• Journal of Aerospace System Engineering
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• v.12 no.4
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• pp.1-8
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• 2018

The state of registry issues a type certificate validation (TCV) based on the satisfactory evidence that the product (aircraft, engine, and propeller) is in compliance with the appropriate airworthiness requirements. The Korean government performs an evaluation to determine whether the product complies with Korean airworthiness standards for issuing TCV according to the Korean aviation safety law. Recently, the Validation Principles Working Group (VPWG) has developed a risk-based model for validation of civil aeronautical products. Also, VPWG proposed to incorporate this validation model into the corresponding ICAO Standards and Recommended Practices and guidance material. In this paper, we have reviewed the validation model and discussed improvements in the validation process.

• Journal of Korean Society for Quality Management
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• v.50 no.4
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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.

• Journal of The Geomorphological Association of Korea
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• v.27 no.3
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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.

• Journal of the Korea Safety Management & Science
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• v.16 no.4
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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.

• Journal of the Korea Institute of Information Security & Cryptology
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• v.14 no.4
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• pp.61-74
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• 2004

Risk analysis model is systematic and structural process that considers internal security problems and threat factors of the information systems to find optimal level of security control. But, the risk analysis model is just only defined conceptually and there are not so many empirical studies. This research used structural equation modeling(SEM) research methodology with rigorously validated research instrument. Based on results of this study, risk analysis methodology was proved to be practically useful in e-commerce environment. Factors like threat and control were significantly related to risk. In conclusion, the results of this study can be applied to general situation or environment of information security for analyzing and managing the risk and providing new approach to comprehend concept of risk in e-commerce environment.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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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.

• Journal of Korean Academy of Nursing Administration
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• v.17 no.4
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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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• v.1 no.1
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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.

• International conference on construction engineering and project management
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• 2013.01a
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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.

• The Journal of the Korea Contents Association
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• v.21 no.2
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• pp.121-129
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• 2021

In this study, we try to minimize the tariff risk by constructing a hazardous cargo screening model by applying Association Rule Mining, one of the data mining techniques. For this, the risk level between supply chains is calculated using the Apriori Algorithm, which is an association analysis algorithm, using the big data of the import declaration form of the Korea Customs Service(KCS). We perform data preprocessing and association rule mining to generate a model to be used in screening the supply chain. In the preprocessing process, we extract the attributes required for rule generation from the import declaration data after the error removing process. Then, we generate the rules by using the extracted attributes as inputs to the Apriori algorithm. The generated association rule model is loaded in the KCS screening system. When the import declaration which should be checked is received, the screening system refers to the model and returns the confidence value based on the supply chain information on the import declaration data. The result will be used to determine whether to check the import case. The 5-fold cross-validation of 16.6% precision and 33.8% recall showed that import declaration data for 2 years and 6 months were divided into learning data and test data. This is a result that is about 3.4 times higher in precision and 1.5 times higher in recall than frequency-based methods. This confirms that the proposed method is an effective way to reduce tariff risks.