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-003 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Internal Audits
1. Does the supplier maintain an internal audit program to verify that its quality system is being followed?
Section 9.2 Internal Audit
The supplier maintains an internal audit program to ensure compliance with the quality system.
How is your internal audit program structured to verify compliance with the quality system? What criteria do you use to schedule internal audits? What is the process for implementing corrective actions after a nonconformance is detected? How are audit results documented and communicated to management? How do you verify the effectiveness of corrective actions through re-audits? How do you ensure the independence and objectivity of your auditors?
Internal audit program documentatio n
No specific mention of audit program structure.
Section 9.2, Define audit program structure.
Internal Audits
2. Are internal audits scheduled based on the status and importance of the activity to be audited?
Section 9.2 Internal Audit
Procedure P-003 Rev. A
Audits are scheduled based on the status and importance of activities.
Audit schedules
No specific mention of audit scheduling criteria. No specific mention of corrective action implementation timeline.
Section 9.2, Define audit scheduling criteria.
Internal Audits
3. Are corrective actions taken without undue delay after detection of nonconformance?
Section 10.2 Nonconformity and Corrective Action
Procedure P-005 Rev. D
Corrective actions are promptly taken following the detection of nonconformances.
Corrective action logs
Section 10.2, Define corrective action implementation timeline.
Internal Audits
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.
Internal Audits
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.
Re-audit reports
No specific mention of re-audit procedures.
Section 9.2, Define re-audit procedures.
Internal Audits
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.
Auditor independence records
No specific mention of auditor independence assurance.
Section 9.2, Ensure auditor independence.
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