nicu-picu/SOPs/SOP-004-Internal-Audit.md

# 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 |

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## 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)

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## Revision History

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