• International Journal of Quality Innovation
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• 제7권1호
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• pp.35-47
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• 2006

Client-supplier collaboration has been an imperative approach to new product development (NPD), in which a good product specification management system and practice is crucial to the assurance of product quality. This study investigates product specification management in client-supplier collaborative NPD. Based on the interviews and survey study, 12 problems and 13 good practices of product specification management are identified. It also compares the importance and degree of the implementation of the product specification practices in Hong Kong electronics industry. The results suggest that more intensive practices should be implemented for better product specification management.

• Fisheries and Aquatic Sciences
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• 제5권1호
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• pp.48-53
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• 2002

The HACCP (hazard analysis critical control point) concept becomes an important aspect of Good Manufacturing Practices (GMP) in safe food production. The HACCP plan was developed with food safety objective. The authors already carried out hazards analysis on Changran Jeotgal manufacturing process in a previous report. In this study we developed a HACCP plan on the manufacturing process of Changran Jeotgal. We could decide two CCPs those were salt concentration and eliminations of foreign materials before packaging. Foreign materials should be certainly checked out with laser detector just before packaging. Salt should be maintained more than $8\%$ to inhibit pathogenic bacteria in end product. On the Jeotgal process free water is removed after salting and Jeotgal is seasoned with several subsidiary materials such as com syrup. In result end products have $8\%$ salt with water activity 0.82. Most bacteria are inhibited but some can live in this condition. Materials on the working may be contaminate by pathogens, chemicals or physical hazards. It will be decreased by SSOP (standard sanitary operating program). The SSOP needed in Jeotgal plants is nearly same as other general food manufacturing plants but essential to fulfill HACCP program.

• International Journal of Quality Innovation
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• 제5권2호
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• pp.70-78
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• 2004

Client-supplier collaboration in new product development (NPD) has been a strategy in response to fierce global competition. Traditionally, Hong Kong suppliers collaborate with worldwide clients through original equipment manufacturing (OEM) arrangement in which suppliers manufacture products according to clients' design. In recent years, a growing number of Hong Kong suppliers have transformed to original design manufacturing (ODM) in which they are assigned a design responsibility other than manufacturing products. The ODM arrangement necessitates a close interaction between clients and suppliers, which brings about intense conflict. Conflict has been recognized as an important factor affecting NPD performance including product quality. This paper studies the conflict handling practices of Hong Kong ODM suppliers based on 87 survey data. The results show that the suppliers frequently adopt effective conflict handling practices by which they can develop products of good quality through better design decisions. The results also suggest that the use of ineffective conflict handling behaviors, particularly avoiding, should be reduced for better product quality.

• 약학회지
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• 제57권6호
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• pp.432-441
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• 2013

It's been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. 'New GMP' in 2008 has adopted validation, pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical Inspection Cooperation Scheme) application by Korea's Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunity to level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzing the differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticals and medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredients and investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall be taken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

• 산업경영시스템학회지
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• 제35권2호
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• pp.80-87
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• 2012

It is well known that ISO 9001 and TQM have significant effects on business success. We analyzed the effects of ISO 9001 requirements and TQM on financial performance with structural equation modeling. Hypotheses are proposed and tested based on existing beliefs, proposition and prior research concerning quality. Survey data were collected from 291 manufacturing companies with ISO 9001 certifications. The data show that ISO 9001:2008 requirements have significant positive direct effects on TQM practices, but do not have positive direct effects on financial performance. As expected, TQM has significant positive direct effects on financial performance. One of the important results is that efforts to meet ISO 9001:2008 requirements enhance TQM practices which, in turn, helps to improve financial performance. Findings in this study support the claims that ISO 9001:2008 would be a good step toward total quality management and is a meaningful component of TQM.

• 한국자원식물학회지
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• 제30권6호
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• pp.693-698
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• 2017

The quality control of natural products is principal key to guarantee the Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) for the functional food, pharmaceuticals and cosmeceuticals in the industry. In this study, we examined the quantitative analysis of berberine as marker substance of Coptidis Rhizoma by high performance liquid chromatography-photodiode array detector (HPLC-DAD). The HPLC method was validated and met all the requirements for the quality control analysis recommended by FDA and ICH. The berberine was separated on a Xterra $C_{18}$ column ($5{\mu}m$, $4.6{\times}250mm$) using mobile phase consisting of distilled water and acetonitrile with $KH_2PO_4$ (3.4 g) and $Na_2SO_4$ (1.7 g). Calibration curve of berberine has been estimated (y = 42293.47x-41589 with the correlation coefficient 0.9999). The amount of berberine was calculated as 4.25%. And berberastine, palmatine, columbamine, jatrorrhizine, epiberberine, berberine and coptisine in the Coptidis Rhizoma were identified by high performance liquid chromatography - electrospray ionization-mass spectrometer (HPLC-ESI-MS) method.

• The Journal of Asian Finance, Economics and Business
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• 제7권11호
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• pp.1041-1047
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• 2020

The intention of this paper is to give a better understanding about the implementation of sustainable manufacturing practice in the textile companies in Indonesia as one of the promising sectors in the manufacturing industry. The data was collected by taking a case study approach in one of the leading textile companies in Indonesia. Questionnaire and interview techniques were used to gather in-depth information about the implementation of a sustainable concept in the company. The result reveals that the extent of the implementation of Sustainable Manufacturing Practices (SMP) in the companies are at a level of moderate to high. From the three dimensions measured which are environment, economy, and social dimensions, the evaluation result shows good performance in terms of the implementation of sustainable concepts, like low level of gas emission, high percentage of renewable energy usage, cost reduction rate, high quality of life, etc. From this result, the authors then develop a sustainable manufacturing model in the wider coverage to be implemented not only in the textile industry but is expected to be implemented in manufacturing sectors as well. This model consists of at least seven basic archetypes which are divided into three dominant areas: technological innovation, economical, and social areas which aim to bring better performance in the manufacturing industry of Indonesia.

• Toxicological Research
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• 제25권1호
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• pp.1-8
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• 2009

Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

• 한국인터넷방송통신학회논문지
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• 제21권1호
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• pp.149-162
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• 2021

본 논문은 개인 맞춤형 화장품 제조산업을 주력으로 하고 있는 도입기업에 제조데이터를 기반으로 설치된 스마트 팩토리를 신규 구축하였다. 기존 CGMP(Cosmetics Good Manufacturing Practices)기반 아날로그로 관리하던 서류 및 데이터들을 데이터답게 사용할 수 있도록 수집, 관리 및 분석하는 시스템을 구축한 사례를 기반으로 작성하였다. 이를 위해 인공지능 스마트팩토리 플랫폼인 LINK5 MOS(Management Operation System)와 POP(Point Of Production) 시스템 도입, PLC(Programmable Logic Controller) 데이터 수집, 바코드 리딩 시스템 등을 대거 적용하여 생산 현장에 모든 데이터를 실시간으로 수집할 수 있는 시스템을 구축하고, 모니터링 시스템 및 현황판 도입 등으로 데이터 확인 및 조회할 수 있는 시스템을 구축한 사례를 기반으로 작성하였다. 또한 이번 프로젝트를 기반으로 하여 신규 비지니스 클러스터 공간 형성을 목표로 하고 있다.

• 한국경영과학회지
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• 제30권2호
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• pp.41-61
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• 2005

The concept of revenue management (RM) has been used widely in the air-transportation industry, and proven as a good system for managing perishable assets. While the airlines are the oldest and most sophisticated users of RM, these practices have been an enormously important innovation in other service industries such as the travel, the railway, the internet and the manufacturing industries. In this paper, reviewing several studies on RM, we introduce the fundamental concepts and the major models of RM covering seat allocation with multiple fare classes and overbooking. Future research directions also are suggested.