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TS-16949 7.6.2 ? Calibration/Verification Records - Assessment of the Impact

G

GoKats78

#1
If there is a process parameter called out on the control plan that is measured by a process gage and the process gage is found to not meet calibration requirements is there a requirement for a record to exist that assesses the impact of the out-of-specification condition?


7.6.2 Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include
- equipment identification, including the measurement standard against which the equipment is calibrated,
- revisions following engineering changes,
- any out-of-specification readings as received for calibration/verification,
- an assessment of the impact of out-of-specification condition,
- statements of conformity to specification after calibration/verification, and
- notification to the customer if suspect product or material has been shipped.
 
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qusys

Trusted Information Resource
#2
Re: TS-16949 7.6.2? Calibration/Verification Records Question

Yes, in the statement you have cited. "Records" is the subject of the statement where the following point are relevant for their need.
 

qusys

Trusted Information Resource
#4
Even if it is a process gage...and does not measure product?
In your original post you mentioned that this process parameter is advocated in the production control plan. In some industrial environments, like semicon ones for instance, the product is indirectly checked ( and measured) by means of some parameters that can affect the quality of the product itself. So, it depends of how much "critical" is this process parameter for you, but, considering that you have inserted in the control plan as per your previous P-FMEA, I guess that you also rely on it to assure the quality of the product in a certain step of your process flow.
 

Kales Veggie

People: The Vital Few
#5
Even if it is a process gage...and does not measure product?
Yes, you have to study the impact. A result of the assessment / investigation could be that the product feature affected by the process gage is measured 100% downstream.

You have would review the calibration interval, usage / environment of the process ("right gage"?) and your calibration specification and maybe even calibration method.
 
G

GoKats78

#6
Thanks for validating my position...

I was having this discussion with a friend...he took the position that an assessment is not needed as the standard states "product"

I tried to convince him of the error of his ways....he wouldn't listen to ...so I had to bring in reinforcements...:lol::lol::lol:
 
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