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articles:re-thinking_capa [2022/03/06 19:21] – [Why should you "re-think" CAPA?] rrandall | articles:re-thinking_capa [2022/03/06 21:42] – [Institutionalized Delusion] rrandall | ||
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Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Notes 1 and 2 to entry.</ | Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Notes 1 and 2 to entry.</ | ||
- | It is vitally important to note that each definition begins with "// | + | It is vitally important to note that each definition begins with "// |
- | The concept of “CAPA” | + | However, there is a MAJOR flaw in the CAPA concept... as it establishes an unrealistic expectation that every problem has an //assignable root cause// that can be eliminated. |
- | However, | + | To suggest (or imply) that all defects are the result of an “assignable cause” is to dismiss all that we’ve learned from Walter A. Shewhart & W. Edwards Deming! |
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+ | Rather than repeat an earlier article, read: [[articles: | ||
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+ | ==== Institutionalized Delusion ==== | ||
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+ | Amazingly, ISO 13485:2016, " | ||
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+ | And this delusion continues to be reinforced by the US FDA (Food & Drug Administration) promoting | ||
+ | https:// | ||
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+ | Sadly, | ||
- | However, there is a MAJOR flaw in the “Zero Defects” concept... as it establishes an unrealistic expectation that every problem has an // | ||
- | To suggest (or imply) that all defects are the result of an “assignable cause” is to dismiss all that we’ve learned from Walter A. Shewhart & W. Edwards Deming! | ||
+ | ===== How do we address this conflict? ===== | ||
- | W. Edwards Deming repeatedly demonstrated that, no matter how vigilant the employees, every process contains inherent (i.e., natural) “Common Cause” variations resulting in defects. This was most popularly demonstrated through Deming’s “[[https:// |