Change Control vs CAPA: When to Raise Which (and Why)
Introduction
CAPA responds to a problem; Change Control manages planned change. Confusing the two doubles work and hides risk. Here’s how to route correctly.
Core concepts
- CAPA: Reactive, rooted in investigation; goal is prevention of recurrence.
- Change Control: Proactive; plan, assess risk/impact, implement, and verify.
When to raise which
- A recurring labeling error? CAPA first; it may require a document or equipment change (Change Control).
- A planned ERP upgrade? Change Control; assess validation impact, train, and verify.
Linking them cleanly
- CAPA → Change: action item triggers a controlled change; effectiveness is measured post‑implementation.
- Change → CAPA: rare, but if a change introduces issues, raise a CAPA to address the underlying deficiency.
Good practice fields
- Impacted processes/records
- Risk assessment and mitigation plan
- Implementation plan and verifications
- Training plan and effectiveness evidence
How an eQMS helps
- Relationship links and impact matrices
- Approvals by role and stage gates
- AI Assist: suggests risk/impact checklists from context and drafts change notes from redlines
Conclusion
Use CAPA to fix causes; use Change Control to manage intentional change. Link them, measure outcomes, and keep the audit story straight.
