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Fig 4.8 OEE

4.5 FAILURE MODE AND EFFECT ANALYSIS (FMEA):
A failure mode and effect analysis (FMEA) is a procedure
in product development and operations management for analysis of
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potential failure modes within a system for classification by the

severity and probability of the failures. A successful FMEA
activity helps a team to identify potential failure modes based on
past experience with similar products or processes, enabling the
team to design those failures out of the system with the minimum
of effort and resource expenditure, thereby reducing development
time and costs. It is widely used in manufacturing industries in
various phases of the product life cycle and is now increasingly
finding use in the service industry. Failure modes are any errors or
defects in a process, design, or item, especially those that affect the
customer, and can be potential or actual. Effects analysis refers to
study the consequences of those failures.
Failure Mode and Effect Analysis (FMEA), also known as
risk analysis, is a preventive measure to systematically display the
causes, effects, and possible actions regarding observed failures.
The objective of FMEA is to expect failures and prevent
them from occurring. FMEA prioritise failures and attempts to
eliminate their causes.
FMEA is an engineering technique used to define, identify
and eliminate known and / or potential failures, problems, errors
which occur in the system, design, process and service before they
reach the customer.
FMEA is a before-the-event action and is done when
existing systems / products / processes are changed or redesigned.
FMEA is a never-ending process improvement tool.

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Fig 4.9 FMEA Cycle

4.5.1 BASIC DEFINITIONS
Failure
"The loss of an intended function of a device under stated
conditions."
Failure mode
"The manner by which a failure is observed and it generally
describes the way the failure occurs."
Failure effect
Immediate consequences of a failure on operation, function
or functionality, or status of some item
Indenture levels
An identifier for item complexity. Complexity increases as
levels are closer to one.
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Local effect
The Failure effect as it applies to the item under analysis.
Next higher level effect
The Failure effect as it applies at the next higher indenture
level.
End effect
The failure effect at the highest indenture level or total
system.
Failure cause
Defects in design, process, quality, or part application,
which are the underlying cause of the failure or which
initiate a process which leads to failure.
Severity
"The consequences of a failure mode. Severity considers
the worst potential consequence of a failure, determined by
the degree of injury, property damage, or system damage
that could ultimately occur."
4.5.2 TYPES OF FMEA:
The several types of FMEA includes,
System FMEA Analyzes components, subsystem and
main system in early stage of design.
Design FMEA Analyzes the products / parts before they
are releases to manufacturing.
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Process FMEA Focuses on manufacturing and assembly

processes.
Service FMEA Analyzes service industry processes
before they are released to impact the customer.
Equipment FMEA.
Maintenance FMEA.
Concept FMEA.
Environmental FMEA.
However in practice, all the above types can be broadly
categorized into two types they are
4.5.2.1 DESIGN FMEA:

Design FMEA involves the analysis of the potential

failures and services due to component or subsystem
unreliability.

Design FMEA is to establish priorities based on expected

failures and severity of those failures.

FMEA can provide an analytical approach, when dealing

with potential failure modes and their associated causes. When
considering possible failures in a design like safety, cost,
performance, quality and reliability an engineer can get a lot of
information about how to alter the development/manufacturing
process, in order to avoid these failures. FMEA provides an easy
tool to determine in which risk has the greatest concern, and
therefore an action is needed to prevent a problem before it arises.

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4.5.2.2 PROCESS FMEA:

Process FMEA involves

manufacturing process.

The process FMEA is used primarily to identify critical

areas of control and to emphasize the design and more
reliable process.

failure

analysis

of

4.5.3 BENEFITS OF FMEA:

Improve product / process reliability and quality.
Increase customer satisfaction.
Early identification and elimination of potential product
/ process failure modes.
Prioritize product / process deficiencies.
Capture engineering / organization knowledge.
Document and track the actions taken to reduce risk.
Provide focus for improved testing and development.
Minimize late changes and associated cost.
Act as catalyst for teamwork and idea exchange
between functions.
4.5.4 INPUTS FOR PREPARATION OF FMEA:
People inputs :
The FMEA methodology is a team effort. The FMEA team
should have an assembly engineer, manufacturing engineer,
materials engineer, quality engineer, service engineer,
suppliers and the customer.
Data inputs:
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The data inputs needed to prepare FMEA are product and

process specifications, reliability data, customer priority
data, process variability data, process description, and
inspection data.
4.5.5 STAGES OF FMEA (FMEA METHODOLOGY)
The FMEA methodology has four stages. They are:
Stage 1. Specifying Possibilities
(i) Functions
(ii) Possible failure modes
(iii) Root causes
(iv) Effects
(v) Detection / prevention
Stage 2. Quantifying Risk
(i) Probability of cause
(ii) Severity of effect
(iii) Effectiveness of control to prevent cause
(iv) Risk priority number (RPN)
Stage 3. Correcting high risk causes
(i) Prioritizing work
(ii) Detailing action
(iii) Assigning action responsibility
(iv) Check points on completion
Stage 4. Re-evaluation of risk
(i) Recalculation of risk number.
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4.5.6 FMEA PROCEDURE (Eg of a FMEA Form- Table 4.1)

The basic steps for implementation of a FMEA are outlined below.
Describe the product / process and its function.
Create a block diagram of the product / process:
The below diagram shows the logical relationship of
components and establishes a structure around which the
FMEA can be developed.
Complete the header of the FMEA form worksheet.
Item, design / process responsibility (i.e., team leader),
prepared by, model number / year, key date, core team (i.e.,
team members name), and revision date. Modify these
headings as needed.
List product / process functions.
Identify failure modes:

A failure mode is defined as the manner in which a

component, subsystem, system process, etc., could
potentially fail to meet the design purpose.

Examples of potential failure modes include:

Corrosion, torque, fatigue, deformation, cracking,
electrical short or open, and hydrogen embrittlement.

Describe the potential failure effects:

For each failure mode identified the engineer should

determine what the ultimate effect will be.

A failure effect is defined as the result of a failure

mode on the function of the product / process as
perceived by the customer.

Examples of failure effects include :

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Injury to the user, impaired operation, poor appearance,

odours, noise, and degraded performance.
Establish a numerical ranking for the severity (S) of the
effect:

Severity (S) is the assessment of the seriousness of the

failure effect. (Detailed explanations given in the
forecoming pages)

A common industry standard scale uses 1 to represent

no effect and 10 to indicate very serious effect.

This numerical ranking enables the engineer to

prioritize the failures and address the real big issues
first.

The class column is used to classify any special product

characteristics for components, sub-systems, or systems
that may require additional process controls.
Identify the potential causes / mechanisms of failure:

A failure cause is defined as a design weakness that

may result in a failure.

The potential causes for each failure mode should be

identified and documented.

The causes should be listed in technical terms and not

in terms of symptoms.

Examples of potential causes include:

Improper torque applied, improper operating
conditions, contamination, erroneous algorithms,
improper alignment, excessive loading, and excessive
voltage.
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Enter the probability factor:

Occurrence (O) is the chance that one of the specific

causes / mechanics will occur. (Detailed explanations
given in the fore-coming pages)

A numerical weight should be assigned to each cause

that indicates how likely that cause is (i.e., probability
of the cause causing).

A common industry standard scale uses 1 to represent

not likely and 10 to indicate inevitable.

Identify current controls (design or process):

Current controls (design or process) are the

mechanisms that prevent the cause of the failure mode
from occurring or which detect the failure before it
reaches the customer.

These controls may be supported through tests,

mathematical studies, feasibility reviews, and prototype
testing.

Determine the likelihood of detection (D):

Detection (D) is an assessment of the likelihood that

the current controls will detect the cause of the failure
mode or the failure mode itself. (Detailed explanations
given in the fore coming pages)

The likelihood of detection is also based on a 1 to 10

scale, with being the certain of detection and 10 being
the absolute uncertainty of detection.

Review risk priority number (RPN):

The risk priority number (RPN) is defined as the

product of the severity (S), occurrence (O), and
detection (D) rankings.
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That is, RPN = Severity Occurrence Detection

or RPN = (S) (O) (D)

The RPN is used to prioritize items that require

additional quality planning or action.

Determine recommended action(s):

Determine recommended action(s) to address potential

failures that have a high RPN.

These actions may include specific inspection, testing,

de-rating, selection of parts and materials, redesign of
the items, monitoring mechanics, and performing
preventive maintenance.

Assign responsibility and a target completion date for these

actions. This makes responsibility clear-cut and facilitates
tracking.
Indicate actions taken:

After these actions have been taken, re-assess the

severity, occurrence and detection and review the
revised RPNs.

Update the FMEA as the design or process changes, the

assessment changes or new information becomes known.

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(Design / Process FMEA)

Function

Failure
mode

Effects

S (severity
rating)

Cause(s)

RPN
CRIT
Responsibility
(risk Recommended
(critical
and target
priority
actions
characteristic
completion date
number)

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Table 4.1FMEA Worksheet

O
D
Current
(occurrence
(detection
controls
rating)
rating)

Action
taken

Core Team ____________________________________________________________________________________________

FMEA Date (Orig) ________________ (Rev)_______________________

Prepared By______________________________Model Number / Year ________________ Key Date _________________

Item ________________________________________Design / Process Responsibility _______________________________

FMEA Number ___________________________________ Page________________________of________________________

Failure Mode Effect Analysis

Fill tub

S
Effects (severity
rating)

High Liquid
level spills
on
sensor
never custom
trips er floor

Failure
Function
mode

level
sensor
failed
level
sensor
disconnect
ed

2
5

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Table 4.2 FMEA Example

Fill
timeout
based
on time
to fill to
low
level
sensor

80

Perform cost
XYZ
analysis of 15/06/2011
adding
additional
sensor
halfway
between low
and high
level sensors

RPN
Responsibility
O
D
CRIT
Current
(risk Recommended and target
Action taken
Cause(s) (occurren
(detectio
(critical
actions
controls
completion
priority
ce rating)
n rating) characteristic
date
number)

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Step 1: Occurrence
In this step it is necessary to look at the cause of a failure
mode and how many times it occurs. This can be done by looking
at similar products or processes and the failure modes that have
been documented for them. A failure cause is looked upon as a
design weakness. All the potential causes for a failure mode should
be identified and documented. Again this should be in technical
terms. Examples of causes are: erroneous algorithms, excessive
voltage or improper operating conditions. A failure mode is given
an occurrence ranking (O), again 110. Actions need to be
determined if the occurrence is high (meaning > 4 for non-safety
failure modes and > 1 when the severity-number from step 1 is 9 or
10). This step is called the detailed development section of the
FMEA process. Occurrence also can be defined as %. If a nonsafety issue happened less than 1%, we can give 1 to it. It is based
on your product and customer specification.
Rating

Meaning

1.

No effect

2/3

Low (relatively few failures)

4/5/6

Moderate (occasional failures)

7/8

High (repeated failures)

9/10

Very high (failure is almost inevitable)

Step 2: Severity
Determine all failure modes based on the functional
requirements and their effects. Examples of failure modes are:
Electrical short-circuiting, corrosion or deformation. A failure
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mode in one component can lead to a failure mode in another

component, therefore each failure mode should be listed in
technical terms and for function. Hereafter the ultimate effect of
each failure mode needs to be considered. A failure effect is
defined as the result of a failure mode on the function of the system
as perceived by the user. In this way it is convenient to write these
effects down in terms of what the user might see or experience.
Examples of failure effects are: degraded performance, noise or
even injury to a user. Each effect is given a severity number (S)
from 1 (no danger) to 10 (critical). These numbers help an engineer
to prioritize the failure modes and their effects. If the severity of an
effect has a number 9 or 10, actions are considered to change the
design by eliminating the failure mode, if possible, or protecting
the user from the effect. A severity rating of 9 or 10 is generally
reserved for those effects which would cause injury to a user or
otherwise result in litigation.
Rating
Meaning
1 No effect
2 Very minor (only noticed by discriminating customers)
Minor (affects very little of the system, noticed by average
3
customer)
4/5/6 Moderate (most customers are annoyed)
High (causes a loss of primary function; customers are
7/8
dissatisfied)
Very high and hazardous (product becomes inoperative;
9/10 customers angered; the failure may result in unsafe
operation and possible injury)
Step 3: Detection
When appropriate actions are determined, it is necessary to
test their efficiency. In addition, design verification is needed. The
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proper inspection methods need to be chosen. First, an engineer

should look at the current controls of the system, that prevent
failure modes from occurring or which detect the failure before it
reaches the customer. Hereafter one should identify testing,
analyzing, monitoring and other techniques that can be or have
been used on similar systems to detect failures. From these controls
an engineer can learn how likely it is for a failure to be identified
or detected. Each combination from the previous 2 steps receives a
detection number (D). This ranks the ability of planned tests and
inspections to remove defects or detect failure modes in time. The
assigned detection number measures the risk that the failure will
escape detection. A high detection number indicates that the
chances are high that the failure will escape detection, or in other
words, that the chances of detection are low.
Rating

Meaning

Almost certain

High

Moderate

4/5/6

Moderate - most customers are annoyed

7/8

Low

9/10

Very remote to absolute uncertainty

After these three basic steps, risk priority numbers (RPN) are
calculated
Risk Priority Numbers
RPN plays an important part in the choice of an action
against failure modes. They are threshold values in the evaluation
of these actions.
After ranking the severity, occurrence and detection the
RPN can be easily calculated by multiplying these three numbers:
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RPN = S O D
This has to be done for the entire process and/or design.
Once this is done it is easy to determine the areas of greatest
concern. The failure modes that have the highest RPN should be
given the highest priority for corrective action. This means it is not
always the failure modes with the highest severity numbers that
should be treated first. There could be less severe failures, but
occur more often and are less detectable.
After these values are allocated, recommended actions with
targets, responsibility and dates of implementation should be noted.
These actions can include specific inspection, testing or quality
procedures, redesign (such as selection of new components),
adding more redundancy and limiting environmental stresses or
operating range. Once the actions have been implemented in the
design/process, the new RPN should be checked, to confirm the
improvements. These tests are often put in graphs, for easy
visualization. Whenever a design or a process changes, an FMEA
should be updated.
A few logical but important thoughts come in mind:

Try to eliminate the failure mode (some failures are more

preventable than others)

Minimize the severity of the failure

Reduce the occurrence of the failure mode

Improve the detection

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