• Title/Summary/Keyword: Safety Audit

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Mission and Operation of Institutional Review Board (임상시험심사위원회의 임무와 운영)

  • Kim, Yong-Jin
    • Journal of Yeungnam Medical Science
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    • v.30 no.2
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    • pp.73-78
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    • 2013
  • An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

Reliability Analysis on the Assessment Indicators for Senior Walking Environment (노인 보행환경 평가항목 신뢰도 분석연구)

  • Lee, Hyung-Sook
    • KIEAE Journal
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    • v.12 no.3
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    • pp.69-75
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    • 2012
  • Developing reliable measures of the environment is important to increase our understanding of the environmental effects on walking among seniors. As a preliminary study for developing an instrument for measuring walkability of seniors' environment, the purpose of this study are to identify important assessment indicators associated with seniors' walking and to test their reliability using inter-rater and intra-rater reliability methods. A set of assessment indicators was identified through literature review, and field studies by trained raters were conducted in three senior centers located in Seongnam area in order to test reliability of the audit tool. The results indicated high percent agreement for most indicators and overall 91.6% and 86.1% of items assessed had good or medium inter-rater and intra-rater reliability, respectively. The reliable assessment indicators would provide reliable data for use in community-based audits of built environment in relation to walking among older adults. The findings showed that the indicators of aesthetics had lower reliability compare to safety, convenience, and access. Rater training with various images would improve rater agreement while reduce rater bias.

Development of Laboratory Safety Management System for Chemistry and Chemical Engineering Laboratory (화학 및 화학공학 실험실의 안전관리 시스템 개발)

  • Yoo, Jin Hwan;Lee, Heon Seok;Choi, Joung Woo;Seo, Jae Min;Park, Chulhwan;Ko, Jae Wook
    • Korean Chemical Engineering Research
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    • v.46 no.2
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    • pp.376-382
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    • 2008
  • There are many accidents such as fire and explosion in laboratories that have caused a great loss to lives and property in spite of the effort to the enhancement of laboratory safety level for years. Development of laboratory safety management system is a necessary to improve safety level because the accidents of similar types have periodically occurred in laboratories. The laboratory safety management system may reduce many accidents and a serious loss in laboratory. In this study, we summarized major items for a risk management and safety improvement based on the analysis results of various accidents in the laboratories. And then the laboratory safety management system was developed containing a laboratory safety management manual, a laboratory management system, a education management system, a MSDS (material safety data sheet) management system and a laboratory safety audit system. It may have a potential application for the laboratory safety management in the chemical laboratories.

A Study on Safe distance of VTS officer and Ship's operator by VTS Communication analysis-2 (VTS 교신 분석을 통한 관제사와 선박운항자의 안전거리에 관한 연구-2)

  • Park, Sangwon;Park, Youngsoo
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2016.05a
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    • pp.15-17
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    • 2016
  • The congestion situation of Korea's port is further inclining due to the number of arriving and departing vessels and increase in the size of the size. Indicators for assessing whether the Vessel Traffic Congestion is called the Marine Traffic Congestion and it is used as a diagnostic entries in the Maritime Traffic Safety Audit System. In the diagnostic system, 6L (longitudinal) X 3.2L (transverse) is used as ship's domain in cases of harbor. This study is to determine the safety distance of the VTS officer and the ship operators by targeting the Busan harbor, which has the most number of ships that arrive/depart in Korea and listen to the communication of the VTS and calculate the communication time of the VTS officer and the ship operators for 7 days. By utilizing the distance communication port, the safety distance between the controllers and the ship operators is derived. It can be used for basic information of VTS Officer and Ship's operator's Safety distance in Busan port's in&out harbor.

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A Study on the Scope of Passenger Vessels and Dangerous Goods Carriers Subject to Maritime Traffic Safety Audits (해상교통안전진단 대상 여객선 및 위험화물운반선 범위에 관한 고찰)

  • Lee, Hong-Hoon;Kim, Sung-Cheol;Kim, Deug-Bong
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.23 no.7
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    • pp.767-774
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    • 2017
  • Maritime traffic safety audits (MTSA) were enacted in order to ensure marine traffic safety throughout changes or the construction of water facilities, port facilities, etc. After the introduction of MTSA, the scope of subject vessels was restricted to an LOA of more than 100 m or a maximum speed of more than 60 knots as of 2014. In this study, the scope of subject vessels was re-examined in comparison with specific marine traffic safety areas and tanker prohibited areas identified in the maritime safety act. Furthermore, the state of subject vessels and exception cases for MTSA were also analyzed. As a result of these analyses, MTSA were deemed necessary for dangerous goods carriers of more than 1,000 G/T in specific marine traffic safety areas and dangerous goods carriers of more than 794 G/T in tanker prohibited areas. Finally, the necessity of further review was suggested given the present scope of subject vessels.

Evaluation of the Microbiological Status of Raw Beef in Korea: Considering the Suitability of Aerobic Plate Count Guidelines

  • Kim, Hye-Jin;Kim, Dongwook;Kim, Hee-Jin;Song, Sung-Ok;Song, Young-Han;Jang, Aera
    • Food Science of Animal Resources
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    • v.38 no.1
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    • pp.43-51
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    • 2018
  • This study was conducted to analyze the microbiological contamination status of raw beef distributed in Korea, and evaluate the suitability of current aerobic plate count (APC) guidelines. We analyzed five years (2010-2014) of microbiological monitoring data obtained from the Ministry of Food and Drug Safety and investigated the microbiological status of raw beef collected from meat packing centers and meat shops in the Seoul/Gyeonggi, Gangwon, and Chungcheong regions in August 2015. From 2010-2014, most raw beef (>94%) displayed APC levels of < $1.0{\times}10^6CFU/g$. However, raw beef samples collected from all three regions in August 2015 had comparatively higher APC levels than those reported in previous years. To evaluate the relationship between the APC level and quality, changes in beef loin were evaluated during cold storage for 15 days at $4^{\circ}C$. On day 11, the mean APC level ($4.7{\times}10^6CFU/g$) conformed to current guidelines in Korea ($1.0{\times}10^7CFU/g$) and the pH value was 5.82. However, the sensory evaluation score for color and overall acceptability was under 3.0, meaning that the beef loin was not acceptable for eating. These results suggest that current APC guideline for raw beef should be lowered to $1.0{\times}10^6CFU/g$ to improve both the microbiological safety and palatability of raw beef.

The Measurement of Road Alignment Using GPS-IMU System (GPS-IMU 통합 시스템을 이용한 도로기하구조 측정에 관한 연구)

  • Park, Jae-Hong;Yun, Duk-Geun;Sung, Jung-Gon;Lee, Jun-Seok
    • Journal of Korean Society of Transportation
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    • v.30 no.5
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    • pp.61-69
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    • 2012
  • It is important for highway maintenance and safety assessment to get the accurate highway geometric information. However, it is difficult to acquire good highway geometric information due to missing blueprints or deteriorated highway sections. This research, to get highway geometric information rapidly, has developed a highway geometric analysis algorithm that uses data from vehicles with GPS-IMU integrated system. In conclusion, the result shows that 3.38% of error-ratio for the horizontal alignment and 0.083 absolute value difference for vertical grade comparing with highway drawings. Therefore, the result suggest that the developed method can be applied to the road safety inspection or road safety audit.

A Study on the Self-Prevention Plan System (자체방제계획서 검토기준 마련 연구)

  • Kim, Sungbum;Noh, Hyeran;Lee, Jinseon;Kim, Jungmin;Ahn, Seungyoung;Seok, Kwangseol
    • Journal of the Society of Disaster Information
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    • v.9 no.1
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    • pp.50-55
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    • 2013
  • Self-Prevention Plan Review Report and Review Standards Process Safety Management(PSM), Safety Management System(SMS), including the contents of the safety management system audit standards, notices and guidelines on the screening form and were analyzed. Were expected through the interview and screening personnel in the screening process to identify problems prior research so that it can be reflected in the. Also divided into methods such as document review and on-site implementation status of the review written Emergency Preparedness Plan depending on the item proposed. Toxic Chemicals Control Act(TCCA) Self-Prevention Plan Review Regulations. However, the substantial approval process, and do not enable the system performance lacked Self-Prevention Plan Review. Review half configuration to enhance the professionalism and efficiency of the work of this research was performed.

A Study on Air Operator Certification and Safety Oversight Audit Program in light of the Convention on International Civil Aviation (시카고협약체계에서의 항공안전평가제도에 관한 연구)

  • Lee, Koo-Hee;Park, Won-Hwa
    • The Korean Journal of Air & Space Law and Policy
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    • v.28 no.1
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    • pp.115-157
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    • 2013
  • Some contracting States of the Convention on International Civil Aviation (commonly known as the Chicago Convention) issue FAOC(Foreign AOC and/or Operations Specifications) and conduct various safety audits for the foreign operators. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident, it is the source of concern from the legal as well as economic perspectives. FAOC of the USA doubly burdens the other contracting States to the Chicago Convention because it is the requirement other than that prescribed by the Chicago Convention of which provisions are faithfully observed by almost all the contracting States. The Chicago Convention in its Article 33 stipulates that each contracting State recognize the validity of the certificates of airworthiness and licenses issued by other contracting States as long as they meet the minimum standards of the ICAO. Consequently, it is submitted that the unilateral action of the USA, China, Mongolia, Australia, and the Philippines issuing the FOAC to the aircraft of other States is against the Convention. It is worry some that this breach of international law is likely to be followed by the European Union which is believed to be in preparation for its own unilateral application. The ICAO established by the Chicago Convention to be in charge of safe and orderly development of the international civil aviation has been in hard work to both upgrade and emphasize the safe operation of aircraft. As the result of these endeavors, it prepared a new Annex 19 to the Chicago Convention with the title of "Safety Management" and with the applicable date 14 November 2013. It is this Annex and other ICAO documents relevant to the safety that the contracting States to the Chicago Convention have to observe. Otherwise, it is the economical burden due to probable delay in issuing the FOAC and bureaucracies combined with many different paperworks and regulations depending on where the aircraft is flown. It is exactly to avoid this type of confusion and waste that the Chicago Convention aimed at when it was adopted in 1944. The State of the operator shall establish a system for both the certification and the continued surveillance of the operator in accordance with ICAO SARPs to ensure that the required standards of operations are maintained. Certainly the operator shall meet and maintain the requirements established by the States in which it operate. The authority of a State stops where the authority of another State intervenes or where the former has yielded its power by an international agreement for the sake of international cooperation. Hence, it is not within the realm of the State to issue FAOC towards foreign operators for the reason that these foreign operators are flying in and out of the State. Furthermore, there are other safety audits such as ICAO USOAP, IATA IOSA, FAA IASA, and EU SAFA that assure the safe operation of the aircraft, but within the limit of their power and in compliance with the ICAO SARPs. If the safety level of any operator is not satisfactory, the operator could be banned to operate in the contracting States with watchful eyes until the ICAO SARPs are met. This time-honoured practice has been applied without any serious problems. Besides, we have the new Annex 19 to strengthen and upgrade with easy reference for contracting States. We don't have no reason to introduce additional burden to the States by unilateral actions of some States. These actions have to be corrected. On the other hand, when it comes to the carriage of the Personal or Pilot Log Book, the Korean regulation requiring it is in contrast with other relevant provisions of USA, USOAP, IOSA, and SAFA. The Chicago Convention requires in its Articles 29 and 34 only the carriage of the Journey Log Book and some other certificates, but do not mention the Personal Log Book at all. Paragraph 5.1.1.1 of Annex 1 to the Chicago Convention even makes it clear that the carriage in the aircraft of the Personal Log Book is not required on international flights. The unique Korean regulation in this regards giving the unnecessary burden to the national flag air carriers has to be lifted at once.

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A Study on the Traffic Patterns of Dangerous Goods Carriers in Busan North and Gamcheon Port (부산 북항·감천항의 위험화물운반선 통항패턴에 관한 연구)

  • Kim, Jong-Kwan;Kim, Se-Won;Lee, Yun-Sok
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.23 no.1
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    • pp.9-16
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    • 2017
  • As a preliminary study of enter or leaving traffic patterns of the Korea main port, port Management Information System (Port-MIS) data was used to check the volume of vessels entering and leaving the port of Busan, and three consecutive days from each seasons were selected for study. Selected 12-day General Information Center on Maritime Safety & Security (GICOMS) data was also used to analyze the traffic pattern in the main traffic lane of Busan port for dangerous goods carrier. Also, the distance between dangerous goods carriers and Oryukdo breakwater of east breakwater in the main traffic lane was analyzed. Collision probability was estimated using the cumulative probability distribution function of the normal distribution for the maritime traffic safety audit scheme based on the assumption that a ship's trajectory has a normal distribution for a section of the route. However, in case of entry or leaving thorough the Oryukdo breakwater and entry thorough the east breakwater, ship's sailing trajectories were revealed not to follow a normal distribution via regularity testing using a KS-test and SW-test. Especially in the north port, the tendency of the right side of the ship to pass was remarkable. It is desirable to develop a traffic model suitable for the characteristics of the port rather than to apply general traffic theories, and to apply this model to a maritime traffic safety diagnosis, so further research is needed.