, a potential explosion and a fire accident from one LPG storage tank may affect the nearby storage tanks, causing secondary and tertiary damage (domino effect). The safety distance standards for LPG used by LPG workplaces, charging stations, and homes in Korea have become stricter following the explosion of LPG charging stations in Bucheon. The safety distance regulation is divided into regulations based on the distance damage and the risk including frequency. This study suggests two approaches to optimizing the safety distance based on the just consequence and risk including frequencies. Using the Phast 7.2 Risk Assessment software by DNV GL, the explosion overpressure and heat radiation were derived according to the distance caused by BLEVE in the worst-case scenario, and accident and damage probability were derived by considering the probit function and domino effect. In addition, the safety distance between LPG tanks or LPG charging stations was derived to minimize damage effects by utilizing these measures.

APPLICATION OF FIRE RESEARCH TO BUILDING FIRE SAFETY DESIGN - CURRENT BENEFITS AND FUTURE NEEDS

  • Bressington, Peter;Johnson, Peter
    • Proceedings of the Korea Institute of Fire Science and Engineering Conference
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    • 1997.11a
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    • pp.392-403
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    • 1997
  • There is a strong international move towards performance based fire regulations for buildings with New Zealand and Australia at the forefront of research in this fold. The reform of regulations is thought to offer more innovation and flexibility in building design and greater cost effectiveness in construction. An important part of the research in this area is related to the development of agreed approaches to fire safety design, such as the Fire Code Reform Centre's "Fire Engineering Guidelines" or New Zealand's "Fire Engineering Design Guide". Such design process documents have incorporated or referenced much of the latest research in areas such as: tenability criteria fire compartment models egress models risk assessment. Use of such design guidelines or equivalents in major projects in countries such as Hong Kong and Australia have highlighted where fro engineering can offer real benefits to building designers and ultimately building owners and operators. However, there is still much research to be done and use of a systematic, logical design approach clearly identifies where design data or modelling techniques are still urgently required. Such areas are: fire growth rates and peak heat release rates for non-residential occupancies pre-movement times related to egress experimental validation and limits of applicability of CFD and other compartment Ire models probability/reliability data on fire protection systems for risk based analysis. Examples from case studies will be shown where lack of such research and poor judgement can lead to inferior design solutions or where unnecessarily conservative designs can lead to cost excesses. In summary, the link between Ire engineering designers and the research community is very important to highlight areas of fire research that will have the most benefit to the building and construction industry.nstruction industry.

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A Study on the Management and Dispensing Standards of Herbal Medicine in Herbal Dispensaries (탕전실의 조제 관리 및 운영 기준에 대한 연구)

  • Kang, Sung Chul;Kim, So Yeon;Yun, Yu Kyung;Kim, Ji-Hoon;Kim, Yun-Kyung
    • Herbal Formula Science
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    • v.27 no.1
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    • pp.31-44
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    • 2019
  • Objective : Herbal dispensaries, where medications are prepared for patients, require specific preparation and operations management for safe herbal medicines. This study aims to propose improvements in the herbal medicine preparation and operation of the herbal dispensaries as series study of the "A Survey on the Management Status of Extramural Herbal Dispensaries" Methods : We first checked current management regulations. In addition, we compared and analyzed related laws which are "State management norm of Traditional Chinese Medicine dispensaries", "Enforcement Rule of Medicinal Product Safety" and " Hazard Analysis and Critical Control Point(HACCP)", to introduce the assessment items of herbal dispenses evaluation and certification system. Results : In this study, we found that the current regulations, "Guideline on Installation and Utilization of Extremal Herbal Pharmaceutical Facility and Shared-use of Herbal Dispensary", are insufficient to ensure the quality and safety of herbal medicines. We suggested articles for the proper management of herbal dispensaries and these were introduced to the Herbal dispensary evaluation and certification system. Conclusion : We recommend evaluation articles in Herbal dispensary evaluation and certification systems need to be popular among herbal dispensaries, then Korean herbal medicine could restore credibility from the people.

Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea (한국, 미국, 유럽의 혁신적 의약품 개발 및 허가제도 비교 연구)

  • Jiyeon Park;Hyewon Shin;Jangik. I. Lee
    • Korean Journal of Clinical Pharmacy
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    • v.34 no.1
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    • pp.39-61
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    • 2024
  • Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

System Development and Field Application for Measuring installation Interval and Height of Road safety Facilities Using a tine Scanning Camera (라인스캔 카메라를 이용한 도로 안전시설 설치간격 및 높이측정 시스템 개발 및 현장적용)

  • Moon, Hyung-Chul;Suh, Young-Chan
    • International Journal of Highway Engineering
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    • v.10 no.3
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    • pp.231-237
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    • 2008
  • One of the basic requirements for the most advanced countries would be the well-planned traffic infrastructures. For such traffic safety systems, foreign countries follow the current tendency to which they manage the traffic facilities and equipments based on the objective assessment for the state of every traffic safety facility in terms of Asset Management(AM). As the road safety facilities related among them are very diverse, and their functions are very important as well, the regulations and directions for installing them are enacted. However, despite the standards and directions for the installations, sometimes, the facilities are not installed in accordance with the standards, not only causing inconvenience to the users but also negatively affecting the safety for them. In the study, for the facilities in which the installation interval and height are standardized according to the designed speed and geometrical structure of the road among the various road safety facilities, the image analysis model capable of measuring them with a line scanning camera was developed. In addition, the program systematically analyzing this was also developed and applied to the field and, as the result of that, the size and installation interval of the facilities could be measured fast and accurately.

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