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 Procedure P-006 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records
6. Are electronic records backed up to prevent loss of data?
Section 7.5.3 Control of Documented Information
Electronic records are backed up to prevent loss of data.
What procedures are in place for backing up electronic records?
Electronic records backup logs
No specific mention of backing up electronic records.
Section 7.5.3, Backup electronic records.
Records
7. Are obsolete records clearly identified and properly disposed of?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Obsolete records are clearly identified and properly disposed of.
How are obsolete records identified and disposed of?
Logs of obsolete records disposal
No specific mention of identifying and disposing of obsolete records.
Section 7.5.3, Identify and dispose of obsolete records.
Records
8. Are records reviewed periodically to ensure they remain relevant and accurate?
Section 7.5.3 Control of Documented Information Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are reviewed periodically to ensure they remain relevant and accurate.
How often are records reviewed to ensure they remain relevant and accurate? What access controls are in place to prevent unauthorized changes to records? How do you ensure records are maintained in compliance with legal
Records review logs
No specific mention of periodic review of records.
Section 7.5.3, Periodically review records.
Records
9. Are access controls in place to prevent unauthorized changes to records?
Procedure P-006 Rev. A
Access controls are in place to prevent unauthorized changes to records.
Access control policies for records
No specific mention of access controls to prevent unauthorized changes. No specific mention of maintaining records in compliance with legal and regulatory requirements.
Section 7.5.3, Implement access controls to prevent unauthorized changes.
Records
10. Are records maintained in a manner that complies with applicable legal and regulatory requirements?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are maintained in compliance with applicable legal and regulatory requirements.
Compliance records with legal and regulatory requirements
Section 7.5.3, Maintain records in compliance with legal and regulatory requirements.
and regulatory requirements?
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