7.1.5.2.1 Calibration/Verification Records

[Sambasi]

Please explain the difference between
7.1.5.2.1 (b) ....Any out-of-specification readings...... and
7.1.5.2.1 (d) .....Out of calibration.........

Please give example of
7.1.5.2.1 (i) Production related software verification

Thanks
Sambasi

 

[Thee Bouyyy]

Hi Sambasi,

7.1.5.2.1 (b) Any out-of-specification readings as received for calibration / verification.
7.1.5.2.1 (d) In the event that inspection measurement and test equipment is found to be out of calibration, documented information on the validity of previous measurement results obtained with this equipment must be retained, including the associated standard last calibration date and the next due date on the calibration report.

 

[Sambasi]

Thank you. Please give example of 'specification'. Some interpret this term as tolerance. Hence clarification requested

 

[Daniel O.]

Hello Sambasi,

For example you can define a limit of uncertainty for a type of equipment, that could be your "specification".

 

[Sambasi]

Thank you for your clarification

 

[malasuerte]

I hope this helps - this is the approach we use and have had it validated several times.

Out of Spec is a subset of Out of Calibration. And as per above "Spec" can equal tolerance, uncertainty, etc as mentioned above.

Out of Calibration = Out of Spec, Negative trend, expired calibration (date), no calibration - basically any negative deviation from a Calibrated piece of equip.


Hope that helps.

 

[Sambasi]

Thank you for your clarification.