Compliance & Regulation

The Seven Steps to Performing FMEA

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The Seven Steps to Performing FMEA

Welcome to this deep dive into the world of FMEA

Failure Mode and Effects Analysis (FMEA) is a powerful tool used in various industries to identify and mitigate potential failures in a process, product, or system. In this blog, we will take a detailed look at the seven steps involved in performing an FMEA.

RELATED: Jama Connect® FMEA Framework for Automotive

1: Define the scope and team.

  • Clearly define the boundaries of the process, product, or system you are analyzing, assemble a multidisciplinary team consisting of experts from different areas to ensure a comprehensive analysis.

2: Break down the process.

  • Divide the process into manageable steps or components. This helps to identify potential failure modes at each stage.

3: Identify potential failure modes.

  • Brainstorm all potential failure modes for each process step. These are the ways in which the process or component could fail to perform its intended function.

4: Assess the severity.

  • Assign a severity rating to each failure mode based on its potential impact on the customer, product, or process. This helps prioritize which failure modes require immediate attention.

5: Determine the causes.

  • Identify the root causes or factors contributing to each failure mode. This requires conducting thorough analysis and gathering relevant data.

6: Evaluate the current detection controls.

  • Assess the effectiveness of the current controls in place to detect or prevent failure modes from occurring. Identify any gaps or weaknesses that need to be addressed.

7: Calculate the risk priority number RPM.

  • The RPM is a numerical score obtained by multiplying severity, occurrence, and detection ratings. This allows you to prioritize which failure modes require immediate action

RELATED: FMEA Framework for Medical Device Development

By following these seven steps, you can perform a comprehensive FMEA and proactively identify and mitigate potential failures or risks in your process, product, or system. Remember, FMEA is an iterative process that requires continuous improvement. Regularly review and update your analysis as new information becomes available and track the effectiveness of your implemented actions. Thank you for diving deep into the seven steps of performing FMEA. Now you have a better understanding of how to apply this critical process in your industry.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom, McKenzie Jonsson, and Decoteau Wilkerson.

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