The CAPA Playbook
How to Investigate, Correct, and Prevent Quality System Failures
The methodology behind a CAPA program that actually closes loops. Covers the CAPA intake decision (when an issue is CAPA-worthy and when it is not), the investigation discipline, the root-cause toolkit, the corrective-versus-preventive distinction that auditors test, the effectiveness-verification gate, and the program-level metrics that signal CAPA health. Walks the failure modes that turn CAPA into a paperwork drill: CAPAs that close without root cause, corrective actions that look like containment, preventive actions that never get evaluated for effectiveness. Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality managers, CAPA program owners, and regulatory affairs leads. Pairs with the CAPA Investigation Workbook by Wade Prescott.
View on AmazonThe methodology behind a CAPA program that actually closes loops. Covers the CAPA intake decision (when an issue is CAPA-worthy and when it is not), the investigation discipline, the root-cause toolkit, the corrective-versus-preventive distinction that auditors test, the effectiveness-verification gate, and the program-level metrics that signal CAPA health.
Walks the failure modes that turn CAPA into a paperwork drill: CAPAs that close without root cause, corrective actions that look like containment, preventive actions that never get evaluated for effectiveness.
Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality managers, CAPA program owners, and regulatory affairs leads. Pairs with the CAPA Investigation Workbook by Wade Prescott.
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