capa-officer - Manage CAPA investigations and effectiveness verification
Manages medical device QMS CAPA investigations, root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics.
Tags
Updated: 2026-09-29Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Conduct CAPA investigations
- Apply root cause methods
- Validate root causes
- Plan corrective actions
- Verify action effectiveness
- Analyze CAPA metrics
Inputs
- CAPA trigger events
- Objective evidence
- Quality records
- Interview notes
- Physical evidence
- Process parameters
- Product specifications
- Related complaints and CAPAs
Outputs
- CAPA investigation findings
- Root cause analysis
- Corrective action plans
- Effectiveness verification records
- CAPA status and metrics