Failure Modes and Effects Analysis (1 day)

Instructor

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 inherent in a product design or manufacturing process.  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 Six Sigma Design and Six Sigma Validation processes.

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 the FMEA fits into the design process.
  • Weaknesses of FMEAs and how to overcome them.
  • How to streamline the FMEA process.
  • Factors for a successful 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 scientist, engineers and other technical staff.

Course Outline

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

Prerequisites

None.

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