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To understand in what all ways we integrate the third-party manufacturer under QMS of organization

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rajan Gupta_07, Mar 26, 2024.

  1. Rajan Gupta_07

    Rajan Gupta_07 Member

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    We just had an external audit, and nonconformity was brought up because our organization's QMS did not evaluate the third-party manufacturer.

    In summary, we are working with a third-party company (a manufacturer) for the manufacturing of some of our products. This supplier packs the finished product for our brand and dispatch are being done into the market. Furthermore, we provide them with other documents such as recipes, control plans, and so on. Wherein the external provider lacks ISO/QMS certification.

    I therefore want to know from the group what I shall do to integrate third party manufacturer (in terms of evaluation, processes) and accommodate it into our organization's quality management system (QMS) in order to comply with the 8.4 Control of externally provided processes, products, and services requirement stated in the 9001:2015 standard. With least minimum effort.
     
    Rajan Gupta_07, Mar 26, 2024
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Unless you own the "3rd party" (are you sure this is the correct description? Suppliers are not third party), it's a practical impossibility to do what you say. If you got a non-conformity because of a failure to evaluate, why not simply create some criteria and evaluate them. Are they packing product only? Contractually require them to create a control plan. Then evaluate them against the control plan. Make it simple.
     
    Andy Nichols, Mar 26, 2024
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  3. Golfman25

    Golfman25 Well-Known Member

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    I would start even simpler. How did you select the provider? How do you monitor their performance? Then work from there.

    You may want to provide the exact wording of the finding for further discussion.
     
    Golfman25, Mar 26, 2024
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  4. Rajan Gupta_07

    Rajan Gupta_07 Member

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    Hi thanks for your valuable input.
    First of all would like to clarify that we don't own the 3rd part manufacturer.

    We are getting our product manufactured from them and have a contract for the same in terms of volume and adherence to the requirement for the quality of product they produce.

    They manufacture the product of our brand i.e they buy the RMS from different vendors and manufacture them as per our formulation, followed by inspection as per our control plan and pack those product in our brand.

    So will require the valuable input in what all possible ways we can integrate this 3rd party manufacturer into the QMS.(List of activities to be performed)

    Please put in simplified manner.
     
    Rajan Gupta_07, Mar 27, 2024
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It is practically impossible to do this.
    I understood this is the issue you are trying to correct. Why do you think integration is the way to correct this? It isn't.
     
    Andy Nichols, Mar 27, 2024
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  6. Rajan Gupta_07

    Rajan Gupta_07 Member

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    What else could done to address the issue if not integration is the not the impossible could you please enlist?
    Support will be appreciated Andy!
     
    Rajan Gupta_07, Mar 27, 2024
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    ISO 9001 requires that you evaluate and re-evaluate your suppliers using defined criteria. If you have engaged a supplier to do all these things for you, don't you currently evaluate how they are doing? How did you select them in the first place? Did your organization get them to do samples? Were they approved? Did they provide a control plan or similar? Do you periodically visit them to see what they're up to? Do you require them to provide any measurement data for you to review? How do you know they ship the correct quantity of product, on time?
     
    Andy Nichols, Mar 27, 2024
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