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8.3.5.b Design and development outputs

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jaltangerel, May 9, 2018.

  1. jaltangerel

    jaltangerel Member

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    Good day everyone!
    Please give me some advice what is "Design and development outputs are adequate for the subsequent processes for the provision of products and services" mean? Please some example of real life.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In an extreme example, to demonstrate the point of the requirement:

    Design output: Shoe must fit adult feet and at least 2 colors

    Adequate design output: Shoe must fit a range of male adult foot sizes ranging from 8 to 12 (US and EU), made of leather, available in black and also cardovan brown, 6 lace holes...
     
    Last edited: May 9, 2018
  3. jaltangerel

    jaltangerel Member

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    Hi Andy
    What is "the subsequent processes for the provision of products and services" mean in this situation? Are the choices of colors of shoe? :)
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The material, the number of lace holes and colours are going to affect the processes of manufacture, for example. If they were plastic shoes, they'd be moulded, instead of die-cut and stitched assembly for leather. This difference has significant impact on the procurement, operation and maintenance of the different types of equipment needed, including supplier involvement (mould tool making for plastics for example) and so on.
     
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  5. jaltangerel

    jaltangerel Member

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    Thanks. Wish happiness for you. :)
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I just realized I mixed input and output, but the principle is the same.
     
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  7. jaltangerel

    jaltangerel Member

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    OK. Thanks
     
  8. tony s

    tony s Well-Known Member

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    Since products and services are varied, there are many forms of design and development outputs, these can include:
    • engineering drawings, prototype - for manufacturing companies;
    • plans, drawings, scale model - for construction companies;
    • beta version - for software developers;
    • sketches and fabric swatches - for dress designers;
    • printing proofs - for printing press companies; etc.
    These design and development outputs must be verified against the design and development inputs (8.3.4c, 8.3.5a). After successful verification, the final requirements/criteria for the subsequent processes such as production, inspection, packaging will now be established. Organizations should also consider, during the verification of outputs against the inputs, the ability/capability of the subsequent processes to produce/deliver the actual product/service. In the manufacturing sector, they need to consider design for manufacturability (DfM).
     
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  9. jaltangerel

    jaltangerel Member

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    Thank you Tony S. Wish goodness for you.
     
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  10. Daniel Padilla T

    Daniel Padilla T Member

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    Hi Tony! My question is, isn't DFM supposed to be one of the inputs of the design and development process? I know it is not mentioned in 8.3.3, that's why I ask.

    Regards.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's a tool. ISO 9001 doesn't prescribe tools.
     
  12. tony s

    tony s Well-Known Member

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    Design for Manufacturability (DfM) is an engineering process intended to optimize the relationship between design function, manufacturability, including assembly (as per Advanced Product Quality Planning manual of AIAG). In the manufacturing sector, particularly in automotive, the design and development process has two phases. One is Product Design and Development and the other one is Process Design and Development. The former is focused on ensuring all the design features and characteristics are developed into a near final form of the product itself (a.k.a. prototype). The latter ensures that the major features and controls for developing the manufacturing process are in place to ensure production of the product in accordance to the former phase's validated output (this is the intent of 8.3.5b). In this context, DfM is an output of product design and development and an input for process design and development.
     
    Last edited: Apr 3, 2019
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  13. Daniel Padilla T

    Daniel Padilla T Member

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    Thanks a lot for this very clear explanation.
     

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