Dear colleagues, hello! 👋
➡️Just like a technician has a toolbox with many different tools, each designed for a specific purpose, risk practitioners should also have in their toolkit different techniques, not just an FMEA!
Here is a recording of last month’s webinar about why FMEA alone is not sufficient for risk analysis. We also discuss a practical method to correctly link your FMEA to hazard/harm analysis.
➡️In light of rapidly changing regulatory environment, an audit is less about compliance and more about effectiveness. But how do you evaluate the effectiveness of a Quality System process as an auditor?
In this Let’s Talk Risk! conversation, Rick Rios advises us to focus on the purpose statement of each procedure to measure process effectiveness.
➡️In the medical device and pharma industries, risk is generally associated with harm to patients. But risk also means opportunity.
This quick tip reminds us that safety is important but not the only objective for risk management. Risk practitioners should broaden their perspective to help achieve business success.
Upcoming events
LTR weekly conversation on LinkedIn: how collaboration between Medical Safety and Quality can help improve patient safety
Join me next Friday, December 15, 2023 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest next week is Mark Armstrong, who will discuss how close collaboration between Medical Safety and Quality can help improve patient safety. Click below to learn more and add it to your calendar!
Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!
Save your spot here to join the next cohort of the LIVE ISO 14971 certification training course starting in January 2024. Watch a course introduction video and check out testimonials from past attendees!
Weekly Knowledge Challenge #12
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer for the question, “which of the following is an element of the risk analysis process according to ISO 14971?”, is “Identification of hazards” (See sub-clause 5.4). Other choices were: Failure modes and effects analysis, probability calculation, standard harms table and policy for risk acceptability.
Here is this weeks’ knowledge challenge.
1-Question Feedback Survey
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LTR Weekly Digest #15 - 9th December, 2023