Quality Risk Management and FMEA

Course Description

This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Areas of instruction cover the topics associated with risk management including risk management definitions, risk management process and risk assessment tools including Failure Modes and Effects Analysis.


Course is required for all scientists, engineer and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to characterize, optimize and improve product and process performance.



8 Hours

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

Upon completion of the course the participants will be able to:

  • Understand the definitions, process and tools associated with Quality Risk Management
  • Identify potential design, process or test issues associates with product and performancerisk
  • Understand the tools and methods for risk assessment and prioritization
  • Understand the various types of FMEAs
  • Apply the basic steps for FMEA generation
  • Know when and how to apply FMEA to product and process development
  • Prioritize and manage risk reduction opportunities from FMEA results

Course Outline:

Quality Risk Management Principles and Process
Risk management principles
Risk management process
Risk assessment
Risk control
Risk communication
Risk review

Risk Analysis Tools
Basic quality tools and risk weighted analysis
Cause and effect diagrams
Process flow and risk assessment
Pareto and Risk Weighted Pareto analysis
Histograms, capability, simulation and margin
Control charts
DOE (product and process) and MSA

Failure Modes and Effects Analysis
Application areas for FMEA
FMEA preparation
FMEA generation workshop

Methods for Reducing Risk
FMEA action plans and risk reduction