Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Material
1. Is there a documented process for material identification and traceability?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
There is a documented process for material identification and traceability.
Can you describe the process for material identification and traceability?
Material identification and traceability process documentatio n Records of material identification and traceability
No specific mention of the process for material identification and traceability.
Section 8.5.2, Define process for material identification and traceability.
Control and Identification
Material
2. Are materials identified and traceable throughout the production process?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
Materials are identified and traceable throughout the production process.
How are materials identified and traceable throughout the production process?
No specific mention of identifying and tracing materials
Section 8.5.2, Identify and trace materials throughout production.
Control and Identification
throughout production.
Material
3. Are non-conforming materials clearly identified and segregated to prevent their use?
Section 8.7 Control of Nonconforming Outputs
Procedure P-011 Rev. C
Non-conforming materials are clearly identified and segregated to prevent their use.
How do you identify and segregate non- conforming materials?
Logs of non- conforming materials
No specific mention of identifying and segregating non- conforming materials.
Section 8.7, Identify and segregate non-conforming materials.
Control and Identification
Material
4. Is there a system for controlling and documenting the status of materials?
Section 8.5.2 Identification and Traceability
Procedure P-010 Rev. B
There is a system for controlling and documenting the status of materials.
What system do you use for controlling and documenting the status of materials?
Status control and documentatio n system records
No specific mention of a system
Section 8.5.2, Control and document material status.
Control and Identification
for controlling material status.
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