ISO 14971 requires the top management to evaluate the suitability and continuing effectiveness of the risk management process for their medical device. But this evaluation is generally done rather implicitly in the medical device industry. Generally speaking, there are no explicit criteria or measures defined to evaluate suitability and effectiveness.

This was a topic of discussion in a recent Weekly Live Discussion. The article below presents a summary of our discussion and poses the same question for further discussion.

Highlights from Episode 5: Effectiveness of risk management process

Check out the video below which opens our discussion with a brief slide presentation on this topic. 

ISO 14971:2019 requirement is for the top management to review the suitability and continuing effectiveness of the risk management process at planned intervals. Generally, the industry practice is to review the risk management process in the Management Review to identify if there are any new risks and/or if the risk files need to be updated. In general, there are no explicit measures or objectives related to the suitability and effectiveness of the overall risk management process itself.

So how can we tell if the process is suitable and effective if we don't have clear objectives and measures? 

In a recent LinkedIn poll, we asked our colleagues to identify the most important factor when evaluating the success of their risk management process. The 4 choices were - 1) Time to Market; 2) No audit findings; 3) Fewer adverse events; and 4) Patient/doctor satisfaction.

The results surprised us! Sure, this was not a scientific poll, but it seemed that the results reflected what people believed the most important factor should be, rather than what it generally is in real practice. This is because, evaluation of suitability and effectiveness, generally, is not a very explicit process.

In our live discussion, we talked about a variety of issues related to this topic and comments/questions from the attendees:  

• ISO 14971 requirements, LinkedIn poll results
• Why evaluate suitability and effectiveness?
• Relationship with Clause 10 of ISO 14971:2019
• Understanding why safety risk should be seen as a business risk
• Linking process outcomes to business objectives for effectiveness
• Why post-production phase is critical for reviewing effectiveness
• Is your process limited to only regulatory expectations?
• Influencing and leading change in your organization
• Using existing risk files as a starting point for new products

Watch the video above to learn more about these key points and common challenges.

Join our weekly live discussions!

In these weekly discussions, we focus on specific questions or topics that practitioners of risk management find challenging from a practical, day-to-day point of view. Our focus is not on regulatory compliance, but on sharing common problems and best practices. 

These sessions generally last for about 30 minutes. We open with a short slide presentation to introduce the topic or a specific question of interest. You can participate by sharing your question or comment via live chat at any time. However, there are a few key points to note:

• This is an open forum; therefore, do not share any proprietary or business sensitive information
• Our discussion is meant to share information and knowledge purely for the purpose of education

 How you can participate

These discussions will occur via live streaming on LinkedIn and YouTube. If you already follow us on LinkedIn or YouTube, you will get a notification as soon as we go live. Otherwise, connect with us here on the Achieve LinkedIn Page or subscribe to our YouTube channel. During the live meeting, you can use the chat/comments section to ask a question or share comments and best practices. 

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