Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
Gaps in the Quality Manual
Category Checklist Questions
OQE to Request
Supplier Information
1. Are the applicable forms identified and controlled within the quality management system?
How are applicable forms identified and controlled within the quality management system?
The applicable forms are identified and controlled within the quality management system.
Section 7.5.3 Control of Documented Information
No specific mention of identification and control of applicable forms.
Section 7.5.3, Define identification and control of applicable forms.
Documented information control process
Applicable Forms
Procedure P-006 Rev. A
2. Are forms reviewed and approved before use to ensure they meet the intended requirements?
Forms are reviewed and approved before use to ensure they meet the intended requirements.
Section 7.5.3 Control of Documented Information
What is the process for reviewing and approving forms before use?
No specific mention of the process for reviewing and approving forms.
Section 7.5.3, Define process for reviewing and approving forms.
Records of form reviews and approvals
Applicable Forms
Procedure P-006 Rev. A
3. Are obsolete forms removed from points of use to prevent unintended use?
Section 7.5.3 Control of Documented Information
Obsolete forms are removed from points of use to prevent unintended use.
How do you ensure that obsolete forms are removed from points of use?
No specific mention of procedures for removing obsolete forms.
Section 7.5.3, Define procedures for removing obsolete forms.
Applicable Forms
Logs of obsolete forms removal
Procedure P-006 Rev. A
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