The Use and Mis-use of FMEA in Medical Device Risk Management
The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.
Description
Most medical device manufacturers use FMEA as a part of their risk management system.
FMEA is a tool designed for product reliability, which has been modified for use in risk management but has some pitfalls in this use. The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.
Areas Covered in the seminar:
- How should I use FMEA in performing risk management?
- What are the problems with FMEA in risk management?
- How should detectability be used in FMEA?
- Is there a role for RPN (Risk Priority Number)?
- Are there other tools to use in conjunction with FMEA?
- Are there FMEA applications in production as well as design?
Who Will Benefit:
This webinar will inform personnel at medical device companies on how to properly use Failure Modes and Effects Analysis (FEMA) in performing risk management.
- Product design teams and personnel assigned to use FMEA at medical device companies
- Quality managers responsible for integrating risk management into quality systems
- Regulatory and compliance personnel who develop premarket filings and technical files for medical devices
- Personnel responsible for verification and validation activities
- Quality system auditors
Instructor Profile:
Edwin L Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.
