Use the FMEA (Failure Modes and Effects Analysis) form to identify the causes of failure and evaluate the risks associated with each cause.

Answers the questions:
  • What are the potential failure modes of a process (usually analyzed at a step level)?
  • Given a failure mode, what is the potential effect on the process output and how severe is it?
  • Given a failure mode, what are the potential causes of that failure mode and how often do they occur?
  • How well can a cause be detected before it creates a failure mode and effect?
  • How can you assign a risk value (risk prioritization number, or RPN) to a process step integrating the frequency with which the cause occurs, the severity of failure, and the capability of detecting the failure mode and effect?
  • On which area of a process should a project be focused?
  • Which inputs are likely nonvital (low RPN) and which are likely key inputs (high RPN)?
  • How can reaction plans be documented as part of process control?
When to Use Purpose
Pre-project Identify and scope potential projects (the listing of the process steps/inputs helps to define the process and the RPN values highlight areas needing improvement).
Mid-project Identify potential Xs.
Mid-project Screen inputs to identify likely vital Xs (key inputs typically have high RPNs).
End of project Document status at the end of project.
End of project Reference reaction plans.
End of project Capture any further improvements required over time.

Data

This form has no data requirements because you use it only to collect and organize data.

Guidelines

  • You can use an FMEA as a standalone project tool. However, it is strongly recommended that you not use it to generate corrective action in a process improvement project (Six Sigma, DMAIC, and so on) before evaluating the measuring system and obtaining a trustworthy baseline.
  • Some practitioners use a cause-and-effect (C&E) matrix as a substitute for the FMEA in the early development of the project and use the FMEA only as a control tool.
  • For the FMEA to be valuable as a control tool, you must keep the document current and of a manageable size.
  • An FMEA is not a trivial tool; rather, it requires significant effort from a diverse team.

How-to

  1. For each process step/input, identify potential failure modes.
  2. Evaluate what failure effects may be associated with those failure modes.
  3. Identify possible causes for each failure mode.
  4. List the current controls used to eliminate the causes from occurring.
  5. Evaluate the severity of the effect, the likelihood of the cause/mode occurring, and the chance of detecting the cause/mode prior to an effect causing a defect.
  6. Multiply the Severity by Occurrence by Detection to get a risk priority number (RPN).
  7. Optionally, enter severity and RPN cutoff values to color code table cells.
  8. Improve any items with a high RPN and record actions taken, and then revise the RPN.
  9. Maintain as a living document.

For more information, go to Insert and fill out a form.

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