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Failure Modes and Effects Analysis Process

The process for conducting a Failure Modes and Effects Analysis (FMEA) is presented here. This process is shown in a flowchart.

Visit the Demonstration Tool to learn more!

Assembling the Team and Establishing a Rating System

It is important to assemble a team that has comprehensive knowledge of the process — from design through operation — to perform the analysis. The team must first establish a method of rating occurrence, severity, and detection of failure modes. For example, a team could use a scale of 1 through 10 to rank occurrence, severity, and detection. Any system can be developed provided it is applied consistently.

The team must then establish a threshold for acceptable risk relative to the rating scale. In general, the established factors (rating values of severity, occurrence, and detection) are multiplied. The result is the Risk Priority Number (RPN). The threshold of tolerance is then established relative to the RPN.

Identifying and Ranking Failure Modes

The team identifies possible failure modes, along with the measures (both design and administrative) used to control hazards. This is done for each failure mode and is documented in a table format. The team then rates each failure mode and calculates the RPN. The analysis continues for each failure mode.

Mitigating Risk

After calculating the RPN for each failure mode, the team assesses risk that falls beyond acceptable levels. Based on the nature of the risk, appropriate prevention and mitigation measures are identified.

Risks can be mitigated, or made less severe, in three ways:

  1. Detection of risk and taking corrective action before negative consequences occur
  2. Prevention of risk by minimizing the probability of occurrence
  3. Control of risk by implementing process parameters to increase margins and minimize severity or frequency.

The following are examples of detection, prevention and control for hydrogen fueling stations:

After all risks are deemed acceptable, the FMEA is included as part of the design documentation. The FMEA is considered a working document that does not end at this step. As operational data are obtained, the FMEA should be reevaluated. Any changes to risk level that result in an unacceptable outcome need to be reevaluated to reduce risk levels. While the FMEA is effective, it does have limitations.