FMEA - Failure Mode and Effects Analysis

* 5th Edition FMEA (AIAG & VDA FMEA 1st Edition) released in QI Macros' October 2019 release *

Preventing Disaster with FMEA, DFMEA, PFMEA and FMEA-MSR

When you are designing a product or a process that can affect human life, you want to anticipate all of the ways things could go wrong and affect your customer.

The automobile and airline industries do this routinely to mitigate and prevent potential problems. The tool they use is the Failure Modes and Effects Analysis (FMEA).

QI Macros add-in for Excel contains an easy-to-use FMEA Template to guide you through your analysis. You can use it to analyze a:

  • Product (car, x-ray, MRI) using a Design FMEA (DFMEA)
  • Part (car door) using a Design FMEA (DFMEA)
  • Process (part stamping process or elective surgery) using a Process FMEA (PFMEA)
  • Project identification (legal and/or technical requirements, customers' wants/needs/expectations) using a FMEA for Monitoring and System Response (FMEA-MSR)
Gary Larson's crisis clinic and fmea

Seven-Step FMEA Approach

The updated AIAG & VDA FMEA 1st Edition handbook describes a Seven-Step approach that guides design development and process, along with monitoring and FMEA system response:

  1. Planning and Preparation: Develop a FMEA project plan.
  2. Structure Analysis: Using a visual method, decide which product or process that will be analyzed.
  3. Function Analysis: For both your Design (DFMEA) and Process (PFMEA), choose which functions will be performed, along with HOW you will evaluate their performance(s).
  4. Failure Analysis: What is/are the failure mode(s)? And what effects or causes these failures?
  5. Risk Analysis: Assign severity of risk, along with occurrence and detection of the cause of failure. This allows you to estimate your level of design or your process risk.
  6. Optimization: Based upon your Risk Analysis from step 6, decide which aspects of your FMEA will require actions that reduce your risk. And what are those actions?
  7. Results and Documentation: Document your findings! How did you reduce risk, and what were the actions taken? Create a comprehensive report that shows your findings.

Example of the QI Macros FMEA Template in Excel

fmea-template

Use the DFMEA or PFMEA template to analyze and prevent the effects of potential failures before they happen. Can you afford an injury or a death? Probably not. Can you afford the time and money involved in litigation? Probably not. Is it cheaper to use an FMEA worksheet and prevent potential problems? No doubt, especially when the consequences are extreme. Are you going to catch everything? No, because some things are outside of our ability to imagine them.


Watch this FMEA Overview Video

*Video recorded using FMEA 4th Edition - format is different, but 5th Edition template functions the same*


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