clinical-inpatient/SOPs/General/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 approach for conducting internal audits to verify the effectiveness of the Quality Management System.

2. Scope

This procedure covers:

• QMS process audits
• Compliance audits
• Product audits
• System audits

3. Definitions

Term	Definition
Audit	Systematic, independent examination to determine conformance
Auditor	Person qualified to perform audits
Finding	Observation of conformance or nonconformance
Observation	Noted item not rising to level of finding

4. Responsibilities

4.1 Lead Auditor

• Plans and schedules audits
• Prepares audit checklists
• Conducts audit activities
• Reports audit findings

4.2 Quality Manager

• Maintains audit program
• Qualifies auditors
• Reviews audit reports
• Reports to management

4.3 Auditee

• Provides access to areas/records
• Responds to findings
• Implements corrective actions

5. Procedure

5.1 Annual Audit Schedule

1. Develop annual audit schedule considering:
   • Previous audit results
   • Process criticality
   • Regulatory requirements
   • Changes to processes
2. Ensure all QMS processes audited at least annually
3. Obtain management approval
4. Communicate schedule to affected areas

5.2 Auditor Qualification

Auditors shall:

• Complete auditor training course
• Conduct at least 2 audits under supervision
• Be independent of area being audited
• Maintain competence through ongoing audits

5.3 Audit Preparation

1. Review applicable procedures and standards
2. Review previous audit reports
3. Prepare audit checklist
4. Notify auditee of audit scope and schedule
5. Confirm auditor availability

5.4 Conducting the Audit

1. Hold opening meeting with auditee
2. Execute audit checklist
3. Gather objective evidence:
   • Document review
   • Personnel interviews
   • Process observation
4. Document findings with evidence
5. Classify findings:
   • Major Nonconformance
   • Minor Nonconformance
   • Observation
6. Hold closing meeting

5.5 Audit Reporting

1. Complete audit report within 5 business days
2. Report shall include:
   • Audit scope and criteria
   • Personnel interviewed
   • Findings with evidence
   • Recommendations
3. Distribute report to auditee and management

5.6 Finding Resolution

1. Auditee responds with corrective action plan within 10 business days
2. Quality reviews and approves plan
3. Auditee implements corrective actions
4. Auditor verifies effectiveness
5. Close finding upon verification

6. Audit Records

Maintain for 5 years:

• Audit schedules
• Checklists
• Reports
• Corrective action records

7. Related Documents

• FRM-006 Audit Checklist Template
• FRM-007 Audit Report Template
• SOP-002 CAPA

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Revision History

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