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]