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  • 1.  Supplier Performance Evaluation - Supplier Quality Audit

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2024 09:14
    This message was posted by a user wishing to remain anonymous

    Hello RAPS Team,

    We are class I medical devices manufacturer (Self Declaration) and buying most of parts from Asian countries. 
    Unfortunately, they are sending very good parts and we raised too many SCARs against them but things are not improving. 

    Our Supplier Performance Evaluations are based on following 5 inputs:
    Timeliness of Deliveries

    Competitiveness of Price

    Quality of Parts upon delivery

    Competitiveness of Payment Terms

    Quality of Service or Technical Support

    Unfortunately, they are doing bad in Quality of Parts upon delivery but good with other 4 inputs and this helped them to stay above the threshold before any action taken.
    Even there was no action required last year after running supplier evaluation performance report, I still audit 3-4 suppliers which are sending bad parts.

     I believe, I need to give more weightage to Quality of Parts upon delivery section, may be 40-50%.

    What I can do better, to improve this supplier performance evaluation ?

    How I can integrate this supplier performance evaluation in supplier quality / supplier general agreement?

    Your valuable feedback would be highly appreciated.

    Thanks 




  • 2.  RE: Supplier Performance Evaluation - Supplier Quality Audit

    Posted 17-Apr-2024 04:53

    Hello Anon,

    Buy local? ;)  this can be challenging dealing with quality of parts from suppliers when everything else might be fine.  There are some things which can be done from weighing the attributes as you suggested, examining the SCARs to better use that process, or even apply business constraints such as back-charging for poor quality.  The information asking is probably well beyond a forum post so you might want to research as this is a fairly broad subject and many different ways could be applied.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 3.  RE: Supplier Performance Evaluation - Supplier Quality Audit

    Posted 17-Apr-2024 05:25

    Richard already gave some good tips on how to handle such a situation. Leveling the weighing factor for poor quality upon delivery proportionate to the risk associated with the final device is certainly a valid option, in line with Clause 7.4.1 of ISO 13485.

    Another issue is the cost of non-quality. If that is taken into account in the competitiveness of price, the outcome of the evaluation may be completely different.



    ------------------------------
    Peter Reijntjes
    Consultant Regulatory & Quality Affairs Medical Devices
    Heteren
    Netherlands
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  • 4.  RE: Supplier Performance Evaluation - Supplier Quality Audit

    Posted 17-Apr-2024 08:49

    Hello

    It is interesting to note that 3 of the 4 performance related factors relate more to the commercial/business side of the relationship. Only 1 - Quality of Parts upon delivery is directly relates to product quality.

    I would also recommend that you look at what quality attributes you have included in this factor. Are they relevant? Are they complete? Are they measurable (not just a simple pass/fail)? 

    It is also a good idea to work collaboratively with your purchasing team to emphasize quality. One good way is to show them the cost of poor quality (both in terms of money and time) that you are experiencing because of quality issues.

    Finally, it is prudent to qualify multiple suppliers to the extent possible.



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
    ------------------------------



  • 5.  RE: Supplier Performance Evaluation - Supplier Quality Audit

    This message was posted by a user wishing to remain anonymous
    Posted 28 days ago
    This message was posted by a user wishing to remain anonymous

    Hello Experts,

    Sounds good and thanks for your feedback.

    Thanks