Regulatory Open Forum

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  • 1.  KPI: Stakeholder Feedback

    Posted 24-Oct-2017 13:36
    ​Regulatory Gurus,

    I hope all is well.  I need your help to create a relevant and measurable Key Performance Indicator for stakeholder feedback.  I have an amorphous statement about "...getting positive stakeholder feedback....", but I am having trouble adding the details.  Is this a survey to our critical suppliers? Or conducting clinical panels?  Any guidance would be appreciated.

    I am measuring feedback to round out the other types of "feedback" from audits, internal metrics, etc, as part of the continual improvement process.


    William Coulston
    Quality & Regulatory Affairs
    Rochal Industries LLC
    San Antonio TX
    United States

  • 2.  RE: KPI: Stakeholder Feedback

    Posted 25-Oct-2017 01:22

    Could you consider tying it stakeholder satisfaction to specific outcomes that they deem important? For example, if one set of your key stakeholders is Marketing and Sales, then their key outcome is most likely how quickly they can begin marketing and selling new devices, so KPIs could focus on submission prep time, time from submission to clearance/approval, etc.  For R&D stakeholders, it could focus on the submission "quality" so the number of deficiencies on content generated by R&D, rounds of questions, etc.  

    Preparing a baseline report of this type of data can help you develop specific measures and targets with your stakeholders, then off you go.   This is also a great way to educate your stakeholders about regulatory stuff.  

    Let us know what you end up doing - I'm always keen for new ways to communicate to the business. 


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  • 3.  RE: KPI: Stakeholder Feedback

    Posted 25-Oct-2017 08:20
    Check out the Net Promoter Score. It's a global standard for customer, employee or other stakeholder feedback and is easy to capture and calculate. It's just one simple survey question and a simple percentage calculated from the neg/neutral/pos responses. 

    Kate Smith
    Toronto ON

  • 4.  RE: KPI: Stakeholder Feedback

    Posted 25-Oct-2017 08:33
    William, I forgot to tie into your question about who to survey. I use customers as we want to find out a general brand value. NPS collects the notion of how the quality of the device and the external services are perceived in the market which is an important net of what the quality system should be aiming to achieve. 

    But you could use it for any stakeholder. 

    I look forward to hearing how others measure other aspects of their QMS. Particularly regulatory functions!

    Kate Smith
    Toronto ON