Sync template from atomicqms-style deployment

SOPs/SOP-004-Internal-Audit.md

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+# Standard Operating Procedure: Internal Audit
+
+| Document ID | SOP-004 |
+|-------------|---------|
+| Title | Internal Audit |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Quality Assurance |
+
+---
+
+## 1. Purpose
+
+To establish a systematic process for conducting internal audits to verify compliance with the Quality Management System and regulatory requirements.
+
+## 2. Scope
+
+This procedure applies to:
+- All NICU/PICU processes and procedures
+- Clinical documentation
+- Equipment maintenance and calibration
+- Staff competency and training
+- Medication safety practices
+- Infection prevention practices
+- Patient safety processes
+
+## 3. Responsibilities
+
+### 3.1 Quality Assurance
+- Develops annual audit schedule
+- Selects and trains auditors
+- Ensures audits are conducted
+- Tracks audit findings to closure
+- Reports audit results to management
+
+### 3.2 Auditors
+- Conduct audits per schedule
+- Document findings objectively
+- Submit audit reports on time
+- Follow up on corrective actions
+
+### 3.3 Auditees
+- Provide information and access
+- Respond to findings
+- Implement corrective actions
+- Verify effectiveness
+
+## 4. Audit Types
+
+### 4.1 Process Audits
+- Review specific processes for compliance
+- Conducted quarterly
+
+### 4.2 Document Audits
+- Review documentation for completeness and compliance
+- Conducted monthly (sampling approach)
+
+### 4.3 Compliance Audits
+- Verify compliance with regulatory requirements
+- Conducted annually or as needed
+
+### 4.4 Mock Surveys
+- Simulate Joint Commission survey
+- Conducted annually
+
+## 5. Procedure
+
+### 5.1 Audit Planning
+
+1. Develop annual audit schedule
+2. Identify audit scope and criteria
+3. Select auditor(s) - must be independent of area audited
+4. Review previous audit findings
+5. Notify auditee at least 2 weeks in advance
+
+### 5.2 Audit Preparation
+
+1. Review applicable documents and standards
+2. Develop audit checklist (FRM-006)
+3. Prepare opening meeting agenda
+
+### 5.3 Audit Execution
+
+1. **Opening Meeting**
+   - Confirm audit scope
+   - Review audit process
+   - Identify key personnel
+
+2. **Evidence Gathering**
+   - Review documents and records
+   - Observe processes
+   - Interview personnel
+   - Take notes and document evidence
+
+3. **Finding Classification**
+   - **Critical**: Immediate patient safety risk or major non-compliance
+   - **Major**: Significant deviation from requirements
+   - **Minor**: Documentation or procedural deviation
+   - **Observation**: Opportunity for improvement
+
+4. **Closing Meeting**
+   - Present findings
+   - Clarify any questions
+   - Agree on corrective action timeline
+
+### 5.4 Audit Reporting
+
+1. Complete audit report within 5 business days
+2. Report includes:
+   - Executive summary
+   - Scope and methodology
+   - List of findings
+   - Positive observations
+   - Recommendations
+3. Distribute to auditee and management
+
+### 5.5 Corrective Action
+
+1. Auditee develops corrective action plan
+2. Submit plan within 10 business days
+3. Quality Assurance reviews and approves plan
+4. Implement actions per timeline
+5. Document completion
+
+### 5.6 Follow-up
+
+1. Verify corrective actions implemented
+2. Assess effectiveness
+3. Close findings or escalate if inadequate
+4. Schedule re-audit if needed
+
+## 6. Auditor Qualification
+
+Auditors must:
+- Complete internal auditor training
+- Have knowledge of QMS requirements
+- Have clinical background (for clinical audits)
+- Maintain objectivity and independence
+
+## 7. Audit Metrics
+
+Quality shall track and report:
+- Number of audits completed vs. scheduled
+- Findings by type and area
+- Average time to close findings
+- Repeat findings
+- Audit effectiveness
+
+## 8. Related Documents
+
+- FRM-006 Audit Checklist
+- FRM-007 Audit Report Template
+- SOP-002 CAPA
+
+## 9. References
+
+- Joint Commission Standards
+- CMS Conditions of Participation
+- ISO 9001:2015 (if applicable)
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |