Before Harm Happens: Medical FMEA in Practice
Before Harm Happens is a practical guide for healthcare professionals who want to identify and reduce risks before patients are harmed.
Healthcare processes are rarely carried out by one person or one profession. They cross departments, shifts, information systems and organizational boundaries. At every handoff, information can be lost, responsibilities can become unclear and safety controls can fail. Failure Mode and Effects Analysis, or FMEA, offers healthcare teams a structured way to examine these vulnerabilities before an adverse event occurs.
Written for clinicians, pharmacists, nurses, therapists, laboratory and imaging professionals, patient-safety specialists, healthcare managers, technical staff and other members of the care team, this book explains FMEA in clear and accessible language. No advanced knowledge of statistics or quality management is required.
The book guides readers through the complete process: selecting and defining a suitable process, assembling a multidisciplinary team, mapping work as it is actually performed, identifying failure modes and their causes, assessing risk, designing effective actions and monitoring whether improvements are sustained.
A continuing case study follows a hospital team as it analyzes medication administration, from the first project charter to the evaluation of the implemented controls. Additional examples show how the method can be applied in hospitals, pharmacies, laboratories, emergency services, home healthcare, long-term care, rehabilitation, dental care, digital health and other settings.
Particular attention is given to human factors, psychological safety, patient and family involvement, health equity, workarounds, digital systems, artificial intelligence, residual risk and the limitations of numerical risk scores. The book also explains when FMEA is appropriate and when other methods, such as Root Cause Analysis, Bowtie Analysis, Fault Tree Analysis or Event Tree Analysis, may be more suitable.
Rather than relying mainly on education, reminders and revised policies, the book encourages teams to redesign processes using stronger controls, including simplification, standardization, automation and forcing functions.
Practical diagrams, facilitator scripts, decision aids and a separate field workbook help readers move from theory to action. Together, they provide healthcare teams with the structure needed to examine everyday work honestly, agree on priorities and build safer processes before preventable harm occurs.
- Language: English
- Format: paperback, 124 pages
- ISBN: 979-81-9047-639-2
- Published: 3 August 2026
Articles
Headlights, Not the Rear-View Mirror
17/09/2026
An organisation learns about its own risks in two very different ways, and most organisations are quietly excellent at one of them and have barely tried the other. The first way begins after something goes wrong. An event occurs, someone is harmed or nearly so, and the organisation investigates: what happened, why, and how do
What a Near Miss Is Actually Telling You
17/09/2026
“No harm done.” Three words that end more safety conversations than any others, and almost always in the wrong place. The dose was caught before it reached the patient. The wrong-site marking was spotted at the time-out. The specimen with no label was noticed before it was run. Relief goes round the room, the moment
The Cheapest Hour in Patient Safety
17/09/2026
Every facilitator hears the objection within the first week, usually from the busiest and most credible person in the room. We do not have time for this. It deserves a straight answer, because the people saying it are not being obstructive. They are describing their week accurately. So let me concede the whole of it
Why Your Best People Keep Making the Same Mistake
17/09/2026
“Human error” is the most reassuring phrase in the whole language of safety, which is exactly what makes it dangerous. It closes the file. Once we have decided that a competent person simply erred, there is nothing left to examine except the person, and the person, being competent, will promise to try harder. Then the
The Failure Was Foreseeable. The Surprise Was Optional.
16/09/2026
Every serious safety event arrives with the same quiet feeling attached, the sense that somewhere in the building, someone already knew. Not the day it would happen, and not the patient. The weak spot. Someone knew that the shift-change handoff ran on one nurse’s memory, that the infusion alarm had been overridden so often it