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]