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articles:re-thinking_capa [2022/03/06 19:16] – [Why should you "re-think" CAPA?] rrandall | articles:re-thinking_capa [2023/03/16 17:51] (current) – [How do we address this conflict?] 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 "// |
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+ | However, there is a MAJOR flaw in the CAPA concept... as it establishes an unrealistic expectation that every problem has an // | ||
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+ | 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 the CAPA concept: | ||
+ | https:// | ||
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+ | Sadly, the medical device & pharmaceutical industries continue to doggedly embrace the ignorance promoted by the cult of "Zero Defects" | ||
- | The concept of “CAPA” is most popular among supporters of the “Zero Defects” motivational management approach. The term “Zero Defects” first appeared in the “// | ||
- | However, the “Zero Defects” concept didn’t gain widespread popularity until it was promoted by Philip B. Crosby in his book “// | ||
- | 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! | ||
- | 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 “Red Bead Experiment”. In fact, point 10 of Deming' |