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.
A control scheme based on the multiblock PLS (MBPLS) model for multi-stage processes (or serially connected processes) is developed. MBPLS arranges a large number of variables into meaningful blocks for each stage of the large-scale system. Two control design strategies, course-to-course (CtC) and within-stage (WS) controls, are proposed for the re-optimization design in the whole multistage course. In CtC, MBPLS control and optimization are done by applying feedback from the finished output quality when one course for all stages is done. It utilizes the information from the current course to improve quality of the next one. In WS, the MBPLS-based re-optimization strategy is developed to explore the possible adjustments of the future inputs at the rest of the stages in order to fix up the disturbances just in time and to maintain the product specification when the current course is finished. The proposed technique is successfully applied to two simulated industrial problems, including a photolithography sequences and a reverse osmosis desalination process, and the advantages of the proposed method are demonstrated.
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