• 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 Korean Society for Quality Management
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• v.32 no.4
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• pp.48-63
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• 2004

On the process of Korean last half century's condensed economic growth, the contribution of quality management was very important. But if we continued the way in which U.S.A. developed and Japan revised, we would not be able to catch up the developed country. This paper says allegedly that we'd better introduce Korean Quality Management system, which is based on Korean traditional thought.

• Knowledge Management Research
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• v.20 no.3
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• pp.39-47
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• 2019

Response surface methodology (RSM) is a group of statistical modeling and optimization methods to improve the quality of design systematically in the quality engineering field. Its final goal is to identify the optimal setting of input variables optimizing a response. RSM is a kind of knowledge management tool since it studies a manufacturing or service process and extracts an important knowledge about it. In a real problem of RSM, it is a quite frequent situation that considers multiple responses simultaneously. To date, many approaches are proposed for solving (i.e., optimizing) a multi-response problem: process capability function approach, desirability function approach, loss function approach, and so on. The process capability function approach first estimates the mean and standard deviation models of each response. Then, it derives an individual process capability function for each response. The overall process capability function is obtained by aggregating the individual process capability function. The optimal setting is given by maximizing the overall process capability function. The existing process capability function methods usually use the arithmetic mean or geometric mean as an aggregation operator. However, these operators do not guarantee the Pareto optimality of their solution. Moreover, they may bring out an unacceptable result in terms of individual process capability function values. In this paper, we propose a maximin-based process capability function method which uses a maximin criterion as an aggregation operator. The proposed method is illustrated through a well-known multiresponse problem.

• Journal of Korean Society for Quality Management
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• v.18 no.2
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• pp.93-99
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• 1990

This paper considers the selection of process plans for a flexible manufacturing machine. Most of the planning models for the automated manufacturing systems are based on the assumption that for each part there is only one process plan available. This paper considers that for each part a number of different process plans are available, each of which may require specific types of tools. If the requisite tools are not on the machine, one or more tool switches must occur before the process plan can be processed. This paper develops an optimal algorithm of branch and bound method for the selection of process plans to minimize the number of tool switches.

• Journal of Korean Society for Quality Management
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• v.31 no.4
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• pp.219-225
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• 2003

Two­dimensional warranty data can be modelled using two different approaches： two­dimensional point process and one­dimensional point process with usage as a function of age. The first approach has three different models. First of all, bivariate model is appealing but is not appropriate for explaining warranty claims. Next, the rest of the two models (marked point process, and counting and matching on both directions independently) are more appropriate for explaining warranty claims. However, the second one (counting and matching on both directions independently) assumes that the two variables (variables representing the two­dimensions) are independent. Last of all, one­dimensional point process with usage as a function of age is also promising to explain the two­dimensional warranty claims. But the models or variations of them need more investigation to be applicable to real warranty claim data.

• Proceedings of the Korean Society for Quality Management Conference
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• 2007.04a
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• pp.302-309
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• 2007

To conduct statistical process control needs the assumption that the process data are independent. However, most of chemical processes, like a semi-conduct processes do not satisfy the assumption because of autocorrelation. It causes abnormal out of control signal in the process control and misleading process capability. In this study, we introduce that Shore's method to solve the problem and to find the optimal subgroup size to estimate variance for AR(l) model. Especially, we focus on finding an actual subgroup size for small samples using simulation. It may be very useful for statistical process control to analyze process capability and to make a Shewhart chart properly.

• Proceedings of the Korea Concrete Institute Conference
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• 2004.05a
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• pp.368-371
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• 2004

It analyzes the quality of the fine aggregate which is reproduced through a dry production process with cyclone and a wet production process. The conclusions of the study are as follows. 1. The recycled fine aggregate through the dry production process with cyclone shows the low rate of absorption and impurity content after the cyclone process. It shows that its density is 2.37, absorption rate is 4.8 and stability is $5.1\%$ and less. Therefore, it satisfies the standards of KS F 2573(recycled aggregate for concrete) as the first grade. 2. The recycled fine aggregate through the wet production process shows the low rate of absorption and foreign substance content after the process of wash and dehydration. It shows that its density is 2.40, absorption rate is 3.12 and stability is $3.2\%$ and less. Therefore, it satisfies the standards of KS F 2573(recycled aggregate for concrete) as the first grade.

• Journal of Korean Society for Quality Management
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• v.32 no.4
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• pp.140-155
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• 2004

Six Sigma Management has been introduced as a management strategy by leading companies and some small and medium-sized companies in Korea. But it is not easy for small and medium-sized companies to implement this new management system because of their business environment such as poor manpower or lack of time, etc. This paper proposes an effective implementation model of the Six Sigma Management for small and medium-sized companies using the management by process. First, We review the concept of Six Sigma Management and consider the problems of introducing the system for small and medium-sized companies. And then, Six Sigma Management model for small and medium-sized companies named SIX SIGMA-s is presented. Finally, we present a case study of applying SIX SIGMA-s for a medium- sized company.

• Journal of the Korean Society of Clothing and Textiles
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• v.30 no.7 s.155
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• pp.1116-1125
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• 2006

This study investigated consumer satisfaction and dissatisfaction experiences in post-purchase product return process. As an exploratory research the study collected qualitative data of subjective consumer experiences using an open-ended questionnaire and identified and classified themes and patterns of satisfaction and dissatisfaction experiences. A total of 113 cases were categorized into satisfied experiences, unsatisfied experiences, and neutral experiences. Further, satisfied experiences were sub-categorized into kind sales associates, quick and easy return process, and services higher than expected based on sources of satisfaction in the return process while unsatisfied experiences were sub-classified into rejection of return, attitude of sales associates, and hassle of return process. In-store adaptive behaviors and intentions on future behaviors were also observed. The results indicated that service quality in the post-purchase service encounter and consumer expectation were important in determining satisfaction and dissatisfaction in the return process. Insights for research questions were proposed.

• Proceedings of the Korean Operations and Management Science Society Conference
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• 2006.11a
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• pp.633-636
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• 2006

In order to determine new settings of key process variables optimally, a new rule induction method through a historical data is proposed without using an explicit functional model between process and quality variables. First, a partial least square is used to reduce the dimensionality of the process variables. Then new process settings that yield the best quality variable are identified by sequentially partitioning the reduced latent variable space using a patient rule induction method. The proposed method is illustrated with a case study obtained from steel-making processes. We also show, through simulation, that the proposed method gives more stable results than estimating an explicit function even when the form of the function is known in advance.