The document provides an overview of Failure Mode and Effect Analysis (FMEA) training for healthcare, aimed at identifying potential failures in processes to enhance patient safety. It outlines the objectives of the training, the importance of FMEA in preventing harm and system failures, and the step-by-step process of conducting an FMEA. Key aspects include assembling a team, mapping processes, identifying failure modes, and implementing strategies for improvement based on risk priority numbers.

1. Failure Mode & Effect Analysis
(FMEA)
Training
for Healthcare
© 2013 Workflow Diagnostics, Inc., unless otherwise noted.
Any redistribution or commercial use of this presentation without permission
from Workflow Diagnostics, Inc., is expressly forbidden.

2. •
•
•
•
Understand the purpose of the FMEA
Understand the steps of the FMEA process
Understand how to use FMEA
Complete an exercise and actually create an FMEA
to begin feeling comfortable with the process
FMEA Training – Objectives
Class objectives
2

3. • A team-based systematic and proactive approach
for identifying the ways that a process can fail,
why it might fail, the effects of that failure, and
how it can be made safer.
• The goal is to eliminate or minimize the potential
for failures, to stop failures before harm reaches
the patient, or to minimize the consequences of
the failure.
FMEA Training – FMEA Explained
What is Failure Mode & Effect Analysis?
3
*Institute for Safe Medication Practices
Canada (ISMP Canada)

4. • Aimed at preventing a tragedy, not simply
responding to it
• Doesn’t require previous bad experience or
close call (“near-miss”)
• Makes a system more fail-proof
• Fault-tolerant
FMEA Training – FMEA Explained
Why Use FMEA?
4
*VA National Center for Patient Safety

5. • Practitioners in the systems know the specific
vulnerabilities and failure points
• Professional & moral obligation to “first do no harm”
• Increased expectation that we create safe systems
FMEA Training – FMEA Explained
Why me? Why you?
5
*ISMP Canada

6. Historically…..
• Accident prevention has not been a primary focus
of hospital medicine
• Misguided reliance on “faultless” performance by
healthcare professionals
• Hospital systems were not designed to prevent
errors; they just reactively changed and were not
typically proactive.
FMEA Training – FMEA Explained
Rationale for FMEA in Healthcare
6
*VA National Center for Patient Safety

7. Joint Commission Requirement
(Standard LD.5.2 effective July 2001)
•
•
•
•
•
Select at least one high-risk process
Identify potential “failure modes”
For each “failure mode,” identify the possible effects
For the most critical effects, conduct a root-cause analysis
Redesign the process to minimize the risk of that failure
mode or to protect patients from its effects
• Test and implement the redesigned process
• Identify and implement measures of effectiveness
• Implement a strategy for maintaining the effectiveness of
the redesigned process over time
*VA National Center for Patient Safety
FMEA Training – FMEA Explained
• Identify and prioritize high-risk processes
• Annually:
7

8. • Specimen identification
• Hospital-acquired conditions – pressure ulcers,
patient falls, VAP, surgical site infections, wrongsite surgery, etc.
• Medication safety and dispensing
• Fall prevention
• Tests – delays and results
• Infection control
• Facility or new process design
FMEA Training – FMEA Explained
Healthcare Applications
8

9. How does FMEA work?
• Severity
• Occurrence
• Detectability
• Rate each failure mode as 1-10 for each of the
three categories. (Some people use 1-5.)
You do this to get to the ultimate goal:
Reduce/eliminate risk to the patient
FMEA Training – FMEA Explained
• To narrow in on key failures to address, assign
each failure mode three ratings:
9

10. Multiply the three ratings together to get the
Risk Priority Number or RPN:
• RPN = Severity  Occurrence  Detectability
FMEA Training – FMEA Explained
Risk Priority Number (RPN)
10

11. FMEA Process Steps
2
3
Select a High-Risk
Clinical Process
Assemble the
team
Map the Process
4
5
Brainstorm
potential failure
modes
Identify effects of
each failure mode
7
8
Implement and
evaluate the
redesign
Develop mitigation
strategies and
redesign process
(Severity; Occurrence;
Detectability)
6
Prioritize the
failure modes
(RPN)
9
Monitor
effectiveness of
new processes.
FMEA Training – Construction
1
11

12. • Select processes with high potential for having an
adverse impact on the safety of individuals served.
• Processes that:
•
•
•
•
•
•
have variable input
are complex
non-standardized
heavily dependent on human intervention
performed under tight or loose time constraints
tightly coupled and hierarchical (not team-oriented)
are all candidates for consideration.
*ISMP Canada
FMEA Training – Construction
Select a High-Risk Process
12

13. • Medication administration
• Surgery
• Transfusions
• Restraints
• Isolation
• Emergency or resuscitative care
• High-risk populations
FMEA Training – Construction
High-Risk Processes – Examples
13
*ISMP Canada

14. •
•
•
•
•
Leader
Facilitator
Scribe/Recorder
Process experts
Include all areas involved
in the process
• “Outsider” – objective, “naïve”
• 6-10 optimal size
FMEA Training – Construction
Assemble a team
14
*ISMP Canada

15. • Pick a manageable portion of the process
• Make sure the topic is narrow enough of a focus
(don’t try to cure world hunger)
FMEA Training – Construction
Map the Process
15
*ISMP Canada

16. Map the Process
• Define beginning and end of the process
• Chart the process as it is normally done, using the
collective process knowledge of the team.
• Number each step
FMEA Training – Construction
• If process is complex, identify the area to focus on.
16
*ISMP Canada

17. Brainstorm Potential Failure Modes
Failure Mode #1
jProcess Step
Failure Mode #2
Failure Mode #3
FMEA Training – Construction
For each step in the process, list all the failure modes –
all the ways the process could break down or go wrong
Failure Mode #4
Could have multiple failures for each process step.
17

18. • Review each failure mode and identify the potential
Effect(s) for each one
• Try not to overlook any Effects -> results will impact
the risk ratings done later
FMEA Training – Construction
Identify Effects
If failure mode occurs,
then what are the
consequences?
18
*ISMP Canada

19. Severity
Process Potential
Potential
step failure mode failure effects
What is the
impact on the
What is In what ways customer if
the can the step the failure
step? go wrong? mode is not
prevented or
corrected?
S
E
V
Potential
causes
N
What causes
the step
to go
wrong?
(i.e.,
How could
the failure
mode
occur?)
O
C
C
Current process
controls
D
E
T
R
P
N
N
What are the
existing controls
that either
prevent the
failure mode
from occurring
or detect it
should it occur?
N
FMEA Training – Construction
• The seriousness and Severity of the Effect (to the process or
patient) of a failure if it should occur.
N
19

20. • Need to have a scale to reference
• Want to have a consistent scale throughout your
organization
• Make it meaningful to your organization
• Start with 1 and end with 10 (don’t use zero)
• 1 is best and 10 is worst
• Relate 1 through 10 to each of Severity,
Occurrence, and Detectability
• Customize the scales to your organization
FMEA Training – Construction
Scoring Scale
20

21. • Also known as Frequency, it is the likelihood or number of times a specific
failure (mode) could occur.
• Before we assign ratings for the probability of occurrence , we’ll list the
possible causes for each failure mode.
• We’ll assign occurrence ratings to each cause of the failure.
• 1 means it almost never happens-10 means it always happens
Process
Potential Potential failure
step
failure mode
effects
What is the
impact on the
In what ways
What is
customer if the
can the step
the step?
failure mode is
go wrong?
not prevented
or corrected?
S
E
V
N
Potential causes
What causes the
step to go
wrong? (i.e.,
How could the
failure mode
occur?)
O
C
C
Current process
controls
D
E
T
R
P
N
N
What are the
existing controls
that either
prevent the failure
mode from
occurring or
detect it should it
occur?
N
FMEA Training – Construction
Occurrence
N
21

22. In the Titanic example, we would rate the probability of
an "iceberg that could potentially cause a hull failure”
and not simply the “probability of a hull failure”
FMEA Training – Construction
Occurrence:
22

23. • The likelihood of detecting a failure or effect of a failure BEFORE it is felt
by the patient.
• Need to understand “Current Process Controls”
• On a scale of 1-10, a “1” means the control is absolutely certain to detect
the problem; “10” means the control has no chance to detect the
problem or no control exists.
Process
Potential Potential failure
step
failure mode
effects
What is the
impact on the
In what ways
What is
customer if the
can the step
the step?
failure mode is
go wrong?
not prevented
or corrected?
S
E
V
N
Potential causes
What causes the
step to go
wrong? (i.e.,
How could the
failure mode
occur?)
O
C
C
Current process
controls
D
E
T
R
P
N
N
What are the
existing controls
that either
prevent the failure
mode from
occurring or
detect it should it
occur?
N
FMEA Training – Construction
Detectability
N
23

24. • “Detectability” means detecting the issue while we
can still do something about it (before it reaches the
customer/patient).
• In the Titanic example, we’re not about detecting
that the watertight compartments are flooded.
We’re about detecting the iceberg and avoiding it.
• That’s why we write “Process Controls,” “Current
Controls” or “Current Process Controls” on our
FMEA forms.
FMEA Training – Construction
Detectability
24

25. • Rates impact of failure on patient / system based on
Severity, Occurrence and Detectability
• Multiply three scores to obtain RPN
 Severity – consequence of failure if it occurs
 Occurrence – probability or actual frequency of failure
 Detectability – probability of the failure being detected or
prevented before the effect is realized
FMEA Training – Construction
Calculate Risk Priority Number (RPN)
• Consider assigning priority to high Severity score
even if RPN is low
25
*ISMP Canada

26. • Prioritize your efforts and improvement resources
according to RPN.
• High RPNs are more serious, should be addressed
first, and deserve more effort and resources.
• Note that functions with low RPN’s might often have
“none” as the recommended action unless the
action were particularly easy and low cost.
FMEA Training – Construction
Prioritizing RPN’s
Note: May use a threshold for action (RPN or severity score)
26

27. Determine Root Cause(s)
•
•
•
•
Fishbone (Ishikawa, Cause and Effect)
5-Why
Pareto
Scatter plots
May be
considered a
separate step
in FMEA
Important: Determine true root cause of each potential Failure Mode before
determining the mitigation strategies, if it is not readily apparent.
FMEA Training – Construction
Use appropriate root-cause analysis tools:
27

28. Reduce Severity
•
•
•
•
•
•
•
•
•
•
Protection – gloves, masks, face shields
Emergency shut-offs, fail-safe operation
Sprinkler systems, fire doors
Patient positioning
Alternative materials, e.g., safety glass, Pyrex
Warnings and messages
Backup and redundant systems
Patient and family awareness and education
Expanding supplier base, multiple sources
Shared design with vendors
Also consider the impact on Occurrence and Detectability
FMEA Training – Construction
Examples to reduce Severity:
28

29. Prevent Occurrence
•
•
•
•
•
•
•
•
•
Continual improvement, problem-solving teams
Increasing process performance (capability)
Address multiple causes
Move checks earlier in the process
Staff education and training
Error-proofing (poka-yoke)
Better data collection, publish data
Protective storage, inventory management
Supplier evaluation and monitoring
FMEA Training – Construction
Examples to Prevent Occurrence
29

30. Improve Detectability
•
•
•
•
•
•
•
•
•
•
In-process checks instead of post-process
Automated checks and early warnings
Barcodes, wristbands, asking name/DOB
Better measuring devices, calibration checks
Verification and double-checks
Error-proofing (poka-yoke)
Use colors, shapes to identify materials
Statistical process control (SPC)
Equipment and process validations
Audits, system testing and monitoring
FMEA Training – Construction
Ways to improve Detectability (and Prevention)
30

31. • Important: Assign a person responsible for each
action item, and a due date for completion
• Follow-up on assigned actions
• Verify actions taken have intended results
FMEA Training – Construction
Implement & Evaluate the
New Process – Key Steps
31

32. Evaluate New Process
• Determine what actions were taken – different than
proposed?
• Collect data on the new process
• Calculate new RPNs based on actions taken
• Reassess RPNs and determine next actions (on same
item if RPN is still high, or new high RPN)
• At regular intervals, re-assess to ensure the new
process remains in place and effective
FMEA Training – Construction
After implementation:
32

33. FMEA TAKEAWAYS
Healthcare FMEA –Takeaways
SECTION 3
33

34. • Start small, aim for early success
• Narrow … Narrow … Narrow
• Use different team members from same dept. for
different parts of the process (compare to RCA –
not able to do that)
Healthcare FMEA –Takeaways
Tips for Success
34
*ISMP Canada

35. •
•
•
•
•
•
•
•
•
•
•
Incomplete flowchart of the process
Confusing Effects (symptoms) with Causes
Not determining the true root causes
Mixing Severity, Occurrence, Detectability
Inconsistent scoring of Sev, Occ, Det
Lack of RPN resolution (not a full 10-point scale)
Not devoting enough time to the effort
Not having a facilitator to keep process moving
Not gathering input from all roles in the process
Not having the right team members
Low accountability for conducting
Healthcare FMEA –Takeaways
FMEA Pitfalls
35

36. • Safety-minded culture
• Proactive problem resolution
• Prevention of failures vs. rework and
damage control
• Failure-proof approach vs.
punitive
• Sense of control and
ownership
Healthcare FMEA –Takeaways
Benefits of Implementing FMEA
36
*ISMP Canada