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--- articles:re-thinking_capa [2022/03/06 19:16] – [Why should you "re-think" CAPA?] rrandall
+++ articles:re-thinking_capa [2023/03/16 17:51] (current) – [How do we address this conflict?] 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.</blockquote>
-It is vitally important to note that each definition begins with "//action to eliminate the cause//". This is the "general assumption" mentioned above.
+It is vitally important to note that each definition begins with "//action to __eliminate__ the cause//". This is the "general assumption" mentioned above.
+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.
+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:whac-a-mole|Corrective Action "Whac-A-Mole"]].
+==== Institutionalized Delusion ====
+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"]].
+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
+Sadly, the medical device & pharmaceutical industries continue to doggedly embrace the ignorance promoted by the cult of "Zero Defects".
-The concept of “CAPA” is most popular among supporters of the “Zero Defects” motivational management approach. The term “Zero Defects” first appeared in the “//Quality and Reliability Assurance Handbook – A Guide to Zero Defects//” (4155.12H) published by the U.S. Department of Defense on November 1, 1965, which explained: “//Zero Defects is a motivational approach to the elimination of defects attributable to human error//”. And “//Zero Defects is dedicated to preventing defects by detecting and removing the causes of their generation. This is an attempt to reverse the unquestioning acceptance of human error as a normal byproduct of personal effort//”.
-However, the “Zero Defects” concept didn’t gain widespread popularity until it was promoted by Philip B. Crosby in his book “//Quality is Free//” (1979). Crosby is credited with having developed the “Zero Defects” concept during the early ‘60s while working at the Martin Company as the quality control manager overseeing the Pershing missile program
-However, there is a MAJOR flaw in the “Zero Defects” concept... as it establishes an unrealistic expectation that every problem has an //assignable root cause// that can be eliminated.
-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!
-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's 14 points specifically rejects the “Zero Defects” concept, stating: "Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity".