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 Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.5.2 Identification and Traceability
Related Procedure Name and Number Procedure P-012 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Material
5. Are materials properly stored to prevent damage and deterioration?
Materials are properly stored to prevent damage and deterioration.
How are materials stored to prevent damage and deterioration?
Material storage procedures
No specific mention of procedures for material storage to prevent damage. No specific mention of ensuring only approved materials are used. No specific mention of maintaining records for material identification and traceability. No specific mention of audit program structure.
Section 7.1.5, Store materials to prevent damage.
Control and Identification
Material
6. Are there procedures in place to ensure that only approved materials are used?
Procedure P-013 Rev. D
Procedures are in place to ensure that only approved materials are used.
What procedures ensure that only approved materials are used?
Approved material usage procedures
Section 8.4, Ensure only approved materials are used.
Control and Identification
Material
7. Are records of material identification and traceability maintained?
Procedure P-010 Rev. B
Records of material identification and traceability are maintained.
How are records of material identification and traceability maintained?
Material identification and traceability records Internal audit program documentatio n
Section 8.5.2, Maintain records for material identification and traceability.
Control and Identification
Audits (Internal and When Required for Level I
1. Does the supplier maintain an internal audit program to verify that its quality system is being followed?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
The supplier maintains an internal audit program to ensure compliance with the quality system.
How is your internal audit program structured to verify compliance with the quality system? What criteria do you use to schedule internal audits?
Section 9.2, Define audit program structure.
Material, External)
Audits (Internal and When Required for Level I
2. Are internal audits scheduled based on the status and importance of the activity to be audited?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Audits are scheduled based on the status and importance of activities.
Audit schedules
No specific mention of audit scheduling criteria.
Section 9.2, Define audit scheduling criteria.
Material, External)
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