In a process FMEA, what is the first step that must be taken?

In a process Failure Mode and Effects Analysis (FMEA), the first step involves documenting process flows. This step is crucial because it establishes a clear understanding of the process being analyzed. By creating a flowchart or a detailed diagram, all stakeholders can visualize how the process operates. This visual representation serves as a foundation for identifying failure modes later in the analysis.

Once the process flows are documented, it becomes easier to pinpoint potential failure modes—possible ways the process could fail and the effects of those failures. The documentation also aids in assessing the severity levels of each failure mode, enabling the team to prioritize risks effectively.

Thus, while identifying failure modes, assessing severity levels, and other tasks are integral to the FMEA process, starting with a precise documentation of process flows ensures that the analysis is comprehensive and grounded in a solid understanding of the operational context. This methodological approach enhances the effectiveness of the FMEA process by ensuring all potential failure points are considered in relation to the documented workflow.