CAPA
Corrective and Preventive Action (CAPA) is the quality system process for identifying, investigating, and resolving product or process quality failures. A corrective action addresses a confirmed nonconformance; a preventive action addresses a potential nonconformance before it occurs. CAPA records are required by ISO 9001, ISO 13485, 21 CFR Part 820, and IATF 16949 as evidence of systematic quality improvement.
Why it matters
CAPA is the most frequent integration point between QMS and PLM because quality failures often require engineering changes. Without a traceable link from the CAPA record in QMS to the engineering change order in PLM and back to the validation record that confirms the fix, the corrective action is not auditably closed — a common regulatory finding in FDA and IATF audits.
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External References
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Cite this definition
Finocchiaro, Michael. “CAPA.” DemystifyingPLM PLM Glossary, 2026, https://www.demystifyingplm.com/glossary/capa