Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
Gaps in the Quality Manual
Category Checklist Questions
OQE to Request
Supplier Information
1. Does the supplier have a quality management system in place that meets the requirements of the applicable standards?
Can you describe how your quality management system meets the applicable standards?
No specific mention of how the quality management system meets applicable standards. No specific mention of the process for establishing and reviewing quality objectives. No specific mention of the process for continuous monitoring and review. No specific mention of the definition and communication of roles and responsibilities.
Section 4.1, Define how the quality management system meets applicable standards.
The supplier has a quality management system that meets the applicable standards.
Quality management system documentation
Section 4.1 General Requirements
General
Procedure P-001 Rev. A
Section 5.4, Define process for establishing and reviewing quality objectives.
How are quality objectives established and reviewed?
2. Are quality objectives established and reviewed regularly?
Quality objectives are established and reviewed regularly.
Records of quality objective reviews
Section 5.4 Quality Planning
General
Procedure P-002 Rev. B
What process is in place for continuous monitoring and review of the quality management system?
3. Is there a process for continuous monitoring and review of the quality management system? 4. Are roles, responsibilities, and authorities for quality management defined and communicated within the organization? 5. Is there evidence of management commitment to the implementation and improvement of the quality management system?
There is a process for continuous monitoring and review of the quality management system.
Quality management system monitoring and review records
Section 5.6, Define process for continuous monitoring and review.
Section 5.6 Management Review
General
Procedure P-003 Rev. C
How are roles, responsibilities, and authorities for quality management defined and communicated?
Roles, responsibilities, and authorities for quality management are defined and communicated.
Section 5.5 Responsibility, Authority, and Communication
Organization charts and role definitions
Section 5.5, Define and communicate roles and responsibilities.
General
Procedure P-004 Rev. D
Can you provide evidence of management's
Section 5.1, Provide evidence of management commitment to the quality management system.
There is evidence of management commitment to the quality management system.
No specific mention of management commitment to the quality management system.
Section 5.1 Management Commitment
Records of management review meetings
General
Procedure P-005 Rev. E
commitment to the quality management system?
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