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Calibration requirements

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Agnes Sopel, Mar 3, 2020.

  1. Agnes Sopel

    Agnes Sopel Member

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    Hello,

    We need to revise our calibration method - procedure.

    We build our own equipment for final inspection and testing by our own engineers. There is no laboratory who can calibrate the equipment, but we calibrate it internally against already calibrated instruments, which are calibrated by accredited to ISO 17025 standard with valid calibration certificate, traceable to international standards.

    my thoughts on the internal methods are:

    - ensure calibration instrument (standard) is calibrated with accredited to ISO17025 and have accredited valid calibration certificate
    - review the certificate of calibrated externally instrument and ensure pass is achieved
    - calibrate our own equipment with the instrument
    - record the findings of the reading and confirm it’s within the required values
    - if not, raise non-conformance with corrective actions

    My question is, whether the above actions are sufficient. To what extend the internal calibration need to be performed I.e. do we must calculate our own uncertainty, do we need to verify the method, do we need to prove competence of the calibration personnel with external training and certification?

    Your thoughts, feedback and help would be much appreciated,

    Agnes
     
  2. Eric Twiname

    Eric Twiname Well-Known Member

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    An example for you...

    We had a CMM.
    We had a calibration grid.
    When the calibration grid was due for verification, we did the following (for cost, there were other possible ways).

    - Have an outside provider bring in a recently calibrated grid and use theirs to calibrate our CMM.
    - Used the now calibrated CMM to measure our grid.
    - Used these good results just justify that our grid was still AOK.
    - Later (a year), we used our grid to recalibrate the CMM.
    - Then used the CMM to calibrate other gages (shim thickness, gage blocks, etc.)

    Had no pushback from auditors or customers...one customer adopted this approach since it was way cheaper than what they were doing.

    So...not a direct answer to your question...but a similar or more extreme "chain". Yours looks fine to me.
    You need to determine the acceptance criteria based on need and risk...there is no fixed right answer for "official training" or "certification" to do the job, your company sets these requirements (including customer input if wise)...I did it most times in my shop, and taught someone else just in case.

    HTH
     
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  3. Agnes Sopel

    Agnes Sopel Member

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    Thank you so much.
    Than, shall I call my internal method a “verification” that is traceable to international standards ? (Since the calibration instruments which we calibrate with have proven traceability)

    For me term “internal calibration” would be an opening subject for an auditor. I want to ensure “verification” will be sufficient in this situation to cover the ISP9001 requirement?

    thank you in advance.

    Agnes
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Verification is fine! Always best to use the most appropriate terms. As long as you can show the unbroken chain of comparisons, you'll be fine (unless the auditor has no clue...)
     
  5. Eric Twiname

    Eric Twiname Well-Known Member

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    Long threads both here and on the Cove regarding the terms "Calibration" and "Verification" and "Validation".
    Through all of the threads, no concrete consensus...
    Call it what you feel comfortable with...and what minimizes later arguments with others...

    The only terminology consensus I've seen is that if you adjust the gage to bring it into acceptability, it is no longer validation or verification, but can only be called calibration.
     
  6. Agnes Sopel

    Agnes Sopel Member

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    Thank you Eric,

    I appreciate your feedback.
    We produce electric and electronic equipment, where calibration is not a requirement (nor by customer or legislations),
    However, during last ISO9001 audit the assessor raised a non-conformance due to “calibration method not being defined”.

    yes, we do make adjustments to the equipment if during the process the measurement is out of value tolerance. (it is our own built measuring equipment - e.g measuring jig) and no one can perform the direct calibration to the equipment.

    Therefore, we are “stuck” with a dilemma and looking for the other professionals solutions, to check whether ISO9001 in our situation can be satisfied without setting an ISO 17025 lab with all its requirements.
    Unless it’s absolutely necessary.

    Our products are being shipped to customers (let’s say verified) and we do not have issues with the quality of the product, nor the business management consider it necessary to go as far as setting ISO 17025 procedures for calibration, therefore understanding the applicability of ISO9001 closure to our situation and applying the method that is adequate is my aim.

    thank you again,

    Agnes
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It may be consensus, but it's inaccurate. The whole idea of calibration = adjustment is a total myth perpetrated by people who don't understand the science.

    For the record:

    Calibration is the act of determining how far "off" a measuring device result is, from a "measurand". Nothing to do with "adjustment" at all. In fact, some devices cannot be adjusted but they can be calibrated and still used - knowing how far "off" the value they are.
     
    Last edited: Mar 6, 2020
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  8. Agnes Sopel

    Agnes Sopel Member

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    Thank you and agreed.
    There is an answer from ISO9001 consultant I have further received when challenging the terms:
    "I can’t find any reference text that relates calibration with adjustment. Please check the calibration and verification definition in the - International Vocabulary of Metrology - https://www.bipm.org/en/publications/guides/vim.html
    I would change to internal verification and elaborate a procedure or instruction with your verification method."
     
  9. Eric Twiname

    Eric Twiname Well-Known Member

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    If the work is just around what an auditor said...go the easier route...define the calibration method as "not required"...then do what you normally do (assuming it is what you think best).
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not certain this is even a requirement! It seems to me the auditor is grasping at ISO straws. I'd reject the non-conformity, citing NO requirements in the ISO 9001:2015 to "define the calibration method"...
     
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  11. Agnes Sopel

    Agnes Sopel Member

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    haha
    We have been checking the results of the verification we do and recording them, but the only other thing we had in the procedure step for the team performing the task was "check for damage before verification".
    I believe the auditor expect to have little more information during the process i.e.
    for example:
    - review calibration standard (the instrument we verify with) certificate whether its traceable,
    - review calibration certificate for PASS / FAIL and understand Uncertainly before verification,
    - measure and record findings of the verification,
    - apply result: PASS/FAIL
    - if failed, look at the previous readings to see what cold affect the instrument, raise corrective actions etc., monitor improvement

    I will call it a verification, review ISO 17025 to see how close we can get with our procedure, but would not implement internal calculation of uncertainty, validation of methods or external training - as its not required for internal verification.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The auditor isn't there to "expect" anything...

    Now, if you have someone who is competent in the verification of measuring equipment, and knows to perform those condition checks etc. it simply becomes your organization's choice to write it down as a method. Otherwise, tell the auditor to pack sand. It's mission creep, pure and simple.
     
  13. Agnes Sopel

    Agnes Sopel Member

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    You are right. Thank you.
    My main goal, is to have a confidence in our measuring equipment, that it performs the tasks within required values - especially for final inspection of the manufactured product.

    With this in mind and your advise above, I am sure we can write down a method that will both cover what what the business really need in terms of measuring equipment and satisfy the ISO 9001 clauses as well.
     
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  14. BradM

    BradM Moderator Staff Member

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    I would be far less concerned with terminology (calibration/ verification/ etc.) and focus on assuring you can defend the validation of the method.

    This step: "calibrate our own equipment with the instrument" to me is the most critical. Did you copy a method you had seen? What steps did you go through to assure you are getting valid results?
    So say... you calibrate this in-house and you say "it's good. no issues" yet, you begin (just hypothetically...) having failed product. How confident are you that your calibration method is robust and not the issue?

    Also within that method validation should be some kind of total uncertainty analysis/ R&R/ accuracy ratio comparison, etc.
     
  15. Agnes Sopel

    Agnes Sopel Member

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    It is all valid information Brad. I appreciate that.
    I am keen and explore the uncertainty calculations, multiple readings and total uncertainty, teaching team on understanding the calibration certificates to spot and determine potential issues, set min and max values allowed, look at the environmental conditions and other factors that could affect the results. However I am not certain this need to be done with an accredited training and methods that are validated by external body possibly accredited.
    Within the ISO we create number of methods : internal audits, risk assessments, training using guides and even standards not necessarily having to prove accredited / validated competence of the methods we use.
     
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  16. BradM

    BradM Moderator Staff Member

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    That's excellent! Honestly, Agnes, it sounds like you have a pretty robust system. Just always keep an eye on things. Maybe set up control charts for your calibration activities you perform and assure it stays stable and predictable.
     
  17. BradM

    BradM Moderator Staff Member

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    I would still recommend you maintain a method validation process for your calibrations/ verifications. This would encompass determining equipment accuracies, method for developing uncertainties, performing repeatability studies, recording results, and making a verification that the process produced as intended results. I think you have listed pretty much everything here; I would just put it into a working document.

    But... that is for good practice. If calibration is not a requirement and isn't identified anywhere as being necessary, why was a non-conformity raised with respect to calibration? Was the citation related to any specific requirement you had listed in your procedures/ quality system? Instead of trying to take a bunch of unnecessary steps or go through the time and expense of ISO 17025 accreditation, I would go back to the non-conformity and dig in more.
    Getting ISO17025 is a great asset, but needs to be done in alignment with corporate strategic goals; not to satisfy an auditors whims.
     

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