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Clause 8.3 - Design in the Custom Manufacturing industry.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Gerald, May 10, 2016.

  1. Gerald

    Gerald Member

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    The company that I work for is a custom manufacturing house. We do not have "shelf" items, nor do we market any specific products we build. Our engineering team is responsible for designing some product, however those designs are based on customer specs/requirements and at the end of the design phase the designs are customer approved. In our quest to reach ISO compliance, we have excluded clause 8.3 from the audit plan. Unfortunately, the president of the company is starting to worry about our ability to "sell" that we aren't actually designing product and that excluding clause 8.3 may not be applicable. All of the CBs I have talked to during the quoting process seemed to be on the side of excluding 8.3 because we dont actually design product and market that product to have specific characteristics and capabilities. We just design and build what our customers want and essentially those customers own that design. However, since our engineering team is doing some design work (again, all customer based) do we need to think about including 8.3 in our audit plan?

    Our current "Design" process is not at all documented because our engineers are typically working one on one with the customer to achieve their desired outcome. Each RFQ has the potential to be handled differently, it just all depends on the customer and the product they want built.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well there's 2 considerations:
    • Does your organization have the authority to change the specifications once the design is "approved"?
    • What's the "scope" of your QMS?
    If you take a leaf out of ISO 9001:2015, then what's the "context of your organization"? Are you actually designing "product" or figuring out how to process the customers' specification?
     
  3. Gerald

    Gerald Member

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    internal design change cannot be processed without customer approval unless the change does not affect overall function. Any change that deviates from the originally approved product must be re-approved by the customer.

    as far as our scope - or the context of the organization - we BUILD and MANUFACTURE product for our industry...we do not claim to design product in our industry. we have the capabilities to design a wide range of product - but those designs are based on customer specs.
     
  4. Miner

    Miner Moderator Staff Member

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    Does your customer provide engineering drawings for you to build to, or do you create drawings that meet specific customer requirements?
     
  5. Gerald

    Gerald Member

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    each situation is different...typically a drawing or a physical sample (for reverse engineering) of the part is supplied. However, project engineers have created drawings if there isn't one supplied.
     
  6. Miner

    Miner Moderator Staff Member

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    Building to a drawing would not typically be considered design. However, reverse engineering and creating drawings that meet customer requirements would be considered design.
     
  7. Miner

    Miner Moderator Staff Member

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    I believe that this is the ISO definition of design: Design and development is a process (or a set of processes) that uses resources to transform general input requirements for an object into specific output requirements.

    By this definition, your company is taking your customer's input requirements and transforming them into out put requirements through a process called design.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I wouldn't consider this to be "design". Taking someone else's product and measuring it (etc) isn't "design".
     
  9. Miner

    Miner Moderator Staff Member

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    Reverse engineering is rarely that easy. Decisions have to be made on the materials to use, the manufacturing processes, etc. It can very difficult to decipher how or why another company did something on a product. There are also patent searches involved to avoid lawsuits for patent infringement. The list goes on...
     
  10. Gerald

    Gerald Member

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    Although you're correct - reverse engineering is a little more labor intensive - at the end of the day the customer is who approves whether or not the design conforms to their requirements.

    If we were designing and building standard product, our customer expectations would revolve around what we tell them a part is capable of doing. The scope of our company would include design and development.

    In our case, the customer expectations revolve around what they tell us a part must be capable of doing, where it must fit, and what regulatory standards it must meet. The scope of our company - what we are based on - is manufacturing custom electromagnetic components built per customer specifications.

    This debate is the same one the president and I are having. I believe its clear cut - although we do some design in our engineering department, its customer regulated and approved. We do not design and market our own product claiming it can do "a, b, and c".
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The key question is whether you can change the spec for the product without customer approval. If not, you aren't design responsible.
     
  12. tony s

    tony s Well-Known Member

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    In ISO 9000:2015, design and development is defined as "set of processes that transform requirements for an object into more detailed requirements for that object".

    So, if we equate "object" here to your company's product and if your company need to perform such "set of processes" to produce your product, then clause 8.3 should be included in your audit plan.
     
  13. Miner

    Miner Moderator Staff Member

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    I still have to disagree. In my prior automotive experience, the OEM would give us a "gray box" drawing with all of the assembly dimensions specified as well as functional requirements, but we had to design the rubber formulations and sub-assembly dimensions that met those functional requirements. The customer had to approve the end result, and we were not allowed to make changes without approval, but it was still design. Otherwise we were paying a lot of design engineers for nothing.
     
  14. Golfman25

    Golfman25 Well-Known Member

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    Your company sounds borderline. Start with the design exclusion. Get registered. Add design later if you find you really need/want it. Good luck.
     

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