Using Failure Mode and Effects Analysis

Marcy A. Metzgar

All healthcare organizations need robust systems and processes that help them provide quality care as part of their commitment to patient safety. When a system or process is being purchased, developed, reviewed, or reconstructed, healthcare organizations can be proactive about risk control and explore what may go wrong with a system or process by applying the Failure Mode and Effects Analysis (FMEA) method. After examining possible failures, a healthcare team can generate measures to prevent their occurrence.

In FMEA, the failure mode refers to how a system or process may fail, and effects analysis is examining how those failures affect the system or process.¹ This risk management tool involves analyzing process steps to identify possible failures, assessing how they may affect the system or process, prioritizing an order in which they need to be addressed, rating their severity and assessing their possible occurrence, and implementing changes to avert failures.

FMEA can also be used in a healthcare organization’s continuous improvement efforts. It can be used during design, process control, and before and during ongoing operations.²

FMEA involves many details; at a high level, some of the basic steps include:

1. Assembling a team: Designate a group of healthcare employees to make a team, including those that use the systems or carry out the processes.
2. Determining the scope: Assess the parameters and narrow down the scope. Use flowcharts to organize the analysis.
3. Specifying the functions: Identify the purpose of the system or process and what is expected from it. Then divide it into separate subsystems or process steps and determine the function for each of them.
4. Assessing the chance of failure: For each function, team members should brainstorm any potential failure modes. If needed, they should revise any functions with additional details so the failure modes indicate a loss of that function.
5. Pinpointing potential consequences: For each failure mode, determine the potential failure effects it may have on the system or process.
6. Rating severity: Assess how serious each failure effect is and assign a number to it from 1 to 10 (1 is insignificant and 10 is catastrophic).
7. Exploring root causes: For each failure mode, explore all the potential root causes. Tools such as the FMEA template and how-to-use documentation may be helpful in this activity.³

It's important to note that FMEA’s one-size-fits-all approach may not always be suitable for a healthcare organization’s needs. The absence of a return on investment may magnify its insufficiency. Additionally, the absence of data may also make it less ideal and more cumbersome. To ease some of these shortcomings, one strategy is to conduct a simpler analysis.⁴

Resources

• Centers for Medicare & Medicaid Services: Guidance for Performing Failure Mode and Effects Analysis with Performance Improvement Projects
• Institute for Healthcare Improvement: Failure Modes and Effects Analysis (FMEA) Tool
• VA National Center for Patient Safety: The Basics of Healthcare Failure Mode and Effect Analysis

Endnotes

¹ American Society for Quality. (n.d.). FMEA. Retrieved from https://asq.org/quality-resources/fmea

² Ibid.

³ Ibid.

⁴ Ibid.

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