FMEA training for Healthcare - Sample

A sample of slides used in our FMEA Training for Healthcare. This 3-day class is ideal for quality facilitators with hospitals and health systems. The key deliverable is a preliminary FMEA on a high-risk process of the client's choosing, complete with an improvement plan.

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. Class objectives
•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

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Objectives

3. What is Failure Mode & Effect Analysis?
•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.
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*Institute for Safe Medication Practices
Canada (ISMP Canada)
FMEA Training
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FMEA Explained

4. Why Use FMEA?
•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

*VA National Center for Patient Safety
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FMEA Explained

5. Why me? Why you?
•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

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*ISMP Canada
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FMEA Explained

6. Rationale for FMEA in Healthcare
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.

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*VA National Center for Patient Safety
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FMEA Explained

7. •Identify and prioritize high-risk processes
•Annually:
•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
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Joint Commission Requirement
(Standard LD.5.2 effective July 2001)
*VA National Center for Patient Safety
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FMEA Explained

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

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

10. Risk Priority Number (RPN)
Multiply the three ratings together to get the
Risk Priority Number or RPN:

•RPN = Severity  Occurrence  Detectability
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FMEA Explained

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

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

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

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15. Map the Process
•Pick a manageable portion of the process
•Make sure the topic is narrow enough of a focus
(don’t try to cure world hunger)
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16. Map the Process
•Define beginning and end of the process
•If process is complex, identify the area to focus on.
•Chart the process as it is normally done, using the
collective process knowledge of the team.
•Number each step
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*ISMP Canada

17. For each step in the process, list all the failure modes –
all the ways the process could break down or go wrong






Could have multiple failures for each process step.
jProcess Step
Failure Mode #1
Failure Mode #2
Failure Mode #3
Failure Mode #4
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Brainstorm Potential Failure Modes
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18. Identify Effects
•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
If failure mode occurs,
then what are the
consequences?
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19. Severity
•The seriousness and Severity of the Effect (to the process or
patient) of a failure if it should occur.


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Process
step
Potential
failure mode
Potential
failure effects
S
E
V

Potential
causes
O
C
C

Current process
controls
D
E
T

R
P
N

What is
the
step?
In what ways
can the step
go wrong?
What is the
impact on the
customer if
the failure
mode is not
prevented or
corrected?
N
What causes
the step
to go
wrong?
(i.e.,
How could
the failure
mode
occur?)
N
What are the
existing controls
that either
prevent the
failure mode
from occurring
or detect it
should it occur?
N N
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20. Scoring Scale
•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
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21. Occurrence
•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

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Process
step
Potential
failure mode
Potential failure
effects
S
E
V

Potential causes
O
C
C

Current process
controls
D
E
T

R
P
N

What is
the step?
In what ways
can the step
go wrong?
What is the
impact on the
customer if the
failure mode is
not prevented
or corrected?
N
What causes the
step to go
wrong? (i.e.,
How could the
failure mode
occur?)
N
What are the
existing controls
that either
prevent the failure
mode from
occurring or
detect it should it
occur?
N N
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22. Occurrence:

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”
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23. Detectability
•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.
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Process
step
Potential
failure mode
Potential failure
effects
S
E
V

Potential causes
O
C
C

Current process
controls
D
E
T

R
P
N

What is
the step?
In what ways
can the step
go wrong?
What is the
impact on the
customer if the
failure mode is
not prevented
or corrected?
N
What causes the
step to go
wrong? (i.e.,
How could the
failure mode
occur?)
N
What are the
existing controls
that either
prevent the failure
mode from
occurring or
detect it should it
occur?
N N
FMEA Training
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24. Detectability

•“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.
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25. Calculate Risk Priority Number (RPN)
•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
•Consider assigning priority to high Severity score
even if RPN is low

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*ISMP Canada

26. Prioritizing RPN’s
•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.


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Note: May use a threshold for action (RPN or severity score)
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27. Determine Root Cause(s)
Use appropriate root-cause analysis tools:
• Fishbone (Ishikawa, Cause and Effect)
• 5-Why
• Pareto
• Scatter plots




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Important: Determine true root cause of each potential Failure Mode before
determining the mitigation strategies, if it is not readily apparent.
May be
considered a
separate step
in FMEA
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28. Reduce Severity
Examples to 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
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Also consider the impact on Occurrence and Detectability
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29. Prevent Occurrence
Examples to 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
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30. Improve Detectability
Ways to improve Detectability (and Prevention)
•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
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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

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Implement & Evaluate the
New Process – Key Steps
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32. Evaluate New Process
After implementation:
•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

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33. SECTION 3

FMEA TAKEAWAYS

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Healthcare FMEA
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Takeaways

34. Tips for Success
•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)
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Healthcare FMEA
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Takeaways

*ISMP Canada

35. FMEA Pitfalls
•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

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Healthcare FMEA
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Takeaways

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

*ISMP Canada