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Risk Management / FMEA Training Course

Risk Management / FMEA Training

Risk Management is a key element of doing business today 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 which uses hands on exercises involving prepared examples. The one day training class can then be supplemented with a 1 day facilitated workshops 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
Risk Management / FMEA
Jon provided facility-wide risk management training focusing on FMEA as an additional or alternate risk-management tool. The training was provided in 3 sessions. Session #1 focused on general principles and practices. Sessions #2 and #3 were team working sessions for PFMEA and DFMEA brainstorming and development. Jon's presentation materials were comprehensive and well-organized. The audiences' previous experience was varied but the content was interesting enough that regardless of expertise all attendees found the training to be a positive learning experience. The actual FMEA exercises were most informative and proved to be very valuable in ensuring uniformity in tool usage across functional areas. I would recommend the training to any organization that intends on using FMEA as a risk-management tool.
Risk Management / FMEA
Jon came to our company headquarters and introduced a large, cross-functional class to the concepts of D/PFMEA, and then worked with a core group to develop templates and explain the underlying theory, philosophy and intent behind the processes. With Jon's guidance, we used our own products to work through real-life DFMEA and PFMEA scenarios for valuable, hands-on experience. As we continue to apply these principles, we have full confidence in Jon's ability to help our processes evolve to the next level.