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...risk levels established by the laboratory.

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by John C. Abnet, Mar 26, 2019.

  1. John C. Abnet

    John C. Abnet Well-Known Member

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    Good ay QF family;
    It is easy to infer from the topic statement "...risk levels established by the laboratory." (7.10.1-b) that these "risk levels" are not ad hoc discretionary levels, but are instead required to be pre-determined levels (based on the term ''established").

    Has anyone had a 3rd party address/weigh in on/present a non-conformance finding relative to this statement?

    Be well.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hmmmm, dangerous... Accreditation Body auditors. Hmmmm. Let me check with some lab buddies.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    .
    Thank you.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Being somewhat of a lab rat - in a previous life - it occurs to me that the risk levels established are, for example, comparisons of the the results obtained to a) the measurement uncertainty established for the testing/calibration, and/or b) the degree of the results compared to the actual specification. It may well be that there are others, however, I'm only 1 coffee into the day...
     
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  5. leyladonmez

    leyladonmez Member

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    Hello,

    There is an unclear point for us coming from internal audit evaluation. We have a machine in laboratory that can't be moved from laboratory. Acredite calibration company calibrates that machine in our laboratory and gave a calibration report to us. But auditor says that acredite calibration company is not responsible and don't have authority for your company(laboratory) conditions. And auditor suggested us to have calibration report without acreditation symbol on it. But isn't it a nonconformity to have a calibration report without acreditation symbol? Do you have a knowledge about that? Thank you.
     
  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @leyladonmez ;
    Hopefully one of the moderators will move this from this specific thread and into the 17025 forum generically where more people will see and respond to it.

    In the meantime, please help me understand more clearly. Here is what I understand from your original post....
    1- You have a piece of equipment manufactured by company "A"
    2- Acredite is an ISO 17025 accredited calibration lab
    3- Acredite came into your facility to calibrate the equipment.
    4- The 3rd party auditor claims the calibration is not valid because of the environmental conditions in your lab.

    Is this correct ?
     
  7. leyladonmez

    leyladonmez Member

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    1,2,3 items correct. 4th item is missing. Auditor says acredited calibration company has its certificate according to its condition not according to ours conditions.so if they calibrate our machine in our lab they have to prepare calibration report without 17025 acreditation symbol. my question is: isn't it nonconformity to have report without symbol? how can we figure out this issue?
     
  8. John C. Abnet

    John C. Abnet Well-Known Member

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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Who is this internal auditor? What are their qualifications? It's normal and very common for an accredited lab to come to a client site and perform a calibration. They can simply ask for the calibration environmental conditions to be controlled or, when necessary, provide adjustment factors. IS it within their scope to perform calibrations at a client site?

    It sounds to me as if the internal auditor knows just enough to be dangerous, that's all. I'd doubt their competency to perform this audit, frankly.
     
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  10. RoxaneB

    RoxaneB Moderator Staff Member

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    Unfortunately, 17025 is not an area of experience for me.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Just the one, then? :D;)
     
  12. John C. Abnet

    John C. Abnet Well-Known Member

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    So @leyladonmez , @Andy Nichols points out something I overlooked. Your "nonconformance" is being identified by an INTERNAL auditor. I missed this point.

    I have likewise had lab equipment on my sites (both 17015 accredited labs and NOT 17025 accredited labs) calibrated AT my site by the calibration company. I would try to understand what education, experience, AND (most importantly) what standard/requirement your internal auditor is using to claim a nonconformance. It certainly sounds unjustified to me (both my opinion and my past/professional experiences).

    Hope this helps.
    Be well.
     
  13. Richard Billings

    Richard Billings Active Member

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    The auditor is wrong.
     
  14. James Doherty

    James Doherty Member

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    Blunt, but true and too the point.

    John, without specific citation of an error to the requirements of ISO/IEC 17025, a non-conformance cannot be issued (unless your QMS has it defined contrary to industry standards). I would say that this should be noted as an OFI and still reviewed internally.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What needs improving? The auditor got it wrong. What needs improving is using auditors who don't understand what they are auditing, using opinions that were formed from zero knowledge...
     
  16. James Doherty

    James Doherty Member

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    What are the lab. environmental conditions? It the equipment and are calibrated devices on said equipment suitable for the labs. environmental conditions? Have the tolerance which may be effect by the labs. environmental conditions been taken into consideration with the total measurement of uncertainty?

    Auditors can always suggest OFIs and I recommend always investigating them as it not only shows an organizations willingness to continuously improve to any certifying agency which may review this audit, but you may in fact discover areas you can improve.

    I agree, the auditor is wrong here!
     
  17. Richard Billings

    Richard Billings Active Member

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    Metrology traceability is a very complicated subject. As long as the calibration service provider can provide a certificate of traceability to demonstrate that the standards used to calibrate my, for example, oscilloscope or fluke meter were traceable to national or international standards I, the internal Auditor, am satisfied. If an external auditor challenged my acceptance I would question his/her competence.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not if they have no clue what they are speaking of. If I say to you, "You could do with shaving, for improvement", what's your reaction?
     
  19. James Doherty

    James Doherty Member

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    My reaction has nothing to do with an auditors issuance of an OFI.

    Andy, I apologize if somewhere/somehow I rubbed you the wrong way, but is is not my intention to argue.

    If the process leaves possible ambiguity and the auditee cannot adequately provide response to satisfy the auditors concerns - whether real or perceived - due diligence I believe would be to have an OFI for further investigation... if anything it will develop talking-points for the next audit so the auditee is better informed.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No rubbing done, James! I tend to address things as I see them, without "sugar coating" for the benefit of those who "lurk" and have no experience as a reference base...

    To your point: This is an internal auditor. When an internal auditor offers an NC based purely on opinion (or a lack of applicable expertise, which was clearly demonstrated in the OP's comments), I see no opportunity, except to coach the auditor NOT to do that again, or to be more diligent in assigning internal auditors to task for which they lack competency. There is no non-conformity. Period. Calling something an opportunity to improve requires some identification of reasons to improve - there aren't any. The auditor didn't "dig". When (any) auditors drop these little "bombs", it is commonly perceived by the auditees in the manner anyone might react to being told to lose weight/shave/etc. - from someone who isn't "expert"...

    Experience tells us that internal auditors are frequently chosen to be "independent" of the process being audited (indeed often from another department) so they a) are unfamiliar with the process and associated requirements b) don't often audit and c) no-one checked to see if they possess the personal characteristics of an auditor (as defined in 19011 - it's a costly guide, after all, not a requirement). To be honest, I'd take anything they said with a grain of salt. I rest my case...
     

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