Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 7.1.5 Monitoring and Measuring Resources
Related Procedure Name and Number Procedure P-020 Rev. A
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Calibration and Measurements
3. Are calibration intervals defined based on manufacturer recommendations or industry standards?
Calibration intervals are defined based on manufacturer recommendations or industry standards.
How are calibration intervals determined for your
Calibration interval schedules
No specific mention of how calibration intervals are defined. No specific mention of handling non-conforming measurement instruments. No specific mention of documenting and investigating out- of-tolerance conditions. No specific mention of labeling calibrated instruments. No specific mention of training for proper use and maintenance of measurement instruments.
Section 7.1.5, Define criteria for calibration intervals.
measurement instruments?
Calibration and Measurements
4. Are non-conforming measurement instruments identified and segregated?
Section 7.1.5 Monitoring and Measuring Resources
Procedure P-020 Rev. A
Non-conforming measurement instruments are identified and segregated to prevent use.
What procedures are in place to handle non- conforming
Non- conformance logs
Section 7.1.5, Implement procedures for non-conforming instruments.
measurement instruments?
Calibration and Measurements
5. Are out-of-tolerance conditions documented and investigated?
Section 7.1.5 Monitoring and Measuring Resources
Procedure P-020 Rev. A
Out-of-tolerance conditions are documented and investigated to determine impact.
How do you document and investigate out-of- tolerance conditions?
Out-of- tolerance condition reports
Section 7.1.5, Document and investigate out-of-tolerance conditions.
Calibration and Measurements
6. Are calibrated instruments labeled with the calibration status and due date?
Section 7.1.5 Monitoring and Measuring Resources
Procedure P-020 Rev. A
Calibrated instruments are labeled with their calibration status and due date.
How are calibrated instruments labeled with their status and due date?
Calibration status labels
Section 7.1.5, Label calibrated instruments with status and due date.
Calibration and Measurements
7. Are personnel trained on the proper use and maintenance of measurement instruments?
Section 7.2 Competence
Procedure P-021 Rev. B
Personnel are trained on the proper use and maintenance of measurement instruments.
What training do personnel receive on the use and maintenance of
Training records for measurement instruments
Section 7.2, Provide training for measurement instrument use and maintenance.
measurement instruments?
20
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