The Use and Mis-use of FMEA in Medical Device Risk Management

Why Should You Attend:

FMEA is one of the most important tools for risk management according to the ISO 14971 standard because it identifies known and unknown risks very early when the cost of reducing risks is very low. It can reveal missing requirements, vague requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. But, the tool has several inherent traps that should be recognized and avoided.

This 90-minute presentation covers the best industry practices in using Failure Modes and Effects Analysis (FMEA). You will learn about what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently. Several case examples will be presented to give a hands-on feel to attendees.

Learning Objectives:

At the conclusion of the module, you will learn:

• The most efficient method for FMEA.
• How FMEAs are misused in medical device industry.
• How to integrate FMEA into the risk management process.

Areas Covered in the Seminar:

• How FMEAs are usually mis-used in medical devices?
• How to get most value from FMEAs.
• The correct way to conduct FMEA.
• How to integrate FMEA in the risk management process.
• Eliminating design defects to reduce risks of recall.
• Eliminating manufacturing defects to reduce risk of recall.
• A new strategy for getting fast results.

Who Will Benefit:

• Design engineers and managers
• Manufacturing engineers and managers
• Maintenance engineers and managers
• Risk Managers
• Compliance Officers
• Legal Professionals
• Senior Management
• Quality Control/Quality Affairs
• Regulatory Affairs
• Internal Auditors
• Operations/Production

Instructor Profile:

Dev Raheja, a respected and sought out expert on medical device and hospital care safety, draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and system reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and customer satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.

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