Anthony Tarantino PhD, Six Sigma Master Black Belt, CPIM, CPM,

© 2008 Cisco Systems, Inc. All rights reserved. Cisco ConfidentialPresentation_ID 1

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


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."


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.”


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


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.


When Reliability is Lacking - Categories of Failure ModeSafety

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.


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.


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.


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


FMEA is a Team Process

Team Formation

Product Development

Design

Manufacturing

Quality

Sales/Marketing

Suppliers

Reliability and testing

Team Roles

Facilitator

Champion

Recorder/librarian

6-10 members is optimal

What are your experiences in FMEA Teams?


Why Use a Team for FMEATeam 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

Soft Skills Are Critical


The Primary Driver for FMEA - What does 99.9% Quality Mean?

One hour of unsafe drinking water

291 incorrect pacemaker operations per year

12 babies given to the wrong parent each day

Two unsafe landings at O’Hare 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

14,208 defective personal computers shipped

each year

268,500 defective tires shipped per year

500 incorrect surgical operations

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

account each hour


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.)


Process Step

Describe how the process step

could go wrong

Describe the impact

What could cause the failure?

Is there anything in place to detect or stop this from

happening?

What actions will you take?

Rankings (1-10)

Sample FMEA Form


Sample FMEA Process - Adding Milk to a Cake Mix


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).


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

Cause 2

Effect 1

Effect 2

Cause 1

Effect 1

Effect 2

Cause 1

Cause 2

Effect 1

1:1

1:M

M:1


CalculationsRisk 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


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)


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.


FMEA ProcessStart with the process map

1 For each step, brainstorm potential failure modes and effects

2

Determine the potential causes to each failure mode

3

Evaluate current controls

4

Determine severity

Determine likelihood of occurrence

Determine detectability

Determine RPN

5

Identify actions

6


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.


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.


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


FMEA & The DMAIC LifecycleQ: At what phase can/should the FMEA be used in a DMAIC project?

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

A: A FMEA can be used in most phases of the DMAIC lifecycle for various purposes

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


FMEA Example

Purchasing Requisition to Purchase Order


ExamplePurchasing Dept.

cust

om

erF

ocu

s T

eam

Pu

rch

asin

gD

epa

rtm

ent

Su

pp

lier

CompletePurchase

Requisition (PR)

Send PR toPurchasing

Dept.

IncorrectPR

Returned

Correct andSend Back

ReceiveGoods

Receive PR

Form Correct

CompleteP.O.

Send P.O.To supplier

Confirm receipt of

P.O.

CompleteCommitProcess

YesNo

ShipGoods

Start



From the process map,

list the process steps

Brainstorm the various ways the

step could fail



Determine the potential effects

Determine the severity ranking using the scale


Severity Rankings



Determine how likely the failure would occur due

to this cause

Determine the potential causes


Occurrence Rankings



Determine how likely the controls in place will detect or prevent the failure mode from

occurring

Identify what controls or measures are currently in place


Detectability Rankings


ExampleCalculate the RPN

5 x 4 x 3 = 60

Severity Occurrence Detectability RPN



Brainstorm potential actions that will lower the

RPN

Assign specific owners

FMEA owner & team update the document as actions are

complete

Recalculate the RPN after

actions are complete

Occurrence Reduced from 4 to 3.

PRN cut in half.


Case Study:

FMEA Logic in Scoring the Risk of Problems


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)


Case Study: Using a FMEA Hybrid - Adding Project Prioritization Index (PPI)


Case Study: Using FMEA+PPI To Score Potential Problem Solutions


Case Study:

San Bruno Gas Pipeline Explosion


Play the Youtube VOD from CBS News

http://www.youtube.com/watch?v=EZ6YbUrnxVM

http://www.youtube.com/watch?v=EZ6YbUrnxVM


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.

Source: http://www.ntsb.gov/surface/pipeline/preliminary-reports/san-bruno-ca.html


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.



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.



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.



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.


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 ...


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

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

11. Weak Federal Regulations by DOT

Causes 1-5 • Tactical in Nature• Six Sigma Tool• Design of Experiments

Causes 6-11• Systemic in Nature• Enterprise-wide • Operational Risk Mgt.


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.


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


Additional Information


FMEA & Other Risk Analysis Tools

FMEA Cause & Effect Diagram Fault Tree Analysis

• 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

• Examines a certain failure mode or event and identifies all the possible causes

• Causes are grouped into several logical categories

• 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


Backup


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

mailto:[email protected]

mailto:[email protected]


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.


Rankings
