What is it, and why use it?
Failure Mode and Effects Analysis (FMEA) examines how a process might fail, the consequences, possible causes, current controls and actions to reduce risk.
It makes preventive discussion systematic and records why the team prioritizes one concern over another.
Explore the FMEA features and local-file workflowWhen to use it
Use it before introducing a changed process or when reviewing known vulnerabilities in an existing one.
When another tool fits better
Use Root Cause Analysis to investigate an event that already occurred. Use Control Plan to record the agreed ongoing checks after risk review.
Before you start
- A process boundary and a team familiar with its operation.
- Locally agreed severity, occurrence and detection rating meanings.
- Known controls and authority to review potential responses.
Use fictional or approved non-sensitive information. Do not include patient details or proprietary records in practice worksheets.
Step-by-step in CI Tools
Agree rating criteria and configure score maxima, prioritization method and local Risk Priority Number (RPN) thresholds before scoring.
Add failure modes, their effects and plausible causes. State current prevention and detection controls.
Apply severity, occurrence and detection ratings consistently. Review high-severity concerns even if their total score is not largest.
Assign actions, owners and due dates. Record revised ratings only after reviewing evidence about action effectiveness.
Save the rationale and the editable worksheet. Scores are prioritization aids, not certification that risk is acceptable.
Ratings are judgments, not probabilities
Severity, occurrence and detection scores depend on an agreed rubric. Multiplying ordinal ratings can help organize discussion but does not produce a precise probability of harm or an automatic approval decision.
Completed worked examples
Demonstrations only: all organizations, observations, targets and results below are fictional. They are not clinical instructions or universal performance standards.
Healthcare operations — fictional
Referral destination risk
Starting information: A fictional service examines a referral sent to the wrong administrative queue.
| Failure / effect | Wrong destination / scheduling delay |
|---|---|
| Agreed example ratings | Severity 6, occurrence 3, detection 4 on a local 1–10 rubric |
| RPN / action | 6 × 3 × 4 = 72; test clearer routing labels and review detection |
What the result means: These fictional scores have no clinical meaning or universal acceptance threshold. The rubric and local risk governance matter more than the number alone.
General business — fictional
Incorrect package label
Starting information: A fictional supplier reviews a label mismatch failure mode.
| Current controls | Manual order-to-label check |
|---|---|
| Agreed example ratings | S = 5, O = 4, D = 3; RPN = 60 |
| Follow-up | Test a revised check; reassess only after observed evidence |
What the result means: A planned action does not justify a lower revised score. Also consider consequences that a simple product of ratings can hide.
Practise in a separate worksheet
Open the tool’s built-in synthetic sample as a new editable worksheet. It may differ from the worked demonstrations above. It never replaces an existing worksheet. Save any work you want to retain to your computer.
Open built-in practice worksheetYou’ll be asked to log in if needed. No worksheet is created just by reading this page.
Common mistakes and how to avoid them
- Changing rating scales halfway through: agree and retain criteria first.
- Comparing RPNs across incompatible rubrics: they are not universal measurements.
- Lowering revised scores when an action is merely planned: evaluate effectiveness first.
Interpret the result
Review severity, the individual rating rationales and controls alongside the prioritization score. The same RPN can describe very different risks. Use appropriate local governance for real safety or compliance decisions.
Record the assumptions and unanswered questions alongside the result. Use the relevant local review process before making operational decisions.
Credible further learning
These independent educational resources explain the methods. They do not endorse CI Tools Suite. Some external resources have their own access requirements.
- ASQ: Failure Mode and Effects Analysis (external resource)
- IHI: Quality Improvement Essentials Toolkit (external resource)
Resource links reviewed 29 October 2026. Our interface instructions and fictional examples are original CI Tools learning material.
Put the method into practice
Start a new worksheet, use the guide beside your work and keep an editable .citools copy on your computer.
Try This ToolChoose another tool