Corrective and Preventive Action (CAPA): Our Most Important Quality Process

1
Disclaimer nothing in this presentation
constitutes formal engineering advice.
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2
Automotive Industry Action Group, 2018. CQI-20,
Effective Problem Solving
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3
The key takeaway from this slide is that, if the
CAPA process does not work properly, the entire
quality management system is at risk.
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4
Ouellette, Penny. 2018. "ISO 90012015
Implementation The Good, the Bad and the
Trending" (Quality, November 8 2018)
https//www.qualitymag.com/articles/95098-iso-9001
2015- implementation-the-good-the-bad-and-the-tre
nding 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-introd
uction-to-qfmea-a-tool-for-qms-risk-
management-0001 https//www.thefdagroup.com/thefd
group-blog/9-top-fda-483-and-warning-letter-proble
ms-for- device-companies-in-2015 which says
explicitly that CAPA is the quality subsystem
related to complaint files and nonconforming
product. Halloran, Laurie. 2016. "CAPA as a Tool
to Prevent a Warning Letter" Applied Clinical
Trials, https//www.appliedclinicaltrialsonline.c
om/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 CAPA process to
correct nonconformances and, by implication,
address complaints.
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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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10
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11
AIAG Automotive Industry Action 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 CAPA process.
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12
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