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Intentional alterations on records are not NCs

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Apr 21, 2018.

  1. tony s

    tony s Well-Known Member

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    Allow me to ask a hypothetical question. If an auditor observes alterations on a record such as backdating to make it look like it conforms to specified requirements AND it was done intentionally, can the auditor raise an NC against clause 7.5.3.2 last paragraph (i.e. "Documented information retained as evidence of conformity shall be protected from unintended alterations")?
     
    tony s, Apr 21, 2018
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No - as long as it's clear the person was authorized to do so, your QMS allows for it and it can be shown through a trail of say, corrective action, the need for the alteration...
     
    Andy Nichols, Apr 21, 2018
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  3. Qualmx

    Qualmx Well-Known Member

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    The answer doesn't come from my experience, but I read somewhere that is a normal practice, in other standards.
    It could be applied in some circumstances and with some limits.
     
    Qualmx, Apr 21, 2018
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    In some place that could be considered falsifying records - unless the thing was done right and the record was incorrect. Is that the case?

    The key word in 7.5.3.2 is "unintended" but you described an intentional alteration.
     
    Jennifer Kirley, Apr 22, 2018
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    To Jennifer's point, this sounds intentional...and it sounds like it was done to a critical piece of information. If the issue was the document has an error such as a spelling mistake - puma was written and then corrected to read pump - that doesn't sound too risky. But if you're back-dating something to - in your words - "make it look like it conforms to specified requirements" and then something catastrophic occurs, where is the evidence that the activity you back-dated actually occurred and that the results were okay and did not play a part in the catastrophe?

    Is there evidence that the activity that was back-dated actually occurred and that the results were acceptable?

    I'd not only be looking at records control here, I'd be looking at the process and wondering if the process where this form is used, was actually conformed to, as well.

    I admit I'm somewhat sensitive to this type of scenario. Working in healthcare where our documentation is our evidence of care provided, one blank field, one incorrectly filled-in field, could make the difference in a client's safety, a nurse's license, or even the outcome of a lawsuit.
     
    Last edited: Apr 25, 2018
    RoxaneB, Apr 24, 2018
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  6. tony s

    tony s Well-Known Member

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    Thanks for the answers. I'm just curious why did the standard feel the need to specify "unintended". Isn't all alterations in a document that contains evidence of conformity (i.e. records) are done "intentionally"? So when an auditor ask you "Is this alteration unintentional?", dodge an NC by answering "No it's done intentionally".:p
     
    tony s, Apr 26, 2018
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  7. Golfman25

    Golfman25 Well-Known Member

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    I can see many examples of "intentional alternation" of documents. The easiest is in January. Most of us spend at least the first few weeks writing last year vs. the current year. Then you may have an instance where something was done, but not recorded until a later date. Such as calibration. We might calibrate, put stickers on, etc. and then after a week enter the data into the computer. Etc.
     
    Golfman25, Apr 26, 2018
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  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Since lots of documentation is in Word or Excel, the hope is that there be protection from writeovers. It can be as simple as read-only protection. Many of my clients limit permissions on various drives and/or files in the network. Still others save their official records as .pdfs. Sure, a savvy person can get around these methods but they are still valid steps that can be taken to address the risk of unintended alterations in documents.
     
    Jennifer Kirley, Apr 27, 2018
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  9. Leonid

    Leonid Well-Known Member

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    May I kindly ask those for whom English is a mother tongue to clarify if the connotation of "retain" inncudes the option "something is changed when retained". If the answer is NO, intentional alterations are excluded. But the answer can be YES. Then intentional alterations apply.
     
    Leonid, May 2, 2018
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In the English language retain means to posses, keep, hold on to. I might retain receipts of expenditure, or retain the services of a gardener.
     
    Andy Nichols, May 2, 2018
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  11. Bob B

    Bob B New Member

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    If you take an approved form (from your QS) and delete sections of it and then add them again to the same form in a manner that causes the original form not to look like the one that was approved. Would that be a Non-conformance?
     
    Bob B, Sep 5, 2024
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome, Bob
    We’d need to know quite a bit more before such a determination could be made.

    May I ask, has an audit non-conformity been written regarding such an issue?
     
    Andy Nichols, Sep 5, 2024
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  13. Bob B

    Bob B New Member

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    There is no audit NC at this time, I am looking at this from a quality system perspective with the "Document Control and Document Changes clauses. If a document is approved (In this case a form where information is recorded) through your change process if one takes this approved document and alters it (Page numbers are out of place scanned portions are included, the document is out of order from its original approved version etc) and it does not look like the approved version, and then uses it for its purpose. Would that be an NC against Document control and document changes. (Ie. you have changed a document without going through the change process.)
     
    Bob B, Sep 6, 2024
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  14. Bev D

    Bev D Moderator Staff Member

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    So…whoever changed the form changed the format but not the content?

    If that is true and your procedures say that any and all changes must be reviewed and approved then an NC is appropriate. If yoru procedures are not clear about this then an external NC might be issued depending on the auditor. Is it supported, It’s certainly a gray area to me as the content ain’t changed - but your process certainly has a weakness if this change got into use. What is to prevent or catch any yahoo who wants to change content?

    Bu too more importance is why did hte person think they needed to change the format? Is there a legitimate improvement to the format change or is the person just a ‘meddler’?

    In other words, it’s not about an NC it’s about necessary control and proper documentation that is usable by the users…if you focus on that then teh question of an NC is moot.
     
    Bev D, Sep 6, 2024
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  15. Bob B

    Bob B New Member

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    The content has changed sections are missing - I see this an NC- Thanks for the input it makes sense
     
    Bob B, Sep 6, 2024
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If, as you suggest, the version of the form changed and a subsequent version is used and it cannot be traced to an approval, then yes, if found during an audit (the change could legitimately be considered a "trigger" event for an audit) the auditor would be justified in writing a non-conformity. A little deeper digging (if they were a really effective auditor) might reveal the question of what came first, review or approval? In other words, was the approval given to change the form, but the resulting (released) version was never reviewed?
     
    Andy Nichols, Sep 6, 2024
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