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ISO 9001:2015 Collated NCs: Different areas audited having NCs on the same clause

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by JUVANNI AYASO, Oct 15, 2024.

  1. JUVANNI AYASO

    JUVANNI AYASO New Member

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    Hi! I'm quite new to ISO 9001:2015. I am currently designated as the Lead Internal Quality Auditor in our company. I would like to know who will be responsible or tagged for collated Nonconformances for each clause in 9001:2015? Thank you in advance for your replies.
     
    JUVANNI AYASO, Oct 15, 2024
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  2. MonsterEnergy22

    MonsterEnergy22 Member

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    What's a 'collated non conformance'?

    Secondly, You would usually assign the Non-conformance to the process owner - It is then their responsibility to address the non conformance.
     
    MonsterEnergy22, Oct 15, 2024
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  3. tony s

    tony s Well-Known Member

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    Can we make the title of this thread more specific?
     
    tony s, Oct 15, 2024
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  4. Bev D

    Bev D Moderator Staff Member

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    The OP also posted the same question on our sister site…with a title of “Collated Nonconformances”.
    In the other site the OP didn’t explain what they meant by ‘collated’. The assumption that I and others had was that the OP meant a situation where the NC is discovered in one department but the cause was in a different department…until they clarify what they mean this is probably the best explanation o_O

    In general a nonconformance finding is assigned to the manager of the place where the NC was discovered. Very often a non-trivial finding has its cause in another department and its solution may lie in yet another department. The auditor usually has no idea of the originating or solution department. Some organizations assign an independent person to be responsible for leading a team of people for the investigation and solution. This is the method I have used for decades as I’ve found that assigning an NC to a single department leads to very shallow investigations and simple non-effective solutions like retraining or disciplining some random operator…or the NC just gets ignored.
     
    Bev D, Oct 15, 2024
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What does that mean? Did you attend training to get this title?

    What does this mean? Did they refer to this in your training?
     
    Andy Nichols, Oct 15, 2024
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  6. JUVANNI AYASO

    JUVANNI AYASO New Member

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    What I meant about collated NC's is: different areas that have been audited having NCs on the same clause.
     
    JUVANNI AYASO, Oct 16, 2024
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  7. JUVANNI AYASO

    JUVANNI AYASO New Member

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    I was able to attend an internal auditor's training and just recently underwent a Lead Auditor Training Course.
     
    JUVANNI AYASO, Oct 16, 2024
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is part of being a Lead Auditor. Didn't they cover this in the training? If not, ask for your money to be refunded
     
    Andy Nichols, Oct 16, 2024
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If this is an internal audit, why are you auditing against ISO 9001? If you find non-conformities against ISO 9001 requirements/clauses, no-one knows what you are talking about. You might just as well be talking a different language. If your trainer didn't explain that in either auditor course, you got the wrong trainer! Sorry to bring bad news.
     
    Andy Nichols, Oct 16, 2024
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  10. Bev D

    Bev D Moderator Staff Member

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    If you have different areas with NCs against the same clause they should still be separate as the cause and/or solution may be different for each. IF investigation finds that the cause and solution are the same then you escalate the solution to the higher authority that covers both areas. But this comes under Corrective Action management and not necessarily the Auditing function
     
    Bev D, Oct 16, 2024
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your job, as an auditor, is to report your findings to management . Non-conformities aren’t “assigned”. Management decide, based on the reported non-conformities, what they will do about them. You don’t have a part in that. If that’s what you got from training, once again, they were wrong in their instruction!
     
    Last edited: Oct 17, 2024
    Andy Nichols, Oct 17, 2024
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  12. Golfman25

    Golfman25 Well-Known Member

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    Do you have an example? I would issue the NC according to the process being audited.
     
    Golfman25, Oct 17, 2024
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That assumes a process was audited. Don't overlook that many, many auditor training courses teach auditing against ISO 9001 clauses because that's what the trainers believe it's about... Our friend @John C. Abnet has some very recent experience of just such a situation...(different standard, same story)
     
    Andy Nichols, Oct 17, 2024
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  14. Bev D

    Bev D Moderator Staff Member

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    As always, specifics help us help the poster. Vague descriptions only result in general - and sometimes completely irrelevant answers.
    @JUVANNI AYASO can you provide specifics? What clauses, what departments and what were the 2 nonconformances?
     
    Bev D, Oct 17, 2024
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  15. vegasconsulting

    vegasconsulting New Member

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    Hi!

    Welcome to ISO 9001:2015 auditing! As the Lead Internal Quality Auditor, your role in managing nonconformances is key to the continuous improvement process. Here’s a guideline on responsibility for collated non-conformances:

    1. Clause-Specific Responsibility:
      • Non-conformances identified in specific clauses are typically assigned to the process owners or department heads directly responsible for those areas. For example, if a nonconformance is related to Clause 7.1.3 (Infrastructure), the Facilities or Maintenance team would be accountable for addressing it.
    2. Quality Management Representative (QMR):
      • In many companies, a QMR (or similar role) oversees the collation, tracking, and resolution of nonconformances. They ensure that each issue is assigned and monitor corrective actions.
    3. Top Management:
      • For high-impact nonconformances, top management may be involved to ensure adequate resources and support are provided. Management reviews are ideal for discussing these issues and ensuring alignment with the company’s quality objectives.
    4. Lead Auditor and Audit Team:
      • While auditors are responsible for identifying nonconformances, they also play a role in verifying corrective actions during follow-up audits. However, they do not own the nonconformance itself.
    Each organization may have unique roles assigned, so it’s a good idea to clarify responsibilities in your documented procedures. This approach ensures that each clause’s nonconformance is managed by the most relevant personnel, supporting effective corrective action and continual improvement.

    Hope this helps, and best of luck in your role!
     
    vegasconsulting, Oct 30, 2024
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Vegas Consulting! I have some questions regarding your statements…
    What if the audit criteria isn’t ISO 9001?
    Since ISO 9001 doesn’t define the role, what then?
    Can you define “high impact”? What makes them different to others?
    I can find no definition of what a “Lead Auditor” is - can you clarify?
     
    Andy Nichols, Oct 30, 2024
    #16