Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 10.2 Nonconformity and Corrective Action
Related Procedure Name and Number Procedure P-025 Rev. D
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Additional Controls
6. Are records maintained of all nonconformances and corrective actions?
Records are maintained of all nonconformances and corrective actions.
How do you maintain records of nonconformances and corrective actions?
Nonconform ance and corrective action records
No specific mention of
Section 10.2, Maintain records of nonconformances and corrective actions.
maintaining
records of nonconformances and corrective actions. No specific mention of competence and training procedures. No specific mention of calibration and maintenance process. No specific mention of supplier evaluation and selection process.
Additional Controls
7. Are there procedures for ensuring the competence and training of personnel?
Section 7.2 Competence
Procedure P-026 Rev. E
There are procedures for ensuring the competence and training of personnel.
What procedures ensure the competence and training of personnel? How do you ensure the calibration and maintenance of monitoring and measuring equipment?
Competence and training procedures and records Calibration and maintenance process documentati on
Section 7.2, Define competence and training procedures.
Additional Controls
8. Is there a process for the calibration and maintenance of monitoring and measuring equipment?
Section 7.1.5 Monitoring and Measuring Resources
Procedure P-027 Rev. F
There is a process for the calibration and maintenance of monitoring and measuring equipment.
Section 7.1.5, Define calibration and maintenance process.
Additional Controls
9. Are suppliers evaluated and selected based on their ability to provide products that meet requirements?
Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.5.1 Control of Production and Service Provision
Procedure P-028 Rev. G
Suppliers are evaluated and selected based on their ability to provide products that meet requirements.
How are suppliers evaluated and selected?
Supplier evaluation and selection records
Section 8.4, Define supplier evaluation and selection process.
Additional Controls
10. Are procedures in place for the control of production and service provision?
Procedure P-029 Rev. H
Procedures are in place for the control of production and service provision.
What procedures are in place for the control of production and service provision?
Production and service provision control procedures
No specific mention of production and service provision control procedures.
Section 8.5.1, Define production and service provision control procedures.
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