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Calibrating maintenance equipment

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jose Ramon Salazar, Feb 3, 2017.

  1. Jose Ramon Salazar

    Jose Ramon Salazar New Member

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    Hi to all.

    My name is Ramon and I just started to work as Quality Engineer in a medical company, I am new in this forum, and the quality environment I wish to ask for your opinion about something that I want to learn about calibration of equipment.

    In the company where I work the maintenance department have measurement equipment mainly measuring tapes and multimeter, as I am new on this company too I noticed that maintenance multimeter is under calibration program but measuring tapes are not.
    The standard states that only measuring devices used for product must be calibrated.

    "The organization shall determine the monitoring and measurement to be undertaken and the
    monitoring and measuring equipment needed to provide evidence of conformity of product to
    determined requirements."

    As the company is very small there is a plant manager for all quality production and supply chain, and he says not having idea why this is like it is.
    What do you suggest me to do?
    Keep measurement equipment as it is
    introduce measuring tapes to calibration program or
    take out the multimeter.

    May be is silly, and the answers may be is obvious but I believe there is maybe a specific requirement for medical devices companies I do not know.
    Thank you in advance.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maintenance activities aren't product measurements. Calibration and or verification (unless they are ensuring process equipment controls are within spec) don't apply to the typical use maintenance has for equipment. I suspect that the multi meters may be calibrated because an auditor told them to do it...
     
  3. ncwalker

    ncwalker Well-Known Member

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    Agree with Andy. But don't necessarily be so hasty to pull the multimeters out of calibration. I can calibrate a tape measure simply by measuring a known object. Doesn't really even have to be a NIST object because like Andy says, they aren't used in controlling parts and also - it's a tape measure. Accuracy isn't great to begin with. A multimeter is not so easy to do and verify it's accurate with things lying around. I mean, you can put it across a 9 volt battery and if it say 87 volts, you know you have a problem. But if it says 7 v, it COULD be the battery. There's not rule that says you CAN'T have extra things in calibration.
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Standards are asking us to maintain equipment, with an expectation that this equipment will help achieve goals. Such goals could be suitable product or service, but also equipment ability to perform within parameters so as to reduce waste or increase reliability. Where this is the case, calibration can indeed be expected outside of test and inspection activities.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's not really calibration, in that case - it's verification.
     
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  6. Jose Ramon Salazar

    Jose Ramon Salazar New Member

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    Thank you all for your reply, I really Appreciate sharing your knowledge.
    I believe the multimeter is in calibration program because auditor as Andy mentioned, I think I let the program as it is, because adding instruments to program will cause additional cost (in our case we use subcontractor for calibration as we do not have internal calibration staff)
    Thank you again =)
     
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Folks like us have debated the terminology for years. Calibration service providers (such as Alicat Scientific) say the terms are clearly different; the French College of Metrology says something different than Alicat. ISO 9000:2015 unfortunately does not appear to define these terms, except in a note. A separate definition of verification is for design.

    What matters is that the process is serving the organization's measuring needs.

    Ah, the lowly tape measure. The poor cousin of measuring instruments. What is your known object, to which you are comparing your tape measures? Maybe their accuracy is not very important to you, but I suspect tape measures are somewhat more carefully calibrated/verified/whatever-you-want-to-call-it. I had a tape measure that was seriously wrong, purchased as new. I mean from one foot to 2 feet etc., not just the little endie tab. And I have a ruler in my desk cubby that I am sure Thomas Moser would not use to confirm their tape measures' accuracy. They probably have at least one steel rule that has been verified accurate to a traceable source, at least once.

    It's about risk, isn't it? And the cost of getting it wrong.
     
  8. ncwalker

    ncwalker Well-Known Member

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    It is EXACTLY this. Which is why one needs an understanding of what one is trying to test with any study and why one also needs a strong understanding of what tests are available and what ALL the results mean. Sadly, too many people want that "everything's good" magic hurdle in one number they can type in an Excel spreadsheet.
     
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  9. Jose Ramon Salazar

    Jose Ramon Salazar New Member

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    I believe that it is eventually the "fear" of many when it comes to being audited, so they think having everything under control will automatically solve all their problems.
     
  10. ncwalker

    ncwalker Well-Known Member

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    Yeah. We do a lot just to keep the customer off our backs. It's not value added (other than it keeps the customer off our backs).

    There's this undercurrent of pushing everyone into a nice, neat model. Doesn't work that way. A high speed stamping operation, for example, is going to be big into SMED. But a complex machining guy with dedicated machines that don't require much changeover, he's going to be all about poka-yokes and uptime. If you customer engineer comes from one type of background, they tend to push you to what THEY know, which in most cases doesn't work at your type of operation.

    Now go global - yes, everyone needs to be doing the manufacturing 101 stuff. But cultural differences are DIFFERENT. Hell, tax laws themselves can make one thing viable in on country, and not in another.

    It generates a lot of work to make us all "look the same" and the trade off is understanding what all these different methods are trying to do. Customer fear is a big part of this.
     

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