Regulatory Open Forum

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  • 1.  Complaint and Recall Handling

    Posted 08-Nov-2019 10:05
    I am looking to find out where the complaint and recall personel fit into a companies QMS system.   Specifically, should these roles be under a Quality Manager or are they best put under the Regulatory Compliance Manager's perview?  We are a Medical Device Distribution Company that also has our own Branded products.  Thanks in advance for any help.

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    Scott Buchheit
    Crystal MN
    United States
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  • 2.  RE: Complaint and Recall Handling

    Posted 10-Nov-2019 15:18
    Scott, this is entirely up to the organization.  The "Complaint Handling Unit" may address complaints, adverse event reporting and recalls/ ​field safety corrective actions, and report to either the Quality Manager or the Regulatory Compliance Manager.  The only requirement is the ability of the CHU to operate in full complaince with all rel;evant requirements of 21 CFR 803 - Medical Device Reporting; 21 CFR 806 - Reports of Corrections & Removals; 21 CFR 820.198 - Complaint Files; etc.

    Hope this helps.

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    Homi Dalal RAC
    Regulatory Affairs Leader
    Christchurch
    New Zealand
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    Original Message


  • 3.  RE: Complaint and Recall Handling

    Posted 11-Nov-2019 09:09
    Agree with Homi on this - it is totally up to the company, and it may even vary according to the workload and skill sets of the various groups/people. Also a note - while it makes sense to have complaint/MDR under the same group, it isn't required - there are companies that have a separate group just for MDR assessments.

    Also, they are not necessarily tied to recall. In my current organization, Recalls are handled by regulatory while complaint/MDR are handled by Quality Systems. For now. As a small company things can change periodically.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: Complaint and Recall Handling

    Posted 11-Nov-2019 08:10
    Hi Scott.

    My thoughts are that you have to determine what works best for your group.  In some cases I have seen complaints handled strictly through the Quality team.  In others I have seen them handled strictly through a Compliance/Regulatory function.  And in some, I have seen the responsibility split where the complaint team has a solid line reporting relationship to Quality or Regulatory/Compliance with a dotted line reporting relationship to the other group.

    What I will suggest is more important is flexibility and understanding the needs of the organization as well as being able to use softer skills to influence others not in your direct line of reporting.  Additionally, I think the company needs to be self-aware and flexible enough to understand when a particular reporting structure isn't working and manage that change as well.  Having been part of some structures that didn't work, I can tell you there is nothing more frustrating or demoralizing to a team than tension/issues with reporting...​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


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