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How often to calibrate an analytical balance

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Mandy, Dec 6, 2015.

  1. Mandy

    Mandy New Member

    Aug 2, 2015
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    Our analytical balance is used for a non-critical part of our process.
    Would it be acceptable to calibrate it twice a year?

    Also - what about a regular balance? Would once a year be sufficient? (Again, not used for anything critical).

  2. Eric Twiname

    Eric Twiname Well-Known Member

    Jul 31, 2015
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    Northeast USA
    You've got me wondering what the difference is between an "Analytical Balance" and a "Regular Balance"...

    The answer is rather non-specific..."in order to assure valid results" or some such...

    We calibrate balances about once a year...based on historical data of stability and 'non-issue'.
    We have considered going to 2yrs.

    You might consider calibrating at 6mnths at first, but on "no issues" consider extending the cycle.
    This type of calibration is a cost-benefit decision.
    If you have the balance looked at and it is out of tolerance, everything since the last calibration is in question...how big of a deal is that?
    For us, having a year's worth in question (not "Bad"...in question) is worth the cost savings ...
    That risk/benefit analysis is where companies tend to part ways from each other, even if they have the same balance.
    The calibration cycle is set partly on the importance/criticality of what you use the balance for...and the historical performance of the equipment regarding stability.