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In general, how many steps should an FMEA proceed in each direction (upstream/downstream) when mapping a process for failure analysis?
A practical FMEA requires enough process context to capture upstream causes and downstream consequences without becoming unmanageably large. A common operational rule-of-thumb is to examine roughly two steps upstream and two steps downstream from a target step to uncover handoffs, dependencies, and failure propagation. Risk management objectives focus on identifying failure modes that originate earlier (e.g., incorrect patient ID at registration leading to lab/specimen mismatch) and harms that emerge later (e.g., delayed result communication causing deterioration). The exact boundary depends on complexity and risk; high-hazard workflows (blood products, surgery, chemo) may require deeper mapping. The goal is usable granularity: map, identify failure modes, score (S--O--D), prioritize, implement controls, and reassess residual risk.