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  • 1.  Critical Supplier change

    This message was posted by a user wishing to remain anonymous
    Posted 11-Mar-2024 09:07
    This message was posted by a user wishing to remain anonymous

    Hi,

    What is the process used for a supplier change? Is it routed through the change process? For a component with more than one supplier (with same specifications) we don't have a different part number. As critical /crucial suppliers are key for regulatory submission, what is the trigger in the QMS, to notify this change?

    thanks,



  • 2.  RE: Critical Supplier change

    Posted 12-Mar-2024 05:45

    Anon,

    Typically the list of suppliers would be listed on the Component Specification.  Therefore when the crucial supplier (I do not personally like to use the word critical) or even any type of supplier is changed the Component Specification would go through change control.  Though some companies do not manage it this way.  Meaning the Component Specification is agnostic to the supplier - as long as the specification of the part, component, or raw material can be met.  This would be items like metal parts, bolts, PCB components, etc., which are common in the industry.  Then the Approved Supplier List (ASL) is controlled through some type of versioning aspect.  When a supplier is changed or new alternate supplier brought on, then the ASL would be updated.  Then as long as the supplier is on the ASL, purchasing or procurement can buy a part or component from those suppliers.  I guess in summary, there are many different ways this can be done and depends on the QMS system, the type of medical device, the purchasing process, and supplier evaluation process.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 3.  RE: Critical Supplier change

    Posted 12-Mar-2024 08:46

    Anon,

    The process used could be an existing process like change control or it could be an independent process determined by your organization based on risks related to the supplier change's impact on safety or effectiveness.  As a medical device manufacturer, we route supplier changes through our change control process, and to answer your last question, for any regulatory impacts we would also consult the FDA GFI on when to submit a new 510(k) for changes to an existing device.

    I'm certain other organizations handle it differently based on their unique QMS requirements and risk management processes.

    Respectfully,

    will



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    William Coulston PMP, MS, RAC
    Director of Quality & Regulatory Affairs
    Rochal Technologies
    San Antonio TX
    United States
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    Original Message


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