2.5 KiB
2.5 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/Sponsor Complaint
- Internal Audit
- External Audit
- Sponsor Monitoring
- Protocol Deviation/Violation
- Adverse Event
- IRB/Ethics Committee Finding
- Participant/Family Concern
- Pediatric Safety Issue
- Nonconforming Product
- Management Review
- Other: ____________
Priority
- Critical - Child Safety Risk (Immediate action required)
- Major (5 business days)
- Minor (15 business days)
Section 3: Problem Description
(Describe the nonconformity or potential nonconformity. For pediatric-related issues, include age group affected, number of participants impacted, and any safety implications.)
Section 4: Immediate Containment
(Actions taken to contain the immediate impact, especially for child safety issues)
Section 5: Root Cause Investigation
Investigation Method Used
- 5 Whys
- Fishbone Diagram
- Fault Tree Analysis
- Timeline Analysis
- Other: ____________
Pediatric-Specific Factors Considered
- Age-appropriateness of procedures/materials
- Developmental considerations
- Family communication
- Parental permission/child assent process
- Pediatric dosing or procedures
- Child safety monitoring
- N/A
Root Cause Determination
Section 6: Corrective/Preventive Actions
| Action | Responsible | Due Date | Status |
|---|---|---|---|
Section 7: Notifications (if applicable)
- Principal Investigator notified
- Sponsor notified (Date: ______)
- IRB/Ethics Committee notified (Date: ______)
- FDA or other regulatory authority notified (Date: ______)
- Participants/families notified (Date: ______)
- DSMB notified (Date: ______)
Section 8: Effectiveness Verification
| Criteria | Method | Result |
|---|---|---|
Verification Date: ____________ Verified By: ____________
Section 9: Closure
| Role | Name | Signature | Date |
|---|---|---|---|
| CAPA Owner | |||
| Quality Approval | |||
| PI Approval (if study-related) |
Form FRM-003 Rev 1.0