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摘要

Quality control/quality assurance controls were originally developed and selected for application because they were effective in preventing, reducing, or detecting specific problems that were occurring in manufacturing processes. With the development and use of quality assurance program standards, there has been a movement toward determining the requirements of a quality program standard that are ''applicable'' to a certain process as the starting point in the determination of the QA controls to be applied. This paper discussed the advantages of reviewing and addressing the problems, past or potential, associated with a process as the initial step in the QA control determination.