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8.6.b) traceability to the person(s) authorizing the release.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jaltangerel, May 11, 2018.

  1. jaltangerel

    jaltangerel Member

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    Hi members!
    Could help me to understand this topic.
    What is "traceability to the person(s) authorizing the release" mean on clause 8.6.b
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    This means the documentation enables us to identify the person who authorized the release. It may or may not be the inspector or lab technician.
     
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  3. tony s

    tony s Well-Known Member

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    Usually this requirement applies to the outgoing inspection prior to delivery. The inspector who performed the outgoing inspection must ensure that the inspection record has:
    • the actual measured values of the inspected products compared with the product specifications - 8.6a;
    • his/her name, signature, or any information identifying the inspector - 8.6b
     
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Your statement seems consistent with the second paragraph in 8.6 @tony s , however, it is also important to note the requirement ("shall") in the first paragraph of 8.6, which states "...at appropriate stages...".

    It is also important to remember that authorized release traceable to the person(s) authorizing the release, be established in a method that is beneficial to the organization and not simply because it is a requirement of the standard. Organizations need to determine the necessary stages (frequency) and methods of verification/release/traceability, which allows the organization to limit exposure if a failure occurs.

    Be well.
     
  5. Erickson Rabena

    Erickson Rabena Member

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    You should have an evidence to show who authorize the release.
     
  6. judegu

    judegu Well-Known Member

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    Hi John. I just wonder besides outgoing, is there any other process step can also be the appropriate stage for authorization of release?
     
  7. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Judgeu;

    In regards to your question, "yes", there are often "appropriate stages" (process steps) throughout an organization where "traceable to the person(s) authorizing the release" may be important.

    Consider this example:
    A manufacturing company has the following processes....

    Material receiving inspection --> Cutting --> Cleaning --> Welding --> Assembly --> Final Inspection --> Packaging --> Shipping

    a) The welding operation has five associates , each using a different piece of equipment (welders A-B-C-D-E) on each of three shifts, all performing the same welding process.
    b1) The weld associates stop and inspect every 100th piece BUT they don't record who inspected or when it was inspected. OR.....
    b2) ...five different roving inspectors on each of the 3three shifts inspect every 100th piece BUT they don't record who inspected and when it was inspected
    c) Suddenly, at Final Inspection, a weld problem is found.

    Wouldn't it have been beneficial to the organization if they had a record of who released the n/g pieces, when they were released, and which piece of equipment they were released from?

    The key is "appropriate stages", which is left to the organization to determine IF there are appropriate stages (other than outgoing) at which it is beneficial to be "traceable to the person(s) authorizing the release"

    Hope this helps.
    Be well
     
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  8. judegu

    judegu Well-Known Member

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    Hi John. Thanks for the always-elaborately-explaned reply. Your reply just gave me another direction to comprehand the standard.
    And here are some questions I want to discuss with you.

    Q1. First in the example(
    ) you mentioned, I just wonder why the roving inspectors and the weil associates don`t record more details about the inspection they performed in the first place. In the place where I work, the traceability would be considered to be totally comprosied if such details were not recorded. Using MES system, we always keep this kind of information(when it is inspected, who inspected it etc.) Or under ISO9001 requiremnets it would be OK?
    ※If I paid a visit to audit this process, I would give a nonconformance.

    Q2. The RELEASE here is not just about the final release of the end product in the Final inspection. The RELEASE here tends to be more generic. So we can release the semiproduct in the weld process, and do the final release in the final inspection. Or the RELEASE of the semiproduct in Weld process serves as a part of the final RELEASE?

    Thanks.
     
  9. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @judegu;
    Not sure I fully understand your question Q1. If your MES system records when, who, etc... then why would you give this a nonconformance? It sounds to me like your organization's processes are indeed "traceable to the person(s) authorizing the release".
    I understand no problem with what you describe.


    Q2. The RELEASE here is not just about the final release of the end product in the Final inspection. The RELEASE here tends to be more generic. So we can release the semiproduct in the weld process, and do the final release in the final inspection. Or the RELEASE of the semiproduct in Weld process serves as a part of the final RELEASE?

    Correct, "release" is generic (as used in the standard) and is NOT determining "final release" or any other stage in the processes. The standard leaves it up to your organization to determine "appropriate stages".

    Hope this helps.
    Be well.
     
  10. judegu

    judegu Well-Known Member

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    Sorry for my poor English communication skill. What I mean is that if the welding process didn`t record the who, when type data of inspection, I would think it as a nonconformance against the relevant traceability requriements of the standard(at least under the requirements of IATF, it is a nonconformance, right?). The ideal way to ensure this kind of traceability is via MES support as the factory where I work does.
    Hope I make myself clear this time.
     
  11. John C. Abnet

    John C. Abnet Well-Known Member

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    Remember @judegu , it's up to your organization to determine "relevant stages". What does your organization NEED in regards to traceability and to ensure product conformance? Determine what the "relevant stages" are for your processes, then ensure traceability to the release at those stages, then audit to ensure that you are meeting the organization's determined intent.

    Hope this helps.
    Be well.
     
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