FMEA RCM Course - Foundations of Effective FMEA - RS 470 CourseNotes - Rev9.1

Language/Region: English/USA
Document Revision: 9.1

2003-2012 ReliaSoft Corporation - ALL RIGHTS RESERVED
RS 470

Foundations of
Effective FMEAs
1
Course Material Copyright & License Information
2003-2012 ReliaSoft Corporation, ALL RIGHTS RESERVED.
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Welcome
Location and Facilities
Any questions regarding the location of
any facilities.
Make sure we are fully aware of the
exits and the most appropriate
egress route in case of an
emergency.
Meeting point in case of an emergency
evacuation.
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About the Course
This course will provide a general overview of FMEA techniques
and an introduction to the use of ReliaSofts Xfmea software.
It is not intended to provide facilitation

for performing FMEAs on
specific products or processes.
A related course, RS 471

FMEA Facilitation and Application
Skills

uses case study examples to allow attendees to practice
FMEA facilitation and application skills.
Note on variation:
There is a good deal of variation among practitioners as to the
specific analysis procedures, terminology, reporting
requirements, etc.
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.
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9:40 to
10:40 am
8:30 to
9:30 am
10:50 to
11:45 am
1:15 to
2:15 pm
2:30 to
3:30 pm
3:30 to
4:30 pm
Lecture
Software
Demo
Typical Course Timeline (USA)

(May be adjusted*)
Lecture Lecture
Lecture
Software Demo &
Examples guide
Class Exercise & Wrap-Up
* Depending on country/location and venue, alternative start times
may be utilized. In such cases, the timeline can be shifted
accordingly.
Lunch

11:45 am
1:15 pm
Class Exercise
Lecture
Lecture
Software Exercise Lecture
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Attendee Introductions
Name, Company, Position/Duties
What is your experience with FMEA/FMECA?
If applicable:
What standards have you used?
What software/tools have you used?
What do you hope to get out of this class?
1.

None. This is my first exposure to the subject.
2.

Peripheral. I have been exposed to some principles.
3.

Beginner. I just started working in this area and have some
basic training.
4.

Intermediate/Practitioner. I have been involved for some
time and use it in my day-to-day work activities.
5.

Subject Matter Expert. I have in-depth knowledge of the
subject and applications.
CRP Credits CRP Credits
This course is eligible for 3 CRP credits.
For more information, see:
http://www.ReliabilityProfessional.org
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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
11.

Implementing an FMEA Process
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
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EDUCATION
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8
1:
Introduction
Introduction
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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
reducing warranty costs in a variety of industries.
As a result of this module students will understand
general information about FMEAs, including why they are
an important part of reliability programs.
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FMEA Definition
Failure Mode and Effects Analysis (FMEA) is a
methodology designed to:
Identify and fully understand potential failure
modes for a product or process.
Assess the risk associated with those failure
modes and prioritize issues for corrective action.
Identify and carry out corrective actions to address
the most serious concerns.
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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
Industry Action Group.
FMEA is now extensively used in a variety of industries including
semiconductor processing, foodservice, plastics, software, automotive
and healthcare.
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Published Guidelines
SAE J1739

for the automotive industry.
AIAG FMEA and APQP

for the automotive industry.
ISO 16949

quality guidelines for the automotive industry.
MIL-STD-1629A

for FMECA.
Cancelled in November, 1984 but still used in some military
and other applications.
IEC 60812

from the International Electrotechnical
Commission.
SAE ARP5580

for non-automotive applications.
BS 5760

from the British Standards Institution (BSI).
ISO 14971

for the medical devices industry.
Other industry-specific and/or company-specific
guidelines exist.
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FMEA Applications
Usually, the primary objective of an FMEA is to
identify and mitigate risks in a product or process in
order to improve product or process design.
In addition, since the FMEA provides a central
location for reliability-related information for the
product or process, it can be used as:
A resource when considering modifications to the design in
the future.
A resource when developing similar designs in the future.
A resource for service personnel to identify possible
corrective actions when problems occur in the field.
A learning tool for new engineers.
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FMEA Applications (contd)
The FMEA can contribute to and/or integrate with
other processes and objectives, such as:
Reliability Growth Testing and Management
FRACAS problem resolution
Design Review Based on Failure Mode (DRBFM)
Design Verification Plans (DVP&Rs) or Test Plans
Process Control Plans
Reliability Block Diagrams or Fault Trees
Maintenance Plans (RCM)
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FMEA Applications (contd)
FMEA is often performed in order to meet a customer
requirement or comply with safety and quality
regulations, such as:
ISO 9001 / QS 9000 / ISO/TS 16949
ISO 14971
FDA Good Manufacturing Processes
Design for Six Sigma

Design for Reliability
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Why Perform FMEAs?
There are a number of business reasons to
implement an effective FMEA process:
When done well, FMEA is a proven tool to reduce life
cycle warranty costs.
When done well, FMEAs will reduce the number of
missed opportunities for design and process
improvement during product development.
FMEAs can be effective in the identification and
resolution of safety issues before a potential
catastrophe.
It is far less expensive to prevent problems early in
product development than to fix problems after launch.
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Benefits of FMEA
Contributes to improved designs and reduced
risk for products and processes.
Higher reliability.
Better quality.
Increased safety.
Enhanced customer satisfaction.
Contributes to cost savings.
Decreases development time and re-design costs.
Decreases warranty costs.
Decreases waste, non-value added operations.
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Benefits of Relational Database
Software for FMEA
Using relational database software to facilitate FMEA
analysis, data management and reporting can:
Provide a keyword searchable knowledge base

of
your organizations FMEAs.
Make it easy to re-use information from existing
FMEAs or from pre-defined phrase libraries.
Help to establish consistency throughout the
organization and allow multiple users to cooperate on
analyses.
Provide a feedback loop for corrective actions.
Provide reports, queries and charts that facilitate
decision making.
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EDUCATION
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2: FMEA and Reliability
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FMEA and Reliability Objectives
FMEA needs to integrate seamlessly into other
reliability tasks in order to achieve maximum benefits.
The objective of this module is to:
Show how FMEA supports the overall reliability
process, including design-for-reliability.
how FMEA fits into other reliability methods and tasks
and the general inputs and outputs of FMEAs.
For the purposes of this presentation:
Design for Reliability covers both product and process
design.
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FMEA & Design for Reliability (DFR)
To understand why FMEAs are important, we need to
begin with the Product Development Process and the
tools that support Design for Reliability (DFR).
Todays corporations are facing unprecedented worldwide
competition as a result of three continuing challenges:
the mandate to reduce costs
faster development times
high customer expectations for the reliability of products and
processes
The necessity for reliability testing and process
verification are still important
However, there is increasing emphasis on Design for
Reliability as a corporate strategy.
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What is Design for Reliability?
In simple terms, whereas reliability analysis
methods enable us to compute the reliability of an
item
Design for Reliability

provides the process of
assuring that the optimum/desired reliability is
designed into the item or process.
This process encompasses multiple tools and
practices in order to drive reliability into products.
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DFR Philosophy
Three important statements summarize the best
practice reliability philosophy of successful
companies:
Reliability must be designed into products and
processes, using the best available science-based
methods.
Knowing how to calculate

reliability is important, but
knowing how to achieve

reliability is equally if not
more important.
Design for Reliability practices must begin early in
the design process and must be well integrated into
the overall product development cycle.
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Pay Now or Pay More Later
By far, it is more cost
effective to design in
reliability than to try to
test it in after the fact.
If reliability cannot fit in
the current budget then
where can you fit the
budget* for fixing field
issues, field recalls, lost
customers, etc?

and we can
save 700 lira by
not taking soil
tests!
*Reportedly, in 2007
Microsoft set aside
a $1,500,000,000 budget
for addressing Xbox

field issues.
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Implementing Reliability is a Process
Reliability is a long-term process.
Proper implementation requires:
Strategic vision
Proper planning
Sufficient organizational resource allocation
Proper implementation
Integration and institutionalization of reliability into
the organization
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Factor of 10 Rule
If you discover a reliability
problem in this stage
it will cost you this much
10x
100x
1,000x
10,000x
100,000x
S
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G
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P
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This illustration is from the book Effective FMEAs,

John Wiley & Sons, 2012, all rights reserved.
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Introduction to Bicycle Example
Throughout this presentation, we will demonstrate key
FMEA analysis techniques and skills using a fictional
example for a new Trail Bike design.
Example slides are identified with the following graphic in
the upper left corner:
The information for the trail bike example was developed
by Mike Schubert, Carl S. Carlson and ReliaSoft
engineers.
Although the example is intended to be representative of
a real-world analysis scenario, it was prepared for
demonstration purposes only and does not represent an
actual product or process.
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EDUCATION
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29
3: Fundamental
Definitions and Concepts
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Types of FMEA
FMEA analyses are often referred to by type
based on the subject of the analysis and the level
of detail. The most common designations are:
System
Design
Process
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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
To analyze the manufacturing process before production begins.
Focuses on potential process related problems (e.g., design
specifications not met during manufacturing).
System, Design and Process FMEA
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Other Types of FMEA
Other types of FMEA may include:
Machinery FMEA
(a Design FMEA focused on tooling and equipment for a
manufacturing plant)
Service FMEA
(can be a DFMEA or a PFMEA depending on focus)
Interface FMEA
(a Design FMEA focused on the interfaces between
assemblies)
Software FMEA
(a Design FMEA focused on software)
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Importance of Engineering Judgment /
Business Judgment
Essentially, FMEA provides a structured
framework and documentation for the engineers
evaluation of products and processes.
Relies heavily on the engineering judgment and
business judgment of the individuals who are
performing the FMEA.
This is a qualitative

(not quantitative) analysis
approach.
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A Living Document
FMEA is most effective when it is a dynamic and
iterative process

a living

document.
The team will need to review and update the
analysis when:
New information becomes available.
Corrective actions are implemented.
Design phases progress.
Operating conditions change.
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Overview of the Typical FMEA Worksheet Elements
What is it
supposed
to do?

What is it
supposed
to do?
How could
it fail?

How could
it fail?
How
bad will
it be?

How
bad will
it be?
What will
happen if it
fails?

What will
happen if it
fails?
Is the problem
likely to
occur?

Is the problem
likely to
occur?
What is the
cause of
failure?

What is the
cause of
failure?
Are you likely to detect
the problem before it
reaches the user?

Are you likely to detect
the problem before it
reaches the user?
What are you
doing to detect
the problem?

What are you
doing to detect
the problem?
What are you
doing to prevent
the problem?

What are you
doing to prevent
the problem?
What
did we
do?

What
did we
do?
What can we do to
improve the design
and reduce the risk?

What can we do to
improve the design
and reduce the risk?
What is the
risk for this
problem?

What is the
risk for this
problem?
How much were
we able to
reduce the risk?

How much were
we able to
reduce the risk?
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Introduction to Exercises
Throughout this module, students will be asked to
exercise their knowledge about FMEA definitions by
identifying and sharing examples of each FMEA element.
Each student should select a familiar item, either design-

related OR

process-related. For example:
A student who wishes to use a design-related example for
the exercises might select an item from their garage, or
from their work (non-proprietary), focusing on product
design.
A student who wishes to use a process-related example for
the exercises might also select an item from their garage, or
from their work, focusing on the manufacturing process.
Any item that can be used to demonstrate FMEA will
suffice.
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Hands-on FMEA Exercises
Demonstration of Xfmea introductory
features.
Follow along with the demonstration:
Launch Xfmea (using the software defaults).
Create a database and project.
Select profile AIAG4
Input analysis information into the database for
the remaining exercises as directed by your
instructor.
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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.
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Sample Item Descriptions:

DFMEA Example 1
Item: Power steering pump
This example is excerpted from the book Effective
FMEAs,

Poorly worded example of an Item:
System
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DFMEA Example 2
Item: Shaft (part of rock grinding equipment)
FMEAs,

Additional
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DFMEA Example 3
Item: Projector bulb
FMEAs,

Additional
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PFMEA Example 1
Process Step: Induction harden vehicle axle shafts
using induction-hardening machine
FMEAs,

Poorly worded example of a Process Step:
Install part A
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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.
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 3
Process Step: Apply lubrication to O-ring using
lubricant gun and fixture AF12345
FMEAs,

Additional
example
for student
reference only
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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.
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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.
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Sample Function Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by
transforming oil pressure at inlet ([xx] psi) into
higher oil pressure at outlet [yy] psi during engine
idle speed
FMEAs,

Poorly worded example of a Function:
Provides hydraulic power
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DFMEA Example 2
Function: Provide mechanical transfer of xx

rotational force while maintaining linear and
angular stability
FMEAs,

Additional
example
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DFMEA Example 3
Function: Provide xx

lumens of light for image
transfer for minimum yy

hours of use
FMEAs,

Additional
example
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PFMEA Example 1
Function: Induction harden shafts using induction-

hardening machine ABC, with minimum hardness
Brinell Hardness Number (BHN) X, according to
specification #123.
Poorly worded example of a Function:
Induction harden the shafts
FMEAs,

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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
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 3
Function: Lube O-ring with ABC lubricant, using XYZ
specification
FMEAs,

Additional
example
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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.
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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.
There may be many failure modes for each function.
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Sample Failure Mode Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by
transforming oil pressure at inlet ([xx] psi) into higher oil
pressure at outlet [yy] psi during engine idle speed
Failure Mode: Inadequate outlet pressure (less
than [yy] psi)
Poorly worded example of a Failure Mode:
Power steering pump fails
FMEAs,

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DFMEA Example 2

rotational force
while maintaining linear and angular stability
Failure Mode: Shaft fractures
FMEAs,

Additional
example
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DFMEA Example 3

lumens of light for image transfer for
minimum yy

hours of use
Failure Mode: Bulb shatters
FMEAs,

Additional
example
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PFMEA Example 1
Function: Induction harden shafts using induction-hardening
machine ABC, with minimum hardness Brinell Hardness
Number (BHN) X, according to specification #123.
Failure Mode: Shaft hardness less than BHN X
Poorly worded example of a Failure Mode:
Shaft fails
FMEAs,

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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
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 3
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
FMEAs,

Additional
example
for student
reference only
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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.
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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.
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Sample Effect Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by transforming oil
pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi
during engine idle speed
Failure Mode: Inadequate outlet pressure (less than [yy] psi)
Effect (Local: Pump): Low pressure fluid goes to
steering gear
Effect (Next level: Steering Subsystem):
Increased friction at steering gear
Effect (End user): Increased steering effort with
potential accident during steering maneuvers
Poorly worded example of an Effect:
Unsafe
FMEAs,

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DFMEA Example 2

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)
FMEAs,

Additional
example
for student
reference only
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DFMEA Example 3

lumens of light for image transfer for minimum
yy

hours of use
Effect: No light, with potential for operator
injury from broken glass
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 1
Process Step: Induction harden vehicle axle shafts using
induction-hardening machine
Function: Induction harden shafts using induction-hardening
machine ABC, with minimum hardness Brinell Hardness
Number (BHN) X, according to specification #123.
Effect (In plant): 100% scrap
Effect (Assembly): Not noticeable during
assembly
Effect (End user): Shaft fractures with
complete loss of performance, and increased
potential for loss of vehicle control
Poorly worded example of an Effect:
Customer unhappy
FMEAs,

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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
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun
and fixture AF12345

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
FMEAs,

Additional
example
for student
reference only
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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.
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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.
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What
severity
would be
assigned
to a
complete
loss of
function
using this
DFMEA
Severity
Ranking
Scale?
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What severity would be assigned if the product functioned at a reduced
level of performance and 100% of production had to be reworked off line
using this PFMEA Severity Ranking Scale?
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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.
By definition, if a cause occurs, the corresponding failure
mode occurs.
There can be many causes for each failure mode.
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Sample Cause Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by transforming oil pressure
at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine
idle speed
Effect (Local: Pump): Low pressure fluid goes to steering gear
Effect (Next level: Steering Subsystem): Increased friction at
steering gear
Effect (End user): Increased steering effort with potential accident
during steering maneuvers
Cause: Fluid incorrectly specified (viscosity too
low)
Poorly worded example of a Cause:
Outlet pressure too low
FMEAs,

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DFMEA Example 2

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
FMEAs,

Additional
example
for student
reference only
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DFMEA Example 3

lumens of light for image transfer for minimum yy

hours
of use
Effect: No light, with potential for operator injury from broken

glass
Cause: Over pressure due to wrong gas
specified
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 1
Process Step: Induction harden vehicle axle shafts using induction-

hardening machine
Function: Induction harden shafts using induction-hardening machine ABC,
with minimum hardness Brinell Hardness Number (BHN) X, according to
specification #123.
Effect (Assembly): Not noticeable during assembly
Effect (End user): Shaft fractures with complete loss of
performance, and increased potential for loss of vehicle control
Cause: Induction machine electrical
voltage/current settings incorrect for part
number
Poorly worded example of a Cause:
Operator error
FMEAs,

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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
FMEAs,

Additional
example
for student
reference only
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PFMEA Example 3
Process Step: Apply lubrication to O-ring using lubricant gun and
fixture AF12345

ABC lubricant evenly around the o-

ring, using XYZ specification
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
FMEAs,

Additional
example
for student
reference only
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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.
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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.
The occurrence ranking has a relative meaning rather than
an absolute value and is determined without regard to the
severity or likelihood of detection.
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What DFMEA occurrence ranking would you
give to a cause that the team estimates 1 in 500?
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What PFMEA occurrence ranking would you
give to a cause that the team estimates 1 in 500?
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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.
In Process FMEAs, they are called Process Controls.
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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
detected before it reaches the end user.
Used as input to the detection ranking.
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Sample Control Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by transforming oil pressure at
inlet ([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle
speed
Effect (Next level: Steering Subsystem): Increased friction at steering
gear
Effect (End user): Increased steering effort with potential accident
during steering maneuvers
Cause: Fluid incorrectly specified (viscosity too low)
Prevention Control: Design guideline #ABC for
hydraulic fluid selection
Detection Control: Vehicle durability testing #123
Poorly worded example of a Prevention Control: Design guide
Poorly worded example of a Detection Control: Vehicle durability test
FMEAs,

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DFMEA Example 2

Effect (Next level: Grinder Subsystem): Rock grinder teeth do not
move

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 test #567, broken
drive-shaft test #890
FMEAs,

Additional
example
for student
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DFMEA Example 3


hours
of use

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
FMEAs,

Additional
example
for student
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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
manufacturing or assembly plant. They are:
Intended to increase the likelihood that the problem will be
detected before it is shipped from the assembly plant.
Used as input to the detection ranking.
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PFMEA Example 1
Process Step: Induction harden vehicle axle shafts using induction-hardening
machine
Function: Induction harden shafts using induction-hardening machine ABC, with minimum
hardness Brinell Hardness Number (BHN) X, according to specification #123.
Effect (End user): Shaft fractures with complete loss of performance, and
increased potential for loss of vehicle control
Cause: Induction machine electrical voltage/current settings incorrect for part
number
Prevention Control: Detailed requirement defined in
machine setup instructions
Detection Control: Routine daily audit of shaft
hardness
Poorly worded example of a Prevention Control: Operator instructions
Poorly worded example of a Detection Control: Audit
FMEAs,

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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
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
FMEAs,

Additional
example
for student
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PFMEA Example 3
fixture AF12345

ABC lubricant evenly around the O-

ring, using XYZ specification

system
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
FMEAs,

Additional
example
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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
or call on you to share what you
have written.
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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
severity or likelihood of occurrence.
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What
ranking
would you
give if you
used virtual
analysis
that is
highly
correlated
with actual
operating
conditions?
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What
ranking
would you
give if the
operator
used
attribute
gaging to
check parts
after they are
produced?
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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.
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Example of RPN for Design FMEA
Function: Delivers hydraulic power for steering by transforming oil
pressure at inlet ([xx] psi) into higher oil pressure at outlet [yy] psi
during engine idle speed
Effect (Local: Pump): Low pressure fluid goes to steering
gear
Effect (Next level: Steering Subsystem): Increased friction
at steering gear
Effect (End user): Increased steering effort with potential
accident during steering maneuvers
Prevention Control: Design guideline #ABC for
hydraulic fluid selection
Sev = 10
(potential injury)
Occ = 4
(1 in 10,000)
Det= 6
(low likelihood
of detection)
RPN = 10 x 4 x 6 = 240
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Example of RPN for Process FMEA
lubricant gun
Function: Lube O-ring with ABC lubricant, using XYZ specification
Failure Mode: Insufficient lubrication

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
Sev = 10
(potential operator
injury)
Occ = 2
(1 in 1000,000)
Det= 3
(high likelihood
of detection)
RPN = 10 x 2 x 3 = 60
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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
cause.
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Sample Action Descriptions:

DFMEA Example 1
Function: Delivers hydraulic power for steering by transforming oil pressure at inlet
([xx] psi) into higher oil pressure at outlet [yy] psi during engine idle speed
Effect (Next level: Steering Subsystem): Increased friction at steering gear
Effect (End user): Increased steering effort with potential accident during
steering maneuvers
Prevention Control: Design guideline #ABC for hydraulic fluid selection
Recommended Action: Increase fluid
viscosity to standard #xyz
Poorly worded example of a Recommended Action:
Change fluid viscosity
FMEAs,

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DFMEA Example 2

rotational force while maintaining linear
and angular stability
Effect (Next level: Grinder Subsystem): Rock grinder teeth do not move

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
test #567, broken drive-shaft test #890
Recommended Action: Increase shaft
strength by using more rigorous
heat-treat standard #ABC
FMEAs,

Additional
example
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DFMEA Example 3


hours of use

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
Recommended Action: Reduce gas
pressure by changing gas properties to
material specification #xyz
FMEAs,

Additional
example
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PFMEA Example 1
Process Step: Induction harden vehicle axle shafts using induction-

hardening machine
Function: Induction harden shafts using induction-hardening machine ABC, with min. hardness
Brinell Hardness Number (BHN) X, according to specification #123.
Effect (End user): Shaft fractures with complete loss of performance, and increased
potential for loss of vehicle control
Cause: Induction machine electrical voltage/current settings incorrect for part number
Prevention Control: Detailed requirement defined in machine setup instructions
Detection Control: Routine daily audit of shaft hardness
Recommended Action: Install machine alert light (red) to
let operator know when voltage or current is set too high
Recommended Action: Implement Statistical Process
Control (SPC) charts on machine voltage and current
Poorly worded example of a Recommended Action:
Implement Statistical Process Control
FMEAs,

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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
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
criteria for replacement or repair
Recommended Action: Temporarily use daily scheduled visual
inspection of clamping tool wear until SPC charts show routine
conformance, with documented process control
Recommended Action: Use increased hardness clamp tool to
reduce wear
FMEAs,

Additional
example
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PFMEA Example 3
fixture AF12345

ABC lubricant evenly around the o-ring, using
XYZ specification

system
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
calibration procedure #12345 and update
maintenance plan to calibrate every 1000 parts.
FMEAs,

John Wiley & Sons, 2012, all rights reserved
Additional
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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.
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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.
109
EDUCATION
109
109
4: Selection and
Timing
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Selection and Timing

Objectives
Few companies have the resources to perform
FMEAs on every subsystem and component and
manufacturing operation. A workable FMEA selection
process is needed.
In addition, doing FMEAs during the window of
opportunity

is important to achieving the best
results.
Demonstrate the primary selection criteria for FMEA projects.
Show at what stage in the product development process the
different types of FMEAs are done.
how to select FMEAs that need to be performed, and
when the different types of FMEAs should be done in
order to achieve optimum results.
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Selection Criteria for FMEAs
High-level selection criteria for FMEA projects:
A Concept FMEA

when risk due to failure is part of the concept
selection process.
A System FMEA

when a new system begins development or when
an existing system will be changed sufficiently so that there are
concerns about risk.
Design FMEAs

when new designs begin development or when
existing designs will be changed sufficiently so that there are
concerns about risk.
Process FMEAs

when a new manufacturing or assembly process is
being developed or when an existing manufacturing or assembly
process will be changed sufficiently so that there are concerns about
risk.
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FMEA Project Selection Criteria
A preliminary risk assessment

may help to focus
the analysis effort on the aspects of the design or
process that have the greatest risk and/or have the
greatest potential benefit from design improvements.
Factors may include:
System FMEA risk identified
Potential for safety issues
New technology
New applications of existing technology
History of significant field or plant problems
Potential for important regulation issues
Supplier capability
Mission-critical or other applications
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Example Form for Preliminary Risk
Assessment
Sample Form

Other formats are acceptable and may be more appropriate for particular applications
Preliminary Risk Assessment for XXXX
1 = Lower Risk 2 = Moderate Risk 3 = Higher Risk
S
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F
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I
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N
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F
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System
Subsystem A
Component A.1
Component A.2
Subsystem B
Component B.1
Component B.2
Configurable
columns
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Example of Preliminary Risk Assessment
(Performed at the Subsystem Level)
Subsystem
R
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I
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b
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S
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F
M
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A
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s
N
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T
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o
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o
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y
N
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w
A
p
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s
F
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P
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R
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O
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FrameSubsys. 3 2 2 3 1 1 1 1 14
FrontWheelSubsys. 3 1 1 1 1 1 1 1 10
RearWheelSubsys. 2 1 1 1 1 1 1 1 9
SprocketSubsys. 1 1 1 1 1 1 2 1 9
ChainSubsys. 1 2 1 1 1 1 2 1 10
SeatSubsys. 2 2 1 1 1 1 1 1 10
HandleBarSubsys. 1 1 1 1 1 1 1 1 8
HandBrakeSubsys. 3 2 1 1 3 1 2 1 14
SuspensionSubsys. 1 2 2 2 1 1 1 1 11
Preliminary Risk Assessment for New Trail Bike Design
1=Lower Risk 2=Moderate Risk 3-Higher Risk
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When to Perform an FMEA
FMEAs should be performed during the
window of opportunity

when they can most
effectively impact the product or process
design.
An up-front

activity, rather than after-the-

fact.
Too early and the needed information is
not available.
Too late and the opportunity to make
design or process changes becomes
difficult.
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Timing Criteria for FMEA
Concept FMEAs should be performed during the time
when concept alternatives are being considered and
before design or process concepts have been selected.
System FMEA should be started as soon as the system
configuration is determined and completed before the
system configuration freeze date.
Design FMEAs should be started as soon as the design
concept is determined and completed before the design
freeze date.
Process FMEAs should be started as soon as the
manufacturing or assembly process is determined at the
concept level, and completed before the manufacturing or
assembly process freeze date.
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System
FMEA
Feasibility
FMEA and Stage Gate
Process

High Level
Requirements
Design &
Development
Qualification Launch
Design
FMEAs
Process FMEA
Concept
FMEAs
Actions to Improve Product and Process

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EDUCATION
118
118
Basic FMEA Analysis Procedure
5: Preparation
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Preparation

Objectives
Proper preparation is essential to success in
any FMEA project.
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
understand the key steps for preparation of
each type of FMEA in order to be fully
successful with FMEA projects.
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Basic Steps for an FMEA Project
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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.
Provide FMEA team training.
Understand legal guidelines for doing FMEAs.
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FMEA Preparation

One-Time Tasks (contd)
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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For Design FMEAs:

Define the System Hierarchy
If you are performing System or Design FMEAs, you
should begin by defining the system configuration.
For example:
System
Subsystem A
Component A.1
Component A.2
Subsystem B
Component B.1
Component B.2
You may choose to perform the analysis at the
system, subsystem (assembly) and/or component
indenture level.

(Reference Preliminary Risk
Assessment)
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For Process FMEAs:

Define the Process Steps
If you are performing a Process FMEA, you should begin
by defining the process configuration. For example:
Line
Station A
Operation A.1
Operation A.2
. . .
Station B
Operation B.1
Operation B.2
. . .
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)
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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
Establish the Ground Rules and Assumptions
Establish the Role of Suppliers
Gather and Review Relevant Information
Prepare FMEA Software for First Team Meeting
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FMEA Inputs and Outputs
The following two slides show the high-

level inputs and outputs for Design and
Process FMEAs
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Design FMEA Inputs and Outputs
Design FMEA Inputs and Outputs

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Process FMEA Inputs and Outputs
Process FMEA Inputs and Outputs

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Determine the Scope
Before you can begin any FMEA, you must decide
specifically what you are going to analyze.
Determining the scope

of the analysis is an extremely
important step because it helps to identify the
boundaries for what issues will be considered and the
approach that the analysts will take during the
analysis. For example, it could be:
A high-level analysis that focuses generally on the entire
system or process, including interfaces and integration.
A detailed analysis that focuses intensively on a specific
aspect of the system or process.
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Determine the Scope (contd)
For System FMEAs, scope typically includes:
System-related deficiencies
System safety
System integration
Interfaces or interactions between subsystems or with other
systems
Interactions with the surrounding environment
Human interaction
Service
Other issues that could cause the overall system not to
work as intended.
The exact scope will need to be determined by the System FMEA team.
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For Design FMEAs, scope typically includes:
Design-related deficiencies (with emphasis on
improving the design and ensuring product
operation is safe and reliable during useful life).
For subsystems, the scope includes the
subsystem itself, as well as the interfaces between
adjacent components.
For component designs, the scope includes the
selected components and parts.
The exact scope will need to be determined by the Design FMEA team.
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For Process FMEAs, scope may include:
Manufacturing-related deficiencies (as identified in
manufacturing operations)
Transporting and handling of materials
Shipping
Incoming parts
Storage
Conveyors
Tool maintenance
Labeling
The exact scope will need to be determined by the Process FMEA team.
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Making the Scope Visible for Design FMEAs:

FMEA Block Diagrams
For each individual FMEA that is performed, it is
useful to define what components, interfaces and
interactions will be included in the analysis.
An FMEA Block Diagram shows the physical and
logical relationships between the components in the
system or assembly. It identifies:
Physical connections
Material exchanges
Energy transfers
Data exchanges
134
AllTerrainSystemFMEABlockDiagram
(withinterfacesbetweensubsystemsandrider)
Rider
SeatS/S
HandleBarS/S
G
G
r
r
o
u
RrWheelS/S
n
Chain
DerailleurS/S
FrameS/S
Sprocket
PedalS/S
SuspensionS/S
o
u
FtWheelS/S
n
d
HandBrakeS/S
PhysicalConnection
MaterialExchange
EnergyTransfer
DataExchange
SomeoftheFMEABlockDiagram
elementsareintentionallymissing.
Canyoudeterminewhattheyare?

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Making the Scope Visible for Process FMEAs:

Process Flow Diagram
A Process Flow Diagram

(PFD) is a logical, graphical
representation of all of the process operations that result
in the manufactured or assembled product, and are within
the scope of the Process FMEA project.
Each of the process operations is represented by a
symbol representing the type of operation, such as Fab,
Move, Store, Get, Inspect, Rework, Scrap or

Contain, and
the symbols are connected in the precise sequence of the
operations in the manufacturing or assembly process.
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Truncated
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Making the Scope Visible for Process FMEAs:

Process Flow Diagram Worksheet
In addition to including symbols and logical sequencing
for the entire set of process steps in the manufacturing or
assembly process, a Process Flow Diagram Worksheet

provides more information about each of the
manufacturing or assembly operations.
This includes a detailed description of the process step,
called Operation Description, and other information, such
as the significant product and process characteristics.
The PFD Worksheet can be useful to make visible the
steps in the process that will be analyzed in the PFMEA
and to determine the functions and critical characteristics
that will be considered in the analysis.
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Op-
Seq #
F
a
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Operation Description
C
l
a
s
s
(
K
P
C
)
Significant Product Characteristics
(Outputs)
C
l
a
s
s
(
K
C
C
)Significant Process
Characteristics
(Inputs)
1.2 FrontWheelSubassemblyStation
1.2.1
Getwheelhubfromparts
presentationdevice
Correct hub selected
Correct hub are in presentation
device
1.2.2
Orientandplacewheelhubin
wheelassemblyfixture
Wheel hub is correctly located in
wheel assy fixture
Fixture does not allow incorrect
hub placement
1.2.3
Getwheelrimfromparts
presentationdevice
Correct wheel rim selected
Correct wheel rims are in
presentation device
1.2.4
Orientandplacewheelrimin
Wheel rim is correctly located in
wheel assy fixture
Fixture does not allow incorrect
rim placement
1.2.5
Getsetofwheelspokesfrom
partspresentationdevice
Correct spoke set selected
Correct spokes are in
presentation device
1.2.6
Orientandplacewheelspokesin
1. Correct number of wheel spokes
2. Correctly oriented spokes properly
connected in wheel assy fixture
1. Correct kit of 36 wheel spokes
2. Error-proofed wheel assy
fixture (orientation,correct parts)
1.2.7
Attachandtightenspokesto
wheelrimandwheelhub
KPC
Spokes correctly tightened to
required specification
KCC
Spoke tightening gun correctly
calibrated (torque management)
1.2.8
Adjustspoketightnesstoensure
wheelrimisroundtospecs
KPC
Wheel roundness meets
specifications
KCC
Correct spoke adjustment
procedure
TRUNCATED
A
Example of PFD Worksheet for a portion of the Front Wheel Subassembly Station
This illustration excerpt is from the book Effective
FMEAs,

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Determining the Scope

Exercise
Draw a Functional Block Diagram for the item you
have selected, keeping in mind the type of FMEA
you are working on and its scope.
This exercise may be done in the Xfmea system,
or on paper.
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A critical step in preparing for an FMEA is
selecting the right team:
FMEA is a cross-functional team activity.
Doing an FMEA by one person, or with an
inadequate or incomplete team, is very likely to
lead to sub-optimized results that will inevitably
result in poor quality.
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Assemble the Correct Team (contd)
There are three primary reasons for the
necessity to have the correct team when
doing an FMEA:
People have blind spots.
The FMEA analysis requires subject-matter
experts from a variety of disciplines to ensure all
necessary inputs are considered.
Cross talk and synergy between subject-matter
experts can discover things that individuals miss.
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Design FMEA Example
A core team for a System or Design FMEA might include
representatives from:
Design Engineering
System Engineering
Manufacturing Engineering
Test Engineering
Field Service
Quality / Reliability
More than one design representative may be required for large
systems or subsystems.
Supplier partners may be included for critical parts on a need to
know basis.
The FMEA core team can invite other experts for specific topics
during Design FMEA meetings, when their topic is being
discussed.
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Process FMEA Example
A core team for a Process FMEA might include
representatives from:
Manufacturing Engineering
Product Engineering
Assembly Operations
Supplier Quality
End-of-line Test
Maintenance
Quality / Reliability
Field Service
The FMEA core team can invite other experts for
specific topics during Process FMEA meetings, when
their topic is being discussed.
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Size of the Analysis Team
The team should be large enough to make
sure that relevant viewpoints and knowledge
are represented but not too large.
If the team is too large:
It will be difficult to have productive discussions
during meetings.
It will be a waste of an extremely valuable
resource

the time (and patience!) of your
organizations Subject Matter Experts (SMEs).
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Focus Team Resources Appropriately
A skilled facilitator can help to make sure that team
meeting time is used effectively and the analysis is
performed correctly.
Team members should be familiar with the FMEA
analysis process, as it is practiced by the
organization.
The composition of the team at any particular
meeting may vary depending on the focus of the
meeting.
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Assemble the Team
FMEA Exercise
Brainstorm, identify, and document a list of potential
participants (team members) 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.
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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., Roberts Rules of
order or other).
How agreement on issues will be achieved (consensus, majority
vote, or other).
How approvals for completion are achieved.
Etc.
Some of these guidelines may already be determined by
the organizations standard practices for FMEA and some
may be specific to the particular analysis project.
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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
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?
Establish the
Ground Rules and Assumptions (contd)
Excerpted from the book Effective FMEAs,

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Ground Rules and Assumptions

Example Questions (contd)
What are the assumed environmental conditions?
What are the assumed operating profiles?
Will the FMEA team assume product abuse by the user? If
so, to what levels?
What is the definition of failure used in the FMEA?
How will the FMEA team use severity rankings and RPNs to
prioritize issues for corrective actions?
To help assure you have a complete understanding of ground rules

and assumptions in your FMEA, please refer to the section titled

Establish the Ground Rules and Assumptions

in chapter 5 of the
book Effective FMEAs.

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Ground Rules & Assumptions
FMEA Exercise
For the exercise you are working on, brainstorm, identify
and document:
3 or 4 ground rules
3 or 4 assumptions
Keep in mind the type of FMEA you are working on and its scope.
The instructor will ask for volunteers or call on you to share
what you have written.
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Gather Information (Pre-Work)
Taking the time to gather (and review)
available information before the analysis
meetings begin can help to:
Make the most efficient use of team meeting time.
Achieve an analysis that is thorough and accurate.
The appropriate resources will vary
depending on the type of FMEA that you are
performing and the specific product or
process that you are analyzing.
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For Design FMEAs:

Gather Information
For System and Design FMEAs, the following is an
example of the type of information that should be
readily available to the FMEA team:
Bill of Materials
Past Design FMEAs
Current System FMEA (if performing a Design FMEA at the
subsystem or component level)
Warranty, recalls and other field history
Engineering requirements (functional, performance, operating
environments, etc.)
Drawings and schematics
Applicable government or safety regulations
For the entire gather information checklist for Design FMEAs
please refer to the section titled Gather and Review Relevant
Information

in chapter 5 of the book Effective FMEAs.

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For Process FMEAs:

Gather Information
For Process FMEAs, the following is an example of the
type of information that should be readily available to
the FMEA team:
Bill of Materials
Bill of Process
Current and Past Design FMEAs (for the products being
analyzed by Process FMEA)
Past Process FMEAs
Operator Instructions
Manufacturing data (plant incidents, etc.)
For the entire gather information checklist for Process FMEAs
please refer to the section titled Gather and Review Relevant
Information

in chapter 5 of the book Effective FMEAs.

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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.
155
EDUCATION
155
155
6:

Procedure
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Procedure

Objectives
Once the FMEA preparation steps have been
properly completed, work can begin with the FMEA
team on the FMEA procedure.
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.
As a result of this module students will be able to
conduct effective FMEAs up to calculation of RPNs.
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Basic Steps for an FMEA Project
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Procedures for doing FMEAs vary from practitioner
to practitioner.
There is no standard methodology for performing the
sequence of steps in the FMEA procedure.
Approaches range from the use of sticky notes and paper
to the use of comprehensive software that minimizes
administration.
It is necessary to establish the approach that will be
used prior to the first meeting. This is usually done
when ground rules and assumptions are defined.
How Meetings are Conducted
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Suggested Practice for Sequence of Steps
Many experienced Design and Process FMEA
teams use the following strategy:
Enter all the primary functions for the item under
analysis.
Beginning with the first function, enter all the failure
modes and corresponding effects, with severity
rankings for the most serious effect of each failure
mode.
For each failure mode, enter all of the causes, with
occurrence rankings for each cause.
More!

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(contd)
For each cause, enter prevention-type controls
and detection-type controls, with detection
rankings for the best detection-type control.
(Some practitioners prefer to enter the prevention-type
controls before the occurrence rankings as prevention-

type controls can influence the value of the occurrence
ranking.)
More!

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(contd)
Enter the next function and continue until all the
functions are analyzed through RPNs.
Review the high severities and high RPNs, and
develop all needed recommended actions that will
reduce risk to an acceptable level.
Review high-risk FMEA issues, and corresponding
recommended actions, with management and
proceed to execution steps.

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Remainder of this module is optional
Time permitting, the remainder of this module
provides additional experience with FMEA procedure,
using the bicycle example. It is optional.
If the remainder of this module is skipped, instructor
may wish to show the slides covering:
key characteristics
failure mechanisms
failure mode progression
and the three types of detection risk.
Skip to end of module

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Identify the Function(s)
The function description is about what the item is
supposed to do.
For each item under consideration, the FMEA team identifies
the primary function(s) and enters the information in the
appropriate field.
Information that is included in the field provided for the
function should be specific and include metrics that define
the standard of performance when possible.
Metrics can often be found in the technical specifications or
product requirements documents. These documents can be
attached or linked to the FMEA during
the research phase of the analysis for
reference as needed during FMEA team
meetings.
Definition

Function
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Identify the Function(s)
Functions for DFMEAs and PFMEAs are described in
terms of an item/operations:
Primary purpose(s).
What its supposed to do.
What its not supposed to do.
Standard of performance.
Concentrate on the major functions of the item or step
and how it will be used:
For DFMEAs and System FMEAs, include ways
that the product is commonly misused (i.e., functions
that the customer assumes the item has or should have).
For System / Subsystem FMEAs, include functions
that occur at interfaces.
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Functions
Trail Bike Hand Brake Design FMEA

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Identify the Function(s) for

Process FMEAs
The function description is about what the operation is
supposed to do. It is the primary purpose of the operation
being addressed.
The description may take the form of:
Do this

(operation)
To this

(part)
With this

(tooling/equipment)
When possible, include metrics that define the standard
of performance the function is intended to achieve.
For the trail bike frame assembly process example, the
function might read:
Securely clamp upper tube in weld fixture without damaging
the part and without looseness or movement of the part in the
fixture.
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Functions
Wheel Spoke Installation Process FMEA

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Function Information
Existing documents may contain detailed information
about the functions that the item or step is intended to
perform. For example:
Quality Function Deployment (QFD) or other planning
information contains design requirements that should be
considered in the DFMEA.
Process Flow Diagrams, process planning sheets, and
other planning information may contain process operation
information that should be considered in the PFMEA.
Function description is input into the FMEA form in the
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.
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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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Identify the Failure Mode(s)
The Failure Mode is the manner in which the item or
operation fails to meet or deliver the intended
function and its requirements.
For each item under consideration, the FMEA team
identifies potential failure modes and enters the
information in the appropriate field.
The next step is to determine the failure modes that
could occur for each item and function.
Definition

Failure
Mode
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Remember!
The failure mode is not merely the antithesis

of the
function; rather, it is the manner in which an
item/operation potentially fails to meet or deliver the
intended function and associated requirements.
Limit failure modes to those of concern

to at least one
member of a properly constituted FMEA team.
Avoid

failure mode wording that is too general

such as
doesnt work

for Design FMEAs or mis-build

for
Process FMEAs.
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Failure Modes

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Failure Modes


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Identify Failure Modes

Exercise
Recall your exercise on Failure Modes.
team when completing the Failure Mode field
for an item.
Enter the two Failure Modes you have
identified for your selected topic into Xfmea.
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Identify the Effect(s) of Failure
After potential failures have been identified, the next
step is to identify potential effects
For each potential failure mode, determine the consequences
that could occur.
A single description of the effect on the entire
system/process is one approach
Another is to identify three levels of effects:
Local Effect: The effect on the item.
Next Higher Level Effect: The effect on the next higher
level assembly.
End Effect: The effect on the top level item (system) and/or
end user.
Definition

Effects
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Local, Next and End Effects
An example of this might be:
Running out of gas in your car:
Local effect:
Fuel injectors fail to supply gas to the engine
Next higher level effect:
Engine stops working
End effect:
Car stops running
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For PFMEA, the effect may be with the
product or effects on the manufacturing
operation. For example:
Station not in operation, production stopped
resulting in specific effects to the production
process.
Component/assembly not to specification resulting
in inferior performance or quality issues for the
customer.
Identify the Effect(s) of Failure
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Effects

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Effects


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Identify Effects

Exercise
Recall your exercise on Effects.
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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Severity of Effect Ranking
Once all of the effects have been identified for a failure
mode, it is appropriate to provide a severity ranking.
Severity is related to the most serious effect for the
identified failure mode.
The severity ranking should be agreed upon by the
analysis team.
NOTE: In order to reduce the severity ranking, a design
change is usually required.
Definition

Severity
Risk
Rank
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Identify Severity of Effect

Exercise
Recall your exercise on Effects.
Refer to the default ranking scale for Severity
in the Xfmea software and rank the severity of
the Effects for your item.
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Use of Classification Column
One of the objectives of FMEA is to identify
significant product or process
characteristics.
The classification column can be used to
visually display where a significant
characteristic is associated with a failure
mode or cause.
This column can also be used to highlight
failure modes or causes for further discussion
or for follow up action.
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Key Product Characteristics
Key Product Characteristics (KPCs) are
significant product characteristics that are
designated by the company for highlighted
attention.
They require follow up in the Process Control
Plan and usually have their own approval
process.
An example is a shaft with a bending problem,
where KPCs can be material hardness and
shaft diameter.
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Key Process Characteristics
Key Control Characteristics (KCCs) are a subset
of the significant process characteristics, and
are designated by the company for
highlighted attention.
They require follow-up in the Process Control
Plan and usually have their own approval
process.
An example is shaft material hardness
problem, where KCCs can be temperature and
duration of water quench.
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Cause(s) of Failure
As the effects of each failure mode are identified, it is
usually most efficient to move on to the causes.
For each potential failure, determine the specific reason for
the failure. This may be found by asking why

until the
basic mechanism that brings about the failure is
determined.
In many cases, there are several levels of detail that could
be used to describe the cause of failure.
In general, it is best to choose the level at which the
organization is able to control the condition and/or take
corrective action.
Definition

Cause
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Failure Mechanisms
Failure mechanisms are the physical, chemical,
thermodynamic or other processes that result in
failure.
The actual physical phenomenon behind the failure mode.
The process of degradation or chain of events leading to and
resulting in a particular failure mode.
All higher risk Failure Modes must be taken to the
root cause and failure mechanism level.
Either asking why

until root cause is determined.
Or, in the case of system FMEAs, using subsystem and
component FMEAs to get to the root cause.
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Failure Mode Progression

John Wiley
& Sons, 2012, all rights reserved.
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Causes

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Causes


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Identify Causes

Exercise
Recall your exercise on Causes.
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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Current Controls
As the causes are discussed, it is also natural to
establish what is currently being done to manage the
risk associated with each cause.
For each potential cause of failure, identify the methods or
actions that are planned or currently in place to reduce or
eliminate risk.
Current controls can be classified as Prevention

or
Detection:
Prevention Controls

are intended to reduce the likelihood
that the problem will occur.
Detection Controls

are intended to increase

the likelihood that the problem will be

detected before it reaches the end user.
Definition

Controls
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Current Controls

DFMEA
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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Current Controls
Trail Bike Design FMEA
Trail Bike -

Bicycle Sub-System

Intentionalerrorshavebeen

introduced.Canyoufindthem?
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Current Controls

PFMEA
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
ongoing basis to assure that parts being produced are
meeting design requirements through inspections or
conformance audits (detection).
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Identify Controls

Exercise
Recall your exercise on Controls.
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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Occurrence Ranking
Once the current controls have been identified for
each failure mode, it is appropriate to rank the
likelihood of occurrence of the cause.
Each failure mode may have several potential causes.
Rank the likelihood of occurrence for each cause.
Prevention type controls are input to the occurrence ranking.
The Occurrence rating should be based on:
History with previous similar designs.
Level of change from baseline design.
Prevention controls in place.
Definition

Occurrence
Risk
Rank
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From AIAG FMEA-4 (2008)
Recall your exercise on Causes and Controls.
Refer to the default ranking scale for Occurrence in
the Xfmea software and rank the occurrence for one
of the causes.
Remember to consider the preventive-type controls
when ranking the occurrence.
Identify Occurrence of the Cause

Exercise
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Detection Ranking
Once the current controls have been identified for each
failure mode, and the occurrence ranking has been
established, it is appropriate to rank the likelihood of
detection.
The detection risk ranking is based on three potential
factors:
The likelihood of detection by the identified controls.
The timing of the opportunity for detection.
The type of test.
Rank the detection risk using the ranking scales
established for this purpose.
Definition

Detection
Risk
Rank
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Likelihood of Detection
The first factor to consider in establishing
ranking for detection is the likelihood of the
control to detect the cause/failure
mechanism.
Strong detection capability
Moderate detection capability
Weak detection capability
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Opportunity for Detection
The second factor is the timing (opportunity) of
detecting the potential cause/failure mechanism.
For DFMEA this includes:
Virtual analysis during the design development
Prior to design freeze
Post design freeze but prior to launch
For PFMEA
In station
During processing
Prior to shipment
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Opportunity for Detection
For DFMEA, the third factor to consider is the type of
test (quality of test):
Degradation
Test to Failure
Pass/Fail
For PFMEA, the third factor is the ability to detect:
Automatically, such as an automated system that stops
production or sounds an alarm when a deficiency is
detected.
Manually, such as audit inspection.
Visually, that relies on human visual acuity.
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Detection Summary
The amount of risk associated with the detection is
a combination of the ability to detect the
cause/failure mechanism, the amount of time
available to react to the detection if found and the
type of control that will be used.
Typically, the FMEA team will want to take the worst of
the three factors in assessing the Detection ranking. For
example, if the likelihood of detection is high (lower risk),
but the timing of the control is late (higher risk), the
detection risk remains high.
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From AIAG FMEA-4 (2008)
Recall your exercise on Causes and Controls.
Refer to the default ranking scale for Detection in
the Xfmea software and rank the detection for one
of the causes.
Remember to consider the detection-type controls
when ranking the detection. No detection control
results in a ranking of 10.
Identify Detection of the Cause

Exercise
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RPN
Once the initial ranking for an item is completed, the
associated RPN is calculated based on the product of the
three rankings:
RPN = S x O x D
Risk Priority Number is the product of the Severity,
Occurrence, & Detection ratings.
At this point it is appropriate to go to the next function,
address failure modes and continue this process until all
the functions are analyzed through to determination of the
initial RPN.
Definition

RPN
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RPNs -

Trail Bike Hand Brake DFMEA
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RPNs

Wheel Spoke Installation PFMEA
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RPN Rating Scales
RPN rating scales usually range from 1 to 10 or from
1 to 5, with the higher number representing the higher
seriousness or risk. In other words, 10 is worse than
1. For example:
Severity = 10 indicates that the effect is very serious and is
worse than Severity = 1.
Occurrence = 10 indicates that the likelihood of occurrence
is very high and is worse than Occurrence = 1.
Detection = 10 indicates that the failure is not likely to be
detected before it reaches the end user and is worse than
Detection = 1.
1 5
1 5
10
10
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Risk Priority Numbers
Exercise
What are the Risk Priority Numbers for your
example?
The instructor will ask for volunteers or call on you
to share what you have written.
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Final Thoughts
The goal is not to just fill out the FMEA
worksheet...
Youre likely to get better results if you:
Use the FMEA worksheet as a tool

for a
meaningful examination of the risks associated
with your product or process design.
Focus on things that can be done to improve the
design

of the product or process.
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Basic Xfmea Demonstration
Demonstration of Xfmea basic features.
Review of basic features including queries,
views, filters, import, export, reports.
Students will exercise features using the bicycle
example.
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EDUCATION
213
213
7: FMEA Action Strategies
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FMEA Action Strategies

Objectives
Developing effective actions strategies to reduce risk
is one of the most important tasks in FMEA projects.
Teach students how to prioritize issues for corrective action.
Identify and implement the most effective action strategies.
Remove roadblocks to successful execution of FMEAs.
As a result of this module students will be able to
address both high-severity and high-RPN issues with
effective actions that reduce risk to an acceptable
level.
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Prioritizing Issues for Corrective Action
Risk Prioritization Task # 1
The FMEA team must adequately address all
high-severity problems. If the team is using a
severity scale of 1 to 10, this means addressing all
9s and 10s at a minimum.
Risk Prioritization Task # 2
In addition to addressing all high severities, the
FMEA team needs to review and prioritize the high
RPNs.
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Addressing High Severity Issues
If using a severity scale of 1 to 10, address all 9s and 10s
at a minimum:
High Severity issues have potential safety, legal, regulatory
and/or major performance consequences, even with low
occurrence.
First focus of the should be on reducing Severity risk to the
lowest possible level (design change).
If this is not possible, take all actions necessary to
achieve the lowest possible occurrence and detection
rankings; then obtain managements concurrence and
support before determining that no further action is
required.
Strategies to reduce severity risk are covered in the
next section.
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Addressing High RPN Issues
There are at least four ways companies use RPN to
determine which issues to address:
1.

RPN Thresholds, where company guidelines require
certain actions when RPN is above a threshold value

this method has significant pitfalls.
2.

Begin with the highest RPN and work down the list,
addressing lower and lower RPNs given available
resources and program goals.
3.

Rank the RPNs and then address an agreed upon
percentage of total issues.
4.

Use guidelines for each combination of severity,
occurrence and detection to determine appropriate
action.
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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.
For example, a severity of 1, occurrence of 8 and detection of 8

has
the same RPN value as a severity of 8, occurrence of 4 and detection
of 2. Clearly, there is very different risk associated between these two
examples.
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Risk Priority Numbers
Exercise
What priority order would you give these four line items
from the Trail Bike example?

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Develop Effective Recommended Actions
Now that the higher risk items have been identified,
recommended actions are developed that will
reduce risk to an acceptable level.
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.

Always coordinate with

management on high risk
severity and RPN issues.
Definition

Recommended
Actions
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Identify and Assign Actions
Starting with the first item identified on the
priority list, establish actions to mitigate the risk.
When identifying a recommended action, the FMEA team
should consider existing controls and the relative
importance (priority) of the issue.
They should drive design or process improvements.
Cost and effectiveness of corrective actions should be
considered.
Recommended Actions should be detailed and executable.
To help ensure you have a complete understanding of how to
develop effective action strategies in your FMEA, please refer to
the sections titled Action Strategies to Reduce Severity Risk,

Action Strategies to Reduce Occurrence Risk

and Action
Strategies to Reduce Detection Risk

in chapter 7 of the book
Effective FMEAs.
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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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Example of Recommended Actions

Trail Bike Hand Brake DFMEA

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Example of Recommended Actions

Wheel Spoke Installation PFMEA

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Implement Recommended Actions
Once recommended actions have been developed, they
need to be assigned owners and timing.
Determine the task owner for action item.
Determine the task timing requirement.
Implement the recommended actions.
Follow-up to assure that actions are completed to an
acceptable lever.
Document the actions taken.
Re-rank severity, occurrence and detection.
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Execution is Everything
FMEA has little value unless the recommended
actions are fully executed.
Follow up each recommended action to ensure:
Completion to satisfaction of FMEA team and management.
Risk eliminated or mitigated to an acceptable level.
Bring problems with execution back to
management.
Update action status and risk reduction in the FMEA
database.
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Document Actions Taken
The FMEA team documents the specific
actions taken to implement the
recommended actions.
Care should be taken to ensure that the
correct actions were implemented and that
the risk is reduced to an acceptable level.
Definition

Actions
Taken
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Execution Enablers
The following are key elements for ensuring timely
execution of FMEA recommended actions:
1.

Recommended actions are well defined.
2.

Recommended actions include specific information.
3.

Recommended actions are energetically followed up.
4.

Execution problems are quickly identified and resolved.
5.

Management reviews all high-severity and high-RPN issues.
6.

The FMEA team remains actively involved until all FMEA
recommended actions have been executed.
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Advance Xfmea Demonstration
Demonstration of Xfmea advanced features.
Review of advanced features including user
settings, database set-up, help feature, my portal,
configurable settings, revision management.
Students will exercise features using the bicycle
example.
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EDUCATION
231
231
8: Case Studies
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Case Studies

Objectives
It is helpful to see actual FMEAs and for
students to learn by evaluating and critiquing
such FMEAs.
Share real-world FMEA applications.
Offer students an opportunity to evaluate and
critique actual FMEAs.
As a result of this module students will better
understand how FMEA is applied and gain
experience in evaluating actual FMEAs.
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Case Studies
See Effective FMEAs

book, Chapter 8:
DMFEA example 8.7 (Projector Lamp) and
corresponding end of chapter problem 8.7
PFMEA example 8.1 (Shock Absorber) and
corresponding end of chapter problem 8.1
234
EDUCATION
234
234
9: FMEA Success
Factors
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FMEA Success Factors

Objectives
Much can be learned by observing mistakes
companies have made in doing FMEAs.
Certain common mistakes show up
repeatedly.
Outline the most common FMEA mistakes and
describe how to avoid them.
As a result of this module students will be
able to recognize common mistakes and
ensure that the FMEAs they are doing meet
defined quality objectives.
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FMEA Key Success Factors
There are four primary focus areas that are
critical to uniformly successful FMEA
application:
1.

Become skilled in the theory and application
of FMEA methodology (Modules 1 through 8).
2.

Meet the FMEA quality objectives (Module 9).
3.

Become an excellent FMEA facilitator
(Module 10 and RS 471).
4.

Solicit management support (Module 11).
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Maxim
Good judgment comes from
experience and experience
comes from poor judgment
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Questions to Consider
What are the experiences that resulted in
best practice

FMEA methods?
What are the poor judgments to avoid?
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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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Becoming an Expert in the FMEA
Methodology
Becoming an expert in the methodology of
FMEA is a path, not a single event. The path
includes:
Basic courses in FMEA (RS 470 and RS 471).
Participating or leading many FMEAs.
Getting feedback on the quality of FMEAs.
Continuing to improve ones personal FMEA skills.
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Experience
There is no limit to the number of ways that
FMEA definitions can be goofed up.
There is no substitute for learning and
applying correctly the definitions.
This is one of the keys to getting actionable
recommendations with minimum effort.
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Meet the FMEA Quality Objectives
Learning the FMEA procedure is not enough
to be a successful FMEA practitioner.
Performing successful FMEAs requires
understanding and implementing the key
factors for effective FMEAs:
What are the primary ways that FMEA can be
done wrong? (Mistakes)
What are the key factors that make for effective
FMEAs? (Quality Objectives)
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Mistake #1
Failure to Drive Design or Process
Improvements:
Some FMEAs do not drive any action at all.
Some FMEAs drive mostly testing.
Some FMEAs drive ineffective action.
Quality Objective #1:
The FMEA drives product or process design
improvements as the primary objective.
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A Note on Quality Objective #1
Reliability engineering has a multitude of
tools to choose from in driving design or
process improvements.
The key is to use the FMEA Recommended
Actions

field to identify and execute best
practice tools that can optimize designs.
This is one of the reasons that reliability
engineers need to participate on FMEAs.
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FMEA Drives Design Improvements
How will you know if your FMEA drives design
improvements as the primary objective?
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Failure to Address All High Risk Failure
Modes:
Risk thresholds can be defined by FMEA Team or
set as company policy.
In addition to high RPN or criticality, high severity
must be addressed.
Some companies fail to take effective action on all
higher risk failure modes.
The FMEA addresses all high risk failure modes,
as identified by the FMEA team, with executable
action plans.
Mistake #2
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The emphasis on this quality objective is to
ensure that all of the higher risk failure
mode/causes are adequately addressed with
effective actions.
Company policy or the FMEA team will define
which RPNs or Criticality will rise to the level
of high risk.
The key is effective

action that reduces or
eliminates the risk.
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High Risk Failure Modes
How will you know if your FMEA addresses all
high risk failure modes?
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Mistake #3
Failure to Improve Test/Control Plans:
Some companies miss the opportunity to improve
Test Plans or Process Control Plans based on
failure modes from the FMEA.
Some FMEA teams do not include representatives
from the test department.
The result is inadequate testing or control plans.
The Test Plan or the Process Control Plan
considers the failure modes from the FMEA.
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The FMEA team will often discover Failure
Modes/Causes that were not part of the
Design Controls or Test Procedures.
The key is to ensure that the test plan
(DVP&R) or Control Plan is impacted by the
results of the FMEA.
This can be done by including test/control
membership on FMEA team or through well-

written actions.
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Improve Test and Process Plans
How will you ensure your FMEA improves test
or process plans?
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Mistake #4
Not Including Interfaces in FMEA:
Empirical data shows that at least 50% of field
problems can occur at interfaces.
Some companies focus on part or subsystem
failures and miss the interfaces.
The FMEA scope includes integration and
interface failure modes in both block diagram and
analysis.
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Interfaces can be included as part of the item
by item analysis or as a separate analysis.
It is recommended that the preliminary FMEA
Block Diagram clearly show the interfaces
that are part of the FMEA scope.
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Interfaces
How will you ensure that your FMEA includes
interfaces?
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Mistake #5
Disconnect from Field Lessons Learned:
Some companies provide no linkage between
FMEAs and field data.
It takes concerted effort to integrate problem
resolution databases with FMEA.
Otherwise serious problems repeat.
The FMEA considers all major lessons learned

(such as high warranty, campaigns, etc.) as input
to failure mode identification.
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Field failure data can be brought into generic FMEAs
on a regular basis.
Then, when new program-specific FMEAs are started,
they benefit from field lessons learned.
If generic FMEAs are not used, new FMEAs should be
seeded with potential field problems and show how
they will not repeat in the new design/process.
The key is to hold the FMEA team responsible to
ensure that major field problems do not repeat.
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Lessons Learned
How will you integrate your FMEAs with field
lessons learned so that high risk failure
modes are not repeated?
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Wrong Level of Detail in the Analysis:
Some FMEAs go into too much detail
Making it difficult to focus on areas of higher risk.
Missing the forest for the trees.
Some FMEAs go into too little detail
Making it difficult to determine root cause and
effective corrective actions.
The FMEA provides the correct level of detail in
order to get to root causes and effective actions.
Mistake #6
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Good FMEA facilitation keeps the team
focused on areas of risk that lead to root
causes and corrective actions.
FMEA discussion should be limited to areas
of concern by team members, and avoid
lengthy discussions on low-risk issues.
The higher the risk the more important and in
depth should be the discussion.
Lower risk issues should receive less, but
appropriate, discussion.
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Level of Detail
How will you assure that your are working to
the proper level of detail for your analysis?
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Mistake #7
Doing FMEAs Late:
Many companies do FMEAs late, and this reduces
their effectiveness.
FMEAs should be completed by design or process
freeze dates, concurrent with the design process.
The FMEA is completed during the window of
opportunity

where it can most effectively impact
the product or process design.
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The key to getting FMEAs done on time is to
start

the FMEAs on time.
FMEAs should be started as soon as the
design or process concept is determined.
Exception is FMEAs done during trade-off
studies, which can be started earlier.
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Timing
When should your FMEAs be done to
maximize their value?
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Mistake #8
Inadequate Team Composition:
Some FMEA teams do not have the right experts
on the core team.
Some FMEA teams do not have good attendance.
Some FMEA team members just sit in their chairs
and dont contribute to team synergy.
The right people participate on the FMEA team
throughout the analysis, and are adequately
trained in the procedure.
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People have blind spots (scotomas).
Key is to get the people who are
knowledgeable and experienced about
potential failures and their resolutions
actually showing up at the meetings.
Attendance takes management support.
Team size is best between 4 to 8 people.
If team gets too large, consider breaking into
additional limited scope FMEAs.
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Analysis Team
How will you ensure that the correct people
show up at all FMEA meetings?
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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.
The FMEA document is completely filled out by
the book,

including Action Taken

and final risk
assessment.
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One of the most common FMEA errors is to
fail to get to the root cause.
Expert input is necessary.
Follow up actions based on poorly defined
causes will not work and FMEA will not be
successful.
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FMEA Procedure
How will you know if your FMEAs are done
with correct procedure?
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Mistake #10
Lack of Efficient Use of Time:
Some companies mandate FMEAs, then do not
ensure the time is well spent.
Pre-work must be completed, meetings well run
and efficient follow up of high risk issues.
Ask FMEA team if there time is well spent, and
take action to address shortcomings.
The time spent by the FMEA team, as early as
possible, is an effective and efficient use of time
with a value added result.
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If this objective is met, then future FMEAs will
be well attended and supported by subject
matter experts and management.
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Time Management
How will you know if the time spent on
FMEAs by subject matter experts is time
well spent?
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FMEA Quality Objectives
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
Warranty, field issues, hardy perennials

included.
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FMEA Quality Objectives (contd)
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.
TIME USAGE
Effective and efficient use of time by FMEA Team.
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Meeting FMEA Quality Objectives
Make FMEA quality objectives part of FMEA
training.
Review them at each meeting.
Participate in FMEA quality audits.
Keep FMEA open until quality objectives are
met.
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Step-by-Step Examples in Guide
The examples guide provides examples with
step-by-step instructions that you can work
through at your own pace.
Feel free to ask any questions as you work
through the guide.
After 1 hour, we will have a brief class discussion
to explore what you learned.
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10: Basic FMEA
Facilitation
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Basic FMEA Facilitation

Objectives
FMEA teams need to be led by someone who is
skilled in team leadership and facilitation.
Provide a brief overview of the primary principles of
excellent FMEA facilitation.
RS 471 will cover this subject in much more detail
including:
The primary FMEA facilitation skills that ensure success in
FMEA applications.
The central elements for conducting effective meetings.
Techniques to resolve difficult facilitation problems.
Techniques to maximize team creativity. and
The unique roles and responsibilities of the FMEA facilitator
in performing each of the steps of the FMEA procedure.
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Successful FMEA Facilitation
FMEA facilitation is a different subject than
FMEA methodology.
FMEA Facilitators must be well trained in
effective meeting facilitation techniques.
FMEA Facilitators must be proficient in FMEA
basics, procedures and the use of software.
FMEA team members need to be trained in an
overview of the FMEA procedures.
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Successful FMEA Facilitation (contd)
Good facilitation is key to prevention of high
risk problems without wasting time.
The simple fact is most FMEA teams will not
achieve a high quality result without expert
facilitation.
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Primary FMEA Facilitation Skills
Brainstorming and Probing Questions
Encouraging Participation
Active Listening
Controlling Discussion
Making Decisions
Conflict Management
Managing Level of Detail
Managing Time
RS 471 will teach these skills and how to apply
them to FMEA projects.
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11: Implementing
an FMEA Process
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Implementing an FMEA Process

Objectives
In order to be fully successful, FMEA teams require
persistent and energetic support from management
as well as involvement

with specific strategies and
organized reviews.
Share a company-wide FMEA process that will result in effective
implementation of FMEA projects.
Outline the specific roles and responsibilities of management.
Explain how FMEA teams should interact with management to
maximize opportunities for success in FMEA projects.
the important role of management in assuring
successful FMEA programs, and the specific tasks
that are needed to enable that support.
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What is an FMEA Process?
It is company-wide systems and tasks
essential to support development of high
reliability products and processes through
timely accomplishment of well done FMEAs.
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Develop a Strategy for Your Organization
Although the basic analysis technique is usually very
similar, the manner in which FMEA is implemented
(the process) may be somewhat different by an
individual organization depending on a variety of
factors, such as:
Organizational culture/tradition
Customer or regulatory requirements
Particular characteristics of the products/processes that are
being analyzed
The consequences of failure
If your organization does not already have an overall
FMEA strategy in place, there are a number of
decisions that may need to be made before analysis
teams begin performing individual FMEAs.
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Management Roles and Responsibilities
in an FMEA Process
The importance of broad support from management
in implementing an Effective FMEA process
cannot be overstated. Here is a short list of key
management responsibilities:
Champion the subject of FMEA with management and
employees.
Provide agreement on FMEA strategy and support
needed resources.
Implement an effective FMEA training program.
Vigorously implement each of the steps of the FMEA
process, as covered in this chapter.

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Management Roles and Responsibilities
in an FMEA Process (contd)
Define roles and responsibilities for all FMEA
participants, and integrate with employee work
instructions.
Assist in integrating FMEA with other business
processes, including Design Reviews, Design
Verification Plans, Process Control Plans and others.
Provide effective reviews of high-risk failure modes
and recommended actions.
Support attendance of expert FMEA team members.
Help ensure FMEAs are fully executed.
Establish an FMEA audit process to continuously
improve the quality of FMEAs.

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Management Review of High Risk Items
Management review of high risk items is essential.
All FMEA high risk issues and recommended actions
should be regularly reviewed with management (to
ensure understanding, buy-in, support and execution).
FMEA reports/charts should be generated per FMEA
strategic plan (use Xfmea).
Feedback from management goes back to FMEA teams
for review and incorporation.
Further development of Managing the FMEA process is beyond the
scope of this training. To better understand how management
best participates in the process, please see the book Effective
FMEAs, Chapter 11 Implementing an Effective Company-Wide
FMEA Process.
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290
12:

FMECA
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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.
Introduce FMECA and explain how it differs from FMEA.
Explain both Quantitative and Qualitative Criticality
Analysis.
As a result of this module students will become
aware of the primary elements of FMECA and its
procedure.
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FMECA Definition
Failure Mode, Effects and Criticality Analysis
(FMECA) is the combination of:
FMEA Analysis
Criticality Analysis
Method to evaluate the seriousness of the issues
that are identified through FMEA.
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Choosing Criticality Analysis
You might choose Criticality Analysis in
addition to, or instead of, RPNs because:
Your customer requires an analysis in the
MIL-STD-1629A format (e.g.,

military and
aerospace clients).
You have quantitative reliability data that you want
to take directly into account.
You want to use criticality values to compare
components for inclusion in a new design.
You want to focus more on severity and likelihood
of occurrence and less on ability to detect.
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Two Types of Criticality Analysis
MIL-STD-1629A describes two types of
Criticality Analysis:
Quantitative
Incorporates the items unreliability and failure
mode apportionments.
Qualitative
Uses pre-defined rating scales.
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Quantitative Criticality Analysis
To use Quantitative Criticality Analysis to evaluate
risk and prioritize corrective actions:
Define the reliability/unreliability for each item in order to
estimate the expected number of failures at a given time
(with the exponential distribution, this is t but it is estimated
differently for other lifetime distributions).
Identify the portion of the items unreliability (in terms of
expected failures) that can be attributed to each potential
failure mode.
Rate the probability of system loss if the failure occurs.
Mode Criticality

= Expected Failures x Mode Ratio of
Unreliability x Probability of Loss
Item Criticality

= SUM of Mode Criticalities
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Mode Criticality
Mode Criticality = Expected Failures x Mode Ratio of
Unreliability x Probability of Loss
Expected Failures
The expected number of failures for the item at a given time.
Failure Mode Ratio of Unreliability
The probability that a failure will be due to the failure mode
under consideration; the portion of the items unreliability due
to the given mode.
Probability of Loss
The probability that a failure will cause a system failure (or a

serious loss).
More detail is available on FMECA in Chapter 12 in the book
Effective FMEAs,

Failure Mode Effects and Criticality Analysis
(FMECA).
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13:
DRBFM
FTA
RCM

Hazard Analysis

Concept FMEA

Software FMEA
Other FMEA Related Applications
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Other FMEA Related Applications

Objectives
Many variants of FMEA build on basic FMEA
principles for unique applications.
Introduce DRBFM, Fault Tree Analysis, Reliability-Centered
Maintenance, Hazard Analysis, Concept FMEA and
Software FMEA.
Show how each of these applications builds on the
fundamentals of FMEA.
As a result of this module students will become
aware of unique applications of FMEA and
understand when they are used.
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Introduction to DRBFM

Objectives
Many companies are incorporating Design Review
Based on Failure Mode

(DRBFM) in addition to
FMEA.
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
aware of DRBFM and how it is done.
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DRBFM and FMEA
A well-done baseline FMEA should precede a
DRBFM project.
Subsequent changes to the design or the
process can be evaluated by proper DRBFM
procedure to ensure that all concerns are
surfaced and addressed.
Many of the elements of FMEA provide input
to the DRBFM analysis.
Xfmea supports this integration between
DRBFM and FMEA.
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DRBFM General Information
DRBFM is customer focused and intended to
flush out all concerns (buds of problems) while
supporting daily engineering activity.
DRBFM is focused on changes

functions,
material properties (size, shape, strength),
supplier, environment, etc.

and interactions
(physical parts, electrical and software).
DRBFM is driven by engineering knowledge and
detailed discussion to support engineering
decisions and is backed up by data.
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DRBFM General Information (contd)
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
Customer expectations
Cost and delivery
Maintenance
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DRBFM Methodology
DRBFM includes three stages:
DRBFM Preparation
DRBFM Procedure
DRBFM Action Closure
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DRBFM Preparation
A DRBFM project begins with Change Point
Analysis.
Change Point Analysis begins with the baseline
design and identifies specific changes and includes
changes as:
Product design
Manufacturing or assembly
Supplier
Supplier design or process
Usage environment
Interfaces
Specifications
Performance requirements
Or any other changes
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DRBFM Preparation (contd)
The next preparation step is similar to preparation for
FMEA and includes gathering documents such as:
Bill of Materials
Past FMEAs
Engineering requirements (functional, performance, operating
environments, etc.)
Drawings and schematics
Applicable government or safety regulations
Test procedures
Preliminary Design Verification Plan
Preliminary test data (if available)
Actual parts (similar to design intent)
Other documents and information that highlight the nature of the

design
concept
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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:
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.
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DRBFM Worksheet (contd)
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,
manufacturing) to address all causes of concerns.
This process tends to reduce the time spent in team
meetings by experts.
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Example of DRBFM
Shimizu,Hirokazu,YuichiOtsuka,andHiroshiNoguchi,Designreviewbasedonfailure

modetovisualizereliabilityproblemsinthedevelopmentstageofmechanicalproducts.

InternationalJournalofVehicleDesign,2010.Volume53(Issue3):p.pages149to165.
Truncated
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DRBFM Action Closure
In order to prove the identified cause is not present,
the detailed data is reviewed from validation and
verification testing.
All design related actions reviewed and approved and
documented in DRBFM worksheet.
All validation and verification testing reviewed and approved and
documented in DRBFM worksheet.
All manufacturing, assembly and supplier related actions are
closed and approved and documented in DRBFM worksheet.
If engineering data is not acceptable the proposed
change should be denied.
For comprehensive examples of DRBFM, please see the book
Effective FMEAs: Chapter 13 Introduction to Design Review Based
on Failure Mode (DRBFM).
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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.
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.
Further training on FTA is needed to become
proficient in its application.
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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
pertinent events that can lead to the undesired event.
A fault tree thus depicts the logical interrelations of basic
events that lead to the undesired event

which is the top
event of the fault tree.
Excerpts from Fault Tree Handbook, by the
U.S. Nuclear Regulatory Commission.
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FTA and FMEA
The primary differences between FTA and FMEA
include:
FTA is a graphical representation of the complex relationships in
the system leading to the unwanted event, whereas FMEA is
worksheet based.
FTA considers the interactions between unwanted events and
multiple contributors, such as two or more contributors that
each must be present in order for the unwanted event to
manifest. FMEA usually considers each contributor separately.
FTA has the capability of incorporating the probabilities for each
of the contributors and the complex interactions and
interrelationships with the top-level unwanted event. FMEA does
not usually support the probability calculation of a top-level
unwanted event.

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FTA and FMEA (contd)
The subject of FTA is outside the scope of
RS 470 FMEA training.
Further information about FTA can be found
in ReliaSoft's System Reliability training.
Modeling Fault Trees can be done with
ReliaSoft's BlockSim software.
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FTA Example
Export from BlockSim file Bicycle FTA
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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.
Provide a brief overview of RCM and explain how it relates to
FMEA.
As a result of this module students will be aware of
when RCM should be used to augment FMEA
projects. Further training on RCM is needed to
become proficient in its application.
* Excerpt from NAVAIR 00-25-403 Guidelines for the Naval Aviation
Reliability-Centered Maintenance Process, Naval Air Systems Command.
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Reliability Centered Maintenance:

Relationship to Traditional FMEA
FMEA is a major component of RCM.
Well-done equipment FMEA(s) can be a
substantial foundation from which to perform an
RCM analysis.
RCM is unique from traditional FMEA in the
following ways:
Selection of the specific equipment items.
A unique worksheet, with some different definitions.
A set of failure-effect-categorization logic diagrams.
Maintenance task selection logic charts to help select
the tasks for the preventive maintenance plan.
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Relationship to Traditional FMEA (contd)
Different definitions for some of the terms are
frequently used:
Function

for FMEA maps to Function

for RCM.
Failure Mode

for FMEA maps to Functional Failure

for RCM.
Effect

for FMEA maps to Effect

for RCM.
Cause

for FMEA maps to Failure Mode (Cause)

for
RCM.
* Approaches and practices for RCM vary significantly among
practitioners as do definitions and terms used in the practice.
Different approaches can be seen when reviewing standards.
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The decision logic requires that the following be
considered for each failure mode being analyzed:
Consequences of failure (safety, environmental, operational,
economical).
Whether the functional failure is evident or hidden to the operating
crews.
Evidence of reduced resistance to failure.
Age-reliability characteristics of each item.
Trade-off analyses comparing various maintenance tasks for
optimum handling of a failure mode.
Maintenance tasks are selected that minimize risk and
provide the desired level of availability for the
minimum cost.
Based on NAVAIR 00-25-403 Guidelines for the Naval Aviation Reliability-

Centered Maintenance Process, Naval Air Systems Command.
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Reliability Centered Maintenance (RCM)

Example
An example of RCM, as implemented in the
aircraft industrys MSG-3 guidelines, involves:
Identifying Maintenance Significant Items (MSIs).
Identifying the functions, failures, effects and
causes for each MSI (FMEA).
Evaluating the potential effects of failure.
Selecting the appropriate maintenance tasks to
address potential causes of failure.
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Reliability Centered Maintenance

More Information
RCM Publications and Procedures
Reliability-Centered Maintenance, by F. Stanley Nowlan and Howard Heap, 1978.
ATA MSG-3 Operator/Manufacturer Scheduled Maintenance Development, 2003.
NAVAIR 00-25-403 Guidelines for the Naval Aviation Reliability-Centered
Maintenance Process, 2001.
SAE JA1011 Evaluation Criteria for Reliability-Centered Maintenance (RCM)
Processes, 1999.
SAE JA1012 A Guide to the Reliability-Centered Maintenance (RCM) Standard,
2002.
Reliability-Centered Maintenance, Second Edition, by John Moubray, 1997.
Practical Application of Reliability-Centered Maintenance, by the Reliability Analysis
Center, 2003.
MIL-STD-2173(AS) Reliability-Centered Maintenance Requirements for Naval
Aircraft, Weapons Systems and Support Equipment, 1986.
The theory and application of RCM that go beyond
FMEA are taught in ReliaSoft's RCM training.
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Example

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Example (contd)

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Example (contd)

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Hazard Analysis
Hazard analysis is the process of examining
a system throughout its life cycle to identify
inherent safety related risks.

(excerpt from FAA System
Safety Handbook, chapter 7)
A hazard is defined by the Department of
Defense in Mil Std 882D as Any real or
potential condition that can cause injury,
illness, or death to personnel; damage to or
loss of a system, equipment or property; or
damage to the environment.
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Hazard Analysis

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
hardware, material, software, procedural, human
factors, environmental and interface.
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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.
Mil-Std 882D, STANDARD PRACTICE FOR SYSTEM SAFETY, 2000.
U.S. Food and Drug Administration, Hazard Analysis and Critical Control Point
Principles and Application Guidelines, adopted 1997.
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Hazard Analysis

Example
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.
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Concept FMEA
A Concept FMEA

is a short version of FMEA
to aid in selecting optimum concept
alternatives or to determine changes to
system design specifications.
It increases the likelihood that potential failure
modes and resulting effects of a proposed
concept are considered before the final
concept is determined and actual design work
proceeds.
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Concept 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)
Occurrence ranking of primary cause(s)
Design control(s)
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Concept FMEA

Example

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Software FMEA
Software FMEA assesses the ability of the
system design, as expressed through its
software design, to react in a predictable
manner to ensure system safety.
Excerpt from Software FMEA Techniques

in Proceedings of the Annual
Reliability and Maintainability Symposium. 2000, by Peter Goddard.
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Software 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
separate software FMEA.
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Software FMEA

Here are some possible objectives for
software FMEA:
Identifying missing software requirements.
Analyzing output variables.
Analyzing a systems 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.
There is no universally agreed-upon standard for
performing software FMEAs.
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Software FMEA

Function Level Example
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Software FMEA

Logic Level Example
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Software FMEA

Code Level Example
337
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337
337
14: Selecting FMEA
Software
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Selecting FMEA Software
Objectives
Using good relational-database software is an
essential element for an effective FMEA
program.
Present the key attributes of good FMEA software.
Show why they are essential to FMEA project
success.
As a result of this module students will be
aware of the most important characteristics of
good FMEA software.
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Benefits of Relational Database
Software for FMEA
Using relational database software to facilitate FMEA
analysis, data management and reporting can:
Provide a keyword searchable knowledge base

of your
organizations FMEAs.
Make it easy to re-use information from existing FMEAs or
from pre-defined phrase libraries.
Help to establish consistency throughout the organization
and allow multiple users to cooperate on analyses.
Provide a feedback loop for corrective actions.
Generate from a common database the various reports,
queries and charts that facilitate decision making.
Link other processes to FMEA.
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Time Savings
Xfmea provides a number of features to help
analysts find and re-use relevant information
from existing FMEAs and failure mode
libraries.
This can significantly reduce the overall FMEA
time, both in and out of meetings.
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Reports and Charts
Xfmea makes it easy to slice and dice

your
data in a variety of different ways (beyond the
traditional tabular spreadsheet).
Broad variety of pre-defined print-ready reports.
Broad variety of graphical charts.
Query utility for customized search and reporting.
Can aggregate reports, charts and queries across
multiple FMEAs.
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All Major Standards Supported
Xfmea supports all major standards.
Military standards
Commercial standards
Individual company standards
Worksheet are easily tailored.
Can enforce consistency within the
organization.
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Linkage to Other Processes
Linkage to Reliability Tools
Reliability block diagrams
Life data distributions
Transfer Functions
Design FMEAs transfer to Process FMEAs
Design FMEAs transfer to DVP&Rs
Process FMEAs transfer to Process Control Plans
and Process Flow Diagrams
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Advanced Hands-on FMEA Exercise
Select an FMEA project.
Divide into small groups.
Each group will perform an FMEA for a specific
portion of the overall project, using Xfmea to record
the results.
Each group selects one person to report the results to
the rest of the class.
The entire class will critique
each FMEA according to the
FMEA quality objectives,
correct definitions and
procedures.
345
EDUCATION
345
345
References
References
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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,
Ch. 6 Failure Modes and Effects Analysis.

CRC Press, Boca
Raton, FL, 1999.
Kececioglu, Dimitri, Reliability Engineering Handbook Volume 2.
Prentice-Hall Inc., Englewood Cliffs, New Jersey, 1991. Pages
473-506.
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References (contd)
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: Authors Edition.
Practical ApplicationsQuality & 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-

2877, 2003.
Stamatis, D.H., Failure Mode and Effect Analysis: FMEA from
Theory to Execution. American Society for Quality (ASQ),
Milwaukee, Wisconsin, 1995.
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References (contd)
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.
November 1974, June 1977, November 1980. (Cancelled in
November, 1984).
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Worldwide Headquarters (North America)

ReliaSoft Corporation
1450 S. Eastside Loop

Tucson, AZ 85710-6703, USA

Phone: (+1) 520-886-0410
(USA/Canada Toll Free: 1-888-886-0410)

Fax: (+1) 520-886-0399
E-mail: Sales@ReliaSoft.com

Web site: www.ReliaSoft.com
South America

ReliaSoft Brasil

So Paulo, Brasil
Europe and Middle East

ReliaSoft Corp. Poland Sp. z o.o.
Warsaw, Poland
India
ReliaSoft India Private Limited
Chennai, India
Asia Pacific

ReliaSoft Asia Pte Ltd
Singapore
Regional Centers

See http://Directory.ReliaSoft.com

for complete contact info.
349
350
EDUCATION
350
350
Reference Material
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Other Tools
In addition to the FMEA Block Diagram, there are
other tools available to the Design FMEA team to
make the scope visible:
Parameter Diagram (P-Diagram)
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Parameter Diagram
The Parameter Diagram (P-Diagram) takes inputs
from a system/ customer and relates those inputs to
desired outputs of a design, considering non-

controllable outside influences.
It is a useful tool in brainstorming and documenting:
Input signals
Noise factors
Control factors
Error states
Ideal response
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An FMEA Interface Matrix is a chart with the
subsystems and/or components (depending on the
scope of the FMEA) on both the vertical and
horizontal axes. The chart shows which interfaces
must be considered in the analysis and the type of
interface.
There are four primary types of interfaces:
A physical connection
A material exchange
Energy transfer
Data exchange
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A Functional Block Diagram is a visual tool to
describe the operation, interrelationships and
interdependencies of the functions of a system or
equipment.
Each primary (high level) function is placed in a
block

and visually laid out in the sequence
performed. Inputs and outputs are added for clarity.
357
Functional Block Diagram for a flashlight operation


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FMEA RCM Course - Foundations of Effective FMEA - RS 470 CourseNotes - Rev9.1

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