Risk Management / FMEA Training Course

Risk Management is a key element of doing business, regardless of your industry. The ability to identify, analyze and mitigate risks is important to protecting customers, employees, and shareholders. This workshop teaches participants how to conduct effective Failure Modes & Effects Analysis (FMEA) for systems, designs, and processes.

FMEAs are required in many industries including Medical Devices (21 CFR 820, ISO 14969, ISO 14971) and Automotive (ISO/TS 16949:2009, APQP). The use of FMEAs is also strongly encouraged in Healthcare by the Joint Commission on Accreditation of Healthcare (JCAHO) and the Joint Commission Resources (JCR).

This workshop consists of a 1-day training class that uses hands on exercises involving prepared examples. The one day training class can then be supplemented with a 1-day facilitated workshop in which the participants will apply the concepts of FMEA to their own processes (PFMEA) or designs (DFMEA).

Class overview:

  • History and importance of FMEA
  • Types of FMEA
  • Key terminology (failure mode, effect, potential causes, mitigation, etc.)
  • Quantifying the concepts of severity, likelihood, and detectability
  • A robust procedure for creating FMEAs
  • Avoiding common problems
  • Case studies
  • Practice exercises