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When does Research become Development?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Graham Thorpe, Feb 25, 2019.

  1. Graham Thorpe

    Graham Thorpe Member

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    I need help! OK I can read the standard OK ( I think) but not sure how to handle this aspect of what we do.

    We are a design and manufacturing company, our own designs. But the process is really like this:

    I had an idea after a beer last night , lets write down what we want to do, lets experiment and build prototypes, test the theory out, then prove it works and if it does lets get on an build and sell it.

    When should 9001 kick in and how should I document the change over? After we are sure it all works we can have real design input and the system can have change notes and other great things but before that we might have 20 changes a day and a formal change system can not stand in the way of research.

    It’s not just design though. We have a supplier selection process but in the research phase suppliers change often but the PO system, or storage system, can not differentiate between bits bought for products in the main production cycle or those we bought from ebay, or that company we thought could make this special bit in the research phase.

    Sorry for rambling on. Last time I had this challenge it was in a medium sized company and it was easy to exclude research from the scope but in a 5 man outfit its not quite as simple :)

    Suggestions, questions, and comment most welcome.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Graham: At the point management fund a development project. When it's determined that, instead of a few people noodling around with some ideas in a lab, there's something viable enough to translate some marketing/customer specifications into a tangible deliverable, by a certain date etc.
     
  3. Graham Thorpe

    Graham Thorpe Member

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    Thanks Andy. I went through a similar situation years ago but in a bigger company. We have 3 rooms and 5 people so the same folks research, design and build, but we are all fully trained on the coffee machine. All comments make me think, and indeed, writing the question made me think. In many ways its all about defining the context of the organization and defining its scope. I can define the inputs and outputs to the design phase and can, I think work about a spit between the two. But what do I so about shared services like purchasing? I guess we need to indicate somehow that item X was bought for a production run or research project, the research suppliers not needing to be approved?
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    Your research suppliers are "approved." They only difference is the criteria -- "can they get me what I need by next week?" Point being, you can have an "exception" in your supplier approval process allowing the use of just about anyone for research projects. So to me, the research stuff can be less formal than the development stuff. When you get to viability is when you can changeover. Good luck.
     
  5. Graham Thorpe

    Graham Thorpe Member

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    Thanks, years ago I worked in a company and a critical comment came from a company in the US. The company ( well one guy) had been supplying us for a few years but standards went down so we went to visit. The product was being made my an old guy and the process went like 'machine, have another slug of Jack Daniels, machine' All done in his back yard :)
     
  6. Golfman25

    Golfman25 Well-Known Member

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    We had the same vendor. :)
     

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