• Journal of Evidence-Based Herbal Medicine
• /
• 제1권1호
• /
• pp.29-34
• /
• 2008

Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

• 정보과학회 논문지
• /
• 제44권9호
• /
• pp.893-907
• /
• 2017

안전 필수 시스템에서 소프트웨어 결함은 심각한 결과를 초래하므로, 개발의 첫 단계인 요구사항 명세부터 안전성을 고려해야한다. 자연어로 작성된 요구사항은 여러 이해관계자들에게서 도출되어 모호함과 부정확성에 의한 결함을 갖고 있어도 검출하기 어렵다. 이러한 문제를 해결하기 위해 표준문안과 GSN 모델을 이용한 요구사항 명세방법을 제안한다. 표준문안은 선 정의된 서식에 맞춰 요구사항을 작성하는 준-정형 언어로, 표준문안에 맞춰 요구사항을 작성하면 표현의 일관성을 갖기 때문에 이해관계자들이 요구사항이 의미하는 바에 대한 모호함을 방지하여 요구사항의 정확한 의미를 정의하는데 도움이 된다. GSN은 시스템이 안전하다는 것을 관련기관에 증명하기 위한 Safety Case 작성에서 적합성을 인정받고 있는 표기법으로 기능목표, Safety Evidence 등을 표현한다. 본 연구에서는 안전 필수 시스템의 요구사항을 명세하기에 적합하도록 설계된 표준문안과 GSN 모델을 이용하여 요구사항 명세단계에서부터 결함을 쉽게 식별하고, Safety Evidence와의 연결을 통해 안전적합성을 증명할 수 있다. 또한 이 과정에서 발견된 요구사항의 결함을 수정하여 안전성 있는 소프트웨어를 개발할 수 있다.

• Journal of Ship and Ocean Technology
• /
• 제1권2호
• /
• pp.31-40
• /
• 1997

The paper begin by examining shipbuilding in the context of competitiveness, specification and cost-effectiveness before considering the impact of safety requirements in the its operations. The basis of the safety case approach is then given, and its application to shipbuilding is illustrated by an example based on the use of staging in ship construction. The key conclusion is that the safety case approach provides the management with a technique for treating potential hazards in shipbuilding so that their risks can be kept within an acceptable level.

• 전기학회논문지
• /
• 제59권12호
• /
• pp.2298-2305
• /
• 2010

The paper presents the Model Based Design(MBD) method which design and verify control algorithm for safety power window. Safety power window are required to work together with the anti-pinch function and have to meet FMVSS118 S5 requirements and equivalent ECC requirements. To meet the requirements, this paper presents the establishment of SILS and RCP environments. The design process can reduce time and support more performance-assured design. As a result of study, it met the regulations and achieved reaction force that close to common products.

• 한국철도학회:학술대회논문집
• /
• 한국철도학회 2007년도 추계학술대회 논문집
• /
• pp.1858-1863
• /
• 2007

Railway systems are one of the best mass transit systems and many people have prevented incidents/accidents and reduced fatalities remarkably. Especially we have tried analyzing and finding the measures to prevent catastrophic accidents like train collision, derailment and fire because of their severities. It is important to assess the safety performances of railway systems like crash-worthiness analysis, body, derailment affecting factor analysis and so on for reducing and finding out the reasonable causes of disastrous accidents. In this paper the refined top-level system requirements to build-up national infra for assessing railway safety performance and the procedures and methodology for reviewing, verifying and validating infra requirements are explained. Basically the authors have used system engineering processes to analyze and verify the requirements and installation procedures and have tried maximizing the practicality of the various safety assessment systems.

• 한국신뢰성학회지:신뢰성응용연구
• /
• 제14권1호
• /
• pp.81-91
• /
• 2014

The IEC 61508 standard was established to specify the functional safety of E/E/PE safety-related systems. Safety life cycle to provide the framework and direction for the application of IEC 61508 is included in this standard. In this paper, we describe overviews, objects, scopes, requirements and activities of each phase in safety life cycle. In addition, we introduce safety integrity level(SIL) which is used for verifying the safety integrity requirements of E/E/PE system and perform a case study to estimate hardware SIL by FMEDA. The SIL is evaluated by two criteria. One of them is the architectural constraints which restrict the maximum SIL by combination of SFF and HFT. The other is the probability of failure which is classified into PFD and PFH based on frequency of demand and calculated by safe or dangerous failure rates.

• 한국정밀공학회:학술대회논문집
• /
• 한국정밀공학회 2008년도 추계학술대회 논문집
• /
• pp.661-662
• /
• 2008

• Safety and Health at Work
• /
• 제6권2호
• /
• pp.146-150
• /
• 2015

Occupational health and safety (OHS) is a broad field of professional practice, which involves specialists from different disciplines including but not limited to engineers, occupational health physicians, physical and biological scientists, economists, and statisticians. The preventive systems required to ensure workers are protected from injuries and illnesses dwell heavily on engineers; however, the extent to which the engineer can go regarding planning and implementing preventive measures is dependent on specific legal requirements, leadership commitment from the company, organization, and nation. The objective of this paper is to identify the areas of opportunities for improvements in OHS management in Ghana with regard to the nation's legal requirements, commitment of the Ghana government, and Ghanaian leadership as well as appropriate structuring of Ghanaian institutions responsible for monitoring and managing OHS in Ghana. This paper identified Ghana's fragmented legal requirements concerning OHS, which are under different jurisdictions with unclear responsibilities and accountabilities. The paper also highlights the training needs of Ghanaian academic institutions regarding OHS. Among other recommendations made including structuring of Ghanaian institutions to manage OHS in line with the ILO-OSH 2001, this paper aligns the recommendations with the articles and elements of International Labour Organization convention number 155 and OHSAS 18001 elements.

• 한국철도학회논문집
• /
• 제8권2호
• /
• pp.161-169
• /
• 2005

In this paper, we provide safety requirements and advices to guarantee the safety of an interface in a level crossing system which is an interface between the conventional facilities and the new ATP (Automatic Train Protection) system, as well as we accomplish a safety management for the facilities of a country that has a different standard with already standardized ATP system. The system model has been made based on a safety activity of the international standard, and then a tolerance of a risk by the safety activity through PHA (Preliminary Hazard Analysis) has been analyzed. finally we achieved HIA (Hazard Identification and Analysis) for the assumptions that have been produced from a operating scenario and a functional interface. Thus, the safety requirements for the interface has been provided from the safety plan of HIA, and we showed the safety activity to guarantee the system safety through HIA which was depend on the design.

• Journal of Ship and Ocean Technology
• /
• 제5권3호
• /
• pp.1-13
• /
• 2001

Present-day rules and regulations for the design and construction of ships are almost without exemption of a prescriptive and deterministic nature. Often it is argued that this situation is far from ideal; it does no right to the advances, which have been made during the past decades in engineering tools in marine technology, both in methodology and in computational power. Within IMO this has been realized for some time and has resulted in proposals to use Formal Safety Assessment(FSA) as a tool to improve and to modernize the rule making process. The present paper makes use of elements of the FSA methodology, but instead of working towards generic regulations or requirements, a Risk Assessment Approach, not unlike a 'safety case'; valid for a certain ship or type of ship is worked out. Delft University of Technology investigated the application of safely assessment procedures in ship design, in co-operation with Anthony Veder Shipowners and safety experts from Safely Service Center BV. The ship considered is a semi-pressurized-fully refrigerated LPG carrier. On the basis of the assumption that a major accident occurs, various accident, scenarios were considered and assessed, which would impair the safety of the carrier. In a so-called Risk Matrix, in which accident frequencies versus the consequence of the scenarios are depicted, the calculated risks all appeared lo be in the ALARP('as low as reasonable practicable') region. A number of design alternatives were compared, both on safety merits and cost-effectiveness. The experience gained with this scenario-based approach will be used to establish a set of general requirements for safety assessment techniques in ship design. In the view that assessment results will be most probably presented in a quasi-quantified manner, the requirements are concerned with uniformity of both the safety assessment. These requirements make it possible that valid comparison between various assessment studies can be made. Safety assessment, founded on these requirements, provides a validated and helpful source of data during the coming years, and provides naval architects and engineers with tools experience and data for safety assessment procedures in ship design. However a lot of effort has to be spent in order to make the methods applicable in day-to-day practice.