Audit Checklist for 14 CFR 21.137 Compliance

1. Supplier Control (Part 21.137(c))

• Approved Vendor List: Verify the existence and current status of an approved vendor list.
• Vendor Assessment Records: Check for recent vendor evaluations, including audit reports.
• Vendor Quality On-Site Checklists: Review completed checklists from vendor audits.

2. Manufacturing Process Control (Part 21.137(d))

• SOP Documentation: Confirm the availability of Standard Operating Procedures for manufacturing processes.
• Process Control Records: Examine records of process monitoring, such as quality control charts.

3. Inspection and Testing (Part 21.137(e)(g))

• Inspection Reports: Look for records of incoming, in-process, and final inspections.
• Test Results: Assess documentation of testing procedures and outcomes.
• Non-Conformance Reports: Check for records of non-conforming products and corrective actions taken.

4. Inspection Measuring and Test Equipment (Part 21.137(f))

• Calibration Records: Verify that calibration of equipment is done regularly and documented.
• Equipment Maintenance Records: Review maintenance logs for inspection and testing equipment.

5. Handling and Storage (Part 21.137(j))

• Storage Procedures: Evaluate documented procedures for material handling and storage.
• Inventory Records: Examine how materials are tracked and managed.

6. Internal Audit System (Part 21.137(l))

• Audit Schedules and Reports: Review internal audit schedules and findings.
• Corrective Action Records: Check for evidence of corrective actions following audits.

7. In-Service Feedback (Part 21.137(m))

• Customer Feedback Logs: Assess how customer feedback is captured and addressed.
• Service Reports: Examine service and maintenance records for in-service products.

8. Quality Escapes (Part 21.137(n))

• Quality Escape Reports: Review any reported quality escapes and subsequent resolutions.
• Preventive Actions: Check for documentation of preventive measures to avoid future issues.

9. Purchasing Documents (Part 21.137(a)(b)(c))

• Purchase Orders and Contracts: Inspect purchase documents for compliance with quality requirements.
• Vendor Approval Documentation: Review the process and criteria for vendor approval.

10. Training Records

• Training Logs: Confirm that training records are maintained and up-to-date.
• Competency Assessments: Verify assessments or certifications of employee competencies.

11. Identifying Markings (45.10)(45.15)

• Product Labeling Records: Check for compliance with product identification and marking requirements.

Collecting and Assessing Objective Evidence:

1. Document Review: Assessing compliance often starts with a review of relevant documents, such as policies, procedures, records, and reports.
2. Interviews: Speaking with personnel to understand how procedures are implemented and followed.
3. Observation: Physically observing processes, equipment, and how tasks are performed.
4. Sampling: Reviewing a selection of records or data to assess compliance and effectiveness.

Required Evidence:

• Documented Procedures and Records: These should be readily available, up-to-date, and comply with the specified regulations.
• Evidence of Implementation: It's not enough to have procedures; there should be clear evidence they are being followed.
• Corrective Action Records: Demonstration of how non-conformities are addressed and resolved.
• Continuous Improvement Evidence: Indications that feedback (both internal and external) is used for ongoing improvement.

This checklist serves as a guide for auditors to systematically assess compliance with 14 CFR 21.137, focusing on tangible evidence to verify that the organization adheres to the specified standards.