1.5 KiB
1.5 KiB
Corrective and Preventive Action (CAPA) Form
| Form ID | FRM-003 | Revision | 1.0 |
|---|
Section 1: CAPA Identification
| Field | Entry |
|---|---|
| CAPA Number | |
| Date Initiated | |
| Initiated By | |
| CAPA Owner | |
| Target Closure Date |
Section 2: Classification
Type
- Corrective Action
- Preventive Action
Source
- Customer Complaint
- Internal Audit
- External Audit
- Process Deviation
- Nonconforming Product
- Management Review
- Other: ____________
Priority
- Critical (5 business days)
- Major (15 business days)
- Minor (30 business days)
Section 3: Problem Description
(Describe the nonconformity or potential nonconformity)
Section 4: Immediate Containment
(Actions taken to contain the immediate impact)
Section 5: Root Cause Investigation
Investigation Method Used
- 5 Whys
- Fishbone Diagram
- Fault Tree Analysis
- Other: ____________
Root Cause Determination
Section 6: Corrective/Preventive Actions
| Action | Responsible | Due Date | Status |
|---|---|---|---|
Section 7: Effectiveness Verification
| Criteria | Method | Result |
|---|---|---|
Verification Date: ____________ Verified By: ____________
Section 8: Closure
| Role | Name | Signature | Date |
|---|---|---|---|
| CAPA Owner | |||
| Quality Approval |
Form FRM-003 Rev 1.0