Why It Matters
FMEA can be an effective tool, especially if you know how to avoid common pitfalls.
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How to Conquer Fears of Failure (Modes and Effects Analysis)

By Frank Federico | Wednesday, February 13, 2019

Photo by Soroush Karimi | Unsplash

To improve workforce and patient safety, many organizations use Failure Modes and Effects Analysis (FMEA) to predict what might go wrong before an adverse event occurs. Though commonly used, FMEA is not always well understood or used effectively, but teams can learn to prepare for common FMEA pitfalls and learn how to avoid them.

The Basics

Failure Modes and Effects Analysis is a tool that came from outside health care. It’s designed to help you examine your processes to determine where potential failures might occur. The goal is to identify possible failures and prevent them by proactively correcting processes rather than addressing adverse events after failures have occurred. FMEA is especially useful for assessing a new process before implementation and evaluating the possible impact of a proposed change to an existing process.

If you are going to put in a computer system, for example, what are all the things that could go wrong? How severe would those problems be? If you’re going to start a new process — such as a new anticoagulation service for patients — you could use FMEA to seek out possible defects.

FMEA differs from other improvement tools or exercises because it can help you prioritize your work. After you map out all the steps in a process, you use the tool to make a series of predictions — including how frequently a breakdown might occur and the severity of the impact if the breakdown occurs, and whether that defect can be identified and intercepted — and assign each category a score. You then use these numbers to determine a risk priority number (RPN). The RPN helps you identify where you need to focus your attention to begin your improvement work.

In industries outside of health care, FMEA is used by engineers and others when they design a piece of equipment. The FMEA helps them think about a series of questions: If this equipment fails, is somebody going to get hurt? If they get hurt, how seriously? How can we put in safeguards in place?

Using FMEA Retrospectively

In health care, many organizations have used it in their medication safety work. When IHI started working on the Safer Patient Initiative in the UK, we introduced FMEA so all the medication safety teams could look at their medication processes to determine the weak points. We’ve introduced FMEA in Scotland and Denmark. We use it around the world now.

In Scotland, they used FMEA to assess their anticoagulation management. The improvement teams identified that the biggest failure point was the communication between the hospital when the patient was being discharged and the patient’s primary care doctor. That breakdown in communication was resulting in patients not taking their medications correctly. This resulted in patients who were bleeding and had lab values that were too high. The team was immediately able to address the problem and they significantly decreased the amount of harm to patients.

How to Prevent Common Pitfalls

It’s important to anticipate common problems and work to prevent them:

  • Engage the right people — Involve people who know the system, know the processes, and know how the work gets done. You may miss some important details if you don’t have the right people engaged.
  • Keep it simple — Pick a simple process to study, like a delivery of a medication process, for example. Within a clinical practice, you could do an FMEA on how you follow up on test results. Choose something with visible steps in the process.
  • Score appropriately — Sometimes people fall into the trap of scoring everything at 10 (out of 10) when predicting the severity of a failure. Not everything is going to injure the patient or cause immediate death.
  • Be willing to compromise — Sometimes people don’t agree on how to score the severity or the frequency of a failure. If you pick five and I pick seven, let’s settle on six. Scoring may not be a perfect science, but if we meet halfway we can go forward and learn.
  • Designate a good facilitator — To use FMEA effectively, it’s good to have a facilitator. Pick someone who will keep the team on track so they don’t get distracted.
  • Develop a plan for acting on what you learn — Sometimes teams do the FMEA and think they’re done. The FMEA is just the beginning. You still have to improve the process! You should then rescore yourself. Every time you fix a piece of the system, go back and determine whether there’s been improvement.

In the beginning, many people think the tool is too complicated. Once they start using it, however, it starts to make more sense. After you become familiar with it, it becomes clear that using FMEA gives you an opportunity to truly understand a multi-step process. You can get a better line of sight into what steps are most likely to cause the whole system to fall apart. Without this kind of deep analysis, we sometimes fix something we think is a problem, but it’s not. Or sometimes we focus on things that aren’t going to have a big impact.

Many processes in health care are complex and in need of improvement. Using FMEA will help you prioritize where to put your precious time and energy.

Frank Federico is IHI Vice President and Senior Safety Expert.

(Having difficulty watching this video? Watch on YouTube.)

You may also be interested in:

Failure Modes and Effects Analysis (FMEA) Tool

IHI Patient Safety Congress (May 15-17, 2019) in Houston, Texas, US

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