This document highlights the importance of the CAPA (Corrective and Preventive Action) process within quality management systems in the automotive and pharmaceutical industries. It underscores that ineffective CAPA can jeopardize overall quality management, while organizational knowledge from completed CAPA cases can serve as a valuable resource for addressing future issues. The document also references various sources and articles discussing CAPA's role in improving compliance and problem-solving.

1. Disclaimer; nothing in this presentation constitutes formal engineering advice.
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2. Automotive IndustryAction Group, 2018. CQI-20, Effective Problem Solving
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3. The key takeaway from this slide is that, if the CAPAprocess does not work properly, the entire
quality management system is at risk.
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4. Ouellette, Penny. 2018. "ISO 9001:2015 Implementation: The Good, the Bad and the Trending"
(Quality, November 8 2018) https://www.qualitymag.com/articles/95098-iso-90012015-
implementation-the-good-the-bad-and-the-trending
Brown, Robert. 2019. "Beyond the IATF Transition:Analysis of Non-Conformities and Next
Steps" (BSI webinar, January 22 2019)
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5. https://www.pharmaceuticalonline.com/doc/an-introduction-to-qfmea-a-tool-for-qms-risk-
management-0001
https://www.thefdagroup.com/thefdgroup-blog/9-top-fda-483-and-warning-letter-problems-for-
device-companies-in-2015 which says explicitly that CAPAis the quality subsystem related to
complaint files and nonconforming product.
Halloran, Laurie. 2016. "CAPAas a Tool to Prevent a Warning Letter" Applied Clinical Trials,
https://www.appliedclinicaltrialsonline.com/view/capa-tool-prevent-warning-letter
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6. https://www.thefdagroup.com/thefdgroup-blog/9-top-fda-483-and-warning-letter-problems-for-
device-companies-in-2015
This comes as no surprise because we rely on the CAPAprocess to correct nonconformances
and, by implication, address complaints.
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8. Organizational knowledge is a resource for CAPA, as the process owner or cross-functional
team can (or should be able to) access CAPAs that have been completed in the past to see if
others have encountered similar problems.
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9. The organizational knowledge data base receives completed CAPAs so future users can obtain
information relevant to their own problems or opportunities for improvement.
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11. AIAG =Automotive IndustryAction Group
AIAG, 2018. CQI-20, Effective Problem Solving Guide
ECR is applicable when the problem or opportunity can be resolved on the shop floor by the
process owner, without the need to involve a cross-functional team. Complex issues can
however be handed off to the formal CAPAprocess.
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