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-034 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Documentation and Records Control
3. Are documents identified and controlled to prevent the use of obsolete documents?
Section 7.5.3 Control of Documented Information
Documents are identified and controlled to prevent the use of obsolete documents.
How are documents identified and controlled to prevent the use of obsolete documents?
Logs of document identification and control
No specific mention of identifying and controlling
Section 7.5.3, Define process for identifying and controlling documents.
documents to prevent use of obsolete documents.
Documentation and Records Control
4. Are records maintained to provide evidence of conformity to requirements?
Section 7.5.3 Control of Documented Information
Procedure P-034 Rev. A
Records are maintained to provide evidence of conformity to requirements.
How do you maintain records to provide evidence of
Records of conformity to requirements
No specific mention of maintaining
Section 7.5.3, Define process for maintaining records of conformity.
conformity to requirements?
records for evidence of conformity.
Documentation and Records Control
5. Are records legible, readily identifiable, and retrievable?
Section 7.5.3 Control of Documented Information
Procedure P-034 Rev. A
Records are legible, readily identifiable, and retrievable.
How do you ensure records are legible, readily identifiable, and retrievable?
Sample records showing legibility and retrievability
No specific mention of ensuring records are legible and retrievable.
Section 7.5.3, Define process for ensuring records are legible and retrievable.
Documentation and Records Control
6. Are there procedures for the retention and disposition of records?
Section 7.5.3 Control of Documented Information
Procedure P-034 Rev. A
There are procedures for the retention and disposition of records.
What procedures are in place for the retention and disposition of records?
Retention and disposition procedures
No specific mention of procedures for
Section 7.5.3, Define procedures for retention and disposition of records.
retention and disposition of records.
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