137 lines
3.1 KiB
Markdown
137 lines
3.1 KiB
Markdown
# Standard Operating Procedure: Internal Audit
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| Document ID | SOP-004 |
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|-------------|---------|
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| Title | Internal Audit |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Assurance |
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---
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## 1. Purpose
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To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System.
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## 2. Scope
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This procedure covers:
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- QMS process audits
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- Compliance audits
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- Product audits
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- System audits
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## 3. Definitions
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| Term | Definition |
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|------|------------|
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| Audit | Systematic, independent examination to determine conformance |
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| Auditor | Person qualified to perform audits |
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| Finding | Observation of conformance or nonconformance |
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| Observation | Noted item not rising to level of finding |
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## 4. Responsibilities
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### 4.1 Lead Auditor
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- Plans and schedules audits
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- Prepares audit checklists
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- Conducts audit activities
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- Reports audit findings
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### 4.2 Quality Manager
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- Maintains audit program
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- Qualifies auditors
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- Reviews audit reports
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- Reports to management
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### 4.3 Auditee
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- Provides access to areas/records
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- Responds to findings
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- Implements corrective actions
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## 5. Procedure
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### 5.1 Annual Audit Schedule
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1. Develop annual audit schedule considering:
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- Previous audit results
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- Process criticality
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- Regulatory requirements
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- Changes to processes
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2. Ensure all QMS processes audited at least annually
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3. Obtain management approval
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4. Communicate schedule to affected areas
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### 5.2 Auditor Qualification
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Auditors shall:
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- Complete auditor training course
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- Conduct at least 2 audits under supervision
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- Be independent of area being audited
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- Maintain competence through ongoing audits
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### 5.3 Audit Preparation
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1. Review applicable procedures and standards
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2. Review previous audit reports
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3. Prepare audit checklist
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4. Notify auditee of audit scope and schedule
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5. Confirm auditor availability
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### 5.4 Conducting the Audit
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1. Hold opening meeting with auditee
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2. Execute audit checklist
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3. Gather objective evidence:
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- Document review
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- Personnel interviews
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- Process observation
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4. Document findings with evidence
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5. Classify findings:
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- Major Nonconformance
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- Minor Nonconformance
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- Observation
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6. Hold closing meeting
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### 5.5 Audit Reporting
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1. Complete audit report within 5 business days
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2. Report shall include:
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- Audit scope and criteria
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- Personnel interviewed
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- Findings with evidence
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- Recommendations
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3. Distribute report to auditee and management
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### 5.6 Finding Resolution
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1. Auditee responds with corrective action plan within 10 business days
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2. Quality reviews and approves plan
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3. Auditee implements corrective actions
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4. Auditor verifies effectiveness
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5. Close finding upon verification
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## 6. Audit Records
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Maintain for 5 years:
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- Audit schedules
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- Checklists
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- Reports
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- Corrective action records
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## 7. Related Documents
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- FRM-006 Audit Checklist Template
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- FRM-007 Audit Report Template
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- SOP-002 CAPA
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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