Quality Basics

Concurrent Session

T07 - A Fresh Approach to Risk Assessment and FMEA

Primary Presenter(s)

• 

  Beverly Daniels

  Sr. Director, Operational Excellence
  IDEXX
  Raymond, Maine

Moderator(s)

• 

  Shawn Armstrong

  Sr. Quality Engineer
  PakTech
  Junction City, Oregon

Level: Intermediate

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.

Learning Objectives:

• Explore why risk prioritization number values are unreliable and mathematically flawed, resulting in incorrect conclusions regarding risk.
• Understand why likelihood is impossible and irrelevant to assess.
• Accurately assess product changes that might affect quality.
• Discover how best to track assessments, testing, and mitigation actions.
• Learn to apply the methodology to general business risk assessments.