Ieee SCV Pses May11

Failure Modes & Effects Analysis (FMEA)
A Great Tool to Improve Product and Process

Reliability and Reduce Risks
Anthony Tarantino
PhD, Six Sigma Master Black Belt, CPIM, CPM,
Sr. Advisor to Ciscos Six Sigma Center of Excellence
Adjunct Professor of Finance, Santa Clara University
May 23, 2011
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2008 Cisco Systems, Inc. All rights reserved.
Cisco Confidential
A Leading Six Sigma Authority:

To me Failure Modes and Effects
Analysis (FMEA) is a versatile, powerful,
process centered tool that belongs in
every Process Owners and Six Sigma
practitioners toolbox."
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A Leading Operational Risk Authority:

Catastrophic failures in operational risk
management are rarely caused by a single and
major point of failure. Rather they are the
cumulative effect of smaller and inter-related
failures. FMEA is the tool of choice to address
these complex operational risk failures at any
level of an organization, whether tactical,
strategic, or enterprise-wide. It works in every
type of organization.
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Objectives
The objectives for this session include:
Understand what a FMEA is, why it is used, and when it
can it be deployed
Understand the different components, definitions, and
calculations used in a FMEA
Learn the steps to developing a FMEA
Use examples and Case Studies to showcase FMEA in
action:
Purchasing Process in Finance
Sample High Tech Project to Reduce RMA Rates
San Bruno Gas Pipeline Explosion
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Reliability Defined
Product reliability is one of the qualities of a product. Quite simply, it
is the quality which measures the probability that the product or
device will work.
As a definition:
Product reliability is the ability of a unit to perform a required
function under stated conditions for a stated period of time.
And, correspondingly, quantitative reliability, as a definition, is:
Quantitative reliability is the probability that a unit will perform a
required function under stated conditions for a stated time.
Source: Fergenbaum, A. V. (1991). Total Quality Control. New York: McGrawHill, Inc.
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When Reliability is Lacking - Categories of Failure Mode

Safety
Any failure mode that directly affects the ability of a product to meet Federal
Safety Standards, or creates a potential product liability issue, or can result in
death or extensive property damage.
Major (Hard)
Any failure mode that stops the operation of a product or system which requires
immediate repair.
Evidenced by a catastrophic event, i.e, TEPCO Nuclear Plant Meltdown
Failure mechanism might be due to a shock to the system or an accumulation
of shocks to the system
Minor (Soft)
Any failure mode that results in a product from meeting one of its intended
functions, but does not preclude it from satisfying its most important functions.
Any failure mode which results in a gradual but not complete ability of the
product to meet its intended function.
Degradation of performance over time, wear are examples of soft failures.
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FMEA Defined
What is a Failure Modes & Effects Analysis?
A FMEA is a systematic method to:
1. Recognize, evaluate, and prioritize (score) potential failures
and their effects
2. Identify actions which could eliminate or reduce the chance
of potential failure occurring
3. Document and share the process
FMEA generates a living document that can be used to anticipate
and prevent failures from occurring.
In DMAIC and Design For Sigma Projects, FMEAs can be used in
various stages and revised as the project moves forward.
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Why Use a FMEA

Use of quality tools such as Statistical Process Control (SPC)
encourage the use of FMEA(s) to help problem-solve quality
problems
ISO/QS 9000 and product liability directives of the EC 1985
strongly encourage its use.
Helps select alternatives (in system, design, process, and service)
with high reliability and high safety potential during the early phases
(Blanchard 1986)
Ensures that all conceivable effects on operational success have
been considered.
Many risk management regimens and standards, such as ISO
31000/31010 used in finance and operations are based on FMEA
logic probability vs. severity scoring and matrix.
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Why Use a FMEA - Continued

Improves the quality, reliability and safety of
products and processes in a proactive manner.
Helps to increase customer satisfaction, by
proactively addressing failures that keep us from
meeting critical customer requirements in
processes or products.
Reduces product development timing and cost
Reduces operational risk
Documents and tracks actions taken to reduce
risk; Prioritize areas of focus
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FMEA is a Team Process

Team Formation
Team Roles
Product Development
Facilitator
Design
Champion
Manufacturing
Recorder/librarian
Quality
Sales/Marketing
6-10 members is optimal
Suppliers
Reliability and testing
What are your experiences in FMEA Teams?

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Why Use a Team for FMEA

Team decision-making takes time. For a team to reach consensus:
100 percent active (express agreement/disagreement) participation.
Participants must be open to new ideas/to influence others.
100 percent agreement not the goal. Majority does not rule.
Sometimes a single individual may be on the right track.
Need a formal system for voting.
Need effective facilitator (leader).
Team process check (how did we do?)
Difficult individuals
Facilitator must resolve such instances.
Effective meeting skills
Planning the meeting
Effective problem-solving skills
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Soft Skills
Are Critical
11
The Primary Driver for FMEA - What does 99.9% Quality Mean?
One hour of unsafe drinking water
268,500 defective tires shipped per year
291 incorrect pacemaker operations per year
500 incorrect surgical operations
12 babies given to the wrong parent each day

Two unsafe landings at OHare Airport per day
Your heart fails to beat 32,000 times per year
6,000 lost pieces of mail per hour
20,000 incorrect drug prescriptions per year
107 incorrect medical procedures performed
daily
performed each week

Two million documents lost by the IRS
per year
880,000 credit card magnetic strips with
the wrong information
19,000 newborn babies dropped at
birth by doctors each year
22,000 checks deducted from the wrong
14,208 defective personal computers shipped
account each hour
each year
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Elements of a Successful FMEA

1. All problems are not the same. This is perhaps the most
fundamental concept in the entire FMEA methodology. Unless a
priority of problems (as a concept) is recognized, workers are likely to
be contenders for chasing fires. They will respond to the loudest
request and/or the problem of the moment. (In other words, they will
manage by emergency.) - Does this sound like your organization?
2. The customer must be known. Acceptance criteria are

defined by the customer, not the engineer.
3. The function must be known.

4. One must be prevention (proactively) oriented. Unless
continual improvement is the force that drives the FMEA, the efforts of
conducting FMEA will be static. The FMEA will be conducted only to
satisfy customers and/or market requirements to the letter rather than
the spirit of the requirements. Unfortunately, this is a common
problem in implementation of an FMEA program.)
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Sample FMEA Form
Describe
the impact
Process
Step
Describe how the

process step
could go wrong
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What could
What actions
cause the
will you take?
failure?
Is there anything in place
to detect or stop this from
happening?
Rankings (1-10)
14
Sample FMEA Process - Adding Milk to a Cake Mix
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History of the FMEA

1940s - First developed by the US
military in 1949 to determine the
effect of system and equipment
failures
1960s - Adopted and refined by
NASA (used in the Apollo Space
program)
1970s Ford Motor Co. introduces
FMEA after the Pinto affair. Soon
adopted across automotive industry
Today FMEA used in both
manufacturing and service
industries
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Types of FMEAs
Design FMEA - examines the functions of a
component, subsystem or main system.
Potential Failures: incorrect material choice, inappropriate
specifications.
Example: Air Bag (excessive air bag inflator force).
Process FMEA - examines the processes used to

make a component, subsystem, or main system.
Potential Failures: operator assembling part incorrectly, excess
variation in process resulting in out-spec products.
Example: Air Bag Assembly Process (operator may not install
air bag properly on assembly line such that it may not engage
during impact).
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Definitions
Failure Mode
The way in which the product or process
could fail to perform its intended function.
Failure modes may be the result of upstream
operations or inputs, or may cause
downstream operations or outputs to fail.
Failure Effects
The outcome of the occurrence of the failure
mode on the system, product, or process.
Failure effects define the impact on the
customer.
Ranking is translated into Severity score
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Definitions
Failure Causes
Potential causes or reasons the failure
mode could occur
Likelihood of the cause creating the
failure mode is translated into an
Occurrence score
Current Controls
Mechanisms currently in place that will
detect or prevent the failure mode from
occurring
Ability to detect the failure before it
reaches the customer is translated in
Delectability score
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Linking Causes to Effects
One to One, One to Many, Many to One, or Many to Many

Cause 1
Effect 1
Cause 2
Effect 2
1:1
1:M
Effect 1
Cause 1
Effect 2
M:1
Cause 1
Effect 1
Cause 2
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Calculations
Risk Priority Number
The Risk Priority Number (RPN) identifies the greatest
areas of concern.
RPN is the product of:
(1) Severity rating
(2) Occurrence rating
(3) Detection rating
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Calculations - FMEA Variables

Severity
A rating corresponding to the seriousness of an effect of a potential
failure mode. (scale: 1-10. 1: no effect on the customer, 10: hazardous
effect)
Occurrence
A rating corresponding to the rate at which a first level cause and its
resultant failure mode will occur over the design life of the system, over
the design life of the product, or before any additional process controls
are applied. (scale: 1-10. 1: failure unlikely, 10: failures certain)
Detection
A rating corresponding to the likelihood that the detection methods or
current controls will detect the potential failure mode before the product
is released for production for design, or for process before it leaves the
production facility. (scale: 1-10. 1: will detect failure, 10: almost certain
not to detect failures)
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Calculations - Risk Priority Number (RPN)

Severity x Occurrence x Detectability =
Risk Priority Number (RPN)
For a given potential failure mode, how bad
the outcome is multiplied by how likely it
would actually happen multiplied by what
things are in place today to prevent or notice
it before it happens.
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FMEA Process
1
Start with the

process map
For each step,

brainstorm
potential failure
modes and effects
Determine
severity
3
Determine the
potential causes to
each failure mode
Determine
likelihood of
occurrence
Determine
detectability
Evaluate current
controls
5
Identify actions
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Determine RPN
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When is a FMEA Started?

As early as possible; that is, as soon as some
information is known (usually through a QFD).
Practitioners should not wait for all the information. If
they do, they will never perform a FMEA because they
will never have all the data or information.
When new systems, designs, products, processes, or
services are designed.
When existing systems, designs, products, processes,
or services are about to change regardless of reason.
When new applications are found for the existing
conditions of the systems, designs, products,
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When is a FMEA Completed?

Only when the system, design, product, process, or service is
considered complete and/or discontinued.
A System FMEA may be considered finished when all the hardware has
been defined and the design is declared frozen.
A Design FMEA may be considered finished when a release date for
production has been set.
A Process FMEA may be considered finished when all operations have
been identified and evaluated and all critical and significant
characteristics have been addressed in the control plan.
A Service FMEA may be considered finished when the design of the
system and individual tasks have been defined and evaluated, and all
critical and significant characteristics have been addressed in the
control plans.
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FMEA Tips
No absolutes rules for what is a high RPN number.
Rather, FMEA often are viewed on relative scale (i.e.,
highest RPN addressed first)
It is a team effort
Motivate the team members
Ensure cross-functional representation on the team
Treat as a living document, reflect the latest changes
Develop prioritization with the process owners!
Assign an owner to the FMEA; ensure it is periodically
reviewed and updated
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FMEA & The DMAIC Lifecycle

Q: At what phase can/should the FMEA be used in a DMAIC project?
A: A FMEA can be used in most phases of the DMAIC lifecycle for
various purposes
How it can be
used:
Project
selection
Project
scope
How it can be
used:
Understand
the process
(w/ process
mapping)
How it can be
used:
Identify
process
variables /
root cause
analysis
How it can be
used:
Assist with
new process
development /
understand
failures in
design
How it can be
used:
Manage
and control
the process
on an
ongoing
basis
FMEA can also be used in each stage of

Design for Six Sigma - DMADV
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FMEA Example
Purchasing Requisition to Purchase Order
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Example
Start
Complete
Purchase
Requisition
(PR)
Send PR to
Purchasing
Dept.
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Incorrect
PR
Returned
Correct and
Send Back
Receive
Goods
No
Form
Correct
Receive
PR
Supplier
Purchasing
Department
customer
Focus
Team
Purchasing Dept.
Confirm
receipt of
P.O.
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Yes
Complete
P.O.
Complete
Commit
Process
Send P.O.
To supplier
Ship
Goods
30
Example
Purchasing Dept.
From the
process map,
list the process
steps
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Brainstorm the
various ways the
step could fail
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Example
Purchasing Dept.
Determine the
potential effects
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Determine the
severity ranking
using the scale
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Severity Rankings
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Example
Purchasing Dept.
Determine the
potential causes
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Determine how
likely the failure
would occur due
to this cause
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Occurrence Rankings
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Example
Purchasing Dept.
Identify what controls

or measures are
currently in place
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Determine how likely

the controls in place
will detect or prevent
the failure mode from
occurring
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Detectability Rankings
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Example
Calculate the RPN
Severity
Occurrence
Detectability
5 x 4 x 3 =
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RPN
60
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Example
Purchasing Dept.
Brainstorm
potential actions
that will lower the
RPN
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Assign
specific
owners
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Occurrence Reduced
from 4 to 3.
PRN cut in half.
FMEA owner &

team update
the document
as actions are
complete
Recalculate
the RPN after
actions are
complete
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Case Study:
FMEA Logic in Scoring the Risk of Problems
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Case Study: Using a FMEA Hybrid

Adding Project Prioritization Index (PPI)
PPI can be used in combination with FMEA to score problem solving
projects by balancing potential savings against project costs, and project
effort/duration against project risks (chance of success).
PPI consists of four metrics:
Project Costs ($)
Project Benefits ($)
Project Probability of Success (Percent)
Project Duration (Years)
The PPI formula balances:
Project Benefits versus Project Costs
Project Probability of Success versus Project Duration
The formula looks like this:
PPI = (Benefits/Costs) x (Probability of Success/Project Duration)

Source: Praveen Gupta, Total Quality Management, in Anthony Tarantino, Risk Management
in Finance: Six Sigma and Other Next Generation Techniques (Wiley and Sons, 2010)
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Case Study: Using a FMEA Hybrid - Adding

Project Prioritization Index (PPI)
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Case Study: Using FMEA+PPI

To Score Potential Problem Solutions
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Case Study:
San Bruno Gas Pipeline Explosion
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Play the Youtube VOD from CBS News
http://www.youtube.com/watch?v=EZ6YbUrnxVM
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San Bruno, CA - September 10, 2010

The ruptured natural gas
pipeline created a crater
approximately 72 feet long
by 26 feet wide.
A pipe segment
approximately 28 feet long
was found about 100 feet
away from the crater.
The released natural gas
was ignited sometime after
the rupture; the resulting
fire destroyed 37 homes
and damaged 18.
Eight people were killed,
numerous individuals were
injured, and many more
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Source: http://www.ntsb.gov/surface/pipeline/preliminary-reports/sanbruno-ca.html
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Loss of Power at Control Terminal

Just before the accident, PG&E was working
on their uninterruptable power supply (UPS)
system at Milpitas Terminal, which is located
about 39.33 miles SE of the accident site.
During the course of this work, the power
supply from the UPS system to the supervisory
control and data acquisition (SCADA) system
malfunctioned so that instead of supplying a
predetermined output of 24 volts of direct
current (VDC), the UPS system supplied
approximately 7 VDC or less to the SCADA
system.
Because of this anomaly, the electronic signal
to the regulating valve for Line 132 was lost.
The loss of the electrical signal resulted in the
regulating valve moving from partially open to
the full open position as designed.
The pressure then increased to 386 psig. The
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over-protection
valve,
which
was pneumatically
Source: http://www.ntsb.gov/surface/pipeline/preliminaryreports/san-bruno-ca.html
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Case Study: San Bruno Gas Pipeline Explosion
There were longitudinal fractures in the first and second pup of the
ruptured segment and a partial circumferential fracture at the girth
weld between the first and second pup. There was a complete
circumferential fracture at the girth weld between the fourth pup in the
ruptured segment and the fifth pup in the north segment.
Source: http://www.ntsb.gov/surface/pipeline/preliminary-reports/san-bruno-ca.html
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Case Study: San Bruno Gas Pipeline Explosion
The longitudinal fracture in the first pup continued south into the pipe
ending in a circumferential fracture in the middle of the pipe.
Source: http://www.ntsb.gov/surface/pipeline/preliminary-reports/san-bruno-ca.html
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Poor Document and Records Retention

SAN FRANCISCO (AP) March 5, 2011
Facing a state Public Utilities Commission
order to produce records on its pipelines by
March 15. the utility has been shipping pallets
loaded with boxes of documents to the Cow
Palace in Daly City, where PG&E employees
are pouring through the paper records.
This effort is an example of the level of
commitment the company is putting forward to
make sure this process is thorough and
complete, PG&E spokesman Paul Moreno
said. it was part of a 24-hour search by
more
than 300 search
employees.
The document
comes after investigators found a seam with inferior welds that was
believed to be the origin of the blast.
PG&Es computer records had shown the pipeline did not have a seam, but PG&E
officials have acknowledged problems when the old paper records were incorporated into
the utilitys computer system.
PG&E President
Chris Johns said
last month the utility had been unable to find
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DOT to Issue New Pipeline Regulations in August

SAN FRANCISCO (Dow Jones)-The U.S. Department of
Transportation will issue new safety
rules for the nation's oil and gas
pipeline operators in August, the
agency's top official said Thursday.
"We and the Obama administration
will redouble our efforts on pipeline
safety," Transportation Secretary
Ray LaHood said, speaking at a
press conference in San Francisco.
LaHood earlier visited the site in
San Bruno, Calif., where a PG&E
Corp. (PCG) gas pipeline exploded
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Mode of Failure - Pipeline Rupture followed by Explosion

Potential Causes of Failure:
1. Faulty Weld (1/2 thickness spec)
2. Pipe Corrosion (Over 50 Years Old)
3. Corrosion of Girth/Lateral Weld
Causes 1-5
Tactical in Nature
Six Sigma Tool
Design of Experiments
4. Corrosion of Circumference Weld

5. Failure of Monitoring Station UPS
6. Lack of Automatic Shut Off Valves
7. Faulty Maintenance Documentation
8. Faulty Maintenance Procedures
9. Lack of Tone-at-the-Top Management
10. Weak Oversight by Calif. PUC
Causes 6-11
Systemic in Nature
Enterprise-wide
Operational Risk Mgt.
11. Weak Federal Regulations by DOT

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FMEA Advantages Over RCA and 5 Whys

A robust FMEA will consider each
of the 5 tactical modes of failure
and combination of modes of
failure.
Design of Experiments (DOE) can
be used to test the most likely
combination of modes and
causes.
A typical Root Cause Analysis
(RCA) may focus on one or more
of the failure modes and causees,
but would not score their risk
profiles.
A typical 5 Whys will focus on only
one of the failure modes, and may
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FMEA Suggested Tests

Design of Experiments (DOE)
Potential Tests & Combination
of Tests:
1. Faulty Weld
2. Corrosion of Pipe
3. Corrosion of Girth/Lateral Weld
4. Corrosion of Circumference Weld
5. Rise In Pressure
6. Faulty Weld (Remove Half Weld)
+ Accelerated Corrosion Test of
Pipe and Welds + Rise in
Pressure
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Additional Information
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FMEA & Other Risk Analysis Tools
FMEA
Cause & Effect Diagram
Bottoms-up approach
to failure analysis
Examines a certain
failure mode or event
and identifies all the
possible causes
Systematic method
for identifying all the
potential failure modes
of a process or
product
Causes are grouped

into several logical
categories
Creates prioritized
ranking of failure
modes within a system
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Fault Tree Analysis

Top-down approach
to failure analysis
Starting point is a
failure or undesired
state
Drill down into lower

level events leading
up to the undesired
state
Similar to the 5 Whys

method
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Backup
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For Further Information

Anthony Tarantino, PhD, MBB
Sr. Consulting Support
agtarantino@hotmail.com, 562-818-3275
Carl Ashcroft, MBB

Ciscos Six Sigma Training and Education Programs
cashrof@cisco.com, 408-525-3929
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Published FMEA Guidelines

J1739 - From the SAE for the automotive industry.
AIAG FMEA-3 - From the Automotive Industry Action Group for the automotive industry.
ARP5580 - From the SAE for non-automotive applications.
EIA/JEP131 Provides guidelines for the electronics industry, from the JEDEC/EIA.
P-302-720 - provides guidelines for NASA GSFC spacecraft and instruments.
SEMATECH 92020963A-ENG - for the semiconductor equipment industry.
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Rankings
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Failure Modes & Effects Analysis (FMEA)

A Great Tool to Improve Product and Process

2008 Cisco Systems, Inc. All rights reserved.

A Leading Six Sigma Authority:

2008 Cisco Systems, Inc. All rights reserved.

A Leading Operational Risk Authority:

2008 Cisco Systems, Inc. All rights reserved.

2008 Cisco Systems, Inc. All rights reserved.

2008 Cisco Systems, Inc. All rights reserved.

When Reliability is Lacking - Categories of Failure Mode

2008 Cisco Systems, Inc. All rights reserved.

2008 Cisco Systems, Inc. All rights reserved.

Why Use a FMEA

2008 Cisco Systems, Inc. All rights reserved.

Why Use a FMEA - Continued

2008 Cisco Systems, Inc. All rights reserved.

FMEA is a Team Process

6-10 members is optimal

What are your experiences in FMEA Teams?

2008 Cisco Systems, Inc. All rights reserved.

Why Use a Team for FMEA

2008 Cisco Systems, Inc. All rights reserved.

268,500 defective tires shipped per year

291 incorrect pacemaker operations per year

500 incorrect surgical operations

12 babies given to the wrong parent each day

performed each week

14,208 defective personal computers shipped

account each hour

2008 Cisco Systems, Inc. All rights reserved.

Elements of a Successful FMEA

2. The customer must be known. Acceptance criteria are

3. The function must be known.

2008 Cisco Systems, Inc. All rights reserved.

Sample FMEA Form

Describe how the

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Sample FMEA Process - Adding Milk to a Cake Mix

2008 Cisco Systems, Inc. All rights reserved.

History of the FMEA

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Process FMEA - examines the processes used to

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2008 Cisco Systems, Inc. All rights reserved.

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Linking Causes to Effects

One to One, One to Many, Many to One, or Many to Many

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Calculations - FMEA Variables

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Calculations - Risk Priority Number (RPN)

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Start with the

For each step,

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When is a FMEA Started?

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When is a FMEA Completed?

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FMEA & The DMAIC Lifecycle

FMEA can also be used in each stage of