5/1/2017

Failure Mode and Effects

Analysis
Prof (Col) Dr R N Basu
Executive Director
Academy of Hospital Administration,
Kolkata Chapter
FMEA
Failure Mode Effects Analysis
Source: A Presentation. Anonymous
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What is Failure Mode Effects

Analysis
 Failure Mode and Effects Analysis (FMEA)
is a systematic method of identifying and
preventing product and process problems
before they occur
Why Use FMEA?
 It is a tool aimed at prevention of errors
 It is done before the incidence occurs
 No previous bad experience or close call
is required to conduct FMEA
 The system becomes more robust
 The system becomes fault tolerant

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Who uses FMEA? FMEA in Healthcare

• Many industries use FMEA  Hospital systems were not designed to
– Aviation industry prevent or absorb errors
– Nuclear power ◦ They were not proactive
– Aerospace ◦ They changed reactively
– Chemical process industries  FMEA can prevent accidents like:
– Automotive industries
• This is in use for over 40 years
• The objective is that accidents do not
occur
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Objects Impacted in MRI Gantry
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NABH and FMEA
 NABH 4th Ed describes the process of
FMEA in the glossary section
 Though not specifically included in any
standard but the intent appears to be
◦ Proactively identifying error risk within a
particular process
 The detailed process of FMEA describes
the steps to be taken
 Quantitative Estimate of likelihood of
error has been provided
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Healthcare FMEA Definitions
 Hazard Analysis:
◦ It collects data on hazards associated with the
selected process
◦ Develops a list of hazards that may cause
harm, if not controlled
 Failure Mode:
◦ Different ways that a process or sub-process
can fail to provide the intended result
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JCI Standard QPS. 11 5th Edition
 An important element of risk management is
risk analysis
 One tool that provides proactive analysis is
Failure Mode and Effects Analysis
 Measurable elements in QPS.11 are:
◦ The hospital’s risk management framework
includes all elements in the intent of the chapter
◦ At least annually, a proactive risk-reduction is
conducted on one of the priority risk processes
◦ High-risk processes are redesigned based on the
analysis of test results
Healthcare FMEA Definitions
• Healthcare Failure Mode & Effect Analysis
(HFMEA)
1. A prospective assessment that
identifies and improves steps in a
process thereby reasonably ensuring a
safe and clinically desirable outcome
2. A systematic approach to identify and
prevent product and process
problems before they occur
Choosing a Process for an FMEA
Project
 Many different processes occur within a
hospital setting
◦ Each of these processes may have varying
degrees of risk
 The possibilities for an FMEA could be:
◦ Sentinel Event Alerts
◦ National Patient Safety Goals
◦ Other identified high-risk processes within
the hospital
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The Healthcare FMEA Process

• It is a five step process
1. Step 1 – Define the Topic

2. Step 2 – Assemble the Team

3. Step 3 – Graphically Describe the Process

4. Step 4 – Conduct the Analysis

5. Step 5 – Identify Actions and Outcome

Measures

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Step 1: Define the Process STEP 2

 Evacuation of ICU patients in Fire  Assemble the Team
Emergency at ABC Hospital ◦ A multidisciplinary team consisting of members
who have expertise in their own domain needs
to be assembled
ICU Name Beds Location ◦ An adviser having experience in HMEA also will
CTVS ICU 12 3rd Floor be needed
ICCU 16 3rd Floor ◦ The team may consist of:
NICU 12 2nd Floor  The ICU in charge
 Senior nursing staff
PICU 12 2nd Floor  Housekeeping manager
TOTAL 52 beds  Biomedical engineer
 Materials manager

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ICU Evacuation Process Flow Diagram

Step 3
Evacuation
 Graphically describe the process Order declared

◦ A flow diagram needs to be developed for the

Emergent/Urgent
process under study Situation
Elective/
Manual
Severity of
END
◦ The various process step identified in the flow Event?

diagram are to be consecutively numbered

◦ A complex process may be broken down in
Emergent
situation
Respond/Evacuate
How many?
Accordingly
smaller sub processes How Far?
Containable?

◦ A sub process needing priority attention to

be identified and studied more thoroughly RACE
B

Proximity-based evacuation

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ICU Evacuation Process Flow Diagram …….

Step 4: Potential Failure Modes,
B
Causes and Effect
A Consider short term
 Identify what “could” go wrong at each of
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placement while a
permanent site is
prepared
the process steps on the flow chart
4
7
Determine severity and probability
Short
Distance Evac.
No
Horizontal or
Vertical Evac.
Vertical

Yes Horizontal
5
Threat
No
Follow Horizontal
Evacuation
Follow Vertical
Evacuation 9
 Identify “why it might happen”
Terminate Procedure
d? 8 Procedure

Yes
Patient Records/
 The causes of those failures
10 Med to accompany
END patient
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 The effects of those failures
Move patients to Decide for how
11 selected safe area long and adjust

◦ These are referred to as the “Failure Modes”

plans accordingly
END
of refuse

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Step 4: Process Failure Modes Step 4: Process Failure Modes

Findings (example) Findings
 Identification of evacuation distance  Evacuation devices like ski sled or ResQ
incorrect Mat not available for vertical evacuation
 Insufficient staff for assisting dependent
 No smoke and fire protected lift for use
patients
 Insufficient mobile life support equipment
by fire service and evacuation of highly
 Location of fire compartments not known to
dependent patients
staff  Triaging could not be done due to
 Emergency supplies at bed side bag not absence of doctors
available as per list
 Patients were not identified

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Step 4: Rate each Failure Mode Step 4: Risk Score

 Three factors to be considered:  A brainstorming session to be done with
◦ Severity, probability of occurrence and the multidisciplinary team assembled for
detection capability FMEA
 Severity is the consequence of the failure if it  The team will identify the “failure modes”
occurs
 Probability of occurrence is the likelihood or
and probability of occurrence and the
chance of the failure mode occurring detection capability
 “Detection rating” is the ability to catch the error  Example:
before causing patient harm
◦ Insufficient staff for evacuation

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Step 5: Action and Outcome

Tools and Techniques
Measures
 Identified causes of failure mode to be either  To record the process of identification of
“Eliminated”, “Controlled” or “Accepted” the “failure modes”, analyzing them and
 Determine the actions to be taken for each allotting severity scores to each of them
failure mode for its elimination or control the tools have been devised.
 Outcome measures to be identified to  These are:
ascertain the success of the redesign actions ◦ Forms
 After top management’s concurrence, assign ◦ Worksheets
responsibility to a competent person to ◦ Hazard scoring matrix and
rectify the defects as recommended ◦ Decision tree

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Hazard Analysis Probability Rating

 The hazards of the failure modes can be  Frequent – Likely to occur immediately
categorized into:
◦ Catastrophic Event (may happen several times in a one year
 FMEA rating of 10 – Failure could cause death or injury
 Occasional - Probably will occur (may
◦ Major Event
 FMEA rating of 7 – Failure causes a high degree happen several times in one to two years
of customer satisfaction
◦ Moderate Event  Uncommon – Possible to occur (may
 FMEA rating of 4 – Failure can be overcome with
modifications to the process happen sometime in 2 to 5 years
◦ Minor Event  Remote – Unlikely to occur (may happen
 FMEA rating of 1 – Failure would not be noticeable to the
customer and would not affect sometime in 5 to 30 years)
delivery of the service

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Hazard Scoring Matrix Determine FMEA Project Success

 Recalculate the Hazard scores after

Severity implementation of the action plan
Catastrophic Major Moderate Minor
Probability

 Address any item with a Hazard score of

Frequent 16 12 8 4
16 or higher
Occasional 12 9 6 3
 Re-do FMEA
Uncommon 8 6 4 2
 Implement action plan
Remote 4 3 2 1
Hazard score is obtained by multiplying severity with probability

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Bibliography
1. The Basics of Healthcare Failure Mode
Effects Analysis. VA National Centre for
Patient Safety
2. Effective FMEAs. Carl S. Carlson. Wiley
3. FMEA. Joint Commission International
Resources, 3rd Ed. 2010
4. Todd A. Reichert. Applying FMEA in
Healthcare. Society for Health System
Presentation, 2004, WakeMed, Raleigh, NC
27610
5. Institute for Healthcare Improvement.
FMEA
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