How do I prepare for an FMEA?

FMEA (Failure Mode and Effects Analysis) is a systematic and proactive method used to identify and mitigate potential failures in a process or product. To prepare for an FMEA, follow these steps:

  1. Define the scope: Clearly define the process or product you want to analyze and identify its boundaries.
  2. Assemble the team: Select a team of subject matter experts (SMEs) who have knowledge and experience in the process or product.
  3. Identify the potential failure modes: Brainstorm all the ways the process or product could fail. Document these in a table or spreadsheet.
  4. Determine the severity of each failure mode: Assess the severity of each failure mode on a scale from 1 to 10, with 10 being the most severe.
  5. Identify the potential causes of each failure mode: Determine the root cause of each failure mode. Ask “why” questions to identify the underlying cause.
  6. Determine the likelihood of occurrence: Assess the likelihood of each failure mode occurring on a scale from 1 to 10, with 10 being the most likely.
  7. Determine the likelihood of detection: Assess the likelihood of detecting each failure mode on a scale from 1 to 10, with 10 being the most likely.
  8. Calculate the Risk Priority Number (RPN): Multiply the severity, occurrence, and detection scores to obtain the RPN for each failure mode.
  9. Prioritize the failure modes: Sort the failure modes by their RPNs, starting with the highest, and identify the top priority failure modes.
  10. Develop an action plan: For each high-priority failure mode, develop an action plan to mitigate or eliminate the risk.

It’s important to involve the entire team in the FMEA process to get a comprehensive understanding of the process or product and its potential failure modes. By following these steps, you can prepare for an FMEA and develop an effective plan to mitigate risks and improve the process or product.