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
Records 6. Are authorized personnel
Section 7.3 Awareness
Procedure P- 022 Rev. E
Requires that all personnel authorized to sign official records, such as NDT certifications, are clearly designated and documented. Stipulates that all documents must be dated with complete information to ensure proper tracking and historical accuracy. Mandates that any changes made to parts are reflected in updated Certificates of Conformance to maintain traceability and compliance. Requires systematic reviews of retention periods to ensure compliance with mandated timelines, especially for electronic records and cloud storage. Highlights the requirement to notify EB before the destruction of any records, ensuring regulatory compliance and historical integrity.
How do you designate and document authorized personnel for signing official records?
Authorization records, NDT certification records
Lack of documented authorization for personnel signing official records. Inaccurate or incomplete dating of documents.
Refer to Section 7.3 of the Quality Manual. Ensure all authorized personnel are designated in writing and documented. Refer to Section 7.5.3 of the Quality Manual. Implement and enforce a policy requiring full dating of all documents.
signing official records designated in writing by the supplier (including NDT certs)?
Records 7. Do vendor procedures state
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
How do you ensure that all documents are dated
Sample documents, dating policy
that documents must include the date, including month, date, and year?
accurately and in compliance with procedural requirements?
Records 8. Do vendor procedures state
Section 8.5.6 Control of Changes
Procedure P- 022 Rev. E
How do you manage the dating of Certificates of Conformance in relation to changes made to parts? How often do you review the retention periods for electronic records, and what is the process? What is the procedure for notifying EB before the destruction of records post-retention period?
Updated certificates, change management records
Lack of proper management of Certificates of Conformance.
Refer to Section 8.5.6 of the Quality Manual. Ensure all changes are reflected in updated Certificates of Conformance.
that a Certificate of Conformance must postdate any changes made to a part?
Records 9. Are retention periods for
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Retention policy, review logs
Inconsistent review of electronic record retention periods.
Refer to Section 7.5.3 of the Quality Manual. Regularly
electronic records (including cloud storage) reviewed to ensure that records are kept for 10 years for electronic parts and assemblies (seven years for other parts)?
review and document retention periods for electronic records.
Records 10. Is the vendor aware that
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Destruction policies, communication records
Lack of notification procedures before record destruction.
Refer to Section 7.5.3 of the Quality Manual. Implement procedures to notify EB before the destruction of any records.
even after the required retention period, EB must be notified before records are destroyed?
9
Made with FlippingBook - Share PDF online