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