BRIEF HISTORY OF RELATED STANDARDS AND REGULATIONS

摘要

1. 1963-MIL-Q-9858A, Quality program requirements started it all. Unfortunately, these requirements placed correction and prevention concepts under one section: section 3.5, corrective action. Our understanding of the principles was quite primitive in those early days. 2. 1970-Things improved greatly when 10CFR50, Appendix B, was issued for nuclear power generating stations. Part 16, corrective action, quite clearly explained the principles. There was no mention of preventive action. 3. 1987-The first edition of ISO 9001-Quality management systems, was published. Clause 16 on corrective action required procedures for "investigating the cause of non-conforming product and corrective action need to prevent recurrence." Those last two words, "prevent recurrence," caused some difficulties. The authors were focusing on two things: finding the cause and removing that cause. (Remember, these words were written more than 25 years ago; we were still learning.) 4. 1994-Because of the poor choice of words in 1987, the second edition of ISO 9001 separated the concepts of corrective action and preventive action. The wording was considerably better, but the "prevent recurrence" misunderstandings from 1987 remained.