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Foundations of
Effective FMEAs
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Welcome
evacuation.
3
The tool has been adapted in many different ways for many different
purposes.
This course will discuss general requirements and common
techniques, with the expectation that individuals may identify
relevant variations to fit their own experiences/needs.
4
Lunch
8:30 to 9:40 to 10:50 to 1:15 to 2:30 to 3:30 to
11:45 am
9:30 am 10:40 am 11:45 am 2:15 pm 3:30 pm 4:30 pm
1:15 pm
Lecture
Lecture Lecture
Class Exercise
Software
Lecture Lecture
Software Exercise Demo Lecture
Attendee Introductions
If applicable:
What standards have you used?
What software/tools have you used?
What do you hope to get out of this class?
CRP Credits
Course Objectives
1. Introduction
2. FMEA and Reliability
3. Fundamental Definitions and Concepts
4. Selection and Timing
5. Preparation
6. Procedure
7. FMEA Action Strategies
8. Case Studies
9. FMEA Success Factors
10. Basic FMEA Facilitation
Implementing an FMEA Process
©2003-2012 ReliaSoft Corporation
11.
12. FMECA
13. Integration with other Analyses and Processes
DRBFM, FTA, RCM, Hazard Analysis, Software FMEA
14. Xfmea User and Administrative Features (integrated throughout
course
8
EDUCATION
1: Introduction
8
9
Introduction Objectives
Many companies are faced with intense global
competition and must shorten product development times
and reduce costs.
Failure Mode and Effects Analysis (FMEA) is one of the
most effective techniques to achieve high reliability during
shorter product development timelines and budget
constraints.
The objectives of this module are to:
Introduce Failure Mode and Effects Analysis.
Illustrate how FMEA improves reliability and safety while
©2003-2012 ReliaSoft Corporation
FMEA Definition
History of FMEA
FMEA was formalized in 1949 by the US Armed Forces in the publication
Mil-P 1629 Procedure for performing a failure mode effect and criticality
analysis. The objective was to classify failures according to their impact
on mission success and personnel/equipment safety.
It was later adopted in the Apollo space program to mitigate risk due to
small sample sizes.
The use of FMEA gained momentum during the 1960s with the push to
put a man on the moon and return him safely to earth.
Ford Motor Company introduced FMEA to the automotive industry in the
late 1970s for safety and regulatory consideration after the Pinto affair.
In the 1980s, the automotive industry began implementing FMEA by
standardizing the structure and procedures through the Automotive
©2003-2012 ReliaSoft Corporation
Published Guidelines
FMEA Applications
…
15
…
16
catastrophe.
It is far less expensive to prevent problems early in
product development than to fix problems after launch.
17
Benefits of FMEA
EDUCATION
19
20
DFR Philosophy
*Reportedly, in 2007
Microsoft set aside
a $1,500,000,000 budget
for addressing Xbox®
field issues.
25
Factor of 10 Rule
If you discover a reliability …it will cost you this much
problem in this stage…
bili ty
a si 10x
Fe
esign
D 100x
Stag
me nt
lop
Dev
e 1,000x
eG
ting
ate
T es
10,000x
Proc
©2003-2012 ReliaSoft Corporation
i ng
ess
ctur
Ma nufa
Field
100,000x
27
©2003-2012 ReliaSoft Corporation
EDUCATION
3: Fundamental
Definitions and Concepts
29
30
Types of FMEA
System FMEA
A high-level DFMEA analysis of the entire system.
Includes interfaces/interactions among subsystems/components
and between the system and the environment or customer.
Design FMEA (DFMEA) focuses on design-related issues
To analyze a new product design before it goes into full production.
Done at the system, subsystem and/or component level.
Focuses on potential design related problems (e.g., “incorrect
dimensions specified).”
Process FMEA (PFMEA) focuses on process-related issues
©2003-2012 ReliaSoft Corporation
A Living Document
…
35
What is
What is it
it What
What are
are you
you What
What isis the
the How
How much
much were
were
supposed
supposed doing to
doing to prevent
prevent risk for this
risk for this we able to
we able to
to
to do?
do? the
the problem?
problem? problem?
problem? reduce the
reduce the risk?
risk?
How
How could
could
it fail?
it fail?
What
What will
will What
What is
is the
the What are
What are you
you
happen
happen if
if it
it cause
cause ofof doing
doing to
to detect
detect What
What can
can we
we do
do to
to
fails?
fails? failure?
failure? the problem?
the problem? improve the design
©2003-2012 ReliaSoft Corporation
Introduction to Exercises
instructor.
38
Definition
Item
An item is the focus of the FMEA project:
For a System FMEA this is the system itself.
For a Design FMEA, this is the subsystem or component
under analysis.
For a Process FMEA, this is usually one of the specific
steps of the manufacturing process under analysis, as
represented by an operation description.
©2003-2012 ReliaSoft Corporation
39
Additional
example Sample Item Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
©2003-2012 ReliaSoft Corporation
Additional
example Sample Item Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
©2003-2012 ReliaSoft Corporation
Additional
example Sample Item Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture
locating the part using self positioning detail and the
hand clamp to secure the tube in position.
©2003-2012 ReliaSoft Corporation
Additional
example Sample Item Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using
lubricant gun and fixture AF12345
©2003-2012 ReliaSoft Corporation
Item Description
Exercise
Write a description of the item you have identified as the
object of your analysis. Enter it in your Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
46
Definition
Function
Function is what the item or process is intended to
do, usually to a given standard of performance or
requirement.
For Design FMEAs, this is the primary purpose or design
intent of the item.
For Process FMEAs, this is the primary purpose of the
manufacturing or assembly operation; wording should
consider “Do this [operation] to this [the part] with this [the
tooling]” along with any needed requirement.
There may be many functions for each item or operation.
©2003-2012 ReliaSoft Corporation
47
Additional
example Sample Function Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx
rotational force while maintaining linear and
angular stability
©2003-2012 ReliaSoft Corporation
Additional
example Sample Function Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image
transfer for minimum yy hours of use
©2003-2012 ReliaSoft Corporation
Additional
example Sample Function Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture
locating the part using self positioning detail and the
hand clamp to secure the tube in position.
Function: Securely clamp upper tube in weld fixture,
without damaging part and without looseness or
movement of part in fixture
©2003-2012 ReliaSoft Corporation
Additional
example Sample Function Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using
lubricant gun and fixture AF12345
Function: Lube O-ring with ABC lubricant, using XYZ
specification
©2003-2012 ReliaSoft Corporation
Function
Exercise
Write a description of a function of the item you have
identified as the object of your analysis. Enter it in your
Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
54
Definition
Failure Mode
Failure Mode is the manner in which the item or
operation fails to meet or deliver the intended
function and its requirements.
Depending on the definition of failure established by
the analysis team, failure modes may include:
failure to perform a function within defined limits
inadequate or poor performance of the function
intermittent performance of a function, and/or
performing an unintended or undesired function.
©2003-2012 ReliaSoft Corporation
Additional
example Sample Failure Mode Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx rotational force
while maintaining linear and angular stability
Failure Mode: Shaft fractures
©2003-2012 ReliaSoft Corporation
Additional
example Sample Failure Mode Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image transfer for
minimum yy hours of use
Failure Mode: Bulb shatters
©2003-2012 ReliaSoft Corporation
Shaft fails
Additional
example Sample Failure Mode Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture locating
the part using self positioning detail and the hand clamp
to secure the tube in position.
Function: Securely clamp upper tube in weld fixture, without
damaging part and without looseness or movement of
part in fixture
Failure Mode: Tube not clamped securely and
shifts during processing
©2003-2012 ReliaSoft Corporation
Additional
example Sample Failure Mode Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using
lubricant gun and fixture AF12345
Function: Lube O-ring with 4 grams of ABC lubricant
evenly around the O-ring, using XYZ specification
Failure Mode: Insufficient lubrication, less than
4 grams applied
©2003-2012 ReliaSoft Corporation
Failure Mode
Exercise
Write a description of a failure mode relating to the
function of the item you have identified as the object of
your analysis. Enter it in your Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
62
Definition
Effect
Effect is the consequence of the failure on the
system or end user.
For Process FMEAs, the team should consider the
effect of the failure at the manufacturing or assembly
level, as well as at the system or end user.
There can be more than one effect for each failure
mode. However, in most applications the FMEA
team will use the most serious of the end effects for
the analysis.
©2003-2012 ReliaSoft Corporation
63
Additional
example Sample Effect Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx rotational force while
maintaining linear and angular stability
Failure Mode: Shaft fractured
Effect (Local: Shaft): No torque output (does
not transfer energy)
Effect (Next level: Grinder Subsystem): Rock
grinder teeth do not move
Effect (End user): No rocks are pulverized, and
product order is not filled (loss of sales)
©2003-2012 ReliaSoft Corporation
Additional
example Sample Effect Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image transfer for minimum
yy hours of use
Failure Mode: Bulb shatters
Effect: No light, with potential for operator
injury from broken glass
©2003-2012 ReliaSoft Corporation
Additional
example Sample Effect Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture locating the
part using self positioning detail and the hand clamp to secure
the tube in position.
Function: Securely clamp upper tube in weld fixture, without
damaging part and without looseness or movement of part in
fixture
Failure Mode: Tube not clamped securely and shifts during
processing
Effect: (In plant): Tube position incorrect, with
potential for defective welds and 100%
scrap
©2003-2012 ReliaSoft Corporation
Additional
example Sample Effect Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun
and fixture AF12345
Function: Lube O-ring with 4 grams of ABC lubricant evenly around
the O-ring, using XYZ specification
Failure Mode: Insufficient lubrication, less than 4 grams applied
Effect: Gas leak at fitting, with potential for
operator injury; system inoperable in field
use
©2003-2012 ReliaSoft Corporation
Effect
Exercise
Write a description of an effect of the failure mode
relating to the function of the item you have identified as
the object of your analysis. Enter it in your Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
70
Definition
Severity
Severity is a ranking number associated with the
most serious effect for a given failure mode, based on
the criteria from a severity scale.
It is a relative ranking within the scope of the specific FMEA
and is determined without regard to the likelihood of
occurrence or detection.
©2003-2012 ReliaSoft Corporation
71
What
severity
would be
assigned
to a
complete
loss of
function
using this
DFMEA
Severity
©2003-2012 ReliaSoft Corporation
Ranking
Scale?
72
Definition
Cause
Cause is the specific reason for the failure, preferably
found by asking “why” until the root cause is
determined.
For Design FMEAs, the cause is the design deficiency that
results in the failure mode.
For Process FMEAs, the cause is the manufacturing
deficiency (or source of variation) that results in the failure
mode.
In most applications, particularly at the component level, the
cause is taken to the level of the failure mechanism.
©2003-2012 ReliaSoft Corporation
low)
Poorly worded example of a Cause:
Outlet pressure too low
This example is excerpted from the book Effective
FMEAs, © John Wiley & Sons, 2012, all rights reserved.
75
Additional
example Sample Cause Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx rotational force while
maintaining linear and angular stability
Failure Mode: Shaft fractured
Effect (Local: Shaft): No torque output (does not transfer energy)
Effect (Next level: Grinder Subsystem): Rock grinder teeth do not
move
Effect (End user): No rocks are pulverized, and product order is not
filled (loss of sales)
Cause: Shaft not strong enough due to
material heat treat incorrectly specified
©2003-2012 ReliaSoft Corporation
Additional
example Sample Cause Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image transfer for minimum yy hours
of use
Failure Mode: Bulb shatters
Effect: No light, with potential for operator injury from broken glass
Cause: Over pressure due to wrong gas
specified
©2003-2012 ReliaSoft Corporation
Additional
example Sample Cause Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture locating the part using
self positioning detail and the hand clamp to secure the tube in
position.
Function: Securely clamp upper tube in weld fixture, without damaging part
and without looseness or movement of part in fixture
Failure Mode: Tube not clamped securely and shifts during processing
Effect: (In plant): Tube position incorrect, with potential for defective
welds and 100% scrap
Effect: (End user): If upper tubes get out of plant with defective
welds, the bicycle frame could collapse, with potential rider injury
Cause: Excessive wear on clamp tooling
©2003-2012 ReliaSoft Corporation
locating tips
Additional
example Sample Cause Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun and
fixture AF12345
Function: Lube O-ring with 4 grams of ABC lubricant evenly around the o-
ring, using XYZ specification
Failure Mode: Insufficient lubrication, less than 4 grams applied
Effect: Gas leak at fitting, with potential for operator injury; system
inoperable in field use
Cause: Lubrication gun calibration incorrect
due to calibration procedure not followed
©2003-2012 ReliaSoft Corporation
Cause
Exercise
Write a description of a cause of the failure mode
relating to the function of the item you have identified as
the object of your analysis. Enter it in your Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
81
Definition
Occurrence
Occurrence is a ranking number associated with the
likelihood that the failure mode and its associated
cause will be present in the item being analyzed.
For System and Design FMEAs, the occurrence ranking
considers the likelihood of occurrence during the design life
of the product.
For Process FMEAs the occurrence ranking considers the
likelihood of occurrence during production.
It is based on the criteria from the corresponding
occurrence scale.
©2003-2012 ReliaSoft Corporation
Definition
Controls
Controls are the methods or actions currently
planned, or that are already in place, to reduce or
eliminate the risk associated with each potential
cause.
Controls can be the methods to prevent or detect the cause
during product development, or actions to detect a problem
during service before it becomes catastrophic.
There can be many controls for each cause.
In Design FMEAs, they are called Design Controls.
©2003-2012 ReliaSoft Corporation
Definition
Design Controls
Prevention-type Design Controls describe how a cause,
failure mode or effect in the product design is prevented
based on current or planned actions. They are:
Intended to reduce the likelihood that the problem will occur.
Used as input to the occurrence ranking.
Detection-type Design Controls describe how a failure
mode or cause in the product design is detected, based
on current or planned actions, before the product design
is released to production. They are:
Intended to increase the likelihood that the problem will be
©2003-2012 ReliaSoft Corporation
Additional
example Sample Control Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx rotational force while
maintaining linear and angular stability
Failure Mode: Shaft fractured
Effect (Local: Shaft): No torque output (does not transfer energy)
Effect (Next level: Grinder Subsystem): Rock grinder teeth do not
move
Effect (End user): No rocks are pulverized, and product order is not
filled (loss of sales)
Cause: Shaft not strong enough due to material heat treat
incorrectly specified
©2003-2012 ReliaSoft Corporation
Additional
example Sample Control Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image transfer for minimum yy hours
of use
Failure Mode: Bulb shatters
Effect: No light, with potential for operator injury from broken glass
Cause: Over pressure due to wrong gas specified
Prevention Control: Currently scheduled
design review that addresses gas properties
Detection Control: Lamp pressure test #456
©2003-2012 ReliaSoft Corporation
Definition
Process Controls
Prevention-type Process Controls describe how a cause,
failure mode or effect in the manufacturing, fabrication or
assembly process is prevented, based on current or
planned actions. They are:
Intended to reduce the likelihood that the problem will occur.
Used as input to the occurrence ranking.
Detection-type Process Controls describe how a failure
mode or cause in the manufacturing, fabrication or
assembly process is detected, based on current or
planned action, before the item is shipped from the
©2003-2012 ReliaSoft Corporation
Additional
example Sample Control Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture locating the part using
self positioning detail and the hand clamp to secure the tube in
position.
Function: Securely clamp upper tube in weld fixture, without damaging part
and without looseness or movement of part in fixture
Failure Mode: Tube not clamped securely and shifts during processing
Effect: (In plant): Tube position incorrect, with potential for defective
welds and 100% scrap
Effect: (End user): If upper tubes get out of plant with defective
welds, the bicycle frame could collapse, with potential rider injury
Cause: Excessive wear on clamp tooling locating tips
©2003-2012 ReliaSoft Corporation
Additional
example Sample Control Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun and
fixture AF12345
Function: Lube O-ring with 4 grams of ABC lubricant evenly around the O-
ring, using XYZ specification
Failure Mode: Insufficient lubrication, less than 4 grams applied
Effect: Gas leak at fitting, with potential for operator injury; system
inoperable in field use
Cause: Lubrication gun calibration incorrect due to calibration
procedure not followed
Prevention Control: Documented in-plant lube-
gun calibration procedures #RJ3765
©2003-2012 ReliaSoft Corporation
Control
Exercise
Write a prevention-type control and a detection-type
control for the cause of the failure mode you are working
on, keeping in mind the definition of control. Enter it in
your Xfmea project.
Students working on a design-related example write down a
Design Control example.
Students working on a process-related example write down
a Process Control example.
The instructor will ask for volunteers
©2003-2012 ReliaSoft Corporation
Definition
Detection
Detection is a ranking number associated with
the aggregate of all current detection-type
controls, based on the criteria from the
detection scale.
The detection ranking considers the likelihood of
detection of the failure mode/cause, according to
defined criteria.
Detection is a relative ranking within the scope of the
specific FMEA and is determined without regard to the
©2003-2012 ReliaSoft Corporation
What
ranking
would you
give if you
used virtual
analysis
that is
highly
correlated
©2003-2012 ReliaSoft Corporation
with actual
operating
conditions?
96
What
ranking
would you
give if the
operator
used
attribute
gaging to
check parts
©2003-2012 ReliaSoft Corporation
Definition
RPN
RPN (Risk Priority Number) is a numerical
ranking of the risk of each potential failure
mode/cause, made up of the arithmetic
product of the three elements:
Severity of the effect.
Likelihood of occurrence of the cause.
Likelihood of detection of the cause.
©2003-2012 ReliaSoft Corporation
98
RPN = 10 x 4 x 6 = 240
99
(high likelihood
of detection)
RPN = 10 x 2 x 3 = 60
100
Definition
Recommended Actions
Recommended Actions are the tasks
recommended by the FMEA team that can
be performed to reduce or eliminate the risk
associated with potential cause of failure.
Recommended Actions should consider the existing
controls, the relative importance (prioritization) of the
issue and the cost and effectiveness of the
corrective action.
There can be many recommended actions for each
©2003-2012 ReliaSoft Corporation
cause.
101
Additional
example Sample Action Descriptions:
for student
reference only
DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
Function: Provide mechanical transfer of xx rotational force while maintaining linear
and angular stability
Failure Mode: Shaft fractured
Effect (Local: Shaft): No torque output (does not transfer energy)
Effect (Next level: Grinder Subsystem): Rock grinder teeth do not move
Effect (End user): No rocks are pulverized, and product order is not filled
(loss of sales)
Cause: Shaft not strong enough due to material heat treat incorrectly
specified
Prevention Control: Heat treat specification #123
Detection Control: Pump pressure shock test #234, cold start durability
©2003-2012 ReliaSoft Corporation
Additional
example Sample Action Descriptions:
for student
reference only
DFMEA Example 3
Item: Projector bulb
Function: Provide xx lumens of light for image transfer for minimum yy hours of use
Failure Mode: Bulb shatters
Effect: No light, with potential for operator injury from broken glass
Cause: Over pressure due to wrong gas specified
Prevention Control: Currently scheduled design review that addresses
gas properties
Detection Control: Lamp pressure test #456
Additional
example Sample Action Descriptions:
for student
reference only
PFMEA Example 2
Process Step: Clamp upper tube in weld fixture locating the part using self
positioning detail and the hand clamp to secure the tube in position.
Function: Securely clamp upper tube in weld fixture, without damaging part and without looseness
or movement of part in fixture
Failure Mode: Tube not clamped securely and shifts during processing
Effect: (In plant): Tube position incorrect, with potential for defective welds and 100%
scrap
Effect: (End user): If upper tubes get out of plant with defective welds, the bicycle
frame could collapse, with potential rider injury
Cause: Excessive wear on clamp tooling locating tips
Prevention Control: (none)
Detection Control: Routine scheduled visual inspection of clamp tool
Recommended Action: Establish a tooling and maintenance plan
that includes scheduled evaluation of wear, and addresses
©2003-2012 ReliaSoft Corporation
Additional
example Sample Action Descriptions:
for student
reference only
PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun and
fixture AF12345
Function: Lube O-ring with 4 grams of ABC lubricant evenly around the o-ring, using
XYZ specification
Failure Mode: Insufficient lubrication, less than 4 grams applied
Effect: Gas leak at fitting, with potential for operator injury; system
inoperable in field use
Cause: Lubrication gun calibration incorrect due to calibration procedure not
followed
Prevention Control: Documented in-plant lube-gun calibration procedures
#RJ3765
Detection Control: 100% End-of-line pressure testing
Recommended Action: Use modified lubrication-gun
©2003-2012 ReliaSoft Corporation
Recommended Action
Exercise
Write a recommended action to address the cause of
the failure mode for the exercise you are working on,
keeping in mind the definition of recommended action.
Enter it in your Xfmea project.
The instructor will ask for volunteers or call on you to
share what you have written.
©2003-2012 ReliaSoft Corporation
108
Definition
Actions Taken
Actions Taken are the specific actions that
are implemented to reduce risk to an
acceptable level.
Each Action Taken correlates to the corresponding
recommended action.
They are assessed as to effectiveness by a revised
severity, occurrence, detection ranking and by a
corresponding revised RPN.
©2003-2012 ReliaSoft Corporation
109
EDUCATION
4: Selection and
Timing
109
110
d
Configurable
ie
t if
columns
en
Id
ns
k
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System
Subsystem A
Component A.1
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Component A.2
Subsystem B
Component B.1
Component B.2
…
Sample Form – Other formats are acceptable and may be more appropriate for particular applications
114
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Frame Subsys. 3 2 2 3 1 1 1 1 14
Front Wheel Subsys. 3 1 1 1 1 1 1 1 10
Rear Wheel Subsys. 2 1 1 1 1 1 1 1 9
Sprocket Subsys. 1 1 1 1 1 1 2 1 9
Chain Subsys. 1 2 1 1 1 1 2 1 10
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Seat Subsys. 2 2 1 1 1 1 1 1 10
Handle Bar Subsys. 1 1 1 1 1 1 1 1 8
Hand Brake Subsys. 3 2 1 1 3 1 2 1 14
Suspension Subsys. 1 2 2 2 1 1 1 1 11
115
Concept
FMEAs
System
FMEA
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Design
FMEAs
Process FMEA
EDUCATION
5:
Basic FMEA Analysis Procedure
Preparation
118
119
Preparation
Objectives
Proper preparation is essential to success in
any FMEA project.
The objectives of this module are to:
Summarize the systematic tasks that need to be done
one time to prepare for future FMEA projects.
Demonstrate the tasks that need to be done for each
new FMEA project.
As a result of this module students will
©2003-2012 ReliaSoft Corporation
FMEA Preparation
One-Time Tasks
The following tasks need to be done once for a series
of FMEA projects:
Obtain FMEA software.
Select or modify FMEA worksheets and scales. (What
will the worksheets look like – what ranking scales will be
used?)
Identify roles and responsibilities.
Establish how the designated facilitator will be
determined.
©2003-2012 ReliaSoft Corporation
FMEA Preparation
One-Time Tasks (cont’d)
Set-up meeting logistics.
Define the system hierarchy (for System and Design
FMEAs).
Determine how the team will work with interfaces and
interactions.
Define the process steps (for Process FMEAs).
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123
...
You may choose to perform Process FMEAs on the entire
manufacturing or assembly process or identify specific
stations operations for analysis (Reference Preliminary
Risk Assessment)
125
FMEA Preparation
Each New FMEA
The following tasks need to be done for each new FMEA project:
Determine the Scope of the Analysis
Make the Scope Visible (for System and Design FMEAs):
FMEA Block Diagram
Parameter Diagram (P-Diagram)
FMEA Interface Matrix
Functional Block Diagram
Make the Scope Visible (for Process FMEAs):
Process Flow Diagram (PFD)
Process Flow Diagram Worksheet (PFD WS)
Assemble the Correct Team
©2003-2012 ReliaSoft Corporation
The exact scope will need to be determined by the System FMEA team.
131
The exact scope will need to be determined by the Design FMEA team.
132
Labeling
The exact scope will need to be determined by the Process FMEA team.
133
Data exchanges
134
All Terrain System FMEA Block Diagram
(with interfaces between subsystems and rider)
Rider
Seat S/S
Handle Bar S/S
G G
r r
o Frame S/S Suspension S/S
o
u Rr Wheel S/S
u
n
Ft Wheel S/S n
d d
Chain‐ Sprocket‐ Hand Brake S/S
Derailleur S/S Pedal S/S
Physical Connection Some of the FMEA Block Diagram
Material Exchange elements are intentionally missing.
Energy Transfer Can you determine what they are?
Data Exchange
This illustration is from the book Effective FMEAs,
© John Wiley & Sons, 2012, all rights reserved.
135
Truncated
This illustration is from the book Effective FMEAs,
© John Wiley & Sons, 2012, all rights reserved.
137
Example of PFD Worksheet for a portion of the Front Wheel Subassembly Station
Store/Get
Significant Process
Contain
Rework
Inspect
Scrap/
Significant Product Characteristics
(KPC)
(KCC)
Op-
Move
Class
Class
Fab
A
1.2 Front Wheel Subassembly Station
Orient and place wheel hub in Wheel hub is correctly located in Fixture does not allow incorrect
1.2.2 wheel assy fixture hub placement
wheel assembly fixture
Get wheel rim from parts Correct wheel rims are in
1.2.3 Correct wheel rim selected
presentation device presentation device
Orient and place wheel rim in Wheel rim is correctly located in Fixture does not allow incorrect
1.2.4 wheel assy fixture rim placement
wheel assembly fixture
Get set of wheel spokes from Correct spokes are in
1.2.5 Correct spoke set selected
parts presentation device presentation device
TRUNCATED
This illustration excerpt is from the book Effective
FMEAs, © John Wiley & Sons, 2012, all rights reserved.
139
know basis.
The FMEA core team can invite other experts for specific topics
during Design FMEA meetings, when their topic is being
discussed.
143
Field Service
The FMEA core team can invite other experts for
specific topics during Process FMEA meetings, when
their topic is being discussed.
144
Establish the
Ground Rules and Assumptions
Before beginning the analysis, the team should discuss
and document the underlying assumptions of the analysis
and specific ground rules for how the analysis will be
performed.
Ground rules are agreements of how meeting business
will be handled. These may include:
Standard rules of order will be followed (e.g., Robert’s Rules of
order or other).
How agreement on issues will be achieved (consensus, majority
vote, or other).
How approvals for completion are achieved.
©2003-2012 ReliaSoft Corporation
Etc.
Some of these guidelines may already be determined by
the organization’s standard practices for FMEA and some
may be specific to the particular analysis project.
148
Establish the
Ground Rules and Assumptions (cont’d)
Assumptions are agreements on what the team will take
as true for the purposes of the analysis. These may
include:
For Design FMEAs, does the FMEA team assume the product will
be manufactured or assembled within engineering specifications?
For Design FMEAs, does the FMEA team wish to consider an
exception, such as the part design may include a deficiency that
could cause unacceptable variation in the manufacturing or
assembly process?
For Process FMEAs, does the FMEA team assume the design is
sound and incoming parts and materials to an operation meet
©2003-2012 ReliaSoft Corporation
design intent?
For Process FMEAs, does the FMEA team wish to consider an
exception, such as incoming parts or materials may have variation
and do not necessarily meet engineering requirements?
Excerpted from the book Effective FMEAs,
© John Wiley & Sons, 2012, all rights reserved.
149
Keep in mind the type of FMEA you are working on and its scope.
Enter this information into Xfmea.
The instructor will ask for volunteers or call on you to share
what you have written.
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151
Gather Information
FMEA Exercise
Brainstorm, identify and document some of the
resources the team may wish to consult for the
exercise you are working on, keeping in mind the
type of FMEA you are working on and its scope.
Enter this information into Xfmea.
The instructor will ask for volunteers or call on you to
share what you have written.
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155
EDUCATION
6:
Basic FMEA Analysis Procedure
Procedure
155
156
Procedure
Objectives
Once the FMEA preparation steps have been
properly completed, work can begin with the FMEA
team on the FMEA procedure.
The objectives of this module are to:
Detail the basic procedure for doing FMEAs, from
Items through calculation of Risk Priority Numbers.
Provide emphasis on how to apply the fundamental
concepts and definitions of FMEA in real-world
applications.
©2003-2012 ReliaSoft Corporation
More!
meetings.
164
Functions
Trail Bike Hand Brake Design FMEA
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Functions
Wheel Spoke Installation Process FMEA
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Function Information
Function field.
To help ensure you have a complete description of functions in your
FMEA, please refer to the sections titled “Checklist of Function Types”
and “Thought Starter Questions” in chapter 6 of the book Effective
FMEAs.
169
Identify Function
Exercise
Recall your exercise on Functions.
Write down two questions you would ask your
team when completing the Function field for
an item.
Enter the two functions you have identified for
your selected topic into Xfmea.
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170
Definition
Failure
Mode
171
Remember!
Failure Modes
Trail Bike Hand Brake Design FMEA
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Failure Modes
Wheel Spoke Installation Process FMEA
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End Effect: The effect on the top level item (system) and/or
end user.
Definition
Effects
176
End effect:
Car stops running
177
customer.
178
Effects
Trail Bike Hand Brake Design FMEA
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Effects
Wheel Spoke Installation Process FMEA
©2003-2012 ReliaSoft Corporation
Identify Effects
Exercise
Recall your exercise on Effects.
Write down two questions you would ask your
team when completing the Effects field for an
item.
Enter the Effects for both failure modes of
your selected topic into Xfmea.
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181
Definition Risk
Rank
Severity
182
Cause(s) of Failure
Failure Mechanisms
Causes
Trail Bike Hand Brake Design FMEA
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Causes
Wheel Spoke Installation Process FMEA
©2003-2012 ReliaSoft Corporation
Identify Causes
Exercise
Recall your exercise on Causes.
Write down two questions you would ask your
team when completing the Cause field for an
item.
Enter two Causes for one of the failure modes
for your selected topic into Xfmea.
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192
Current Controls
For DFMEA
Design Controls are design practices that are performed
prior to production parts being made.
They are typically standards, procedures, virtual analysis,
analytical or other pre-testing evaluations used to
establish design parameters (prevention).
They are used by the design community to establish if
design deficiencies exist – frequently through testing or
analysis (detection).
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194
Current Controls
Trail Bike Design FMEA
Trail Bike - Bicycle Sub-System
©2003-2012 ReliaSoft Corporation
For PFMEA
Process Controls are ongoing manufacturing operation
control practices that are performed during the production
process that address and mitigate the potential for non-
conformity.
They are typically maintenance procedures, process
controls/specs or other ongoing evaluations used to
maintain a process such that it is manufacturing parts that
meet design requirements (prevention).
They are used by the manufacturing community on an
©2003-2012 ReliaSoft Corporation
Current Controls
Wheel Spoke Installation Process FMEA
©2003-2012 ReliaSoft Corporation
Identify Controls
Exercise
Recall your exercise on Controls.
Write down two questions you would ask your
team when completing the Controls field for
an item.
Enter one preventive type control and one
detection type control for one of the causes
into Xfmea.
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198
Occurrence Ranking
Definition Risk
Occurrence Rank
199
Detection Ranking
Likelihood of Detection
Prior to shipment
203
Detection Summary
RPN
Detection = 1.
1 5 10
210
Final Thoughts
EDUCATION
213
214
level.
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215
216
RPNs.
217
RPN Limitations
It is enticing for management to use thresholds for RPN
values and require defined action if the RPN value exceeds
the given threshold.
In most cases, this is a flawed approach, as it can easily become a
numbers game.
If RPN thresholds are used at all, they should only trigger a
heightened level of review, not specifically mandated action.
RPN ratings tend to be subjective in nature and cannot be
used to compare risk objectively across analyses.
Even two identical RPN values can have different levels of
risk.
©2003-2012 ReliaSoft Corporation
Remember!
• It usually takes multiple actions to reduce high
severity or high RPN risk.
• Use the entire array of quality and reliability tools
to develop strategies.
©2003-2012 ReliaSoft Corporation
Recommended Actions
Exercise
Recall your exercise on RPNs.
Write down two questions you would ask your team
when completing the Recommended Actions field
for your highest risk item.
Enter two recommended actions to address one of
the causes.
Enter the Recommended Actions for your high risk
item into Xfmea.
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224
Execution is Everything
Definition
Actions
Taken
229
Execution Enablers
EDUCATION
8:
Basic FMEA Analysis Procedure
Case Studies
231
232
Case Studies
Objectives
It is helpful to see actual FMEAs and for
students to learn by evaluating and critiquing
such FMEAs.
The objectives of this module are to:
Share real-world FMEA applications.
Offer students an opportunity to evaluate and
critique actual FMEAs.
As a result of this module students will better
©2003-2012 ReliaSoft Corporation
Case Studies
EDUCATION
FMEA Success
Factors
234
235
Maxim
Questions to Consider
Level of Detail
How will you establish the proper level of
detail in your FMEAs?
How will you keep your FMEA team focused
on risk?
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240
Experience
Mistake #1
Mistake #2
Mistake #3
written actions.
251
Mistake #4
analysis.
253
Interfaces
How will you ensure that your FMEA includes
interfaces?
©2003-2012 ReliaSoft Corporation
255
Mistake #5
Lessons Learned
How will you integrate your FMEAs with field
lessons learned so that high risk failure
modes are not repeated?
©2003-2012 ReliaSoft Corporation
258
Mistake #6
Level of Detail
How will you assure that your are working to
the proper level of detail for your analysis?
©2003-2012 ReliaSoft Corporation
261
Mistake #7
Timing
When should your FMEAs be done to
maximize their value?
©2003-2012 ReliaSoft Corporation
264
Mistake #8
Analysis Team
How will you ensure that the correct people
show up at all FMEA meetings?
©2003-2012 ReliaSoft Corporation
267
Mistake #9
Improper Procedure:
There are hundreds of ways to do FMEAs wrong.
Some companies do not encourage or control
proper FMEA methodology.
Training, coaching, reviews are all necessary to
success.
Quality Objective #9:
The FMEA document is completely filled out “by
©2003-2012 ReliaSoft Corporation
FMEA Procedure
How will you know if your FMEAs are done
with correct procedure?
©2003-2012 ReliaSoft Corporation
270
Mistake #10
Time Management
How will you know if the time spent on
FMEAs by subject matter experts is time
well spent?
©2003-2012 ReliaSoft Corporation
273
DESIGN IMPROVEMENTS
FMEA primarily drives Design Improvements.
HIGH RISK FAILURE MODES
FMEA addresses all high risk Failure Modes.
DVP&R/CONTROL PLAN
Comprehends failure modes from the Design/Process FMEA.
INTERFACES
FMEA scope includes integration and interface failure modes.
LESSONS LEARNED
©2003-2012 ReliaSoft Corporation
LEVEL OF DETAIL
The FMEA provides the correct level of detail in order to get to
root causes and effective actions.
TIMING
The FMEA is completed during the “window of opportunity.”
TEAM
The right people participate as part of the FMEA team.
DOCUMENTATION
FMEA document is completely filled out “by the book.”
©2003-2012 ReliaSoft Corporation
TIME USAGE
Effective and efficient use of time by FMEA Team.
275
EDUCATION
10:
Basic FMEA Analysis Procedure
Basic FMEA
Facilitation
277
278
Managing Time
RS 471 will teach these skills and how to apply
them to FMEA projects.
282
EDUCATION
11:
Basic FMEA Analysis Procedure
Implementing
an FMEA Process
282
283
EDUCATION
12:
Basic FMEA Analysis Procedure
FMECA
290
291
FMECA
Objectives
Although MIL-STD-1629A for FMECA was cancelled
in November, 1984, it is still used in some military
and other applications.
Some companies may choose to add (or are
mandated to add) a Criticality Analysis to the FMEA
procedure, according to specific procedures.
The objectives of this module are to:
Introduce FMECA and explain how it differs from FMEA.
Explain both Quantitative and Qualitative Criticality
Analysis.
©2003-2012 ReliaSoft Corporation
FMECA Definition
Mode Criticality
serious “loss”).
More detail is available on FMECA in Chapter 12 in the book
Effective FMEAs, ‘Failure Mode Effects and Criticality Analysis
(FMECA)’.
297
EDUCATION
13:
Other FMEA Related Applications
DRBFM
FTA
RCM
Hazard Analysis
Concept FMEA
Software FMEA
297
298
Introduction to DRBFM
Objectives
Many companies are incorporating Design Review
Based on Failure Mode (DRBFM) in addition to
FMEA.
The objective of this module is to:
Introduce the DRBFM methodology.
Explain how it is different from FMEA, when it should
be used and briefly how it is done.
As a result of this sub-module students will become
©2003-2012 ReliaSoft Corporation
DRBFM is:
A combination of Design Review and FMEA.
It includes a discussion by subject matter experts
of all concerns without limitations:
Design concerns
Validation and verification concerns
Process concerns
Manufacturing concerns
Supplier concerns
©2003-2012 ReliaSoft Corporation
Customer expectations
Cost and delivery
Maintenance
303
DRBFM Methodology
DRBFM Preparation
Usage environment
Interfaces
Specifications
Performance requirements
Or any other changes
305
DRBFM Worksheet
Once the preparation is complete, the two step
Procedure begins:
Step one
The responsible engineer completes the first portion of the
DRBFM worksheet and provides a draft to the team for their
review prior to the team meeting.
This step focuses on changes to the existing design and is
defined in detail in the first column (directly from the
preparation document).
The worksheet documents:
©2003-2012 ReliaSoft Corporation
“Points of concern”
“Effects to the customer”
“Detailed causes (circumstances of concerns)”
“Actions taken to eliminate concern.”
Some variations in the structure of the worksheet.
307
Step two
The team discusses the area of change and interfaces.
The engineer explains changes to the existing design and
reviews the detailed analysis.
Experts from required areas participate to make sure nothing was
missed by the responsible engineer.
The Experts identify additional “points of concern,” “effects to the
customer,” “detailed causes,” and “actions taken to eliminate
concern.”
The team provides detailed actions (design, validation,
©2003-2012 ReliaSoft Corporation
Example of DRBFM
©2003-2012 ReliaSoft Corporation
Truncated
Shimizu, Hirokazu, Yuichi Otsuka, and Hiroshi Noguchi, Design review based on failure
mode to visualize reliability problems in the development stage of mechanical products.
International Journal of Vehicle Design, 2010. Volume 53 (Issue 3): p. pages 149 to 165.
309
Introduction to FTA
Objectives
Undesirable events or other high-risk situations can
have numerous and complex potential contributors.
There are times when Fault Tree Analysis (FTA)
should be used in addition to FMEA.
The objective of this module is to:
Provide a brief overview of FTA and explain how it relates to
FMEA.
As a result of this module students will be aware of
when FTA should be used to augment FMEA projects.
©2003-2012 ReliaSoft Corporation
Definition of FTA
A Fault Tree Analysis can be described as an analytical
technique whereby an undesired state of the system is
analyzed in the context of its environment and operation
to find all credible ways in which the undesired event can
occur.
The fault tree itself is a graphical model of the various
parallel and sequential combinations of faults that will
result in the occurrence of the predefined undesired event.
The faults can be events that are associated with
component hardware failures, human errors or any other
©2003-2012 ReliaSoft Corporation
FTA Example
©2003-2012 ReliaSoft Corporation
Introduction to RCM
Objective
“Reliability-Centered Maintenance (RCM) is an analytical
process used to determine preventive maintenance
(PM) requirements and identify the need to take other
actions that are warranted to ensure safe and cost-
effective operations of a system.”
The objective of this module is to:
Provide a brief overview of RCM and explain how it relates to
FMEA.
As a result of this module students will be aware of
©2003-2012 ReliaSoft Corporation
Hazard Analysis
Hazard Analysis
Relationship to Traditional FMEA
The primary difference with a Hazard Analysis
is that it focuses entirely on safety hazards,
whereas the scope of an FMEA covers safety
as well as performance, quality and reliability.
There are other procedural and worksheet
differences, such as:
Unique scales and worksheet.
Focus on various types of hazards, including
©2003-2012 ReliaSoft Corporation
Hazard Analysis
More Information
Hazard Analysis References and Standards:
ANSI/GEIA-STD-0010-2009, Standard Best Practices for System Safety Program
Development and Execution.
FAA System Safety Handbook, Chapter 7: Integrated System Hazard Analysis,
2010.
FAA System Safety Handbook, Chapter 8: Safety Analysis/Hazard Analysis Tasks,
2010,
IEEE STD-1228-1994 Standard for Software Safety Plans.
ISO 14971:2007, Medical devices - Application of risk management to medical
devices.
SAE ARP4761, Guidelines and Methods for Conducting the Safety Assessment
Process on Civil Airborne Systems and Equipment, 1996.
©2003-2012 ReliaSoft Corporation
Hazard Analysis
Example
©2003-2012 ReliaSoft Corporation
Truncated
Available from: http://www.mech.utah.edu/ergo/pages/Educational/safety_modules/Pha/PHA_ns.pdf intended for use in the fourth year
mechanical engineering design sequence, Department of Mechanical Engineering.
328
Concept FMEA
proceeds.
329
Concept FMEA
Relationship to Traditional FMEA
The Concept FMEA includes the following
elements from a traditional FMEA.
Item(s)
Function(s)
Failure mode(s)
Effect(s)
Severity ranking of the most serious effect
Cause(s)
©2003-2012 ReliaSoft Corporation
Concept FMEA
Example
©2003-2012 ReliaSoft Corporation
Software FMEA
Software FMEA
Relationship to Traditional FMEA
FMEA methodology applies very well to
software as well as hardware.
It is possible to include software functionality
in the System FMEA as part of the functional
descriptions.
However, especially for complex software
functionality such as embedded control
systems, it may be useful to perform a
©2003-2012 ReliaSoft Corporation
Software FMEA
Relationship to Traditional FMEA (cont’d)
Here are some possible objectives for
software FMEA:
Identifying missing software requirements.
Analyzing output variables.
Analyzing a system’s behavior as it responds to a request that
originates from outside of that system.
Identifying (and mitigating) single point failures that can result in
catastrophic failures.
Analyzing interfaces in addition to functions.
Identifying software response to hardware anomalies.
©2003-2012 ReliaSoft Corporation
Software FMEA
Function Level Example
©2003-2012 ReliaSoft Corporation
335
Software FMEA
Logic Level Example
©2003-2012 ReliaSoft Corporation
336
Software FMEA
Code Level Example
©2003-2012 ReliaSoft Corporation
337
EDUCATION
14:
Basic FMEA Analysis Procedure
Selecting FMEA
Software
337
338
Time Savings
EDUCATION
References
345
346
References
Automotive Industry Action Group (AIAG), Potential Failure Mode
and Effects Analysis. (February 1993, February 1995, July 2001
and June 2008).
Automotive Industry Action Group (AIAG), Advanced Product
Quality Planning and Control Plan (APQP). (June 1994 and July
2008).
Crowe, Dana and Alec Feinberg, Design for Reliability, Ch. 12
“Failure Modes and Effects Analysis.” CRC Press, Boca Raton,
FL, 2001.
Dhillon, B.S., Design Reliability: Fundamentals and Applications,
©2003-2012 ReliaSoft Corporation
References (cont’d)
McCollin, Chris, “Working Around Failure.” Manufacturing Engineer,
February 1999. Pages 37-40.
McDermott, Robin E., Raymond J. Mikulak and Michael R.
Beauregard, The Basics of FMEA. Productivity Inc., United States,
1996.
Palady, Paul, Failure Modes & Effects Analysis: Author’s Edition.
Practical Applications…Quality & Reliability, United States, 1998.
Shimizu, Hirokazu and Imagawa, Toshiyuki, “Reliability Problem
Prevention Method for Automotive Components: Development of
the GD3 Activity and DRBFM,” JSAE 20037158 SAE 2003-01-
©2003-2012 ReliaSoft Corporation
2877, 2003.
Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from
Theory to Execution. American Society for Quality (ASQ),
Milwaukee, Wisconsin, 1995.
348
References (cont’d)
Society of Automotive Engineers (SAE), Aerospace Recommended
Practice ARP5580, "Recommended Failure Modes and Effects
Analysis (FMEA) Practices for Non-Automobile Applications," June
2000.
Society of Automotive Engineers (SAE), Surface Vehicle
Recommended Practice J1739, Potential Failure Mode and Effects
Analysis in Design (Design FMEA), Potential Failure Mode and
Effects Analysis in Manufacturing and Assembly Processes
(Process FMEA). July 1994, August 2002 and August 2008.
U.S. Department of Defense, MIL-STD-1629A, Procedures for
Performing a Failure Mode Effects and Criticality Analysis.
©2003-2012 ReliaSoft Corporation
Regional Centers
See http://Directory.ReliaSoft.com for complete contact info.
Asia Pacific
ReliaSoft Asia Pte Ltd
Singapore
South America
©2003-2012 ReliaSoft Corporation
ReliaSoft Brasil
São Paulo, Brasil
India
ReliaSoft India Private Limited
Chennai, India
349
350
EDUCATION
Reference Material
350
351
Ideal response
353
Energy transfer
Data exchange
355