11. DFSS Risk Management Process

  1. Basem S. El-Haik and
  2. Khalid S. Mekki

Published Online: 15 APR 2008

DOI: 10.1002/9780470264003.ch11

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

How to Cite

El-Haik, B. S. and Mekki, K. S. (2008) DFSS Risk Management Process, in Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470264003.ch11

Publication History

  1. Published Online: 15 APR 2008
  2. Published Print: 11 APR 2008

ISBN Information

Print ISBN: 9780470168615

Online ISBN: 9780470264003

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Keywords:

  • risk management process planning;
  • risk estimation - requirements and hazards;
  • robust design failure mode and effects analysis

Summary

This chapter contains sections titled:

  • Introduction

  • Planning for Risk Management Activities in Design and Development

  • Risk Assessment Techniques

  • Risk Evaluation

  • Risk Control

  • Postproduction Control

  • Summary

  • Appendix 11A: Robust Design Failure Mode and Effects Analysis