Introduction to Failure Mode and Effects Analysis for Product and Process

Failure Mode and Effects Analysis (FMEA) is a systematic method for preventing failure through the discovery and mitigation of potential failure modes and their cause mechanisms. Actions are developed in a team environment and address each high: severity, occurrence or detection ranking indicated by the analysis. Completed FMEA actions result in improved product performance, reduced warranty and increased product quality. This course assists FMEA team members to apply severity, occurrence and detection rankings consistently and efficiently and explores, in detail, the linkage of the Design FMEA and the Process FMEA through special characteristics development and product and process design collaboration. The relationships between FMEA and other popular tools, including Fault Tree Analysis (FTA), Design Verification Plan and Report (DVP&R) and Control Plans will also be discussed. Participants can expect dynamic "hands-on" activities with in-class Design and Process FMEA creation, facilitation skill development and risk analysis best practices. Instruction and clarification will be provided for relevant portions of the SAE J1739 standard, Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA), a copy of which will be included with the course materials.

What Will You Learn

Upon completion of this seminar, attendees will be able to:

  • List the benefits, requirements, and objectives of an FMEA
  • Demonstrate the steps used in developing an FMEA
  • Follow the methodology to efficiently create an FMEA
  • Describe other tools used in, or related to the FMEA
  • Identify corrective actions resulting from proper FMEA development
  • Identify and classify the levels of risk requiring corrective action
  • Show the links between Design and Process FMEA
  • Demonstrate the FMEA's role in developing Special Characteristics and Design and Process Controls
  • Summarize the objectives of the SAE standard  J1739 

Is This Course For You

This seminar is designed for engineers involved with manufacturing, product design, reliability, testing, quality, development, logistics/support, product assurance/design assurance, materials, and their management or anyone responsible for the design and development of manufacturing, assembly or service processes in the completion of a Design or Process FMEA.

Materials Provided

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Course Requirements

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  • Pretest - Set baseline of knowledge and determine Voice of the Customer (participants) wants needs and desires
  • FMEA Process Overview
    • Introductions and course objectives
    • What is risk?
    • The history and purpose of FMEA
    • SAE J1739 introduction
    • FMEA - where it fits in the product development process
    • System/Subsystem/Component Design FMEA
    • Manufacturing and Assembly Process FMEA
    • Machinery and Equipment FMEA (Logistics Support)
  • FMEA Development Methodology
    • Design FMEA development methodology - the three path model
    • Failure Mode Avoidance FMA /FPA Failure Prevention Analysis
    • Team structure and rules for efficiency - cross functional teams
  • The Links between Design and Process FMEA
    • Special characteristics (critical and significant)
    • Collaboration on special characteristics
    • Characteristics as inputs to PFMEA
  • Workshop 1: Review product and processes to be performed
  • Practical Application of the Design FMEA Technique
    • Robustness Tools: Interface Analysis/Boundary (BLOCK) Diagrams; Parameter Diagram (P Diagram)
  • Workshop 2: Construct Boundary/Block Diagrams and P Diagrams
  • Review of Days Activities and Q&A

  • Methodology and Hands-on Experience
  • Path 1
    • Functions/Failure Modes/Effects of Failure/Severity
    • Severity ranking guidelines
    • Actions for high severity (9,10)
  • Workshop 3: Path 1 Exercise
  • Path 2
    • Causes/prevention controls/occurrence
    • Occurrence ranking guidelines
    • Inputs to FTA (Fault Tree Analysis)
    • Actions to eliminate and/or reduce cause probability
  • Workshop 4: Path 2 Exercise
  • Path 3
    • Test and verification methods
    • Detection ranking guidelines
    • Links to DVP&R
    • Actions to improve tests and verification techniques
    • RPN - Risk Priority Number
  • Workshop 5: Path 3 Exercise
  • Fault Tree Analysis Fundamentals
    • When to use FTA instead of or in combination with FMEA
    • Similarities and differences with FMEA
    • Symbols and structure
    • Cut set development
  • Workshop 6: FTA Exercise
  • Process FMEA Pre-Work
    • Process flow diagrams
    • Characteristics matrix (QFD III)
  • Workshop 7: Process FMEA Development (Three Path Model)
  • Keys to Success and Efficient FMEA Development
    • Technology blocks for failure mode/ cause mechanism history
    • FMEA legacy matrices (Lean FMEA)
  • Other Tools and Techniques Used or Related to FMEA
  • Statistical Process Control (SPC) for special characteristics
  • Design for Assembly and Manufacturing DFA/M
  • 8D - Eight Disciplines of Problem Solving and FMEA Links
  • Role of FMEA software
  • Reliability and Maintainability (Logistics Support)
  • Q&A
  • Post Test and VOC Closure