• Title/Summary/Keyword: global compliance

Search Result 102, Processing Time 0.025 seconds

Basic Principles of the Validation for Good Laboratory Practice Institutes

  • Cho, Kyu-Hyuk;Kim, Jin-Sung;Jeon, Man-Soo;Lee, Kyu-Hong;Chung, Moon-Koo;Song, Chang-Woo
    • Toxicological Research
    • /
    • v.25 no.1
    • /
    • pp.1-8
    • /
    • 2009
  • Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

Health Promotion at Work: A Comparison of Policy and Practice Across Europe

  • Verra, Sanne E.;Benzerga, Amel;Jiao, Boshen;Ruggeri, Kai
    • Safety and Health at Work
    • /
    • v.10 no.1
    • /
    • pp.21-29
    • /
    • 2019
  • Background: Promoting healthy lifestyles at work should complement workplace safety programs. This study systematically investigates current states of occupational health and safety (OHS) policy as well as practice in the European Union (EU). Methods: OHS policies of EU member states were categorized as either prevention or health promotion provisions using a manifest content analysis. Policy rankings were then created for each prevention and promotion. Rankings compared eight indicators from the European Survey of Enterprises on New and Emerging Risks-2 data on prevention and promotion practices for each member state using Chi-square and probit regression analyses. Results: Overall, 73.1% of EU establishments take preventive measures against direct physical harm, and about 35.4% take measures to prevent psychosocial risks. Merely 29.5% have measures to promote health. Weak and inconsistent links between OHS policy and practice indicators were identified. Conclusion: National OHS policies evidently concentrate on prevention while compliance with health and safety practices is relatively low. Psychosocial risks are often addressed in national policy but not implemented by institutions. Current risk assessment methods are outdated and often lack psychosocial indicators. Health promotion at work is rare in policy and practice, and its interpretation remains preventive. Member states need to adopt policies that actively improve health and well-being at the workplace.

Design of CIM(Common Information Model) Profile for Smart City Energy Monitoring (스마트시티 에너지 감시를 위한 CIM(Common Information Model) 프로파일 설계)

  • Youngil, Kim;Changhun, Chae;Yeri, Kim;Jihoon, Lee
    • KEPCO Journal on Electric Power and Energy
    • /
    • v.8 no.2
    • /
    • pp.127-135
    • /
    • 2022
  • With the advent of high technologies such as the 4th Industrial Revolution and artificial intelligence and big data, efforts are being made to solve urban problems and improve the quality of life by applying new technologies in the smart city field. In addition, as carbon neutrality has emerged as an important issue due to global warming, smart city energy platform technologies such as urban energy management, efficiency improvement, and carbon reduction are in the spotlight. In order to effectively manage urban energy, energy resource information such as electricity, water, gas, hot water, heating, etc. must be collected from the management system of various energy utilities and managed on the central platform. The centrally integrated data is delivered to external city management systems that require city energy information through an energy platform. This study developed a CIM profile for smart city energy monitoring required to provide energy data to external systems. Electric data model were designed using the CIM class of IEC 61970, and water, gas, and heat data model were designed in compliance with the UML-based design ideas of IEC 61970.

A Comparison of Dynamic Analysis for the Flexible Riser in Shallow Water (천해에서 유연라이저의 동적해석 결과 비교)

  • Jo, Chul-Hee;Kim, Do-Youb;Rho, Yu-Ho;Kim, In-Ho
    • Journal of Coastal Disaster Prevention
    • /
    • v.1 no.4
    • /
    • pp.149-155
    • /
    • 2014
  • Flexible risers have been used extensively in recent years for floating and early production systems. Such risers offer the advantage of having inherent heave compliance in their catenary thereby greatly reducing the complexity of the riser-to-rig and riser-to subsea interfaces. Another advantage with flexible risers is their greater reliability. Concerns about fatigue life, gas permeation and pigging of lines have been overcome by extensive experience with these risers in production applications. In this paper, flexible riser analysis results were compared through coupled and uncoupled dynamic analyses methods. A time domain coupled analysis capability has been developed to model the dynamic responses of an integrated floating system incorporating the interactions between vessel, moorings and risers in a marine environment. For this study, SPM (Single Point Mooring) system for an FSU in shallow water was considered. This optimization model was integrated with a time-domain global motion analysis to assess both stability and design constraints of the flexible riser system.

Compliance of Electronic Bill of Lading Regulation in Korea with Model Law on Electronic Transferable Records

  • Choi, Seok-Beom
    • Journal of Korea Trade
    • /
    • v.23 no.3
    • /
    • pp.68-83
    • /
    • 2019
  • Purpose - The UNCITRAL Model Law on Electronic Transferable Records (Model Law) is based on the principles of non-discrimination against the use of electronic means, functional equivalence, and technology neutrality underpinning all UNCITRAL texts on electronic commerce. Investigating the disagreements between the Model Law and the Koran Commercial Act (KC Act), including the B/L Regulation, and suggesting the revision of the KC Act including the B/L Regulation, could be a valuable study. The purpose of this paper is to contribute to the harmonization of Korean legislation regarding electronic bill of lading in compliance with the Model Law. Design/methodology - The Model Law is flexible to accommodate the use of all technologies and models, such as registries, tokens, and distributed ledgers: that is, blockchain. In 2007, the KC Act was revised to regulate electronic bills of lading to promote the widespread legal use of electronic bills of lading. In addition, The Regulation on Implementation of the Provisions of the Commercial Act Regarding Electronic Bills of Lading (the B/L Regulation) was enacted to regulate the detailed procedures in using electronic bills of lading in 2008. This paper employs a legal analysis by which this paper does find differences between two rules in light of technology neutrality and global standard of electronic bills of lading model. Findings - The main findings are as follows: i) the Korean registry agency has characteristics of a closed system. ii) The KC Act has no provision regarding control. iii) The KC Act discriminates other electronic bills of lading on the ground that it was issued or used abroad. Moreover, this study does comprehensive analysis of Korean Acts in comparison with the Model Law and, in particular, this study analyzes the differences between the KC Act and the Model Law by comparing article by article in view of the harmonization of the two rules. Originality/value - The subject of previous several studies was draft provisions on Electronic Transferable Records before completion of the Model Law; thus, these studies did not take into consideration the character of the Model Law as the Model Law was chosen at the final stage of legislation. This study is aimed at the final version of the Model Law. So, this study is meaningful by finding the suggestion and directions for the Korean government to revise the KC Act and the B/L Regulation in line with the Model Law.

A Study of the Development of Apartment's Structural Cost Saving Checklist through the Case Research (사례분석을 통한 공동주택 골조공사의 원가절감 체크리스트 개발에 관한 연구)

  • Lee, Kyeong-Seob;Suh, Sang-Wook
    • Korean Journal of Construction Engineering and Management
    • /
    • v.11 no.6
    • /
    • pp.65-77
    • /
    • 2010
  • Our nation's housing construction is given much weight over 32% in 2007 and especially apartment is taking over 67%. If we put into construction environment consideration, we are having a trouble with price cap policy and the realestate recession due to the global economic crisis. So in order to get competitive power and supply of cheap apartment, the necessity of cost saving is increasing. This research collected the past constructed apartment project's cost saving examples which were influencing on the construction cost, quality and time. We analyzed collected cost saving datum and assorted these in compliance with classification system. By analysis of correlation among datum with exclusion and integration, we make a propose cost saving Checklist that will be a base data to give a chance to use in working level and other research.

Synchronization and identification of ship shaft power and speed for energy efficiency design index verification

  • Lee, Donchool;Barro, Ronald Dela Cruz;Nam, Jeonggil
    • Journal of Advanced Marine Engineering and Technology
    • /
    • v.38 no.2
    • /
    • pp.123-132
    • /
    • 2014
  • The maritime sector is advancing with dedicated endeavor to reduce greenhouse gas in addressing issues with regards to global warming. Since 01 January 2013, the International Maritime Organization (IMO) regulation mandatory requirement for Energy Efficiency Design Index (EEDI) has been in place and should be satisfied by newly-built ships of more than 400 gross tonnage and the Ship Energy Efficiency Management Plan (SEEMP) for all ships type. Therefore, compliance to this necessitates planning during the design stage whereas verification can be carried-out through an acceptable method during sea trial. The MEPC-approved 2013 guidance, ISO 15016 and ISO 19019 on EEDI serves the purpose for calculation and verification of attained EEDI value. Individual ships EEDI value should be lower than the required value set by these regulations. The key factors for EEDI verification are power and speed assessment and their synchronization. The shaft power can be measured by telemeter system using strain gage during sea trial. However, calibration of shaft power onboard condition is complicated. Hence, it relies only on proficient technology that operates within the permitted ISO allowance. On the other hand, the ship speed can be measured and calibrated by differential ground positioning system (DGPS). An actual test on a newly-built vessel was carried out to assess the correlation of power and speed. The Energy-efficiency Design Index or Operational Indicator Monitoring System (EDiMS) software developed by the Dynamics Laboratory-Mokpo Maritime University (DL-MMU) and Green Marine Equipment RIS Center (GMERC) of Mokpo Maritime University was utilized for this investigation. In addition, the software can continuously monitor air emission and is a useful tool for inventory and ship energy management plan. This paper introduces the synchronization and identification method between shaft power and ship speed for EEDI verification in accordance with the ISO guidance.

Behavior Improvement of Unethical Information-Sharing by The Ethical Program : Social Capital and Ripple Effect (윤리 프로그램을 통한 비윤리적 정보공유 행동의 개선: 사회적 자본과 잔물결 효과)

  • Jung, Byoung-Ho;Kim, Byung-Cho
    • Journal of Digital Convergence
    • /
    • v.15 no.8
    • /
    • pp.169-182
    • /
    • 2017
  • The purpose of this study is to empirically examine a behavior improvement of unethical information sharing through the ethics program in organization. An unethical behavior of information sharing on organization members is to be get to private interests through divulgence of company's confidential information. An unethical information-sharing of individual is the opportunist and selfish behavior for an expansion of social capital and shows a negative ripple effect in organization. When conducting the research methods, the analysis order performs the cluster, discriminant, t-test and multiple regressions. According to the study, There are differences the behavior of unethical information sharing between opportunist and non-opportunist. The opportunist member for unethical behavior improvement required the program operation both value and compliance oriented program. Non-opportunist member required only the value-oriented program. The upcoming research needs to explore both ethics program's frequency and action of a punished person.

An Empirical Investigation on the Effect of Logistics Security in Import and Export Risk Management (물류보안이 수출입 리스크관리에 미치는 영향에 관한 실증연구)

  • Yi, Hong-Won;Kim, Jae-Bong
    • Journal of Navigation and Port Research
    • /
    • v.38 no.3
    • /
    • pp.317-325
    • /
    • 2014
  • The government of South Korea has introduced various security measures in the supply chain, such as CSI (including a 24-hour rule) and AEO (Authorized Economic Operator), in compliance with global security trends and the war on terror. However, many participants in the import and export process are still unfamiliar with the purposes and functions of CSI, the 24-hour rule, and AEO. As such, considering these risks as obstacles or as factors that interfere with the import and export process, this study suggests proper management schemes, which can identify, measure and evaluate these risks.

A Study on the IUU Governance System of Regional Fishery Management Organization and Major State (국제 지역 수산 관리 기구와 주요 국가의 IUU 통제제도 연구)

  • Park, Min-Gyu
    • The Journal of Fisheries Business Administration
    • /
    • v.41 no.3
    • /
    • pp.103-127
    • /
    • 2010
  • The FAO reports that IUU fishing activities have widespread economic, social, and management consequences, including depriving legitimate fishers of harvest opportunities. It affects all fisheries from small scale to industrial. It also affects the ability of governments to support sustainable livelihoods for fishers and, more broadly, to achieve food security. The complexity of IUU requires various measures to combat IUU fishing such as adoption of IUU vessel lists; stronger port State controls; improved monitoring, control and surveillance (MCS); implementation of market-related measures to help ensure compliance; and capacity-building assistance. Trade and market measures reduce opportunities for IUU fishing activities by precluding or impeding access to markets for IUU product in a manner consistent with international law. ICCAT, CCAMLR, and IATTC, have put in place trade tracking programs or catch documentation schemes, and WCPFC is considering such a program. Vessel lists assist enforcement authorities in determining which vessels are or are not authorized to be fishing or conducting fishing support activities in specified areas. A number of RFMOs maintain records of IUU vessels: CCAMLR, IATTC, ICCAT, NAFO, NASCO, NPAFC, WCPFC. Section 608 of the US MSRA calling on the Secretary of Commerce, in consultation with the Secretary of State, and in cooperation with relevant regional fishery management councils and any relevant advisory committees, to take actions to improve the effectiveness of international fishery management organizations in conserving and managing stocks under their jurisdiction. EU IUU Regulation entered into force on 1 January 2010, was intended to regulate the highly complex multi-channel fisheries supply system of the European Community (EC) in an effort to improve global fisheries sustainability.