Failure Mode & Effects Analysis for Design Improvement & Control for Medical Devices, Live Webinar 2015

Topics

• Design FMEA Procedure
  • Identifying failure modes
  • Defining failure mode
  • Assessing frequency of failure
  • Identifying failure mechanisms
  • Assessing the detection rating
  • Assessing the severity of failure
• FMEA methodology-the right way
  • Avoiding wrong practices
  • FMECA process overview for Design Control
  • Using FMEA to control design process and validation
  • Best practices
• Process FMECA Procedure
  • Team selection
  • Identifying critical process features
  • Developing process flow charts
  • Team performance criteria
  • Assessing frequency
  • Identifying process failure modes
  • Assessing detection rating
  • Assessing severity
• Developing Elegant Design Solutions
  • Avoiding the failure
  • Identifying critical design features
  • Fail-safe
  • Fault tolerance
  • Workshop on actual product
  • Prognostics health monitoring
• FMEA for Planning Design Validation
  • Determining the accelerated test levels
  • Determining the variables for test design
  • Monitoring validation
  • Developing acceptance criteria
• Elegant Process Reliability Improvement
  • Early fault detection
  • Redesign the process
  • Quick root cause analysis
  • Redundant monitoring of critical fea
  • Workshop on actual process
  • Innovative solutions
• FMEA for Planning Process Validation
  • Developing a process reliability plan
  • Planning qualification of critical design features
  • Developing acceptance criteria

Who should Attend

• Senior management
• R&D, Scientists
• Product Management, Product development
• Engineers
• Safety, Reliability, Quality Assurance
• Manufacturing managers and engineers
• Purchasing & Production
• Regulatory
• Sales