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CA/PA-RCA : Advanced Tool
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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
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Agenda 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?
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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.
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What is FMEA ?
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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
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What is FMEA ?
What it can do for you!
1.) Identifies Design or process related Failure Modes before they
happen.
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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.
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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.
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The FMEA Team Roles
Champion / Sponsor
Provides resources & support
Attends some meetings
Promotes team efforts
Shares authority / power with team
Kicks off team
Implements recommendations
Recorder
Keeps documentation of teams efforts
FMEA chart keeper
Coordinates meeting rooms/time
Distributes meeting rooms & agendas
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FMEA Terminology
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FMEA Terminology (continued)
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Getting Started on FMEA
What Must be done before FMEA Begins!
Understand your
=QFD
Ready?
Customer
Needs
Determine 4 Determine5 66
Determine2
Determine1
Product or “Causes” of “Controls” Calculate &
Failure Modes The Failure
Process Assess Risk
of Function Mode
Functions Detection Rating
Occurrence Rating
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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 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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FMEA Scoring
Severity
Severity of Effect Rating
May endanger machine or operator. Hazardous without warning 10
Extreme
No effect 1
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FMEA Scoring
Occurrence
Failure Capability
Likelihood of Occurrence Rate (Cpk) Rating
Very High
1 in 2 < .33 10
Failure is almost inevitable
1 in 3 > .33 9
1 in 8 > .51 8
High
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FMEA Scoring
Detection
Very Low Likelihood that control will detect failure Rating
9
Low
of a failure
3
Very High
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FMEA Scoring
RPN or Risk Priority Number
The Calculation !
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Failure Modes & Effect Analysis
(FMEA) Part or Process Improvement
FMEA is a technique utilized to define, identify, and eliminate known or
potential failures or errors from a product or a process.
Identify each candidate Part or Process, list likely failure mode, causes,
and current controls
Prioritize risk by using a ranking scale for severity, occurrence, and
detection
Mitigate risk – Can controls be added to reduce risk? Recalculate RPN.
Characteristics with high Risk Priority Numbers should be selected for
Improvement and Action Plans Created
Recalculate RPN After Completion of Action Plans to Validate
Improvements
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
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Hole Oversize Unable to Wrong Ball Gage Kit Drill
Drilling Hole Install BP 5 Drill Bit 8 Visual Insp 3 Bits
010103 51 1 5
Fastener Used
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Failure Modes & Effect Analysis
Questions?
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