Regulatory Open Forum

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  • 1.  Fostering a Culture of Quality

    This message was posted by a user wishing to remain anonymous
    Posted 11 days ago
    This message was posted by a user wishing to remain anonymous

    Hoping for some input from this community re: initiatives that have been effective at fostering a culture of quality within your organizations. Thank you!



  • 2.  RE: Fostering a Culture of Quality

    Posted 10 days ago

    Ensure that the leadership team has someone with a strong voice for quality excellence in its ranks. That person leads the charge in demonstrating the importance of a quality culture and building quality into the organization from the start. If you are part of a leadership team that does not value quality, it can be very challenging to overcome that, but there are numerous examples of how poor quality leads to bad business outcomes that you can point to when building your case. Ultimately you need to terminate the employment of those who don't buy into the quality culture, which is difficult. This includes those in leadership positions. Whenever I need a reminder of the importance of quality when making decisions, I try to think about if I would take the medicine or use the medical technology myself, or would I give it to my children. If you have reasonable doubts about your own product when thinking of it in this manner, there are likely problems that need to be fixed.

    Curious to know what prompted your question in this forum, but understand if you cannot elaborate.

    Kind Regards,

    Nathan



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    Nathan Blazei
    Head of Quality & Regulatory Affairs
    Kymanox
    Morrisville NC
    United States
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    Original Message


  • 3.  RE: Fostering a Culture of Quality

    Posted 8 days ago

    Anon,

    It always starts from the top management.  If the top management concentrates on stock price or selling the company or supporting their customers, this is the attitude which will pervade through the rest of the organisation.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 4.  RE: Fostering a Culture of Quality

    This message was posted by a user wishing to remain anonymous
    Posted 8 days ago
    This message was posted by a user wishing to remain anonymous

    Partly it's how we talk about things.....

    We take pride in quality.

    We celebrate our good products, sharing stories about the difference they have made in patients' lives, or how much the healthcare professionals like them.

    We recognize the people in production and design areas who have good ideas about how to improve or maintain quality.

    When there's an error in production, the whole team in that area gets together to talk about what went wrong and the various things that could have contributed to the problem and what things we might change to prevent something like that from happening again.

    We try to hire people who will care about quality. When we have someone whose work is shoddy and who won't care about the results, we let them go.

    We keep quality metrics and targets. The management team meets regularly to review the graphs, recognize the good numbers, and encourage action to find ways to improve where needed.


    Original Message


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