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.
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.