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Dr. Wayne Taylor - Taylor Enterprises, Inc.
Applied Statistics
for Engineers and Quality in the FDA Regulated Industries

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FMEA for Software Engineers (1 day)


Dr. Wayne A. Taylor

Course Description

Failure Modes and Effects Analysis (FMEA) is a risk evolution and management tool used to identify and resolve risks inherit in software.  This course covers the step-by-step procedure for constructing an FMEA as well as the overall process for managing effective FMEAs and where they fit into the design process.  This course is similar to the course Failure Modes and Effects Analysis, except it focuses on software applications with all the examples, failure modes, risk scales and exercises based on software applications. 

Also covers the related tools Fault Tree Analysis (FTA), and Mistake Proofing.

What You Will Learn

  • The basic steps for performing an FMEA to identify risks.
  • Types of FMEAs including Usage, Product Design, and Process.
  • Where software FMEAs fits into this scheme and how to adapt the process to software.
  • Where the FMEA fits into the design process.
  • Weaknesses of FMEAs and how to overcome them.
  • How to streamline the FMEA process.
  • Factors for a succesful FMEA.
  • Additional uses of an FMEA including tracking corrective actions, determining when the design can be frozen, determining the sample sizes for validation/verifications, scoping revalidations and as part of CAPA investigations.

Primary Audience

All software engineers and other technical staff.

Course Outline

  • FMEA
    • Basic Procedure
    • Types of FMEAs
    • Corrective Actions
    • Control Plans
    • Managing an FMEA
    • Regulations & Standards
  • Mistake Proofing



Related Courses

Failure Modes and Effects Analysis




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Last modified: September 08, 2017