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IATF Calibration Question calibration or verification

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by Fabrisco, Feb 22, 2021.

  1. Fabrisco

    Fabrisco Member

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    Hello and Good Morning,


    I'm new in this forum so I say hello to all members.


    I would like to take your help related to a discussion and also a minor NC I had with an external Auditor during last IATF 16949 recertification audit audit.


    I work for a big automotive company (tier-1) and I'm responsible for the gauge calibration Lab. In the plant we have recorded around 20.000 gauges and we perform periodical verification (between 1 month and 24 months interval, depending on the usage) with masters and/or primary gauges. To track this activity we have a company software, were we record all verification results.


    Current procedure:

    Before expiring date we collect the gauge from production line, for example a micrometer, and we perform measurements of a Johnson block (i.e. 10mm). According to our corporate norm that particular micrometer (according also to the usage) should give back for example a result with a maximum error of 3 microns compared to te expected value of 10,000 mm. We perform 4 measurements and if all results are within the expected limit we give the gouge free for the next period. We record the 4 measurements in our system. In our Lab report it is also present the primary gouge number used for calibration and its measuring uncertainty given from our internal calibration lab (if possible) or from external Lab.


    Request from the auditor:

    For every secondary gauge calibration (around 20.000 in our plant, calibrated more than one time per-year in average), it is necessary to introduce in the report the complete (extended) measuring uncertainty related to the measuring procedure used. This is depending not only from the primary gouge (as we obviously already do), but during the calibration procedure, it must be taken several measurement (at least 10) and according to a statistical approach, we have to define the extended uncertainty and apply the statistical uncertainty to assess if the result of the calibration is compliant or not to spec and decide if we can release the gauge for next period.

    Regarding this point he raised a minor Non Conformity, telling we are not compliant with IATF requirement 7.1.5.2.1 Calibration/verification records


    My questions:


    - Looking at or current procedure, are we compliant with IATF?

    - Is the request of the auditor correct?

    - If no/yes, can you link the international norm telling exactly, which is the minimum requirement?


    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome to QFO. Did the auditor write this as an actual non-conformity? If not, please post the (sanitized) version here.

    Based on what you posted, it seems as if the auditor is over reaching because they think they know calibration! I can find nothing in IATF 16949 which mentions this, so it can't be a requirement. On the other hand, if you have signed up to customer requirements which require such calibration techniques (can't imagine they do) -0 that would result in a non-conformity to that customer requirement, first and foremost.
     
  3. Fabrisco

    Fabrisco Member

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    Hello Andy,
    Thank for your reply.

    Yes, this was written as a minor non-conformity
    NO, we have no customer requirement.

    In the auditor explanation this is the only way to perform a proper calibration according to international calibration standards, this was the explanation. The minor NC can be summed up like this: the way we calculate the calibration uncertainty is not considering the uncertainty of the primary gauge AND the uncertainty of the secondary gauge. This is not according to international standards of gauge calibration.

    As I wrote in my original post, I'm very interested in understanding, which international standard can be applied in this case.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is nothing more than opinion. Yes, it may be an informed opinion, but since there's no specific requirement in IATF which gets even close to such a technical a requirements - don't overlook that calibration is only an option, after all - and you must reject this minor back to the CB's management, since there is no specific requirement IN IATF which comes close to mentioning this. My guess is it's some "buzzwords" he's heard about and now asks his clients, who don't have a good response and he feels justified in writing a finding. If someone who knows about Type A and Type B Uncertainty, the influences on the measurements being made and had determined from looking at your results and compared those to the equipment used, that there was an issue, that's very different.
     
    Last edited: Feb 22, 2021
  5. Fabrisco

    Fabrisco Member

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    Thank you for your answer.

    We didn’t had a specific discussion about results. He was just looking at one calibration report and complaining because in addition to calibration results, there was not an evaluation of the secondary gauge uncertainty.


    Could you suggest a right way to get rid from this situation?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, indeed. Reject the minor NC back to the CB management and tell them you cannot find any requirements in IATF 16949 under the 7.1.5.2.1 requirement which requires this "evaluation of second gauge uncertainty". Ask them for the requirements if 7.1.5.2.1 if the mistake is in the clause. (I see nothing here even close to what the auditor is on about)

    "The organization shall ensure that calibration/verification and records shall include the following details:

    a)Revisions following engineering changes that impact measurement systems;
    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;
    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 on the validity of previous measurements result 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;
    e)Notification to the customer if suspect product or material has been shipped;
    f)Statements of conformity to specification after calibration/verification.
    g)Verification that the software version used for product and process control is as specified;
    h)Records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer owned equipment, or on-site supplier owned equipment);
    i)Production- related software verification used for product and process control (including software installed on employee- owned equipment, customer owned equipment, or on-site supplier- owned equipment)."
     
  7. Fabrisco

    Fabrisco Member

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    Thank you for answer. Could you be more precise regarding "Reject the minor NC back to the CB management" this is not the Auditor or the audting company, isn't it?
     
  8. BradM

    BradM Moderator Staff Member

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    Hello Fabrisco!

    I moved your posts to your own thread here. I was incredibly confused because your other thread which I replied to was removed from view with no clarifying post. In the future, please just start one thread on a particular topic. Thank you so much!!
     
  9. BradM

    BradM Moderator Staff Member

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    I think the point is.... as it seems at this moment, the auditors NC has no merit/ base/ linkeage to an actual non conformity. Audit findings should be really clear. So when they're not, instead of guessing or doing a bunch of stuff that is not needed/required, more engagement with the auditing body is needed.

    So... you list "primary" and "secondary". Are the primary used to calibrate the secondary instruments? Are the secondary instruments the instruments on the production floor/actually being used? Or are secondary instruments then used to calibrate process instruments (process being the instruments actually in use)? I'm just trying to understand your situation. By the way, your initial post was really well done, with lots of details in it. Thank you for doing that!
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You probably have a contact at the Auditing company (AKA Certification Body or CB) Ask them how you do not accept the non-conformity the auditor reported and want it cancelled. They should have a process to "appeal" the finding (which the auditor should have explained). Check the Auditing company website, too. It might tell you there. As Brad says, the finding has no merit.
     
  11. Fabrisco

    Fabrisco Member

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    Thank you very much for reply. Yes Primary are used to calibrate secondary. And NO we don't calibrate process instruments with secondary. I agree with your consideration. Thanks


    Yes we have the right contact for the "appeal". Thanks.
     
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  12. Sergen

    Sergen New Member

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    If I understand and remember correctly maybe the auditor wanted to emphasize that requirement is take place in the scope of 7.1.5.2.1 clause h. section
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    We must seek to understand that there's a difference between what an auditor "wants" and what an IATF requirement states. Only the latter can be reported as a non-conformity...
     

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