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

[Englishman Abroad]

My interpretation of this:

In Sebastian's example - I create a software program for my automated welding process.

I initially validate that this sofware version (say weld program 12B) is correct, and produces good parts and is capable.

This initial validation of the software program is 7.1.5.2.1 point i).

Then I put the auto welder into production.

Part of the set up check / Control plan etc. is to check that I am using weld program 12B. This is the point 7.1.5.2.1 g).


Please note this point was not covered in my IATF transition training; If any one has another opinion or a 3rd Party auditor point of view or a CB point of view, please feel free.

 

[Sebastian]

In "analogue" calibration we always use masters, therefore I wouldn't rely on manufactured sample(s) of product, as evidence of process control software reliability.

 

[morteza]

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...

Hi all,

Regardless of risk assessment before or after, the risk assessment for gauge failure has two options:

1) the risk is that control results were out of tolerance (risk of usage of NC product), so the consequences were be those mentioned in FMEA
2) The risk is that the results were in tolerance limits (positive risk), which there is no need to take any action.

So, what is the difference between this risk assessment and FMEA?

I think that risk assessment for this requirement would be one dimensional and it is the “severity column” of FMEA, i.e., this risk assessment have three columns: one for the risk (usage of nonconforming product), another for consequences and the last for its severity.

Is it right?