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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 that affect patient care quality and safety in the NICU/PICU.
+
+## 2. Scope
+
+This procedure applies to:
+- Patient safety events and near-misses
+- Healthcare-associated infections
+- Medication errors and adverse drug events
+- Equipment failures
+- Process deviations
+- Audit findings
+- Regulatory findings
+- Potential nonconformities identified through risk analysis
+
+## 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 |
+| Sentinel Event | Unexpected occurrence involving death or serious physical/psychological injury |
+
+## 4. Responsibilities
+
+### 4.1 CAPA Owner
+- Investigates the issue
+- Identifies root cause
+- Develops and implements corrective/preventive actions
+- Verifies effectiveness
+
+### 4.2 Quality Assurance
+- Manages CAPA system
+- Assigns CAPA numbers
+- Tracks CAPA status
+- Reviews and approves CAPAs
+- Reports CAPA metrics to management
+
+### 4.3 Unit Leadership
+- Provides resources for CAPA implementation
+- Reviews CAPA trends
+- Ensures timely closure
+- Communicates serious events to appropriate parties
+
+## 5. Procedure
+
+### 5.1 CAPA Initiation
+
+1. Identify nonconformity or potential nonconformity
+2. Document issue on CAPA Form (FRM-003)
+3. Classify severity and priority:
+   - Critical (patient harm or high risk)
+   - Major (potential for patient harm)
+   - Minor (process deviation, no patient impact)
+4. Assign CAPA owner
+5. Notify Risk Management if patient safety event
+
+### 5.2 Investigation
+
+1. Gather relevant data and evidence
+2. Interview personnel involved
+3. Review related documents and records
+4. Review patient chart if applicable
+5. Use appropriate investigation tools:
+   - Root Cause Analysis (RCA)
+   - Failure Mode and Effects Analysis (FMEA)
+   - 5 Whys
+   - Fishbone Diagram
+
+### 5.3 Root Cause Analysis
+
+1. Identify potential root causes
+2. Verify root cause through evidence
+3. Document root cause determination
+4. Consider systemic implications
+5. Identify contributing factors
+
+### 5.4 Action Development
+
+1. Develop corrective/preventive actions
+2. Assign responsibilities and due dates
+3. Assess actions for:
+   - Appropriateness to problem severity
+   - Impact on other processes
+   - Resource requirements
+   - Sustainability
+
+### 5.5 Implementation
+
+1. Execute approved actions
+2. Document implementation evidence
+3. Update affected documents/processes
+4. Provide staff training as needed
+5. Communicate changes to all affected personnel
+
+### 5.6 Effectiveness Verification
+
+1. Define effectiveness criteria (measurable outcomes)
+2. Allow sufficient time for actions to take effect
+3. Collect and analyze data
+4. Document verification results
+5. If ineffective, reopen CAPA for further action
+
+### 5.7 Closure
+
+1. Review all CAPA documentation
+2. Verify all actions completed
+3. Confirm effectiveness verified
+4. Obtain approval for closure
+5. Share lessons learned with team
+
+## 6. CAPA Metrics
+
+Quality Assurance shall track and report:
+- Number of open CAPAs by category
+- CAPA aging
+- On-time closure rate
+- Effectiveness rate
+- CAPAs by source (safety event, infection, medication error, etc.)
+- Repeat events
+
+## 7. Related Documents
+
+- FRM-003 CAPA Form
+- SOP-005 Patient Safety Event Reporting
+- Risk Management Policies
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |