- Owner
- Lead Auditor
- Effective date
- September 15, 2026
- Review cycle
- Every 12 months
1.Purpose
To verify through planned, independent audits that processes are being followed as documented and that the quality management system is working effectively, identifying nonconformances for correction.
2.Scope
Applies to scheduling, planning, conducting, reporting and following up on internal audits across departments and processes. External or customer audits and the execution of corrective actions are handled separately from this SOP.
Definitions
- Audit criteria
- The procedure, standard or requirement an auditor checks the process against.
- Nonconformance
- A finding where a process does not meet the defined audit criteria.
- Objective evidence
- Verifiable facts, such as records, observations or measurements, that support a finding.
- Closing meeting
- The meeting at the end of an audit where findings are presented to the auditee.
3.Responsibilities
- Lead Auditor
- Maintains the audit schedule and assigns independent auditors to each audit.
- Auditor
- Plans and conducts the audit, gathers evidence, and reports findings.
- Process Owner
- Participates in the audit as auditee and raises CAPAs for nonconformances found.
- Quality Manager
- Tracks findings to closure and summarizes audit trends for management review.
RACI matrix
| Activity | Lead Auditor | Auditor | Process Owner | Quality Manager |
|---|---|---|---|---|
| Schedule and assign the audit | R | I | I | R/A |
| Plan and conduct the audit | C | R/A | C | I |
| Present findings at the closing meeting | C | R/A | I | I |
| Raise CAPA for nonconformances | I | C | R/A | I |
| Track findings to closure | I | C | C | R/A |
R = Responsible, A = Accountable, C = Consulted, I = Informed
4.Materials and PPE
Materials, tools and systems
- →Annual internal audit schedule
- →Audit checklist and criteria
- →Audit report template
- →CAPA log cross-reference
5.Procedure
- 5.1
Maintain the audit schedule
Quality ManagerThe Quality Manager maintains an annual internal audit schedule covering every process and department in scope.
- 5.2
Assign an independent auditor
Lead AuditorThe Lead Auditor assigns an auditor who is independent of the area being audited, so no one reviews their own work.
Warning: An auditor should never audit their own work area, even temporarily due to staffing constraints.
- 5.3
Prepare the audit plan
AuditorThe Auditor prepares an audit plan and checklist based on the procedure and criteria applicable to the area being audited.
- 5.4
Notify the auditee
AuditorThe Auditor notifies the Process Owner of the audit date, scope and plan well in advance of the audit.
- 5.5
Hold an opening meeting
AuditorThe Auditor holds a brief opening meeting with the Process Owner to confirm scope, criteria and logistics before starting the audit.
- 5.6
Gather objective evidence
AuditorThe Auditor gathers objective evidence by observing the process, interviewing staff and reviewing records against the audit criteria.
Checkpoint: Every finding is backed by specific objective evidence rather than opinion or impression.
- 5.7
Record nonconformances
AuditorThe Auditor records each nonconformance found against the defined criteria, with the supporting evidence noted alongside it.
- 5.8
Hold a closing meeting
AuditorThe Auditor presents the findings to the Process Owner in a closing meeting before leaving the audited area.
Checkpoint: The auditee sees every finding in the closing meeting; nothing new appears later in the written report.
- 5.9
Issue the audit report
AuditorThe Auditor issues the written audit report with findings, supporting evidence and due dates for a response.
- 5.10
Raise CAPA for findings
Process OwnerThe Process Owner raises a CAPA for each nonconformance identified, following the CAPA SOP for investigation and correction.
- 5.11
Track findings to closure
Quality ManagerThe Quality Manager tracks open findings against their due dates until each one is closed.
- 5.12
Verify prior findings
AuditorThe Auditor verifies that corrective actions from the previous audit were completed and effective during the next scheduled audit.
- 5.13
Summarize results for management review
Quality ManagerThe Quality Manager summarizes audit results and trends for the next management review meeting.
6.Quality checks
- →Auditors are independent of the area they audit.
- →Every finding is backed by objective evidence recorded in the audit report.
- →The auditee sees findings in the closing meeting before the written report is issued.
- →Open findings are tracked to closure against their due dates.
7.Records
- →Audit plan and checklist
- →Audit report with findings
- →CAPA reference for each nonconformance
- →Audit schedule and completion status
8.KPIs
- →Percentage of scheduled audits completed on time
- →Average time to close audit findings
- →Number of nonconformances per audit
- →Repeat finding rate across audit cycles
9.Common mistakes
- →Assigning an auditor to audit their own process.
- →Surprising the auditee with findings they never heard in the closing meeting.
- →Recording a finding without supporting objective evidence.
- →Not tracking findings through to CAPA closure.
10.Revision history
| Revision | Date | Description | Reviewed by |
|---|---|---|---|
| 1.0 | September 15, 2026 | Initial release | Ilia Pirozhenko |
This is a template. Adapt it to your organization, equipment and local regulations before use.
