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. The course requires 16 hours of instruction.


This course is required for all scientists, engineers 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.


There are no prerequisites for this course.

Course Objectives

  1. Understand the definitions, process and tools associated with Quality Risk Management
  2. Identify potential design, process or test issues associated with product and performance risk
  3. Understand the tools and methods for risk assessment and prioritization
  4. Understand the various types of FMEAs
  5. Apply the basic steps for FMEA generation
  6. Know when and how to apply FMEA to product and process development
  7. Prioritize and manage risk reduction opportunities from FMEA results

Detailed Course Outline

Section I: Quality Risk Management Principles and Process

Risk management principles
Risk management process
Risk assessment
Risk control
Risk communication
Risk review

Section II: 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

Section III: Technical Risk Assessment and Failure Modes and Effects Analysis

Application areas for FMEA
FMEA preparation
FMEA generation workshop

Section IV: Methods for Reducing Risk

FMEA action plans and risk reduction