Regulatory Open Forum

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  • 1.  Management Review

    Posted 21-Apr-2023 11:40

    Management Review Research
    I hope everyone is having a great week.  I am trying to gather background information on the effectiveness of MRM.  This information will support a digital transformation learning tool.
    1. Do you feel the MRM is effective with excitive leaders?
    2. Would it help if your MRM could be proactive before your set meetings per your SOPs? 
        This could be accomplished using different Systems of Records to create a dashboard with current standing based on your KPIs.




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    Zillery Fortner
    Product Advisor QA/RA Life Science


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  • 2.  RE: Management Review

    Posted 26-Apr-2023 10:41
    1. It depends on the leaders. With the good ones, absolutely yes. They are active in reviewing the data, asking questions and suggesting new items of value to monitor. With the bad ones, they intentionally don't care and view quality as a cost and burden. No MR going will change them. With those who are simply new to the space or uninformed, the MR can be a good tool for educating them, but it also depends on the quality leader and their willingness to teach and to be forceful when needed.

      2. not sure what you mean by "be proactive before your set meetings"

      3. many companies already have some level of dashboard that they use for quality metrics, not sure what would be different?

      g-


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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 3.  RE: Management Review

    Posted 27-Apr-2023 10:45

    Thanks for the response, Ginger.
    My thoughts about proactive before the meeting is if the team had access to a live dashboard connected to multiple systems of records to show you a red, yellow, and green risk page on your current KPIs.  Example: I work in supplier quality and I open up this "app" and it shows me the live dashboard on the KPIs related to supply. How many suppliers are at risk, and #who needs auditing, vetting etc? 
    I might not be explaining it well, sorry. 



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    Zillery Fortner
    Product Advisor QA/RA Life Science
    Florence KY
    United States
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