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root cause for form number missing due to a photocopy?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by tsloss, Sep 4, 2017.

  1. tsloss

    tsloss New Member

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    Recent audit found a form that someone had photocopied, and cut off the bottom of the form, which included the form number. In addition, there was a "worksheet" a supervisor had written out for an operator, to show him what order he wanted the day's work to be done.

    What would the root cause for this be? I think corrective action is a shop wide training/ADKAR to let everyone know that the form numbers must be present before use. I can do a follow-up audit to ensure no repeats of this are found.

    Any advice or thoughts? Thanks
     
  2. Golfman25

    Golfman25 Well-Known Member

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    I don't like either. These are such ticky tack findings.

    Was the form any different than what was currently in use? Even with the form number how does he know it's the current form? To me it's no harm, no foul. Get the guy a fresh copy of the form.

    And what is wrong with a worksheet communicating what you want to be done?
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you need one - a root cause? What type of audit was this? If it was an internal audit, then your auditor needs some coaching to get beyond this type of silliness. If it was your CB, you should appeal the finding and tell them to stop wasting your time and money. If it was a customer audit, just fix it...
     
  4. tsloss

    tsloss New Member

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    It was an external audit by our registrar. I didn't really like the findings either, but sometimes it's easier to fix it than to argue about it. The form he found was missing the number. I showed him that it was the same as the current revision (just missing the bottom), but he wasn't interested in hearing about it. He got real defensive, and I'm pretty sure he would have gotten real picky if I kept going. I've never been a fan of "not following procedure" and/or lack of training as root cause, but can't really think of anything else.

    We were looking at expiration dates of grease used on dock plates, and whether a parts list from a machine made by a company that's been out of business for 20 years was the most current revision. I guess I should feel pretty good that this is all he came up with!

    If anyone has a suggestion on root cause help, I'd appreciate it.
     
  5. Golfman25

    Golfman25 Well-Known Member

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    There is no root cause because it isn't a systemic problem. The guy who made the copy put it on the machine wrong. Looks like he has to go to copy machine training. This guy could probably help

    http://www.nbc.com/saturday-night-live/video/copy-machine/n10022?snl=1
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed, but it's not him you take it up with, because clearly he's incompetent. Reject it back to the CB. I ask you to do this because there are too many people who roll-over on this nonsense and, because no-one complains, he feels vindicated, he goes off to other clients and writes similar stupidity and the whole idea of Certification becomes a (bigger) farce. There is no root cause. You have nothing to fix, except the relationship with a CB who doesn't know their auditor is being no-value. Withhold payment until they rescind the finding.
     
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  7. tony s

    tony s Well-Known Member

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    There's no value in finding the root cause if there's no need for it. Just correct it. Not all NCs warrant Corrective Actions. Clause 10.2.1b requires you to "evaluate the need" before determining and implementing the CA.
    I don't see this issue as an NC.
     
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  8. Miner

    Miner Moderator Staff Member

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    Root cause: Form design did not allow sufficient margins to allow for photocopying.
    Corrective action: Modify form design to provide sufficient margin to prevent incomplete copying.

    No disagreement that this was a picky finding, but the RC and CA are simple.
     
  9. Golfman25

    Golfman25 Well-Known Member

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    Yeah but what in your form design process would allow such a thing. :)
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Since there's no requirement to even have a number on any document (to facilitate effective document control) I'd suggest

    that's NOT the root cause! The root cause is not understanding effective document control methods...(Keeping a number within photocopying margins is, frankly, a bizarre requirement and more attention should be given to the need to record data ON the form. Fire the auditor! Why make unnecessary work?
     
  11. Golfman25

    Golfman25 Well-Known Member

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    Because that is what auditor's do. :) (ok some, not all)

    Over the past 15 years we have been doing this, I separate NC into substantive and non-substantive. I can count on one hand the number of substantive NCs we have had. Most are not, unfortunately. Sometimes, you pick you battles.
     
  12. David Bradley

    David Bradley Active Member

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    Or how about getting rid of form (document) numbers? They have never been required.
     
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    ^^^^ What he said ^^^^ ;)
     
  14. BradM

    BradM Moderator Staff Member

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    So I guess there is something in your quality system that specifies all completed documents are to have the form numbers on them; and then second, that individuals cannot write up a worksheet "on the fly".

    OK... let's explore:
    Why was the form being photocopied in the first place? Was there a need? Why were they using this photocopy? Was there not some review of the completed document where a second set of eyes would have caught the missing form #?
    Is there a bunch of settings on the copier that makes it.. not simple, to make a copy?

    For the worksheet, was the information something that should have been controlled? Was it buried somewhere on a drive or in a book on some shelf, difficult (inaccessible) for the operators and supervisors?

    For that matter, why did the operator need to get instructions from the supervisor? Is there not a process where that is documented somewhere? Is it OK for the supervisor to give instructions like that? And possibly the procedure should have been revised before?

    Determined what caused these things to occur. It sounds like an awful lot of human judgment/ action was needed by the employees to get their jobs done. So find out why the processes let them down.

    Once you have addressed the Root Cause, I do agree with the others about possibly reviewing your system and determine what is needed/required as part of the CAPA.
     
  15. Candi1024

    Candi1024 Well-Known Member

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    For a paper quality document to become official in the electronic form, it should always include a review of the scans or copies for quality issues including lack of ink and edges being cut off.

    Call it what you may, but it should be done every time.
     

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