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
1. Is there a documented process for the creation, maintenance, and disposition of records?
Section 7.5.3 Control of Documented Information
There is a documented process for the creation, maintenance, and disposition of records.
Can you describe the process for the creation, maintenance, and disposition of records?
Documented process for record creation, maintenance, and disposition
No specific mention of the process for record creation, maintenance, and disposition. No specific mention of ensuring records are legible, identifiable, and traceable. No specific mention of measures to protect records from damage, deterioration, or loss. No specific mention of defining and adhering to retention times. No specific mention of procedures for storing records to ensure retrievability.
Section 7.5.3, Define process for record creation, maintenance, and disposition.
Records
2. Are records legible, identifiable, and traceable to the relevant product?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are legible, identifiable, and traceable to the relevant product.
How do you ensure records are legible, identifiable, and traceable to the relevant product?
Sample records showing
Section 7.5.3, Ensure records are legible, identifiable, and traceable.
legibility, identification, and traceability
Records
3. Are records protected from damage, deterioration, or loss?
Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Records are protected from damage, deterioration, or loss.
What measures are in place to protect records from damage, deterioration, or loss? How are retention times for records defined and adhered to? How are records stored to ensure they are readily retrievable?
Records protection measures
Section 7.5.3, Implement measures to protect records from damage, deterioration, or loss.
documentatio n
Records
4. Are retention times for records defined and adhered to?
Section 7.5.3 Control of Documented Information Section 7.5.3 Control of Documented Information
Procedure P-006 Rev. A
Retention times for records are defined and adhered to.
Records retention schedule
Section 7.5.3, Define and adhere to retention times.
Records
5. Are records stored in a manner that ensures they are readily retrievable?
Procedure P-006 Rev. A
Records are stored in a manner that ensures they are readily retrievable.
Records storage procedures
Section 7.5.3, Store records to ensure retrievability.
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