FMEA is the proactive end of root cause analysis — you score what could go wrong, rank by Risk Priority Number, and act on the top of the list. It’s required by IATF 16949 (automotive), ISO 14971 (medical devices), and The Joint Commission (healthcare, as HFMEA). The articles below cover methodology, worked examples, and the templates I’ve used in real audits.
FMEA was developed by the US military in 1949 and formalised by NASA in the Apollo programme. Today it’s mandatory in automotive supply chains (DFMEA for design, PFMEA for process), in medical-device development (per ISO 14971), and in hospital quality assurance (HFMEA, per The Joint Commission standard LD.04.04.05). Unlike 5 Whys or Fishbone, it is proactive — you don’t wait for a failure to happen.
The four articles below cover the whole landscape: the complete methodology (RPN, rating scales, DFMEA vs PFMEA), worked examples across six industries, a healthcare-specific deep-dive with HFMEA scoring, and the free template I use when auditing supplier documentation.
In a regulated industry? Start with the healthcare examples if you’re in a hospital, or the complete guide if you’re in automotive or medical devices.
Methodology, cross-industry examples, a healthcare-specific HFMEA deep-dive, and the free template.
RPN formula (Severity × Occurrence × Detection), rating scales, DFMEA vs PFMEA, and examples from automotive, healthcare, and software.
ExamplesComplete FMEA worksheets with RPN scores from manufacturing, automotive, healthcare, software, food processing, and aerospace.
HealthcareFive complete HFMEA worksheets: medication administration, patient ID, blood transfusion, ED triage, discharge reconciliation.
TemplateBlank FMEA worksheet with all 12 columns, what each column means, step-by-step Excel setup, and DFMEA vs PFMEA tips.
Risk Priority Number = Severity × Occurrence × Detection, each rated 1–10. It ranges from 1 to 1000. Use it to rank failure modes within the same FMEA — not to compare across projects. Many modern standards (AIAG-VDA 2019) now prefer Action Priority (AP: High / Medium / Low) over raw RPN, because two failure modes with identical RPN can carry very different severity.
DFMEA (Design FMEA) is applied to a product design before manufacturing, asking “how could this design fail in use?” PFMEA (Process FMEA) is applied to a manufacturing or service process, asking “how could this process produce a defect?” Most automotive suppliers run both for every programme. The complete guide walks through each with worked examples.
Almost — HFMEA (Healthcare FMEA) uses a 4-point Severity and 4-point Probability matrix producing a Hazard Score 1–16 instead of RPN 1–1000, and adds a Decision Tree to check whether existing controls already mitigate the hazard. It was developed by the VA National Center for Patient Safety in 2001 and is recommended by The Joint Commission. See five worked HFMEA examples.
Whenever the design or process changes, when field data reveals a new failure mode, after a recall or non-conformance, or on a fixed cadence (annually for regulated industries, every 18 months for healthcare per Joint Commission). The FMEA document is a living artefact, not a one-time deliverable.
Yes — the free FMEA template includes all 12 columns (item, function, failure mode, effects, S, cause, O, controls, D, RPN, recommended action, responsibility) in Excel and Google Sheets formats. A guided online FMEA tool is coming next — watch the tools page for updates.
Use the 5 Whys tool to investigate any failure mode that reaches production — a guided FMEA tool is coming next.