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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")?
     
  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...
     
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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.
     
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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.
     
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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
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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
     
  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.
     
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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.
     
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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.
     
  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.
     
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