Pitfalls and Pratfalls

Abstract:Corrective and preventive action (CAPA) systems are widely used in many industries to assess how a quality management system (QMS) is performing. Investigations using CAPA systems are crucial to keeping up with continuous improvements, but those investigations can sometimes be flawed. Common missteps when working with a CAPA system can lead improvement projects astray. These pitfalls include lack of investigation plans, lack of time to complete investigations, lack of trending in incidents, unidentified root causes, root causes that have not been addressed, focus on symptoms rather than causes, lack of preventive actions, inability to verify that root causes have been fixed, multiple CAPA systems causing issues with each other, human error and overreliance on software. When utilizing a CAPA system to identify issues with a QMS, avoiding these pitfalls can lead to a successful …

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This is a very informative article providing useful insights for all involved in CAPA activities from fieldwork through software selection. I loved the use of examples drawn from participants on training course particularly the over use of human error as RC
--Bob Kennedy, 11-03-2018

This article serves as a reminder on why the same problems kept repeating, even after they are supposedly addressed.
--Kah-Marn Lee, 10-04-2018

Very good article.
--Jim Kramer, 09-27-2018

Enjoyed this article! It came right on time. We will be taking pointers as we revamp our non-conformance system.
--Akeara Johnson-Cobin, 09-07-2018

Well written addressing the important points. One suggestion is to include the concept of correction (an interim measure), Corrective action (decided based on the RCA to prevent recurrence) and preventive action. The concept of preventive action may be elaborated and the fact that corrective action cannot be a preventive action in all cases needs to be emphasized.

--Sujatha Prakash, 09-04-2018

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