Have you ever heard that an upcoming change is low risk? Or perhaps you’ve heard that it’s only a small change, so validation isn’t necessary? Or maybe you’ve grown frustrated by endless debates regarding the potential risks of an adverse event that deteriorate into the probability of a meteor strike or the zombie apocalypse? Risk assessment and failure mode and effects analysis (FMEA) are not a matter of filling out a form. They should not be a matter of opinion or debate. When properly performed, they can be a powerful approach to preventing and mitigating the effect of adverse events. Modern thinking is moving away from the traditional approach to FMEA and the calculation of a risk priority number. This session will cover the weaknesses of the traditional risk prioritization number calculations and provide a simpler, more robust approach to risk assessment (and FMEA). Examples will be covered that explain each concept, including change management activity to deploy the methodology.