Insights on risk management topics and tips and techniques for implementation.

Weekly Live Series, Episode 1: Understanding Hazard Analysis

achievelivesessions fmea hazard analysis live series risk management Apr 29, 2022

This week, we kicked off our Weekly Live Discussion Series! We talked about Hazard Analysis and why it becomes challenging if you try to combine it within a FMEA (Failure Mode Effects Analysis). Check out the video recording below and join us next week!

Introducing the weekly live discussion series

The practice of risk management in the medical device industry is challenging. Technology is rapidly evolving and regulatory environment is getting more complex to navigate. As risk management professionals, we not only have to ensure regulatory compliance, but also establish a process that is both highly efficient and effective in accelerating innovation. 

In these weekly discussions, we will focus on specific questions or topics that we 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 will last about 30 minutes. We will start with a few introductory slides to set the stage. However, it is not meant to be a webinar or a lecture. The goal here is to set the stage on a very specific topic, describe the requirements and highlight a few common challenges in implementation. This will be followed by a more open discussion on comments or questions from the attendees.

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. 


Highlights from Episode 1: Understanding Hazard Analysis

In our introductory slide presentation, we provided an overview of ISO 14971:2019 requirements for risk analysis, which also includes a systematic analysis of hazards, sequence of events, hazardous situations and harms. Hazard analysis is not the same as a failure mode effects analysis (FMEA). This is a common point of confusion in the industry and often a source of complexity and challenges in the risk management process. It is very important to understand how a trigger event, which may or may not be related to a device issue, can cascade into a chain of events leading to a hazardous situation where a patient or user may experience harm. We described this linkage in detail and provide an example of a single line in a hazard analysis. We also shared a link to our free PHA template that can be used for this purpose. 

Following the opening presentation, we discussed the following comments/questions from the attendees:

  • Why using an FMEA for hazard analysis is challenging for hazard analysis.
  • Why we need to look at all foreseeable events to identify all potential harms of different severity levels, not just the worst case outcome.
  • Why it is critical to work with medical experts/clinicians. 
  • Is it reasonable to require the occurrence level to be 1 in a million?
  • What are the limitation of component failure analysis in a dFMEA with respect to hazard/harm analysis?
  • How does the FDA define the term "harm"?
  • What are the hazards related to environmental harm and cybersecurity?

Watch the video above to learn more about these questions. You can use the time stamps to jump ahead to a specific topic of interest. 

Special Offer - if you watch the whole recording, you will find a special exclusive discount offer to our on-demand Risk Management Fundamentals course! This course will help you master 25 key terms used in risk management of medical devices for ISO 14971:2019 compliance. 





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