The Standard (10.2 Nonconformity And Corrective Action)
- Shall retain documented information as evidence of...
- The nature of nonconformities and any subsequent actions taken
- The results of any corrective action
Auditor's Objective Evidence
- Look for repeat nonconformances
- Verify root cause really defines cause
- Verify corrective action addresses root cause exactly
- Small issue = small corrective action
- Verify Corrective Actions closed timely
- Verify the CA was completed
On your portal
- Use the built in CAPA system to identify and log N/C processes
- Show reports showing repeat N/Cs, timely resolutions
