Sync template from atomicqms-style deployment

Forms/FRM-003-CAPA-Form.md

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+# 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*