Understanding FMEA: A Tool for Safer Healthcare

In today’s complex healthcare environment, proactively identifying and mitigating risks is crucial to improving patient safety. One powerful tool used to achieve this goal is Failure Mode and Effects Analysis (FMEA) — a structured approach that helps teams anticipate potential failures before they occur.  

Originally developed in the aerospace and manufacturing industries, FMEA is now widely used in clinical settings to prevent errors, streamline processes, and promote a culture of safety. 

What is a Failure Mode and Effects Analysis (FMEA)? 

Failure Mode and Effects Analysis is a systematic, proactive method for evaluating a process to identify where and how it might fail and assessing the relative impact of different failures.  

In an FMEA, each step of a process is analyzed to determine: 

• Failure modes (the ways in which a step could fail) 
• Causes of those failures 
• Effects of the failures on the outcome 
• The likelihood, severity, and detectability of each failure 

By analyzing these elements, teams can prioritize potential issues and develop targeted strategies to reduce the risk of harm before any error actually occurs. 

What is FMEA used for? 

FMEA is commonly used to: 

• Improve patient safety 
• Redesign or improve clinical workflows 
• Prepare for the implementation of new procedures, technologies, or equipment 
• Identify and reduce risks in high-alert or high-risk processes (e.g., medication administration, blood transfusion, surgery) 
• Comply with accreditation and quality improvement requirements, such as those set by The Joint Commission 

Some hospitals and facilities have processes in place within charting systems to alert nurses when a change in patient status is critical and action needs to be taken. In healthcare, where mistakes can have serious consequences, FMEA empowers teams to act before harm happens. 

FMEA in clinical and nursing environments 

In nursing, FMEA is particularly valuable because nurses are often on the front lines of patient care and have critical insights into where risks may lie in day-to-day processes. Some examples of FMEA applications in nursing and clinical environments include: 

• Analyzing the medication administration process to prevent dosage errors
• Evaluating patient handoff procedures between shifts or departments
• Assessing the use and maintenance of central lines or other invasive devices
• Improving the process for responding to patient deterioration or code situations 

By engaging nurses in FMEA teams, healthcare organizations ensure that the analysis reflects real-world workflows and practical solutions. 

Steps in the FMEA process 

The FMEA process typically follows these key steps: 

1. Select a process to analyze 
     Choose a high-risk or high-impact process that could benefit from a proactive risk assessment.
2. Assemble a multidisciplinary team 
     Include individuals who are familiar with the process and represent different perspectives—nurses, physicians, pharmacists, quality and safety personnel, and more.
3. Map the process 
     Break down the process into individual steps using a flowchart or process map. This provides a clear overview of how the process is supposed to work.
4. Identify potential failure modes 
     For each step, ask: What could go wrong? List possible ways each step could fail.
5. Analyze the causes and effects 
     Determine the likely causes and possible effects of each failure mode. This helps in understanding the full scope of risk.
6. Assign severity, occurrence, and detection ratings 
     Each failure is scored based on:
7. Severity (S): How serious is the effect?
8. Occurrence (O): How likely is it to happen?
9. Detection (D): How likely is it to be detected before causing harm? 

Multiply these scores to calculate a Risk Priority Number (RPN): 
  RPN = S × O × D 

7. Prioritize the failure modes 
     Use RPNs to prioritize which failure modes should be addressed first. Focus on high-RPN items that represent the greatest risk.
8. Develop and implement action plans 
     Design and implement interventions to mitigate the highest risks. This could involve training, process redesign, policy changes, or equipment modifications.
9. Monitor and reassess 
     After implementing changes, evaluate their effectiveness and repeat the analysis as needed. Continuous improvement is key.  

A culture of proactive safety 

FMEA is not just a checklist — it’s a mindset. It encourages healthcare teams to think critically about their systems and processes, to look for vulnerabilities, and to take ownership of patient safety. By empowering frontline staff, especially nurses, to participate in FMEA, organizations can create safer, more reliable systems that support both patients and care teams.