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
1 Source 2
What is Failure Mode Effects
Why Use FMEA?
Analysis
It is a tool aimed at prevention of errors
It is done before the incidence occurs
No previous bad experience or close call
Failure Mode and Effects Analysis (FMEA) is required to conduct FMEA
is a systematic method of identifying and The system becomes more robust
preventing product and process problems The system becomes fault tolerant
before they occur
3 4
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
5 6
1
5/1/2017
Objects Impacted in MRI Gantry 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
7 8
NABH and FMEA Healthcare FMEA Definitions
NABH 4th Ed describes the process of • Healthcare Failure Mode & Effect Analysis
FMEA in the glossary section (HFMEA)
Though not specifically included in any 1. A prospective assessment that
standard but the intent appears to be identifies and improves steps in a
◦ Proactively identifying error risk within a
particular process
process thereby reasonably ensuring a
The detailed process of FMEA describes safe and clinically desirable outcome
the steps to be taken 2. A systematic approach to identify and
Quantitative Estimate of likelihood of prevent product and process
error has been provided problems before they occur
9 11
Choosing a Process for an FMEA
Healthcare FMEA Definitions
Project
Hazard Analysis:
Many different processes occur within a
◦ It collects data on hazards associated with the
selected process
hospital setting
◦ Each of these processes may have varying
◦ Develops a list of hazards that may cause
degrees of risk
harm, if not controlled
Failure Mode: The possibilities for an FMEA could be:
◦ Sentinel Event Alerts
◦ Different ways that a process or sub-process
can fail to provide the intended result ◦ National Patient Safety Goals
◦ Other identified high-risk processes within
the hospital
12 13
2
5/1/2017
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
14 15
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
16 17
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
18 19
3
5/1/2017
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
6
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
12
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
20 21
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
22 23
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
24 25
4
5/1/2017
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
26 27
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
28 29
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
30 31
5
5/1/2017
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
32 33
