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Process Failure Mode Effect Analysis: CA/PA-RCA: Advanced Tool
Process Failure Mode Effect Analysis: CA/PA-RCA: Advanced Tool
Process Failure
Mode Effect
Analysis
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.
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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The FMEA Team Roles
Champion
Champion // Sponsor
Sponsor
Provides resources & support
Provides resources & support
Attends
Attendssome
somemeetings
meetings
Promotes
Promotes teamefforts
team efforts
Shares
Shares authority / powerwith
authority / power withteam
team
Kicks
Kicksoff
offteam
team
Implements
Implementsrecommendations
recommendations
FMEA
FMEA Core
Core Team
Team
Team Leader 44––66Members Facilitator
Members “Watchdog“ of the process
“Watchdog” of the project
Expertise Keeps team on track
Good leadership skills Expertisein
inProduct
Product/ /Process
Process
Respected & relaxed Cross functional FMEA Process expertise
Cross functional
Honest Encourages / develops team dynami
Leads but doesn’t dominate HonestCommunication
Communication
Maintains full team participation Active participation Communicates assertively
Active participation
Positive Ensures everyone participates
Typically lead engineer Positiveattitude
attitude
Respects
Respects otheropinions
other opinions
Participates
Participatesininteam
teamdecisions
decisions
Recorder
Recorder
Keeps documentation of teams efforts
Keeps documentation of teams efforts
FMEA
FMEAchart
chartkeeper
keeper
Coordinates
Coordinates meetingrooms/time
meeting rooms/time
Distributes
Distributesmeeting
meetingrooms
rooms&&agendas
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
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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
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
120
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?
Call or e-mail:
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