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| articles:re-thinking_capa [2022/03/06 21:36] – [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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| ==== Institutionalized Delusion ==== | ==== Institutionalized Delusion ==== |
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| Amazingly, ISO 13485:2016, "Medical devices — Quality management systems — Requirements for regulatory purposes” was re-affirmed in 2020 (with no changes). This standard retains the CAPA concept (addressed in ISO 13485, sec. 8.5) in the misguided belief that it will one day achieve the mythical "Zero Defects"... completely oblivious that it is promoting the inefficiency of [[articles:whac-a-mole|"Corrective Action Whac-A-Mole"]]. | Amazingly, ISO 13485:2016, "Medical devices — Quality management systems — Requirements for regulatory purposes” was re-affirmed in 2020 (with no changes). This standard retains the CAPA concept (addressed in ISO 13485, sec. 8.5) under the misguided belief that it will one day achieve the mythical "Zero Defects"... completely oblivious that it is perpetuating the inefficiency of [[articles:whac-a-mole|Corrective Action "Whac-A-Mole"]]. |
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| And the CAPA concept continues to be promoted by the US FDA (Food & Drug Administration): | And this delusion continues to be reinforced by the US FDA (Food & Drug Administration) promoting the CAPA concept: |
| https://www.fda.gov/corrective-and-preventive-actions-capa | https://www.fda.gov/corrective-and-preventive-actions-capa |
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| Sadly, the medical industry continues to doggedly embrace the ignorance promoted by the cult of "Zero Defects". | Sadly, the medical device & pharmaceutical industries continue to doggedly embrace the ignorance promoted by the cult of "Zero Defects". |
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| ===== How do we address this conflict? ===== | |
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