Failure Mode and Effects Analysis (FMEA)

It is a systematic method of assessing both new and existing processes and systems to understand where
and how they could fail, Failure Mode and Effects Analysis (FMEA). FMEA is a formal design technique
developed by the aerospace industry in the 1960s to meet reliability and safety standards. Ford Motor Company
introduced FMEA to the automobile industry in the late 1970s for safety and regulatory purposes. It is used to
identify probable failure modes, assess their effect on the product's operation, and identify steps to mitigate the
failures. It identifies possible reliability concerns early in the development cycle when it is simpler to take
corrective steps, ultimately improving reliability via design. Assessment of present systems or processes is to
understand how proposed changes might influence the system. FMEA is widely utilized in manufacturing
sectors at various stages of the product life cycle and is currently prevalent in a wide range of industries such as
semiconductor processing, food service, plastics, power plants, software, and healthcare. FMEA is used in the
healthcare system when a new process, function, or service with an associated hazard has not yet been
implemented. When a current process, function, or service is modified or changed affects a previous failure or
sentinel event. Alternatively, when the present process, function, or service is used in a new or comparable
place. It is used during the design stage to avoid future failures. The FMEA technique is cost reduction, which
has a significant influence on warranty returns, a decrease in the time required from the project phase to market
launch, and an improvement in product quality and dependability while boosting the safety of their operation.
FMEA is pretty comparable to what most people do on a daily basis. For example, you may listen to the radio
or television to find out where there are likely to be traffic jams or delays in public transportation. You can
adjust your driving route or means of transportation if you know there are issues on the road.
FMEA is frequently done and updated whenever a new product or process is introduced when
modifications are made to present circumstances or the design, when new rules are implemented, or when an
issue is identified through consumer feedback.
There are Two major types of Failure Mode and Effects Analysis the Design Failure Mode and Effects
Analysis (DFMEA) and Process Failure Mode and Effect Analysis (PFMEA)
Design Failure Mode and Effects Analysis (DFMEA) is also known as Product FMEA. DFMEA aims
to avoid product design-related difficulties, such as potential malfunctions, reduced service life, or safety and
regulatory issues before production. This type of FMEA is to identify probable failure modes early in the design
development process to eliminate their effects, select the optimal design variant, and develop a documentary
base to support future designs to reduce the risk of faulty products reaching customers.
Process Failure Mode and Effect Analysis (PFMEA). PFMEA aims to detect possible failures or
modifications to processes throughout the planning and execution phases. Manufacturing, assembly,
transactions, or services might all be included. This form of FMEA focuses on probable process failure modes
induced by manufacturing or assembly process defects. In PFMEA, the team focuses on failure modes and their
causes that may occur during the actual manufacturing or service process rather than product design.

Steps of Failure Mode and Effects Analysis (FMEA)

1. Select a process to analyze
 Choose a process that is known to be problematic in your facility or one that is known to be
problematic in many facilities.
 Define the Scope, along with a clear definition of the process to be studied
2. Describe the Process
3. List of Potential failure mode
 Where the people directly involved in the process describe the problems that can or do occur.
4. Actions and Outcome Measures
 Pick which problems to work on eliminating, controlling, or accepting
 Describe an action for each failure mode cause that will eliminate or control it.
  Identify outcome measures that will be used to analyze and test the re-designed process
5. Design and implement changes to reduce or prevent problems
 What actions are implemented to prevent this cause from occurring again?
 Calculate the criticality.
 Identify special characteristics
6. Measure the success of process changes
 Are the actions effective and efficient?

Figure 1. Process Map of Failure Mode and Effects Analysis

Definition of Terms in FMEA

Failure Mode. The process through which a failure occurs and is detected.
Potential Failure Effect. The impact is the result of the preceding failure. More than one effect may be
detected. Some of the consequences include user harm, inoperability of the product or process, degradation of
product quality, noncompliance with standards, smells, noise, and so on.
Severity Factor. The degree of the failure's influence It is worth noting that the severity denotes the
significance of the failure rather than the form of failure. The severity of the effect is assigned a severity number
(S) ranging from 1 (no danger) to 10. (critical).
Cause of Failure. Determine all possible causes for each form of failure. Defects in the product or process, as
well as any other quality flaws, would cause additional degradation, eventually leading to failure.
Probability Occurrence. The probability of a specific effect occurring and failing. The chance of occurrence
can be assessed on a scale of 1 to 10, with 1 being an extremely low probability and 10 representing a very high
probability. If this value is more than 4, the actions required to find and evaluate them must be more meticulous.
Process Controls. The present controls in place to avoid or identify problems, which might be tests, processes,
or methods that guarantee failures do not reach the customer
Detection. It estimates the probability of identifying a failure using the present process controls. On a scale of 1
to 10, one indicates that the control is very likely to identify the failure, and 10 indicates that the control is
extremely unlikely to detect the failure.
Risk Priority Number (RPN). The RPN is determined by multiplying the severity by the occurrence and the
detection (S x O x D). This number helps in the classification and prioritization of identified failures, indicating
the order in which they should be addressed and whether immediate action is necessary.

Example of Failure Mode and Effect Analysis

Process Failure Mode and Effect Analysis
1 2 3 4 5 6 7 8 9
Process Failure Failure Severity Failure Occurrence Process Detection Risk
step Mode Effect (S) Cause Probability Controls (D) Priority
(O) Number
(RPN)
Improper Examine
adminis- operator
The tering of 4 training, 5 225
device transtho-racic device
failure electrical mainte-
to arrhythmias 9 nance
detect The device Preparedness
rhythm detection Check
s system does 7 Before Any 5 186
Test of not work Clinical Use
finished
Defibrillators
FDA
examine
operator
training,
device
Poor operator mainte-
knowledge 7 nance, and 4 240
clinical use
of
The defibrillators
device Defibrillator
failure Patient Working
to survival is 10 Group
deliver critical use of shift
shock checklists by
Errors in clinical
defibrillator 3 operators 4 200
care  and
adherence to
a schedule of
periodic
maintenance
Figure 2. PFMEA Example: Process of Testing of a Defibrillators
 As a starting point, we examine the process of testing finished defibrillators. We identified two failure
modes in this FMEA example: The device failed to detect rhythms or fails to deliver a shock. So we question
ourselves, "What may happen if this failure occurs?" The consequences of the failures are arrhythmias and
patient survival in critical conditions. Because a patient survival is critical is in the worst-case situation. We rate
the severity as 10 and the second effect as a 9. Improper administering of transthoracic electrical or the device
detection system does not work and poor operator knowledge or Errors in defibrillator care are the two most
likely causes of each failure condition.
Because this is a brand-new defibrillator, we can consider: the chance of occurrence as 4 (occasional)
for the problem with the administering and 7 (high) for the problem with the detection system. Process controls
can either avoid failures or identify them after they have occurred. The FDA conducts a multistate survey to
examine operator training, device maintenance, and clinical use of defibrillators or Defibrillator Working Group
recommends the use of shift checklists by clinical operators and adherence to periodic maintenance. Each of
which signifies a different type of control. Multiply the three ratings to get the Risk Priority Number (RPN) for
each probable failure mode. These figures will help the team prioritize fixing the failure modes and causes.

Design Failure Mode and Effect Analysis Example

1 2 3 4 5 6 7 8 9
Process Failure Failure Severity Failure Occurrence Process Detection Risk
step Mode Effect (S) Cause Probability Controls (D) Priority
(O) Number
(RPN)
-Patient -Measure
Bed is not Patient is does not average
comfortable not 7 fit 6 users 2 84
Bed/ comfortable -Bed is -Smooth
Provide too soft surfaces
bed -Metal
comfort threads
to shear -Fastener
patients Bed flexes Bed feels 6 -Bed is 5 shear 1 30
too much unstable too thin analysis
(bends
or
shakes)
Figure 3. DFMEA Example: Bed for the Hospital Design Evaluation

For the DFMEA, we examine the design of beds for the hospitals. We identified failure modes in this
FMEA example: The bed is not comfortable, or the bed flexes too much. So we question ourselves, "What may
happen if this failure occurs?" The consequences of the failures are: Patients will not be comfortable, and the
bed will be unstable. Because a patient's comfort always should be at the top, having the patient uncomfortable
is the worst-case scenario. We rate the severity as a 7 and the second effect as a 6.
We can consider: the chance of occurrence as 6 (moderate) for the problem with the comfort and 5
(moderate) for the problem with the stability of the bed. Process controls can either avoid failures or identify
them after they have occurred. The Measuring of average users or Smoothening of surfaces and Fastener shear
analysis, each of which signifies a different type of control. Calculate the Risk Priority Number (RPN) for each
probable failure mode by multiplying the three ratings. These figures will help the team choose how to prioritize
resolving the failure types and causes.

References:
Cummins, R. O. (1990). Defibrillator Failures. JAMA, 264(8), 1019. doi:10.1001/jama.1990.03450080105041
 
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