Accreditation Resource Services Newsletter
November 2020

CIHQ-ARS Blog

RCA and FMEA: What's the Difference?

By: Connie W. Compton
We all know working with the right tool can make all the difference. Although, there are numerous tools used in hospitals for managing risks and improving patient safety. This discussion will only focus on two tools commonly used: Root Cause Analysis (RCA) and Failure Mode Effects Analysis (FMEA.) Let’s get started with an overview of each one.

The Root Cause Analysis (RCA)

Commonly performed by risk management departments and safety leaders, the RCA is conducted after an adverse event, incident, or near-miss has occurred. RCAs may also be used for complaint analysis. Typically, teams are comprised of 4-6 persons involved in the incident and should be conducted within 72 hours of the incident (RCA2: Improving root cause analyses and actions to prevent harm). The RCA process consists of asking a series of questions to identify potential cause(s) and propose solution(s) to prevent recurrence.
Questions asked during the RCA process include:
  • What happened? Tell the story by outlining chronological steps of the event.
  • Why did it happen? Identify contributing factors resulting in the event.
  • What is/are the root cause(s)? Analyze the contributing factors to identify process issues.
  • What action(s) can be taken to prevent recurrence? Brainstorm changes that could prevent or remove the cause(s).
  • How will we know if the actions worked? Determine how to evaluate the impact of change after implementation.
An important, but sometimes missed step is following implementation of possible solutions; the team should evaluate the impact of the action(s) taken. It is important to remember blame is not the objective of the RCA. The focus of the RCA is on evaluating processes and not individual performance. (Guidance for Performing Root Cause Analysis (RCA) with Performance Improvement Projects).

The Failure Mode Effects Analysis (FMEA)

The FMEA begins by proactively selecting a high-risk system process before an event occurs. The FMEA is an excellent tool for large, complicated processes. As with RCAs, teams are comprised of persons involved in the process. Teams can be quite large with no limitation, but you may want to limit the number of representatives. For instance, every nurse or every pharmacist doesn’t need to be involved, but you do want a representative that is involved in the process.
Teams are commonly led by risk management, quality, or safety leaders which begin with outlining each step of the process. Tackling a large process may seem overwhelming, but no need to worry. Most FMEA system processes are broken down into phases to make it more manageable and complete the FMEA faster (Guidance for Performing Failure Mode and Effects Analysis with Performance Improvement Projects). After mapping the process, each step is analyzed by answering the following questions:
  • Failure Mode - What could go wrong?
  • Failure Cause - What could cause the failure?
  • Failure Effects - What would be the consequences of the failure?
Once the failures have been identified, it is time to score each failure by answering the following questions with a numeric score:
  • Likelihood of Occurrence – (Using a 1-10 scale, with 10 most likely) What is the likelihood the failure would occur?
  • Likelihood of Detection – (Using a 1-10 scale, with 10 most likely NOT) What is the likelihood the failure would be detected?
  • Severity – (Using a 1-10 scale, with 10 most likely) If the event occurs, what is the likelihood the failure will cause severe harm or death?
failure will cause severe harm or death? Time to tally the votes! Calculate the Risk Profile Number (RPN) for each failure mode. To calculate the RPN, you simply multiply the three scores (i.e., Occurrence x Detection x Severity = RPN). What’s the final step? You guessed it! Propose solution(s), implement action(s), and evaluate. With the FMEA, use the RPN to help measure successfulness of actions. For instance, decreasing the RPN by 50% makes a great measurable goal (Failure Modes and Effects Analysis (FMEA) Tool: IHI 2017).

Comparison & Summary

In summary, both the RCA and FMEA are excellent tools when used with the right job. The FMEA is best for large systematic processes before events occur while the RCA is better for small teams evaluating an incident after occurrence. As for regulatory compliance, CMS and all CMS-approved accreditation providers, require hospitals to evaluate processes and take action to improve patient safety. It is important to note, The Joint Commission does include a timeframe requirement with standard LD.03.09.01 EP. 7 which requires hospitals conduct a proactive risk assessment at least every 18 months on a one high-risk process.
 Root Cause Analysis (RCA)Failure Mode Effects Analysis (FMEA)
Before or After an Event After Before
Steps
  • What happened?
  • Why did it happen?
  • What is/are the root cause(s)?
  • What action(s) can be taken to prevent recurrence?
  • How will we know if the actions worked?
  • What could go wrong?
  • What could cause the failure?
  • What would be the consequences of the failure?
  • Likelihood of Occurrence –What is the likelihood the failure would occur?
  • Likelihood of Detection –What is the likelihood the failure would be detected?
  • Severity – What is the likelihood the failure will cause severe harm or death?
Team Size Small teams (4-6 persons) Large (May be broken down into smaller groups)
Examples Patient received wrong medication Medication administration process (preventing patients from receiving the wrong medication.)
Related Hospital Standards
CMS CMS §482.21(c)(2)
CIHQ QA-02
TJC LD.03.09.01 EP.5 LD.03.08.01 EP.1
LD.03.09.01 EP.7 (one high risk process every 18 months)
DNV QM.8

References

Failure Modes and Effects Analysis (FMEA) Tool: IHI. (2017). Retrieved August 31, 2020, from http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx
Guidance for Performing Failure Mode and Effects Analysis ... (n.d.). Retrieved August 31, 2020, from https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/GuidanceForFMEA.pdf
Guidance for Performing Root Cause Analysis (RCA) with PIPs. (n.d.). Retrieved August 31, 2020, fromhttps://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/GuidanceforRCA.pdf
RCA2: Improving Root Cause Analyses and Actions to Prevent Harm: IHI. (n.d.). Retrieved August 31, 2020, http://www.ihi.org/resources/Pages/Tools/RCA2-Improving-Root-Cause-Analyses-and-Actions-to-Prevent-Harm.aspx
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