Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.4 Control of Externally Provided Processes, Products, and Services
Related Procedure Name and Number Procedure P-009 Rev. B
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Supplier Control
3. Are records of supplier evaluations and approvals maintained?
Records of supplier evaluations and approvals are maintained.
How do you maintain records of supplier evaluations and approvals?
Supplier evaluation and approval records
No specific mention of maintaining records of supplier evaluations and approvals.
Section 8.4, Maintain records of supplier evaluations and approvals.
Supplier Control
4. Is there a process for monitoring and measuring supplier performance?
Procedure P-009 Rev. B
There is a process for monitoring and measuring supplier performance.
What is the process for monitoring and measuring supplier performance?
Supplier performance monitoring records
No specific mention of process for monitoring supplier performance.
Section 8.4, Define process for monitoring supplier performance.
Supplier Control
5. Are corrective actions taken when supplier performance does not meet requirements?
Procedure P-009 Rev. B
Corrective actions are taken when supplier performance does not meet requirements.
How do you handle situations where supplier performance does not meet requirements?
Corrective action records for supplier performance issues Nonconforman ce reports and corrective action requests to suppliers
No specific mention of corrective actions for supplier performance issues.
Section 8.4, Implement corrective actions for supplier performance issues.
Supplier Control
6. Are suppliers informed of nonconformances and required to implement corrective actions?
Procedure P-009 Rev. B
Suppliers are informed of nonconformances and required to implement corrective actions.
How are suppliers informed of
No specific mention of informing suppliers of nonconformances and requiring corrective actions.
Section 8.4, Inform suppliers of nonconformances and require corrective actions.
nonconformances and required to implement corrective actions?
30
Made with FlippingBook - Share PDF online