How can you identify and evaluate potential failure modes in FMEA risk prioritization?

1 Define the scope

The first step in FMEA is to define the scope of the analysis, which includes the product or process to be examined, the function or performance requirements, and the customer or stakeholder expectations. You should also establish a cross-functional team that includes experts from different areas, such as design, engineering, production, quality, and maintenance. The team should agree on the objectives, assumptions, boundaries, and deliverables of the FMEA.

2 Identify potential failure modes

The next step is to identify potential failure modes, which are the ways that the product or process can fail to meet its function or performance requirements. You can use various tools and techniques to generate a list of potential failure modes, such as brainstorming, checklists, flowcharts, diagrams, historical data, testing results, and feedback. For each failure mode, you should describe its cause, effect, and current controls.

3 Evaluate and prioritize failure modes

The third step is to evaluate and prioritize failure modes based on their risk level, which is calculated by multiplying three factors: severity, occurrence, and detection. Severity is the degree of impact that the failure mode has on the customer or stakeholder, ranging from 1 (no effect) to 10 (hazardous). Occurrence is the frequency or probability that the failure mode will happen, ranging from 1 (unlikely) to 10 (very high). Detection is the likelihood that the failure mode will be detected before it reaches the customer or stakeholder, ranging from 1 (very high) to 10 (no detection). The risk level, or risk priority number (RPN), is the product of these three factors, ranging from 1 (low risk) to 1000 (high risk).

4 Develop and implement actions

The fourth step is to develop and implement actions to reduce or eliminate the risk of the failure modes with the highest RPNs. These actions can include designing out the failure mode, improving the process or product, adding or enhancing controls, increasing inspections or tests, providing training or instructions, or implementing contingency plans. For each action, you should assign a responsible person, a target date, and a expected outcome.

5 Review and update FMEA

The final step is to review and update FMEA periodically or whenever there are changes in the product or process, such as new requirements, design modifications, process improvements, or customer feedback. You should verify the effectiveness of the actions, measure the reduction in RPNs, and document the results and lessons learned. You should also communicate the FMEA findings and recommendations to the relevant stakeholders and ensure that they are implemented and followed up.

FMEA is a valuable tool for identifying and evaluating potential failure modes in your manufacturing operations, and prioritizing them based on their risk level. By following these steps, you can use FMEA to prevent or reduce the risk of failures, improve quality and reliability, and optimize resources and costs.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?