• 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.

• Natural Product Sciences
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• v.27 no.4
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• pp.264-273
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• 2021

Simultaneous quantification of multiple marker compounds in herbal medicine by high performance liquid chromatography (HPLC) analysis is still a challenge due to the complexity in various parameters to be considered and co-existing multi-components. As a case study, a reliable HPLC method for simultaneous quantification of paeoniflorin from Paeoniae Radix and decursin from Angelicae Gigantis Radix in various commercial herbal medicine was developed based on analytical quality by design (AQbD) strategy. As a first step, risk assessment was performed to select the critical method parameters (CMPs) which were decided as organic mobile phase ratio and column oven temperature. In order to evaluate the effect of the CMPs on critical method attributes (CMAs) of peak resolution and tailing, central composite design (CCD) was employed. The final chromatographic conditions were optimized as follows: column- C₁₈, 4.6 × 250 mm, 5 ㎛ particle size; mobile phase- A: acetonitrile, B: 0.1% acetic acid water; detection wavelength- 235 nm for paeoniflorin, 325 nm for decursin; column oven temperature- 25℃; flow rate- 1.0 mL/min; gradient mobile phase system as Time (min) : % A, 0:14, 25:14, 30:50, 60:50, 61:100, 65:100, 66:14, 75:14. The method was successfully validated according to the International Conference on Harmonization (ICH) guidelines and piloted for ten commercial herbal medicines.

• Journal of the Korean GEO-environmental Society
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• v.3 no.3
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• pp.5-13
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• 2002

In tunnel design, geotechnical survey of over 200m tunnel depth is required because of its characteristical topography. For this reason, there are difficulties in collecting information of basic data in tunnel design because of large-scale costs in borehole tests, of limits to a geotechnical analysis by the existing refraction seismic survey and of analytical errors in steep mountainous area. Seismic tomography has many advantages as follows; 1) seismic velocity as absolute value is more reliable than electrical resistivity, 2) geotechnical analysis in deep tunnel depth is available by seismic velocity, 3) analytical errors is reduced in steep mountainous area. In this paper, it was found out a correlation of seismic velocity and Q in tunnel design in the neighborhood of the National Capital region and the reduction effect of tunnel construction cost using reliable rock quality by seismic tomography compared with by borehole data and electricity resistivity data.

• 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.

• The Journal of Economics, Marketing and Management
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• v.6 no.1
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• pp.9-16
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• 2018

Purpose - Benefit delay type services have a characteristic of benefit delay that does not immediately appear at the time of delivery of service. Due to a characteristic of benefit delay, the customer's participation in the service delivery system is hindered, and the quality of service declines. As a result, customer satisfaction would be reduced. The purpose of this study is to construct an analytical framework to analyze a mechanism that promotes customer participation in benefit delay type services. Research design, data, and Methodology - Existing research has considered only the performance of service companies to enhance the quality of service and customer satisfaction. This study focused on customer participation as a factor affecting the quality of service and customer satisfaction and attempted to construct an analytical framework based on a theoretical perspective of motivational research. Results - By adopting the motivation theory, this research derived three concepts, the possibility of gaining benefits, the emotional experience, and the desire of benefit. And motivation is created when the three factors interact with each other. Conclusions - This paper has constructed an analytical framework for analyzing factors that promote customer participation in the benefit delay service and finally has proposed case study for further research.

• Transactions of the Korean Society of Automotive Engineers
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• v.6 no.3
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• pp.154-160
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• 1998

Ride quality of medium truck became a very important factor in the suspension design, to the demand of more comfortable ride of passengers. This study describes how to determine and evaluate design parameters related to the chassis suspension system with time and frequency analysis. The spring stiffness and damping force of the chassis suspension system were obtained by observing the vertical acceleration PSD. The simulation was carried out on various road profiles, which was suggested by ISO. The pitching motion of the medium size truck was observed to improve the ride quality. A computer simulated truck model was constructed using DADS, a commercial dynamic analysis software, in order to simulate the truck motions. From the analyzed process of suspension parameters, it was concluded that the spring and the shock absorbers affect the pitching of the vehicle. In order to validate the computer simulated truck model, a physical prototype was constructed and tested.

• Journal of Korean Society for Quality Management
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• v.19 no.1
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• pp.151-162
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• 1991

The purpose of this study is to propose a facility layout design algorithm based on artificial intelligence concept, and then to develop a computer program which is more practical than any other conventional facility layout design systems. The algorithm is composed of five step layout procedures; knowledge and data input, knowledge interpretation, priority determination, inference of layout design, and evaluation, In the step of priority determination, the algorithm is divided into single row and multi row layout problem. In the step of inference of layout design, alternatives are generated by constraints-directed reasoning and depth first search method based on artificial intelligence concept. Alternatives are evaluated by the moving cost and relationship value by interactive man-machine interface in the step of evaluation. As a case study, analytical considerations over conventional programs such as CRAFT and CORELAP was investigated and compared with algorithm propsed in this study. The proposed algorithm in this study will give useful practical tool for layout planner. The computer progran was written in C language for IBM PC-AT.

• Journal of Korean Society for Quality Management
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• v.41 no.4
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• pp.673-681
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• 2013

Purpose: The purpose of this study is to investigate the design optimization modeling of screening procedures based on the assessment of misclassification errors. Methods: Misclassification errors due to measurement variability are derived for normally distributed quality characteristics. Further, an optimization model for ensuring the level of outgoing quality is proposed and demonstrated through an illustrative example. Results: It is shown that two types of misclassification errors (i.e., false acceptance and false rejection) may be properly compromised through an analytical assessment of measurement errors and an optimization modeling. It is also discussed that a variety of optimization modeling may be enabled based on the derivation of measurement errors. Conclusion: It may be concluded that the design of screening inspection may further be facilitated by including the effect of measurement errors on the performance of screening inspection procedure.

• Smart Structures and Systems
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• v.17 no.2
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• pp.313-325
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• 2016

The paper provides a comprehensive procedure for the mechanical and magnetic design of Langevin transducer based on giant magnetostrictive material. The the transducer is designed to work at its second mode of vibration, having high mechanical quality factor and low damping coefficient. The design procedure is based on an analytical model and it is verified by finite-element analysis. Experimental tests based on impedance response analysis in first and second modes are carried out on the prototype. Results confirm the appropriate design of this transducer, demonstrating the highest mechanical quality factor between the resonant transducers in the literature.

• Journal of Distribution Science
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• v.21 no.1
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• pp.65-72
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• 2023

Purpose: The purpose of this study was to determine the effect of Service Quality on Brand Performance through Satisfaction at an aviation campus in the Special Region of Yogyakarta, Indonesia. Research design, data, and methodology: This research design was hypothesis testing using primary data obtained by distributing questionnaires directly to 200 respondents who were active students at an aviation campus in the Special Region of Yogyakarta, Indonesia. The analytical method used was the Structure Equation Model (SEM). Results: The results of this study show that: (1) there was a significant and positive relationship between Service Quality and Satisfaction, (2) there was a significant and positive relationship between Satisfaction with Brand Performance, and (3) there was a significant and positive relationship between Service Quality and Brand Performance. Conclusion: This study concludes that for the dimension of Academic service quality distribution from the service quality variable, it is suggested to improve detailed recording by academic teaching staff. For the dimensions of Administrative Service Quality distribution from the Service Quality variable, it is recommended to increase the hospitality in the campus environment. For the dimensions of Facility Service Quality distribution from the Service Quality variable, it is recommended to increase satisfaction in terms of facilities on campus. For the Satisfaction variable, it is suggested to improve the performance of the staff and the academic community.