111 lines
2.1 KiB
Markdown
111 lines
2.1 KiB
Markdown
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# Corrective and Preventive Action (CAPA) Form
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| Form ID | FRM-003 | Revision | 1.0 |
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---
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## Section 1: CAPA Identification
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| Field | Entry |
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|-------|-------|
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| CAPA Number | |
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| Date Initiated | |
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| Initiated By | |
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| CAPA Owner | |
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| Target Closure Date | |
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## Section 2: Classification
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### Type
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- [ ] Corrective Action
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- [ ] Preventive Action
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### Source
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- [ ] Patient Safety Event
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- [ ] Medication Error
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- [ ] Healthcare-Associated Infection
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- [ ] Equipment Failure
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- [ ] Internal Audit
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- [ ] External Audit/Survey
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- [ ] Family Complaint
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- [ ] Process Deviation
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- [ ] Sentinel Event
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- [ ] Management Review
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- [ ] Other: ____________
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### Priority
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- [ ] Critical (patient harm occurred or high risk - 5 business days)
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- [ ] Major (potential for patient harm - 15 business days)
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- [ ] Minor (process deviation, no patient impact - 30 business days)
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## Section 3: Problem Description
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*(Describe the nonconformity or potential nonconformity - include patient impact if applicable)*
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## Section 4: Immediate Containment
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*(Actions taken to contain the immediate impact and protect patient safety)*
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## Section 5: Root Cause Investigation
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### Investigation Method Used
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- [ ] Root Cause Analysis (RCA)
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- [ ] Failure Mode and Effects Analysis (FMEA)
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- [ ] 5 Whys
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- [ ] Fishbone Diagram
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- [ ] Fault Tree Analysis
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- [ ] Other: ____________
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### Root Cause Determination
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### Contributing Factors
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## Section 6: Corrective/Preventive Actions
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| Action | Responsible | Due Date | Status |
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|--------|-------------|----------|--------|
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## Section 7: Staff Communication and Training
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| Training/Communication Required | Target Audience | Completion Date |
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|--------------------------------|-----------------|-----------------|
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## Section 8: Effectiveness Verification
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| Criteria | Method | Result |
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|----------|--------|--------|
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Verification Date: ____________
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Verified By: ____________
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## Section 9: Closure
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| Role | Name | Signature | Date |
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|------|------|-----------|------|
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| CAPA Owner | | | |
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| Quality Approval | | | |
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### Lessons Learned
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---
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*Form FRM-003 Rev 1.0*
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