About this lesson
FMEA preparation normally follows a structured process and uses a standard format. Many organizations will take an industry standard process or format and customize it based upon their local organization structure and practices. However, the major steps still occur in the same sequence.
When to use
Whenever completing an FMEA analysis, use your organization’s process and formats. If your organization does not have its own procedure and formats, use the ones presented in this course.
FMEA analysis follows a common process or sequence of steps.
- Select the product, system, or process to be analyzed. Ensure boundaries are clear so the team stays focused.
- Identify the FMEA team and schedule meetings. Based upon the scope of the analysis, subject matter experts should be selected.
- Diagram the product or process and decompose it. Design FMEAs are normally diagrammed with functional block diagrams. Process FMEAs are normally diagrammed with a process map.
- Determine function and failures for each element in the diagram. A diagram element can have multiple functions and they should be listed separately. Each function can have multiple failures and they should be listed separately.
- Analyze each failure mode for severity, probability of occurrence, and capability to detect it. Combine the three scores into a RPN value. If appropriate, aggregate elements into sub-system or processes and repeat the analysis. The level of aggregation is a judgement call by the team.
- Implement mitigation where appropriate. After the mitigation, the failure mode should be rescored based upon the changed process.
- Document results of the analysis. On the one hand, you should be documenting everything as you go in the form. But when the analysis is complete, date and revision control it. It should then accompany the product or process design package.
These steps align with fields in the typical or generic Design FMEA and Process FMEA formats.
Hints & tips
- Follow your organization’s process and use your organization’s forms. If they don’t exist, the ones in this course are good examples of typical steps and forms.
- Pick your team based upon what is in scope for the analysis. That is why the analysis boundaries are set before the team is selected.
- Some organizations don’t rescore after mitigation – that is a mistake.
- The level of decomposition is a judgement call. Try to decompose so that each functional block performs one or two steps significant to the customer. If the block is a subsystem, treat it like it is a single component.
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