Concurrent Sessions (T23 - T28)
Presentation Description: 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 perhaps 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 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 presentation will cover the weaknesses of the traditional RPN 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.