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 several hands-on 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.

Objective:

RM #104 offers knowledge on the following topics:

• Concept of FMEA
• Types of FMEA
• FMECA vs 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 safety 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 an affiliate professor at Drexel University, school of biomedical engineering.  Passionate about risk management, Bijan has trained over 10,000 people worldwide, on the best practices and knowledge on medical device safety risk management. 

For more details, please visit MedtechSafety.com