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No Quality Manual, now what?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Andy Nichols, Aug 28, 2015.

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  1. tony s

    tony s Well-Known Member

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    Salamat Andy. We're really considering this.
     
    tony s, Sep 22, 2015
    #41
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  2. MCW8888

    MCW8888 Well-Known Member

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    The
    The CB looks at the Quality Manual but I have never been given a nonconformance on this document. The reference documents are the once that are being reviewed. We have an integrated manual and the auditor asks questions and we just try our best to respond, and the auditor moves on. My manual iuis far from perfect, but it meets the minimum intent of ISO/TS16949. Thank you.
     
    MCW8888, Sep 22, 2015
    #42
  3. tony s

    tony s Well-Known Member

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    To provide a sample of CB auditors going beyond the requirements of 4.2.2, I just want to share our CB's audit findings on our Quality Manual during our ISO/TS 16949 Stage 1 audit. Mind you that we have other documentation, procedures and records in place to satisfy the requirements but our CB auditor is very particular that such controls MUST be specified in the quality manual.

    Here are the statements in their report:

    Areas of concern that could be classified as a Major or Minor non-conformance during the stage 2 audit:​
    • 8.2.2 Internal audit – manufacturing process audit is not clearly demonstrated in the Quality Manual. No provision as well for correction or immediate action.
    • 4.2.4 Control of Records – Requirements for control of records is not explicitly stated in the manual.
    • 8.5.2 Corrective action – The manual has no provision for Corrective action impact
    • 8.3 Control of nonconforming products – While there is a list of Level 1 and Level 2 abnormalities in the Hold Tag form, these are not defined in the quality manual.
    • 8.2.4.1 Layout inspection. There is no provision in the manual for layout inspection.
    • 7.6.1 Measurement System Analysis – There is no provision in the manual for MSA. While there is procedure for MSA, this is not referenced in the manual and the need is not properly identified.
    • 7.4.1 Purchasing process. The manual has no provision for evaluation and selection of suppliers. While there is a specific procedure for this requirement, this is not referenced in the quality manual.
    • 4.1 General requirements - Business process map does not clearly show linkage with Sales office in Japan.
     
    tony s, Sep 22, 2015
    #43
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I hope, Tony S, your question back to the auditor was "Where is the requirement in ISO 9001:2008 to do this?" ;)
     
    Andy Nichols, Sep 22, 2015
    #44
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  5. Nikki

    Nikki Well-Known Member

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    I am definitely guilty of having a quality manual that spits back the standard. I would really like to re-write it (with or without the requirement now) and make it our own...

    I would love to know the best approach....

    Thoughts?
     
    Nikki, Sep 25, 2015
    #45
  6. MCW8888

    MCW8888 Well-Known Member

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    8.2.2 Manufacturing process audit should be described in your Internal audit procedure which at this point is one of the required procedure for TS16949.

    4.2.4 The manual must reference a procedure for control of records.
    8.5.2 The Manual should reference a procedure for Corrective Action which will describe the Corrective Action Impact.
    8.3 Again the manual must state reference to a procedure for controlling NC products
    8.2.4.1 The Manual should refer to customer specific requirements.
    7.6.1 Make reference to a section in your Laboratory Scope. You do have a documented Lab Scope, don't you?
    7.4.1 The comment is correct. The manual must cite a reference document
    4.1 This is a valid comment. Our business Flow Chart links activities at remote location.
     
    MCW8888, Sep 25, 2015
    #46
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Best approach? Something YOU'D like to read, and be proud of!
     
    Andy Nichols, Sep 25, 2015
    #47
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    How about writing it from your customers' perspective? What would they want to know? Not what ISO says (it's probably what their manual is based on!) that's for sure...
     
    Andy Nichols, Sep 25, 2015
    #48
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  9. tony s

    tony s Well-Known Member

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    Clause 4.2.2b of ISO or TS states that "The organization shall establish and maintain a quality manual that includes...b) the documented procedures established for the quality management system, or reference to them". We opted to adopt the "referencing approach". What we have is a separate Quality Manual with reference to the documented procedures that we have established for our QMS. The details on how we can demonstrate conformance to the individual clauses/subclauses of ISO or TS are clearly specified in the referenced documented procedures.
     
    tony s, Sep 26, 2015
    #49
  10. MCW8888

    MCW8888 Well-Known Member

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    MCW8888, Sep 26, 2015
    #50
  11. Nikki

    Nikki Well-Known Member

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    I would love to re-write it from the customers perspective. Thank you for the idea Andy :)
     
    Nikki, Oct 5, 2015
    #51
  12. RoxaneB

    RoxaneB Moderator Staff Member

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    I'd rather write it from our perspective, in our language. It's like an autobiography of sorts. It's why we do what we do...how we do it...what we do...who we are...

    An appendix in the back can list the various standards applicable to the organization and which section(s) address the sections of the standard(s).
     
    RoxaneB, Oct 6, 2015
    #52
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  13. MCW8888

    MCW8888 Well-Known Member

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    I do not really like to "pss" th auditor this way. I would politely tell this individual that " I believe that ISO9001:2008 does not require us to do that".
     
    MCW8888, Oct 6, 2015
    #53
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's going to depend on the personality of the auditor, I'd have thought. If you have one who reacts badly to being asked to point out that requirement should be shown the door, frankly, as they don't posses the characteristics defined in ISO 19011. Too many people see to think and act like these folks walk on water. If they don't understand a requirement, or there's some misunderstanding it's up to THEM to resolve it, not for the client to walk on egg shells...
     
    Andy Nichols, Oct 6, 2015
    #54
  15. MCW8888

    MCW8888 Well-Known Member

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    Auditors are like wine. They get better with age. What I mean is this: once you get accustom to the auditor and make them understand that they are there to make sure your certificate is preserved, it does not matter whether or not we know the clauses of the standard, they are there to verify that we are meeting the requirements of the standard. And if we do not, as a partner supplier, they have an obligation to point out where we violated our own policies. Once stage 2 is finished, every finding has to be factual not auditor's gut feelings.
     
    MCW8888, Oct 6, 2015
    #55
  16. RoxaneB

    RoxaneB Moderator Staff Member

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    I disagree. We, the organization, are responsible to ensure we meet the requirements and thus retain our certification (especially if such a status is required by our customers).

    I disagree. It is our system...our organization...we better know and understand the requirements that we are attempting to meet and/or fit into our system.

    I partially agree. They are there to provide an external assessment of our conformance to the requirements of the standard. Just our internal auditors are to be independent of the scope they are auditing, external auditors are to provide an unbiased evaluation of our management system. We should also be able to verify our conformance to the requirements of the standard.

    I partially agree. They are also to indicate where we fail to address and/or conform to the requirements of the standard. Just as we, the organization, are required to identify how we believe we do (hence the need for us to understand the requirements of the standard).

    What does Stage 2 have to do with this? Any audit...no...every audit is to be factual and not based on belief or feeling. An audit is a comparison to some level of standard. If you assess conformance to a documented procedure, the procedure is the standard against which you assessing conformance. If you assess conformance to ISO 9001 or ISO 14001 or any other external standard, those are the requirements against which you are assessing conformance. If you have nothing to assess against, you are not really auditing.
     
    RoxaneB, Oct 6, 2015
    #56
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  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agree, RB! (Hey, that rhymes...)
     
    Andy Nichols, Oct 6, 2015
    #57
  18. equilibrium

    equilibrium Member

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    This is a simple, but far too often overlooked point in my view. Sometimes people dig in so deep during an audit they lose sight of what they were sent there to do. Who benefits from that?
     
    equilibrium, Oct 6, 2015
    #58
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  19. MCW8888

    MCW8888 Well-Known Member

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    Good feedback. Conformance to external standard plus the company's specific policy is the criteria for internal auditing. With regards to CB's if we feel that they are not factual in documenting NC's we try to reason out and most of the time the discussion stops there. There is no need to dismiss the CB auditor. Thanks.
     
    MCW8888, Oct 6, 2015
    #59
  20. MCW8888

    MCW8888 Well-Known Member

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    I love this discussion because I feel more comfortable dealing with my own CB experience. We do not want to show them out of the door without giving us all a win win experience.
     
    MCW8888, Oct 6, 2015
    #60
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