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articles:re-thinking_capa [2022/03/06 19:27] – [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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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” is most popular among supporters of the “Zero Defects” motivational management approach. The term “Zero Defects” first appeared in the “// | + | 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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- | However, the “Zero Defects” concept didn’t gain widespread popularity until it was promoted by Philip B. Crosby in his book “// | + | |
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- | However, there is a MAJOR flaw in the “Zero Defects” | + | |
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! | 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! | ||
Rather than repeat an earlier article, read: [[articles: | 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" | ||
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