Risk Management and Analysis in Medical Device Manufacturing using DFMEA

Design Tools Including SFMEA / DFMEA and Associated Tools for Risk Management

Seminar Content

This two-day hands-on seminar is intended to offer insight into, and hands-on experience with, the linkages between various aspects of the Risk Management process. Specifically, the development and linkage of Block Diagrams, System and Design FMEAs and Design Verification (Test) Plans (DVPs) are addressed.

Design FMEAs (DFMEA) or System FMEAs (SFMEA) are performed during the Design phase for Risk Management and Prevention. SFMEAs are used to identify Special Requirements, Critical Items and Key Characteristics to assist in the flow-down to sub-assemblies and components.

This class includes breakout exercise sessions using an example of a Medical Device sub-assembly project and product launch. This running example will be used throughout the five-day Risk Management and Analysis in Medical Device Manufacturing Series (This also includes: ISO 14971:2009 Risk Management for Medical Devices Overview and Practical Risk Management using PFMEA).

Who Should Attend

  • Program Managers
  • Project Managers
  • Quality Managers
  • Design Engineers
  • AQP Team Members
  • All other Risk Management personnel

Recommended Training and/or Experience

Participants should possess a working knowledge of quality systems and methodologies.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals

  • Provide a hands-on approach to S/DFMEAs and their relationship to program deliverables and status reporting
  • Provide the competencies needed to introduce new products and processes smoothly
  • Gain knowledge and understanding in:
    • Block Diagrams and Interface Matrix
    • Linkages between Block Diagrams, SFMEAs, DFMEAs, DVP and other design tools
    • Linkages between PFMEAs and S/DFMEAs
    • Using FMEA as an analytical process
    • S/DFMEAs and DVPs

Seminar Outline

  • FMEA Introduction
  • Putting an FMEA Together
  • DFMEA Prerequisites
    • Breakout Exercise: Customers & Functional Requirements
    • Breakout Exercise: Boundary Diagrams
  • Developing the DFMEA
    • Breakout Exercise: Starting the DFMEA Form
    • Breakout Exercise: Failure Modes
    • Breakout Exercise: Design Causes
    • Breakout Exercise: Design Control
    • Breakout Exercise: Effects, Severity and Action Plans
  • DFMEA – Component Level
    • Breakout Exercise: Developing a Component DFMEA
  • Test Planning and Reporting