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Citing wrong reference for acceptance criteria - NC?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jasmin b, May 5, 2022.

  1. jasmin b

    jasmin b New Member

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    The operations manual cited several references where instructions for acceptance criteria can be found. However, during audit, it was identified that some of the references identified do not actually contain the instructions required for.
    Example: In designing the ____, dimension of ___ shall be referred to <reference>.
    But dimension requirements were not in the identified reference

    Should I, as internal auditor, report this as NC or merely an observation?

    Certainly, I cannot audit their output without the reference. I am inclined on giving them an NC since the instruction referred to an acceptance criteria but I cannot find a definitive ISO clause referring to wrong citations.

    If this is an NC, what is the ISO criteria not met?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Jasmin, welcome!

    A few questions, so let's take them one by one:

    NC or observation? This is a method of grading audit findings which confuses people (despite many, many training courses teaching it) and to be honest, grading has no place in internal audits. It's the content of the audit NC which is most important, not how it's graded. Indeed, by grading it, you take the pressure off management from doing anything. "Oh it's just an observation"...

    As an internal auditor, it's most important to related your NC to the internal planned process requirement, not the ISO 9001 requirement. As mentioned above, it's common - by incorrect - that internal auditors are "taught" to audit to ISO 9001. Your PRIMARY purpose is to determine, a) if the QMS is being implemented and b) if it is effective.

    Do you know, can you find out, what is the effect of not complying with the instructions? That would help you case. (BTW, this sounds like a design output requirement 8.3.5?)
     
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  3. jasmin b

    jasmin b New Member

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    Hi Andy.

    Thank you for the warm welcome!

    Love this.
    This frustrates me the most as our IQA requires us to audit to ISO 9001.. even our checklist was templated with ISO clauses!! but yes, we also audit our QMS.

    Anyways, the only effect is that it may potentially lead to not meeting their own set criteria as correct reference is not available.
     
  4. Bev D

    Bev D Moderator Staff Member

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    An incorrect reference? Why not just tell them about it and ask that they fix the error?
    In internal audits why are we so obsessed with copying the 2nd and 3rd party auditing?
    The purpose of internal audits is simply to improve your system not punish people or add busy work
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Best response for ever! May I offer an answer? Because that's what auditing model is taught in virtually every and any ISO internal auditor course since it became a "thing"...
     
  6. Qualmx

    Qualmx Well-Known Member

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    Bev D
    Not agree with you.
    Doing it this way, in some way It starting to lose importance of the QMS, showing this to people.

    In fact is hard to involve people in the system and if you add this practice..... is not good choice.
    It should be a NC.

    Thanks
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "It's hard to involve people in the system..." Yes, and writing a non-conformity won't improve things.
     
  8. Qualmx

    Qualmx Well-Known Member

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    In my point of view, the raised NC invites you to analize or think what is needed to correct the problem.
    Just correct it? it may work, but there is not evidence that something was wrong and was fixed.
    Evidences are important.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A lot of people won't agree with you on that.
    Why not?

    Auditors are not the police. We don't have to right the wrongs of our organization. Discretion is the better part of non-conformity...(to paraphrase Shakespeare)
     
  10. Qualmx

    Qualmx Well-Known Member

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    Andy
    I will share my story
    In my experience, in companies I have been working, is difficult to involve people into the QMS.
    I started to apply practices, call it, "very light", not so much commitment in the system.
    examples, when a problem arises lets apply correction, not a full deep analysis, some documents with wrong revision, just fix them, and thats all.
    dont do a corrective action (full analysis).
    Once these kind of practices are followed, most of the people, started to do the same.
    Finally I got people with very little commitment, not involved in the QMS.
    I changed my way of adddressing Non conformances, more strictly practices (What I referred before)
    Now people, also is changing, thus in benefit of the company.
    Hope is clearly explained.
    My position is a QMS coordinator,
    Regards
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Of course. That's true of most things in an organization. If you are attempting to "interest" the workers in the QMS, you are doing it wrong. Nothing will change for the better, although you may feel as if you've gained ground, it will all disappear in an instant. You don't have to change the working people. Especially as the Quality coordinator. I'd suggest that you should rethink the whole thing.
     
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  12. RonR Quality Pro

    RonR Quality Pro Active Member

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    Just to add my $0.02 on this. I agree that it COULD be dealt with informally, however this would only mask the REAL problem. The finding would drive me to look deeper, and determine if this is a bigger issue which has 'leaked' across the system, or if it is just an oversight/error.
    If it IS a bigger problem, then a true root cause and effective CA is required, so that it doesn't happen again in future.
     
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  13. Bev D

    Bev D Moderator Staff Member

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    I certainly don’t disagree with RonR’s point. But I think it ‘stepped over’ the initial post. The internal auditor didn’t really do any investigation - or at least did not include any information regarding an investigation - into the nature of the discrepancy. Was the author asked about the discrepancy? How did the users of the process do their jobs / handle the discrepancy? Are there a lot of these discrepancies? Was it possible that the discrepancy was a typo? It is my belief that internal auditors should do more than issue NCs. They should not be traffic cops handing out punishment - to be effective they need to be part of the process of improvement.
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    POST OF THE YEAR!:D
     
  15. tony s

    tony s Well-Known Member

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    There are requirements in the standard that pertain to establishing "acceptance criteria". These include:
    • 8.1b.2 - establishing criteria for: the acceptance of products and services;
    • 8.3.5d - include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
    • 8.5.1a.1 - the availability of documented information that defines: the characteristics of the products to be produced;
    • 4.4.1c - determine and apply the criteria and methods...
    If the issue is: "I cannot audit their output without the reference", then an auditor can cite the clauses above. If the issue is: "I cannot find a definitive ISO clause referring to wrong citations", then the standard is silent about this.

    The issue could be about the "suitability" of the documented operations manual and the references contained in it. The closest requirement in the standard that this issue can be tied against is in clause 7.5.3.1a which states that: "Documented information required by the quality management system... shall be controlled to ensure: it is available and suitable for use, where and when it is needed".

    An audit finding is either a conformity or nonconformity as per 3.10 of ISO 19011:2018. "Observation" is an obsolete approach in classifying an audit finding. According to ISO 19011, "observation" is one of the methods for collecting information or objective evidences. I don't know why CBs are still using this obsolete approach. If an auditor find an issue that is not, in actual, violating an established requirement but he/she deemed it may lead to a nonconformity, then this issue could be considered as a "risk" that may need to be addressed. NOTE 2 in the definition of an audit finding says: Audit findings can lead to the identification of risks, opportunities for improvement or recording good practices".
     
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Great comment! I'd offer that it's because a significant proportion of auditors cannot perform effective audits - for many reasons. As a way to "bring value" to a client - who typically don't like a non-conformity (especially when it's bogus) the auditors were encouraged to offer "observations". Indeed it was coded into QS-9000 because the people who wrote it anticipated that CB auditors would know about the suppliers' products in the same way as their SQAs did. Of course, nothing was further from the truth, but the damage was done. Auditors ran around offering "observations" as thinly disguised consulting or poorly researched minor ncs.
     
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  17. tony s

    tony s Well-Known Member

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    From the obsolete international standards, the word observation was defined as:
    • Quality Audit Observation – statement of fact made during a quality audit and substantiated by objective evidence (4.10 of ISO 8402:1994 – Quality Management and Quality Assurance Vocabulary);
    • Observation – a statement of fact made during an audit and substantiated by objective evidence (3.6 of ANSI/ISO/ASQC Q10011-1-1994 Guidelines for Auditing Quality Systems – Auditing)
    When the first edition of ISO 19011 was published in 2002 (Guidelines for Quality and/or Environmental Management Systems Auditing), the word observation was dropped from the Terms and Definitions section but was repeatedly mentioned in the latter sections as one of the methods for collecting information. This is still what the current 2018 version of ISO 19011 says.

    So, who introduced this “observation”? Some articles I dug in the web might give us further information about this “obsolete approach”.

    https://elsmar.com/ubb/Forum13/HTML/000101.html

    https://www.whittingtonassociates.c...nonconformance-defect-finding-or-observation/
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    LRQA used the terminology for a "minor" non-conformity. They also used "On-going improvement". It was a way to make non-conformity "palatable" to clients, instead of "majors" and "minors" etc. Larry Whittington had it correctly.
     
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