Risk analysis for defective measuring or measuring equipment out of calibration

Booker

Starting to get Involved
Dear,

In respect to the requirement of IATF 16949 - 7.1.5.2.1 Calibration/verification records.

c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition

d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including the associated standard's last calibration date and the next due date on the calibration report.

I would like to ask you for help with a proposal of topics for risk analysis when any measuring equipment is found as defective or out of calibration.
Such a risk analysis should be an input for containment action.

Thank you for all the inputs.
 

dwperron

Trusted Information Resource
I would like to ask you for help with a proposal of topics for risk analysis when any measuring equipment is found as defective or out of calibration.
Such a risk analysis should be an input for containment action.


The basics go like this:
Determine what was out of tolerance, and by how much.
Determine what the equipment was being used for, what functions, what ranges, etc.
Determine what your accuracy requirements are for the equipment in question for the functions that were out of tolerance. Not the specifications of the instrument, but how accurate that equipment needs to be in order to be adequate for your product / process.
Determine if the out of tolerance condition added any risk to the product / process that the equipment was used on.

If the risk requires containment then you need to recall, moving backwards in time, to see if the product was affected.
 

Bev D

Heretical Statistician
Leader
Super Moderator
two clarifications:
in this case 'risk' only applies to what will happen if out-of-specificaiton parts are shipped.
you must determine with data whether or not parts were out of spec. there are several action s to take:
- how much was the gauge out of spec?
- what were the results of the parts measured
- was there any trend in the measured results that would indicate that parts may have been out of spec but were measured in spec. were any of the parts measured close enough to the specification that the gauge error would be sufficient to make the parts 'look' in spec?
 
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