Focused CAPA on Calibration - Out of Calibration Instruments used!

#1
1) The calibration lab reported that 4 calipers failed their annual re-calibration. The last successful calibration was performed a year back.
The inspection data was not archived

My Approach:

- Query the parts that were inspected within 1 whole year for each of those calipers

- Reinspect all the parts that are not consumed in production and confirm that there is no non-conformance

- The parts which are already consumed needs to be eveluated for a failure risk.


Any thoughts from the cove fellow members ?
 
Elsmar Forum Sponsor
J

Juan Dude

#2
Re: Focused CAPA on Calibration of Calipers Issue

1) The calibration lab reported that 4 calipers failed their annual re-calibration. The last successful calibration was performed a year back.
The inspection data was not archived

My Approach:

- Query the parts that were inspected within 1 whole year for each of those calipers

- Reinspect all the parts that are not consumed in production and confirm that there is no non-conformance

- The parts which are already consumed needs to be eveluated for a failure risk.


Any thoughts from the cove fellow members ?
Reinspection results of all the parts that are not consumed in production should give you an idea of your next course of action.
 

harry

Super Moderator
#3
Re: Focused CAPA on Calibration of Calipers Issue

You posted a question on the use of an out-of-calibration instrument (or a similar situation) a while back. Many advices were given to you then. Many, including myself suggested that you should carry out regular validation of your instrument to limit the damage such situation caused. If you had done so, your damaged will be limited.

Since you had not done so, looks like you need to fall back to what you had proposed. You want to query the parts inspected by that instrument for the last whole year - were the parts still with you? Had they been delivered to your customer? If so, how are you going to do it?

This is a very good example and explanation of what "Good Manufacturing Practice" means.
 
J

Juan Dude

#4
I moved your thread to the "ISO 17025 - Calibration, Measurement Gages and Test Laboratories" forum. You should get additional response here.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#5
Thanks for the move Juan.

First question for me here is the failure. What was the uncertainty from the last calibration that passed and from the one that failed? That may provide some answers.

You mentioned the readings are not archived. Is the calibration lab accredited? I realize this came from the health board.

Now, as to the CAPA. Juan suggests a great point to begin. Once the calipers are recalibrated correctly, or replacement ones are, then a comparison of the most recent non-consumed parts will give a good idea. If you have older ones around as "holds" then check them also. If everything checks out OK then document the devil out of this and move on.

But if the recent items fail, you are likely looking at something really messy.
 
R

RetroVirus

#6
what's missing from your actions is the preventative part. which as an earlier poster said is to prevent reoccurance of nonconformity or at least reduce the severity.
-if regular verification checks are performed on instruments, then document them so that if calibration fails you just go back as far as the latest verification check instead of all the way back a year.
-stagger the calibration of the calipers so that not all instruments are in use or out for calibration at the same time. this way if you can't get away with <1yr calibration cycle at least you can transition to a freshly calibrated instrument part way through a cycle

just some ideas.

RV
 
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