• 항공우주시스템공학회지
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• 제12권4호
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• pp.1-8
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• 2018

형식증명승인은 외국 감항당국으로부터 형식증명을 받은 후 국내로 도입되는 항공기, 엔진, 프로펠러에 대한 형식설계 검증을 통해 항공기의 안전성을 확인하는 것을 말한다. 우리나라는 항공안전법 제21조 "형식증명승인"에 따라 국내로 수입되는 항공기에 대한 설계 적합성을 확인하고 있다. 최근 미국, 중국, 싱가포르 등으로 구성된 Validation Principles Working Group은 위험평가 기반의 형식증명승인 모델을 개발하였으며 국제 표준화를 위해 노력하고 있다. 이에 따라, 위험평가기반의 형식증명승인 모델을 분석하고, 우리나라의 형식증명승인 제도의 개선방향을 고찰하였다.

• 품질경영학회지
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• 제50권4호
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• pp.831-842
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• 2022

Purpose: This study carried out the Quality by Design (QbD)6σ process to verify the effectiveness and equivalence of the finished D-antigen quantitative test method, and compared the OFAT-based method validation and test result acceptance criteria with the Analytical Quality by Design (AQbD)-based method validation and test method. This is a study on how to reduce the risk of delay in permit change by increasing the reliability of permit data in the existing method by statistically analyzing the results. Methods: With the QbD6σ process, the effectiveness and equivalence of the D-antigen quantitative test method were verified with the data of the existing test method and the new test method. Results: Method validation tests are performed based on AQbD. Critical Method Parameters are identified through risk assessment, and single/combined actions are verified by designing and performing tests for Critical Method Parameters (analysis of variance, full factorial design method). Method validation can be effectively accomplished with the QbD6σ process. Conclusion: The use of QbD6σ can be used to achieve satisfactory results for both pharmaceutical companies and regulators by using appropriate statistical analytical methods for method validation as required by regulatory agencies.

• 한국지형학회지
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• 제27권3호
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• pp.87-103
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• 2020

The purpose of this study is to evaluate the risk of cropland and man-made infrastructures in a landslide-prone area using a GIS-based method. To achieve this goal, a landslide inventory map was prepared based on aerial photograph analysis as well as field observations. A total of 550 landslides have been counted in the entire study area. For model analysis and validation, extracted landslides were randomly selected and divided into two groups. The landslide causative factors such as slope, aspect, curvature, topographic wetness index, elevation, forest type, forest crown density, geology, land-use, soil drainage, and soil texture were used in the analysis. Moreover, to identify the correlation between landslides and causative factors, pixels were divided into several classes and frequency ratio was also extracted. A landslide susceptibility map was constructed using a bayesian predictive model (BPM) based on the entire events. In the cross validation process, the landslide susceptibility map as well as observation data were plotted with a receiver operating characteristic (ROC) curve then the area under the curve (AUC) was calculated and tried to extract a success rate curve. The results showed that, the BPM produced 85.8% accuracy. We believed that the model was acceptable for the landslide susceptibility analysis of the study area. In addition, for risk assessment, monetary value (local) and vulnerability scale were added for each social thematic data layers, which were then converted into US dollar considering landslide occurrence time. Moreover, the total number of the study area pixels and predictive landslide affected pixels were considered for making a probability table. Matching with the affected number, 5,000 landslide pixels were assumed to run for final calculation. Based on the result, cropland showed the estimated total risk as US $ 35.4 million and man-made infrastructure risk amounted to US $ 39.3 million.

• 대한안전경영과학회지
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• 제16권4호
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• pp.123-131
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• 2014

Modern weapon systems are getting more complex in terms of the functionality and also the conditions on the environment and range in which they are deployed and used. Therefore, many development programs can easily be exposed to a variety of risks, resulting in delayed schedules and cost overrun. As such, effective means are necessary to keep the defence budget at an affordable level while competitive edges on technological aspects are retained. As one way to meet those need, modeling and simulation (M&S) methods have widely been used, particularly in the test and evaluation (T&E) process for weapon systems development. The result of M&S-based systems development should be evaluated by the verification, validation & accreditation (VV&A) process to assure keeping reliability at a desired level. On the other hand, due to the explosiveness, the weapons systems development naturally requires to consider safety issues in both the T&E and operational periods. The purpose of this paper is to improve the VV&A process by reflecting the safety requirements therein. To do so, the VV&A process has been analyzed and graphically modeled first and then safety elements have been incorporated effectively. The use of the improved process in the war ships development has also been discussed. Based on the process proposed and the consequent database constructed, the target system can be expected to benefit from reducing development risks while assuring systems safety.

• 정보보호학회논문지
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• 제14권4호
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• pp.61-74
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• 2004

위험분석모델은 정보시스템 보안과 관련된 위험을 자산, 위협, 취약성, 보안통제의 관계를 통해서 설명하는 체계화 된 방법이다. 그러나 위험분석모델의 실증적인 연구가 이루어진 경우는 상당히 드물며, 특히 위험분석모델의 타당성 논의는 거의 없는 실정이다. 구조방정식모델을 적용하여 전자상거래 환경에서 위험분석모델의 타당성에 대한 실증적 분석을 한 결과, 위험의 수준에 영향을 미치는 요인으로 언급되는 위협과 보안통제는 통계적으로 유의한 것으로 나타났다. 본 연구는 전자상거래 이용자의 위험인지에 영향을 미치는 요인을 위험분석 접근법을 이용하여 모델 화하여 검증함으로써 전자상거래 위험에 영향을 미치는 선행요인을 규명할 뿐만 아니라 위험분석접근법을 통한 전자상거래에 대한 새로운 관점에서의 접근을 가능하게 한다.

• Journal of Pharmaceutical Investigation
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• 제37권6호
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• 간호행정학회지
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• 제17권4호
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• pp.484-492
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• 2011

Purpose: The aims of study were; (1) to evaluate the validity and sensitivity of a fall-risk assessment tool, and (2) to establish continuous quality improvement (CQI) methods to monitor the effective use of the risk assessment tool. Methods: A retrospective case-control cohort design was used. Analysis was conducted for 90 admissions as cases and 3,716 as controls during the 2006 and 2007 calendar years was conducted. Fallers were identified from the hospital’s Accident Reporting System, and non-fallers were selected by randomized selection. Accuracy estimates, sensitivity analysis and logistic regression were used. Results: At the lower cutoff score of one, sensitivity, specificity, and positive and negative predictive values were 82.2%, 19.3%, 0.03%, and 96.9%, respectively. The area under the ROC was 0.60 implying poor prediction. Logistic regression analysis showed that five out of nine constitutional items; age, history of falls, gait problems, and confusion were significantly associated with falls. Based on these results, we suggested a tailored falls CQI process with specific indexes. Conclusion: The fall-risk assessment tool was found to need considerable reviews for its validity and usage problems in practice. It is also necessary to develop protocols for use and identify strategies that reflect changes in patient conditions during hospital stay.

• Safety and Health at Work
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• 제1권1호
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• pp.29-36
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• 2010

This article describes a systematic roadmap master plan for advanced industrial safety and health policy in Korea, with an emphasis on. Since Korean industries had first emergence of industrial safety and health policy in 1953, enormous efforts have been made on upgrading the relevant laws in order to reflect real situation of industrial work environment in accordance with rapid changes of Korean and global business over three decades. Nevertheless, current policy has major defects; too much techniques-based articles, diverged contents in less organization, combined enforcement and punishments and finally enforcing regulations full of commands and control. These deficiencies have make it difficult to accommodate changes of social, industrial and employment environment in customized fashion. The approach to the solution must be generic at the level of paradigm-shift rather than local modifications and enhancement. The basic idea is to establish a new system integrated with a risk assessment scheme, which encourages employers to apply to their work environment under comprehensive responsibility. The risk assessment scheme is designed to enable to inspect employers' compliances afterwards. A project comprises four yearly phases based on applying zones; initially designating and operating a specified risk zone, gradually expanding the special zones during a period of 3 years (2010-2012) and the final zone expanded to entire nation. In each phase, the intermediate version of the system is updated through a process of precise and unbiased validation in terms of its operability, feasibility and sustainability with building relevant infrastructures as needed.

• 국제학술발표논문집
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• The 5th International Conference on Construction Engineering and Project Management
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• pp.397-402
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• 2013

In super-tall building construction projects, schedule risk factors which vertically change and are not found in the low and middle-rise building construction influence duration of a project by vertical attribute; and it makes hard to estimate activity or overall duration of a construction project. However, the existing duration estimating methods, that are based on quantity and productivity assuming activities of the same work item have the same risk and duration regardless of operation space, are not able to consider the schedule risk factors which change by the altitude of operation space. Therefore, in order to advance accuracy of duration estimation of super-tall building projects, the degree of changes of these risk factors according to altitude should be analyzed and incorporated into a duration estimating method. This research proposes a simulation model using Monte Carlo method for estimating activity duration incorporating schedule risk factors by weather conditions in a super-tall building. The research process is as follows. Firstly, the schedule risk factors in super-tall building are identified through literature and expert reviews, and occurrence of non-working days at high altitude by weather condition is identified as one of the critical schedule risk factors. Secondly, a calculating method of the vertical distributions of the weather factors such as temperature and wind speed is analyzed through literature reviews. Then, a probability distribution of the weather factors is developed using the weather database of the past decade. Thirdly, a simulation model and algorithms for estimating non-working days and duration of each activity is developed using Monte-Carlo method. Finally, sensitivity analysis and a case study are carried out for the validation of the proposed model.

• 한국콘텐츠학회논문지
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• 제21권2호
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• pp.121-129
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• 2021

본 연구에서는 데이터마이닝(Data Mining) 기법 중 하나인 연관관계분석(Association Rule Mining)을 적용하여 위험화물 선별모델을 구축함으로써 관세위험을 최소화하고자 한다. 이를 위해 관세청 수입신고서 빅데이터를 활용하여 연관관계분석 알고리즘인 어프라이어리 알고리즘(Apriori Algorithm)을 적용하고 공급망 간의 위험정도를 계산한다. 대규모의 수입신고 데이터로부터 해외공급자와 수입업체 간의 세율관련(과세가격, 품목, 중수량 등), 원산지표시 위반 등에 관련한 적발결과 관한 규칙셋(Rule Set)과 이 규칙들의 신뢰도(Confidence)을 확보하여 우범공급망 간의 거래패턴을 예측할 수 있는 선별모델을 구축한다. 총 2년 6개월 치의 수입신고 데이터를 활용하여 5-겹 교차검증(5-fold cross validation)을 수행한 결과 16.6%의 Precision과 33.8%의 Recall을 보였다. 이는 빈도기반 방법보다 Precision 기준 약 3.4배 Recall 기준 약 1.5배 높은 결과이다. 이로써 논문에서 제안하고 있는 방법이 관세위험을 줄일 수 있는 효과적인 방법임을 확인하였다.