Root Cause Analysis

Root Cause Analysis

Ghassan Saleh, DMD, DS-MaineHealth Director of Operational Excellence


  • Utilize root cause analysis in the planning phase of Plan-Do-Study-Act (PDSA) cycles
  • Describe two RCA tools: the 5 Whys and Fishbone

When a patient visits his/her physician complaining about “headache,” the provider doesn’t simply deal with the symptoms. They try to figure out the underlying cause of the headache. They take a patient history, perform a physical examination, and do other investigations like blood work or imaging. They are interested in the root cause of the headache so that they can treat the headache and also prevent its recurrence.

Performing Root Cause Analysis (RCA) for a quality problem is essential during the “planning phase” of any Plan-Do-Study-Act (PDSA) cycle. RCA calls upon us to figure out and then solve the real cause(s) of the problem and helps to address more than its symptoms. This technique proposes that once we solve for the root cause, the same problem should not happen again or, at least, we significantly reduce the likelihood.

In quality circles we use RCA tools to drill deeper into the problem. There are number of RCA tools, but the most common two are 5 Whys and Fishbone. Both require us to take on the mindset of a five-year-old child. First we ask “why” did this happen? As soon as we answer the first question, we have to ask: “why” did this ever happen in the first place? Then, we continue to ask more “whys.” The difference between a five-year-old child and healthcare professionals is the cumulative wisdom that tells us to stop asking “why” once we feel that we have reached an actionable root cause to counteract.

5 Whys is used to break a linear problem into its root causes by asking why it happened multiple times, usually 5 times, or generally between 4 to 6 times. The Fishbone, on the other hand, is a tool that helps parse through a multi-factorial problem to its root causes. First, we identify categories of causes, and then we ask “why” multiple times for each one of those categories, while writing them down using the fishbone structure.

Figure 1 demonstrates the use of 5 Whys to discern the cause of a speeding ticket, and Figure 2 uses a fishbone to exemplify the root causes of cooking a “bad burger.”

In the healthcare setting, we often schedule formal gatherings to perform RCA to either discern gaps in the process of quality improvement or to analyze a clinical harm or near harm event in safety. The collective wisdom of subject matter experts provides the foundation for deconstructing the categories and asking the Whys for each branch of the Fishbone. A key to RCA process is to avoid transitioning too quickly into “solutions” – this poses the risk of premature closure and failure to identify a true root cause. Through patience and deliberate query, RCA helps us to identify the correct causes of our failures and expedite our journey to improvement and success.





Failure Mode(s) and Effects Analysis (FMEA)

MITE PSQI Hot Topic- March 2020:  Failure Mode(s) and Effects Analysis (FMEA)

Erin Graydon Baker, MS, RRT, CPPS, CPHRM

Clinical Risk Manager, MaineHealth

Learning Objectives:

  1. Recognize the differences between Root Cause Analysis and Failure Mode(s) and Effects Analysis (FMEA)
  2. Describe the application of FMEA techniques to any new or existing process

Failure Mode(s) and Effects Analysis (FMEA) versus Root Cause Analysis (RCA):

What’s the difference and which investigative, quality improvement method should I choose when evaluating harm or potential for harm? FMEA is a proactive risk assessment, whereas RCA is a reactive risk assessment.


  • A thorough and credible case review to identify basic or contributing factors underlying variation in performance
    • Focus is on processes, systems, and culture, not on individual performance
    • Focus relates to a specific case that either caused harm or had the potential to cause harm
  • Thorough and credible is defined as multidisciplinary participation and inclusion of subject matter experts, facilitated by trained individuals.
  • Uses Tools including time lines ( sequence of events) , fishbone diagram, action plans


  • A systematic method of identifying and preventing process failures before they occur
  • First formal FMEAs were conducted in aerospace industry to look for safety issues
  • FMEA was used primarily to look at new processes to identify points of failure before launching a new process or product but is also used to review existing processes
  • RCAs focus on how did particular adverse event occur whereas FMEAs focus on how could an adverse event occur
  • RCAs can guide an FMEA; using specific cases to highlight system weaknesses
  • FMEA similarly to RCA, uses tools to help evaluate potential failures
  • FMEA starts with a flow/process map

FMEA brings subject matter experts, both optimists and pessimists, in a room together to review each step in a new or existing process. Typically, the facilitator(s) prepares a process map in advance of the exercise. Tracking through the process steps, the group discusses potential failures, the likelihood that certain failures will occur and the potential for harm to a patient or to operations if a failure occurs.  The likelihood (probability) and the potential for harm (severity) are each scored and then multiplied to assign a risk priority number, or RPN. The RPN helps the team prioritize which are the most vulnerable steps to fix.

This process can become more sophisticated by adding another variable such as ability to detect the failure before it happens. If we have alarms that warn us or electronic hard stops to prevent an error, we can decide that a particular step is safe and needs no intervention.

Once the high RPN step failures have been prioritized, the team assigns responsible persons to complete the corrective action items that will mitigate the chance of each failure occurring. Each responsible person will provide updates to the team and ask for help in removing barriers.

Once the FMEA action items are completed, the team measures the success and modifies the process as appropriate in PDSA (Plan-Do-Study-Act) format.

Here’s the sample template used to list the steps, failures, RPN scoring and action planning.

Anyone can do this process using this format. You must be sure that you have appropriate leaders who can help remove barriers engaged from the beginning of the process.

For more information; use the link provided or contact:

The Jigsaw Puzzle

The Jigsaw Puzzle

 Omar Hasan, MD, MPH  Chief Quality Officer, MaineHealth

Choosing a suitable approach to accomplish a desired change can be challenging in the complex and dynamic hospital environment. Not infrequently, the person leading the change effort has a number of options that can be pursued to achieve the desired objective. Under these circumstances, it is helpful to choose the option that matches the complexity of the problem and the time available to address it. The schematic below illustrates this approach in a simplified way.

For troubleshooting minor issues, such as failure to consistently follow a few simple steps in a known protocol, applying Lean daily management (a part of MaineHealth’s Operational Excellence program, also referred to as ‘OpEx’) can help resolve the issue in a few short weeks. This same approach can also be used to address gaps from a known standard, such as failure to adhere to published clinical practice guidelines. In these cases, using OpEx methods and tools can highlight areas for improvement that can be prioritized for testing and implementing process changes using Plan-Do-Study-Act cycles.

Over time, technological advances or significant changes in clinical practice guidelines may require substantial redesign of clinical care delivery systems. This much change requires a more organized approach with appropriate attention to planning and project management. In some cases, rapid innovation or changing organizational needs necessitate a visionary and open-ended approach that leverages the full complement of systems engineering skills and practices to predict and manage the reconfiguration of teams and services.

As one engages in progressively more complex quality improvement projects over time, the morass of approaches used to accomplish change in a large teaching hospital begins to come into focus just like the picture formed by a jigsaw puzzle becomes clear as the pieces fit together.


Schematic adapted from Art Smalley

Leveraging Kaizen to Achieve Continuous Improvement

Leveraging Kaizen to Achieve Continuous Improvement

Learning Objectives:

  • Describe Kaizen and how it can help you execute improvement work
  • Recognize the role that staff empowerment plays in sustaining improvement

Too often in healthcare we make an improvement, only to see behaviors and performance revert back to pre-improvement levels as time moves on. What are the causes of this? Why is so much time and energy put into the change, but not into the sustainment? Previously my colleague, Dr. Mark Parker, detailed the Model for Improvement, the framework to structure improvement in a goal driven way. Today, I would like to build off of that and explore Kaizen, a key driver within Lean management to execute and sustain improvement. One of the central components of Lean methodology, Kaizen is simply translated from Japanese as “change for the better.”1

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Do You Genuinely Understand the Problem You Are Trying to Solve? The Model for Improvement

Do You Genuinely Understand the Problem You Are Trying to Solve? The Model for Improvement

Learning objectives:

  • Recognize early barriers that can prevent interprofessional teams from making sustainable improvement
  • Gain insight into an established framework to organize and systematically align interprofessional groups in shared improvement goals

Traditional research is about discovery. Quality improvement is about… improvement. We need to study the evidence for best practices and apply them consistently in our own healthcare delivery sphere in order to achieve the best possible outcomes for our patients. How do we get there? Too often, we see opportunities for improvement and we struggle to organize the work in a systematic, goal driven way. We bog down in a series of efforts that center on fixing imperfect processes without clear, measurable outcome targets. We sense we have a problem, but we don’t know our true baseline data and we don’t develop a measurement plan or a methodology to guide us to our goal.

Improvement science provides us with a way out of this rabbit hole. One simple and effective model to understand the problem we are trying to solve is promoted by the Institute for Healthcare Improvement and was developed by Associates in Process Improvement. Appropriately, it is called the Model For Improvement (MFI).1

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