Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 10.2 Nonconformity and Corrective Action
Related Procedure Name and Number Procedure P-005 Rev. D
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Audits (Internal and When Required for Level I
3. Are corrective actions taken without undue delay after detection of nonconformance?
Corrective actions are promptly taken following the detection of nonconformances.
What is the process for implementing corrective actions after a nonconformance is detected? How are audit results documented and communicated to management?
Corrective action logs
No specific mention of corrective action implementation timeline.
Section 10.2, Define corrective action implementation timeline.
Material, External)
Audits (Internal and When Required for Level I
4. Are audit results documented and reported to responsible management?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Audit results are documented and reported to management for review.
Audit reports No specific mention of audit result documentation procedures.
Section 9.2, Define audit result documentation procedures.
Material, External)
Audits (Internal and When Required for Level I
5. Are re-audits conducted to verify the effectiveness of corrective actions taken?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Re-audits are conducted to ensure the effectiveness of corrective actions.
How do you verify the effectiveness of corrective actions through re-audits?
Re-audit reports
No specific mention of re-audit procedures.
Section 9.2, Define re-audit procedures.
Material, External)
Audits (Internal and When Required for Level I
6. Are auditors independent of the areas being audited to ensure objectivity?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Auditors are independent of the areas being audited to maintain objectivity.
How do you ensure the independence and objectivity of your auditors?
Auditor independence records
No specific mention of auditor independence assurance.
Section 9.2, Ensure auditor independence.
Material, External)
Audits (Internal and When Required for Level I
7. Are internal audit records maintained for an adequate period to support quality system reviews?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Internal audit records are kept for a sufficient period to support quality reviews.
How long are internal audit records maintained and how are they used in quality system reviews?
Internal audit records
No specific mention of record retention period for internal audits.
Section 9.2, Define record retention period for internal audits.
Material, External)
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