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6.4.8 Calibration Labels

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Carlee Gruizinga, Oct 25, 2023.

  1. Carlee Gruizinga

    Carlee Gruizinga Member

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    Hello,

    We are in the process of our recertification audit for ISO 17025 - the auditor has brought up calibration labels per section 6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled, coded or otherwise identified to allow the user of the equipment to readily identify the status of the calibration or period of validity.

    Our process is that each gage is identified with an ID number then the technician can look up that gage for the calibration status via our intranet system where we store the data of recent tests and when the next one is due (IQS database).

    The audit is informing us that we should have a physical label on each gage. Our work environment is oily and we have found that labels just slide off and do not stay on...which is why we have an engraved ID number.

    We have interpreted the standard as it is labeled and you can easily look up the status therefore it falls under the otherwise identified part of the standard.

    Does anyone have any experience with this part of the standard or advice on how they have handled meeting this requirement?

    Thanks!
    -Carlee
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Carlee!

    With any accreditation body, despite what the requirements say, there are always "preferences" that the specific accreditation body - and hence auditor - may require. Firstly, check the "fine print" of the AB's agreement/contract with your organization. If there is no specific preference, I'd engage with the AB's management and let them know you don't appreciate the auditor bringing their bias. It's contrary to ISO 19011 and ISO 17021 (I think that applies here - Conformity assessment of Management Systems). Let me know if I can help.

    If it was a Product QMS audit, you can tell the auditor to pound sand!
     
    Last edited: Oct 25, 2023
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  3. Carlee Gruizinga

    Carlee Gruizinga Member

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    Hello Andy,

    Thanks for the quick response! I am glad that we were not being unreasonable pushing back on the auditor. I believe we were able to showcase our process and prove that we are meeting this requirement. The auditor was trying to convince us that we would need to label that storage area with the status, which just felt silly when we have this easily accessible database that already has to be updated when you complete the calibration.

    Thanks!!
    -Carlee
     
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  4. Miner

    Miner Moderator Staff Member

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    Some of these expectations are carry overs from times before computers. Before computers, a label with a date was much easier than generating a report. Today, it's the opposite. Unfortunately, you still get people that think the old ways are best.

    I agree with Andy, your ID number meets the "...coded, or otherwise identified..." requirement.
     
  5. John C. Abnet

    John C. Abnet Well-Known Member

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    Your approach is most acceptable (my professional experiences have placed me in similar situations as you describe). As @Andy Nichols and @Miner indicated, my counsel is you have the auditor define/show how your method is inconsistent with the requirement (he/she can not, because your described process clearly meets the requirement). If unsuccessful, appeal the result.



    Hope this helps.
    Be well.

     
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  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Well done.
     
  7. Golfman25

    Golfman25 Well-Known Member

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    Just make sure everyone who uses the gages knows how to look up the status. That is where you might get pinched -- if someone is unsure.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Typically, less of an issue in a Lab. I know Carlee's organization and the lab isn't likely to fall foul of that issue...
     
  9. SeanNguyen

    SeanNguyen New Member

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    Hi Carlee, risk-based thinking is that how often do technicians check the calib. status via Intranet before using the equipment? and how likely do they use expired gage? In my lab, they omit this step sometimes, even when the expiration date is clearly on the physical label. So, it really depends on how advanced your lab/incl. personnel is. And the auditor might have good reasons to note it an NC. Work environment is oily? do the technicians use gloves? do they have to take their gloves off before working with computer/keyboard? etc.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sean, what makes you say this?
    Suggesting that others do things based on one lab experience may not be as helpful as you think.

    If they do, they need to cite a requirement, not their opinion. So far, all we've been given by the auditor is opinion...
     
  11. SeanNguyen

    SeanNguyen New Member

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    Hi Andy, What would you do with the test result if your technician discovered post-testing that he inadvertently utilized expired equipment? In my situation, given the substantial risk involved, I've chosen to prominently document the expiration date on the equipment label to prevent such oversights.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd follow a root cause analysis of the situation and focus on how management could have provided such an item of equipment, since "inadvertently" in a lab is apparently a significant risk. When we point a finger at anyone doing work, we point 3 back at ourselves, don't we?
     
  13. SeanNguyen

    SeanNguyen New Member

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    Yes. But it's essential to consider that your test results might become inaccurate. Moreover, there's a concern about the potential impact if these results have already been shared with clients or incorporated into their records. Naturally, it falls on everyone to minimize risks, with the management holding the ultimate responsibility. In the case of Carlee's laboratory, the auditor has recommended the implementation of physical labels on each piece of equipment. However, if this isn't feasible due to the presence of an oily environment, it might not be a non-conformance (NC), but rather an opportunity for improvement (OFI). In similar situations, some technicians may opt for a more traditional approach, where they jot down the IDs and expiration dates of frequently used equipment on a piece of paper that they keep in their pockets for convenience and time-saving. How can the management assist them? Is this approach considered old-fashioned?
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not their job, however.