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Vocabulary:
FAILURE MODE: How a part or process can fail to meet
specifications.
CAUSE: A deficiency that results in a failure mode
sources of variation
EFFECT: Impact on customer if the failure mode is not
prevented or corrected.
1
Overview Objective
Failure Mode Effect Analysis (FMEA)
Provide a Basic familiarization with a tool
that aids in quantifying severity,
occurrences and detection of failures, and
guides the creation of corrective action,
process improvement and risk mitigation
plans.
Agenda
FMEA History
What IS FMEA
Definitions
What it Can Do For You
Types of FMEA
Team Members Roles
FMEA Terminology
Getting Started with an FMEA
The Worksheet
FMEA Scoring
5
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 1960s.
Initial automotive adoption in the 1970s.
Potential serious & frequent safety issues.
What is FMEA ?
What is FMEA ?
Definition: FMEA is an Engineering Reliability 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.
What is FMEA ?
What it can do for you!
1.) Identifies Design or process related Failure Modes
before they happen.
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.
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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.
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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.
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Team Leader
FMEA
FMEA Core
Core Team
Team
4466Members
Members
Expertise
Expertisein
inProduct
Product/ /Process
Process
Cross
functional
Cross functional
Honest
HonestCommunication
Communication
Active
participation
Active participation
Positive
Positiveattitude
attitude
Respects
other
Respects otheropinions
opinions
Participates
Participatesin
inteam
teamdecisions
decisions
Facilitator
Recorder
Recorder
Keeps documentation of teams efforts
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FMEA Terminology
1.) Failure Modes: (Specific loss of a function) is a
concise
Assuming that the cause of the failure did occur, assess the capabilities of th
controls to find the design flaw..
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xOx
DOften the RPNs are sorted from high to low for consideration in the action plann
step (Caution, RPNs can be misleading- you must look for patterns).
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Create
an Effective
FMEA Team
=QFD
Ready?
=Brain Storming
= What we
Define the FMEA are and are
Scope
not working
Determine
3
Effects of
The Failure
Mode
Develop and
Drive
7
Action Plan
Severity Rating
Determine4
Determine1
2
Determine
Causes of
Product or
Failure Modes The Failure
Process
of Function
Mode
Functions
Occurrence Rating
Determine5
Controls
66
Calculate &
Assess Risk
Detection Rating
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Failure
Mode
Determine
Product or
Process
Functions
S
O
Failure
E Causes C Controls
Effects
V
C
Determine
Effects of
The Failure
Mode
Severity
Determine
Rating
Failure
Modes
of Function
Determine
Causes of
The Failure
Mode
Occurrence
Rating
D R
Actions
E P
/ Plans
T N
Resp. &
Target
Complete
Date
p
S
E
V
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E
T
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Develop
and
Drive
Action Plan
Determine
Controls
Detection
Rating
Calculate
&
Assess
Risk
If an 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
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p
R
P
N
FMEA Scoring
None
Low
Moderate
High
Extreme
Severity
SeverityofEffect
Rating
Mayendangermachineoroperator.Hazardouswithoutwarning
10
Mayendangermachineoroperator.Hazardouswithwarning
Majordisruptiontoproductionline.Lossofprimaryfunction,100%scrap.Possiblejiglockand
MajorlossofTaktTime
Reducedprimaryfunctionperformance.ProductrequiresrepairorMajorVariance.
NoticeablelossofTaktTime
Mediumdisruptionofproduction.Possiblescrap.Noticeablelossoftakttime.
Lossofsecondaryfunctionperformance.RequiresrepairorMinorVariance
Minordisruptiontoproduction.Productmustberepaired.
Reducedsecondaryfunctionperformance.
Minordefect,productrepairedor"UseAsIs"disposition.
Fit&Finishitem.Minordefect,maybereprocessedonline.
8
7
6
5
4
3
MinorNonconformance,maybereprocessedonline.
Noeffect
1
18
<.33
10
1in3
>.33
1in8
Process is not in statistical control.
Similar processes have experienced problems.
1in20
>.51
>.67
1in80
>.83
>1.00
1in2000
>1.17
1in15k
>1.33
>1.50
>1.67
Moderate
High
1in2
Low
LikelihoodofOccurrence
Failure Capability
Rate
(Cpk) Rating
Remote
VeryHigh
FMEA
Scoring
Occurrence
Failure is almost inevitable
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FMEA
Scoring
Detection
VeryLow
Rating
Low
Likelihoodthatcontrolwilldetectfailure
9
8
Moderate
High
4
Controls have a good chance of detecting the existence
of a failure
VeryHigh
6
5
3
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FMEA
Scoring
RPN or
Risk Priority Number
The Calculation !
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Failure
Mode
Failure
Effects
S
O
E Causes C Controls
V
C
Wrong
Drill Bit
Used
Ball Gage
8 Visual Insp 3
120
Hole
Oversize Unable to
Drilling
Hole Install BP 5
Fastener
D R
Actions
E P
/ Plans
T N
Kit Drill
Bits
Resp. &
Target
Complete
Date
010103
p
S
E
V
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p
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p
R
P
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51 1 5
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