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

Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested.

Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process is largely a documentation exercise - rarely does this FMEA affect the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process.

Areas Covered in the Session:

• What is an FMEA
  
  • What are the components of an FMEA?
• How should I use FMEA in performing risk management?
• What are the problems with FMEA in risk management?
• How is an FMEA conducted
  
  • What and who are needed
  • Identifying significant risks
  • Development of mitigating actions
• Discussion of specific elements of an FMEA
• Follow up activities
  
  • Post action risk
• Advantages
• Disadvantages and pitfalls
• How should delectability 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 (FMEA) in performing Risk Management.

• Product Design Teams and personnel assigned to use FMEA at medical device companies
• Quality Managers
• Regulatory and Compliance Personnel
• Personnel Responsible for Verification and Validation Activities
• Quality System Auditors