Effectiveness verification
A structured check that a corrective or preventive action actually worked, building on the root cause identified through our root cause analysis.
What's included
What the effectiveness check covers
- A defined effectiveness check window and method set at the time each CAPA is approved
- Verification that the corrective action removed the original finding, not just the immediate symptom
- Verification that the preventive action holds up under a subsequent audit or data check
- Escalation and reopening of any CAPA that fails its effectiveness check, rather than closing it on schedule regardless
- A documented closure record tying the finding, root cause, action, and verification together
Defensible closure
A closure record that documents evidence of effectiveness, not just a completion date, so the CAPA holds up under later scrutiny.