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National Guard
Black Belt Training
Module 32
Failure Modes and Effects
Analysis (FMEA)
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CPI Roadmap – Analyze
8-STEP PROCESS
6. See
1.Validate 2. Identify 3. Set 4. Determine 5. Develop 7. Confirm 8. Standardize
Counter-
the Performance Improvement Root Counter- Results Successful
Measures
Problem Gaps Targets Cause Measures & Process Processes
Through
Define Measure Analyze Improve Control
ACTIVITIES TOOLS
• Value Stream Analysis
• Identify Potential Root Causes • Process Constraint ID
• Reduce List of Potential Root • Takt Time Analysis
Causes • Cause and Effect Analysis
• Brainstorming
• Confirm Root Cause to Output
• 5 Whys
Relationship
• Affinity Diagram
• Estimate Impact of Root Causes • Pareto
on Key Outputs • Cause and Effect Matrix
• FMEA
• Prioritize Root Causes
• Hypothesis Tests
• Complete Analyze Tollgate • ANOVA
• Chi Square
• Simple and Multiple
Regression
Note: Activities and tools vary by project. Lists provided here are not necessarily all-inclusive. UNCLASSIFIED / FOUO
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Learning Objectives
Understand why we use Failure Modes and Effects
Analysis (FMEA)
Summarize the different types of FMEAs
Learn how to link the FMEA to other LSS tools
Learn the steps necessary to work through an FMEA
Complete an exercise to create an FMEA
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Unintended Consequences
For any new or redesigned process…
Your solution has to be aligned with your organization’s strategic
and tactical goals in order to yield benefits that will be judged
significant
You want to know about any unintended consequences or
problems related to your solution before you implement or
promote it
Awareness of potential difficulties will allow you to prevent or
mitigate the effects of any failure
You want to minimize any “start up” problems and move to full
implementation in the shortest possible time
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Risk Management
Any significant issues identified
in the FMEA must then be
addressed by taking:
Preventive Action
Steps that reduce the likelihood of a problem occurring at all
Focused on reducing/eliminating root causes prior to occurrence
Contingent Action
Measures implemented to limit the damage caused by a potential
problem should it occur
Focused on achieving the goal in spite of difficulties
We can mistake proof our new or revised processes by
proactively focusing on the “meaningful many”….
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Example: Risk Management
Use FMEA in Analyze
to find potential
causes of a problem
Pizza Delivery Process and evaluate from a
risk perspective
Task – Assign a van to each delivery driver
Potential Problem – Not enough drivers with vehicles to meet order
demand (due to less flexibility in moving drivers to vehicles)
Preventive Action – Review volume patterns and match staff/vehicle
schedules to ensure adequate coverage/capacity
Contingent Action – Identify “on-call” delivery staff and short-term
vehicle rentals for expected or unexpected demand spikes (e.g., Super
bowl)
Alarm – Delivery times >28 minutes and/or driver/vehicle shortages
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FMEA
Stands for Failure Modes and Effects Analysis.
FMEA is a structured approach to:
Identifying the areas and ways in which a process or system can
fail (failure mode)
Identifying potential root causes and estimating the risk
associated with theses causes
Identifying and prioritizing the actions that should be taken to
reduce those risks
Evaluating and documenting proposed improvement plans or
current control plans
FMEA is used to identify and reduce risk, and
therefore unintended consequences, in the problem
solving process
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When to Conduct an FMEA
When existing designs or processes are being changed
When new systems, products and processes are being
designed.
When carry-over designs are used in new applications
After system, product or process functions are defined,
but before beginning detailed final design
When the improvement idea has been decided
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Types of FMEAs
System
Analyzes systems and subsystems in early concept and
design stages
Design
Analyzes new process, product or service design before
rollout
Process
Used to improve existing transactional and operational
processes
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FMEA Procedure
1. For each process step (start with steps that give highest
value from C&E Matrix) determine the ways in which the
input to the step or the function of the step can go wrong
(failure mode)
2. For each failure mode, determine effects
Select a severity rating for each effect (1-10 scale)
Any failure with a severity rating of 9 or 10 should be
worked immediately
3. Identify potential causes of each failure mode
Select an occurrence rating for each cause (1-10 scale)
4. List current monitoring and controls for each cause
Select a detection rating for each cause (1-10 scale)
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FMEA Procedure (Cont.)
5. Calculate the Risk Priority Number (RPN) by
multiplying the 3 ratings together (Max Score = 1000)
6. In the Improve phase, develop recommended actions,
assign responsible persons, and note actions taken.
Prioritize so the highest RPNs are addressed first
Some level of risk may be accepted and no action is
taken on RPNs below an established limit
7. Implement solutions from the first round of actions,
create a re-prioritized FMEA and analyze for further
necessary action
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FMEA Inputs and Outputs
Determine by utilizing the following CPI tools as
needed:
Inputs Outputs
Brainstorming List of actions to
C&E Matrix prevent causes or
Process Map detect failure
Process History modes
Procedures FMEA
Knowledge History of
Experience actions taken
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Failure Modes and Effects
The relationship between failure modes and effects is
not always 1 to 1.
Failure Mode 1 Effect 1
Failure Mode 2 Effect 2
Failure Mode 1
Effect 1
Failure Mode 2
Effect 1
Failure Mode 1
Effect 2
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Severity, Occurrence, and Detection
Severity
Importance of the effect on customer requirements
Often can’t do anything about this without fundamentally
changing the system or design
Occurrence
Frequency with which a given cause occurs and creates
failure modes (or probability it will occur)
Detection
The ability of the current monitoring and control
method to detect before or after occurrence of a given
cause
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Rating Scales and RPN
Rating formats can be quantitative or qualitative
The rating scales provided in this module were adopted from the
Automotive Industry Action Group, AIAG – may need to be adjusted
for transactional or service CPI projects
Typically:
1 = Not severe, not likely to occur or likely to detect
10 = Very severe, very likely to occur or not likely to detect
RPN is a product of the severity, occurrence and detection ratings:
(Severity) x (Occurrence) x (Detection) = RPN (maximum of 1000)
A customized rating scale may be created or the RPN level at which
action is taken may be adjusted for your particular organization
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 16
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Severity Scale 1 of 2
Effect Criteria: Severity of Effect Defined Ranking
Hazardous: May endanger operator or others. Failure mode affects safe
Without product operation and / or involves noncompliance with 10
Warning government regulation. Failure will occur WITHOUT warning.
Hazardous: May endanger operator or others. Failure mode affects safe
With product operation and / or involves noncompliance with 9
Warning government regulation. Failure will occur WITH warning.
Major disruption to production line. 100% of product may have to
Very High be scrapped. Product inoperable, loss of primary function. 8
Customer very dissatisfied.
Minor disruption to production line. Product may have to be sorted
High and a portion (less than 100%) scrapped. Product operable, but at 7
a reduced level of performance. Customer dissatisfied.
Minor disruption to production line. A portion (less than 100%)
may have to be scrapped (no sorting). Product operable, but
Moderate 6
some comfort / convenience item(s) inoperable. Customers
experience discomfort.
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Severity Scale 2 of 2
Effect Criteria: Severity of Effect Defined Ranking
Minor disruption to production line. 100% of product may have to
be reworked. Item operable, but some comfort / convenience
Low 5
item(s) operable at reduced level of performance. Customer
experiences some dissatisfaction.
Minor disruption to production line. The product may have to be
sorted and a portion (less than 100%) reworked. Fit / finish /
Very Low 4
squeak / rattle item does not conform. Defect noticed by most
customers.
Minor disruption to production line. A portion (less than 100%) of
the product may have to be reworked on-line but out-of-station. Fit
Minor 3
/ finish / squeak / rattle item does not conform. Defect noticed by
average customers.
Minor disruption to production line. A portion (less than 100%) of
the product may have to be reworked on-line but in-station. Fit /
Very Minor 2
finish / squeak / rattle item does not conform. Defect noticed by
discriminating customers.
None No effect. 1
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Likelihood of Occurrence Scale
Probability of Failure Possible Failure Rates Cpk Ranking
Very High: > 1 in 2 < 0.33 10
Failure is almost inevitable 1 in 3 > 0.33 9
High: Generally associated with
1 in 8 > 0.51 8
processes similar to previous
processes that have often failed 1 in 20 > 0.67 7
Moderate: Generally associated
1 in 80 > 0.83 6
with processes similar to
previous processes which have 1 in 400 > 1.00 5
experienced occasional failures,
1 in 2,000 > 1.17 4
but not in major proportions
Low: Isolated failures associated
1 in 15,000 > 1.33 3
with similar processes
Very Low: Only isolated failures
associated with almost identical 1 in 150,000 > 1.5 2
processes
Remote: Failure is unlikely. No
failures ever associated with < 1 in 1,500,000 > 1.67 1
almost identical processes
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 19
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Detection Scale
Detection Criteria: Likelihood the existence of a defect Ranking
will be detected by test content before product
advances to next or subsequent process
Almost Test content detects < 80 % of failures 10
Impossible
Very Remote Test content must detect 80 % of failures 9
Remote Test content must detect 82.5 % of failures 8
Very Low Test content must detect 85 % of failures 7
Low Test content must detect 87.5 % of failures 6
Moderate Test content must detect 90 % of failures 5
Moderately High Test content must detect 92.5 % of failures 4
High Test content must detect 95 % of failures 3
Very High Test content must detect 97.5 % of failures 2
Almost Certain Test content must detect 99.5 % of failures 1
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 20
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FMEA Example
We will conduct an FMEA on the All Ranks Club coffee
example
A Black Belt wants to improve customer satisfaction
with the coffee served at the All Ranks Club
Use the process map and completed C&E matrix
follow
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 21
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All Ranks Club Coffee Process Map
Primary Y = Taste
Select process steps with biggest impact on taste
Inputs Outputs Inputs Outputs
Hot Water Cleaned Carafe Customer Complete Order
Clean Carafe Receive
Soap Dirty Water Order Coffee Order
Scrubber Wet Scrubber Size Specification
Clean Carafe Full Carafe
Fill Carafe Complete Order Pour Coffee Filled Cup
Cold Water w/Water Hot Coffee into Cup
Measuring Mark Cup
Full Carafe Filled Maker Customer Reply
Pour Water into Filled Cup Offer
Maker Empty Carafe Amount Specified
Customer Cream &
Cream Sugar Complete Order
Filter Place Filter in Maker Maker w/Filter
Sugar
Amount Desired
Maker w/Filter Maker w/Filter &
Put Coffee in
Fresh Coffee Coffee Complete Order Make Change
Filter Complete
Dosing Scoop Money Transaction Temperature
Taste
Maker w/Filter & Operating Maker
Turn Maker On Strength
Coffee Heat
Brewed Coffee
Coffee Delivery Smile
Say Thank You
Brewing Coffee Hot Coffee Happy Customer
Select Temperature
Setting
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 22
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Step 1. Determine Potential Failure Modes
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Effects E Causes C E P Recommended Taken E C E P
Failure V C T N V C T N
Mode E U E E U E
What is the In what ways What is the impact R What causes R What are the existing C What are the What are the R R C
process step does the Key on the Key Output I the Key Input R controls and T actions for completed actions I A T
and input Input go Variables T to go wrong? E procedures I reducing the taken with the T N I
under wrong? (Customer Y N (inspection and test) O occurrence of the recalculated RPN? Y C O
investiga- Requirements)? C that prevent either the N cause, or E N
tion? E cause or the Failure improving
Mode? detection?
Fill carafe Wrong
with water amount of
water
Water too
warm
Carafe not A FMEA is a vertical process. Each step should
clean be completed for the entire process before
proceeding to the next step.
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 23
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Step 2. Identify Failure Effects and Severity
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Mode E Causes C E P Recommended Taken E C E P
Failure V C T N V C T N
Effects E U E E U E
R
What is the In what ways What is the impact I What causes R What are the existing C What are the What are the R R C
process step does the Key on the Key Output T the Key Input R controls and T actions for completed actions I A T
and input Input go Variables Y to go wrong? E procedures I reducing the taken with the T N I
under wrong? (Customer N (inspection and test) O occurrence of the recalculated RPN? Y C O
investiga- Requirements)? C that prevent either the N cause, or E N
tion? E cause or the Failure improving
Mode? detection?
Fill carafe Wrong Coffee too
with water amount of strong or too
water weak
Water too Coffee too
warm strong
Carafe not Foreign
clean objects in
coffee
Bad taste
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 24
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Step 2. Identify Failure Effects and Severity
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential Potential S Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Mode Causes C E P Recommended Taken E C E P
Failure E C T N V C T N
Effects V U E E U E
What is the In what ways What is the impact E What causes R What are the existing C What are the What are the R R C
process step does the Key on the Key Output R the Key Input E controls and T actions for completed actions I A T
and input Input go Variables to go wrong? N procedures I reducing the taken with the T N I
under wrong? (Customer
I C (inspection and test) O occurrence of the recalculated RPN? Y C O
investiga- Requirements)? T E that prevent either the N cause, or E N
tion? Y cause or the Failure improving
Mode? detection?
Fill carafe Wrong Coffee too 5
with water amount of strong or too
water weak
Water too Coffee too 5
warm strong
Carafe not Foreign 6
clean objects in
coffee
Bad taste 6
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 25
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Step 3. Identify Potential Causes/Occurrence
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible: FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential S Potential O Current Controls
Potential D R Actions Resp. Actions S O D R
Input Failure Mode Failure Effects
E
V
Causes C C
E P
T N
Recommended Taken E
V
C
C
E P
T N
What is the In what ways What is the impact E What causes U What are the E What are the What are the E U E
process step does the Key on the Key Output R the Key Input R existing controls C actions for completed R R C
and input Input go Variables I to go wrong? R and procedures T reducing the actions taken I A T
under wrong? (Customer T E (inspection and test) I occurrence of with the T N I
investiga- Requirements)? Y N that prevent either O Y C O
the cause, or recalculated
tion?
C the cause or the N improving RPN? E N
E Failure Mode? detection?
Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4
water water too weak marks on
carafe
5 Water spilled 5
from carafe
Water too Coffee too strong 5 Faucet not 8
warm allowed to run
and cool
5 Employee not 7
aware of new
need for cool
water
Carafe not clean Foreign objects in 6 Carafe not 4
coffee washed
Bad taste 6 Carafe stored 7
improperly
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 26
27. UNCLASSIFIED / FOUO
Step 4. List Current Controls and Score
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential PotentialS Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Mode Failure Effects
E Causes C P Recommended Taken E C E P
V C E N V C T N
What is the In what ways What is the impact E What causes U What are the existing What are the What are the
process step does the Key on the Key Output R the Key Input R controls and
T actions for completed actions E U E
and input Input go Variables I to go wrong? R procedures E reducing the taken with the R R C
under wrong? (Customer T E (inspection and test) C occurrence of the recalculated RPN? I A T
investiga- Requirements)? Y N that prevent either the cause, or T N I
tion? T
C cause or the Failure improving Y C O
E Mode? I detection? E N
O
N
Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4
water water too weak marks on carafe
5 Water spilled 5 None 10
from carafe
Water too Coffee too strong 5 Faucet not 8 Finger 4
warm allowed to run
and cool
5 Employee not 7 None 10
aware of new
need for cool
water
Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4
coffee washed
Bad taste 6 Carafe stored 7 Visual Aid 5
improperly
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 27
28. UNCLASSIFIED / FOUO
Step 5. Calculate RPNs
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential PotentialS Potential O Current Controls D Actions Resp. Actions S O D R
Input Failure Mode E
Failure Effects Causes C E R Recommended Taken E C E P
What is the
V
In what ways What is the impact E What causes
C
U What are the existing
T
E
P What are the What are the
V
E
C
U
T
E
N
process step does the Key on the Key Output R the Key Input R controls and C N actions for completed actions R R C
and input Input go Variables I to go wrong? R procedures T reducing the taken with the I A T
under wrong? (Customer T E (inspection and test) I occurrence of the recalculated RPN? T N I
Y N O Y C O
investiga- Requirements)? that prevent either the cause, or
C N E N
In the Analyze
tion? E
cause or the Failure improving
Mode? detection?
Fill carafe with Wrong amount of
water water
Coffee too strong or
too weak
5 Faded level
marks on carafe
4 Visual inspection 4 80 phase, FMEA is
5 Water spilled 5 None 10 250 used to help
from carafe
Water too Coffee too strong 5 Faucet not 8 Finger 4 160
identify potential
warm allowed to run
and cool causes of process
5 Employee not
aware of need
7 None 10 350 problems related to
for cool water
the Primary Y. Sort
Carafe not clean Foreign objects in
coffee
6 Carafe not
washed
4 Visual inspection 4 96 by RPN to find most
Bad taste 6 Carafe stored 7 Visual Aid 5 210 critical Xs for
improperly
further analysis.
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 28
29. UNCLASSIFIED / FOUO
Step 6. Develop Recommended Actions
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential Potential
S Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Mode Failure Effects
E Causes C E P E C E P
V C T N Recommended Taken V C T N
What is the In what ways What is the impact E What causes U What are the existing E What are the actions What are the E U E
process step does the Key on the Key Output R the Key Input R controls and C for reducing the completed actions R R C
and input Input go Variables I to go wrong? R procedures T occurrence of the taken with the I A T
under wrong? (Customer T E (inspection and test) I cause, or improving recalculated RPN? T N I
investiga- Requirements)? Y N that prevent either the O detection? Y C O
tion? C cause or the Failure N E N
E Mode?
Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4 80
water water too weak marks on carafe
Complete this
5 Water spilled 5 None 10 250 Train employees Flo Employees trained
from carafe
Water too
warm section Faucettonot 8 FMEA
Coffee too strong 5
allowed the
of run Finger 4 160
in 5the Improve None
and cool
Employee not 7 10 350 Train employees Mel Employees trained
phase.
aware of new
need for cool
water
Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4 96
coffee washed
Bad taste 6 Carafe stored 7 Training 5 210 Create storage bin & Alice New storage bin &
improperly train employees employees trained
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 29
30. UNCLASSIFIED / FOUO
Step 7. Compare RPN Before and After
Process or
Product Name:
Prepared by: Page ___ of ___
Process/Product
Responsible:
FMEA Date (Orig) _____________ (Rev) ______________
FMEA Form
Process Step/ Potential Potential
S Potential O Current Controls D R Actions Resp. Actions S O D R
Input Failure Mode Failure Effects
E Causes C E P Recommended Taken
V C T N E C E P
What is the In what ways What is the impact E What causes U What are the existing What are the What are the
process step does the Key on the Key Output R the Key Input R controls and
E
actions for completed actions
V C T N
C
and input Input go Variables I to go wrong? R procedures T reducing the taken with the E U E
under wrong? (Customer T E (inspection and test) I occurrence of the recalculated RPN? R R C
investiga- Requirements)? Y N that prevent either the O cause, or
tion? I A T
C cause or the Failure N improving
E Mode? detection? T N I
Y C O
E N
Fill carafe with Wrong amount of Coffee too strong or 5 Faded level 4 Visual inspection 4 80
water water too weak marks on carafe
5 Water spilled 5 None 10 250 Train employees Flo Employees trained 5 2 7 70
from carafe
Water too Coffee too strong 5 Faucet not 8 Finger 4 160
warm allowed to run
and cool
5 Employee not 7 None 10 350 Train employees Mel Employees trained 5 1 8 40
aware of new
need for cool
water
Carafe not clean Foreign objects in 6 Carafe not 4 Visual inspection 4 96
coffee washed
Bad taste 6 Carafe stored 7 Training 5 210 Create storage bin & Alice New storage bin & 6 2 3 36
improperly train employees employees trained
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 30
31. UNCLASSIFIED / FOUO
Exercise: Prepare an FMEA
Objective
Create an FMEA for the GGA's Budget Department
Instructions
Select one process step critical to improving the Primary Y
Complete the FMEA through the first RPN calculation
Sort by RPN to determine critical Xs for further analysis
Be prepared to report results to the group
Time = 20 Minutes
UNCLASSIFIED / FOUO 31
32. UNCLASSIFIED / FOUO
FMEA Template
Process/Product
Failure Modes and Effects Analysis Form
(FMEA)
Pag
Process or
Prepared by: e
Product Name:
____
Responsible: FMEA Date (Orig) ______________ (Rev) _____________
O
Process Potential Failure Potential Failure D
S Potential Causes C Current Controls
Step / Input Mode Effects E
E C
T
What is the In what ways does What is the impact V What causes the Key U What are the existing
E
process the Key Input go on the Key Output E Input to go wrong? R controls and procedures RP
C
step and wrong? Variables (Customer R R (inspection and test) that N
T
Input under Requirements)? I E prevent either the cause
I
investiga- T N or the Failure Mode?
O
tion? Y C
N
E
0
0
0
Required Deliverable 0
0
0
0
0
0
UNCLASSIFIED / FOUO 0
33. UNCLASSIFIED / FOUO
Takeaways
Use FMEA in the Analyze phase to determine potential and
significant Xs impacting Y from a risk perspective
Include significant Xs identified here in the improvement
plan
Show impact of improvements using before and after RPN
calculations
Failure Modes and Effects Analysis UNCLASSIFIED / FOUO 33
34. UNCLASSIFIED / FOUO
What other comments or questions
do you have?
UNCLASSIFIED / FOUO