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Corrective and Preventive Action Procedure
Procedure for managing CAPA including root cause analysis, corrective actions, preventive measures, and effectiveness verification.
30 min
Read Time
Intermediate
Level
Topics:CAPARoot cause analysis5 WhysFishboneEffectiveness verification
PROC-AI-CAPA-001
Corrective and Preventive Action (CAPA) Procedure
STD-AI-009: Quality Management Standard, STD-AI-013: Incident Management Standard
Controls Covered
QMS-006QMS-007QMS-008INC-005INC-006
Effective Date
[To be filled]
Next Review
[To be filled]
Purpose & Scope
Purpose
This procedure establishes the process for identifying, documenting, implementing, and verifying corrective and preventive actions (CAPA) for AI systems. It ensures that issues are systematically addressed at their root cause and that measures are implemented to prevent recurrence or occurrence of similar issues.
Applies To
- Non-conformities identified in AI systems
- Incidents and near-misses involving AI systems
- Audit findings related to AI compliance
- Customer complaints related to AI system performance
- Risk control failures
- Performance deviations
- Regulatory observations
18
Procedure Steps
6
Roles Defined