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External Audit NCR not addressed in time for next audit.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by MonsterEnergy22, Apr 8, 2024.

  1. MonsterEnergy22

    MonsterEnergy22 Member

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    Good morning all,

    (First of all please move if not in the correct location as this isn't related to ISO 9001 but generally, still applies.)

    We had a a surveillance Audit for Production Control in December 2023 for which an NCR was rightfully raised.

    Now, we're due our follow up Audit on April 16th 2024 and absolutely nothing has been done to address the NCR. We're 6 working days away and I know due to the scope of the NCR that this absolutely can not be addressed within that time. If it is, then I know it's been half arsed.

    So my question is, what generally happens in an Audit if NCRs aren't addressed? I've never been in this situation before...


    Thank you
     
    MonsterEnergy22, Apr 8, 2024
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Typically, a CAB auditor will/should take a dim view of an unaddressed NC from a year ago. They will likely, either because they are required to review previous NC status (for action to close out or at least provide some evidence of addressing it - work in progress which may be appropriate) or actually because it falls in the scope of the next audit event.

    I suspect there will be a lot of "tut-tuts", some eye rolling, "Cor blimey's" and potentially a minor will be escalated to a major...
     
    Andy Nichols, Apr 8, 2024
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  3. Golfman25

    Golfman25 Well-Known Member

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    Why would you have an audit less than four months after the last one?
     
    Golfman25, Apr 9, 2024
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  4. MonsterEnergy22

    MonsterEnergy22 Member

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    Doesn't sound like the complete end of the world, but going back over the Audit report, I noticed the auditor didn't grade the NCR raised as a minor/major as she had done previously.
     
    MonsterEnergy22, Apr 9, 2024
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  5. MonsterEnergy22

    MonsterEnergy22 Member

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    Morning Glofman25,

    Unfortunately I can't answer that, unless there's something within the contract that states as to why. I don't have the answer at hand.
     
    MonsterEnergy22, Apr 9, 2024
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It was reported on the formal CAB-provided documents? I have encountered a situation where a local auditor - renowned for their practices - writes up a (long) list of things they want to see "fixed" but on a normal sheet of lined paper... Nothing gets reported formally. The client is then "warned" verbally about escalation at the next annual visit.
     
    Andy Nichols, Apr 9, 2024
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  7. MonsterEnergy22

    MonsterEnergy22 Member

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    Afternoon Andy,
    Yes it's on the CAB provided document, there is a column to categorise the finding, Either NC-Maj, NC-Mi or OFI. In March 2023 she had entered this information (Minor NCs), whereas in December 2023 she only wrote "NC", so I have no idea as to how she's "graded" it. It's impossible for me/us to interpret.
     
    MonsterEnergy22, Apr 9, 2024
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  8. Golfman25

    Golfman25 Well-Known Member

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    I would delay the audit and get everything figured out.
     
    Golfman25, Apr 9, 2024
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It would be worthwhile pushing it back to your Certification Body management for clarification. Their reviewers should have caught that and pushed it back to the auditor for correction, but, clearly, that didn't happen. If nothing has been done to address the NC, is it really a valid finding? I'm thinking that, for the most part, when management read a useful finding they will do something about it...
     
    Andy Nichols, Apr 9, 2024
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  10. MonsterEnergy22

    MonsterEnergy22 Member

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    Morning Andy, Unfortunately I'm not privy to CAB processes. Are all Audit reports usually reviewed by another entity within the CAB?

    Unfortunately it is a valid finding as it indicates our design processes are not controlled, planned & managed properly. It just seems that our R&D Department has done little to nothing to action it, I'm making some enquiries this morning with the R&D Manager, depending on his answer I'll be using Golfman25's suggestion to potentially delay & advise to my QA Manager that we delay the audit if it's not too late.
     
    MonsterEnergy22, Apr 10, 2024
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    From my "inner sanctum" knowledge of a couple that I worked for, yes. I'll check to see what ISO/IEC 17021 - the CAB management standard, requires (even if for my own purposes).

    You can do this and it's not unreasonable - with one exception...

    Is this the first surveillance after your initial ISO 9001 Certification? If so, that can't be rescheduled, according to ISO/IEC 17021.

    If your previous auditor didn't grade the finding, it's difficult to see how the next auditor can escalate it, in my mind. Is there provision for an "OFI" too? How does the non-conformity read? Is it a damning statement of failure?
     
    Andy Nichols, Apr 10, 2024
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  12. MonsterEnergy22

    MonsterEnergy22 Member

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    Morning Andy, This isn't for ISO 9001 (See first post) this is for factory production control (Separate Standard). There is provision for OFI too, you're correct as you say there's no way for the next auditor to know how to escalate this.

    I'll share the finding later today, as i've been called down into production for the day.

    Thank you
     
    MonsterEnergy22, Apr 12, 2024
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Aha! My bad - however, I think we got to a place where the conclusion is still applicable... Phew!
     
    Andy Nichols, Apr 12, 2024
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  14. MonsterEnergy22

    MonsterEnergy22 Member

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    Apologies for the delay in reply, I had been pulled away from my QA duties to assist in manufacturing...

    Apparently, (The day before :confused:) the R&D Manager managed to perform some sort of review and perform basic corrections to the NCR. The auditor has reviewed and not raised anything, I've yet to see or read the report but I think it went fine.

    Money for old rope.
     
    MonsterEnergy22, Apr 17, 2024
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