• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• Journal of Advanced Navigation Technology
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• v.15 no.5
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• pp.687-695
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• 2011

The defect caused by the software industry that is the source of knowledge-centric, information-centric and technology-centric affects an engine which operate a major role for operation of aircraft. Therefore, we should minimize the danger from the defect by strengthening the stability of aviation through the stability analysis of software. In this paper, we examine the laws and systems about the aircraft defects and software safety and propose the enhancement and the enactment of the law or measures to strengthen aviation safety. We should the existing law or system as items, such as the revision related to the safety analysis, standards of quality assurance including safety, application of quality assurance that you must attach the safety analysis report, assessment of detailed instructions of certification authorities. In addition, we should enact the new law and system as items such as the mandatory software evaluation and certification, continuous assessment based on the software life cycle, mandatory introduction of a standardized development methodology, strengthening of advanced workforce system. We can expect the improvement of software quality and an enhanced aviation safety by improving existing laws or systems and enacting new laws or systems.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.4 no.1
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• pp.65-75
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• 2006

Transparency on the Total System Performance Assessment (TSPA) is the key issue to enhance the public acceptance for a radioactive repository. To approve it, all performances on TSPA through Quality Assurance is necessary. The integrated Cyber R&D Platform is developed by KAERI using the T2R3 principles applicable for five major steps : planning, research work, documentation, and internal & external audits in R&D's. The proposed system is implemented in the web-based system so that all participants in TSPA are able to access the system. It is composed of three sub-systems; FEAS (FEp to Assessment through Scenario development) showing systematic approach from the FEPs to Assessment methods flow chart, PAID (Performance Assessment Input Databases) being designed to easily search and review field data for TSPA and QA system containing the administrative system for QA on five key steps in R&D's in addition to approval and disapproval processes, corrective actions, and permanent record keeping. All information being recorded in QA system through T2R3 principles is integrated into Cyber R&D Platform so that every data in the system can be checked whenever necessary. Throughout the next phase R&D, Cyber R&D Platform will be connected with the assessment tool for TSPA so that it will be expected to search the whole information in one unified system.

• Journal of KIISE:Software and Applications
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• v.33 no.7
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• pp.605-614
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• 2006

The success of a software development project can be determined by the use of QCD. And as a software's size and complexity increase, the importance of early quality assurance rises. Therefore, more effort should be given to prevention, as opposed to correction. In order to provide a framework for the prevention of defects, defect detection activities such as peer review and testing, along with analysis of previous defects, is required. This entails a systematization and use of quality data from previous development efforts. FMEA, which is utilized for system safety assurance, can be applied as a means of software defect prevention. SW-FMEA (Software Failure Mode Effect Analysis) attempts to prevent defects by predicting likely defects. Presently, it has been applied to requirement analysis and design. SW-FMEA utilizes measured data from development activities, and can be used for defect prevention on both the development and management sides, for example, in planning, analysis, design, peer reviews, testing, risk management, and so forth. This research discusses about related methodology and proposes defect prevention model based on SW-FMEA. Proposed model is extended SW-FMEA that focuses on system analysis and design. The model not only supports verification and validation effectively, but is useful for reducing defect detection.

• The Journal of Information Systems
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• v.16 no.1
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• pp.159-178
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• 2007

As generalization of using PC and the Internet information technology (IT) users in organizations are not passive clients but active producers of information services. One of the reasons for the change of users' role is social interactions with other users and IT department staffs. That is, users can find and develop new functions and usefulness of IT, especially, Web-based ones through communication with other users or IT department staffs. The objective of this study is to investigate the relationship between IT department service quality and social interactions with other users. For this purpose, we suggest a research model based on adaptive structuration theory (AST), which is to explain the changes in social structure (rules and resources) of IT by social interactions, as well as service quality theory. Our model's exogenous variable is service quality which is a second-order factor consisting of reliability, responsiveness, assurance, and empathy. As endogenous variables, we adopt two variables for appropriateness of using IT, faithfulness of appropriation and consensus on appropriation. Finally, dependent variables of ow model are usefulness and ease of use which can be considered as attitude on IT as well as other variables for appropriateness. For empirical test our model is applied to users of groupware and ERP in organizations and analyzed by partial least square. In result, all hypotheses suggested in our model are supported statistically.

• Quality Improvement in Health Care
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• v.1 no.1
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• pp.66-94
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• 1994

Hospital Accreditation Programme(HAP) has been introduced in many countries in the world for these recent years. This article reviews the HAP in the aspects of the organization, survey and evaluation process, evaluation criteria, and its impact to the hospital quality improvement. The nations included in this study are USA, UK, Canada, Australia, and Korea. To carry out this comparative study, the authors have reviewed articles and accreditation manuals having been issued in many countries. An expert panel of medical doctor, nurse, pharmacist, administrator, and specialist in health facilities formulated a study framework. The results of this study enhance understanding about hospital accreditation activities according to each nation's health care system. In recent years, the Korean government has launched the plan to improve the quality of health services by strengthening the hospital accreditation programme. This study results can provide useful information in development and implementation of the national hospital accreditation programme in Korea.

• Proceedings of the Korean Radioactive Waste Society Conference
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• 2005.11a
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• pp.126-133
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• 2005

Securing of radioactive waste disposal site and the related operations for disposal of low and intermediate level radioactive waste is being actively carried out in Korea. For disposal of radioactive wastes, physicochemical and radiological status and integrity of radioactive wastes must be secured first. Also, waste generators must provide this information to disposers. In addition, to secure the safety of waste disposal, waste acceptance criteria (WAC) and site specific waste acceptance criteria (SWAC) to consider characteristics of the disposal site are required. Radioactive wastes must be processed, generated, managed and transferred in accordance with these criteria. [1] For this, evaluation of properties on each of the radioactive wastes must be performed. However, in reality, atomic power plants are experiencing difficulties in relation to this due to the large quantity of radioactive waste generation. In order to solve this problem, IAEA and major overseas countries have developed, thus are using waste certification program (WCP) and quality assurance program (QAP) [2,3]. On the basis of these programs, radioactive waste certification program has been developed for safe disposal of radioactive wastes in Korea to satisfy the provisions specified in 'low and intermediate level radioactive waste transfer guidelines' of announcement No. 2005-18 from the Ministry of Science and Technology and specific site waste acceptance criteria (tentative plan). In addition, it is being planned to administer amendment on commercial atomic power plant related procedures and ensile staff training in order for early introduction and operation of radioactive waste certification system.

• Proceedings of the Korean Institute of Building Construction Conference
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• 2015.11a
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• pp.202-203
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• 2015

In light of the recent media outlets revealing structural waterleakage problems, construction workers, design planners and related enterprises are investing more effort towards forming a solution plan for these issues. This study proposes the structuralization of a information network system that allows the selection and discussion of optimal measures for waterproofing related techniques and expert informations online in a realtime setting.

• 제어로봇시스템학회:학술대회논문집
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• 2001.10a
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• pp.56.6-56
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• 2001

The FDAS(Flight Data Analysis & Animation System) is a comprehensive analysis system designed for the improvement of flight safety. FDAS provides decoding, analysis and animation tools that can be used for investigation of data origination primarily from Flight Data Recoders(FDRs), Quick Access Recoders(QARs), Using FOQA(Flight Operation Quality Assurance) Data Analysis, an analyst can perform a variety of functions including data smoothing, interpolation, differentiation, integration, calculator function, flight path generation, performance routines, as well as user-programmed functions. Utilizing data captured and processed by our FDAS software module, FDAS provides high-fidelity 3-D aircraft views and instruments views. Multiple windows enable you to view the situation from a variety of perspectives, including out-of-window, chase plane ...

• Proceedings of the Korean Institute of Building Construction Conference
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• 2012.05a
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• pp.235-242
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• 2012

In recently constructed building, It has become fashionable again that the heavy external skin system such as a Stone Finished Envelope. There are Squared Steel Pipe Methods, C-Shaped Steel Pipe Methods, and Aluminum Beam Methods in the structure of a heavy external skin system. The Aluminum Beam Methods is often misunderstood as a Plane Truss Structure, but this method is not appropriate to be called to a truss structure but a beam methods. The Aluminum Beam Methods is the most Eco-friendly methods in terms of Quality assurance, Efficiency, Safety, Construction period, Durability, and Recyclability. And this Methods is also very appropriate in considering the point of Energy conservation, Waste reduction, Long-life architecture, Replacement parts, Environmental protection, Public efficiency, and Building demolition.