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articles:re-thinking_capa [2022/03/06 19:02] – created rrandall | articles:re-thinking_capa [2022/03/06 21:42] – [Institutionalized Delusion] rrandall | ||
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To explain this, let's quickly cover the definitions for these two terms. For sake of consistency, | To explain this, let's quickly cover the definitions for these two terms. For sake of consistency, | ||
+ | < | ||
+ | Preventive Action** \\ | ||
+ | action to eliminate the cause of a potential nonconformity or other potential undesirable situation \\ | ||
+ | Note 1 to entry: There can be more than one cause for a potential nonconformity. \\ | ||
+ | Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.</ | ||
+ | < | ||
+ | corrective action** \\ | ||
+ | action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence \\ | ||
+ | Note 1 to entry: There can be more than one cause for a nonconformity. \\ | ||
+ | Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.12.1) is taken to prevent occurrence. \\ | ||
+ | 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 "// |
- | action to eliminate | + | |
+ | However, there is a MAJOR flaw in the CAPA concept... as it establishes an unrealistic expectation that every problem has an // | ||
+ | |||
+ | To suggest (or imply) that all defects are the result | ||
+ | |||
+ | Rather than repeat an earlier article, read: [[articles: | ||
+ | |||
+ | ==== 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:// | ||
+ | |||
+ | Sadly, the medical device & pharmaceutical industries continue to doggedly embrace the ignorance promoted by the cult of "Zero Defects" | ||
- | Note 1 to entry: There can be more than one cause for a potential nonconformity. \\ | ||
- | Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.</ | ||
+ | ===== How do we address this conflict? ===== | ||