Abstract
Abstract This research took part in the research and development (R&D) and manufacturing processes of platelet agitator instruments at the W-ESPR Technology Company. First, two measurement indexes, the hazard probability and hazard severity, were used to evaluate all possible hazardous events drawn from ISO 14971 (the quality management of medical devices regulations) in the R&D and manufacturing processes. All possible hazardous events were then sifted to find potential hazardous events. Second, these two measurement indexes were combined into a complex risk index to identify the key hazardous events from the potential hazardous events. Third, this study then used the contradiction matrix theory of TRIZ to search for problem solutions for the key hazardous events. Finally, the Taguchi quality engineering method was used as a reference for imported platelet agitators to solve the key hazardous events. Using the systematic procedure proposed in this research, W-ESPR Technology Company developed high quality platelet agitators which were adopted by the Taiwan Blood Donation Center.
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