IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Peters

Quite Involved in Discussions
#1
I have a problem with the interpretation of the "risk assessment" in gages control.

7.1.5.2.1 Calibration/verification records
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition

Risk assessment - before or after?
First option: Preparation for each measurement (and each gage) the assessment of the risk associated with the failure of every gage used in measurements and giving incorrect results.
Second option: After finding the failure of the gage - preparation of the risk assessment for this gage failure (risk connected with giving by this gage incorrect results).
First option - it will be a lot of work...
 
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qusys

Trusted Information Resource
#2
Re: Problem with 7.1.5.2.1 "Calibration/verification records" interpretation

In my opinion this clause comes from the prior 7.6.2. of the old standard. The focus should be on the measured product that could be potentially suspect, just in case.

In my opinion the risk assessment could be done after the organization has caught a non conformity and evaluate the risk to ship a potential non conforming product to customer. The organization could analyze other additional data and evaluate that risk.

At a prior stage the organization could make a risk assessment from a general standpoint of the measurement system in place, to decide the risk to manage or accept for that process.
 

Sebastian

Trusted Information Resource
#3
Re: Problem with 7.1.5.2.1 "Calibration/verification records" interpretation

Risk assessment - before or after?
First option: Preparation for each measurement (and each gage) the assessment of the risk associated with the failure of every gage used in measurements and giving incorrect results.
Second option: After finding the failure of the gage - preparation of the risk assessment for this gage failure (risk connected with giving by this gage incorrect results).
First option - it will be a lot of work...
7.1.5.2.1 requires risk assessment after out of specification condition was found and 6.1~ sections require risk assessment before out of specification condition was found.
You have to establish system with documented information clearly pointing when equipment for whom out of specification condition was found, had been used. Limit quantity of inspection equipment used at the same time or record every time ID of inspection equipment used.
 

Peters

Quite Involved in Discussions
#4
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Thank You!

Next question:

What's the difference between g and i?
g) verification that the software version used for product and process control is as specified;
i) production-related software verification used for product and process control.

Difference I can see:
g) verification of the software version
i) verification of the software (for example - is properly processing the data or not)

That's all?
 
C

cj80f

#5
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I agree with interpretation, I gave the same.
 
E

ec1608

#6
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

But the scope of verifying the software csn be very wide. Is it really expecting a calibration technician to verify the production-related software? I would expect the tool user to br responsible.
 
A

ashepherd

#7
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Wondering if anyone has any thoughts related to verifying software version as Peter mentioned below. Obviously any device with software used to inspect to test product product should be managed.

In our scenario, we have vision cameras that are used to verify product components which we believe would be covered by 7.1.5.2.1.

Would this potentially extend to process controllers that are not used to inspect or verify product, but that have an influence on the product such as water temperature controllers or equipment automation PLC's (again that have no designed functionality related to inspection). They are not necessarily inspection and test equipment so I believe the answer is no, but wondering what others interpretation may be.

Thanks,
Aaron


What's the difference between g and i?
g) verification that the software version used for product and process control is as specified;
i) production-related software verification used for product and process control.

Difference I can see:
g) verification of the software version
i) verification of the software (for example - is properly processing the data or not)

 
A

aprice006

#8
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I have the same question. Have you received any feedback or guidance on the expectations and difference between 7.1.5.2.1 g) & i) ?
 
Y

yw8906

#9
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I also confused on different between clause 7.1.5.2.1 g&i. Can anyone clarified on this?:confused:
 

Sebastian

Trusted Information Resource
#10
g)
Work instruction used for product manufacturing, specifies its engineering change level. When needed, it is updated following new engineering change level. This update is identified with a document revision number.
Software used for product and process control shall be treated in a same manner as work instruction. It means controlled and I see here relations to 7.5.3.1 (b) and 7.5.3.2 (a, b and especially c).
At the end we have "...as specified". So, what documented information specifies software version? Work instruction, drawing, testing standard and does currently used version complies to specified one?

i)
Let's take example of welding process. Software specifies displacements, angles and speeds of torch movement and current and voltage parameters during product welding. So, what are real displacement, angle, speed, current, voltage when we press "RUN"?
 
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