Calibration Failure - CAPA (Corrective and Preventive Action)

[QE]

Dear Coves

Has any one dealt with a calibration issue, where a measuring instrument like caliper or a test adapter failed on a calibration cycle and now you are assessing the situation through CAPA process. what can be the corrective or preventive actions in such a scenario.

please advise ASAP.

- QE.

 

[Doug Tropf]

Re: Calibration Failure - CAPA

Dear Coves

Has any one dealt with a calibration issue, where a measuring instrument like caliper or a test adapter failed on a calibration cycle and now you are assessing the situation through CAPA process. what can be the corrective or preventive actions in such a scenario.

please advise ASAP.

- QE.

Included in the assessment should be an evaluation of the adverse effects on quality. Preventive actions could include more frequent calibrations of the instruments.

 

[Jeff Shirk]

I think first understand how off is/was the gauge when it was in service. Next determine if that gauge could have released product to the customer that could cause catastrophic failure. If the answer is yes, then I would proceed to try and identify 1) How much delivered product could be involved, 2) identify customers...the bottom line being what do you need to do to correct/rectify this with your customers. If the answer to your first question is no, then I would document your investigation within CAPA system as interim action taken, document your proof that your investigation showed that catastrophic failure did not occurr due to the faulty gauge, and with regards for preventive actions; take a look at your cal frequencies of your other like gauges and adjust to prevent it from happening. Hope this helps.

 

[Duke Okes]

Dear Coves,Has any one dealt with a calibration issue, where a measuring instrument like caliper or a test adapter failed on a calibration cycle and now you are assessing the situation through CAPA process. what can be the corrective or preventive actions in such a scenario.,
please advise ASAP. - QE.

No different than for any other CAPA. Do containment and remedial action, decide if you're going to identify the cause(s) of the out-of-calibration, if so, investigate, and take action to prevent recurrence.