Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 7.1.5 Monitoring and Measuring Resources
Related Procedure Name and Number Procedure P-022 Rev. E
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
General Workmanship/ Quality Practices
5. Does the supplier maintain cleanliness and provide for protection of test equipment?
Highlights the importance of maintaining cleanliness and protecting test equipment to ensure accuracy and reliability of measurements.
How do you maintain cleanliness and protect your test
Maintenance logs, cleanliness standards documentatio n Cleanliness logs, process documentatio n
Lack of maintenance and protection protocols for test equipment.
Refer to Section 7.1.5 of the Quality Manual. Implement and document protocols for maintaining cleanliness and protecting test equipment.
equipment from contamination or damage?
General Workmanship/ Quality Practices
6. Does the supplier maintain cleanliness during assembly, test, and packaging?
Section 8.5 Production and Service Provision
Procedure P-022 Rev. E
Requires maintaining cleanliness throughout all stages of production, including assembly, testing, and packaging, to prevent contamination. Mandates that the inspection department must verify the cleanliness of products before they are packaged and shipped to ensure quality control. Requires documentation and tracking of all materials, particularly post-processing such as heat treatment, to ensure traceability.
How is cleanliness maintained during assembly, testing, and packaging processes?
Inconsistent cleanliness practices during assembly, testing, and packaging. Lack of verification procedures for cleanliness before packaging and shipping.
Refer to Section 8.5 of the Quality Manual. Implement and document clear cleanliness practices during assembly, testing, and packaging. Refer to Section 8.6 of the Quality Manual. Implement and document verification procedures to ensure cleanliness before packaging and shipping. Refer to Section 8.5.2 of the Quality Manual. Ensure comprehensive documentation and tracking of material processing and traceability.
General Workmanship/ Quality Practices
7. Does the supplier’s inspection department verify cleanliness prior to packaging and shipping?
Section 8.6 Release of Products and Services
Procedure P-022 Rev. E
How does your inspection
Inspection reports, cleanliness
department verify cleanliness before packaging and shipping products?
verification
records
General Workmanship/ Quality Practices
8. Does the supplier’s material control system document when material is worked or heat treated, resulting in changes to mechanical properties and is it uniquely marked or re-identified to provide traceability to the final condition?
Section 8.5.2 Identification and Traceability
Procedure P-022 Rev. E
How is material processing documented and tracked within your control system?
Processing logs, material traceability records
Inadequate documentation and tracking of material processing.
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