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SOPs/SOP-002-CAPA.md

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+# Standard Operating Procedure: Corrective and Preventive Action (CAPA)
+
+| Document ID | SOP-002 |
+|-------------|---------|
+| Title | Corrective and Preventive Action |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities in pediatric clinical research operations.
+
+## 2. Scope
+
+This procedure applies to:
+- Product and process nonconformities
+- Protocol deviations and violations
+- Adverse events requiring corrective action
+- Audit findings (internal, sponsor, regulatory)
+- Customer/sponsor complaints
+- Process deviations
+- IRB/Ethics Committee findings
+- Potential nonconformities identified through risk analysis
+- Child safety concerns requiring systemic response
+
+## 3. Definitions
+
+| Term | Definition |
+|------|------------|
+| 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 a nonconformity |
+| Effectiveness Check | Verification that implemented actions achieved desired results |
+| Protocol Deviation | Unplanned departure from protocol requirements |
+| Protocol Violation | Serious protocol deviation that may impact participant safety or data integrity |
+
+## 4. Responsibilities
+
+### 4.1 CAPA Owner
+- Investigates the issue
+- Identifies root cause
+- Develops and implements corrective/preventive actions
+- Verifies effectiveness
+- For pediatric safety issues, escalates immediately
+
+### 4.2 Quality Assurance
+- Manages CAPA system
+- Assigns CAPA numbers
+- Tracks CAPA status
+- Reviews and approves CAPAs
+- Reports CAPA metrics to management
+- Monitors trends affecting pediatric participant safety
+
+### 4.3 Principal Investigator
+- Reviews CAPAs related to study conduct
+- Determines if protocol deviations/violations require CAPA
+- Reports to sponsor and IRB/Ethics Committee as required
+- Ensures child safety concerns are addressed
+
+### 4.4 Management
+- Provides resources for CAPA implementation
+- Reviews CAPA trends
+- Ensures timely closure
+- Escalates pediatric safety concerns to appropriate authorities
+
+## 5. Procedure
+
+### 5.1 CAPA Initiation
+
+1. Identify nonconformity or potential nonconformity through:
+   - Internal/external audits
+   - Protocol deviations
+   - Adverse events
+   - Sponsor monitoring
+   - IRB findings
+   - Participant/family complaints
+   - Quality metrics
+
+2. Document issue on CAPA Form (FRM-003)
+
+3. Classify severity and priority:
+   - **Critical**: Immediate threat to child safety or data integrity
+   - **Major**: Significant impact on quality or compliance
+   - **Minor**: Limited impact, easily correctable
+
+4. For pediatric safety concerns:
+   - Immediate interim measures implemented
+   - Principal Investigator and Medical Monitor notified
+   - IRB/Ethics Committee notification per requirements
+
+5. Assign CAPA owner
+
+### 5.2 Investigation
+
+1. Gather relevant data and evidence:
+   - Study records and source documents
+   - Interview personnel and families involved
+   - Review environmental factors
+   - Consider age-specific factors
+
+2. Review related documents and records:
+   - Protocol and protocol amendments
+   - Informed consent/assent documents
+   - Training records
+   - Prior CAPAs
+
+3. Use appropriate investigation tools:
+   - 5 Whys
+   - Fishbone (Ishikawa) Diagram
+   - Failure Mode and Effects Analysis (FMEA)
+   - Timeline analysis
+
+### 5.3 Root Cause Analysis
+
+1. Identify potential root causes, considering:
+   - Human factors (training, fatigue, workload)
+   - Process failures
+   - Equipment or facility issues
+   - Communication breakdowns
+   - Pediatric-specific factors (age-appropriateness, family dynamics)
+
+2. Verify root cause through evidence
+
+3. Document root cause determination
+
+4. Consider systemic implications:
+   - Impact on other studies or sites
+   - Need for system-wide changes
+   - Regulatory reporting requirements
+
+### 5.4 Action Development
+
+1. Develop corrective/preventive actions that address root cause
+
+2. For pediatric research CAPAs, consider:
+   - Impact on child participants (current and future)
+   - Changes to assent/consent processes
+   - Age-appropriateness modifications
+   - Family communication needs
+   - IRB/Ethics Committee approval requirements
+
+3. Assign responsibilities and due dates
+
+4. Assess actions for:
+   - Appropriateness to problem severity
+   - Impact on other processes and studies
+   - Resource requirements
+   - Regulatory implications
+
+5. Obtain necessary approvals:
+   - Quality Assurance
+   - Principal Investigator
+   - Sponsor (if applicable)
+   - IRB/Ethics Committee (if required)
+
+### 5.5 Implementation
+
+1. Execute approved actions per timeline
+
+2. Document implementation evidence
+
+3. Update affected documents/processes:
+   - Revise SOPs
+   - Update training materials
+   - Modify study documents (with IRB approval)
+
+4. Provide training as needed:
+   - Staff training on changes
+   - Refresher training if knowledge gaps identified
+
+5. Communicate changes to:
+   - Study team members
+   - Sponsor
+   - IRB/Ethics Committee
+   - Participants/families (if applicable)
+
+### 5.6 Effectiveness Verification
+
+1. Define effectiveness criteria (measurable outcomes)
+
+2. Establish verification timeframe:
+   - Minimum 30 days for routine CAPAs
+   - Shorter for critical safety issues with ongoing monitoring
+
+3. Collect and analyze data:
+   - Review metrics
+   - Monitor for recurrence
+   - Audit compliance
+
+4. Document verification results
+
+5. If ineffective:
+   - Reopen CAPA for further action
+   - Perform additional root cause analysis
+   - Develop alternative actions
+
+### 5.7 Closure
+
+1. Review all CAPA documentation for completeness
+
+2. Verify all actions completed
+
+3. Confirm effectiveness verified
+
+4. Obtain Quality Assurance approval for closure
+
+5. Document lessons learned
+
+6. Update risk assessments if applicable
+
+## 6. Special Considerations for Pediatric Research
+
+### 6.1 Child Safety Issues
+- Immediate action required for any threat to child safety
+- Principal Investigator and Medical Monitor notification
+- IRB/Ethics Committee and regulatory authority notification per timelines
+- Parental notification process activated
+- Consider Data Safety Monitoring Board (DSMB) review if applicable
+
+### 6.2 Assent/Consent Issues
+- Any CAPA affecting informed consent or assent requires IRB approval
+- Age-appropriateness concerns addressed by pediatric specialist
+- Updated documents require re-consent/re-assent per regulations
+
+### 6.3 Family Communication
+- Transparent communication with affected families
+- Age-appropriate explanations for child participants
+- Cultural sensitivity in communications
+
+## 7. CAPA Metrics
+
+Quality Assurance shall track and report:
+- Number of open CAPAs
+- CAPA aging (days open)
+- On-time closure rate
+- Effectiveness rate
+- CAPAs by category/source:
+  - Protocol deviations/violations
+  - Adverse events
+  - Audit findings
+  - Pediatric safety concerns
+- Repeat/recurring issues
+
+## 8. Related Documents
+
+- FRM-003 CAPA Form
+- SOP-004 Internal Audit
+- SOP-REG-001 Regulatory Reporting
+- SOP-SAF-001 Pediatric Safety Monitoring
+- SOP-PED-004 Protocol Deviation Management
+
+## 9. References
+
+- ICH-GCP E6(R2) Section 5.20 (Noncompliance)
+- 45 CFR 46.103 (Assurance of Compliance)
+- 21 CFR 312.56 (Review of Ongoing Investigations)
+- ISO 13485:2016 Section 8.5 (Improvement)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |