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Internal Quality audit for Equipment Calibration laboratory

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by Jessica Peralta, Sep 28, 2022.

  1. Jessica Peralta

    Jessica Peralta Member

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    How to conduct internal audit in calibration laboratory?
    Auditor competency?
    Are we required to conduct system audit and technical audit?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Jessica:

    These are great questions. Let me start with the last one, first. Yes, ISO/IEC 17025 requires the lab to conduct internal audits of the lab's QMS. To answer the first two questions, we need a bit more information. I carry out lab internal audits for a calibration lab, but they are very small (only 5 people) and to a) learn how to do audits and b) gain competency doesn't happen overnight, so they use me.

    Tell us more about your lab organization. Are you accredited or seeking accreditation?
     
  3. Jessica Peralta

    Jessica Peralta Member

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    We just recently established internal calibration laboratory last year. We are working on accreditation around the 1st half of next year. The laboratory is composed of 8 people. Our current scope Digital Multimeter (up to 8 1/2 digits) - DCV, ACV (0.1V to 1000V up to 10Mhz) DCI, ACI (10uA to 1A), DC Resistance (10Ohm to 100Mohm), and Frequency (1Hz to 10Mhz) but will eventually expand.

    I understand that we do the system audit (QMS), but does the internal audit also requires us to do the technical audit?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Before accreditation it’s wise to audit the technical aspects of the lab. The accreditation audit will itself focus on that and you wouldn’t want to risk a non-conformity there.
     
  5. Jessica Peralta

    Jessica Peralta Member

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    Thank you for sharing. In terms of internal auditor, what are the needed competency? Can you share samples of their training program
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Hello Jessica,

    I have been hired as Internal Auditor based on ASQ Auditor certification, but I cannot say for sure that this ASQ Certification made me the effective auditor my employer needed. I think we could agree that auditors need:
    • An understanding of the standard(s) we are auditing to
    • An understanding of the processes, if not the products in the QMS we are evaluating
    • The ability to interview people in processes
    • The ability to understand the processes reviewed and the retained information of the QMS in the processes reviewed
    • A clear understanding of the Nonconforming process(es)
    Competency in auditors can be behavior-based. We should not make auditees cry if we can avoid doing so, and we need to stick to the "shall" requirements of standard and customer contracts, in addition to product specifications.

    I hope this helps.
     
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    For a lab technical audit, the internal auditor should be familiar with the method(s) used in calibration, and have a sound understanding of the derived information regarding measurement uncertainty and so on. This is unlike most (internal) auditors (as Jennifer Kirley describes, this is the external auditor's view on internal audits, IMHO) where it's typical that auditors are trained on "the standard" (which most people don't care or need to know about).

    With such a small number of people in your lab and if you haven't had anyone already trained and experienced in QMS auditing, I'd suggest that to expedite your preparation for your accreditation, you find someone who already knows how to audit and has cal. lab experience. What part of the World are you in?
     
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  8. Jessica Peralta

    Jessica Peralta Member

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    Th
    Thanks Jennifer. I am an internal auditor for the ISO 9001, ISO 14001 and ISO 45001 in the organization. My team maintains the competency of the organizations internal auditors.
     
  9. Jessica Peralta

    Jessica Peralta Member

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    Thanks Andy, I am from the Philippines... In terms of QMS auditing, we do not have an issue with that as internal auditors are experienced. It is the technical audit I am most worried about, we plan to train on November. In terms of the methods of calibration and MU, so it is a must for the internal audit to learn or be knowledgeable on this aspect.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, as with ALL audits, if the auditor is not familiar with what they are auditing, how will they know what to investigate?
     
  11. tony s

    tony s Well-Known Member

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    Similar with other management systems standards' requirement in internal audit, ISO 17025 requires organization to determine conformity with:
    • the laboratory's own requirements (this will include the lab's operational procedures, technical requirements, externally mandated requirements, etc.);
    • the requirements of ISO 17025.
    So, yes. You are required to audit system and technical requirements.

    Since you are seeking accreditation by the Philippine Accreditation Bureau (PAB), your internal audit activities should take into account the checklist of requirement of PAB (see page 103 of this pdf file).
     
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  12. Jessica Peralta

    Jessica Peralta Member

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    Thank you all, the information shared were all of great use.
     
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