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Non calibrated items without registration

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Paulus, Mar 12, 2024.

  1. Paulus

    Paulus New Member

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    I have a question. Working on a case where production dept. uses measuring tools, partly calibrated, partly non calibrated. The non calibrated ones are used for irrelevant tasks and therefor not calibrated.

    Registration only covers all calibrated items and a few non calibrated ones. Ofcourse this was found by the auditor. Afterwards i found more and more tools without a registration, all tools used indicative only. To an extend that I prefer not to register them at all but mark them as non calibrated item.

    It this possible? Can i define the difference in a procedure and then stick to labelling non calibrated ones with a permanent sticker stating "non calibrated item" without registering them in the big list?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    May I ask why? If you don't calibrate them, are they even checked periodically?

    I'm not sure what this means. Items of measuring equipment are to be calibrated and/or verified and should be controlled within the quality management system.

    See the first question. The standard doesn't allow for you to ignore the accuracy of equipment being used to perform measurements. Have you asked yourself why people are measuring things which, apparently, no-one cares if the results are correct. You are paying people to do this and ignoring the results? How long do you want to remain in business? BTW - what have your internal auditors being doing all this time?

    Sure. Then, I'd start looking for another job because the organization you work for is going to be in big trouble losing money...
     
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  3. Paulus

    Paulus New Member

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    Thanks for your reply. I totally get what you are saying, it was my first thought. But there is a good reason. The measuring tools act more as indicator instead of measuring tool now. For instance an old caliper. Not used as an official and calibrated item it is used to setup a machine. Perhaps not accurate to the 0.1mm it used to be but now used to measure a distance of 10mm where 2 or 3mm more or less is no problem.

    The caliper is used inside the machine, an environment with dust or grease and oils etc. It makes sense to use for instance old calipers that no longer are checked or cheaper ones instead of the official periodically checked calipers that are used to measure the final product. I prefer calibrated measuring tools not to be subjected to environments that (might) have a negative impact on their precision. Especially since it is needed for an indication in the machine, not a measurement. The tools used for this indication can almost be "checked" visual. If they are bent because the fall in a machine or the mechanism is stuck they are thrown away. Only using calibrated measuring tools would also mean they have to calibrate these tools way more often which is quite a burdon on a small compagny.

    Next to that, this is only production. There is an other department that performs official measurments and produces measuring reports for customers after cleaning products. They measure in microns which for production is often not even possible or nessecary in that part of the process.

    Obviously it is clear that the final product should never be measured with non calibrated items! But there are a few lines of defence.
     
    Last edited: Mar 12, 2024
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And you rarely or never have internal rejects where something is made, gets to final inspection and is rejected? What is inspected at final 100% of product? Fewer or what?
     
  5. yodon

    yodon Well-Known Member

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    Besides the good discussion from @Andy Nichols, this struck me:

    Why are people doing irrelevant tasks? Sounds rather wasteful.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Absolutely...
     
  7. Golfman25

    Golfman25 Well-Known Member

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    This is very common. And should be ok. All of our old calipers go to the tool room. They use them for setups. A quick check with a caliper saves a lot of time vs. fumbling around with a mic. Once they get close, the precision gages come out.
     
  8. Golfman25

    Golfman25 Well-Known Member

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    By registration do you mean on some master gage list? Those can be a pain to keep updated, for sure. I would be ok if the non-calibrated ones where so labeled and your people knew the difference. A smaller, more controlled list would be of some benefit.
     
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  9. tony s

    tony s Well-Known Member

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    Measuring equipment used for checking conformity against specifications is the intent of clause 7.1.5.1 where it says: "The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements". These measuring equipment are required by the standard to be subjected against the requirements under 7.1.5.2.

    The use of old calipers to set-up the production machines, although with measurement capability, is not the measuring equipment that 7.1.5.2 refers to.

    There is a guidance document about auditing monitoring and measuring resources (Auditing Practices Group Guidance) at this link saying:

    "Depending on the specific circumstances, measuring or monitoring equipment can be used either for indication, monitoring or measuring purposes... The level of control depends on the intended use and determines whether or not measuring equipment needs to be calibrated or verified"
     
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  10. Paulus

    Paulus New Member

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    Yes indeed, we use them to set up specialized and adjusted machines for milling. You don't want tooling to crash into the product, and you don't want to wait too long cause you use huge safety margins, but one or 2 mm more or less won't make a difference for us.


    Yes. Indeed a pain to keep up if I also have to keep track of the old ones. And for what? Just to mention they are not used for proper measurements. It would save a lot of time and I think also be more clear for operators if non calibrated ones are not registered but marked red. Or indeed be labeled saying it is an indicative tool. And if they bend or drop just get rid of them without having to think about registration etc. We can focus on what is important: those tools that need our control.
     
  11. Paulus

    Paulus New Member

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    Thank you Tony! Appreciated.
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    There still remains issues which need to be addressed, however, if the solution is to be cost effective and not simply "window dressing":
    and