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8.4.1 Tools and manufacturing equipment

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by MRH_2019, May 6, 2019.

  1. MRH_2019

    MRH_2019 Member

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    Hi All,

    first post. I apologize if this has been answered but I have not been able to find anything specifically answering this question.

    Quick background, we manufacture vehicles.

    Do tools, manufacturing equipment (cranes, lifts, etcs), and other products used to manufacture products need to be controlled per 8.4?
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @MRH_2019 and welcome to the site.

    The short answer is "no".

    However, it is important that your organization's quality management system should be selfishly established to support your organization and what is best (while meeting the requirements of the standard), what is best for your organization and its customers.

    However, the standard is clear that 8.4 applies (a paraphrase) only to...
    - Products (or services) INCORPORATED into your products
    - Products (or services) which your organization arranges to be provided DIRECTLY to your customer from an external provider.
    - Outsourcing of processes that are performed on your products (or replace your services).

    I emphasize that I am paraphrasing, but you get the point.

    The equipment you speak of would be more correctly considered within clause 8.5.1...
    d) Suitable infrastructure...


    Hope this helps.
    Be well.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The use of outsourced processes, typically applies to products and services which add value to the product (or service) the organization is providing. In that case, John is accurate. However, having seen first hand, the issues created by acquiring tooling and equipment WITHOUT similar controls to 8.4, I'd always commend some form of plan to assure (provide confidence) that the T & E is capable.
     
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  4. MRH_2019

    MRH_2019 Member

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    Thank you for your input. We had this issue brought up by an auditor and I thought it was a bit strange since it is not used in the final product. I do agree that these items should go through evaluation of some sort.

    If I apply 8.5.1, how could I explain "determining the resources needed" to an auditor? Does anyone have a suggestion on how they do that. We have thousands of different tools and equipment needed for the manufacturing of our final product.
     
  5. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @MRH_2019

    Just be careful not to overthink this and do it "for the auditor".
    I'm not sure if your organization uses PFMEA or Control Plans, but, that is an area for considering identifying and CONSOLIDATING (nothing worse than multiple/fragmented documentation) product/process requirements. I

    If, for example, the crane is a special crane, with special handling abilities and part of its role is to prevent "damage" to the product, then ….
    1- "no damage" would be a specification/requirement, and ...
    2- "control" would be "robotic crane model 'superspecial2000' "

    Remember the scope of the ISO 9001 standard.
    * Meet customer requirements
    * Enhance customer satisfaction

    The standard and what we do should revolve around this simple scope.

    Hope this helps.
    Be well.
     
  6. Golfman25

    Golfman25 Well-Known Member

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    If you have been in business for any length of time, most of it is habit. You figure out what you need to do the job, then go about getting those things required.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's unanswerable. Since the auditor brought it up (CB? Internal?) it seems as if they don't understand something basic. If you imagine a picture (attached) this might help the auditor to understand (fingers crossed)
     

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  8. MRH_2019

    MRH_2019 Member

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    Hi all,

    Thanks for the help!

    This was a CB. I thought it was strange that they were asking for this process to be followed since it wasn't part of the final product. My understanding based on the requirement is only items that are used in the final product (vehicles in our case). We have already determined any statutory and regulatory requirements that these types of tools require and have multiple processes in place to ensure conformity.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe a legacy issue from the days when the auto industry had something called the T&E supplement to QS-9000. It went away, so it clearly got no traction. It sounds like the auditor is grasping at straws and it's nothing more.
     

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