Healthcare FMEA: finding failure points before a new process starts

Why this matters

When a service or workflow changes, teams need not wait for harm to learn. IHI describes FMEA as a proactive review of where a process might fail, why and with what effects. It is useful before implementing a new process or changing an existing one. ^[1]

Evidence and important boundaries

AHRQ PSNet describes assembling people with different expertise, mapping the process, identifying failure modes and prioritising mitigation. ^[2] RCEM’s healthcare FMEA guidance similarly uses staff collaboration to describe vulnerabilities. ^[3] Agree any scoring method within the team; a score supports discussion rather than predicting that an event will occur.

Suggested local application

ICORP suggests selecting a bounded, important process such as an interdepartmental order handoff. Map actual work, including out-of-hours conditions. Identify missing information, handoff points and existing controls. Choose changes using both potential severity and opportunities for prevention. Do not let one combined score obscure a concern about serious harm.

What to monitor

Test the revised process and check that controls function in practice. Review near misses and newly identified concerns, then update the process map and actions. FMEA should remain a learning activity rather than a one-time document. Completing it does not guarantee safety or accreditation.