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-033 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Management Review
1. Is there a documented process for conducting management reviews of the quality management system?
Section 9.3 Management Review
There is a documented process for conducting management
Can you describe the process for conducting management reviews of the quality management system? How often are management reviews conducted and what is reviewed to ensure the continuing suitability, adequacy, and effectiveness of the quality management system? How do you maintain records of management reviews?
Management review process documentatio n Management review schedules and agendas
No specific mention of the process for conducting management reviews. No specific mention of the frequency and content of management reviews. No specific mention of maintaining records of management reviews. No specific mention of the process for control of
Section 9.3, Define process for conducting management reviews.
reviews of the quality management system.
Management Review
2. Are management reviews conducted at planned intervals to ensure the continuing suitability, adequacy, and effectiveness of the quality management system?
Section 9.3 Management Review
Procedure P-033 Rev. A
Management reviews are conducted at planned intervals to ensure the continuing suitability, adequacy, and effectiveness of the quality management system.
Section 9.3, Define frequency and content of management reviews.
3. Are records of management reviews maintained?
Section 9.3 Management Review
Procedure P-033 Rev. A
Records of management reviews are maintained.
Records of management reviews
Section 9.3, Maintain records of management reviews.
Management Review
Documentation and Records Control
1. Is there a documented process for the control of documented information (documents and records)?
Section 7.5.3 Control of Documented Information
Procedure P-034 Rev. A
There is a documented process for the control of documented information (documents and records).
Can you describe the process for the control of
Documented information control process
Section 7.5.3, Define process for control of documented information.
documented information?
documented information.
Documentation and Records Control
2. Are documents reviewed and approved for adequacy prior to issue?
Section 7.5.3 Control of Documented Information
Procedure P-034 Rev. A
Documents are reviewed and approved for adequacy prior to issue.
How are documents reviewed and approved for adequacy prior to issue?
Records of document reviews and approvals
No specific mention of reviewing and approving documents prior to issue.
Section 7.5.3, Define process for reviewing and approving documents.
24
Made with FlippingBook - Share PDF online