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  • 1.  Devices / Returned Product and Complaint Processing

    Posted 10-Nov-2015 08:17

    Can several people, please, share how returned product is managed relative to complaint processing.

    1) Specifically, who makes the first assessment to determine if a returned product has malfunctioned, manufacturing or quality team?

    2) Is one workflow more efficient then the other?

    In our current workflow, manufacturing makes the initial assessment and returns any failed parts  to quality for further complaint analysis. I have gotten some recent advice, however, that suggests quality should be making the first assessment and that this is a more efficient workflow. I am of the general opinion that either flow works as long as you have a complete complaint record, but am interested to understand other ways this process is being managed.

    I appreciate, in advance, all thoughts and experiences! 

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    Diane Arpino MPH
    Director
    Mindray DS USA, Inc.
    Mahwah NJ
    United States
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  • 2.  RE: Devices / Returned Product and Complaint Processing

    Posted 10-Nov-2015 10:54

    Hi Diane,

    As you stated, key to any return or complaint is to ensure "control" and to document/verify the complaint and reason for return.  In my experience, returns and complaints are handled by Quality as the independent group to receive, document and maintain control of the product.  I worked on customer complaints and returns for a while in my past and this function resided in Quality/Technical operations with input and evaluation from manufacturing, device engineering, etc as appropriate. I am in the camp that Quality should be the initial evaluator of returns and complaints. 

    Hope this is helpful,

    Dar

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    Darlene Rosario MBA, RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States

    Original Message


  • 3.  RE: Devices / Returned Product and Complaint Processing

    Posted 10-Nov-2015 15:04

    Having evaluated devices due to complaints as a quality engineer and having set-up QMS in companies, I've found it easier in my experience for Quality Assurance to do the initial evaluation.  This doesn't mean that the other engineers in manufacturing or R&D cannot be present during the initial evaluation.  Sometimes it helps to have multiple eyes specially if you're dealing with a product that is complex or if stability of the product is an issue.  The initial product assessment/root cause analysis can tell you a lot and on a very rare occasion even end up leading you to submit to FDA under the MDR system. QA are more sensitive to rules of MDRs and this ensures the company meets the deadline for MDR submission.

    Hope that helps,

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    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message