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.

Attendees:
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.

  

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

  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.

Software: JMP, Microsoft Excel
Prerequisites:  None

Detailed Course Outline:

Quality Risk Management Principles and Process  
Risk management principles
Risk management process
Responsibilities
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
Regression
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