RM #104 – Failure Modes and Effects Analysis (FMEA)

Course description:

This course is intended to teach the fundamentals of Failure Modes and Effects Analysis (FMEA) with a focus on product safety.  The course is comprised of both theory, and practice in the form of several workshops: DFMEA, PFMEA, Use/Misuse FMEA, and Software FMEA. The Use/Misuse FMEA workshop includes an introduction to usability engineering, and the Software FMEA workshop includes a segment on software risk management. The learners become familiar with the strengths and weaknesses of FMEA and learn how to be efficient and effective in the use of this analytical technique.  FMEA is a complementary technique to Fault Tree Analysis (FTA).  It is recommended that risk management analysts have a working knowledge of both techniques.

Intended Audience:

RM #104 intended for people who will be performing Failure Modes and Effects Analysis, or will be reviewing and approving FMEAs.  This includes quality, engineering (mechanical, electrical, software), process engineering (manufacturing, installation, service, etc.), and usability engineering.


RM #104 offers knowledge on the following topics:

  • History of FMEA
  • Types of FMEA
  • Objective of FMEA
  • Vocabulary of FMEA
  • Strengths and weaknesses of FMEA
  • The connection between FMEA and Fault Tree Analysis (FTA)
  • Failure Theory
  • Deep understanding of Severity, Occurrence and Detectability rankings
  • Hierarchical multi-level FMEAs
  • FMEA cascade
  • Role of FMEA in risk management
  • Role and benefits of facilitation in FMEAs
  • Common mistakes in FMEAs
  • Tips and advice for success in FMEA


Upon completion, participants should:

  1. Understand what FMEA is, its purpose, objective, strengths and weaknesses
  2. Understand hierarchical multi-level FMEAs and how to produce reusable FMEAs
  3. Be able to properly rank Severity, Occurrence and Detectability in FMEAs
  4. Know what it takes to be successful and efficient in performing FMEAs


Duration: 4:00 hours (theory section) + 2-3 hours for each workshop

Language of instruction: English

Means of delivery: In-person (preferred), and online via Zoom

CEU: ASQ and CSQE certified professionals can receive CEUs. Ask for a certificate of attendance.

About the Instructor

Award winning, international educator, consultant, and author

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups.  He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering.  At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results.  Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

Interviews – Podcasts (audio)

· ISO 14971; What’s difficult about risk mgmt; Quantitative risk mgmt; AFAP … (2023)

· Risk Management – Aerospace to Medical Devices; Uncommon Knowledge (2023)

· Risk-Based Decision Making (2023)

Interviews – Podcasts (video)

· Risk management for software – SaMD (2023)

· Wisdom of Risk Management (2022)

Articles about Bijan

· 5 Nuggets of Wisdom (2022)


· Quantification of Benefits for Medical Devices


· Safety Risk Management for Medical Devices (2nd Edition, 2022) (1st Edition, 2018)