“Risk Based approach” is a frequently used statement in the Life Science industries. Companies have thrown the term around for years, without really knowing what it meant or how to implement it. One of the largest gaps has been the use of consistent systems to ensure a full risk analysis. In recent years companies have implemented tools like Failure Mode and Effect Analysis (FMEA) to evaluate risk. While FMEA is a valuable tool to look at risk, it has its limitations. Primarily, it looks at single points of failure. In reality we have found that most failures are a complex interaction between many factors that in and of themselves don’t analyze out as a high risk. Fault Tree Analysis (FTA) is a different analysis tool which takes a top down approach starting with the failure, and analyzing factors and interactions that could cause this failure. Join us as we look more in depth at the Fault Tree Analysis, and how it can help your company with their "Risk Based Approach.