Differences
This shows you the differences between two versions of the page.
Both sides previous revisionPrevious revisionNext revision | Previous revisionLast revisionBoth sides next revision | ||
articles:re-thinking_capa [2022/03/06 19:16] – [Why should you "re-think" CAPA?] rrandall | articles:re-thinking_capa [2022/03/06 21:42] – [Institutionalized Delusion] rrandall | ||
---|---|---|---|
Line 24: | Line 24: | ||
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! |
- | However, there is a MAJOR flaw in the “Zero Defects” concept... as it establishes an unrealistic expectation that every problem has an // | + | Rather than repeat an earlier article, read: [[articles: |
- | To suggest | + | ==== Institutionalized Delusion ==== |
+ | |||
+ | Amazingly, ISO 13485:2016, " | ||
+ | |||
+ | And this delusion continues to be reinforced by the US FDA (Food & Drug Administration) promoting the CAPA concept: | ||
+ | https://www.fda.gov/ | ||
+ | |||
+ | Sadly, the medical device & pharmaceutical industries continue to doggedly embrace the ignorance promoted by the cult of "Zero Defects" | ||
+ | |||
+ | |||
+ | |||
+ | ===== 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 “Red Bead Experiment”. In fact, point 10 of Deming' |