T27 - A Fresh Approach to Risk Assessment of Product Changes
Tuesday, February 25, 2020
2:45 PM – 3:45 PM
Location: Salon CD
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.
Why RPN values are unreliable and mathematically flawed resulting in incorrect conclusions regarding risk.
Why likelihood is impossible and irrelevant to assess.
How to accurately assess product changes that might affect quality
How best to track assessments, testing and mitigation actions.
How to apply the methodology to general business risk assessments