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  • 1.  QM & QA reporting lines

    This message was posted by a user wishing to remain anonymous
    Posted 05-Mar-2018 08:49
    This message was posted by a user wishing to remain anonymous

    Dear community,

    I been confronted over and over again with the question where QM/QA should report into in a medtech company (especiall in a low risk class I, II (mostly without 510(k)s)).
    It would be great if you could share some thought or experience on this?

    thank you


  • 2.  RE: QM & QA reporting lines

    Posted 06-Mar-2018 09:08
    It depends on the structure of the company, size of the company, culture of the company, and how the management organisation is established.  The important part is that the "quality" function remain an independent, unbiased position that can inform the management team with sometimes difficult information providing recommendations on yet further difficult decisions.  My time in industry I was usually reporting to the CEO/President in ~100-200 person companies as the Quality Manager/Management Representative.  The expectation by regulatory agencies is the individual responsible for quality, i.e. product release, putting product on hold, quarantine release, reporting on QMS, reporting on metrics, is an independent function that can complete their job function without reprisal.  Such as if the quality position reported to the Operations Manager who was also responsible for production, this may not allow product to be placed on hold in volatile situations because the Operations Manager is responsible for getting orders shipped.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: QM & QA reporting lines

    Posted 06-Mar-2018 10:35
    It never ceases to amaze me that people think there is a "right" answer to this question. Much depends on the overall organization structure, the engagement of the President of CEO with QA/RA matters, and the dynamics between groups. Over the years, I have been in RA organizations that reported through legal, through quality, straight to the GM or President, through the COO etc. Similarly, for quality I reported to legal, to the President, the COO, the CEO and the CTO. They all had different strengths and weaknesses, more related to the individuals than the org structure.

    For example, by far the best leader I reported to, and the most dedicated to "doing things right" was an R&D guy who had evolved into our COO. Yes, he had charge of operations and R&D, but that was a positive, not a negative. We also had a super-engaged President at that time. Similarly, given my background, I think that even as CTO, having RA report to me is reasonable.

    I can tell you what DOESN'T work.
    - a top QA/RA leader who isn't able to influence and get things done without their boss having to make people agree
    - reporting through a functional leaders (Ops, R&D whoever) that has an agenda that does not include doing things right
    - having top management that doesn't give a [blank] about QA/RA/Compliance

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: QM & QA reporting lines

    Posted 13-Mar-2018 06:47
    Ginger,

    I think you are right on here. I have recommended to a few clients to read your posting. The ability of RA/QA to influence the organization in showing we are part of the team that works together to accomplish ALL of the organization's objectives (business, quality, etc.) the better performing the organization will be in the end. 

    Good luck!

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


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