FMEA Without Tears


Have you been in endless meetings on risk analysis where you feel the results were not useful or invalid?

This webinar provides a process to assess risk in an efficient way where everyone can agree on the results. It focuses on applying Failure Mode & Effects Analysis (FMEA) and another, greatly simplified, risk assessment tool.

Course description

This is a 2-hour webinar designed to facilitate the successful application of FMEA as a valuable risk analysis and risk management tool. There are many books, articles, and standards published on Failure Mode & Effects Analysis (FMEA). Unfortunately, when professionals in the field are asked about their experiences with FMEA, they often talk about the pain and suffering involved in the application. So, should we abandon this risk analysis tool because it is just too hard to use or too easy to misuse?

This webinar will give you an opportunity to hear about how to lead teams to apply FMEA across a wide variety of organizations. Over the past 3 decades the presenter successfully led teams tasked with risk analysis and risk management through a mentoring and “divide-and-conquer” approach.

In most cases, an FMEA exercise lasts 1-4 hours, depending on the complexity and risk involved. In one case, a thorough FMEA for a complex, high-risk (Class 3) medical device was completed, documented, and submitted in only three days. In another case, a risk analysis was conducted in 30 minutes using a simplified FMEA! But the key measure of success is that all team members felt that their effort yielded credible and actionable results.

Course outline

  • Task Preparation
  • Deciding on type of FMEA
  • Selecting an FMEA format
  • Establishing scope
  • Forming and Training a Team
  • Facilitating Teamwork Through a 12-Step Approach
  • Guidance on steps
  • Divide-and-conquer method
  • Reviewing results
  • Summarizing Results for Risk Management

Learning objectives

At the end of this webinar, participants will be able to:

  • Facilitate a Failure Mode & Effects Analysis (FMEA) team effort with no tears shed
  • Avoid the common misuses and abuses of FMEAs
  • Apply a simplified FMEA to achieve results in a flash
  • Apply the industry-standard format for an FMEA

Who should attend

Instruction is targeted to professionals involved in risk analysis and management. Given the broad application of risk analysis, this material will be of value to professionals working across the entire product or process lifecycle.


There are no prerequisites.



IndustryCombination products, Medical Device, Pharmaceuticals

Peter L. Knepell