Improving Quality and Safety in Radiation Medicine

The Flexible FMEA     Prospective Patient Safety


The Flexible FMEA

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In terms of quality and safety, no other risk management strategy gives you more bang for your buck (or time) than Failure Modes and Effects Analysis (FMEA). Whether you're new to patient safety, or a seasoned quality expert, our Flexible FMEA provides fast, usable results while maintaining all the functionality of a full fledged analysis.

In theory, an FMEA provides a structured way of prioritizing risk reduction strategies and helps to focus efforts aimed at minimizing the probability and severity of adverse outcomes.

In practice, an FMEA helps you to identify the most error-prone steps in a process, giving you a chance to implement changes, or to add QA checks, that minimize the likelihood of an error's occurring before it occurs.

FMEAs are best performed with a multi-disciplinary team, but can still be very informative even when performed solo. To get started, you'll need to choose a lead person from your institution. That person should register your institution, free of charge, and nominate team members. Once your institution is registered, and your team defined, you can follow the five easy steps listed below to perform the FMEA.

Help!  Use these buttons for step-by-step guidance as you move through the FMEA process.

At any point in the process you can request an automated summary report that highlights the most error-prone steps in the process, as determined by your FMEA team analysis at the time of the query.

If you're new to FMEA and are looking for a thorough explanation of how best to perform one, here is an excellent comprehensive guide.

If you're familiar with the FMEA process, and just want to get started, go here.

If you just want the basic idea, here are five easy steps.

Five Easy Steps

Step 1 - Define, or Select, a Failure Mode

A Failure Mode describes how a step in a given treatment process can fail to meet specifications. To facilitate the process, we've created a list of Failure Modes for each step in the treatment process. All you need to do is select those (there will likely be multiple Failure Modes for each process step) that are of interest to you. If you're performing a more comprehensive FMEA, you can also define your own free-text Failure Modes. If you chose to define your own Failure Modes, every effort should be made to define the Failure Mode as clearly, and unambiguously, as possible.

Step 2 - Assign a Severity Ranking

The Severity Ranking is a number between 1 and 10 that describes the effects of the undetected Failure Mode on the patient. The Severity Scale used in our Flexible FMEA is loosely based on unpublished tables in AAPM's TG-100 report, where a Severity Ranking of 1 indicates no effect on the patient, and a Severity Ranking of 10 indicates catastrophic effects. Where there is a range of effects for a given Failure Mode, think about the most severe when choosing the Severity Ranking.

Step 3 - Define, or Select Failure Pathways

Failure Pathways briefly describe the events that led up to the Failure Mode. There can be several Failure Pathways for each Failure Mode. Just as we did for Failure Modes, we've created a list of Failure Pathways for you to choose from, but you can also enter your own free-text Failure Pathways if you prefer.

Step 4 - Assign an Occurrence Ranking

The Occurrence Ranking is a number between 1 and 10 that describes how frequently a given Failure Pathway is likely to be followed. An Occurrence Ranking of 1 indicates a frequency of ~ 1/10,000, and an Occurrence Ranking of 10 indicates a frequency of ~ >5% (again based on unpublished tables in AAPM's TG-100 report).

Step 5 - Assign a Detectability Ranking

The Detectability Ranking is a number between 1 and 10 that describes how likely the error, along that Failure Pathway, will go undetected. A Detectability Ranking of 1 indicates the probability of an error going undetected of about 1/10,000, and a Detectability Ranking of 10 indicates the probability of an error going undetected of >20% (also based on unpublished tables in AAPM's TG-100 report).

The Golden Rules of FMEA

Safety in Numbers

The more people you involve in the FMEA process, the more comprehensive your results will be.

Variety is the Spice of Life

People from different disciplines bring different perspectives to the table. Your FMEA team should be as multi-disciplinary as possible.