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Audit Planning

Audit type identified as layered process audit critical (required)

Confirm the audit is a layered audit and not a full system audit.

Process area and audit scope defined critical (required)

Record the department, line, cell, or process being audited and the boundaries of scope.

Audit layer assigned critical (required)

Identify the management layer performing the audit.

Audit frequency confirmed critical (required)

Enter the planned audit frequency for this process area.

Note (optional)

Audit criteria and reference documents available critical (required)

Select the documents used to verify conformance.

Previous audit findings reviewed critical (required)

Confirm prior non-conformances and open corrective actions were reviewed before the audit.

Yes No N/A

Audit date and time scheduled

Record the planned date and time for the layered audit.

Audit Execution

Audit conducted at the actual work area critical (required)

Confirm the audit was completed where the work is performed, not only from records.

Yes No N/A

Auditor observed the process directly critical (required)

Confirm the auditor observed the process, equipment, or transaction in real time.

Yes No N/A

Sample size reviewed

Enter the number of observations, records, or units reviewed during the audit.

Evidence collected

Select the evidence types used to support the audit result.

Process owner present during audit

Confirm the process owner or delegate participated in the audit discussion.

Yes No N/A

Audit completed on schedule critical (required)

Confirm the audit was completed within the planned frequency window.

Yes No N/A

Process Conformance

Work instruction available and current at point of use critical (required)

Verify the current approved work instruction is accessible where the task is performed.

Yes No N/A

Operator follows defined sequence of steps critical (required)

Confirm the observed work sequence matches the approved standard work or control plan.

Yes No N/A

Required PPE is worn correctly critical (required)

Verify required personal protective equipment is present and used correctly for the task.

Yes No N/A

Critical process parameter within limits critical (required)

Record the measured critical parameter and verify it is within the approved range.

Calibration or verification status current for measuring devices critical (required)

Confirm gauges, meters, or test devices used in the process are within calibration or verification status.

Yes No N/A

Material or product identification maintained

Verify traceability, labeling, or status identification is maintained throughout the process.

Yes No N/A

Findings and Nonconformities

Any non-conformance identified

Indicate whether any non-conformance, deficiency, or layered audit miss was found.

Yes No N/A

Finding severity

Classify the most significant finding identified during the audit.

Finding description

Describe the observed deficiency or non-conformance with enough detail to support follow-up.

Immediate containment action taken

Record any short-term containment or risk control applied at the time of discovery.

Root cause analysis initiated

Confirm root cause analysis was assigned or started for the finding.

Yes No N/A

Finding owner assigned

Enter the responsible person or role for corrective action follow-up.

Corrective Actions and Closure

Corrective action due date assigned

Record the target completion date for corrective action.

Corrective action plan documented critical (required)

Confirm a documented corrective action plan exists for each applicable finding.

Yes No N/A

Effectiveness verification completed critical (required)

Confirm follow-up verification was completed and the issue did not recur.

Yes No N/A

Finding closed

Confirm the audit finding has been formally closed with evidence of completion.

Yes No N/A

Auditor signature critical (required)

Auditor sign-off confirming the audit results and findings are accurate.

Process owner acknowledgment

Process owner acknowledgment of the audit result and required follow-up actions.

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Run: Internal Layered Audit Schedule

Audit Planning

Audit Execution

Process Conformance

Findings and Nonconformities

Corrective Actions and Closure

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