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| articles:re-thinking_capa [2022/03/06 21:40] – [Institutionalized Delusion] rrandall | articles:re-thinking_capa [2022/03/06 21:42] – [Institutionalized Delusion] 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) 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"]]. | 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 this delusion continues to be reinforced by the US FDA (Food & Drug Administration) as it continues to the CAPA concept: | 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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