Transcript Presentation

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 Cisco’s Six Sigma Center of Excellence
Adjunct Professor of Finance, Santa Clara University
May 23, 2011
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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:
McGraw-Hill, 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, FMEA’s 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
Soft Skills
Are Critical
 Planning the meeting
Effective problem-solving skills
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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 O’Hare Airport per day
performed each week
 Two million documents lost by the IRS
per year
 Your heart fails to beat 32,000 times per year
 880,000 credit card magnetic strips with
 6,000 lost pieces of mail per hour
 20,000 incorrect drug prescriptions per year
 107 incorrect medical procedures performed
daily
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
What actions
will you take?
Is there anything in place
to detect or stop this from
happening?
Describe how the
process step could
go wrong
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What could
cause the
failure?
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Rankings (1-10)
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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
1:1
1:M
Effect 2
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
2
Start with the
process map
For each step,
brainstorm
potential failure
modes and effects
Determine
severity
3
4
Determine the
potential causes to
each failure mode
Determine
likelihood of
occurrence
Determine
detectability
Evaluate current
controls
5
6
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,
processes, or services.
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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.
 As a general rule, the FMEA should be available for the entire product
life. The FMEA is a working document.
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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
Yes
Form
Correct
Receive
PR
Supplier
Purchasing
Department
customer
Focus
Team
Purchasing Dept.
Confirm
receipt of
P.O.
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Complete
P.O.
Complete
Commit
Process
Send P.O.
To supplier
Ship
Goods
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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
5
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Occurrence
x
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Detectability
x
3
=
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
were evacuated from the
area.
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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
over-protection valve, which was pneumatically
activated and did not require electronic input,
maintained
the pressure at 386 psig.
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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 employees.
The document search comes after investigators found a seam with inferior welds that
was believed to be the origin of the blast.
PG&E’s 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 utility’s computer system.
PG&E President Chris Johns said last month the utility had been unable to find
documents
for 30 percent of its 1,000-plus
miles of pipeline running under urban areas.
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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
last September, killing eight people
and destroying ...
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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
Causes 6-11
• Systemic in Nature
• Enterprise-wide
• Operational Risk Mgt.
10. Weak Oversight by Calif. PUC
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
not point to a solution.
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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
• Bottoms-up approach
to failure analysis
• Systematic method for
identifying all the
potential failure modes of
a process or product
• Creates prioritized
ranking of failure modes
within a system
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Cause & Effect Diagram
• Examines a certain
failure mode or event
and identifies all the
possible causes
• Causes are grouped
into several logical
categories
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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 Why’s
method
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Backup
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For Further Information
Anthony Tarantino, PhD, MBB
Sr. Consulting Support
[email protected], 562-818-3275
Carl Ashcroft, MBB
Cisco’s Six Sigma Training and Education Programs
[email protected], 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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