Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 8.7 Control of Nonconforming Outputs
Related Procedure Name and Number Procedure P-017 Rev. D
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Level I
5. Are non-conforming Level I materials identified and controlled to prevent their use?
Non-conforming Level I materials are identified and controlled to prevent their use.
How do you identify and control non-conforming Level I materials?
Logs of non- conforming Level I materials
No specific mention of controlling non- conforming Level I materials. No specific mention of corrective actions for Level I material issues. No specific mention of training for handling Level I materials. No specific mention of calibration process documentation. No specific mention of calibration record maintenance and traceability.
Section 8.7, Control non-conforming Level I materials.
Material
Level I
6. Are corrective actions implemented and documented for any issues related to Level I material?
Section 10.2 Nonconformity and Corrective Action
Procedure P-018 Rev. E
Corrective actions are implemented and documented for any issues related to Level I material.
What corrective actions are implemented for issues related to Level I material? How are personnel trained on the requirements and procedures for handling Level I materials?
Corrective action records for Level I material issues
Section 10.2, Implement corrective actions for Level I material issues.
Material
Level I
7. Are personnel handling Level I materials trained on the specific requirements and procedures?
Section 7.2 Competence
Procedure P-019 Rev. F
Personnel handling Level I materials are trained on the specific requirements and procedures.
Training records for personnel handling Level I materials
Section 7.2, Train personnel for handling Level I materials.
Material
Calibration and Measurements
1. Is there a documented process for calibration of measurement instruments?
Section 7.1.5 Monitoring and Measuring Resources Section 7.1.5 Monitoring and Measuring Resources
Procedure P-020 Rev. A
There is a documented process for the calibration of measurement instruments.
Can you describe the process for calibrating
Calibration process
Section 7.1.5, Define calibration process documentation.
measurement instruments?
documentatio n
Calibration and Measurements
2. Are calibration records maintained and traceable to the equipment?
Procedure P-020 Rev. A
Calibration records are maintained and traceable to the specific equipment.
How do you maintain and ensure traceability of calibration records?
Calibration records
Section 7.1.5, Ensure calibration record maintenance and traceability.
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