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
Level I
1. Is there a documented process for the identification and handling of Level I material?
Section 8.5.2 Identification and Traceability
Procedure P-014 Rev. A
There is a documented process for the identification and handling of Level I material.
Can you describe the process for the identification and handling of Level I material?
Identification and handling process documentatio n
No specific mention of the process for identification and handling of Level I material. No specific mention of identifying and segregating Level I materials.
Section 8.5.2, Define process for identification and handling of Level I material.
Material
Level I
2. Are Level I materials clearly identified and segregated from other materials?
Section 8.5.2 Identification and Traceability
Procedure P-014 Rev. A
Level I materials are clearly identified and segregated from other materials.
How are Level I materials identified and segregated from other materials?
Segregation logs for Level I materials
Section 8.5.2, Identify and segregate Level I materials.
Material
Level I
3. Are records maintained for the receipt, handling, and disposition of Level I material?
Section 8.5.2 Identification and Traceability
Procedure P-015 Rev. B
Records are maintained for the receipt, handling, and disposition of Level I material.
How do you maintain records for the receipt, handling, and disposition of Level I material?
Records of receipt, handling, and disposition of Level I material
No specific mention of maintaining records for Level I material.
Section 7.5.3, Maintain records for Level I material.
Material
Level I
4. Is there a process for the inspection and testing of Level I materials to ensure compliance with specifications?
Section 8.6 Release of Products and Services
Procedure P-016 Rev. C
There is a process for the inspection and testing of Level I materials to ensure compliance with specifications.
What is the process for the inspection and testing of Level I materials?
Inspection and testing reports for Level I materials
No specific mention of inspection and testing process for Level I materials.
Section 8.6, Define inspection and testing process for Level I materials.
Material
18
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