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
Compliance Description
Suggested Audit Interview Question
OQE to Request Gaps in the Quality Manual
Supplier Information
Additional Controls
11. Are records maintained of the results of production and service provision activities? 12. Are there procedures for the identification and traceability of products? 13. Is there a process for the control of documented information? 1. Is there a documented process for the evaluation and selection of suppliers? 2. Are suppliers periodically re-evaluated to ensure continued compliance with quality and delivery requirements? 3. Are records of supplier evaluations and re- evaluations maintained?
Section 8.5.1 Control of Production and Service Provision
Procedure P- 029 Rev. H
Records are maintained of the results of production and service provision activities. There are procedures for the identification and traceability of products.
How do you maintain records of production and service provision activities? Can you describe the procedures for the identification and traceability of products? How is documented information controlled within your organization? Can you describe the process for the evaluation and selection of suppliers? re-evaluated to ensure compliance with quality and delivery requirements? How do you maintain records of supplier evaluations and re-evaluations? How are suppliers periodically
Records of production and service
No specific mention of maintaining records of production and service provision activities. No specific mention of product identification and traceability procedures. No specific mention of documented information control process. No specific mention of supplier evaluation and selection process.
Section 8.5.1, Maintain records of production and service provision activities. Section 8.5.2, Define product identification and traceability procedures. Section 7.5.3, Define documented information control process. Section 8.4, Define supplier evaluation and selection process.
provision activities
Additional Controls
Section 8.5.2 Identification and Traceability
Procedure P- 030 Rev. I
Product identification and traceability procedures Documented information control process
Additional Controls
Section 7.5.3 Control of Documented Information
Procedure P- 031 Rev. J
There is a process for the control of documented information.
Supplier
Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.4 Control of Externally Provided Processes, Products, and Services
Procedure P- 032 Rev. A
There is a documented process for the evaluation and selection of suppliers.
Supplier evaluation and selection process documentation Records of periodic supplier re-evaluations
Evaluation
Supplier
Procedure P- 032 Rev. A
Suppliers are periodically re-evaluated to ensure continued compliance with quality and delivery requirements. Records of supplier evaluations and re-evaluations are maintained.
No specific mention of periodic re-evaluation of suppliers.
Section 8.4, Define periodic re-evaluation criteria for suppliers.
Evaluation
Supplier
Section 8.4 Control of Externally Provided Processes, Products, and Services
Procedure P- 032 Rev. A
Supplier evaluation and re-evaluation records
No specific mention of maintaining records of supplier evaluations and re-evaluations.
Section 8.4, Maintain records of supplier evaluations and re-evaluations.
Evaluation
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