developmental-pediatrics/SOPs/SOP-002-CAPA.md

# Standard Operating Procedure: Corrective and Preventive Action (CAPA)

| Document ID | SOP-002 |
|-------------|---------|
| Title | Corrective and Preventive Action (CAPA) |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Quality Assurance |

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## 1. Purpose

To establish a systematic approach for identifying, investigating, and addressing nonconformities, clinical errors, and opportunities for improvement in developmental pediatric services.

## 2. Scope

This procedure applies to all aspects of developmental pediatric services including:
- Diagnostic assessment procedures
- Screening programs
- School liaison activities
- Clinical operations
- Documentation and reporting
- Family communication
- Multidisciplinary coordination
- Safety incidents

## 3. Responsibilities

### 3.1 All Staff
- Report nonconformities, incidents, and improvement opportunities
- Participate in CAPA investigations
- Implement assigned corrective actions

### 3.2 Quality Assurance Manager
- Coordinates CAPA process
- Assigns CAPA owners
- Tracks CAPA completion
- Reports CAPA metrics to management

### 3.3 CAPA Owner
- Investigates root cause
- Develops action plan
- Implements corrective/preventive actions
- Verifies effectiveness

### 3.4 Clinical Director
- Reviews clinical CAPAs
- Approves clinical protocol changes
- Ensures assessment standardization maintained

## 4. Definitions

| Term | Definition |
|------|------------|
| Nonconformity | Failure to meet specified requirements or standards |
| Corrective Action | Action to eliminate the cause of a detected nonconformity |
| Preventive Action | Action to eliminate the cause of a potential nonconformity |
| Root Cause | Fundamental reason for occurrence of a problem |

## 5. Procedure

### 5.1 CAPA Initiation

CAPAs may be initiated from:
- Internal audits
- Management reviews
- Clinical incident reports
- Family complaints
- Assessment protocol deviations
- Documentation errors
- Diagnostic discrepancies
- School liaison communication issues
- Training gaps
- Equipment/tool malfunctions

### 5.2 CAPA Documentation

1. Complete FRM-003 CAPA Form
2. Describe the issue in detail
3. Include relevant data (dates, affected cases, assessment tools involved)
4. Assign severity level:
   - **Critical**: Affects patient safety or diagnostic accuracy
   - **Major**: Significant impact on service quality
   - **Minor**: Limited impact, easily corrected

### 5.3 Root Cause Analysis

1. CAPA Owner assigned by QA Manager
2. Gather facts and data
3. Use appropriate analysis tools:
   - 5 Whys
   - Fishbone diagram
   - Timeline analysis
4. Consider contributing factors:
   - Training adequacy
   - Protocol clarity
   - Assessment tool fidelity
   - Communication breakdown
   - Workload/scheduling
   - Documentation systems
5. Document root cause findings

### 5.4 Action Plan Development

1. Identify corrective actions to address root cause
2. Identify preventive actions to prevent recurrence
3. Assign responsibilities and target completion dates
4. Consider impact on:
   - Assessment standardization
   - Clinical protocols
   - Staff training
   - Documentation systems
   - Related processes

### 5.5 Implementation

1. Execute action plan
2. Document implementation activities
3. Update affected procedures/protocols
4. Provide staff training if needed
5. Communicate changes to relevant personnel

### 5.6 Effectiveness Check

1. Verify actions implemented as planned
2. Monitor for recurrence (minimum 30 days)
3. Review relevant metrics:
   - Assessment completion rates
   - Documentation accuracy
   - Family satisfaction
   - Protocol adherence
4. Document effectiveness check results

### 5.7 CAPA Closure

1. QA Manager reviews for completeness
2. Verify all actions completed
3. Confirm effectiveness demonstrated
4. Close CAPA in tracking system
5. Archive CAPA records

### 5.8 Trending and Analysis

1. QA reviews CAPA data quarterly
2. Identify trends and patterns
3. Report findings to management
4. Initiate preventive actions for recurring issues

## 6. Special Considerations for Clinical CAPAs

### 6.1 Assessment Protocol Deviations
- Document impact on diagnostic validity
- Review with Clinical Director
- Consider need for case re-evaluation
- Update assessment training

### 6.2 Diagnostic Discrepancies
- Review assessment data and scoring
- Verify DSM-5-TR criteria application
- Consider multidisciplinary team review
- Document clinical reasoning

### 6.3 School Liaison Issues
- Review IEP/504 documentation accuracy
- Verify IDEA compliance
- Improve school communication protocols

## 7. Related Documents

- FRM-003 CAPA Form
- SOP-001 Document Control
- SOP-004 Internal Audit
- Clinical Incident Report Form

## 8. References

- ISO 9001:2015 Clause 10.2 (Nonconformity and Corrective Action)
- Clinical quality improvement methodologies
- Patient safety best practices

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |