A UNISON Framework for Manufacturing Process Validation and an Empirical Study at a liquid crystal manufacturing plant

• Main Author: 林繼勇
• Other Authors: 簡禎富
• Format: Others
• Language: zh-TW
• Published: 2008
• Online Access: http://ndltd.ncl.edu.tw/handle/06512770197289335114

碩士 === 國立清華大學 === 工業工程與工程管理學系 === 96 === AbstractProcess validation is a process commonly used in chemical, food and pharmaceutical industries. Process validation is a critical activity that contains a systematic procedure to verify that the workflow, manufacturing process, equipment, raw materials or systems can constantly provide consistent product quality that meets the product specification. This thesis aims to propose a framework for process validation to enhance the quality and avoid potential impacts due to decision making traps or bias. This study reviews relevant literature and international standard management systems as a basis and then follows the UNISON Decision Framework to establish a set of indicators and design a check list for the engineers to systematically review the results from every ancillary perspective. This research has conducted an empirical study in a liquid crystal mixture production site to estimate the validity of the proposed framework and thus, based on the result, to review related issues emerged to improve the decision making process flow and its quality. This thesis concludes with discussions on the contributions and future research directions.