Intelligent Use of FMEA Presented By: Quality Associates International
Intelligent Use of FMEA Presented By: Quality Associates International
Intelligent Use of FMEA Presented By: Quality Associates International
Presented by
Quality Associates International
Visit us at:
www.quality-one.com
This guideline is for training purposes only; Not ISO controlled
Potential
__ System
Failure Mode and Effects Analysis
__ Subsystem (Design FMEA)
__ Component FMEA Number:
Page 1 or 1
Model Year/Vehicle(s): Design Responsibility Prepared by: Lee Dawson
FMEA Date (Orig.):
Core Team: Key Date:
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What Is An FMEA?
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FMEA Deployment
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FMEA Strategy
Strategic Deployment of
FMEA to support DFSS
(Design for Six Sigma)
The requirements cascade to
achieve success
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Life Cycle
CPPDM Overview
Plan
Approved & Phase 0 Phase 1 Phase 2 Phase 3 Phase 4
Project
Started
PPAP/IPPAP,
Equipment, Tooling
Definition Complete & Design, Development, and Processes Ready, Project Close
Concept Developed / Design Feasibility Vehicle Integration and FPE Vehicles Built, Out and Make
Business Rationale Demonstrated Parts Authorized Approved to Launch Good
Business Business Rationale Business Project Plan Business Case Business Case After Action
Developed Case Complete Confirmation Confirmation Reviews
Developed
Resources
Initial Motorcycle
Assigned Systems, Sub-
Service Life Make vs. Buy Support
systems, and
Cycle Costs decisions & Information
Components are Make Good
sources
Qualified Regulatory Req’s Reports
selected
Base E.O. Complete &
Assigned Design Risk Documented
Assessment Product
(FMEAs) Validation
PPAP/IPPAP,
Equipment, Tooling
Definition Complete & Design, Development, and Processes Ready, Project Close
Concept Developed / Design Feasibility Vehicle Integration and FPE Vehicles Built, Out and Make
Business Rationale Demonstrated Parts Authorized Approved to Launch Good
Business
Product
Concept Verification Validation
Design
Process
Concept Verification Validation
Process
Plan & Define Section 1 RELIABILITY BY DESIGN
IDEA
APQP Tool Linkage
Opportunity Design & Development - Section II
Defined
GD & T
Process Design & Development - Section III
- Drawings
Form Team - Math Data Process Flow
- Timing Finalized
- Resources
f?
Prototype Control
DFMEA Special Characteristics
oo
DFMEA Plan Characteristic
Pr
Customer Matrix Pre - Launch
ke
Collect
sta
Wants/Needs/Desires Control Plan
Market Research
Mi
- QFD - Risk/Action
PFMEA YES
- Special Characteristics
- Manufacturing IF
- Assembly
- Current Controls Process Validation - Section IV
Priorities Develop Concepts Packaging
Input Design Test Plans NO
Design Actions Designs Process Trial
From Wants/Needs/ - Product Change - Design Verification
Special Run
5 Desires - Process
Controls Min 300 pcs/Hits/shots Validation
Process Validation Plan
- Failure Mode IF Testing
No - Gage Plan
Analysis Design Plan
- Capability Plan
- History Develop Product OK
Feasibility Instructions GR & R
- Past Performance Specifications
- Team Yes - Initial - Gage Plan Repeatability OK?
- Lessons Learned - Linked to Customers
Reproducibility
Process Development
- Gages
IF
- Controls NO
- Instructions YES
- Equipment Installation - Plans Can we change YES
Initial Process Kick Off Tools / Equipment Gages - Tooling Progress - Status of Open Issues process to IF
CAPABLE?
- Gage Design & Progress contain? NO
IF
NO
Concept
Initiation/Approval Design YES
Program Change Sample The Process
Approval Prototype Pilot Launch Back to II
Create Production - Source Warrants
Control Plan - Supporting Documentation
PLANNING PLANNING - Level of PPAP
- Reduced (n)
PRODUCT DESIGN AND DEV. - Reduced (f)
- Optimizing Characteristics
PRODUCTION
CONTROL PLANS
Phase
Progression
Systems / Sub-Systems /
Phase II Components
QFD
Customer
Wants
(Marketing
Information)
Product
Specifications System DFMEA
Sub-System DFMEA
Component DFMEA
Inputs
•Drawings •Boundary Diagram
•Warranty •P-Diagram
•FMA •Interface Matrix
SEAL
FACE
SHOULDER
SERATION DAMAGE
Matrix
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Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Severity
DFMEA
and Critical
0 Receive Material
81 Material handling
F
Characteristics from
Potential Significant
81 Shipping Damage
F
72 Component Manufacture
H
Y
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
relative to risk
FIXTURE
of process steps
Op 100 Step 2
Prioritized ranking
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
Op 100 Step 3
PRE-LOAD PRIMARY
0
HOUSING BUSHING TO
FIXTURE
Op 110
0 Pre-load bearing to fixture #2
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
Importance
Op 200
54
Characteristics
H
H
Housing to fixture #1
Op 210
Ranked in order of
261
F
F
F
F
Operate press
Op 220
3
G
Housing to fixture #2
Op 310
81
F
H
H
Operate press
Process Steps
Op 320
3
G
Housing to table
Op 410
0 Reserved
Primary Drive Manufacturing Process Steps
Op 420
45
F
Op 510
0
Clamp to shifter tube
Process Operation
Op 20
from Process Flow
0
Assemble shifter lever
0 Op 520
Wave washer to shifter lever
Op 530
0
causes/failure modes in
11
The Completed Characteristics Matrix
Phase III Process
System DFMEA
Sub-System DFMEA
QFD Operations
Component DFMEA
Phase IV
QFD
Process
Parameters /
High Priority Process Variables
Operations
S 9 Safety/Regulatory
E 8 SIGNIFICANT
V 7 CHARACTERISTICS
E 6 Customer Dissatisfaction
R 5
I 4 ANNOYANCE
T 3 ZONE
SC’s & CC’s
ALL OTHER CHARACTERISTICS
Y 2 Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
Process Related
SC’s & CC’s Failure Modes Causes on
From all DFMEA’s on PFMEA PFMEA Key Control
Characteristics
Process FMEA
Inputs
•Failure Data •Process Flow
Control Plan
•Process •Line Layout
Capability •MFMEA
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QFD Phase Progression 12
Potential Key Characteristic Development
Requirements Documents
•Regulatory
•Dimensional
•Cosmetic
Robustness Tools
Req. Spec. Document
Drawings Boundary Diagram
Warranty History P-Diagram Item / C O D Action Results
Process Potential Current Response &
Potential Potential S l c e R
Interface Matrix
Step Cause(s)/ Design Recommended Target
Failure Effect(s) of e a c Controls t P S O D R
Mechanism(s) Actions Complete Action
Mode Failure v s
Of Failure
u e N
Date Taken E C E P
Function
s r c V C T N
Prevent Detect
DFMEA
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
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Special
Sources
•Drawings
•Regulations
•DFMEA (Potential
Characteristics
Potential Critical and Significant
SEAL
FACE
KPCs: Significant and
SHOULDER
Critical Characteristics)
SERATION DAMAGE
Matrix
Relative Importance
Weighted Importance
DOWEL PINS 0.260 TO 0.270 " TO
Direction of Improvement
Special Characteristics
5
9
9
3
9
3
5
Severity
0 Receive Material
81 Material handling
F
81 Shipping Damage
F
72 Component Manufacture
Y
H
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
H
FIXTURE
Op 100 Step 2
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
IF
Op 100 Step 3
END
0 PRE-LOAD PRIMARY
HOUSING BUSHING TO
START
YES
FIXTURE
Op 110
0
OPERATION
OPERATION
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
54 Op 200
H
Housing to fixture #1
261 Op 210
H
F
F
F
F
Operate press
Process Flow
Op 220
3
G
0 Op 230
Reload fixture #1
54 Op 300
H
H
Housing to fixture #2
81 Op 310
F
Operate press
Process Steps
Op 320
3
G
0 Op 330
Mandrel to main shaft bore I.D.
0 OP 340
Operate press
0 Op 350
Re-load fixture #2 and mandrel
27 Op 400
Primary Drive Manufacturing Process Steps
Housing to table
0 Op 410
Reserved
Op 420
45
F
Op 430
9
G
9 Op 445
G
0 Op 10
O-ring to shifter tube
0 Op 500
Shifter tube to housing
0 Op 510
Clamp to shifter tube
Op 20
0
Assemble shifter lever
0 Op 520
Wave washer to shifter lever
Op 530
0
Shifter lever to shifter tube
0 Op 535
Que for final assy line
Customer
Assessment
14
Characteristics Matrix Development
Potential Critical and Significant
SEAL
FACE
SHOULDER
SERATION DAMAGE
Matrix
Sources
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Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Potential Significant and
Severity
0 Receive Material
81 Material handling
F
81 Shipping Damage
F
72 Component Manufacture
H
Y
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
relative to risk
FIXTURE
of process steps
Op 100 Step 2
Prioritized ranking
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
Op 100 Step 3
PRE-LOAD PRIMARY
0
HOUSING BUSHING TO
FIXTURE
Op 110
0 Pre-load bearing to fixture #2
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
Importance
Op 200
54
Characteristics
H
H
Housing to fixture #1
Op 210
Ranked in order of
261
F
F
F
F
H Operate press
Op 220
3
G
Housing to fixture #2
Op 310
81
F
H
H
Operate press
Process Steps
Op 320
3
G
Housing to table
Op 410
0 Reserved
Primary Drive Manufacturing Process Steps
Op 420
45
F
Op 510
0
Clamp to shifter tube
Process Operation
Op 20
from Process Flow
0
Assemble shifter lever
0 Op 520
Wave washer to shifter lever
Op 530
0
causes/failure modes in
15
Characteristics Matrix
FMEA Preparation Vertical Approach
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System/Subsystem/ Design FMEA
FUNCTION
(ANTI)
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System/Subsystem/ Design FMEA
Effect
Customer view/customers words
Regulation violation
Level of dissatisfaction
Consider All Customers
End User
Engineering Community
Manufacturing Community
(Operators/Employees)
Regulatory Body
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Severity Column
Severity
Column
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AUTOMOTIVE EXAMPLE SEVERITY EVALUATION CRITERIA
Hazardous- Very high severity ranking when a potential failure mode affects safe vehicle
without operation and/or involves noncompliance with government regulation without
10
warning
warning
Hazardous- Very high severity ranking when a potential failure mode affects safe vehicle
with operation and/or involves noncompliance with government regulation with warning
9
warning
Very High Vehicle/item inoperable (loss of primary function). 8
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most
Very Low customers (greater than 75%). 4
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of
Minor customers. 3
Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by
Very Minor discriminating customers (less than 25%). 2
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FMEA General
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Failure Mode/Cause Relationship
In Different FMEA Levels
Inadequate
Electrical
Connection
Failure
Cause Mode
Motor
Stops
Failure
Mode Inadequate
Electrical Connection
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Causes
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Occurrence Column
Occurrence
Column
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Occurrence Evaluation Criteria
*Note: Zero (0) rankings for Severity, Occurrence or Detection are not allowed
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Occurrence Rating
10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
ALL OTHER CHARACTERISTICS
Y 2
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
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Classification And Definition Column
C O D Action Results
Item Potential Response &
Potential Potential S l c Current e R. Recommended
Cause(s) / Target
Failure Effect(s) of e a c Design t P. Actions Actions S O D R.
Mechanism(s) Complete
Mode Failure v s u Controls e N. Taken e c e P.
of Failure Date
Function s r c v c t N.
Classification and
Definition Column
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Design Verification (Current Design Controls)
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Detection Rating
SUGGESTED DETECTION EVALATION CRITERIA
DETECTION CRITERIA RNK.
Design Control will not and/or cannot detect a potential cause/ mechanism and
Absolute
subsequent failure mode; or there is no 10
Uncertainty Design Control.
Very Remote chance the Design Control will detect a potential cause/mechanism and
Very Remote 9
subsequent failure mode.
Remote chance the Design Control will detect a potential cause/ mechanism and
Remote 8
subsequent failure mode.
Very Low chance the Design Control will detect a potential cause/mechanism and
Very Low 7
subsequent failure mode.
Low chance the Design Control will detect a potential cause/mechanism and
Low 6
subsequent failure mode.
Moderate chance the Design Control will detect a potential cause/ mechanism and
Moderate 5
subsequent failure mode.
Moderately Moderately High chance the Design Control will detect a potential cause/mechanism
4
High and subsequent failure mode.
High chance the Design Control will detect a potential cause/ mechanism and
High 3
subsequent failure mode.
Very High chance the Design Control will detect a potential cause/ mechanism and
Very High 2
subsequent failure mode.
Almost Design Controls will almost certainly detect a potential cause/ mechanism and
1
Certain subsequent failure mode.
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Analysis Of Risk
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RPN / Risk Priority Number
R
P
N
Failure Modes
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Evaluation by RPN Only
Case 1
S=5 O=5 D=2 RPN = 50
Case 2
S=3 O=3 D=6 RPN = 54
WHICH ONE
Case 3
S=2 O=10, D=10 = 200
IS WORSE?
Case 4
S=9 O=2 D=3 = 54
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Example
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Example of Significant/ Critical Threshold
10 POTENTIAL CRITICAL
9 CHARACTERISTICS Safety/Regulatory
S
E 8 POTENTIAL
V 7 SIGNIFICANT
E 6 CHARACTERISTICS
Customer Dissatisfaction
R 5
I 4 ANOYANCE
T 3 ZONE
ALL OTHER CHARACTERISTICS
Y 2
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
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Actions
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Actions
EXAMPLE:
Project: Date Of
Meeting:
Issue Issue Status/ Issue Action Action Action Person Resp. Completion
Number Open Date Champion Number Date Team Date
143
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Re-rating RPN After Actions Have Occurred
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Re-rating RPN After Actions Have Occurred
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FMEA & Requirement/Specification
Cascades for CPPDM
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V Model
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Voice of the Customer/Market
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Vehicle Requirements
Vehicle performance
and features with
measures are listed
Developed directly
from Voice of the
Customer/Market
Legacy
Engineering and styling
inputs
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Concept FMEA
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System Specifications
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System FMEA
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Example Boundary Diagram
Engine Mounting System
Engine Lubrication System Electrical System Evaporative Emissions
-breather System
Carburetor
External Shift Linkage
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Example P-Diagram
Noise Factors
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Example Interface Matrix
Halfshafts (2)
2 2 2 2 2
Power Conversion Unit
2
2 2 2 2 2 2 2 2 2 2
Motor / Gear Box
2 2
Park Mechanism Acuation
2 2
Halfshafts (2)
2 2
Mounting sub frame #1
2 2
Mounting sub frame #2
2 2
Mounting sub frame #3
2 2
PCU Signal Connector
2
2
Shield Motor Power leads
2 2 -2
High voltage power leads (positive)
-2
High voltage power leads (negative)
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System Verification Testing (DVP&R)
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Risk Strategy
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Sub-System FMEA
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Sub-System Verification Testing (DVP&R)
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Component Specifications
All component
specifications are cascaded
from the System
Specifications, the System
FMEA, and the Sub-System
FMEA
The component
specifications will be used
to determine, in conjunction
with the risk strategy from
the Sub-System FMEA,
which component FMEA’s
need to be completed.
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Risk Strategy
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Component FMEA
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Component Bench Testing (DVP&R)
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Risk Strategy
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Design Review
Phase
Progression
Systems / Sub-Systems /
Phase II Components
QFD
Customer
Wants
(Marketing
Information)
Product
Specifications System DFMEA
Sub-System DFMEA
Component DFMEA
Inputs
•Drawings •Boundary Diagram
•Warranty •P-Diagram
•FMA •Interface Matrix
SEAL
FACE
SHOULDER
SERATION DAMAGE
Matrix
www.quality-one.com
Relative Importance
DOWEL PINS 0.260 TO 0.270 " TO
Weighted Importance
BUSHING TO FACE OF JACK SHAFT
Special Characteristics
Direction of Improvement
5
9
9
3
9
3
5
Severity
DFMEA
and Critical
0 Receive Material
81 Material handling
F
Characteristics from
Potential Significant
81 Shipping Damage
F
72 Component Manufacture
H
Y
0 Vehicle Assembly
Op 100 Step 1
9 PRE-LOAD DOWEL PINS TO
relative to risk
FIXTURE
of process steps
Op 100 Step 2
Prioritized ranking
41 PRE-LOAD JACK SHAFT
G
G
SEAL TO FIXTURE
Op 100 Step 3
PRE-LOAD PRIMARY
0
HOUSING BUSHING TO
FIXTURE
Op 110
0 Pre-load bearing to fixture #2
Op 120
27 Pre-load main shaft oil seal to
H
mandrel
Importance
Op 200
54
Characteristics
H
H
Housing to fixture #1
Op 210
Ranked in order of
261
F
F
F
F
Operate press
Op 220
3
G
Housing to fixture #2
Op 310
81
F
H
H
Operate press
Process Steps
Op 320
3
G
Housing to table
Op 410
0 Reserved
Primary Drive Manufacturing Process Steps
Op 420
45
F
Op 510
0
Clamp to shifter tube
Process Operation
Op 20
from Process Flow
0
Assemble shifter lever
0 Op 520
Wave washer to shifter lever
Op 530
0
causes/failure modes in
63
The Completed Characteristics Matrix
Phase III Process
System DFMEA
Sub-System DFMEA
QFD Operations
Component DFMEA
Phase IV
QFD
Process
Parameters /
High Priority Process Variables
Operations
S 9 Safety/Regulatory
E 8 SIGNIFICANT
V 7 CHARACTERISTICS
E 6 Customer Dissatisfaction
R 5
I 4 ANNOYANCE
T 3 ZONE
SC’s & CC’s
ALL OTHER CHARACTERISTICS
Y 2 Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE
Process Related
SC’s & CC’s Failure Modes Causes on
From all DFMEA’s on PFMEA PFMEA Key Control
Characteristics
Process FMEA
Inputs
•Failure Data •Process Flow
Control Plan
•Process •Line Layout
Capability •MFMEA
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QFD Phase Progression 64
Summary
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Training and Facilitation
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