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Our internal document on calibration states:
"Test and measurement equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
T & ME suitability shall be reviewed on a semi-annual basis per QOP-120, Management Review."
In an audit recently, the Auditor asked our QE, who also supervises the Cal Lab, how the measurement uncertainty of a device is determined and how uncertainties are compared to measurement capabilities. The Supervisor is new and does not have a strong background in calibration, and was unable to answer the question. A little research showed that the individual who wrote the document knew a lot about measurement uncertainty, but he left years ago, and no one on the current staff understands this topic at all. We are not making highly refined or precise measurements with our gauges, nor are we in an industry where such measurements are an expectation.
In writing up the audit finding, I am stuck. 7.6 does not mention anything about measurement uncertainty, although there is a reference to see ISO 10012-1 and -2 for guidance.
We do not claim conformance to any calibration standards, like 17025. We only certify to 9001:2000.
I think this is a case where the document should have been revised to remove this reference, making it a document control issue, vs a calibration issue.
Opinions?
"Test and measurement equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
T & ME suitability shall be reviewed on a semi-annual basis per QOP-120, Management Review."
In an audit recently, the Auditor asked our QE, who also supervises the Cal Lab, how the measurement uncertainty of a device is determined and how uncertainties are compared to measurement capabilities. The Supervisor is new and does not have a strong background in calibration, and was unable to answer the question. A little research showed that the individual who wrote the document knew a lot about measurement uncertainty, but he left years ago, and no one on the current staff understands this topic at all. We are not making highly refined or precise measurements with our gauges, nor are we in an industry where such measurements are an expectation.
In writing up the audit finding, I am stuck. 7.6 does not mention anything about measurement uncertainty, although there is a reference to see ISO 10012-1 and -2 for guidance.
We do not claim conformance to any calibration standards, like 17025. We only certify to 9001:2000.
I think this is a case where the document should have been revised to remove this reference, making it a document control issue, vs a calibration issue.
Opinions?