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Failure Mode and Effects Analysis (FMEA)

The Model for Improvement and PDSA Cycles

Maggie Dunham

on 29 January 2014

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Transcript of Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA)
This material was prepared by CFMC (the Medicare Quality Improvement Organization for Colorado), the Integrating Care for Populations & Communities National Coordinating Center, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services.  The contents presented do not necessarily reflect CMS policy. [PM-4060-168 CO 2013]

Learn how to apply FMEA to processes
Course Objectives
Define Failure Mode and Effects Analysis (FMEA)
Highlight why FMEA is a useful tool for quality improvement
Outline the steps to conduct a FMEA
You are conducting FMEA!
Light dinner night before
Real Life Scenario
an examination
Failure Mode and Effects Analysis
“FMEA is a systematic method of identifying and preventing product and process problems before they occur.”
FMEA Defined
Developed by Military
Adopted by many other industries thereafter
Always the same goal
A Short History
Nuclear Power
Aerospace (NASA)
Healthcare and more…
Industries using FMEA
Became part of The Joint Commission standard in 2001
Prevention was not always the primary focus of hospitals
What types of problems may be prevented with FMEA?
Power failures
Gas failures
Patient Falls
Missed Appointments
FMEA Comes to Healthcare
Prevent potentially significant problems
Strengthen your system
Fault tolerant
Why conduct FMEA?
Why would you want to use FMEA in your work?
A, B, and D
Reflection Question #1
Supports patient safety
Encourages teamwork
Drives communication
Systematic problem solving
Ideally prevents errors before they occur
Improves system design
Cost savings
Benefits of FMEA
FMEA team identified vulnerability in the monitoring system
Recommended new actions when critically high glucose values were identified, like regular recording
Also discovered a potential computer process failure
MRI Safety
Patient Safety Benefits from FMEA (VA Health System)
Consider the “Rule of Ten”
The earlier you identify problems the less they typically cost.
Financial Benefits of FMEA
What is the notion of costs increasing ten-fold as issues are found closer to the field?
None of the above
Reflection Question #2
Model for Accidents – James Reason
Team project
Investigative techniques
Outcome measurement development
Root Cause Analysis
Which of the following indicate differences between root cause analysis (RCA) and FMEA?
FMEA focuses on systems and RCA focuses on individuals.
Reflection Question #3
Internal analysis of failures
Subject Matter Experts
Customer complaints
Policies and procedures
Use What You Have
The FMEA Process
Example: Consistently arriving at work on time in the morning.
Group of a few key stakeholders
Create clear scope of work
Identify and define what will be studied
High-risk / error-likely
New process
Process change
New equipment
Gather materials needed
Prepare agenda and plan
Identify potential team members
Step 1
Our Goal: get me to work on time in the morning
Our Team: me, spouse, kids, sponsor
Sponsor or Advisor
“consultant” on project
Subject Matter Experts
Involvement in the process
Further define your goal
Step 2
Which of the following are characteristics of a well-framed FMEA team?
All of the above
Reflection Question #4
3. Describe Process Graphically
2. Assemble the Team
1. Define the Scope and Topic
Create Flow Diagram
Number each process step in diagram
For very complex processes
Break it down to pieces
Show sub-processes
Step 3
Flow Diagram
Step 1 – Define Scope and Topic
Let’s Review
Identify and list failure modes for each step in the flow diagram
Organize potential failure modes in a document
Determine the severity and probability of occurrence
Identify the hazard score
Use decision tree to decide whether to proceed or stop the investigation
Identify the causes of failure modes
Step 4
Identify and List Failure Modes
Organize and Document Failure Modes
– not noticeable to customer and would not affect
service delivery
Determine the Severity of occurrence
Probability – likelihood of the occurrence taking place
Determine the Probability of occurrence
Hazard Score Matrix
Hazard Score Analysis
Use the Decision Tree to identify what to manage
Decision Tree and Potential Causes
What actions are part of the process of conducting the hazard analysis in FMEA?
A, B, and C
Reflection Question #5
Take action to eliminate risk
Assign individuals to mitigate risk and maintain accountability
Set an outcome measure to compare results
Continuously monitor process and adjust as needed
Step 5
Identify Actions and Outcome Measures
When creating an action plan after conducting a FMEA, should you continue to monitor the process?
Reflection Question #6
Now Let’s Look at a Healthcare Example
Conduct a FMEA on the implementation of these new insulin pens.
We know conducting FMEA is a best-practice
Define the Scope and Topic
Further define the goal
Reduce likelihood of improper technique while injecting a patient with our new insulin pens
Director of Quality Improvement

Director of Nursing

Systems Engineer

2 Staff Nurses
Assemble the Team
Flow Diagram and Potential Failure Modes
Conduct the Hazard Analysis and identify potential causes
Identify Actions and Outcome Measures
The FMEA Process
Course Objectives
Stalhandske, Erik, et. al. “Healthcare FMEA in the Veterans Health Administration." Patient Safety & Quality Healthcare. September/October 2009: 30-33. Print.
Big presentation to executives at work
Set multiple alarms
Full tank of gas
Tell your spouse
Clothes pre-hung
Failure Mode
the way processes can fail
a result or consequence
- VA National Center for Patient Safety
It can make your system less prone to error
It can prevent significant problems
It is
fault tolerant
It is proactive rather than reactive
FMEAs assessed multiple facilities MRI safety
Identified that people did not know when machines were on, leading to unauthorized equipment being left in the room – a possible risk to patients
Improved the use of monitors and signage in multiple languages
Blood Glucose Monitoring
Rule of Savings
Rule of Ten
Saving Ten Rule
Both are
Tries to prevent errors before they occur
Allows you to choose what you investigate
Focuses on the process in the future
FMEA is team-based and RCA is done by an individual.
FMEA is preventative and RCA is reactive.
You pick the topic of an FMEA and don’t choose the topic of a RCA.
Both B and C
Define the Scope and Topic
Assemble the Team
Contains a sponsor or advisor
Come from a variety of disciplines
Includes individuals who are experts in the area
Describe the Process Graphically
Conduct the Hazard Analysis
Severity – how severe the issue would be
– devastating effects of problem occurrence
– problem would cause high degree of dissatisfaction
- can be overcome with modification with minor
– likely to occur immediately or within a short
period (may happen several times in one year)

– probably will occur (may happen several
times in 1 to 2 years)

– possible to occur (may happen sometime in
2 to 5 years)

– unlikely to occur (may happen sometime in 5 to
30 years)
Identifying and documenting possible failure modes
Determining the severity and probability of potential failures
Identifying potential causes of failure modes
Identifying who caused failures
Identify Actions and Outcome Measures
Gather a few key stakeholders that will be involved in the FMEA at a high level
Review our current insulin injection policies and procedures
Learn how to apply FMEA to processes
Define Failure Mode and Effects Analysis (FMEA)
Highlight why FMEA is a useful tool for quality improvement
Outline the steps to conduct a FMEA
Alarm goes off
Get up
get dressed
eat breakfast
get in car
drive to work
arrive at work
Side Roads
Step 3 Describe Process Graphically
Step 2 Assemble the Team
Alarm goes off
Get up
get dressed
eat breakfast
get in car
drive to work
arrive at work
Side Roads
Alarm does not go off!
Snooze > 1 time
Become ill from food
Car doesn't start
Needle, Pen & Patient prepare for insulin injection
RN inserts needle in patient
RN injects insulin solution into patient
RN removes needle from patient
RN injects insulin solution into patient
Failure Mode #1 - Remove needle too early
Failure Mode #2 - RN unable to push needle down without removing needle
Failure Mode #3 - RN does not keep needle in for appropriate amount of time
Failure Mode #4 - Insulin not distributed evenly in pen
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