# Corrective and Preventive Action (CAPA) Form

| Form ID | FRM-003 | Revision | 1.0 |
|---------|---------|----------|-----|

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## Section 1: CAPA Identification

| Field | Entry |
|-------|-------|
| CAPA Number | |
| Date Initiated | |
| Initiated By | |
| Department | |
| CAPA Owner | |

## Section 2: Problem Description

### Source of CAPA
- [ ] Internal Audit
- [ ] External Audit
- [ ] Management Review
- [ ] Clinical Incident
- [ ] Family Complaint
- [ ] Assessment Protocol Deviation
- [ ] Documentation Error
- [ ] Staff Observation
- [ ] Other: _______________

### Severity Level
- [ ] Critical (affects patient safety or diagnostic accuracy)
- [ ] Major (significant quality impact)
- [ ] Minor (limited impact)

### Description of Nonconformity or Issue
*(Provide detailed description including what happened, when, where, and who was involved)*




### Affected Processes/Areas
- [ ] Diagnostic Evaluations
- [ ] Screening Programs
- [ ] School Liaison
- [ ] Documentation
- [ ] Assessment Administration
- [ ] Clinical Protocols
- [ ] Training/Competency
- [ ] Other: _______________

## Section 3: Immediate Action (if applicable)

### Immediate Containment Actions Taken
*(Actions to prevent immediate recurrence or mitigate impact)*




## Section 4: Root Cause Analysis

### Investigation Method
- [ ] 5 Whys
- [ ] Fishbone Diagram
- [ ] Timeline Analysis
- [ ] Other: _______________

### Root Cause Findings
*(Document the fundamental cause of the problem)*




### Contributing Factors
- [ ] Training inadequacy
- [ ] Protocol unclear
- [ ] Communication breakdown
- [ ] Assessment tool issue
- [ ] Workload/scheduling
- [ ] Documentation system
- [ ] Equipment/materials
- [ ] Other: _______________

## Section 5: Corrective/Preventive Actions

### Action Plan

| Action # | Description | Responsible Person | Target Date | Status |
|----------|-------------|-------------------|-------------|--------|
| 1 | | | | |
| 2 | | | | |
| 3 | | | | |
| 4 | | | | |

### Type of Action
- [ ] Corrective (address detected issue)
- [ ] Preventive (prevent potential issue)

### Affected Documents/Procedures
*(List SOPs, protocols, or forms that need updating)*




### Training Required
- [ ] Yes
- [ ] No

If yes, describe:



## Section 6: Implementation

### Implementation Notes
*(Document actions taken)*




### Implementation Date | |
### Implemented By | |

## Section 7: Effectiveness Check

### Verification Method
- [ ] Follow-up audit
- [ ] Metric monitoring
- [ ] Process observation
- [ ] Record review
- [ ] Other: _______________

### Verification Period
- Start Date: _______________
- End Date: _______________

### Effectiveness Results
*(Describe results of monitoring - has the issue been resolved?)*




### Effectiveness Verified By | |
### Verification Date | |

## Section 8: CAPA Closure

- [ ] All actions completed
- [ ] Effectiveness demonstrated
- [ ] Records complete

### Closed By | |
### Closure Date | |

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*Form FRM-003 Rev 1.0*