Maps to
FDA QMSR (Part 820): §820.90/820.198
ISO 13485: ISO 13485 §8.5.2/8.5.3
Requirement text
The organization shall establish documented procedures for corrective action to eliminate the cause of nonconformities, and preventive action to eliminate causes of potential nonconformities. FDA-Plus: CAPA procedures must include analysis of quality data sources (complaints, audits, NCRs, service records) to identify existing and potential causes of nonconforming product. Effectiveness of CAPA must be verified and documented.
Atomic constraints
- •Documented CAPA procedures must exist.
- •Root cause analysis must be performed for corrective actions.
- •Preventive actions must address potential nonconformities before they occur.
- •CAPA effectiveness must be verified and documented.
- •Quality data sources must be systematically analyzed to identify CAPA needs.
- •CAPAs must be escalated to management review when they indicate systemic issues.
Evidence signals
- •
FILE_EXISTS
(CAPA|Corrective.*Action|Preventive.*Action|Root.*Cause)
- •
CONTENT_MATCH
Does this document describe CAPA procedures including root cause analysis, action plans, implementation tracking, and effectiveness verification?
Audit defense
Our CAPA system ([your document ID]) ensures that every corrective and preventive action for [your product] undergoes formal root cause analysis with verified effectiveness. Quality data from complaints, audits, and NCRs feeds CAPA initiation, with trends reported to management review.