Design For Excellence Pocketguide

ACKNOWLEDGEMENTS
A team
team of
of Design
Design Excellence
Excellence Subject
Subject Matter
Matter Experts
Experts
within Johnson
Johnson&&Johnson,
Johnson,with
withsupport
supportfrom
fromoutoutside consultants,
consultants, developed the
this Design
Design Excellence
Excellence
pocket guide
guidefor
in 2003
for exclusive
use by&Johnson
exclusive
use by Johnson
Johnson&
Johnson
associates.
These
experts represented
associates.
These experts
represented
not only thenot
only
the different
groups
within
Johnson
different
company company
groups within
Johnson
& Johnson,
&
but also
different
focus areas
(product,
butJohnson,
also different
focus
areas (product,
process
and
process
and service
development).
In 2004,
service design
and development).
I would
likethe
to DEx
curriculum
with
new
and/orefforts
modified
acknowledgewas
the revised
passionate
and
dedicated
of
materials
to reflect
our
latest consultants
thinking. This
these individuals
and
outside
in version
of
the pocket
guide
reflects
changes
the
developing
this
pocket
guidethe
to enable
andtoimprove
course
material. I would
likeExcellence
to acknowledge
the implementation
of Design
within the
passionate
and dedicated efforts of these individuals
Johnson & Johnson:
and outside consultants in developing and improving
DEx course material
this
pocket
guide
Kentthe
Allen
EES, DExand
SME
Team
Leader
to enable and improve
successful implementation of
2000-2002
Design
Excellence atMD
Johnson
Bill Dean
& D & Johnson.
Vanessa Evans
CPC
Gregg
Alexander Pharm
JJPRD, USA
Doug Fraits
Ken
DePuy Codman, USA
John Creasy
Gilbert
CPC
Tracy
Flathmann
JJPRD,
Jerry Mergen
CP
& N USA
Barbara
M. Hansen JJPE,
CPC,World
USA Headquarters
Patrick Murphy
Carl
COIM,
USA
BarryLewis
Rhein
JJPE,
Assessment
Jeff
Ortho Clinical Diagnostics, USA
FilipMorris
Vanhoutte
Pharm
Barry Rhein
JJPE, USA
Helen
Venky Tai
Gopalaswamy,CPC,
Ph.DUSA
Filip
JJPRD,
JJPE, Vanhoutte
Methodologies and
DExBelgium
SME Team Leader
Venky Gopalaswamy, Ph.D
JJPE, Methodologies and DEx SME Team Leader
Johnson
2003
Johnson & Johnson 2005
INTRODUCTION
DEx Pocket Guide

Welcome
Design Excellence
Excellence (DEx)
(DEx) Pocket
Pocket
Welcome to the Design
Guide.
This guide
guide is
is designed
designed to support
support you
Guide. This
you durduring
implementation
of DEx
projects.
ing the the
implementation
of DEx
projects
andThis
not
pocket
guide
is not
meantortoguidance
replace training
or
meant to
replace
training
from Master
guidance
MasterMatter
Black Belts
or Subject
Black Beltsfrom
or Subject
Experts.
It is meant to
Matter
Experts.
It primary
is meantsources
to supplement
these
supplement
these
of DEx subject
sources
of information.
matter expertise.
Other supporting materials for
DEx is
deployment
include
off-the-shelf
software and
DEx
a set of design
tools
and methodologies
for
electronic
tool
templates,
information
for
which is
improving product/services/processes developprovided
with the course
material.
ment
to consistently
provide
reliable and manufacturable products/services/processes that
DEx is the disciplined
application
of tools and
consistently
meet customer
requirements.
This
methodologies
used
to
design
and
develop
guide highlights key tools used in the
phasesprodof the
ucts, methodology.
processes andItservices
that consistently
meet
DEx
is arranged
in the phases
of
or exceed
internaland
external
customer
requirethe
methodology
Define,
Measure,
Analyze,
2
ments. Verify/Validate
This guide highlights
key tools
used
in few
the
Design,
DMADV
. In the
next
phases
of
the
DEx
methodology.
It
is
arranged
pages, representations of the linkage between DExin
the phases
of New
the methodology
Define, (NPD
Measure,
roadmap
and
Product Development
/ 2
Analyze,
Design,
and
Verify/Validate
DMADV
Information System Development Life Cycle (SDLC).
In the
next few
pages,
of the linkage
are
provided.
Please
userepresentations
the one that is applicable
to
between
DEx roadmap and New Product
your
project.
Development (NPD/Information Systems
Development Life Cycle (SDLC) are provided. If an
existing NPD/SDLC roadmap in your company
supports your project please make sure you map
the DEx tools to appropriate design phases.
Otherwise, please use one of the applicable
roadmaps in this pocket guide.
Johnson
Johnson&& Johnson
Johnson 2003
2005
INTRODUCTION
There
XIIThere are
arealso
alsotwo
twotables
tablesprovided
providedononpages
pages
XIIXVIII,
XVIII, one
oneeach
eachfor
forNew
NewProduct
ProductDevelopment
Development
(NPD)
These
(NPD) and
andServices
Servicesand
andProcesses
Processes(S&P).
(S&P).
These
tables
the
DEx
tables include
includereferences
referencestotoDEx
DExtools
toolsand
and
the
DEx
phases
note
phases where
wherethey
theyare
aremostly
mostlyapplicable.
applicable.Please
Please
that
in these
are provided
only as
notethe
thatlinkages
the linkages
in tables
these tables
are provided
references
based onbased
common
practice. These
linkages
only as references
on common
practice.
can
be linkages
different can
depending
on thedepending
emphasis placed
These
be different
on the
on
specificplaced
tools within
your operating
company.
emphasis
on specific
tools within
your operating
company.
As you move through project implementation, call
on your Process Excellence (PE) leaders and
As you Black
move Belts
through
implementation,
Master
for project
assistance
and guidance.call
on
your
Process
Excellence
(PE)
leaders
and Master
The PE leaders role is to ensure successful
Black
Belts
for
assistance
and
guidance.
PE
identification and completion of projects The
employleaders
role
is to ensure successful
ing
the PE
methodology.
The role ofidentification
the Master
and completion
of projects
employing
the the
PE
Black
Belts is to coach
and guide
you with
methodology.
The
role
of
the
Master
Black
Belts is
correct use of tools and roadmaps to meet your
to coach and guide you with the correct use of tools
deliverables.
and roadmaps to meet your deliverables.
II
Johnson
2003
INTRODUCTION
INTRODUCTION
Representations of Design Excellence and NPD linkage in MD&D

Def ine
Measure
Concept
Planning
Concept
Strategy
DEx Charter
MGP
Gantt Chart
SIPOC
Market Research
Value Proposition
Affinity Diagram
Johnson
2003
Anal yz e
Development
Feasibility
Design
Feasibility
Market Research
QFD
Benchmarking
Structure Tree
Design Scorecards
MSA/Gage R&R
Process Capability
Statistical Analysis
Design for X
Design Scorecards
Brainstorming
Functional Diagram
Process Map
FMEA
Risk Analysis
Reliability Analysis
Pugh Matrix
III
III
V e rify /
Vali da te
Desi gn
Pre-Launch & Scale-Up
Implementation
DOE/Simulations
Design Scorecards
Functional Diagram/
Structure Tree
Fault Tree/Reliability
Analysis
Tolerancing
Robust Design
MSA/Gage R&R
QFD
Post-Launch
Mfg.
Implem.
Pilot
Development
DMAI IC
Control Charts
Base Business
INTRODUCTION
Global New Product Process (GNPP) + DEx
IV
Johnson
2003
INTRODUCTION
INTRODUCTION
Johnson
Johnson && Johnson
Johnson 2003
2005
INTRODUCTION
Objectives
Purpose
NPDP
Stage
M
cN eil Consumer
C onsum eand
r a nSpeciality
d Speci al tPharmaceuticals
y Pha rmaceu t i cal s
McNeil
Stage I
Des i g n
Analyze a specific
product/platform
opportunity for its
potential, strategic
assessment, and
preliminary financial
attractiveness as
efficiently as possible
Validate the refined

business concept
and business opportunity against prior
assumptions and to
develop an initial
project plan
Design the product

attributes, primary
packaging and manufacturing technology
Complete an
assumptionbased
business opportunity
Refine assumption
based business
proposition with
metrics
DEx Key Tools and Method
Bus ine ss
Fe as ibi l it y
C on ce pt
Idea Generation &

Evaluation
Multi-Generational
Plan
Voice of Customer
Charter
Risk Management
Voice of Customer
Market Research
Value Proposition
Quality Function
Deployment
(House 1)
Design Scorecards
Financial Analysis
Project Planning/Management
Metrics Analysis
Metrics
Dashboards
Risk management
Intellectual Property
Packaging Concept Generation &
Evaluation
Sta ge II
Deve lo p me nt
Develop a pre
commercialization
product, process and
package that delivers
design requirements
Finalize the commercial product, I. e.,

product, process,
claims and indications
Update business
proposition and project plan
Updated challenge
statements
Develop design
requirements
Updated business
proposition
Updated challenge
statements
Updated project
plan
Confirmation of
design requirements
Updated business
proposition
Updated challenge
statements
Updated project
plan
Confirmation of
design requirements
Updated business
proposition
Updated challenge
statements
Updated project
plan
Confirmation of
design requirements
Intellectual Property
Voice of Customer
Quality Function
Deployment
Design Scorecards
Critical Parameters
Process Mapping
Design for X
(Cleaning)
Risk Management
Tolerance D esign
Statistical (Clinical)
Planning & Analysis
DEx
De fine
Sta ge IIV
V
Stage
La uLaunch
n ch Re ad iness
Readiness
Sta ge III
III
Stage
Comme rc ializ aCommercialization
tion
Me as ure
(Clinical)
Process Mapping
Design Scorecards
and Critical Parameters
Design of Experiments
Process Capability
Analysis
Measurement System Analysis/Gage
R&R
Tolerance Design
FMEA
Design For Processing & Packaging
Lean Design
Process Control
Planning
Vertical Startup
Planning
Supply Chain
Business Qualification
An aly ze
Marketing Planning
Sales Planning
Process Capability
Analysis
Process Control
Planning
Process Mapping
Stability Analysis
Verification/Validation
Methods
Design of Experiments
Design Scorecards
and Critical Parameters
Reliability Centered
Maintenance
Engineering
Transfer
D es ign
Prepare the market,

achieve approval of
regulatory submission
and validate the
manufacturing process.
Sales Launch Planning

Dashboards
Process Control
Planning
Materials Management Planning
Process Validation
(PQ)
Engineering
Transfer
Ve rify an d
Val i d ate
VI
VI
Stag e V
La un ch
Stag e V I
Pos t Launc h
Launch the product.

Collect Lesson
Learned
Evaluate the performance of the

NPDP for the individual project
Monitor the inmarket performance
of the product on an
ongoing basis
Execute Launch
Process Control
Plans
Master Batch Record
Statistical Process
Control
Process Improvement Stra tegy

2
(DMAI C)
Process Capability
Design Scorecards
Operational Efficiency & Effectiv eness (OEE)
Collect qualitative
and quantitative
lessons learned on
NPDP for project
Track in-market
performance vs
launch metrics (3,
6, 12 month/ Year
1, 2, 3)
Process Control
Plans
Operational Efficiency & Effe ctiveness (OEE)
Statistical Pro cess
Control
Root Cause
2
Analysis (DMAI C)
Process Improvement Strat2
egy (DMAI C)
DM AI C
Johnson
2003
INTRODUCTION
INTRODUCTION
Johnson & Johnson

Johnson 2005
2003
VII
VII
INTRODUCTION
VIII
VIII

2003
Johnson
INTRODUCTION
Overview of Phases of DEx

I.
DEFINE Projects
II. MEASURE Requirements

II.1 Gather VOC and Competitive Information
II.2 From Needs to CTQs
II.3 Design Scorecards
Review of Measure Phase
III. ANALYZE Concepts
III.1 Concept Generation/Selection
III.2 Concept Feasibility
III.3 Do It By Design
Review of Analyze Phase
IV. DESIGN in Detail
IV.1 Work Out Detailed Designs
IV.2 Statistical Design
IV.3 Controlling the Process
IV.4 Pilots
Review of Design Phase
IX
INTRODUCTION
V.
VERIFY AND VALIDATE

V.1 Plan and Conduct Verification & Validation
Activities
V.2 Evaluate Results: Iterate Design
V.3 Scale Up and Launch
Review of V&V Phase

Define
Measure
No
Does the
process/
service
exist?
Yes
Measure
Design
No
Verify/
Validate
Innovate/
Improve
Is
incremental
improvement
enough?
Yes
Design Excellence
Analyze
Analyze
Six Sigma
Transfer
Control
INTRODUCTION
WHICH METHODOLOGY BEST FITS

YOUR NEEDS?
XI
INTRODUCTION
List of Tools Used in DEx for New Product

Development
Phase of NPD DMADV2 in
Tool Name
A ctiv ity flow charts

A ffinity d iag rams
A rrhe nius
Be nc hmark ing
Brainsto rming
Ce ntral co mp os ite d e sig ns
Charter
Co mmunicatio n p lan
Co nc e p t re view
Co njoint analys is
CTQ (Critical to Quality)
De p lo yme nt flow d iag rams
De sign fo r
manufacturability
De sign o f Ex p erime nts
De sign re v ie ws
De sign s co re card s
Effective team dynamics
XII
which tool is most

c
Chapter ommonl y used (Define,
Number Measure, Anal yze, Design,
and Veri fy & Val idate)
D M A D V2
Page
3/107
2/38
4/186

2/50
3/96
4/168
1/ 2
1/17

3/138
3/131
2/43
3/108
4/148
4/158
1/20
2/82
1/3

INTRODUCTION
Tool Name
Failure truncate d tes ts

Fault tree analys is
Flo w d iag rams
FM E A
Fo cus g roup s
Functio nal analys is
Gantt Charts
HALT
HASS
In/o ut-of-sc o pe To o l
Intervie ws
IP analys is
Kano analys is
Krus kal-Wallis Tes t
Lo s s func tio n
Mann-Whitne y Te s t
M E OS T

which tool is most
c
D M A D V2
Page
4/182

3/123
3/106
3/118
2/33
3/116
1/13

4/182
4/182
1/ 7
2/31
2/86
2/40

3/135
2/73
3/135
4/188

XIII
INTRODUCTION
Tool Name
Multi-g e ne ratio nal Plan

Mixture d e signs
Mo od 's me d ian te st
Ne two rk d iag rams
PERT c harts
Po ka-y o ke
Proc e ss co ntro l p lan
Proc e ss mo de l
Proje c t p lan
Proto ty p ing
Pugh matrix
QFD
Rapid ap p licatio n
d e ve lo p me nt (RA D)
Re liability te s ts
Re q uire me nts flow do wn
Ris k manage me nt
RSM
XIV

which tool is most
c
Page D M A D V 2
1/ 6
4/174

3/136

1/ 10
1/14
4/152

4/192

3/112

1/ 9
3/137

3/115

2/45

3/131
4/182
4/142
3/117
4/160

INTRODUCTION
Tool Name
So lution mapp ing

Stability testing
Stake ho ld e r analys is
Surv ey s
To tal life c yc le co s ts
TRIZ
Value stream mapping
V OC
Weib ull analys is
Work b reakd o wn struc ture
Worst case analysis

which tool is most
Chapter commonl y used (Define,
Page D M A D V 2
3/98
4/191
1/15
2/35
3/129
3/100
3/109
2/24
4/183
1/ 11
4/180

XV
INTRODUCTION
List of Tools Used in DEx for Service &

Process Development
Tool Name
A ctiv ity Flo w Charts

A ffinity Diag rams
Be nc hmark ing
Brainsto rming
Busines s Cas e
Co mmunicatio n Plan
Co njoint Analy sis
Co ntro l Charts
Deployment Flow Diagrams
De sign Re views
De sign Sc ore card s
Effective Team Dynamics
Fault Tre e Analys is
FM E A
Fo cus Gro up s
Functio nal A nalysis
Gantt Charts
In/Out-o f-Sco p e To ol
XVI
Phase of S&P DMADV2 i n

which tool i s most
c
Chapter ommonly used (Defi ne,
Number Measure, Analyze, Desi gn,
and Verify & Val idate)
D M A D V2
Page
3/107
2/38
2/50
3/ 96
1/2
1/17
3/131
4/194
3/108
1/20
2/ 82
1/3
3/123
3/118
2/ 33
3/ 116
1/13
1/7

INTRODUCTION
Tool Name
Inte rvie ws
Kano Analys is
Krusk al-Wallis Te s t
Lo ss Functio n
Mann-Whitney
Moo d 's Te st
Multi-Ge ne ratio nal Plan
Ne two rk Diag rams
Op p o rtunity Flow Diagrams
PERT Charts
Pro c es s Contro l Plans
Pro je ct Charte r
Pro je ct Plan
Pro to typ ing
Pug h Matrix
QFD (HOQ)
Re liab ility Te sts
Phase of S&P DMADV2 i n

whi ch tool i s most
Chapter commonly used (Defi ne,
Number Measure, Analyze, Desi gn,
and Verify & Vali date)
D M A D V2
Page
2/ 31
2/40
3/135
2/ 73
3/135
3/136
1/6
1/10

3/106
1/ 14
4/192
1/2
1/9

3/137
3/115
2/ 45
4/182

XVII
INTRODUCTION
Tool Name
Stake ho ld e r analys is
Surv ey s
To tal life c yc le co s ts
Value stream mapping
V OC
Weib ull analys is
Work b reakd o wn struc ture
XVIII
Phase of S&P DMADV2 in

which tool is most
Chapter commonl y used (Define,
Page D M A D V 2
1/15
2/35
3/129
3/109
2/24
4/183
1/11

CHAPTER ONE DEFINE
I. DEFINE Projects
Introduction
The main purpose of the DEFINE phase is to define

the project and the opportunity. This phase is where
management and the team define the objectives,
allocate and secure resources (people, money, and
equipment), creates a multi-generational plan, develops a project plan based on the scope, and assigns roles
and responsibilities. During the DEFINE phase, the
team also identifies stakeholders, evaluates their
support levels, and develops strategies to improve
support as well as creating a communication plan.
When the DEFINE phase activities are not done (or not
done well), the team may find themselves failing to
meet objectives later in the project and will ultimately
revisit this phase. This causes time delays, disillusioned teams, and generally threatens a projects
viability.
CHAPTER ONE DEFINE
Charter
The charter is a contract between the organizations
leadership and the team. Its purpose is:
To clarify what is expected of the team
To keep the team aligned with organizational
priorities
To transfer the project from the champion to
the team
To secure/commit team members and their
time
Elements of the charter:
Goal Statement
Process & Project Scope
Business Case
Opportunity Statement
Project Plan
Team Selection
The Goal Statement defines the deliverables of the
project, but does not specifically describe the
product/service/process that is yet to be developed.
The Process & Project Scope defines the boundaries
of the project. Two tools for defining scope for DEx
projects are: the In/Out-of-Scope Tool and MultiGenerational Plan (MGP).
The Business Case describes the benefit to the
business for undertaking this project. It connects the
project to key business strategies.
2
CHAPTER ONE DEFINE
The Opportunity Statement describes the benefit

to the customers, or the value added, that the new
product/service/process will deliver. This can be a
description of problems or challenges that customers
have which could be addressed by a new product/
service/process. Often key market or customer
segments are described here.
The Project Plan specifies the milestones and dates
for the steps and activities in the project. Since
projects can be complex, more attention is given to
project planning for these projects than is usually
necessary for sigma improvement projects.
The Team Selection describes team roles and
responsibilities. It is expected that the team and the
team members stay committed for the duration of
the project.
Effective Team Dynamics

A team is a group of people who are interdependent
working on a common goal. Teams are different
than work groups because members are interdependent on one another for task accomplishment. A
team typically:
1. has a specific business reason, objective, or
purpose for working together
2. needs each others expertise, ability, cooperation, and commitment to obtain mutual goals
CHAPTER ONE DEFINE
3. believes that working as a group leads to more

effective output than working alone
4. is accountable for results in a larger organizational context
Following are the characteristics of effective teams:
Common Purpose
Clear Roles and Responsibilities
Appropriate Procedures and Processes
Open Communication
Active Listening
Broad Participation and Contribution
Shared Leadership
Informal, Relaxed Atmosphere
Supportive, Cooperative Relationships
Confidence, Cohesion and Trust
Diversity and Disagreement Valued
Consensus Decision Making
Planning and Coordination
Follow Up and Ongoing Evaluation
There are many tools available to a team to ensure
that they perform effectively. Two of the key ones
will be highlighted in this section.
Personal Shield: During the early stages of team
formation, personal shield tool is used to effectively
identify and manage needs of all the individuals on
the team.
CHAPTER ONE DEFINE

Name:
What I Need To Be
Successful Here:
Unique Skills:
My Leadership Credo:
Something you don't

know about me:
Development
Needs:
Responsibility (RACI) Chart: When the team is

going through the storming phase, primary attention
shifts from what the team should do to how it should
be done. Team members can fight for control, and
many attempts are made to gain influence. Some or
all of the team challenges the leader, either overtly or
covertly. To manage the situation better, it is
important to define responsibilities using tools such
as RACI chart.
CHAPTER ONE DEFINE
Multi-Generation Plan (MGP)

The MGP helps communicate the step-wise fashion
the business expects to deliver the ultimate vision.
A series of releases/transitions which includes:
A long-term vision for the desired state,
product, service, or process
A series of generations, with short-term
results, moving toward that ultimate vision
Generation 1 Generation 2 Generation 3
V is io n
Pro d uct/
Se rvice Ge ne ratio n
Te chno lo g ie s/
Platfo rms
Vision Long-term direction for the product or

service based on anticipated evolution of customer
needs and competitor services beyond current
applications.
Product/Service Generation Series of service/
process releases; each release characterized by
distinct combinations of features or technology
(At least three generations planned).
Technologies/Platforms Service/process competencies which can be leveraged to introduce a number
of generations quickly, and to reduce cost of new
service/process development. Ability to execute
the MGP with current technology and identification
of needed technological developments including
platforms for each generation.
6
CHAPTER ONE DEFINE
In-and-Out-of-Scope Tool
Once the first generation has been described, it is
often useful to further define what is within the
scope of the first generation project. The In-and-Outof-Scope Tool can help this work.
Often the team and sponsor will have several
discussions about project scope. Using the In-andOut-of-Scope Tool can help both the team and
sponsor be clear about the boundaries of the first
generation product/service or process.
Brainstorm elements of the project
Write each element on a self-stick note
Draw a circle on a flipchart to indicate
project boundaries
Place the notes either inside or outside
the circles boundaries to show whether
the element is within the teams scope
or not
Review with the sponsor
CHAPTER ONE DEFINE
New functionality
Use current technology
Redefine jobs
New IS platform
IN SCOPE
US vs. Metric
Adding personnel
IN-AND-OUT-OF-SCOPE
CHAPTER ONE DEFINE
Project Planning Tools

Project plans often start with identifying key
milestones.
Milestones represent important decision
points.
The whole team should participate in defining and establishing dates for milestones.
There should be about 10-15 milestones.
Once milestones are defined, group them
into logical sequences.
Use tools such as GANTT Charts, Program
Evaluation and Review Technique (PERT)
Charts, or Network Diagrams to show the
relationship between milestones.
In order to estimate the target date for each milestone, the team needs to:
Estimate the tasks needed to reach each
milestone.
Estimate the actual work time required for
each task.
Estimate the resources available for each task.
Take into account factors such as vacations,
personal time off, overtime required, learning
curve, meetings, and time for consensus.
Understand the relationships between the
tasks needed to accomplish each milestone.
Use the above information to determine total duration time for each task and the overall project
timeline.
CHAPTER ONE DEFINE
Network Diagrams
Network Diagrams can be useful in helping the team
visualize the relationships between milestones.
PROJECT START
Result
Path
B
Result
Path
A
B1
Result
Path
C
C1
A1
B2
C2
B3
C3
A2
B4
10
PROJECT
OBJECTIVE
CHAPTER ONE DEFINE
Work Breakdown Structure

To help map out detailed tasks, an activity scheduler
should be used and take into consideration activities
such as:
Work activities
Control activities
Commitment activities
Communication activities
Evaluation activities
11
21/5
22
Activity/ Task Na me
Legend:
4
Quantify Res. Co mpass I
Identify Sys. Co mpa ss I
Quantify Res. Furies I

x
Identify Sys. Furie s I
T C
x
4
1
Angela
x
David
Yolanda
Describe Syste m Jade I
Clarify Opera tions
Translate English/Norwegian
No.
28/5
T C
Scheduled completion date
20
21
14/5
Describe Syste m Jade III
7/5
Describe Syste m Jade II
19
Named Functions/Named Persons
Leonard
Actual completion date
23/4
D Tak es decision solely

d Tak es decision jointly
P M anages progress
T Prov ides training on the job
C M ust be consulted
I M ust be informed
A Av ailable to adv ise
X Ex ecutes the w ork
Brian
30/4
Target Comp le tion: 30 Jun
Period Length: Two Days
Period
Period
Approved by: TH
Chart Issue s/Da te: A - 1

APR
Work C ont
Mile stone No./Name: 5T4 5V4
Frank
George
x
Alan
Activity Schedule
Lisa
12
Project: Jade
CHAPTER ONE DEFINE
ACTIVITY SCHEDULE

Simulatio n
8
9
me ntatio n
re me nt
11 De sig n Re vie w
10 Co st Analysis
De sig n Re vie w
De ve lo p De tails
lo p Hig h- e ve l De sig n
lo p Co nce p ts
Q' s
eds
sto me rs
Name
Qtr 4, 2000
Qtr 1, 2001
Qtr 2, 2001
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
CHAPTER ONE DEFINE
GANTT Charts
GANTT Charts are useful in summarizing the flow

of tasks across a timeline. Like the PERT chart, the
sequencing of tasks is identified.
13
CHAPTER ONE DEFINE
PERT Charts
Procurement
Cost Analysis
Simulation
Develop Details
Project
Start
ID
Customers
ID Needs
Develop
CTQs
Develop
Concepts
Review
Design
Review
Develop
High Level
Design
Design
Review
Implementation
PERT Charts display tasks and task dependencies

as a flowchart. A box (sometimes called a node)
represents each task and a line connecting two
boxes represents the dependency between the
two tasks. This tool helps to identify the sequence
or parallel tasks.
14
CHAPTER ONE DEFINE
Stakeholder Analysis
Stakeholder analysis is the proactive process of
identifying, understanding, supporting and influencing key individuals or groups to increase their
readiness to carry out organizational initiatives and,
thus, to facilitate the ultimate success of these
initiatives.
Stakeholder analysis is important because it can
help:
Gain buy-in and consensus required to make
implementation of improvement initiatives
successful;
Establish sponsorship and support networks,
and then leverage these as solutions are
implemented;
Lay the groundwork, if done early enough in
the project life cycle, for managing inevitable
resistance encountered during implementation;
Minimize the impact of resistance by preparing key stakeholders;
Understand the communication needs (email,
voicemail, meeting involvement, one-on-one
updates, etc.) of each stakeholder and develop
a communication plan (including frequency of
updates) to ensure each stakeholder is getting
the right amount of information during the
project.
15
CHAPTER ONE DEFINE
Names
Stongly
Against
Moderately
Against
Neutral
Moderately
Supportive
Strongly
Supportive
Steps:
1. Plot where individuals currently are with
regard to desired change ( = current).
2. Plot where individuals need to be (X = desired)
in order to successfully accomplish desired
change identify gaps between current and
desired.
3. Indicate how individuals are linked to each
other, draw lines to indicate an influence link
using an arrow ( ) to indicate who influences
whom.
4. Plan action steps for closing gaps.
EXAMPLE OF STAKEHOLDER ANALYSIS

16
CHAPTER ONE DEFINE
Communication Plan
A communication strategy or plan is a proactive
process of identifying, planning and delivering
strategic communications designed to address the
unique information needs of different audiences
(stakeholders). It is another means of building
commitment to change by increasing awareness and
providing relevant information.
The stakeholder analysis and communication plans
are iterative processes to be refined throughout the
project life.
17
CHAPTER ONE DEFINE
Project Risk
It is important to manage potential risks
during the project
At the end of each step, plan time to assess
potential risks to the projects success:
Identify potential problems
Determine the likelihood of their
occurrence
High
Yellow light:
Proceed with
caution
Medium
Yellow light:
Proceed with
caution
Yellow light:
Proceed with
caution
Red light:
Reassess
project
Low
Probability of Occurrence
Take steps to avoid or deal with the likely

problems
Green light
Yellow light:
Proceed with
caution
Red light:
Address before
proceeding
Red light:
Red light:
Address before Do not Proceed
proceeding
Impact on Project
18
CHAPTER ONE DEFINE
Review of Define Phase

At the end of the DEFINE Phase, the following are
in place:
Properly chartered project and business case
Plan for next generation products/process/
technology platforms
Project plans
Project risks are identified, assessed, and
addressed
Stakeholders are clearly defined and prioritized
Deliverables for the DEFINE Phase include:
Aligned team project charter
Multi-generational plan
Project milestone plan
Project risk assessment plus mitigation plan
Stakeholder assessment and communication
plan
Project risk analysis
19
CHAPTER ONE DEFINE
Design Review
The organization and independent reviewers
check and agree that Product/Service, Process,
and Supply chain are ready for rollout. The review
team agrees on the Launch strategy. Where applicable within Johnson & Johnson, a decision about
readiness to file to regulatory bodies must also be
made. Typically, while the regulatory authorities
review the file, the product/service/process team
gets ready for launch.
Design Reviews
A design review is a process for objectively
evaluating the quality of a design at various
stages of the design process.
It provides the opportunity for voices external to
the design team, including customers, to provide
feedback on the design, as the product and service
is being developed.
A well-conducted design review helps to ensure
that the design will satisfy customers, and that the
design process will function effectively to produce
a high quality product or service. Design Reviews
should focus on both effectiveness and efficiency
of the design process. This will ensure that customer requirements are well addressed without
leading to any potential cost-related conflicts.
20
CHAPTER ONE DEFINE
Formal design reviews: These are reviews for

which companies have well-established procedures that are part of the project plan for every
project. They involve external (to the organization,
company, or design team depending on the
circumstances) feedback, the results of which are
consistently and systematically reported in the
design documentation.
Informal design reviews: These are typically
internal reviews conducted regularly or as needed
to ensure that the project is on target and to
resolve specific technical and coordination issues.
Design reviews need to be conducted at each
stage of the design process. The rule of thumb is to
organize a design review whenever external
feedback appears appropriate or when there are
coordination issues. (Also, the design review
process is cyclic, and multiple design reviews may
be needed at each stage of the design process.)
21
CHAPTER ONE DEFINE
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22
CHAPTER TWO MEASURE
II. MEASURE Requirements

Introduction
The MEASURE Phase includes:

Identifying quantified requirements to provide
the team the goals they will shoot for to
produce a competitive product, service, or
process.
Identifying Critical-to-Quality Requirements
(CTQs) that are most important to achieve in
the design.
Ensuring these requirements are linked to
customer needs and in tune with the competitive environment.
Creating scorecards to ensure that CTQs are
attained during further development.
23
CHAPTER TWO MEASURE
II.1 Gather Voice of the Customer (VOC)

and Competitive Information
Voice of the Customer
Voice of the customer, the foundation for projects
success, is used to identify and quantify customers needs
and their perception of your product or service. The
VOC is critical to an organization to identify and
quantify:
Which products and services to offer
Critical features and specifications for products
and services
Baseline measures of customer satisfaction
Key drivers of customer satisfaction
IDENTIFYING CUSTOMERS
Identify external and internal customers (SIPOC)
Customers should be segmented or grouped
according to their similar needs for products/
services/processes
Businesses should focus products/services/
processes on the customer segment(s) they have
chosen to achieve their business strategies
Businesses should choose their customer segments
based upon the businesses capability to serve
existing customer needs profitably today, tomorrow, and in the future, as well as upon the businesses ability to develop the capability to serve
potential/new customer needs
24
CHAPTER TWO MEASURE
1.
Identify
customers
and
determine
what you
need to know
2.
Collect and
analyze
reactive
system data
then fill gaps
with
proactive
approaches
3.
Analyze
data to
generate a
key list of
customer
needs in
their
language
Often a design team will focus only on the ultimate customer of the process or service. Some
broader customer groups to consider include:
Government
Regulatory agencies
Internal departments
Intermediary external customers
The design teams composition should include
representatives (or permanent members or guests) of
internal departments who are stakeholders (e.g.,
human resources, legal, etc.).
25
CHAPTER TWO MEASURE
Descriptive
Geographic
Demographic
Service Feature
Channel
Attitudinal
Price
Value
Service
Other
Co-op
F
Franchise
Sole
proprietor
Private
ely
held
Publicly
ublicly
held
REVENUE
Price
Service
Number of Customers
Economic
Frequency
Size of Customer
Cost
Revenue
Month
PRICE & SERVICE
WAYS TO SEGMENT CUSTOMERS
26
CHAPTER TWO MEASURE
Your process or service is viewed by the customer

from many different angles.
1.
Identify
customers
and
determine
what you
need to know
2.
Collect and
analyze
reactive
system data
then fill gaps
with
proactive
approaches
3.
Analyze
data to
generate a
key list of
customer
needs in
their
language
There are two basic types of VOC systems, Reactive

Systems (Information comes to you whether you take
action or notinitiated by customer in the form of
complaints, returns, sales, etc.) and Proactive
Systems (You need to put effort into gathering the
informationinitiated by the business in form of
customer surveys and market research).
Existing or readily available customer information is
often mistakenly overlooked. We have a responsibility to our customers to first understand, analyze and
act on the information they have already been
providing before we solicit more information from
them. This existing information is often called a
Reactive VOC since it comes unsolicited from the
27
CHAPTER TWO MEASURE
customer. By studying the reactive data along with

already existing research we can optimize our time
with the customer.
Consider these components or dimensions of
quality in planning the type of customer information you will need to gather as part of customer
research.
QUALITY
Focus on the benefits, functions/use

provided by the product/service/process
COST
Focus on how much the benefits cost

the customer
DELIVERY
Focus on the timeliness or quantity of

the benefits
SERVICE/
SAFETY
Focus on after sales service, not

injuring the customer
CORPORATE
RESPONSIBILITY
Focus on legal, regulatory, or

environmental needs
Additional sources of relevant customer/industry

information are likely available. Some possible
information you may have can be found on the next
page.
28
Listening Tool

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Note: The P or R designation indicates the primary use of the tool.
Suitable for Listening to:

Individuals Small Group Large Group
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
R = Reactive Tool, i.e., the information comes to you whether you take action or not
X
X
X
X
X
X
Quantitative
Type of Information
Qualitative
X
X
P = Proactive Tool, i.e., you initiate the information request
Call Ce nte r/Se rv ic e Ce nte r Mo nito ring (R)

Cas ual Co ntac ts (R)
Co njo int Me s ure me nt (P)
Co nv e ntio ns and Trad e Sho ws (R)
Critic al Inc id e nt Ev aluatio n (R)
Cus to me r Pane ls (P)
Cus to me r Se rv ic e Aud it (R)
Fo c us Gro up s (P)
Inb o und Co mmunic atio n Mo nito ring (R)
Inte rac tiv e Re s e arc h (P)
Inte rv ie ws (P)
My s te ry Sho p p e r Aud its (P)
Ob s e rv atio n Re s e arc h: Co ntro lle d Env iro nme nt (P)
Ob s e rv atio n Re s e arc h: Natural Env iro nme nt (P)
Outb o und Co mmunic atio ns Mo nito ring (R)
Pro d uc t/Se rv ic e Re g is tratio ns (R)
Se g me nt Pane ls (P)
Se ns itiv ity Me as ure me nt (P)
Se rv ic e Cy c le Wo rk s ho p s (P)
Surv e y s - Auto mate d Te le p ho ne Callb ac k (P)
Surv e y s - Gro up Se s s io ns (P)
Surv e y s - In-p e rs o n Inte rv ie ws (P)
Surv e y s - Mail (P)
Surv e y s - Po int o f Sale /Se rv ic e (P)
Surv e y s - Te le p ho ne (P)
Value Re s e arc h (P)
CHAPTER TWO MEASURE
ADDITIONAL SOURCES OF INFORMATION
29
CHAPTER TWO MEASURE
Three most common methods for gathering proactive

customer data are interviews, focus groups, and
surveys. In most cases, tools need to be used in
combination.
Tools, used in combination, move you from one
level of certainty to the next.
Telephone
interviews to
identify baseline
issues and
opinions
Focus groups to
obtain deeper
understanding
Survey to verify
and quantify
All tools need to move you towards greater
certainty - uncertain
certain
more certain. The
issues for selection include:
How much certainty do you need?
How much certainty can you afford?
How much uncertainty can you risk?
30
CHAPTER TWO MEASURE
Interviews
Purposes of using interviews are to learn about a
specific customers point of view on issues, attributes, and performance indicators/measures.
The different types of interviews are:
Types of
Intervi ews
Characteristics of Informati on Needed
Ind iv idual
Uniq ue p e rs p ec tive s
Se nio r-le v e l p articip ation
Inp ut fro m larg e-vo lume c us to me r
Group
Info rmati on from c us to mers with s imilar

s e rvi ce nee d s
Mid - to lo we r-le v el p articip ati on
Info rmati on from many p eo p le from a
s ing le s e gme nt
Te lep hone /
mail
Inp ut fro m custo me rs who are wi de ly

d is pe rse d g e og rap hic all y
Info rmati on o n basic o r simp le iss ue s
Quic k turnaro und of info rmatio n c o lle ctio n
Advantages:
Flexibility: Able to obtain more detailed
explanations; can probe and clarify
Greater complexity: Able to administer
highly complex questionnaires/surveys; can
explain questions to interviewee
31
CHAPTER TWO MEASURE
Able to reach all population types: Able to

interview populations that are difficult or
impossible to reach by other methods
High response rate: Degree to which
information collection process reaches all
targets is higher
Assurance that instructions are followed
Disadvantages:
High cost: Process of administering is costly
Interviewer bias: The least reliable form of
data collection the interviewer may
influence the responses to the questionnaire
Less anonymity
Limit to 15-20 minutes (business-to-business
45-50 minutes)
Difficult to analyze or to generate supportable
quantitative evidence
Sample size may not be sufficient to draw
supportable conclusions
Positive response bias (people give higher
ratings in personal interviews)
TIP:
Interviews are generally used to gather
qualitative information. If your need is for
quantitative data, gather information through
well-designed surveys.
32
CHAPTER TWO MEASURE
Focus Groups
Focus groups, lead by a moderator, are typically
composed of 7 to 13 participants who share characteristics that relate to the focus group topic. A
minimum of three focus groups are conducted asking
participants to thoroughly discuss a limited number
of topics and are two to four hours in duration.
Use Focus Groups When:
You need to make or confirm market segmentation decisions
Hypotheses about the market and customer
values need to be developed or tested in
exploratory or preliminary studies
A communication gap appears to exist between
your company and the market segment
Insight is needed into complicated topics
where opinions and attitudes are conditional
Synergy among individuals would be useful in
creating ideas
Hypotheses need to be developed in preparation for a broad survey or large scale study
A higher value is placed on capturing openended comments than data from the target
audience
Do Not Use Focus Groups When:
The environment is emotionally charged and
more information of any type is likely to
intensify the conflict
33
CHAPTER TWO MEASURE
Highly valid quantitative data is needed

Other methodologies can produce either better
quality or more economical information
Selling services
Steps for conducting a focus group include:
1. Plan the focus group session:
Determine why you are conducting the study
Determine who the participants should be
Write the research questions keep the list
short
Draft the structure and flow of the session
Select focus group location and schedule
groups
Develop a plan and estimate resources needed
Test the questions
Finalize the questions and the flow of the
session
2. Lead the focus group
3. Analyze the focus group findings
34
CHAPTER TWO MEASURE
Surveys
Surveys are used to measure the importance and
satisfaction/perception of performance against an
attribute or customer characteristic. Some of the
different types of surveys are listed in the table on
the following page.
The wording and question format must be chosen
with care. Wording of the questions should:
Use simple words
Avoid ambiguous words or questions
Avoid biased or leading questions
Avoid generalizations and estimates
Avoid double-barreled questions
Types of question formats include:
open-ended questions
multichotomous (fixed alternative) questions
dichotomous questions (Yes or No)
scales
matrix
The order in which questions are presented can be
crucial to the success of the data collection effort and
therefore, the success of the benchmarking effort.
The questionnaire should have a logical order.
Sudden changes in topics or jumping around
from topic to topic should be avoided. The
general order of issues in the questionnaire
should mimic the outline of the final report.
35
CHAPTER TWO MEASURE
Use simple, interesting, and nonthreatening

opening questions. The first few questions
may determine whether respondents decide if
they will even participate in the study. If
respondents cannot answer the first questions
easily or find them threatening in any way,
they may refuse to look at the rest of the
questionnaire.
Use the funnel approach. The funnel approach
starts with broad questions and progressively
narrows down the scope as necessary.
Design branching questions with care.
Branching questions direct respondents to
different places in the questionnaire based on
their response to the question at hand. (For
example If you answered no, go to question
17.) These types of questions are more
effective in a telephone or in-person interview
as they may appear cumbersome or confusing
to those responding via the mail.
Ask for classification information last.
Place difficult or sensitive questions throughout the questionnaire. Involvement lessens the
probability of negative actions.
It is useful to first pilot the survey with a group of
people who are not part of the project. Their feedback provides important information on the clarity
of the questions as well as the delivery mode.
36

No ne
Lo ng
Lo w
Hig h
Interviewer bias
Acceptable length of
survey
Ability to obtain openended responses

Perceived anonymity
Lo w
Hig h
Lo w
Me d ium
Sho rt
(max imum
15
minute s )
Lo w
No ne
Mo d e rate
Me d ium
Mo d e rate
Phone
Automated
Call Back
Mo d e rate
Hig h
Lo w
Mo d e rate
Phone
Interview
Lo w
Hig h
Me d ium to
Lo ng
Hig h
Hig h
Hig h
Hig h
Interviewer
Administered
DIFFERENT TYPES OF SURVEYS AND THEIR EFFECTIVENESS
Mo d e rate
Hig h
Time required to collect

data
Response data
Lo w
Mail
Data collection costs
Characteristic
Mo d e rate
Hig h
Lo ng
Lo w
Hig h
Me d ium
Mo d e rate
Group
Sessions
Written
No ne
Me d ium
Sho rt
(5 - 10
minute s )
No ne
Hig h
Lo w
Lo w
Electronic
CHAPTER TWO MEASURE
37
CHAPTER TWO MEASURE
Affinity Diagrams
An affinity diagram is a good tool to organize
language data into related groups. Unlike other data
tools, the creation of an affinity diagram stresses
creative or intuitive thinking more than logical
thinking.
The affinity diagram is used when analyzing
qualitative customer data, dealing with complex
problems or issues or organizing ideas, issues, and
opinions.
1. Gather ideas from interview transcripts, surveys,
etc.
Read through your customer notes
Highlight statements you think are related to
customer needs
The need statements used for an affinity
diagram should be in the customers own
language if at all possible
2. Transfer data onto index cards or self-stick notes
Transcribe the strongest of these statements to
cards or self-stick notes you can use for the
affinity diagram
One sentence per card
Try to identify positive statements turn I
dont want X into I want Y
3. Group the cards to find the affinity
Shuffle the cards and lay them out, or randomly place self-stick notes on flipchart
38
CHAPTER TWO MEASURE

CHAPTER TWO MEASURE
Statements written on
individual cards or notes
Notes are clustered

based on intuition, not
logic
Theme 1
Need 1
Theme 3
Need 2
Title notes identify

themes
Need 6
Theme 2
Need 3
Need 4
Need 5
OK to have
clusters of
one note
Need 7
Can be several
layers of
clustering
Read each card or note slowly two or three

times to yourself
Group cards that seem to fit together
~ similar based on feeling and pre-logic
(right brain sorting)
~ let the cards group themselves
4. Label the groups of cards
5. Optional: group the clusters
6. Draw the diagram
The data can now be taken into a structure tree
or CTQ Tree
39
CHAPTER TWO MEASURE
Kano Analysis
Method of understanding that product/service/
process characteristics relate to different types of
customer needs. This model of quality was developed by Dr. Noriaki Kano, one of the most prominent figures in Japans quality movement. He
outlines three basic types of customer reactions to
quality features or characteristics.
Must-Be: For any process or product/service,
certain features or characteristics must be
present or the customer will be frustrated or
angry. For instance, when you buy a shirt, you
expect it to have all its buttons. As indicated by
the line on the diagram, the absence of a MustBe feature will disappoint or anger us, but its
presence can only bring us up to neutral.
More is Better: Customers view other features
or characteristics as more is better. A small,
skimpy towel in a hotel room might be
disappointing, while a larger, luxurious towel
might be delightful. However, there are
usually limits. For instance, wed have trouble
using a towel the size of a bedspread.
Delighters: Special features or characteristics
that the customer doesnt expect, but finds
useful when present, are called delighters.
The more unexpected and more useful a
feature, the more likely it is to create true
delight. Finding a coffee maker and cable TV
40
CHAPTER TWO MEASURE
with free movie channels in a budget hotel

room, for instance, might delight us.
Customer perceptions are a moving target. Something that starts off as a Delighter can soon become a
Must-Be (such as remote controls for TVs and VCRs).
TIPS
Customers generally only mention More is
Better issues.
Must-Bes are generally more important to
them, even though they are taken for granted.
Do not omit these Must-Bes from the design.
The importance of Delighters is generally
guessed at based on expert knowledge from
the marketplace, since customers seldom
mention needs they dont know can be
fulfilled.
Dont expect that you will get Must-Bes from
the regular VOC. Must-Bes are generally
unspoken and need to be uncovered through
special research, i.e., complaint data, regulations, etc.
Use for trade-offs, prioritization.
Focus first on the must-bes and, more
importantly more is better
41
CHAPTER TWO MEASURE
KANO ANALYSIS
Customer Satisfaction
Delight
Delighters
Resigned
to Reality
Neutral
or
M
Not
Pleased
Pleased
Is
Be
tte
Must Be
Taken for
Granted
Dissatisfaction
Absent
Fulfilled
Degree of
Achievement
42
CHAPTER TWO MEASURE
1.
Identify
customers
and
determine
what you
need to know
2.
Collect and
analyze
reactive
system data
then fill gaps
with
proactive
approaches
3.
Analyze
data to
generate a
key list of
customer
needs in
their
language
IDENTIFY KEY CUSTOMER ISSUES

1. Group similar and common statements
received from customers. Select or adjust
comments from each group to form a single
statement which best represents the VOC.
2. Based on clarification gathered through
VOC, state the key customer issue (concerns, values or expectations) associated
with each VOC statement.
3. Clarify, in measurable and specific terms, the
customer requirement(s) associated with the
key customer issues.
4. In gathering the VOC, steer customers away
from solutions; keep them focused on needs
and wants. This will prevent the design team
from prematurely locking into one or two
ideas.
CTQ (Critical to Quality)

A design CTQ is a quantifiable (and measurable)
characteristic of the product/process/service for
which targets, allowable variation, and allowable
defect rates (sigma levels) can be established.
43
44
Voice of the Customer
CTQ TREE
This package doesnt do squat

squat.
squat
I want
want to talk to the right person
person and
dont w ant to wait on hold too long.
This mower should

should be easy to start.
start
The cord shouldnt be too hard to
pull.
pull.
Actual customer statements and

comments whic h reflect their
perception of:
of:
An attribute of a process or
service
An experience with a process of
or
service or its delivery
An encounter or experience w ith a
business processes
process or or
representativ e
Key Customer Issue
The softw are does what the vendor

said it w ould do.
Wants to talk to the right person

quickly .
Wants the mower to start quickly and

painlessly .
The real customer concerns, values

or expectations regarding a product
or service. Void of emotion or bias,
the statement describes the prim ary
issue a customer may have with the
product or service.
services. Describes
Describesthe
the
ex perience surrounding the attributes
of the product or service expected or
desired by the customer.
Critical to Quality Requirement
Ev ery design feature needed is

built into the package
The softw are is fully operational
on the customers ex is ting system
Customer reaches
Customer
reachescorrect
correctperson
person
the first
first time
time wwithin
ithin 30
the
30seconds
seconds
(good)
(good)
Add additional
additional menu
Add
menuitems
itemstotothe
the
voice
(bad)
voic e system
system (bad)
Mower starts w ithin tw o pulls on

the cord
Mower starts w ith an effortless
pull on the cord not exceeding 24
in length
The specific, precise and measurable

characteris tic of the process or serv ic e
CHAPTER TWO MEASURE
CHAPTER TWO MEASURE
II.2 From Needs to CTQs

Quality Function Deployment (QFD)
QFD is a tool to effectively translate customer
needs and competitive information into a prioritized list of critical to quality design measures with
competitive targets and specifications. The QFD
process involves constructing one or more
matrices (sometimes referred to as Houses of
Quality (HOQ).
HOUSE OF QUALITY (HOQ)

The House of Quality (HOQ) is a graphical depiction
of the logic flow from identifying customer needs to
the complete detailed development of actions to
ensure customer satisfaction. It is also based on
benchmarking work to understand key competitive
measures, specification, and relative performance
among the competition.
The HOQ organizes information into various
rooms. The HOQ displays the customers wants
and needs (the Voice of the Customer) along the
left, and the development teams technical response to meeting those wants and needs along
the top. The matrix consists of several sections or
submatrices joined together in various ways, each
containing information related to the others.
45
CHAPTER TWO MEASURE
THE HOUSE OF QUALITY
7
Correlation (I)
Target goals
Characteristics/Measures (How)(I)
1
6
5
Relationships
(What vs. How)
(I)
Importance (V)
Customer
Needs
(V)
Customer
Rating
(B) (V)
How important
Targets/Specs (B)(I)
Technical Evaluation (B)
(V) = Comes from VOC Information

(B) = Comes from Benchmarking Information
(I) = Comes from Internal Expertise
46
CHAPTER TWO MEASURE
ROOM 1 CUSTOMER NEEDS (WHAT)

Room 1 contains a structured list of customer wants
and needs. The structure is determined by research
(proactive and reactive VOC tools).
The sorted needs are then placed in Room 1 utilizing
a structure tree or CTQ tree. (See reference to CTQ)
The outptut for Room 1 is a detailed list of customer
needs.
Customer
Needs
47
48
The re s ult o f trans lating the c us to me r
re q uire me nts to CTQs .
Re latio ns hip o f id e ntifie d CTQs to c us to me r Inte rnal Ex p e rtis e
re q uire me nts .
Co mp aris o n ag ains t c o mp e tito rs .
What p e rfo rmanc e is re q uire d to me e t o r
e x c e e d c us to me r re q uire me nts .
The c o rre latio n b e twe e n the me as ure s .
3 Charac te ris tic s /Me as ure s
4 Re latio ns hip s
5 Te c hnic al Evaluatio n
6 Targ e ts /Sp e c ific atio ns
7 Co rre latio n
Inte rnal Ex p e rtis e
Be nc hmarking
Be nc hmarking
Cus to me r ranking o f re q uire me nts and ho w Be nc hmarking

the y p e rc e ive the p e rfo rmanc e o f o ur
Vo ic e o f the Cus to me r
c urre nt p ro d uc t and that o f main c o mp e tito rs .
2 Cus to me r Rating
Where does this

information come
from?
Vo ic e o f the Cus to me r
De taile d c us to me r ne e d s .
What's In It?
1 Cus to me r Ne e d s
Room
CHAPTER TWO MEASURE
THE HOUSE OF QUALITY ROOMS
CHAPTER TWO MEASURE
Importance
ROOM 2 CUSTOMER RATING
Customer
Rating
Objectives for completion of Room 2:

Determine customer importance rating and
customer competitive review
Establish rating scale (1 to 5 scale is typical
with 5 the highest). The high number in the
scale should represent best-in-class
The ratings come from the quantitative VOC
Define how your organization is perceived
compared to the best of the competition
Review of competitive product performance from
benchmarking study
Compare at least two competitors (best of the
competition) performance to customer wants
and needs
Rate organizations performance to customer
wants and needs
49
CHAPTER TWO MEASURE
Benchmarking
In Measure, you may benchmark for technical
comparisons to see how well competitors meet
customer requirements (Rooms 2 and 5 of the House
of Quality).
In Analyze, you may benchmark for best practices
to see how organizations provide their products/
services or perform their processes.
Benchmarking is not just copying what another
organization is doing. Benchmarking requires deep
understanding of how and why a product or service
works and what enables the benchmarked organization to consistently perform at world class levels.
Teams can benchmark with another part of its
organization, an organization similar to theirs, or an
organization quite different from theirs.
Two types of benchmarking are:
Performance: To Assist in Assessing Business
Competitive Position
Process: To Focus on Best Work Processes
and Operating Systems
50
CHAPTER TWO MEASURE
BENCHMARKING METHODOLOGY
Plan
Measure
Learn
Apply
These are the phases of the benchmarking process.

These phases serve as the framework for this
section.
Many of the steps are executed in overlapping
phases. During the planning phase, consider any
potential legal issues associated with benchmarking
before conducting the study.
1. In the Plan Phase, existing data may be
reviewed as a preliminary step to establishing
the baseline. Identify benchmarking study
boundaries such as who, what budget, how
much time, any legal considerations and
areas of focus.
Conduct preliminary research to identify
possible measures and performance levels,
best practices and to find other sources of
information. Determine which method(s) to
use, e.g., internal/company, direct competition, industry, or best-in-class.
2. The Measure Phase is when the team
establishes the baseline, researches and
selects benchmarking partners, drafts the
questionnaires, collects preliminary research
and data and identifies best practice leaders.
51
CHAPTER TWO MEASURE
3. The Learn Phase consists of collecting data

and interpreting the information. Part of
analyzing results includes correlating process
to performance and understanding critical to
process variables.
4. The Apply Phase consists of listing the
interpretations you have made regarding:
Desired design measures (CTQs) and their
corresponding specifications
Information about the performance,
features, customer satisfaction, or competitors for your proposed design
Design concept ideas that may be useful in
Analyze
52
CHAPTER TWO MEASURE
In the Measure phase:

Benchmark from like (same industry) and
unlike (different industry) organizations to
determine best-in-class measures and specifications
Benchmark from like organizations to compare
performance, features, and relative customer
satisfaction
In the upcoming Analyze phase:
Benchmark from like and unlike organizations
to borrow concepts that might be of use when
developing process/product/service concepts
TIPS to Complete Room 2:

The customer should be the primary source for
determining the importance of a need
Choice of competitors should be market leader
or most distinguished organizations, your
direct competitors
The customer provides perceptions of competitors effectiveness in satisfying needs
The highest rating on the scale is typically
reserved for how the perfect product
performs
The output for Room 2 is the customers ranking of
requirements and how they rate the performance of
suppliers.
53
54
Short distance to carry
luggage
Help with luggage
HOTEL CHECK-IN EXAMPLE
Provide directions &

advice - local
Provide information Hotel Services
Resolve problems quickly
5
4
Provide packages &

messages upon arrrival
Clerk should be friendly
5
3
Get the room I reserved
Get my room key quickly
COMPLETED EXAMPLE: ROOMS 1 AND 2
My "Stuff"
Information
Check-in
Experience
The "Right" Room
Competition Comparison
Import: 1
2
3
4
5
My Hotel Motel Six Sigma Holiday Out
Key:
CHAPTER TWO MEASURE
CHAPTER TWO MEASURE
ROOM 3 CHARACTERISTICS AND MEASURES (HOW)

Translate customer wants and needs to product/
service/process characteristics and measures (CTQs).
Generate many possible ideas so the most important
ones can be selected to shape the requirements.
55
CHAPTER TWO MEASURE
METHODS
Use your knowledge of the process/product to
identify characteristics and associated measures.
Use benchmarking information to list how
processes are commonly measured in like and
unlike industries.
Use VOC information by asking, How might
you measure if this need was being met?
Also list existing measures currently in use for
similar designs.
Generally, there is an m-to-n relationship
between customer needs and CTQs.
TYPE
EXAMPLE
11
Customer Need is to arrive at a

destination at a given time.
CTQ is on-time arrival of airplane.
1Many
Customer Need is friendly service.

CTQs include greeting customer by
name, smiling, eye contact, tone of
voice, etc.
ManyMany
Customer Needs are resistance to

abrasion, ability to flex on impact,
ability to accept coating, resistance
to corrosion, etc.
CTQs include material hardness,
tensile strength, and surface
characteristics.
56
CHAPTER TWO MEASURE

Service
Tertiary Need
CTQ
Secondary Need
CTQ
Primary Need
CTQ
CTQ
PRODUCT AND PROCESS CTQs RESPOND TO NEEDS IN A

MANY-TO-MANY (m-to-n) MANNER
The CTQ Must Be Important:
Does this CTQ relate to the achievement of one
or more customer needs?
If this CTQ showed improvement, does this
imply significant improvement in the performance of the product/service?
Would the customer willingly pay you to
collect and analyze the data on this CTQ?
The CTQ Must Be Easy To Understand:
Have you used and retained raw values
rather than dollarized figures, values beyond
some limit, percentages, or other ratios?
57
CHAPTER TWO MEASURE
Does the CTQ have a target or an unambiguous direction, which represents good, or
improving? (Will people be able to argue
that movement in either direction, or no
movement at all, is good?)
Do the employees understand how to interpret
the CTQ?
The CTQ Must Be Sensitive to the Right Things
and Insensitive to Other Things:
Does the CTQ detect process or product/
service changes?
Do the CTQs together reflect every major
defect or upset in the product/service or
process? (Consider frequency of observation
and inherent sensitivity of the measure.)
Is the CTQ insensitive to changes in products/
services or processes other than those it is
designed to assess?
Is it unlikely for the CTQ to change value
significantly when very little has changed in
the product/service or process it is designed to
assess?
The CTQ Promotes Appropriate Analysis and
Action:
Can the CTQ actually be used in a timely way?
Do appropriate people pay attention to the
CTQ?
Does the existence of this CTQ create apprehension or does it energize people to take
positive action?
58
CHAPTER TWO MEASURE
Does the CTQ focus attention on improvement of processes?

Is the CTQ used to assess process performance rather than individual employee
performance?
CTQs should be predictive for customer satisfaction.
CTQs should:
Be measurable during the conceptual phase
and after
If it can only be measured after the product/service is on the market or process is
being performed, it wont help the team
during design.
Be controllable
If the team cannot adjust the value of a
measure through design decisions, they
will not be able to improve the designs.
Be implementation independent
If a measure is only applicable for a particular design approach, it may tend to
force the team away from other, more
satisfactory approaches.
Have a preferred target or direction of improvement
The team should be able to determine if
the product/service or process will better
satisfy the customer if the measure is
targeted to a particular value, increased
or decreased.
59
60
Strong
9
My "Stuff"
Information
Check-in
Experience
The "Right" Room
Primary Want
Weight:
Weak
1
Length of Check-in Desk
Distance Entrance to Check-in
Bellhop Availability
Clerk Authority
Clerk Knowledge
Message/Package Delivery Time

Message Accuracy
Correct Room Attributes

Clerk Demeanor
Time to Receive Room Key
Key:
Import: 1
2
3
4
Help with luggage

luggage
3

advice - local
Provide packages &

Distance Check-in to Elevators
Attractive Uniforms
Number of Clerks
Secondary Want
Moderate
3
Reltaionship Matrix:
Target Goals
CHAPTER TWO MEASURE
EXAMPLE OF ROOMS 1, 2 AND 3 COMPLETED
CHAPTER TWO MEASURE
TIPS:
Needs may have many characteristics/
measures and these, in turn, may work for
many needs; dont try to maintain a one-to-one
need-to-characteristic ratio
Some needs may not have an obvious characteristic/measure; you may have to rely on a
secondary or tertiary relationship to define an
effective measure
Brainstorming after reviewing VOC and
benchmarking information is an effective way
to identify characteristics and measures
The question to answer is:
What can we measure and control now that is
predictive for customer satisfaction later?
The output for Room 3 is the translation of customer
requirements to measures. At this point, the requirements are quantified into measurable CTQs.
61
CHAPTER TWO MEASURE
ROOM 4 RELATIONSHIPS (WHAT VS. HOW)

Room 4 shows the strength of the relationship
between our potential characteristics/measures and
the customers wants/needs. Can this how (characteristic) achieve this what (customer requirement)?
And to which level?
Customer Importance
Requirement
"How" Meas
Relationships
(What vs. How)
"What"
Customer
Requirement
4
nship
Weight
Value
Weight:
Strong
9
Moderate
3
Weak
1
CTQ Importance Score

Importance Score = Sum (Customer Importance Requirement Score x Relationship Weight Value)
62
CHAPTER TWO MEASURE
DETERMINING SIGNIFICANCE USING THE MATRIX:

This is a vital step in the QFD process. The
final analysis stage relies heavily on the use of
the relationship symbols at the intersection of
customer needs and CTQs.
Generally the strong relationships are reserved
for those cases in which the characteristics/
measures are clearly a primary means to meet
the related customer want and need.
The moderate and weak relationships are
lesser relations as determined by the judgment
of the cross-functional QFD team.
METHOD:
Using strong, moderate, weak, rate the
relationship
Calculate a score for each cell by multiplying
the priority rating (1 5) for the customer
want/need by the relationship weight value (9,
3, or 1) of each related cell
Add up these individual cell scores to determine the CTQs importance
Conduct a reality check at the end to make
sure CTQ priorities make logical sense
63
CHAPTER TWO MEASURE
ROOM 1-4 EXAMPLE
Attractive Uniforms
Number of Clerks
Clerk Knowledge
Secondary Want
Weak
1
Clerk Authority
Primary Want
Moderate
3
Clerk Demeanor
Strong
9
Message Accuracy
Weight:
Target Goals
Key:
Import: 1
2
3
4
The "Right" Room
Check-in
Experience
Information
My "Stuff"
Provide packages &


advice - local
Help with luggage

luggage
How Important
45 42 59 36 36 49 81 45 42 27 42 76 15
Target
Technical Evaluation
5
4
3
2
1
TIPS:
Always document assumptions supporting the
characteristics/needs relationships
Dont attempt to assign a relationship to all
cells of the room; at most, about 1/3 to 1/2 of
the cells should be filled
If a direct cause and effect relationship exists,
assign a double circle for a strong relationship
64
CHAPTER TWO MEASURE
The relationship map provides the team

with a method of identifying the characteristics/measures that drive overall customer
satisfaction, thus providing the most important
criteria against which to evaluate the design
The output for Room 4 is the display of the relationship of identified measures to customer requirements.
ROOM 5 TECHNICAL EVALUATION

Room 5 develops the comparison of how your
company compares to its most serious competitors.
Benchmarking your own and others services/
products/processes against the design measures
which the team has established, helps to define the
level of real performance. It also helps you to answer
the following questions:
Has the team defined the right measures to
predict customer satisfaction?
Does the product have perception, as opposed
to technical problems?
Going back to benchmark additional measures is a
relatively expensive and time-consuming process in
most industries. Therefore, it is recommended
practice to benchmark only against the critical
design measures. Critical measures will typically be
the ones with high importance scores. Special
consideration may need to be given to a measure
that is new or complex. Typically, a team might only
benchmark 50% of the design measures.
65
CHAPTER TWO MEASURE
ROOM 5
5
METHOD:
Obtain competitors product data by
benchmarking
Follow up on the benchmarking information to
get additional information for the key measures you have selected if needed
Strive to develop a competitive rating for every
key measure
Capturing the raw data throughout the benchmarking process and using it directly tends to
make it easier to understand exactly how well a
product has to perform in order to achieve a desired
competitive position. However, the raw data
sometimes implies too much precision for the
66
CHAPTER TWO MEASURE
process. For example, if the team were

benchmarking Number of Commands Required to
Perform the Desired Functions as a way of predicting whether a software package would be perceived
to be Is easy to use, they could easily get caught
up in counting precise numbers when, in reality,
Less than 10, 10 to 20, and More than 20
might be sufficiently accurate for the purposes of the
team. On the other hand, translating the raw
benchmark data into the same rating scale as was
used to capture perceived performances forces the
team to repeatedly translate those ratings back into
their original values. This tends to make nuances in
the data disappear and be lost from consideration.
5
4
3
2
1
EXAMPLE OF COMPLETED ROOM 5
TIPS:
If possible, anticipate desired CTQ measures
before beginning benchmarking
Good choices for competitors are market share
leaders, competitors recognized in the industry, or product/service providers with innovative technology
The output for Room 5 is the technical comparison of
the competitors.
67
CHAPTER TWO MEASURE
ROOM 6 TARGETS AND SPECIFICATIONS

Room 6 helps teams to understand the establishment
of preliminary competitive targets and specifications
for the CTQs that will deliver customer satisfaction.
The final goal of many QFD projects is to set the
Target Values for the design measures. This step
occurs when the data gathered throughout the
process is brought together and final decisions are
made to answer the question What are we really
going to do (with respect to this product or service)?
Setting Target Values should be relatively easy
because:
The team has already defined where they want
their product/service or process to be positioned for the customer.
The team has benchmarked the existing
products/services/processes to gain a good
understanding of which level of actual performance is required in order to produce the desired
level of perceived performance.
68
CHAPTER TWO MEASURE
SETTING SPECIFICATION FOR CTQS

In manufacturing, specification limits often come
from technical or mechanical requirements. Otherwise, base specification limits on data about customer needs; set specifications where customer
satisfaction starts to fall off appreciably.
Specifications can either be one-sided or two-sided.
If there is a single value that the process output
should not go above or below, it is a single-sided
specification. If you can define both a lower and
upper boundary, you have two-sided specifications.
By following the VOC data collection process, we
can help ensure that we have understood the current
situation from the customers perspective.
69
CHAPTER TWO MEASURE
HOQ ROOM 6
6
Taking into account all of this information, the team
decides upon the Targets, which they will shoot for.
Normally at this point, the team would not decide
how they are going to achieve the Target Values.
They are just stating, We know that we have to
achieve this level of performance if we are going to
be perceived the way in which we want to be
perceived.
METHODS:
Identify the level of performance which the
team believes is required to meet customer
requirements and attain the desired competitive position
Evaluate targets by asking:
70
CHAPTER TWO MEASURE
Will this satisfy the customer?

Will it make the company more competitive?
Specify allowable variation
Where does a loss of function occur?
At what point will the customer not tolerate
performance?
Adjust measures based on conclusions derived
from the answers to the questions.
To set CTQ targets and specifications there is no
cookbook. This is a function of business know-how
and technical expertise.
CTQ
CTQ
Kan o
Dr iver s
Custom er Need
Co mp etitio n
CTQ Tar get/

Spec ific ation
Consider ation
Com petitions
Per form anc e
CT Q
T h em
Relation ship
Cu st.
Sat.
Own Cap ab ility

CT Q
USL
SET CTQ TARGETS
71
CHAPTER TWO MEASURE
Specifications should be set such that most

customers will be satisfied with the results.
Sigma targets should be set for CTQs - this is key
to evaluating the design.
Bad Design
LSL
T arget
Good Design
USL
LSL
T arget
USL
Thought Question: Do all CTQs need to be at Six

Sigma?
72
CHAPTER TWO MEASURE
Loss Function
Taguchi defines loss to the customer as a quadratic
function of variation from a target of some quality
characteristic. As the measurement of the characteristic moves away from the target, the loss increases
regardless of where the specifications are. In the
Measure phase, the targets are set based on data
available. At this point, targets and specification are
considered based on Loss Function concept of how
much loss is acceptable.
The traditional interpretation of being within
specification implies a loss function that is zero
while inside the limits and constant while outside
the limits.
EXAMPLE #1
N o Good
N o Good
Loss
Loss
Good
LSL
m = Target
USL
USL = Upper Spec Limit

LSL = Low er Spec Limit
73
CHAPTER TWO MEASURE
The traditional mindset regarding quality was

more of a go/no go decision. If it was within
specifications, it was good, and anything outside
specifications was bad. One problem with this
approach is that it would consider all products
equal if they were within specifications, regardless
of the fact that some products may have less
variation than others.
Also, while it might cost more to purchase or
produce a product with less variation, this mindset
would suggest that any additional cost associated
with reducing variation within the specification
limits is not cost-beneficial. Therefore, the cost/
benefit cannot be answered properly with the go/
no go approach.
The loss function attains its minimum at the target
value and increases as the quality characteristic
deviates from the target value.
74
CHAPTER TWO MEASURE
There are three cases of the target value:

$
Poor
Poor
$Loss
Fair
Fair
Good
Good
Best
m = Target
TIPS:
Stratify overall satisfaction targets into
need-specific targets
Use customer requirements as a basis to
specify targets whenever possible
Consider Kanos model can we provide
more of something for one-dimensional
needs, what targets should be set for customer
delighters?
Do not settle for just meeting the competitors
performance
The output for Room 6 is specification of the performance required to meet or exceed customer expectations.
75
CHAPTER TWO MEASURE
ROOMS 1-6 COMPLETED
Attractive Uniforms
Number of Clerks
Clerk Knowledge
Secondary Want
Clerk Authority
Weak
1
Primary Want
Moderate
3
Message Accuracy
Strong
9
Weight:
Clerk Demeanor
Target Goals
Key:
Import: 1
2
3
4
The "Right" Room
Check-in
Experience
Information
Provide packages &


advice - local
Help with luggage

luggage
How Important
76
Focus Group
Reaction > 90%
See Staffing
Model
< 50 feet
< 50 feet
15 "Guest
Widths"
TBD
< 15 sec.
# Allowed
Decisions
5 Seconds
1% Errors
Target
Various
Attributes
6 Seconds
45 42 59 36 36 49 81 45 42 27 42 76 15
6 Sigma
My "Stuff"
5
4
3
2
1
CHAPTER TWO MEASURE
ROOM 7 CORRELATION (THE ROOF)

Room 7 helps the team to understand and establish
the pairwise correlation between the CTQs. It is
recommended that the relationship matrix be filled
by working in columns, considering the nature of the
technical requirement and its orientation (For
Maximize, Minimize, and Target). While the targets
are being evaluated here in Room 7, remember that
these targets were established earlier in the process.
7
Correlation (I)
Target goals
Method:
Determine target goals orientation by asking the following
questions:
If we increase this measurement, will that
help to achieve the customer want?
If we reduce this measurement, will that
If we hit the measurement target, will that
77
CHAPTER TWO MEASURE
Establish the relationship between the hows and

associated strength of relationship.
METHOD:
Correlations
++
+
Strong Positive
Positive
Negative
Strong Negative
Use four symbols to represent relationships: positive

relationships indicate synergy, negative relationships
may indicate conflicts between requirements.
TIPS:
Negatively correlated characteristics and
measures typically require a lot of time and
forward thinking (innovation) in an attempt to
satisfy both conflicting measures (e.g., TRIZ
methods designed to help identify and
invent solutions to administrative, technical
and physical contradictions).
Conflict resolution should attempt to focus on
meeting the customer needs, not the
organizations.
The output for Room 7 is the correlation between the
characteristics and measures from the other rooms.
78
CHAPTER TWO MEASURE
A COMPLETED HOUSE OF QUALITY
+
+
+
Attractive Uniforms
Number of Clerks
Clerk Knowledge
Secondary Want
Weak
1
Clerk Authority
Primary Want
Moderate
3
Message Accuracy
Strong
9
Weight:
Clerk Demeanor
Target Goals
Key:
Import: 1
2
3
4
The "Right" Room
Check-in
Experience
Information
Provide packages &


advice - local
Help with luggage

luggage
How Important
Focus Group
Reaction > 90%
< 50 feet
15 "Guest
Widths"
See Staffing
Model
< 50 feet
< 15 sec.
TBD
# Allowed
Decisions
5 Seconds
1% Errors
Target
Various
Attributes
6 Seconds
45 42 59 36 36 49 81 45 42 27 42 76 15
6 Sigma
My "Stuff"
5
4
3
2
1
79
CHAPTER TWO MEASURE
ANALYZING YOUR HOUSE OF QUALITY
Pattern
Interpretation
Hig he st sco re o n
co mp e titive co mp ariso n
Ab le to le ad the marke t with e xisting

p ro d uct/se rvice .
Lo w sco re o n co mp e titive
Marke t te chnical ad vantag e s to imp ro ve
co mp ariso n, b ut hig h sco re
custo me r p e rce p tio n.
o n te chnical e valuatio n
Emp ty ro ws in Ro o m 4
Unad d re sse d custo me r want - te am

sho uld d e fine re q uire me nts to ad d re ss
the se ne e d s.
Emp ty co lumns in Ro o m 4
Po ssib le "e xtra" re q uire me nt - first

che ck to se e if a ne e d has b e e n
misse d that this re q uire me nt me e ts, if
no t, the n co nsid e r d e le ting this
re q uire me nt.
Stro ng ne g ative
co rre latio ns in Ro o m 7
CTQ trad e -o ffs will b e re q uire d

unle ss re so lvab le via inno vative
so lutio ns (TRIZ).
Diag o nal p atte rn o f stro ng

co rre latio ns in Ro o m 4
Line ar alig nme nt o f

me asure s/characte ristics with custo me r
re q uire me nts. Po ssib le lack o f le ve rag e
in satisfying multip le custo me r
re q uire me nts.
Lo w te chnical e valuatio n
Po o r lo ng -te rm marke t p e rfo rmance se t ag g re ssive targ e ts fo r CTQs he re .
80
CHAPTER TWO MEASURE
QFD should not be done mechanically. The real

value of QFD lies in the understanding of customer
needs and how the attribute of the new product/
service relates to these needs. Documenting the
House of Quality helps ensure this understanding
throughout the design project.
House
of
Quality
House
of
Quality
#3
Pro cess Con trols

(Ho ws)
(Whats)
#2
Pro cess Variab les

(Ho ws)
Process Variables
House
of
Quality
Process Requirements
(Whats)
#1
Pro cess Requ iremen ts

(Ho ws)
Requirements/CTQs
(Whats)
Customer Needs
(Whats)
Req uiremen ts/CT Qs

(Ho ws)
House
of
Quality
#4
As shown, it is possible to develop several houses

to achieve a very detailed understanding of the
variables, which must be controlled to ensure that
the customer requirements are satisfied.
81
CHAPTER TWO MEASURE
II.3 Design Scorecards

Scorecards purpose and how they should be used:
Predict the Final Quality of a Product/Service/
Process During Design
Predict How Input Variation Translates to
Output Variation
Surface Quality Problems/Risks (Design
Outputs and Inputs)
Link Process & Supplier Capabilities to Design
Ys
Provide Rationale for Design Effort DecisionMaking
Help Design Team Focus on Vital Few Xs in
Design
How NOT To Use a Scorecard:
Grading the Design (or Design Team)
Substitute for Design Judgment
DESIGN PROCESS
Define
Define
Requirements
Requirements
Develop
DesignDesign
Develop
Assess
Capability
Assess
Capability
Not
OK
OK
Develop
MoreMore
Develop
Details
Details
(To Production)
82
CHAPTER TWO MEASURE
Sample Design Scorecard
83
CHAPTER TWO MEASURE
Typical design process requires flow down of CTQ

targets and specification limits with sigma targets.
Design is iterated until targets and specifications are
met at desired sigma (e.g., defect) levels.
TYPES OF SCORECARDS
Service:
CTQ Tracks Performance of the Overall
Service in Meeting Requirements
Service Processes Tracks Performance of
Individual Processes (Useful When Multiple
Design Teams Working on Processes)
Supplier Processes Tracks Performance of
Vendor Supplied Processes
Software Tracks Defects in Software Required for Service Functions
Product:
CTQ Tracks Performance of the Overall
Product in Meeting Requirements
Systems Tracks Performance of Product
Systems in Meeting Deployed Requirements
(Useful When Multiple Design Teams Working
on Systems)
Manufacturing Processes Tracks Capability
of In-House Fabrication and Assembly Processes
Suppliers Tracks Performance of Vendor
Supplied Parts, Components/Raw Materials, or
Processes
84
CHAPTER TWO MEASURE
Software Tracks Defects in Software Required for Product Functions
SCORECARD DEVELOPMENT PROCESS

1. Identify Requirements Associated With Service
or Product
2. Quantify Requirements Target, Specification
Limits, Sigma Target
3. Predict Capability of Design to Meet Requirements Mean, Standard Deviation, Distribution, Defect Rate
4. For Requirements Measured on Continuous
Scale:
Calculate Capability in Sigma Values
5. For Requirements Measured on Attribute
Scales:
Translate Defects/Unit into Sigma Values
6. Gap Analysis Compare Predicted Sigmas to
Target Sigmas, Identify Most Important Gaps
85
CHAPTER TWO MEASURE
Intellectual Property Analysis

Intangible creations of the mind, such as inventions,
information, processes, designs, expressions, slogans,
technical know-how.
WHAT IS INTELLECTUAL PROPERTY (IP)?

Trade Secrets - any formula, pattern, machine
or process of manufacturing, or any device or
compilation of information used in ones
business, which is maintained in secrecy and
which may give the owner an advantage over
competitors who do not know or use it. Risks:
can be lost/can be patented by others
Copyrights - protection for original works of
authorship that are fixed in any tangible
medium of expression. Examples: books,
paintings, CDs, computer programs
Trade Names - a name used to identify a
business entity. Examples: Johnson & Johnson,
De Puy, Janssen Pharmaceutica
Trademarks - an arbitrary and distinctive
name, mark, word, phrase, slogan, design or
symbol used in connection with the
proprietors sale of goods to identify and
distinguish those goods from competitive
products; denoted by TM prior to registration.
Examples: Prepulsid, BX Velocity, One Touch,
Clean & Clear
Service Mark - a mark, like a trademark, that
refers to services rather than goods; denoted by
86
CHAPTER TWO MEASURE

SM prior to registration. Example: The

Computer Superstore (Comp USA)
Trade Dress - a products image or overall
appearance, including size, shape, color or
color combinations, texture, graphics, or even
particular sales techniques
Example: McDonalds products and restaurants
Design and Models - appearance of a product
resulting from features such as lines, contours,
shape and material
In US: Design Patent
Two dimensional (design). Example: wall
paper
Three dimensional (model). Examples:
Mercedes car, shampoo bottle
Patents - a grant of rights conferred by a
government to the applicant in exchange for
publication of the invention
IP CHECKLIST

Patent Strategy
Patent Clearance
Patent Estate
Patent Filing(s)
International Filing Strategy
Invention Disclosure
Idea Memo Submission
Patent Marking
Commercial Use
87
CHAPTER TWO MEASURE
Defensive Publications
Patent Search
Patent Mapping
Competitive Benchmarking
Patent Bar Date
Agreements
Trademarks
Intellectual Property Contacts
TIPS
Always:
Know your Patent Strategy
File patent applications before public disclosure or commercial benefit
Respect the Patents of others
Use Patent & Intellectual Property Handbook
Include Patent Liaison and Johnson &
Johnson Legal on your team
Capitalize trademarks and use them as an
adjective
Use agreements and know what is in them!
Never:
Render Infringement Opinions
Characterize what claims cover
Offer a product for sale or disclose information
outside Johnson & Johnson without knowing
the impact on patent protection
Use trademarks as a noun
88
CHAPTER TWO MEASURE
Disclose any confidential information without

an agreement
Collaborate with an outside party without an
agreement that controls who owns any
resulting intellectual property
Sign an agreement from an outside party
without legal review
89
CHAPTER TWO MEASURE
Review of the Measure Phase

At the end of the MEASURE Phase, the following
are in place:
All internal and external customers are
identified, segmented, and prioritized.
All requirements and competitive information
to build/exceed customer satisfaction are
gathered from proactive and reactive sources.
The context of use and user population of the
future product/service/process is fully known
and described.
Meaningful, concept independent Critical-toQuality (CTQ) requirements, predictive for
project success and measurable at the concept
level, are defined and agreed.
Design scorecards are installed to predict and
track performance of product/service/
process to the CTQs.
Design Review: The organization and independent reviewers verify that the CTQ list is
clear, non-conflicting, complete, and properly
documented.
90
CHAPTER TWO MEASURE
Deliverables for the MEASURE Phase include:

Prioritized list of internal and external
customers (segments)
VOC plan
List of customer needs organized by importance and perception
Competitive information
Context description of the use environment,
users populations, lifecycle
Complete list of verifiable CTQs and measurement methods
Design scorecard
Documented review
91
CHAPTER TWO MEASURE
92
CHAPTER THREE ANALYZE
III. Analyze Concepts

Introduction
The ANALYZE Phase includes:

Defining the purpose and the outputs of the
Analyze Step
Using a House of Quality to deploy CTQs to
design pieces
Using creative techniques to develop
alternative concepts
Evaluating conceptual designs
Developing high-level product/service/
process designs
Assessing and selecting the best high-level
product/service/process design
Assessing the risk of your high-level product/service/process design
93
III.1 Concept Generation/Selection

A Variation on the Open/Narrow/Close
Decision-Making Process
Product
/Service
Idea
Design
Inputs
Screen
Generate
Paper Unlikely
Concepts Candidates
Combine
Concept
Pieces
Analyze
Concepts
Feasibility;
Address
Conflicts
Select
MostPromising
Concept(s)
Product
/Service
Concept
Mature
Technology
94

Brainstorming
Start With
What You
Know
Candid
Comments
Challenge
Assumptions
Six Thinking
Hats
20 Questions
Musical Chairs
Benchmarking
Get Other
Perspectives
Lateral
Thinking
Random Word
Mind Mapping
SCAMPER
Non-Linear
Thinking
Solution
Mapping
Build On
Ideas
Build On
Ideas
Idea Box
Combine
Ideas
Benchmarking
Compare
OVERVIEW OF THE CREATIVITY TOOLS
95
Brainstorming
Brainstorming should always be the first creativity
tool to use because it brings out what is already on
your mind. Effective means of generating design
concepts when no Invention is required.
OSBORNS BRAINSTORMING RULES:

No criticism. Dont evaluate ideas during idea
generation.
No constraints. Take a freewheeling approach.
Its welcome, even preferred the wilder the
idea, the better. Its easier to tame ideas than to
make them more and more outrageous.
Go for quantity. Generate as many ideas as
possible. More ideas increase the odds of good
ideas emerging.
Build on existing ideas. Dont leave an idea
alone because someone else came up with it.
Build on that idea to create others or combine
and improve them.
96
BRAINSTORMING CONCEPTS CAN BE APPROACHED

TWO WAYS:
1. One approach starts by brainstorming ideas at
the broad cross-functional system level, and
then breaks the high-level concepts down into
functional components for a deeper understanding of each concept.
2. The second approach starts at the functional
level first identify what functions need to be
performed to accomplish the product or
service and then mixes and matches
functions to develop different system-level
concepts.
Eventually you will have to design at the functional
level, but often creativity is enhanced if you stay at
the conceptual or systems level initially.
97
Solution Mapping
Solution maps start with a core premise that can be
stated as either an objective or a challenge. The
objective of this technique is to create more and
better ideas by combining systematic, analytical
thinking with spontaneous, unconstrained thinking.
HOW TO CREATE A SOLUTION MAP:

1. Start with a core premise, validated root cause,
or the problem statement. Begin brainstorming,
forming clusters of related potential solutions
around the core premise.
2. Using the principles of brainstorming, one
person offers an idea and other team members
try to expand it, give it a new twist, or turn it
into another idea.
3. Build your solution map as you go so the team
can see its ideas begin to take shape.
98

Train
operators
operators
Put
workstations
workstations
on line
on line
New sorting
procedures
procedures
Streamline
Improve internal
internal
Improve
mail distribution
New sorting
equipment
equipment
Increase
Increase
no.
daily
no. ofofups
daily
pickups
Eliminate
Eliminate
Dept.Head
Headapproval
approval
Dept.
Buy new
machines
machines
Automate
Automate
input
input
Label mail:
Label mail:
high,
high,medium,
medium,
low priority
Edit input
Dept. Head
Head
Dept.
approval
approvalfor
for
exceptions
only
exceptions only
Establish
Establish
processing
processing
priorities
priorities
Eliminate
Eliminate
non-value
non-valueadded items
added items
Create new
new
Create
acceptance
criteria
criteria
Establish
Establish
pre-processing
pre-processing
sort
sort
Prove
Prove
guidelines
guidelines
totousers
users
Simplify
Simplify
Revise
Revise
input
input
form
form
Surveyfor
Survey users
users for
needs
needs
Eliminate
MakeMake
easier
to easier
useuse
to
No
Nohigher
higher
approval
approval
(above
operator)
(above
operator
for routines )
for routines
Reduce
Reduce
errors
inputinput
errors
Dept.
Dept.Head
Head
approvalfor
for
approval
high
priority items
high priority items
Supervisor
Supervisor
approval
approval
for routines
routines
for
Examples of Solution Mapping
99
Systematic Innovation Tools

TRIZ - The Theory of Inventive Problem
Solving
There is a strong need to significantly improve the
engineers' ability to quickly solve difficult and
seemingly impossible engineering problems as
these problems frequently lead to next generation
"innovative" products.
TRIZ is an inventive problem solving tool that
allows us to generate concepts by resolving
conflicts.
TRIZ helps the problem solvers combine their
knowledge with the knowledge of thousands of
"silent" inventors. Inventive principles have been
derived from an analysis of over two million
patents, allowing quick, efficient, creative, and
elegant solutions to some of the most difficult
engineering or manufacturing problems.
TRIZ helps by defining the next evolution of the
technology.
100

All that
Is known
(Academia,
Society,
Pure R&D,
etc)
NonCompetitive
Industries
Technical
Knowledge
Your
Competitive
Industries Companys
Technical
Technical
Knowledge
Knowledge
Your
Teams
Technical
Knowledge
Your
Technical
Knowledge
The TRIZ Knowledge Model

101
PATENT CLASSIFICATION LEVELS (AS CLASSIFIED

IN TRIZ)
1 Simple Solutions Fairly Obvious
2 System Modification/Small Improvement
3 Inventive Solution/Major Change
4 Significant Invention/Radical Change
5 New Phenomena/Discovery
(4) < 4%
(5) < 1%
(3) - 18%
(1) - 32%
(2) - 45%
TRIZ is best utilized for

problems of levels 2-4
Level 1 Simple Solutions/Fairly Obvious
(No Invention) - A well known and available
solution exists.
No engineering contradictions exist.
The original object, system, or method being
improved is not changed.
102
A typical engineer will be able to easily solve

by evaluating only a few variants using his/her
own personal knowledge with some common
sense.
Level 2 System Modification/Small Improvement
(No Invention) - Improvement within the
original problems branch of technology
(Mechanical, Electrical, etc.).
Engineering contradictions do exist, and
solution usually contains compromises.
The original object, system, or method is
changed but not substantially.
A typical engineer must investigate dozens of
variants, within his/her discipline/specialty, to
find the solution.
A good problem solver with patience will solve
the problem.
Level 3 Inventive Solution/Major Change
(Invention Inside the Paradigm) - Contradictions exist.
The original object, system, or method is
seriously improved.
Solution is within the same engineering
discipline as existing problem.
The system still provides the same engineering
function. The problem solver typically must
investigate hundreds of variants and look
outside their specialty to find the solution.
103
The solution will have broad applicability for

other applications.
The problem solver must have great patience and persistence to solve the problem.
Level 4 Significant Invention/Radical Change
(Invention Outside the Paradigm) - Engineering problem with same engineering function,
but uses a new physical principle to perform
the function.
The original object, system, or method has
totally changed. The solution still provides the
same engineering function.
A typical problem solver must investigate
thousands of variants and look beyond his/her
discipline to find the solution. The solution
must be sought not in technology but in
science through physical and chemical effects
and phenomena.
Problem solvers must have great patience and
persistence.
Level 5 New Phenomena/Discovery
(Invention of Discovery) - Invention of a new
function which is beyond the limits of contemporary science.
Once in a lifetime discovery - Spurs the birth of
entire new industries.
104
A typical engineering team must investigate

tens or hundreds of thousands of variants
and look beyond his/her discipline and
todays knowledge base to find the solution.
Often happens by accident.
Generation of new scientific data or phenomena.
Problem solvers must have great patience
and persistence or will not be able to solve
problem.
Primary use of TRIZ is to resolve conflicts in
Levels 2, 3, and 4.
105
Flow Diagrams
During the design of process elements or during a
redesign of a process different types of flow charts
can be utilized. Flow diagrams are graphical
displays that make a process visible.
Why use flow diagrams?
To create a common understanding
To clarify the steps in a process
To identify improvement opportunities in a
process (complexity, waste, delays, inefficiencies and bottlenecks)
To uncover problems in the process
To reveal how the process operates
When to use flow diagrams
To build consensus on how a process
actually operates and how it should operate
To understand the cause of common problems with how all units are processed
106
Start
Start

Submit
Purchase
Order
Yes
Authorization
Authorization
Required?
Required?
No
Obtain
Obtain
Authorization
Authorization
Determine
Required
Materials
Determine
Approved
Vendor(s)
Send to
Vendor
Complete
Purchase
Order (P. O.)
End
Activity Flow Charts
These are specific about what happens in a process.

They often capture decision points, rework loops,
complexity, etc.
107
Deployment Flow Diagrams

Deployment Flowcharts show the detailed steps in a
process and which people or groups are involved in
each step. They are particularly useful in processes
that involve the flow of information between people
or functions, as they help highlight handoff areas.
People or groups
listed across the top
Sales
Invoicing Process
Billing
Steps listed in
column of person or
group doing step or
in charge
Shipping
Customer
1
Delivers goods
2
Notifies sales of
completed delivery
8
Receives
delivery
Elapsed
Time
Time flows
down the
page
5 days
9
Records receiptand
claims against
this delivery
3
Sends invoice
to customer
10 days
10
Receives invoice
4
Notifies billing
of invoice
5
Files invoice
11
Checks invoice
against receipt
12
Pays bill
6
Receives and
records a payment
7
Receives weekly
report of overdue
accounts
108
Horizontal lines
clearly identify
handoffs
Value Stream Mapping

Value Stream Mapping is an extension of process
mapping:
It focuses on the customer and its definition of
Value and
Helps visualize and understand the flow of
Material/Product, and Information within the
total value stream.
VSM highlights (1) Sources of Waste: non-value
added steps, defects,etc., (2) Flow characteristics
such as speed, inventory /WIP build-up etc., and (3)
Provides visibility by allowing the users to see
interaction between customers, processes, and
suppliers. As a result, teams are able to work on the
big picture and improve the whole and not just
optimize the parts.
A value stream is created using many icons and steps
in the process by adhering to the following principles:
Value-added steps: process steps that must comply
to all 3 criteria
1. Customers are willing to pay for it
2. It changes the process
3. Its done right the first time OR the step is
required by authorities
Non-value-added steps = WASTE
Does not add value to the output but consumes resources
Non-value added steps such as Defects, errors,
omissions, preparation/setup, control/
109
inspection, over-production, processing,

inventory, transport, motion, waiting, delays
etc.
110
A completed Value Stream Map might look like the

one below:
111
III.2 Feasibility
Process Modeling and Simulation
A method of simulation of processes before
further design for predictability. Outputs from
process modeling:
Identify and eliminate bottlenecks
Establish resources needed
Overview of Process Modeling

Understand Problem To Be Studied And
Objective Of Doing Simulation
Develop A Project Plan And Define Roles &
Responsibilities
Describe Model Based On Expert Interviews
And Observation Of Process
Collect Data Needed To Define Process
Properties
Prepare Software Model (Using Process
Model, Other Method)
Determine That Computer Model Executes
Properly; Compare Model Output With Real
Process (If Exists)
Establish The Experimental Options (Scenarios) To Be Simulated
Execute Options (Scenarios) And Collect
Performance Measures
Analyze Simulation Results
Make Recommendations
112
Seven Principles of Effective Modelers

1. Stays Oriented Toward Project Goals/
Purpose Model construction is not the end
2. Includes Only Necessary Detail Practices
Keep It Simple Statistically (KISS)
3. Evolves Model Over Time Starts simple
and adds complexity until the model suits
the goals/purpose
4. Describes All Critical Activities/Events
With Appropriate Detail
5. Flexible Makes model design easy to
modify because it will change
6. Robust Doesnt make model applicability
narrow through structure or assumptions
7. Clearly Displays Results Makes sure all
measured responses are available and
understood
113
114
The Ag e nts Use d to Pe rfo rm
Staff, Lathe , He at Tre at Ove n, Ro b o tic
Activitie s, o r Mo ve Entitie s
A s s e mb le r
Co nne ctio ns Links Be twe e n Entitie s, Activitie s, Entity Arrivals (e .g ., Calls), Entity Ro uting s
and Re so urce s
(e .g ., Parts to Sto rag e ), Re so urce
Assig nme nts to Activitie s (e .g ., Staff to
Tasks)
Pro p e rtie s
Nume rical Characte ristics o f
Arrival Rate s, Pro ce ssing Time s, Staff
Entitie s, Activitie s, Re so urce s &
Ho urly Co sts
Ro uting s
Co ntro l Lo g ic
Rule s By Which Entitie s Flo w
Batching , Ro uting Asse mb lie s, Shifts
Thro ug h the Pro ce ss o r
Re so urce s Assig ne d to Activitie s
Re so urce s
Do cume nts, Pe o p le , Parts, Pro d ucts
Examples
The Task Be ing Pe rfo rme d o n an Co mp le te Do cume nt, Hire Pe rso n, Machine
Entity
Part, Asse mb le Pro d uct
The Ite m Be ing Pro ce sse d
Entity
Activity
Definition
Model Element
MODEL ELEMENTS
Concept Selection Tools

Pugh Matrix
In the Pugh Matrix, the concepts are compared with
regard to each criteria. The Pugh Matrix is also used
to select the best design concepts from among
alternatives.
All concepts and criteria are represented in the
matrix.
One concept is selected as the baseline or datum.
Pugh Concept Selection Matrix
1) The Shangri-la
2) The Jetsons
3) Homer Simpson
Sum of Positives
Sum of Negatives
Sum of Sames
Weighted Sum of Positives
Weighted Sum of Negatives
0) Ritz Carlton (Datum)
Minimizes cost of construction

Operational cost
Uncluttered layout / appearance
Guest sees other services - ease of getting
information
Importance Rating
Criteria
Ease of guest finding check-in (easily viewable
from both entrances)
Limited confusion within queue
Minimizes wait times for issues not related to
check-in
Ease of guiding guests to elevators
Time to receive key
Miminize errors in room assignment
Allows for efficient (variable) allocation of lobby
staff (VA time) to minimize guest wait time
Minimize time to final build complete
Concepts
5
5
D
A
+
+
+
S
+
S
5
5
5
5
T
U
M
+
+
+
+
+
+
+
+
+
S
S
4
4
+
+
S
+
S
-
4
4
3
+
S
+
S
9
1
2
42
4
7
1
4
33
4
2
4
6
10
17
3
0
0
12
0
0
How to use the Pugh Matrix:

Select one of the concepts to serve as the baseline.
Compared to the baseline concept mark the
result as either:
115
~ same as S
~ worse as
~ better than +
Compute the scores of positives, negatives, and
sames as shown in the example.
Analyze the results to identify between one and
three very strong concepts.
The Pugh Matrix may be used to spur another round
of concept generation, eliminate concepts that clearly
have few positives and seek to Accentuate the
Positive, Eliminate the Negatives for the concept that
appears superior after the first round.
Functional Analysis
Functional analysis is the approach of identifying
product/service/process functions necessary to meet the
customers needs and is often used in the design process.
It helps teams break down a complex product/service/
process into manageable pieces. Different sub-teams can
be assigned different functions to help manage the design
project as it moves into more detailed work.
The idea is to allocate the CTQs to the functions, so that
we know which CTQs each function supports and which
requirements each function must satisfy. This in turn
gives the various sub-teams clear direction for their
design efforts.
Function Definition: The High-Level What That
Needs to Occur in Order for the Product/Service/
Process to Happen. Functional Analysis May Be
Continued to Define Lower-Level Functions as Design
Proceeds from High-Level to Detailed Processes.
116
Concept Feasibility
Risk Analysis Tools
A Formal Methodology To:
Set Risk Targets & Goals
Identify Design Risks
Analyze Design Risks
Identify, Plan, and Implement Risk Reduction
Activities
Control, Monitor, and Track Risk Reduction
Activities
Hazard Analysis
Review Design
Examine the Current State of Design Inputs &

Outputs
Identify Design
Characteristics
What Qualitative & Quantitative Characteristics

of the Design Could Affect Safety; What Current
Limits Exist?
Identify Possible
Hazards
What Potential Hazards Could the Design

Produce? Under Normal & Fault Conditions?
Estimate Risk
Each Hazard
Quantify the Level of the Risks Consider

Initiating Events, Event Sequences, Mitigating
Features, Risk Frequencies
Evaluate Risks
Evaluate Risks: Acceptability, Possibility of

Reducing Severity, Frequency, Possibility of
Detection, Do Changes Introduce New Risks?
Report/Review
Risk Analysis
Document Risk Assessment; Disposition

Designs Risks; Review Risks on New
Information
117
III.3 Do It By Design
FMEA (Failure Mode and Effects
Analysis)
The FMEA is a structured approach to identify,
estimate, prioritize, and evaluate failures and risk
issues in new designs aims at Failure Prevention.
Two Applications:
1. Is focused on Prevention/Mitigation of New
Product/Service/Process Failure Modes &
Causes (Both Risk and Reliability Related)
2. Is used to Limit the Risk Involved in Changing the Product/Service/Process
Types of FMEAs:
Application FMEA: on the use of the product
Design FMEA: on the detailed product/
service designs
Process FMEA: on the Manufacturing/
Assembly Process
118
FMEA STEPS
1.
2.
3.
4.
Determine the FMEA Purpose.

Organize the FMEA Effort.
Review the Product, Service or Process.
Determine Process Step Failure/Error
Modes Identify ways in which the product,
service, or process might fail.
5. Determine Effects of Failure/Error Modes
Identify potential effect of each failure and rate
its severity.
6. Determine Causes of Failure Modes/Step
Error Modes Identify cause of the effects
and rate their likelihood of occurrence.
7. Determine Failure Mode/Error Mode/Cause
Detectability Rate ability to detect each
failure mode.
8. Prioritize the Failures/Errors Criticality
Analysis and the RPN Multiply the three
numbers together to determine the risk of
each failure mode (RPN = Risk Priority
Number).
9. Carry out the FMEA Action Feedback Loop.
10. Validate the FMEA.
119
Potential
Failure
Mode
Potential
Effect(s)
of Failure
Severity
Cause
Cause&&Effect
Effect
Analysis
Analysisofof
System/Process
System/Process
Potential
Potential Failures
Failures
Item or
Process
Step
Potential
Cause(s)
Occurrence
Action Taken
After
____ ___ ___ _ (original )

____ ___ ___ _ (revised )
Occurrence
Countermeasure
Countermeasure
Identification
Identificationand
and
Impact
ImpactAssessment
Assessment
Responsibility
and
Target Date
Date
Detection
FMEA is a Three - for - One Tool

Cause and Effect, Pareto, and Countermeasure Matri x!
Pareto
ParetoAnalysis
Analysis
Failure
FailurePriorities
Priorities
Current
Controls
Recommended
Action
FMEA Analysis
Detection
Team: ___ ___ ___ ___ ___ ___ ___
RPN
120
Severity
Project: ___ ___ ___ ___ ___ ___ ___
RPN
Sample Severity Rating Scale

(Severity = likely impact of the failure)
Rating
Bad
Good
10
Criteria: A failure could

Injure a custom er or employee
Be illegal
Provide a servic e that is unfit for use
Cause extreme customer dissatisfaction
Result in partial malfunction
Cause a loss of perform ance likely to result in a complaint
Cause minor performance loss
Cause a minor nuisance; can be overcome with no loss
Be unnoticed; minor effect on performance
Be unnoticed and not affect the performance
Sample Occurrence Rating Scale

Rating
10
10
Time Period
More than once per day
Probability
30%
Bad
Good
Good
Once every 3 44days

days
Once per week
30%
5%
Once per month
1%
Once every 3 months
.03%
Once every 6 months
1 per 10,000
Once per year
6 per 100,000
Once every 1 3 3years

years
6 per million
Once every 3 6
6 years
years
3 per 10 million
Once every 6 100

100 years
years
2 per billion
121
Sample Detection Rating Scale
Bad
Bad
Good
Good
Rating
Rating
10
10
Definition
Definition
Defect caused by failure is not detectable
Occasio nal process outputs are checked for defects
Process output is systematically sampled and inspected
All outputs are manually inspected
Manual inspection with mistake - proofing

proofing modifications
modifications
Process is monitored (SPC) and manually in spected
SPC used with an immediate reaction to out of control

conditions
SPC as above w ith 100% inspection surrounding out of

control conditions
All process outputs are automatically inspected
Defect is obv ious and can be kept from affecting customer
2
1
It is preferable to have the FMEA session facilitated by a person familiar with the tool. It is a
good idea to complete the form by completing one
row at a time rather than one column at a time.
122
Fault Tree Analysis

Fault Tree Analysis (FTA) is used qualitatively to
identify the weak points in a design. Quantitatively,
FTA is employed as a model that relates the
reliability of components to the overall system
reliability.
Features include:
Fault Trees are logic diagrams expressing the
occurrence of some Top Event (e.g., Service
Failure) in terms of hardware, software, and
human Faults
Fault Trees allow the analyst to include
complex fault logic (e.g., redundant process
steps, redundant IT servers)
Fault Trees may be Quantified the tree logic
can be converted to a boolean algebra expression; this can be converted into a probability
equation
123
Note: A fault is not necessarily the same as a failure

(a door lock that opens prematurely in response to a
spurious signal has Faulted, but not failed).
Door
Open
Failure
Lock
Failure
Primary
Key Fails
Key
Failure
Secondary
Key Fails
Validation
Validation
Failure
Key
Not Given
Key
Not
Validated
FAULT TREE CONSTRUCTION

1.
2.
3.
4.
5.
6.
Understand the system to be analyzed

Define the undesired top event
Establish the analysis boundaries
Decompose the top event into sub-events
Define the top event/sub-event fault logic
Continue decomposition until basic events
are identified
7. Solve the tree - identify minimal cutsets
8. Quantify top event probability
124
TYPICAL FAULT EVENTS

Normally Closed
Relay Contacts
Fail to Open
An Intermediate Event, represented by a rectangle,

is a fault event that results from the combination of
two or more lower-level faults acting through logic
gates. The Top Event and all Sub-Events down to
(but not including) the Primary Events fit into this
category.
The Basic Event, represented by a circle, describes a

basic initiating fault event that cannot be developed
further or a basic event in the lowest level whose
probability of occurrence can be obtained independently.
The Undeveloped Event, represented by a diamond,

describes fault events that are not further developed,
either because the event is of insufficient consequence or because of the lack of necessary
125
information. In order to obtain a solution for the

Fault Tree, both circles and diamonds must be
represented by probabilities of failure.
Typical Logic Gates
OUTPUT
OR
INPUTS
The OR gate provides an output if one or more of the

input events occur. This equates to the union of the
events. For example, a relay fails if either or both of
the following occur: contacts fail to close, coil fails to
energize.
OUTPUT
AND
INPUTS
The AND gate provides an output if and only if all

input events occur concurrently. This equates to the
intersection of the events. For example, loss of
electric power occurs if the normal supply and the
backup diesel generator fail.
126
Proactive Reliability
Reliability The probability that an item will
perform its intended function under stated conditions for a given period of time.
Typical Reliability Activities:
Plan Reliability Activities & Cost
Communicate & Interface
Evaluate Existing Reliability Data
Develop Reliability and Maintainability
(RAM) Requirements (Quantitative)
Develop Requests For Proposals and
Evaluate Vendor Proposals
Perform RAM Predictions
Specify Parts Derating
Perform Failure Modes, Effects & Analysis
Develop/Implement Reliability Test Plan
Perform Stability Studies (Pharma)
Analyze Root Causes of Test Failures
Perform Maintainability Analyses
Develop Operations/Maintenance Processes
Analyze Root Causes of Field Failures
127
128
Hazard Rate - h(t)
Useful Life Period
Random-in-time
Failures
The Bathtub Curve
Operating Time (t)
Wearout
Failures
THE BATHTUB CURVE
Useful Life Before Wearout
Early Life
Failures
An Important Reliability Concept - The "Bathtub Curve":
Total Life Cycle Cost TLCC

Total Life Cycle Costing is a cradle-to-grave assessment that accounts for all of the resources used and
the costs associated with the life cycle of a product.
It begins with the product concept and ends with the
final disposal of the product.
The Total Life Cycle Costs should be expected
and planned during Concept Generation. Cost
drivers need to be specifically identified and
estimated.
Costs associated with the planned design,
development, and distribution of the product
should be included but also consideration of
the costs associated with unplanned events
(e.g., delays in the schedule, raw materials not
available as planned, etc.) should be included
when possible.
Applying TLCC concepts early in the design
phase can make the difference in a well
designed product being profitable and acceptable to the marketplace.
Following are the stages of the TLCC model. The
descriptions should help when applying the TLCC
Model to your business.
Product
Concept
Prototype
Production
Production
Field
Field Use
Use
Disposal
129
Product Concept - Initial determination of product

concept, nature, function, market, use, market scope,
etc.
Prototype & Development Testing - Testing for
functionality, usability, durability, safety, destructive
testing, product modifications, etc.
Production - Pilot or validation runs, initial production, scale-up, full scale manufacturing.
Field Use - Costs associated with the integration of
the product into the marketplace.
Disposal - Cost effective and sensitive recycling and
retirement.
130
Conjoint Analysis
A method of assessing customers perceived value
for products, processes, and services.
METHOD
Identify Key Product/Service Attributes
Example: Pizza Pepperoni, Cheese, Crust,
Price
Identify Possible Levels/Combinations of
Attributes
Example: Pepperoni 100 Slices, 50 Slices;
Cheese 5 oz., 8 oz.; Crust Thick, Thin;
Price $6.99, $8.99
Present Combinations to Customers
Example: Use Full Factorial Design of
Attribute Combinations
Have Customers Rate or Rank the Combinations
Analyze the Resulting Data (Utility Analysis, Logistic Regression, Others)
Rapid Application Development (RAD)

Approach applied in software development to
rapidly design, obtain customer feedback and iterate
design until needs are met.
RAD should only be started after the initial VOC to
prevent the customer and/or designer from locking
into a solution prematurely.
131
Choosing a Specific Information

System Development Methodology
within DEx
High
Procedural
Rigor
Low
RAD
Traditional,
Life-Cycle,
aka waterfall
Prototyping
Iterative
Show & tell

(left brain)
Formal narrative
(right brain)
Approach to Specs
132
Statistics to Support Evaluation of Concepts

Customer research done at this stage usually has the
following characteristics:
Design concepts are tested on a relatively
small number of customers
Customers are often asked to rank order or
score their preferences
For these reasons, standard statistical approaches
such as regression analysis and hypothesis testing
may perform poorly. Methods that do not assume
normal error or specialized methods for understanding preferences may be helpful.
Hypothesis tests are used to see if two samples
are significantly different. Parametric implies that a
distribution is assumed for the errors. When
performing standard hypothesis tests, it is commonly assumed that the errors are from the
normal distribution. Nonparametric implies that
there is no assumption of a specific distribution.
The parametric tests work better (have more
power) when the normal assumptions hold. This is
why they are generally used. However, if the
assumptions dont hold, the non-parametric tests
are better protection against drawing the wrong
conclusion.
133
134
2-samp le t-te st
Paire d t-te st
Analysis o f Variance
Distinct g ro up s o f p e o p le
sco re 2 d e sig ns
Same g ro up o f p e o p le
sco re s 2 d e sig ns
Distinct g ro up s o f p e o p le
sco re many d e sig ns
Kruskal-Wallis Te st, Mo o d ' s

Me d ian Te st
1-Samp le Sig n Te st
Mann-Whitne y te st
Non-Parametric Equivalent
These tools are more applicable to Services & Processes; non-normal data.
Refer to the Six Sigma Pocket Guide for information on tools such as DOE
and ANOVA.
Appropriate Normal
Theory Hypothesis Test
Situation
Mann-Whitney Test
A two-sample rank test (also called the MannWhitney Test) of the equality of two population
medians. An assumption for the Mann-Whitney Test
is that the data are independent random samples
from two populations that have the same shape and
a scale that is continuous or ordinal if discrete. The
two-sample rank test is slightly less powerful (the
confidence interval is wider, on the average) than the
two-sample test with pooled sample variance when
the populations are normal, and considerably more
powerful (the confidence interval is narrower, on the
average) for many other populations. If the populations have different shapes or different standard
deviations, a two-sample t-test may be more
appropriate.
Kruskal-Wallis Test
The Kruskal-Wallis Test of equality of medians for
two or more populations. This test is a generalization of the procedure used by Mann-Whitney Test
and, like Moods Median Test, offers a non-parametric alternative to the one-way analysis of
variance.
135
An assumption for this test is that the samples

from the different populations are independent
random samples from continuous distributions,
with the distributions having the same shape. The
Kruskal-Wallis Test is more powerful than Moods
Median Test for data from many distributions,
including data from the normal distribution, but is
less robust against outliers.
Moods Median Test

Moods Median Test can be used to test the
equality of medians from two or more populations
and, like the Kruskal-Wallis Test, provides a nonparametric alternative to the one-way analysis of
variance. Moods Median Test is sometimes called
a median test or sign scores test.
An assumption of Moods Median Test is that the
data from each population are independent random
samples and the population distributions have the
same shape. Moods Median Test is robust against
outliers and errors in data and is particularly
appropriate in the preliminary stages of analysis.
Moods Median Test is more robust than is the
Kruskal-Wallis Test against outliers, but is less
powerful for data from many distributions, including
the normal.
136
Hypothesis Testing
A hypothesis test is a procedure that summarizes
data so you can detect differences among groups.
It is used to make comparisons between two or
more groups.
Prototyping
Prototyping helps you get customer requirements
through feedback early in the development process,
before changes become more expensive.
Guidance on how to use prototyping for a design:
It is not simply building a smaller version or working
prototype of the end service or process. The purpose
is to gain the maximum amount of information as
early as possible in the design process. It is important
to focus on key questions, unknowns, or risk factors
that need to be explored with a prototype. Customers
and stakeholders seem to respond more to prototypes than illustrations and descriptions.
137
Concept Review
Conducted after two to three key concepts have
been identified and their feasibility has been
determined.
High-Level Design Review

Conducted after a selected concept has been
designed to some level of detail and tested, and
before detailed design begins. The high-level
design review is intended to review the capability
testing results to ensure that the design is expected
to meet the CTQs. Project management issues for
detailed design and high-risk areas are also
identified and discussed at this stage.
138
Review of Analyze Phase

At the end of the ANALYZE Phase, the following
are in place:
The concept generation, evaluation, and
optimization is directed to the creation of
value and quality as defined in the CTQ list.
Feasibility checked for the following:
Technology
Intellectual property
Safety and performance risk
Design for X adherence
Reliability
CTQ performance
Needed development effort
A proactive engineering approach is adhered
to maximize development success of the
concept; do-it-by-design when it is still
possible.
The optimal concept is selected.
check and agree that this product/service/
process method concept has maximal
chance to meet the design input requirements, and that we will be able to manufacture, repeat, and control the design. The
review team agrees on the future development strategy.
139
Deliverables for the ANALYZE Phase include:

The optimal concept, validated with customers
and stakeholders
Feasibility evaluation report
Residual risk; no showstoppers
Intellectual property strategy
Initial figures in the design scorecard
Sourcing site
Further development strategy
Go decision from the documented stage gate
review
140
CHAPTER FOUR DESIGN
IV. DESIGN in Detail

Introduction
The DESIGN Phase includes:

Developing a detailed service/process/
product design
Continuing to optimize the process to meet
quality, cost, delivery and safety goals
Developing process capability predictions
Developing control plans for pilot tests of the
design
Developing a Verification/Validation plan for
the design
141
CHAPTER FOUR DESIGN
IV.1 Work Out Detailed Designs

Flow-Down of Requirements
DEFINITION:
Translate CTQs and Priorities, Targets, and Specs
from overall product/process/service to detailed
designs.
Example:
Top-level Customer CTQ: My automated
report should be generated in 30 seconds.
What does that mean for my software, data
architecture, hardware, and data management?
Top-level Customer CTQ: Analysis result
given to customer within 3 workdays. What
does that mean to the process, organization,
and equipment in our analytical lab?
Top-level Customer CTQ: Product should
contain max 0.05% of impurity A. What does
that mean for the process parameters and
specs on the intermediate before?
How?
Qualitative: cascade of QFDs
Quantitative: statistical flow-down of
tolerances; experimentation
142
CHAPTER FOUR DESIGN
Flow-Up of Process Capabilities

DEFINITION:
The FEASIBILITY to attain the established targetstolerances. If not, revisit the design or change the
trade-offs between Xs.
Can we consistently manufacture the
product/deliver the service? Can the
suppliers consistently deliver materials of
that quality? - Process Capability
Is our measurement method accurate,
precise, specific, stability indicating enough?
- Method Capability
Does the product/service deteriorate over
time? - Stability/Reliability Profile
Model for Device:
Establish CUSTOMER
Costs and Quality Losses
Establish
PRODUCT
Requirements & Tolerances
Establish
PRODUCT
CAPABILITIES
Establish SYSTEM
Establish ASSEMBLY PROCESS

CAPABILITIES
Establish COMPONENTS
Establish COMPONENTS
CAPABILITIES
Establish
PROCESS
Tolerances
Establish
PROCESS
CAPABILITIES
Flow-up Capability
Requirements Flow-down
Establish CUSTOMER
143
CHAPTER FOUR DESIGN
Design Elements
There are seven design element categories that need
to be considered when designing any service or
process:
Service
Process/Methods
Information Systems
Human Systems
Facilities
Equipment
Materials
To aid in the development of the high-level design
for each design element there are:
Specific deliverables
Design principles
Design
Element
Se rvice
144
Specific
Deliverables
Design Principles
- De scrip tio ns/

d rawing s
- Le g al & re g ulato ry
imp acts
- Mo d e ls/p ro to typ e s
- Sp e cificatio ns
Have yo u co nsid e re d d e sig n

fe ature s that:
- Transfo rm the se rvice to
so me thing b e tte r o r
mo re d e sirab le ?
- Disting uish the p ro ce ss
o r se rvice ?
- Cre ate mo re value to
the custo me r?
- Make the p ro ce ss o r
se rvice e xp and ab le ?
CHAPTER FOUR DESIGN
Design
Element
Specific
Deliverables
Design Principles
Pro ce ss/
Me tho d s
- Pro ce ss
flo wcharts: SIPOC
- Pro ce ss
flo wcharts: activity
- Pro ce ss
d e p lo yme nt map s
- Fo cus o n inte ractio ns with

the custo me r, so calle d
"Mo me nts o f Truth"
- Fo cus o n Value -Ad d e d
activitie s
- Minimize re wo rk
- Minimize o r e liminate
ine fficie ncie s o r no n-value ad d e d activitie s
- Minimize insp e ctio ns
- Minimize variab ility
- Minimize hand o ffs
- Minimize p o te ntial
e rro rs/failure s
Info rmatio n
Syste ms
- Lo g ical d e sig n
- Physical d e sig n
- Hard ware d e sig n
- Te st p lan/so ftware
scrip ts
- Data mig ratio n
p lan
- Te st and
p ro d uctio n
e nviro nme nt
- Facilitie s ne e d e d
- Ob tain curre nt and o ng o ing

custo me r fe e d b ack
- Make ap p ro p riate
info rmatio n acce ssib le at
the wo rkp lace
- Auto mate co lle ctio n,
sto rag e , and transfe r o f
info rmatio n
- Clarify what info rmatio n is
ne e d e d , whe n it is
ne e d e d , whe re in the
p ro ce ss, and b y who m
- Ensure the re is time ly and
e asy acce ss to the
info rmatio n
145
CHAPTER FOUR DESIGN
Design
Element
Specific
Deliverables
Design Principles
Human
Syste ms
- Jo b /task analysis
- Erg o no mic
analysis
- Training d e sig n
- Re ward s and
re co g nitio n p lans
- Org anizatio nal
d e s ig n
- E mp lo y e e
d e ve lo p me nt
p lans
- Org anize aro und wo rk

p ro ce sse s
- Assig n re sp o nsib ilitie s fo r
co mp le te p ro ce sse s
- Mo ve d e cisio n-making to
the wo rkp lace
- Enlarg e and e nrich jo b s
- Match jo b s with skill le ve l
- Id e ntify and nurture co re
co mp e te ncie s
- Cre ate an e nviro nme nt fo r
intrinsic mo tivatio n
- Custo me r co ntact vs. o ff
p latfo rm
- Pro vid e o p p o rtunity fo r
care e r g ro wth
Facilitie s/
Site s
- Archite ctural
d rawing s
- Scale mo d e ls
- Co mp ute r mo d e ls
- Layo ut d iag rams
- Co mb ine ce ntralizatio n and

d e ce ntralizatio n
- Minimize mo tio n and
d istance s trave le d (utilize
SMED p ractice s)
- Org anize wo rksp ace in the
ap p ro p riate se q ue nce o f
the wo rk p ro ce ss
- Co nsid e r e rg o no mic issue s
such as lig hting , p ro p e r
b o d y me chanics, fatig ue ,
mo rale , d istractio ns
- Injury p re ve ntio n
- Pe rso n-machine
inte ractio ns
146
CHAPTER FOUR DESIGN
Design
Element
Eq uip me nt/
Mate rials
Specific
Deliverables
- De scrip tio ns/
d rawing s
- Sp e cificatio ns
- Fo rms d e sig ns
- Bill o f mate rials
- Purchasing and
inve nto ry imp acts
Design Principles
- Fo rm p artne rship with

sup p lie rs
- Minimize inve nto ry
- Maximize inve nto ry turno ve r
- Minimize fixe d inve stme nts
- Auto mate ro utine wo rk
- Ensure re liab ility and
maintainab ility o f ne ce ssary
e q uip me nt
147
CHAPTER FOUR DESIGN
Design for Manufacturability and

Assembly (DFMA)
DFMA is a method of analyzing design and saving
manufacturing and assembly costs.
An overview of the techniques to optimize the
relationship between design function,
manufacturability, and ease of assembly follows:
Traditional Design Approach
Initial concept
Design
Test/Prototype
Redesign
DFMA Approach (early in design process)
Various concept alternatives
Design alternatives
Evaluation against DFMA principles
Cost effective design
Minimal redesign
148
CHAPTER FOUR DESIGN
There are 14 key principles of DFMA:

1. Simplify Design/Reduce Number of Parts
Reduces probability for defects
Reduces fabrication and assembly costs
Makes automation more feasible
Inventory and WIP goes down
Reduces lead times and paperwork
2. Standardize Parts/Components
Easier to train people
Reduces inventory and WIP
Makes automation easier
Easier to develop suppliers for components
Increases interchangeability and availability
of parts
3. Simplify Fabrication
Processes are more compatible with materials used
Processes are more compatible with required volume
Avoids need for complex tooling
Decreases number of process steps
Reduces cost
4. Design Within Known Production Process
Capabilities
Reduces inspection activity
Makes it easier to develop suppliers
Reduces scrap and rework
149
CHAPTER FOUR DESIGN
Functions are not affected by assembly process

variations
5. Maximize Functionality Per Part/Component
Reduces cost
Makes assembly easier (could hurt serviceability)
Reduces cycle times
6. Mistake-Proof Design (Poka-Yoke)
Assembly becomes foolproof, fewer frustrations
Reduces inspection activity and defects
Self-testing (where applicable) saves time and
resources
Decreases/simplifies adjustments
7. Design for Ease of Assembly
Minimizes non-value-added manual effort
Pre-oriented parts facilitates automation
Minimal/easy handling of parts will cause less
damage
Gravity is used to aid, rather than hinder
assembly process
8. Minimize Flexible Parts and Interconnections
Parts less susceptible to damage
Fewer misconnected wires and cables
Flimsy materials are difficult to assemble and
handle
9. Maximize Accessibility
150
CHAPTER FOUR DESIGN
Tasks become less time consuming and

frustrating
Easy accessibility facilitates disassembly and
service/repair
Decreases life-cycle costs of the product
10. Design for Modularity
Facilitates sub-assembly processes
Allows for product variation
Reduces total number of parts
Modules can be tested before final assembly
Facilitates production scheduling
11. Design for Automation
Allows for robotic (high speed) assembly
Reduces cycle time and variability in repetitive
tasks
Increases reliability
12. Design to the Quality Standards of Operations
Typical for regulated industries
Operations subject to FDA inspections
13. Design for Scale-ability/Capacity
Typical for batch industries
Critical for biotech
14. Collaborate with Manufacturing Personnel on
the Design Team
Key principle of cross-functional development where manufacturing is brought in
early as part of the development team
151
CHAPTER FOUR DESIGN
Additional Information on Poka-Yoke

Poka-Yoke: loosely translated means mistake
proofing.
It is from Japanese:
yokeru: to avoid
poka: inadvertent errors
Key Attributes:
Respect for Worker Intelligence
Focus on Repetitive Activities that Rely on
Vigilance and Memory
Free Worker to Pursue Creative, Value-Added
Activities
Principles of Poka-Yoke
Elimination eliminate the possibility of error
Replacement substitute a more reliable
process for the worker
Facilitation make the work easier to perform
Detection detect the error before further
processing
Mitigation minimize the effect of the error
152
CHAPTER FOUR DESIGN
Design for the Environment (DfE)

DfE is a systematic process to identify and
minimize regulatory and public opinion risks and
environmental impacts of products and processes
throughout their entire life cycles.
DfE points to consider:
Prevent use of restricted or banned substances in products / processes / packaging
Insure that the product will adhere to
environmental regulations, such as electronic recovery, battery recovery, packaging
design
Avoid using materials of regulatory or public
opinion concern
Toxic metals
Endocrine disrupters
PVC
Minimize the environmental and public
concerns about end of life issues of the
product (recovery, degradation, disposal)
Design the product in an environmentally
friendly manner (reduce energy use, raw
material use and waste generation)
153
CHAPTER FOUR DESIGN
IV.2 Statistical Design

GOALS:
Optimize CTQ performance and reliability/
stability through experimentation
Understand, minimize, and control variation
Establish functional relationships between
ys and xs at various levels
154
CHAPTER FOUR DESIGN
Tolerance Analysis
1. Determine the high-level requirements
standard deviation necessary to meet the
specification limit and sigma level
2. Determine the relationship between the highand low-level requirements (i.e., transfer
function or other relationship)
3. Flow down the high-level standard deviation
to the low-level standard deviations
4. Convert the low-level standard deviation to a
tolerance (e.g., upper/lower specification
limits)
Design Process
Define
Define
Requirements
Requirements
Develop
DesignDesign
Develop
Assess
Capability
Assess
Capability
Not
OK
OK
Develop
MoreMore
Develop
Details
Details
(T o Operations)
155
156
Xs
FLOW-DOWN of Requirements
TARGET - TOLERANCES- ALLOWED VARIANCE
CONTROL PLANS
TOLERANCING of Xs
MSA on critical Xs
CHARACTERIZATION DoE
OPTIMIZATION DoE
SCREENING DoE: critical Xs ?
SOURCES of VARIATION
PRIORITIZATION
WORK OUT DETAILED DESIGN

PROCESS MAPPING
MEASUREMENT SYSTEMS
ANALYSIS (MSA) on Ys
Ys TARGET - TOLERANCES- ALLOWED VARIANCE
COMPRESSION MIXTURE
CHARACTERISTICS
CTQs
COMPRESSION
PROCESS PARAMETERS
TABLET CHARACTERISTICS
CHAPTER FOUR DESIGN
For NPD:
functional analysis
design principles
lean principles - value stream
best practices - benchmarks
DfX + reliability principles

FLOW-DOWN of Requirements
DETAILED
DESIGN ELEMENTS
Quality CTQs
Reliability CTQs
Delivery CTQs
Cost CTQs
OVERALL SERVICE
Quality CTQs
Reliability CTQs
Delivery CTQs
Cost CTQs
Xs
TARGET- TOLERANCES- ALLOWED VARIANCE
INSTALL CONTROLS: error proofing / standardization / documentation / training/ SLA/ control plans
TOLERANCING of CRITICAL Xs
IDENTIFY KEY CRITICAL XS (+MSA) and

OPTIMIZE DETAILED DESIGNS via
EXPERTISE
PROCESS ANALYSIS & OPTIMIZATION TECHNIQUES
SIMULATION & SENSITIVITY ANALYSIS
TESTING-EXPERIMENTS
IDENTIFY POTENTIAL SOURCES of VARIATION

PRIORITIZE
PROCESS MAPPING ON ACTIVITIES + THING
WORK OUT DETAILED DESIGN
SERVICE CONCEPT &

HIGH-LEVEL DESIGN
Ys TARGET- TOLERANCES- ALLOWED VARIANCE
CHAPTER FOUR DESIGN
For S&P:
157
CHAPTER FOUR DESIGN
Design of Experiments to Maximize CTQ

Performance
SCREENING
SCREENING
What
What are
are the
the important
important factors?
factors?
What
factors
What factors are
are not
not important?
important?
Direction
Direction for
forimprovement?
improvement?
Resolution III or
IV Designs
In
In the
the vicinity
vicinityof
of the
the optimum,
optimum,
CHARACTERIZE:
CHARACTERIZE: all
allmain
main factors
factorsand
and secondsecondorder
interactions
order interactions
Higher
Resolution
(Res. V Designs)
OPTIMIZATION:
OPTIMIZATION: Optimize
Optimize THE
THE process
process for
forthe
the
multiple
multiple responses.
responses.
Find
Find optimal
optimalsettings
settings ++tolerances
tolerances
Establish
Establish the
the Model
Modelequation
equation
Augment Design
to Response
Surface Methods
(RSM)
Optimize
Optimize or
of Confirm
Confirm ROBUSTNESS
ROBUSTNESS
RSM
Plackett-Burman
Designs
158
CHAPTER FOUR DESIGN
2-Level Factorial Designs for Screening

and Characterization
RESOLUTION OF 2 LEVEL DESIGNS
N umber of Factors
R uns
Full
III
16
Full
IV
III
III
III
Full
IV
Full
32
64
10
11
12
13
14
15
IV
IV
III
III
III
III
III
III
III
VI
IV
IV
IV
IV
IV
IV
IV
IV
IV
Full
VII
IV
IV
IV
IV
IV
IV
IV
Full
VIII
VI
IV
IV
IV
IV
128
Main
effects
Aliasing
2-way
interactions
Resolution III
aliased with
2-way interactions
and higher
Resolution IV
aliased with
3-way interactions
and higher
aliased with
main effects,
2-way interactions
and higher
aliased with
2-way interactions
and higher
Resolution V
aliased with
4-way interactions
and higher
not aliased
aliased with
3-way interactions
and higher
not aliased
Full Factorial
3-way
interactions
aliased with
main effects,
2-way interactions
and higher
aliased with
main effects,
2-way interactions
and higher
aliased with
2-way interactions
and higher
not aliased
159
CHAPTER FOUR DESIGN
Design Optimization Methodology

Response Surface Methods (RSM)
The response is denoted as:
y = f ( x1, x2 ) + error
The response surface shown here indicates a
maximum yield when considering two factors
time and temperature within the operating
window.
160
CHAPTER FOUR DESIGN
RSM Model
3 factors
augmented
110
100
Yield
90
80
70
-1.5
-1.0
-0.5
Time
0.0
0.5
1.0
1.5
0.0
-0.5
-1.0
-1.5
0.5
1.0
1.5
Temperature
161
CHAPTER FOUR DESIGN
STRATEGY OF RSM
Response Surface Designs (RSM) are
especially good for optimization and robust
designs.
Optimization - finding the best settings to
either maximize, minimize, or hit a specific
target.
Robust designs - making the product or
process insensitive to its environment.
These designs are often aimed at hitting a
target while minimizing variability.
RSM is basically an augmented factorial
design that describes the behavior of the
response (CTQ or requirement) across a
combination of the predictor variable
(factors). A three-dimensional model with
two predictors and one response can be
displayed by 3D surface plots.
162
CHAPTER FOUR DESIGN
ELEMENTS OF RSM STRATEGY

1. First-order model design.
To determine if the area of the optimum has
been reached.
Are we in the area of the optimum?
If Yes, conduct second order experiments.
If No, determine the most efficient path
toward the optimum, using the path of
steepest ascent, or using sequential
simplex optimization methods, the most
efficient direction toward the optimum.
FIRST-ORDER
163
CHAPTER FOUR DESIGN
2. Path of steepest ascent.

To determine the most likely and most
efficient direction toward the optimum.
What is the most efficient direction toward
the optimum?
The contour lines help determine a logical
direction.
Approach
Use the first-order model to create a
contour plot and a response surface.
Construct a perpendicular to the contour
lines in the direction of the maximum (or
minimum).
This direction will indicate the path of
steepest ascent toward the optimum.
The product moment correlation can be
used to calculate the direction.
Practical consideration and process
knowledge are key factors in the decision.
SECOND-ORDER AUGMENTED
164
CHAPTER FOUR DESIGN
3. Second-order model.
To apply more elaborate models to locate the
optimum.
A first-order design will detect curvature but it
cannot model that curvature.
The second-order design or response surface
design will model curvature by using quadratic or squared terms.
First-Order Function
Requires at least two data points
two levels for each factor.
Second-Order Function
Requires at least three data points three
levels for each factor.
165
CHAPTER FOUR DESIGN
MAIN EFFECTS & INTERACTIONS: ONLY MAIN

EFFECTS AND INTERACTIONS ARE IN THE MODEL
130
120
110
Y7
100
90
80
-1.5
-1.0
-0.5
X1
0.0
0.5
1.0
0.0
-0.5
-1.0
-1.5
0.5
1.0
1.5
X2
1.5
Contour Plot of Y7
95
105
115
125
X2
-1
-1
X1
FIRST-ORDER LINEAR MODEL

166
CHAPTER FOUR DESIGN
SECOND-ORDER OR QUADRATIC MODELS

WITH AN INTERACTION TERM
100
90
Y12
80
70
60
50
40
30
20
10
0
-1.5
-1.0
-0.5
X1
0.0
0.5
1.0
0.0
-0.5
-1.0
-1.5
0.5
1.0
1.5
X2
1.5
Contour Plot of Y12

45
70
X2
95
-1
-1
X1
Y = b0 + b1 ( x1 ) + b2 ( x2 ) b3 ( x1 ) b4 ( x2 ) b5 ( x1 x2 )
2
The models discussed here will meet the needs of the

designs required in most situations.
167
CHAPTER FOUR DESIGN
Central Composite Designs

Introduced by George Box and K.B. Wilson in an
article On the Experimental Attainment of Optimum Conditions (1951).
This paper produced Central Composite Designs
(CCDs) which served as the foundation for most
response surface designs.
They have the basic structure identified
previously.
Basic factorial design with axial or star points
added.
Twice as many star points as factors.
One star point for each face of the design.
Central Composite Designs (CCD) - Augmenting a factorial design with axial runs. These
experiments are determined based on an axis
through the center point of each two factor
combination.
CCC
CCF
168
CHAPTER FOUR DESIGN
Properti es of Central Composi te Design

Circums crib e d
(CCC)
- Ro tatab le
- Hig h q uality p re d ictio ns (lo w e rro r)
o ve r the d es ig n s pace
- Fac tor s e tting s b e yo nd o riginal
rang e
- Re quire s fiv e le ve ls fo r e ac h
fac tor
Fac e -Ce nte re d

(CCF)
- No t Ro tatab le
- Re lativ e ly g o o d q uality
p re dic tio ns
- Fac tor s e tting s are within the
o riginal rang e
- Re quire s thre e le ve ls fo r each
fac tor (fe we r runs)
- Re sp o nse surface is no t as
accurate as CCC o r CCI
169
CHAPTER FOUR DESIGN
The star points are from the center of the design

space. is determined based on the factorial points
in the design and is calculated as follows:
= [Number of points in the Factorial Box]
In the full factorial design 2k determines the

number of runs. k = the number of factors. The
following table shows the number of factors, the
number of points in the box, and the calculated
value for .
170
Number of
Factors in
Factorial Mix
Number of
points in the
Box
Scaled value for

relative to 1
4 (22)
2(2/4) = 1.414
8 (23)
2(3/4) = 1.682
16 (24)
2(4/4) = 2.000
32 (25)
2(5/4) = 2.378
64 (26)
2(6/4) = 2.828
CHAPTER FOUR DESIGN
CCD Practical Table

Number of Runs and default number of center
points (brackets) for Response Surface Methods.
For some designs it is possible to include blocks.
The number of blocks is, however, limited. It is
possible to adapt the number of center points.
If factors cannot be set at extremes, Box-Behnken
is another response surface method.
Type Design
General Full
Factorial with
3-levels
Central Composite Unblocked
Full
Blocked
2
9
3
27
Number of factors
4
5
6
81
243
729
7
2187
13 (5) 20 (6) 31 (7) 52 (10) 90 (14)
14 (6) 20 (6) 30 (6) 54 (12) 90 (14)
Central Composite Unblocked

Half
Blocked
32 (6)
53 (9)
33 (7)
54 (10)
Box-Behnken
(=3 level)
Unblocked
46 (6)
54 (6)
62 (6)
Blocked
46 (6)
54 (6)
62 (6)
15 (3) 27 (3)
-
27 (3)
171
CHAPTER FOUR DESIGN
Design for Robustness

DEFINITION OF ROBUST PROCESS:
A process where:
All responses are close to target
With minimal variation
Low sensitivity to the noise variables, i.e.,
the variables we dont control
PRINCIPLE:
Find the settings on controllable factors
where there is minimal transmission of the
variation from the controllable factors and
the noise factors to the CTQs
172
CHAPTER FOUR DESIGN
HOW:
Screen which noise variables and controllable factors are important
Set up a multiple response optimization on
mean + variance of the Y's to find the 'robust'
optimum
Honor DfX principles, Regulatory,
Quality, Compliance considerations in
your trade-off decisions
Aim to achieve the targeted quality by
settings of the Process Parameters =
"Quality for Free"
If not sufficient:
- we may need another grade of raw material =
may have a cost price.
- But, invest money in the right critical

parameter
Sensitivity Analysis:
"Which parameters are most responsible for variation on the outcomes?"
173
CHAPTER FOUR DESIGN
Mixture Designs
Factorial Design and Response Surface Modeling
assumes that the factors are independent of the
values of other factors.
A mixture design is used in constrained
experiments where ingredients are mixed in
various proportions; the response being
sensitive to the relative amounts of the
factors rather than the absolute amount. The
factors are therefore not independent and
must add to 100%.
MIXTURE EXPERIMENTS:
Tend to have higher-order designs such as
quadratic and cubic models.
Tend to identify complex relationships
among the components.
Often include the entire operability region as
the experimental design space.
Simplex designs are regularly sided figure with k+1
vertices for k factors.
They are used to study the effects on the
response variable (y) based on the mixture of
the components.
174
CHAPTER FOUR DESIGN
Two types of Simplex designs are widely used:

1. Simplex lattice designs
A lattice is a web, a net, network, or pattern.
The experimental region is defined by 0 X i 1.
Therefore, simplex lattice designs are based on
very orderly, equally spaced patterns of experimentation, much like factorial designs.
2. Simplex centroid designs
A centroid is a center point.
Simplex lattice designs explore the boundary of
the design space while simplex centroid designs
explore the interior of the design space, as well.
175
CHAPTER FOUR DESIGN
{3,2} Simplex Lattice

3 factors and 3 equally spaced experiments.
Note: Only pure blends and two-factor experiments are conducted.
X1 = 1
X2 = 1
X3 = 1

The number of points in this type of design is:
N =
176
(p + m 1)!
m!(p 1) !
CHAPTER FOUR DESIGN

3 factors and 4 equally spaced experiments.
X1 = 1
1 2
xi = 0, , ,1
3 3
X2 = 1
X3 = 1
x1 , x2 , x3 = (1,0,0) , (0,1, 0) , (0, 0,1) , (1/3,1/3,1/3) , (2/3, 0,1/3) ,

(0,1/3, 2/3) etc.
When selecting a design, it is important to consider
the maximum order of the fitted model required to
adequately model the response surface.
Mixture experiments frequently require a higherorder model than is initially planned. Therefore, it is
usually a good idea, whenever possible, to make
additional runs beyond the minimum required to fit
the model.
Augmentation is a way to add additional experiments in the interior of the model and will give more
information about the shape of the response surface.
177
CHAPTER FOUR DESIGN
Tolerancing
Statistical Tolerancing - Methods
1. Worst Case Analysis
2. Root Sum of Squares (RSS)
3. General Non-linear Variance Decomposition
4. Monte Carlo Approach
5. Sensitivity Analysis
6. Shelf-life Trend Analysis
Error Allocation - Methods
1. Standard Deviation Analysis
2. Other Techniques
METHOD
Mean, StDev
% R&R
Accuracy
Observed PROCESS
@ Release & Shelf-life
Mean, StDev
Accuracy
Cp, Ppk
Short-Term Defect Rate
Long-Term Estimations
% P/T
FEASIBILITY
REQUIREMENTS
SPECIFICATIONS
LSL,Target, USL
DEMANDS of
Down-stream
Guidelines & QA
Safety-Efficacy
178
CHAPTER FOUR DESIGN
Root Sum of Squares

APPLICATIONS:
More Realistic Estimate of Y Variability
Than Worst Case
Used for Additive Y = f(x) Relationships
(e.g., Y = x1 + x2 + x3 )
Employs Property of Additivity of Variances
PROCESS:
1. Determine Critical Parameter (Y) for Root Sum
of Squares Analysis
2. Establish Functional/Mathematical Relationship Among Assembly Components
( y = f (x1 , x2 , x3 x4 , ... x N ) )
3. Determine Mean Values for Components;
Use Relationship (Step 2) to Determine Mean
of Critical Parameter
4. Determine the Standard Deviation Values for
Components (e.g., Tolerance/3 May Be
Employed)
5. Determine Standard Deviation for Critical
Parameter:
sY =
s12 x1 + s22 x 2 + s32 x3 + L + sN2 x N
179
CHAPTER FOUR DESIGN
Worst Case Analysis

Applications:
Useful Early in Design Process (Back-of-theEnvelope Calculations)
For Simple Assemblies of Few Components
Process:
1. Determine Critical Parameter (y) for Worst
Case Analysis
2. Establish Functional/Mathematical Relationship Among Assembly Components
( y = f (x1 , x2 , x3 x4 , ... x N ) ), Linear, NonLinear)
3. Determine Mean Values for Components
4. Determine Worst-Case Values for Components (e.g., Nominal +/- 3 Standard Deviations)
5. Determine Worst Case Value for Assembly
Critical Parameter
180
CHAPTER FOUR DESIGN
General Non-Linear Variance

Decomposition
Application:
General Case of Root Sum of Squares (RSS)
Used When Y = f(X) relationship is Not
Linear
Process:
Same as Root Sum of Squares, Except
Standard Deviation of Y is Found by:
2
f 2
f 2
f
s + K
s2 +
s Y =
X1
X2
x
x1
x 2
n
1/ 2
2
2
s
Xn
1/ 2
f 2
s 2X
s Y =
i x i i
where :
f
- Partial Derivative of Y = f(x) wrt xi
x i
181
CHAPTER FOUR DESIGN
Reliability Tests
Failure Truncated Test
(All data represents times to failure)
In this case, the 1 - confidence interval (for a 95%
confidence interval, is 5% or 0.05) is:
2 t i
MTBF
x (1 a / 2,2r )
where :
t i are the times to failure
2
2 t i
x (a / 2,2r )
2
r is the number of failures

MTBF is mean time between failures
HALT Highly Accelerated Life Test

Application of Step-Stresses to system to quickly
uncover failure modes; root causes determined and fixes
determined; rapid, iterative approach saves time and
cost over Test-Analyze-And-Fix (TAAF).
HASS Highly Accelerated Stress Screens

Continuous process of stressing components and
assemblies during production; combines six-axis vibration, tickle vibration, power cycling, other stresses with
thermal; powered-on monitoring is essential; reduces
production costs, warranty cost (Dead-on-Arrival and
infant mortality).
182
CHAPTER FOUR DESIGN
Weibull Analysis of Failure Data

Advantages of Weibull:
Let the Data Select the Best Distribution and Fit
the Parameters! Chameleon Distribution Fits a
Wide Variety of Life Data Sets
Works with Extremely Small Samples (Even
Two or Three Data; WeiBayes Technique Deals
With No Failures!)
Wide Body of Application Research Knowledge
Weibull is three parameter distribution:
183
CHAPTER FOUR DESIGN
Weibull Steps:
1. Rank Order the Time to Failure Data (Lowest
to Highest)
2. Establish Median Ranks for Each Failure
3. Plot Points (X Time, Y Median Rank) on
Weibull Probability Paper (see next page)
4. Draw a Line Through Points
- Find Rise/Run (Use a Ruler)
- Intersection (on X-Axis) of Fitted
Line and 63.2% Cumulative
Probability
184
CHAPTER FOUR DESIGN
WEIBULL PROBABILITY PAPER

Cumulative Probability of Failure (%)
99.9
63.2
rise
run
0.1
10
100
Time (or Cycles) - Log Scale
- Data Point
185
CHAPTER FOUR DESIGN
Arrhenius Stress Relationship

In considering accelerating time to failure, testing
under normal stresses is not practical for long-lived
items. Testing at higher stresses induces failures in
less time, but what correlation exists between stress
and life?
Arrhenius relationship employed to model product
life as a function of temperature.
Arrhenius rate reaction equation suggests product
life is inversely proportional to temperature.
This Motivates the Arrhenius Life Relationship:
Taking the natural log of the Arrhenius life
equation:
TTF = Ae E/kT ln (TTF ) = ln A +
E 1
k T
Where TTF is the rate coefficient, A is constant, E is

the activation energy or the minimum energy needed
for the reaction to occur, K is the universal gas
constant (8.314 x 10-3 kJ mol-1K-1), and T is the
temperature (in degrees Kelvin).
186
Temperature Scale
Linear in Inverse
Absolute Temperature:
Log Scale
for Life:
Product Life
(Hours)
0
25
50
75
100 125
Temperature ( C )
150
200
250
300
CHAPTER FOUR DESIGN
187
CHAPTER FOUR DESIGN
MEOST Multiple Environment OverStress Testing

Provides assurance of product reliability over design
stress conditions (No-Failure Test), then overstresses
device to determine reliability under worst-case
conditions (Weibull Analysis of Overstress Failures).
By experiment or experience, identify the
significant few (3 to 5) stressors on the product.
These can be either environmental stress or
those applied during use.
Identify the easiest and hardest value for each
stressor within the intended application. The
difference is the normal range. If possible, use
the 97.5th percentile from customer surveys.
By experiment or experience, identify the
stressor which (by itself) induces product
failure with the least overstress range. Least
is judged as a percentage of the normal range,
the difference between hardest and easiest
value.
Divide this overstress range into 10 steps and
use this as the overstress step size for simultaneously increasing all stressors beyond the
black dot.
Precondition eight units using the worst case
environment any product will see before
reaching the customer. This may involve
sterilization, temperature, vibration, etc.
Starting with the least stressful (easiest) value
for each stressor, simultaneously increase these
188
CHAPTER FOUR DESIGN

stressors to reach the maximum (hardest)

customer values at the black dot. This may
be done in four or five steps.
Continue into the overstress region by
simultaneously increasing all stressors in the
ten predetermined steps beyond the black
dot.
Record all failures and use Weibull Analysis to
compute reliability at the maximum customer
values; at the black dot.
MEOST is useful for single-use products or
when mission time is short enough to allow
actual testing beyond specifications.
Failures which do not occur until a particular
stressor is fairly high, with one stressor
applied at a time, will occur at lower levels
with multiple stressors applied, simultaneously.
Failures in the guaranteed customer region
must be corrected. Failures in the overstress
region may be corrected depending on their
severity, cost of corrective action, and other
factors.
Reliability is quantified using Weibull Analysis
to verify that product is good enough.
189
CHAPTER FOUR DESIGN
190
Normal Operating
Region
Black Dot
in
arg
M
ty
afe
MEOST
CHAPTER FOUR DESIGN
Stability Testing:
For products that change over time (i.e., degrade) such
as pharmaceuticals or drug-device combination
products, stability trend must be factored into setting
specifications. The modalities are described in the
guideline ICH Q1E on Statistical Analysis and Data
Evaluation for quantitative stability data. The
guideline describes the rules on pool-ability of the data
from different batches, factors, etc., (Note: If the data
cannot be pooled the worst case must be taken.), how
shelf life can be estimated by regression analysis and
rules for a limited extrapolation beyond real-time.
The determination of shelf life and specifications is
often an iterative approach. Shelf life is the time where
the confidence limit on the stability trend regression
line intersects the shelf-life specification limit:
191
192
in the context of
the entire organization
monitoring
plan of action
Managing the process end-to-end

instead of in organizational silos
Reason for control is to assess and

stabilize, providing the framework for
continuous process improvement
Focus on actionable steps and

integration with day-to-day
management
CHAPTER FOUR DESIGN
IV.3 Control the Process
Process Control Plan
A process control plan is a well-defined plan of

action for monitoring processes in the context of
the entire organization.
CHAPTER FOUR DESIGN
A process control plan consists of five elements:

Structure and composition of process
management team
Documentation of key processes, including
test methods, if any
Critical metrics such as process specifications for ingredients or components for
monitoring performance (Ys & Xs)
Data collection, analysis, and reporting plan
Intervention and process improvement
strategy
193
CHAPTER FOUR DESIGN
Control Chart Selection Tree

Start
Type
of data
?
Discrete
Proportions
(defectives)
Counting
proportions
or counting
occurrences?
Continuous
Need to
detect small shifts
quickly?
Occurrences
(defects)
Yes
No
No Equal
sample
sizes
?
Equal
opportunity
?
No
Yes
Either/Or
p chart
np chart
Individual
measurements
or subgroups
?
Rational
Subgroups
u chart
Do limits
look right?
No
Try individuals chart
194
Yes
Yes
c chart
Individual
measurements
Individuals
chart
EWMA
chart
X, R chart
I-MR-R/S
Yes
Do limits
look right?
No
Try transformation to make data normal
CHAPTER FOUR DESIGN
Pre-pilot Design Review

Conducted when the detailed design is complete and
the product/service/process is ready to be piloted.
The pre-pilot design review tests for completeness of
the design (i.e., ensuring that nothing is left out) and
evaluates the results of any tests conducted in the
detailed design stage.
It is conducted when the detailed manufacturing
design is complete and the service is ready to be
piloted.
195
CHAPTER FOUR DESIGN
PARTICIPANTS AT A PRE-PILOT REVIEW ARE:

Design team: The team responsible for the
design. If a separate design review is
conducted for each design element, the team
may be the sub-team responsible for the
particular piece of the design, along with
some representation from the overall team.
Implementation team: If the design team is not
responsible for implementation, this is the
team that will take the product/service/
process from pilot to general availability.
Process management team: The team responsible for managing the service when it is in
operation. Since the control plan should be
developed at this stage, participation by the
process management team is critical to
ensure that a smooth transition from design
to process management takes place.
Operational employees: These are the people
responsible for operating the process when
it is implemented. Examples would be
assembly line supervisors, customer service
agents, maintenance specialists, and anyone
else whose day-to-day work would be
impacted by the new service. Participation
of these people is important for change
management.
Pilot partners: Participants from the pilot test
sites and any customers identified to take
part in the pilot.
196
CHAPTER FOUR DESIGN
PRE-PILOT REVIEW OBJECTIVES:

Ensure completeness of design: Different elements of
the design are usually the responsibility of different
sub-teams, who may be working independently with
their own individual requirements. The design review
process should ensure that nothing remains incomplete.
Integration of design elements: Completion does not
always imply integration. For example, the design of
the processes and the IT systems may be complete, but
the IT systems may not completely support the
processes. This is especially true when the design is
made up of a mixture of new and existing technologies.
The design review process should, where appropriate,
ensure that the design elements are properly integrated.
Failure points: FMEAs should have been completed on
the critical aspects of the design. The results of these
FMEAs should have identified areas where, despite the
predicted results, testing using real data is necessary.
These areas should be targeted in the pilot plan.
Reviewing pilot and implementation plans: Making
sure that adequate timing has been allowed for pilots,
that systematic data collection and analysis methods
have been developed, and that the implementation plan
is structured to incorporate the findings of the pilot.
Reviewing control plans: Making sure that the process
control system is completely designed and that data
collection, analysis, and intervention plans are in place.
197
CHAPTER FOUR DESIGN
Review of the Design Phase

At the end of the DESIGN Phase, the Development
Strategy is in place:
1. All remaining risks are mitigated to acceptable or as-low-as-reasonably-practical risk
level.
2. Flow-down of requirements/Flow-up of
process capabilities.
3. Requirements (CTQs) are deployed upstream and process capabilities are checked
downstream.
4. DfX principles are honored in the work-out,
optimization, and trade-off decisions of the
detailed designs.
5. Statistical design: statistical experiments
used to understand, predict, and control
variation as well as maximize the chance of
meeting CTQ performance, reliability/
stability, and manufacturability goals.
6. The new process is piloted to improve both
solution and implementation.
198
CHAPTER FOUR DESIGN
Deliverables for the DESIGN Phase include:

Comfort Level: all data, residual risk, and
investigations prove that we have a good
product/service, use procedure, and process
Documentation: the cascade of critical parameters is fully documented
Design Review: the organization and independent reviewers agree that the product/service/
process is ready for transfer/upscaling. The
review team agrees on the future development
strategy
199
CHAPTER FOUR DESIGN
200
CHAPTER FIVE VERIFY & VALIDATE
V. Verify & Validate

Introduction
The Verify & Validate Phase includes:

Analyzing root causes of verification &
validation pilot test failures and determining
countermeasures
Making a scale-up decision based on validation tests
Transferring the product/service/process
design to operations
Continual Improvement
201
Definitions:
Note: The terminology used can differ from one J&J
sector to another. However, the following controls
are mainly performed:
Design Verification confirms that the product/
service/process meets the design requirements
(Targets and Specifications).
Key Question to ask: Was the product/service/
process designed right?
Design Validation means establishing by objective
evidence that the product/service/process conforms
to customer needs and intended use(s). It is performed under defined operating conditions on
manufacturing/steady-state processes. It includes
testing of the product/service/process under actual
or simulated use conditions.
Key Question to ask: Did we design the right product/service/process?
Design Transfer means ensuring and establishing by
objective evidence that the design is correctly
translated into production specifications/steadystate process parameters.
Scope of Verification
Customer
Requirements
Design
Input
Measure,
Analyze,
Design
(MAD)
Design
Output
Product/
Service/
Process
Scope of Validation
202
V.1 Plan & Conduct Verification &

Validation Activities
Important Note:
Follow the SOP's, Policies, and Guidelines of your
company where applicable. The current section
only gives a high-level overview of what is typically done across industries. Note that the topics
in V.1.1 and V.1.2 are presented in the order of their
occurrence.
203
V.1.1 Design Verification & Validation in

NPD
A general requirement prior to V&V activities is adequate process design or development. This includes:
Establishment of in-process controls and
product specifications
Establishment of process robustness
including the effect of process parameters
on the process
In addition to adequate design and development effort, there are general plant/supply
chain preparatory activities and projectspecific preparatory activities.
204
The plant (J&J or contract) must have a

compliance system according to the sector it
belongs (Drugs, Medical Devices, Cosmetics,
Biologics, Combined device and drugs,
diagnostics, etc.). Sections in the compliance
system include but not limited to:
1. Product Development
2. Validation
3. Training
4. Quality Involvement
5. Auditing
6. Contract Facilities
7. Laboratory Control
8. Product Stability
9. Change Control
10. Investigations
11. Material Control
12. Quality Systems and Annual Product
Reviews
13. Customer complaint handling
205
Project Specific Preparatory Activities:

Plant, suppliers, contractors:
- Compliance and Quality systems audit
Manufacturing and Packaging:
Facilities and Utility systems validated for
intended use
Equipment qualified for intended use
Computerized systems/Automated GMP
Process validated for intended use
Raw materials/components and Suppliers qualified for intended use
People extra trained and qualified for
intended process
Cleaning procedure validated for in
tended use
Testing:
Lab equipment and data systems qualified/validated for intended use
People trained and qualified
Test Methods validated and successfully
transferred
Reagents and Standards: specified,
qualified, and characterized, and
approved
206
Equipment Qualification:
Note: The definitions for IQ, OQ, and PQ can
be different in your sector.
Installation Qualification (IQ)
- Establishing documented evidence that
process equipment and systems conform
to design specifications and regulatory
requirements.
- Elements to be considered include:
safety, environmental compliance,
equipment design requirements, verification that equipment conforms to engineering drawings and specifications,
calibration requirements maintenance
procedures, Ergonomics (e.g., repetitive
motion), Cleaning, Safety Features,
training, spare parts and related documentation, and GMP compliance.
Operational Qualification (OQ)
- Establishing documented evidence that
the equipment and process are effective
and reproducible at the plant site. This is
accomplished by challenging Process
Parameters to assure product/service
meets all defined requirements, and
worst case testing.
207
Additionally, OQ demonstrates that local

conditions do not negatively impact the
process and/or operational limits, tolerances, etc. A successful OQ test initiates
the pre-production phase of the plant startup.
- Elements to be considered include: DOE,
Process Capability Studies, Process
Control Limits, Software Parameters,
Material Specifications, Process Operating Procedures, Preventive Maintenance,
Training, Cleaning & Calibration
Performance Qualification (IQ)
- Establishing documented evidence under
routine and challenged conditions of
operation, that the equipment/system
continues to operate as expected and
that the outcome of processing is
acceptable.
- Elements to be considered include:
Process Stability/Repeatability, Attributes
for continuous monitoring and maintenance, Process challenges which include
range of Conditions allowed in SOPs;
Repetition of challenges to assure results
are meaningful and consistent; Analysis
of process data for variation. (Note:
Challenged condition = demonstrate
reliable performance at the limits of
acceptable operating conditions.)
208
Plan and Protocol:

Document the V&V plan and procedures
in controlled documents before V&V
begins
Protocol:
- Establish acceptance criteria for the
V&V event before the V&V begins: i.e.,
testing parameters, limits of acceptability, and methods of analysis for equipment, process, and resulting product
- Predetermine parameters for multiple
runs according to valid test procedures
During/After the V&V:
Demonstrate that the product of the
process, or equipment system meets the
predetermined quality characteristics for
multiple runs according to valid test
procedures
Demonstrate that the:
- V&V event has been performed as
planned
- Outcome meets predetermined specification, and event has been documented,
reviewed, and approved according to
established procedures
209
V.1.2 Design Verification & Validation

Activities in S&P
Verification testing may include simulations, walkthroughs, or other pre-production versions of the
service/process. Test the complete design exercise all functions and processes. Conduct
verification tests according to approved written
protocols.
Software Verification Testing:
Unit and string integration test:
Unit: check test results against expected
results, and correct errors
String test: verify communication between
programs or application components
(prior to integration test)
User acceptance testing: simulates actual
working conditions of new system (including
user manuals & procedures). This type of
testing also supports user training and
provides feedback to programmer/designer.
Other types of software testing:
Component - some or all of the components tested, all program externals tested,
based on project specs
Performance - testing using typical user/
system resource loads - measured
against CTQs
210
Regression - ensures addition of new

features/functions does not introduce
problems with existing system functions
Stress - investigates behavior of software/
hardware in and out of ordinary operating
conditions
Software Validation:
Software is evaluated and reviewed against
the software specifications during ongoing
development of the service/process.
When the "final" production-version service
is ready, the software and associated
processes are validated to make certain
specifications are met.
Before testing the software in actual use, the
detailed code should be visually reviewed
versus flow charts and specifications.
All cases, especially decision points and
error/limit handling, should be reviewed
and the results documented
In all cases, algorithms should be checked
for accuracy.
211
Hardware/Software Validation:
The testing includes normal operation of the entire process/service. This phase of the validation
pro-gram may be completed before software
validation to make certain that the process/
service meets the basic performance and safety
specifications.
Concurrently or afterward, the overall service
(including processes, hardware, "human ware"
and software) should be challenged with abnormal inputs and conditions, including:
Staff errors;
Induced failure of service components;
Exposure to expected environmental conditions;
Power losses and restart (e.g., information
systems);
Simultaneous inputs or interrupts; and,
As appropriate, deliberate application of
extremely high input values (e.g., volumes,
transaction rates).
212
V.1.3 Design Transfer

Controlled, planned transfer of the fully documented processes from the source department to
the receiving department. This includes but not
limited to:
Transferring and documenting the transfer
of:
1. Specifications and Test Methods
2. Development Reports
3. Batch Records: documents to manufacture
and test lots
4. SOP's + Work Instructions
Training operating company personnel
Documenting the evidence of successful
transfer against an approved protocol with
predetermined acceptance criteria on the
equivalence between sourcing and receiving
department: e.g., Method transfer
Note that when there is a difference in process
equipment between source department and the
receiving department, first a process characterization will have to be run.
213
Where DEx tools can help:
List of Changes and Differences

between Pilot Plant and Launch Plant
and its supply chain
Risk Analysis (FMEA)

Critical steps
Critical inputs
Insufficient Control
Proven Critical
parameters from Development
New potential critical

Sources of Variation
Gaps in Control Plan
Studies to define/confirm the final critical parameters and final process settings
Actions to mitigate the risks to broadly acceptable or adequately reduced
214
V.2 Evaluate Results: Iterate Design

After verification and validation data has
been collected and the results verified, the
team could determine the next steps toward
solution implementation. Only after an
objective and comprehensive assessment of
the data can responsible "next step" decisions be made. Some questions a team
should ask upon the completion of the V&V
to help guide them toward identification of
the proper next steps are:
Did the V&V have anticipated results?
Was the plan for conducting the V&V
effective?
Can the solution be implemented "as-is"?
What lessons learned and best practices
can we apply during solution implementation?
Did the solution achieve the required
design goals?
If the team determines that the design goals
have been verified, then planning full-scale
implementation can commence. If not, then
the team should choose to make another
turn of the PDCA cycle, until design goals
are met.
215
V.3 Scale-up and Launch

Once pre-pilot review followed by successful pilot
efforts are complete, project teams typically embark
on scale-up and launch of the new product/service/
process. The Launch and logistics flow are finalized
in this step to ensure strategic capacity coverage and
to ensure Launch Readiness and Sustainability.
Ensure proper delivery of launch quantities (on time,
correct quantities, etc.). The first step is to create a
Scale-up and launch plan that includes:
(1) The full scale implementation plan for each
element which should include: Objectives, A
list of major activities and their target dates,
Who will be responsible for each activity, A
description of the methods and resources they
will use and Identification of the critical path.
(2) The plan for ongoing Process Management
should contain the following: Clarification of
the process roles (process owner, process
management team, process review team) and a
plan for who will fill those roles, a plan for
transition from the design team to the implementation team, a starting draft of the Process
Control System Chart with major categories of
process and checks, a draft of the dashboards
that will be used to manage the process on an
ongoing basis (What will be measured, How
will it be tracked etc.) and an explicit plan to
calculate and review process sigma when the
design is completed.
216
(3) Training plan that typically include: List of

what information needs to be transferred, a
plan to develop materials used in training,
a description of the audience for the training
and an assessment of their training needs, a
plan for how training will be spread throughout the appropriate people in the organization and a plan to test the effectiveness of the
training.
(4) Typical communication plans include: An
explanation of the business case for the new
product/service/process, a Whats In It
For Me? analysis, a description of how the
effort is supported by company leadership
and a review of the implementation and
training plan
Technology Transfer
Technology transfer is typically linked with new
product development. It can be described as The
seamless and effective transfer of process knowledge from Project Teams to Operations/Deployment group(s) to achieve a vertical startup curve
and sustain world-class final project objectives. It
includes effective transfer of products, associated
supply-chain processes and knowledge. The
benefits are depicted in the figure below:
217
Design History File (DHF)

The DHF shall contain or reference the records
necessary to demonstrate that the design was developed
in accordance with the approved design plan and
associated requirements. Basic design history
incorporates the following:
Detailed design and development plan specifying design tasks and deliverables.
Copies of approved design input documents and
design output documents.
Documentation of design reviews.
Validation documentation
When applicable, copies of controlled design
documents and change control records.
For additional information on Design History Files can
be typically found in company-specific procedures.
218
Next Steps
The steps following after V&V are Monitor, and
Optimize. During this period the following activities
are typically performed:
The quality, reliability, manufacturability, and
market penetration of the product/service is
permanently monitored.
Out-of-Specs (OOS)/out-of-trends (OOT),
deviations and complaints are prioritized
according to risk and proper actions are
initiated to prevent harm. Documented
investigations are started to find the true
cause, to eliminate the problem and
prevent recurrence.
Opportunities for further optimization are
identified.
Relationship between full-scale long-term
process performance is compared with
what was predicted during development
to improve the prediction models.
Feedback on the launched commercial
product/service/process is gathered
from external & internal customers, and
stakeholders.
Lessons' learned are captured and used
for future developments.
219
Verify & Validate tips

It is recommended that project teams focus on the
following during Verify & Validate phase of Design.
The outputs (Ys) and Inputs (Xs) (And Their
Variation!)
Active communication between Design Teams
and Operations/Deployment group(s) including
suppliers Dont Wait to Involve them until just
prior to Design release
Treating Process Verification and Process
Validation as activities with different objectives.
Use of lots of Process Excellence tools and
available methods Theres No Magic Bullet
Performing a Lessons Learned evaluation at
project closure in addition to celebration of
success.
220
Review of Verify & Validate Phase

At the end of the Verify & Validate Phase, the
following are in place:
Transfer/upscaling (either before or after
V&V); reconsider need for re-characterization, verification, validation
Final
Process instructions and use instructions
Control plan in accordance with the list of
critical parameters
Independent reviewers check and agree on
readiness for V&V
Verification testing
Validation testing
Finalize all development documentation, risk
summary report, and deviation investigation
documentation
check and agree the product/service/
process is ready for launch
221
Deliverables for the Verify & Validate Phase include:

Documented verified and validated process
and product
Finalized manufacturing and control specifications
Design history file
Transfer file
Risk summary report
Deviation summary report
Registration file
222
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ACKNOWLEDGEMENTS

DEx Pocket Guide

Representations of Design Excellence and NPD linkage in MD&D

Pre-Launch & Scale-Up

Global New Product Process (GNPP) + DEx

Validate the refined

Design the product

DEx Key Tools and Method

Idea Generation &

Finalize the commercial product, I. e.,

Prepare the market,

Sales Launch Planning

Launch the product.

Evaluate the performance of the

Process Improvement Stra tegy

Johnson & Johnson

Johnson & Johnson 2005

Overview of Phases of DEx

II. MEASURE Requirements

Johnson & Johnson 2005

VERIFY AND VALIDATE

Johnson & Johnson 2005

Johnson & Johnson 2005

WHICH METHODOLOGY BEST FITS

List of Tools Used in DEx for New Product

A ctiv ity flow charts

which tool is most

Failure truncate d tes ts

Phase of NPD DMADV2 in

Multi-g e ne ratio nal Plan

Phase of NPD DMADV2 in

Johnson & Johnson 2005

So lution mapp ing

Johnson & Johnson 2005

Phase of NPD DMADV2 in

List of Tools Used in DEx for Service &

A ctiv ity Flo w Charts

Phase of S&P DMADV2 i n

Phase of S&P DMADV2 i n

Phase of S&P DMADV2 in

Johnson & Johnson 2005

CHAPTER ONE DEFINE

The main purpose of the DEFINE phase is to define

CHAPTER ONE DEFINE

Johnson & Johnson 2005

CHAPTER ONE DEFINE

The Opportunity Statement describes the benefit

Effective Team Dynamics

CHAPTER ONE DEFINE

3. believes that working as a group leads to more

Johnson & Johnson 2005

CHAPTER ONE DEFINE

Something you don't

Responsibility (RACI) Chart: When the team is

Johnson & Johnson 2005

CHAPTER ONE DEFINE

Multi-Generation Plan (MGP)

Vision Long-term direction for the product or

Johnson & Johnson 2005

CHAPTER ONE DEFINE

Johnson & Johnson 2005

CHAPTER ONE DEFINE

Johnson & Johnson 2005