158 lines
2.9 KiB
Markdown
158 lines
2.9 KiB
Markdown
# 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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| Department | |
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| CAPA Owner | |
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## Section 2: Problem Description
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### Source of CAPA
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- [ ] Internal Audit
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- [ ] External Audit
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- [ ] Management Review
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- [ ] Clinical Incident
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- [ ] Family Complaint
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- [ ] Assessment Protocol Deviation
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- [ ] Documentation Error
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- [ ] Staff Observation
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- [ ] Other: _______________
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### Severity Level
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- [ ] Critical (affects patient safety or diagnostic accuracy)
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- [ ] Major (significant quality impact)
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- [ ] Minor (limited impact)
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### Description of Nonconformity or Issue
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*(Provide detailed description including what happened, when, where, and who was involved)*
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### Affected Processes/Areas
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- [ ] Diagnostic Evaluations
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- [ ] Screening Programs
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- [ ] School Liaison
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- [ ] Documentation
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- [ ] Assessment Administration
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- [ ] Clinical Protocols
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- [ ] Training/Competency
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- [ ] Other: _______________
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## Section 3: Immediate Action (if applicable)
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### Immediate Containment Actions Taken
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*(Actions to prevent immediate recurrence or mitigate impact)*
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## Section 4: Root Cause Analysis
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### Investigation Method
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- [ ] 5 Whys
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- [ ] Fishbone Diagram
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- [ ] Timeline Analysis
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- [ ] Other: _______________
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### Root Cause Findings
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*(Document the fundamental cause of the problem)*
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### Contributing Factors
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- [ ] Training inadequacy
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- [ ] Protocol unclear
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- [ ] Communication breakdown
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- [ ] Assessment tool issue
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- [ ] Workload/scheduling
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- [ ] Documentation system
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- [ ] Equipment/materials
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- [ ] Other: _______________
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## Section 5: Corrective/Preventive Actions
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### Action Plan
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| Action # | Description | Responsible Person | Target Date | Status |
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|----------|-------------|-------------------|-------------|--------|
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| 1 | | | | |
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| 2 | | | | |
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| 3 | | | | |
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| 4 | | | | |
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### Type of Action
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- [ ] Corrective (address detected issue)
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- [ ] Preventive (prevent potential issue)
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### Affected Documents/Procedures
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*(List SOPs, protocols, or forms that need updating)*
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### Training Required
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- [ ] Yes
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- [ ] No
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If yes, describe:
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## Section 6: Implementation
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### Implementation Notes
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*(Document actions taken)*
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### Implementation Date | |
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### Implemented By | |
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## Section 7: Effectiveness Check
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### Verification Method
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- [ ] Follow-up audit
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- [ ] Metric monitoring
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- [ ] Process observation
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- [ ] Record review
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- [ ] Other: _______________
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### Verification Period
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- Start Date: _______________
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- End Date: _______________
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### Effectiveness Results
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*(Describe results of monitoring - has the issue been resolved?)*
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### Effectiveness Verified By | |
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### Verification Date | |
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## Section 8: CAPA Closure
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- [ ] All actions completed
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- [ ] Effectiveness demonstrated
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- [ ] Records complete
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### Closed By | |
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### Closure Date | |
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---
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*Form FRM-003 Rev 1.0*
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