SAND2012-1363 C

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Failure Modes and Effects

Analysis (FMEA)
Dr. Cecelia Venuk

Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed
Martin Corporation, for the U.S. Department of Energy’s National Nuclear Security Administration under contract DE-AC04-94AL85000.
Overview Objectives

 Learn how to Create a Failure Modes and Effects Analysis

(FMEA)
 Learn how to incorporate Customer Survey Data into a
FMEA
Agenda
• FMEA History
• What is FMEA
– Definition
– What it Can Do For You
• Types of FMEA
• FMEA Terminology
• Getting Started with an FMEA
• The FMEA Worksheet
• FMEA Scoring
• Incorporate Customer feedback into a FMEA
• Use Survey Data to Update FMEA
• Celebrate, Reward and Improve
 Why does it always seem
we have plenty of time to
fix our problems, but never
enough time to prevent the
problems by doing it right
the first time?
FMEA History
This “type” of thinking has been around for
hundreds of years. It was first formalized in
the aerospace industry during the Apollo
program in the 1960’s.
 Initial automotive adoption in the 1970’s.
 Potential serious & frequent safety issues.

 Required by QS-9000 & Advanced Product Quality Planning Process

in 1994.
 For all automotive suppliers.

 Now adopted by many other industries.

 Potential serious & frequent safety issues or loyalty issues.
 What is FMEA ?
IS / IS-NOT, Cause & Effect,
Root Cause Analysis,
Fishbone Diagram
5-Why Etc. = Root Cause Analysis
Tools

Failure Modes and Effects Analysis

= Proactive Documented
Prevention
What is FMEA ?

Definition: FMEA is a tool that:

 Helps define, identify, prioritize, and eliminate known and/or
potential failures of the system, design, or manufacturing process
before they reach the customer. The goal is to eliminate the Failure
Modes and reduce their risks.
 Provides structure for a Cross Functional Critique of a design or a
Process

 Facilitates inter-departmental dialog.

 Is a mental discipline “great” engineering teams go through, when
critiquing what might go wrong with the product or process.

 Is a living document which ultimately helps prevent, and not react

to problems.
What is FMEA ?
What it can do for you!
1.) Identifies Design or Process related Failure Modes before they
happen (D = Design & P = Process FMEA).

2.) Determines the Effect & Severity of these failure modes.

3.) Identifies the Causes and probability of Occurrence of the

Failure Modes.
4.) Identifies the Controls and their Effectiveness.

5.) Quantifies and prioritizes the Risks associated with

the Failure Modes.
6.) Develops & documents Action Plans that will occur to
reduce risk.
Types of FMEAs ?
System/Concept “S/CFMEA”- (Driven by System functions) A system
is a organized set of parts or subsystems to accomplish one or more
functions. System FMEAs are typically very early, before specific
hardware has been determined.

Design “DFMEA”- (Driven by part or component functions) A

Design / Part is a unit of physical hardware that is considered a
single replaceable part with respect to repair. Design FMEAs are
typically done later in the development process when specific
hardware has been determined.

Process “PFMEA”- (Driven by process functions & part

characteristics) A Process is a sequence of tasks that is
organized to produce a product or provide a service. A
Process FMEA can involve fabrication, assembly, transactions
or services.
FMEA Terminology
1.) Failure Modes: (Specific loss of a function) is a concise
description of how a part, system, or manufacturing process may
potentially fail to perform its functions. Examples of potential failure
modes include:
Some Process Failure Modes
-Deliver Wrong Product -Deliver Wrong Service
-Deliver Poor Product Quality -Deliver Poor Service
-Customer Gets “Lost” (Walk out) -Data Gets Lost
-Overcharge -Undercharge

2.) Failure Mode "Effect”: A description of the consequence or

ramification of a system or part failure. A typical failure mode may
have several “effects” depending on which customer you consider.
Keep in mind the internal as well as the external customer.
Examples of failure effects include:
Some Process Failure Mode Effects
-Customer Waits Too Long -Product or Service Costs Increase
-Customer is Unhappy -Company Reputation is Damaged
-Customer Injury -Loss of Business or Market Share
-Legal Issues or Fines -Death
FMEA Terminology (continued)
3.) Severity Rating (S): (Seriousness of the Effect) Severity is the
numerical rating of the impact on customers.
 When multiple effects exist for a given failure mode, enter the worst
case severity on the worksheet to calculate risk.

4.) Failure Mode "Causes”: A description of the design or process

deficiency (global cause or root level cause) that results
in the failure mode. The causes should be listed in technical terms
and not in terms of symptoms.
Examples of potential causes include:
Some Process Failure Mode Causes
-Skipped Process Step -Incomplete / Incorrect Data Collection
-Poor Communication -Too Complex or Too Confusing
-Poor Coordination -Poor Change Management
-All of the Human Factor Error Precursors (Fatigue, High Work Load, Time Pressure)
You must look at the causes not the symptoms of the failure. Most failure
Modes have more than one Cause.
FMEA Terminology (continued)
5.) Occurrence Rating (O): Is an estimate number of frequencies
or cumulative number of failures (based on experience) that will
occur (in our design concept) for a given cause over the intended
“life of the design”.
6.) Failure Mode "Controls”: The mechanisms, methods, tests,
procedures, or controls that we have in place to PREVENT the
Cause of the Failure Mode or DETECT the Failure Mode or Cause
should it occur .
Design Controls prevent or detect the Failure Mode prior to engineering
release
7.) Detection Rating (D): A numerical rating of the probability that a
given set of controls WILL DISCOVER a specific Cause of Failure Mode to
prevent bad parts leaving the facility or getting to the ultimate customer.
Assuming that the cause of the failure did occur, assess the capabilities of the
controls to find the design flaw.
FMEA Terminology (continued)

8.) Risk Priority Number (RPN): Is the product of Severity,

Occurrence, & Detection. Risk= RPN= S x O x D
Often the RPN’s are sorted from high to low for consideration in the action planning
step (Caution, RPN’s can be misleading- you must look for patterns).

9.) Action Planning: A thoroughly thought out and well developed

FMEA With High Risk Patterns that is not followed with corrective
actions has little or no value, other than having a chart for an audit
Action plans should be taken very seriously.
If ignored, you have probably wasted much of your valuable time.
Based on the FMEA analysis, strategies to reduce risk are focused on:

Reducing the Occurrence Rating.

Reducing the Detection Rating.
Getting Started on FMEA
What Must be done before FMEA Begins!
Understand your
=Quality Function

Ready?
Customer
Needs Deployment
(QFD) – Marketing
Develop & Evaluate
Product/Process =Brainstorming
Concepts

Create =4 to 6 Consensus Based Multi Develop and

an Effective
Level Experts Drive 7
FMEA Team Determine
= What we “Effects” of 3 Action Plan
Define the FMEA are and are The Failure
Scope not working Mode
on Severity Rating

Determine 4 Determine 5 66
Determine 2
Determine 1
Product or “Causes” of “Controls” Calculate &
Failure Modes The Failure
Process Assess Risk
of Function Mode
Functions Detection Rating
Occurrence Rating
 The FMEA Worksheet

Resp. & p p p p
Product S O D R
Failure Failure Actions Target S O D R
or E Causes C Controls E P
Mode Effects / Plans Complete E C E P
Process V C T N
Date V C T N

1 2 3 4 5 6 7
Develop
Determine Determine Determine
and
Product or “Effects” of “Controls”
Drive
Process The Failure Detection
Action Plan
Functions Mode Determine Rating
Severity “Causes” of
Determine Rating The Failure Calculate
Failure Mode &
Modes Occurrence Assess
of Function Rating Risk

If a FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly
FMEA Scoring

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FMEA Scoring
RPN or Risk Priority Number

The Calculation !

Severity x Occurrence x Detection= RPN

How can we incorporate Customer
feedback into a FMEA?
• Denise Wymore covered the Net Promoter Score at the
AQN January breakfast.

• In summary
– On a scale of 0 - 10, how likely is it that you will recommend the
(insert your business or service here) to a friend, coworker or
family member?
– What is the primary reason for your score?

• Transaction Score = weekly surveys of key touch points

- Weekly
• Relationship Score = random sample of entire customer
base - Quarterly

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Simplified Survey
Detractor Passives Promoter
How likely is it that you will recommend Circle One:
us to a friend, coworker or family
member?  Very Unlikely  Neutral  Very Likely
Why or Why Not?

Name (Optional) Phone Number / Email / Address (Optional)

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Use Survey Data to Update FMEA
• Identify your key touch points or customer processes
– Going out to a Restaurant
– Opening a New Account
– Obtaining a Loan
– Handling a Customer Call
– Admitting a Patient
– Developing Diet and Providing Food
• Administer Survey (2 questions)

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Use Survey Data to Update FMEA

• Analyze data weekly

– Sort Promoters and Detractors
• Address Detractor Reasons – What’s not working
– Group the Detractor primary reasons into affinities
– Identifies the Causes of the Complaints.
• CAUTION: Causes may need further investigation or Formal
Root Cause Analysis (RCA)
– Review the Controls and their Effectiveness.
– Brainstorm new Controls

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Use Survey Data to Update FMEA

• Address Detractor Reasons – What’s not

working
– Identify Actions and Responsibility and Target Date
– Follow-up and Document Actions Taken
– Revaluate Occurrence and Detection and RPN

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Celebrate, Reward, and Improve

• Address Promoter Reasons – What is working

– Highlight the key touch points or customer processes, or
Controls that are Effective
• Celebrate successes
• Publish wins
• Acknowledge teams and key individuals
• Reward “good” behavior
• Document and instutionalize
• Acknowledge customers

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Failure Modes & Effect Analysis
(FMEA)

Questions?
Call or e-mail:

Dr. Cecelia M. Venuk

505-284-4848
[email protected]