Quick Tip - Create a process to update risk files
Failing to update your risk files can get you a warning letter from the FDA!
Dear colleagues - I am super excited to launch a new series called Quick Tips as part of the Let’s Talk Risk! newsletter.
Every week, I will share a quick tip to help you master the art and science of risk management, especially in the context of medical devices. These tips are based on my personal experience and ongoing research. My goal is to share the best thinking about risk management with you!
Sometimes, these tips will give you actionable insights you can immediately apply in your practice. At other times, they will help you develop a more strategic perspective on risk.
Whenever possible, I will also provide links to additional resources and related articles for a deeper understanding.
Let me know in your comments below if you find this information useful. Feel free to also suggest specific questions or topics of interest to you.
I think the wording of this Warning Letter may lead to some confusion, Naveen. They use the term "Risk Matrix" here which is commonly identified in most systems as the table that has Severity of Harm on one axis and Probability of Occurrence of Harm on the other. The intersection of a Severity and a Probability is used to establish the risk.
I don't think Risk Matrix in this Warning Letter means that. I believe they are talking about the lack of an entry in the Risk Analysis for the situation encountered by the manufacturer which was not identified in the risk management system. Perhaps the manufacturer used the term in their encounter with the FDA and this is what led to the confusion in terminology.
We always need to make sure we are using the right terms and definitions when we communicate with others so we do send the intended message and it is received with the same meaning.