RCA, FMEA, and Culture SafetyComparison of Root Cause and FMEA

Failure Mode and Effects Analysis (FMEA) and Root cause analysis (RCA) are tools
used to identify and address problems within a system or process. While they exhibit similarities,
some key differences exist between the two approaches (Patient Safety Network, 2019). At a
high level, RCA is a process used to identify the underlying or root cause of a problem. At the
same time, FMEA is a process used to identify potential failure modes and the associated effects
of those failure modes within a system or method (Anjalee et al., 2021). One key difference
between RCA and FMEA is their focus. RCA is focused on understanding and addressing a
specific problem that has already occurred, while FMEA is focused on proactively identifying
and addressing potential failure modes within a system or process (Patient Safety Netowork,
2019). RCA is typically used after a problem has occurred, while FMEA is used before a
problem arises as a preventative measure.
Another difference between the two approaches is the level of detail and analysis. RCA
involves a more in-depth analysis of the problem and its underlying causes, typically using a
structured problem-solving process such as the 5 Whys or the 8D method. FMEA, on the other
hand, involves identifying and ranking potential failure modes based on their likelihood of
occurrence and the severity of their effects and then developing and implementing corrective
actions to address those failure modes (AHRQ, 2012). For example, RCA might be used in a
healthcare setting to identify the root cause of a patient safety incident, such as a medication
error. The RCA process would involve collecting and analyzing data about the incident,
including any contributing factors or underlying causes, and then identifying and implementing
corrective actions to prevent similar incidents (Anjalee et al., 2021). On the other hand, FMEA

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might proactively identify potential failure modes within a process, such as a medication
administration process, and then develop and implement corrective actions to address those
failure modes (AHRQ, 2012). For example, the FMEA process might identify a potential failure
mode of administering the wrong medication to a patient and then implement corrective actions
such as double-checking the prescription and the patient’s identification before administering the
medication

Questions Regarding RCA and FMEA Effectiveness

Several questions come to mind when considering the usefulness or effectiveness of both
root cause analysis and Failure Mode and Effects Analysis (FME):
i. How well does RCA identify and address the root cause of a problem?
In some instances, it can be challenging to identify the root cause of a problem, especially
if there are multiple contributing factors or the problem is complex (Patient Safety Network,
2019). It is vital to ensure that the RCA process is thorough and systematic and includes the
involvement of relevant stakeholders to ensure that the root cause is identified and addressed
effectively.
ii. How well does FMEA identify and address potential failure modes?
FMEA relies on subjective assessments of likelihood and severity, which can be
subjective and may vary among different individuals or teams. It is crucial to ensure that the
FMEA process is well-defined and consistent and includes the involvement of relevant
stakeholders to ensure that potential failure modes are identified and addressed effectively.
iii. How well do the corrective actions identified through RCA or FMEA prevent future
problems or failures?

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It is vital to ensure that the corrective actions identified through RCA or FMEA are
implemented effectively and avoid future problems or failures. It may be helpful to conduct
follow-up evaluations or assessments to determine the effectiveness of the corrective actions.
iv. Are RCA and FMEA the most appropriate tools for addressing a particular problem or
issue?
It is essential to consider whether RCA or FMEA is the most appropriate tool for
managing a specific problem or issue. In some cases, other approaches or tools may be more
appropriate, such as a Lean or Six Sigma process improvement approach (Anjalee et al., 2021).
For example, suppose a hospital is experiencing a high rate of patient falls. In that case, the
hospital might consider using RCA to identify the root cause of the problem and implement
corrective actions to prevent future falls. However, the hospital is looking to improve its overall
efficiency and effectiveness in its medication administration process. In that case, it might
consider using FMEA to identify and address potential failure modes within the process and
implementing Lean or Six Sigma process improvement techniques to streamline the process and
eliminate waste.

How FMEA and RCA can be Used to Assess the Culture of Safety
FMEA and RCA can be used to assess the culture of safety within an organization by
identifying areas where safety practices are not being followed or where there are gaps in safety
processes that may lead to accidents or errors. RCA could be used to assess the safety culture in
a healthcare organization by examining the root causes of accidents or errors that have occurred
in the past. For example, if a nurse accidentally administered the wrong medication to a patient,
an RCA could be conducted to identify the root causes of the error (AHRQ, 2012). This might
involve examining the processes and procedures in place for administering medication, as well as

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looking at factors such as the nurse’s training, workload, and the availability of resources
(AHRQ, 2012). By identifying the root causes of the error, the organization can take steps to
prevent similar mistakes from occurring in the future, which can help to improve the overall
culture of safety within the organization.
FMEA can also be used to assess the culture of safety in a healthcare organization. This
tool involves identifying potential failure modes or problems within a system or process and then
analyzing the potential effects of these failures on staff, patients, and the organization (Patient
Safety Network, 2019). For example, if a healthcare organization is concerned about the risk of
falls among patients, they might conduct an FMEA to identify potential failure modes that could
lead to falls. This might include inadequate staffing, poor lighting, or inadequate assistive
devices for patients. By identifying and addressing these failure modes, the organization can
reduce the risk of falls and improve patient safety.
RCA and FMEA can be valuable tools for assessing the safety culture within a healthcare
organization by identifying areas where safety practices may be lacking and taking steps to
address these issues (Patient Safety Network, 2019). By regularly conducting these analyses and
implementing the recommendations that result from them, an organization can continuously
improve its safety culture and reduce the risk of accidents and errors.

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References

Anjalee, J. A. L., Rutter, V., & Samaranayake, N. R. (2021). Application of failure mode and
effect analysis (FMEA) to improve medication safety: A systematic review. Postgraduate
Medical Journal, 97(1145), 168-174. http://dx.doi.org/10.1136/postgradmedj-2019-
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AHRQ. (2012). Surveys on patient safety culture. https://www.ahrq.gov/sops/about/index.html
Patient Safety Network. (2019). Root cause analysis. https://psnet.ahrq.gov/primer/root-cause-
analysis
Patient Safety Network. (2019). Detection of safety hazards.
https://psnet.ahrq.gov/primer/detection-safety-hazards
Rezaei, F., Yarmohammadian, M. H., Haghshenas, A., Fallah, A., & Ferdosi, M. (2018). Revised
risk priority number in failure mode and effects analysis model from the perspective of
the healthcare system. International journal of preventive medicine, 9.
https://doi.org/10.4103/2F2008-7802.224046