Lean Six Sigma for the Healthcare Practice

Lean Six Sigma for the

Healthcare Practice

A Pocket Guide

Also available from ASQ Quality Press:

The Certified Six Sigma Green Belt Handbook

Roderick A. Munro, Matthew J. Maio, Mohamed B. Nawaz, Govindarajan

Ramu, and Daniel J. Zrymiak

Six Sigma for the Office: A Pocket Guide

Roderick A. Munro

Six Sigma for the Shop Floor: A Pocket Guide

Roderick A. Munro

Automotive Internal Auditor Pocket Guide: Process Auditing to

ISO/TS 16949:2002

Roderick A. Munro

The Certified Six Sigma Black Belt Handbook, Second Edition

T. M. Kubiak and Donald W. Benbow

Applied Statistics for the Six Sigma Green Belt

Bhisham C. Gupta and H. Fred Walker

Statistical Quality Control for the Six Sigma Green Belt

Bhisham C. Gupta and H. Fred Walker

5S for Service Organizations and Offices: A Lean Look at Improvements

Debashis Sarkar

The Executive Guide to Understanding and Implementing Lean Six

Sigma: The Financial Impact

Robert M. Meisel, Steven J. Babb, Steven F. Marsh, and James

P. Schlichting

Transactional Six Sigma for Green Belts: Maximizing Service and

Manufacturing Processes

Samuel E. Windsor

Defining and Analyzing a Business Process: A Six Sigma Pocket Guide

Jeffrey N. Lowenthal

The Certified Manager of Quality/Organizational Excellence Handbook,

Third Edition

Russell T. Westcott, editor

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Lean Six Sigma for the

Healthcare Practice

A Pocket Guide

Roderick A. Munro, PhD

ASQ Quality Press

Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203

Printed in the United States of America

15 14 13 12 11 10 09 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Munro, Roderick A.

Lean Six Sigma for the healthcare practice : a pocket guide / Roderick A. Munro.

p. cm.

Includes bibliographical references and index.

ISBN 978-0-87389-760-0 (soft cover, spiral bound : alk. paper)

1. Six sigma (Quality control standard) —Handbooks, manuals, etc.

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ISBN: 978-0-87389-760-0

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Printed in the United States of America

Printed on acid-free paper

This book is dedicated to the Quality

Improvement Coaches (QICs) and Primary

Care Providers (PCPs) in Michigan

who have embarked on the Improving

Performance in Practice (IPIP) process.

The State of Michigan has combined the

reporting requirements of the Patient-

Centered Medical Home and the national

IPIP into one reporting process to

reduce redundancy and to focus more on

improvements in healthcare quality.

Most especially to the many overloaded,

stressed-out healthcare professionals who

may feel that they can not take on one more

task or new patient. The methodologies and

tools found in this book will help you.

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vii

Contents

Acronym List ............................. xi

Preface.................................. xiii

Acknowledgments ........................ xv

Suggested Use of This Book................. xix

The DMAIC Matrix Guide................... 1

What Is Lean Six Sigma? ................... 5

Your Role in Lean Six Sigma ................ 11

What Is Variation? ........................ 17

Things You Might Be Involved With.......... 25

The DMAIC Model ........................ 29

Teams ................................... 41

The Lean Six Sigma Road Map for

the Practice ........................... 47

Summary ................................ 49

Tools.................................... 53

7S ................................... 53

Advanced Practice Quality Planning

(Healthcare APQP)................... 58

Auditing (Sampling, Sampling Plans) ...... 62

Benchmarking . . . . . . . . . . . . . . . . . . . . . . . . . 66

Brainstorming ......................... 71

Business Operating System (BOS) for

Healthcare Organizations ............. 76

Cause-and-Effect Diagram (Fishbone

Diagram, Ishikawa Diagram) .......... 79

Check Sheets .......................... 84

Continual Improvement (Kaizen,

Kaizen Events) ...................... 89

Cost–Benefit Analysis (Cost of Quality,

Quality Cost, Cost of Poor Quality,

Return on Investment) ............... 93

Cycle Time Analysis ..................... 98

Failure Mode and Effects Analysis......... 101

Flowchart (Flow Map, Process Map,

Current State/Could Be/Should

Be Map)............................ 113

Histogram ............................ 118

Kanban (Wait Time, Patient Pull-

Through)........................... 122

Lessons Learned ....................... 124

Management Involvement ............... 126

Measurement Systems Analysis (MSA) ..... 129

Mistake-Proofing (Error-Proofing,

Poka-Yoke) ......................... 133

Pareto Chart........................... 136

PDSA Cycle (Plan–Do–Study–Act) ......... 141

Practice Strategy (Future State) Project

Planning ........................... 145

Problem Solving ....................... 148

viii Table of Contents

Table of Contents ix

Process Behavior Charts (Statistical

Process Control) ..................... 152

Process Identification ................... 158

Process Improvement (PI) ................ 160

Run Chart ............................. 163

Scatter Diagram........................ 166

SIPOC Diagram......................... 170

Standard Operating Procedures (SOPs) .... 173

Standardization (SDCA—Standardize–

Do–Check–Adjust) ................... 175

Systems Thinking....................... 177

Team Meetings (Huddles) ............... 181

Teams (Employee Involvement,

Improvement, Self-Directed) .......... 185

Value Analysis ......................... 192

Value Stream Map (VSM) ................ 195

Variation Reduction .................... 199

Visual Controls, Aids .................... 202

Voice of the Customer (Patient

Feedback) .......................... 204

Walkaround/Walkthrough/Waste Walk .... 207

References............................... 211

Index ................................... 217

(This page intentionally left blank)

Acronym List

7S—sort, set-in-order, shine, standardize,

sustain, safety, oversight

8D—eight disciplines to problem solving

APQP—healthcare advanced practice quality

planning

BOS—business operating system

C&E —cause-and-effect diagram

CI—continual improvement

COPQ—cost of poor quality

COQ—cost of quality

CPHQ—Certified Professional in Healthcare

Quality

CQIA—Certified Quality Improvement

Associate

DMAIC—define, measure, analyze, improve,

control

FMEA—failure mode and effects analysis

xii Acronym List

IPIP—improving performance in practice

IPO—input, process, output

ISO—International Organization for

Standardization

LCL—lower control limit (see “Process

Behavior Chart”)

M P CC—Michigan Primary Care Consortium

MSA—measurement systems analysis

PCMH—patient-centered medical home

PCP—Primary Care Provider

PDCA—plan–do–check–act

PDS A—plan–do–study–act

PI—process improvement

QIC—Quality Improvement Coach

ROI—return on investment

RPN—risk priority number (see “FMEA”)

SDCA—standardize–do–check–adjust

SIP OC—supplier, input, process, output,

customer

SOP—standard operating procedure

SPC—statistical process control

UCL—upper control limit (see “Process

Behavior Chart”)

VSM—value stream map

xiii

his book is a continuation of a series of

works started by the author, referred to as

QUIT—“Quality in Training.” It is hoped

that through this ongoing series people will be

helped in finding joy in the work that they do,

leading to healthier, happier lives.

A Zen Buddhist text on The Art of Living

states:

The Master in the art of living makes little

distinction between his work and his play,

his labor and his leisure, his mind and his

body, his education and his recreation,

his love and his religion. He hardly knows

which is which. He simply pursues his vision

of excellence in whatever he does, leaving

others to decide whether he is working or

playing. To him he is always doing both.

It will be left to the reader to decide at what point

the author is/was doing each in this text.

Preface

xiv Preface

We are discussing the concept of healthcare

quality sometimes called “quality of care and

services.” In this book, our focus is on how well

the organization performs the many activities

and functions involved in patient care. The term

“quality of care and services” is not limited to the

technical quality of care provided to patients;

“quality of care and services” is a broader, more

general category that includes not only the tech-

nical quality of care, but also includes how well

patient service needs are met.

If you would like to make comments to

the author about this book, please contact him at

authors@asq.org.

s in any work, a lot of people were

involved in developing this book. I would

like to thank all the class participants,

suppliers, and peers that I have worked with in

the past 30 years. I continue to learn from all

your input.

I especially would like to thank Dr. Dean H.

Stamatis and Dr. Elizabeth J. Rice for their years

of friendship and their encouragement and sup-

port of this work.

Thanks also go to the staff at ASQ Quality

Press and the reviewers for their time, efforts,

and support in making this book a reality. Thanks

especially to Paul O’Mara and Matt Meinholz for

their ongoing support of this series.

Special thanks goes to the Michigan IPIP team

of professionals. The Healthcare Improvement

Model on page xvi is a summary of some of the

early work that has been accomplished in assist-

ing Practices toward healthcare improvements.

Acknowledgments

xvi Acknowledgments

DS/C

Health system

professionals

Community

Facilitate the project

using best processes

“Lean” the practice

Solve problems/

breakthrough improvement

Quality and lean

professionals

Informed,

activated

patients

Project

management

Needs

assessment

Team building

7 wastes

Kaizen

Value stream

Current state

Future state

DMAIC

Process mapping

5 whys Root cause analysis

Measurement systems

FMEA

Visual controls

Waste walk

Value analysis

Error-proofing

Pull systems

Quick changeover

Standardized work

Set up controls

Kanban

Scoping

Cost of poor quality

Scheduling

Brainstorming

ROI

Training

Leadership

Productive

interactions

Improved outcomes

Patient-Centered

Medical Home

Prepared,

proactive

practice team

I would like to especially acknowledge the follow-

ing individuals:

Dr. Walt Talamonti, MD, Chair, Michigan

IPIP Steering Committee

Dr. Ernest Yoder, MD, Vice Chair,

Michigan IPIP Steering Committee

Dr. Joseph Fortuna, MD, Medical

Champion

Rose Steiner, RN, Director, Michigan IPIP

Dr. Kevin Piggott, MD, Chair, IPIP

Learning Collaborative

Quality Improvement Coach team volunteers:

Lou Ann Lathrop (General Motors), Chair

John Casey (Whitehall Group)

John Katona (Delphi)

Dave Lalain (AIAG)

Victor Lloyd (St. John Health)

Rebecca Snyder (Ford Motor Company)

Advisor to Michigan MPCC/AIAG IPIP process:

Barry Klein (GlaxoSmithKline

Pharmaceuticals)

Acknowledgments xvii

(This page intentionally left blank)

xix

his book is for those in the Practice or

staff activities of your organization whose

customers/payers may be encouraging or

requiring you to use Lean Six Sigma in your

workplace or to simply improve the way health-

care is being provided. The book is intended to

be a basic, easy-to-read, quick and handy ref-

erence to the process improvement topics that

are so important in healthcare (page xx shows

a Venn diagram of tools found in this book). The

first seven sections of the book cover the basics

of Lean Six Sigma (“What Is Lean Six Sigma? ”

through “Lean Six Sigma Road Map for the Prac-

tice”) and how it can be applied and implemented

in the Practice. The tool matrix guide beginning

on page 2 has been arranged alphabetically for

ease of finding tools as needed. The remainder of

the pocket guide gives a brief description of the

various tools and methodologies used in Lean

Six Sigma. Each discussion has purposefully

Suggested Use of

This Book

xx Suggested Use of This Book

been kept short and simple to allow for a basic

understanding and includes some tips on how

or when to use the tool. If more detail is needed,

other references can be consulted to realize the

full impact of the tool.

Everyone in the organization, from the janitor

to the senior executive or Practice oversight com-

mittee, should know the basic information found

in this book. Some have felt in the past that this

type of information belonged only on the manu-

facturing floor. Today we have learned that there

is probably more opportunity within the Practice

than ever thought before (Berwick and Leape

Problem identification

Value stream map

Flowchart

Value analysis

Check sheet

Voice of the

customer

Histogram

Scatter diagram

Process

behavior chart

Measurement

systems analysis

Cycle time

Audit

Sampling

Pareto chart

Run chart

Stratification

Cause-and-effect chart

Brainstorming

Visual controls

Visual aids

Problem analysis

Venn diagram of tools covered in this book.

Suggested Use of This Book xxi

1999). Especially since many healthcare practi-

tioners have received a large amount of scientific

training, the use of statistical tools to improve

processes in healthcare and quality of care and

services should be a natural combination.

Persons who can pass a designated test, either

internally created or one of many offered by var-

ious organizations, can be designated as Lean

Six Sigma Green Belts. Green Belts work with

teams to gather data and to analyze, improve,

and control the processes in the Practice. People

who become exceptionally expert in the use of

the Lean Six Sigma methods and processes and

who pass advanced testing are called Lean Six

Sigma Black Belts. Black Belts use experiments

and other advanced tools to help solve especially

difficult problems.

Your Practice may or may not have a Black

Belt (a full-time or part-time person dedicated to

doing Lean Six Sigma in your Practice). However,

everyone should become involved in continual

improvement efforts to help ensure your organiza-

tion’s survival and the improved care and health

of patients. Some process improvements can be

very simple to identify and implement while

others may take some time for the staff to fully

understand the dynamics of the issues involved.

These improvement efforts can be accomplished

by using this book and the tools within it to guide

your improvement projects.

xxii Suggested Use of This Book

In addition, you may deal with customer audit

personnel, government auditors, people desig-

nated as “rent a Black Belts,” or other coaches or

consultants to help with the advanced aspects of

Lean Six Sigma. By using all the resources that

are available, you can help your Practice stay

competitive in today’s global marketplace.

One of the biggest challenges in the Practice is

to allow time to understand the use of these tools

and to start collecting the data and information

that will be needed to make continual improve-

ment efforts a reality. Everything can be defined

as a process, and processes can be measured so

that they can be monitored for improvement. In

the past, you may not have thought about how to

measure work that is done in the Practice. Keep-

ing an open mind will be paramount to the suc-

cess of Lean Six Sigma in your Practice and to

making your work easier and more fulfilling.

Experience has shown that the journey can be

fun and rewarding for those who get honestly

involved in using the improvement tools and

methods. This effort is the “how to” of learning to

“work smarter, not harder!”

The DMAIC

Matrix Guide

he DMAIC model (shown in Figure 1) is

referred to throughout this book. The acro-

nym stands for define, measure, analyze,

improve, and control. The reader will find the

Verify

Design

SDCA SDCA

PDSAPDSA

PDSA

MeasureControl

Improve Analyze

Define

Practice strategy

Employee involvement

Team meetings

Figure 1 The DMAIC model.

2 The DMAIC Matrix Guide

following matrix helpful as he or she matches

particular tools and approaches to particular

phases in the DMAIC process.

When used

in Lean

Name of tool/approach Six Sigma Page

7S DMAIC 53

Advanced practice quality planning D 58

Auditing DMAIC 62

Benchmarking MA 66

Brainstorming DAI 71

Business operating system (BOS) DMAIC 76

Cause-and-effect diagram DMA 79

Check sheets MA 84

Continual improvement AIC 89

Cost–benefit analysis DMAIC 93

Cycle time analysis DMIC 98

Failure mode and effects analysis DIC 101

(FMEA)

Flowchart DAI 113

Histogram M 118

Kanban IC 122

Lessons learned DIC 124

Continued

The DMAIC Matrix Guide 3

When used

in Lean

Name of tool/approach Six Sigma Page

Management involvement DMAIC 126

Measurement systems analysis MC 129

(MSA)

Mistake-proofing IC 133

Pareto chart M 136

PDSA cycle (plan–do–study–act) MAI 141

Practice strategy DMAIC 145

Problem solving I 148

Process behavior charts DC 152

Process identification D 158

Process improvement I 160

Run chart MC 163

Scatter diagram MAI 166

SIPOC diagram DM 170

Standard operating procedures IC 173

(SOPs)

Standardization DC 175

Systems thinking DI 177

Team meetings DMAIC 181

Teams D 185

Value analysis MAC 192

Continued

4 The DMAIC Matrix Guide

When used

in Lean

Name of tool/approach Six Sigma Page

Value stream map D 195

Variation reduction IC 199

Visual controls, aids IC 202

Voice of the customer DC 204

Walkaround/walkthrough/ DMAIC 207

waste walk

What Is Lean Six Sigma?

L6s

ean Six Sigma is a term describing the

overall concept of continual improvement

of everyday processes (Deming 1993). Con-

tinual improvement can be defined as the use of

problem-solving techniques and quick deploy-

ment to implement improvements, and then the

use of process behavior charts (Wheeler and

Poling 1998) to maintain the gains. Lean Six

Sigma is about strategic alignment, applied

learning, and culture or belief system transfor-

mation that uses four distinct but interrelated

characteristics: a strategy deployment approach,

a belief system, a statistical calculation, and a

suite of project improvement methods (Caldwell,

Brexler, and Gillem 2005). Lean Six Sigma is

being used in many organizations today in a

variety of applications (for example, schools, hos-

pitals, and private Practices). Basically, Lean Six

Sigma is about collecting data on a process and

using that data to analyze and interpret what

6 What Is Lean Six SIgma?

is happening in that process so that the process

can be improved to better satisfy the customer. A

basic process can be defined as an input, trans-

formation, and output (see Figure 2).

Lean Practice is simply the banishment of

waste. It is the elimination of waste by better

organizing and managing customer relations,

the supply chain, product development, and ser-

vice activities. Many service organizations, espe-

cially the larger ones, have been designed with

the idea of creating large service runs over short

periods of time (sometimes resulting in repetitive

checking of work done)—typically called mass

production. In Lean Practice, the organization

develops a process for processing/producing just

what is needed, as it is needed, by the patients/

customers that eliminates waste in time, energy,

effort, rechecking/verifying, inventories, mate-

rial handling, storage, and so on. This process is

also called the pull concept because the patient/

customer “pulls” what is needed from the suppli-

ers or Practice instead of the supplier making and

stockpiling large quantities until the customer

decides it wants some, as in mass production.

Transformation

(Process)

Input Output

Figure 2 The process model.

What Is Lean Six Sigma? 7

So, bringing these two concepts together we

get Lean Six Sigma for Healthcare. This is a pro-

cess that uses continual improvement techniques/

methodologies to eliminate waste in the Practice.

Waste is defined as anything that stifles health-

care staff personnel or patients, or results in

lost time, productivity, or simply sitting around

an office waiting for something to happen. But

is this really important in the way healthcare is

delivered today?

Dr. Donald Berwick has stated, “With the

rising complexity and reach of modern medi-

cine have come startling

levels of risk and harm

to patients” (Berwick and Leape 1999). Many

people who work in healthcare may not recog-

nize the things that they do as being part of a

process. Since they do not work repetitively as a

person in a factory running a machine, the Prac-

tice employee might be tempted to say, “I do not

have a process.” A process does not have to be a

repetitive task done exactly the same each and

every time. When we come into work each day,

we have general tasks that we do every day. The

specific items may change or be done in different

sequences; however, we do have procedures that

we follow to get our work done. This is what we

will be looking at and studying throughout this

guidebook.

Lean Six Sigma started at Motorola in the late

1980s as Six Sigma on the shop floor (process) and

8 What Is Lean Six SIgma?

then moved into the front office (transactional).

What we know today as Lean Six Sigma for

Healthcare has been honed with the addition

of lean methodologies at General Electric and a

growing number of other organizations. Following

a prescribed process, an entire organization starts

to look at everything that it does in the light of

reducing variation and waste—with the result

of increasing customer satisfaction. Customers

are defined as anyone from the next person who

uses the work we do (internal customer) to the

ultimate customer who uses the products or ser-

vices that our organization produces (external

customer). To assist in this process, sometimes

the supplier and customer are added to the basic

process flow (input, transformation, output),

creating the SIPOC (supplier, input, process,

output, customer) identification. This is espe-

cially useful in helping to define the boundaries

of what is to be studied (see Figure 3).

FeedbackFeedback

Transformation

(Process)

Input Output

Supplier Customer

Figure 3 The SIPOC model.

What Is Lean Six Sigma? 9

For some, the idea of improving a process

is a waste of time and should not be bothered

with (“we are already working the hardest that

we can”). Lean Six Sigma is not about working

harder, it is about working smarter! Juran (1964)

points out that the work we do is a result of the

fact that “changes creep up on us week by week,

a little bit at a time. Over a year or two, there

are 50 or 100 of these bits, which amounts to

quite a bit. The skills of the staff or managers

have not necessarily kept pace, and we wake up

to the existence of a wide gap.” This is one expla-

nation for why accidents and procedural errors

happen in healthcare today. If the root cause is

found for an accident or rejection of a product or

service, it usually can be traced back to either

many small changes that occurred in our orga-

nization or something having been omitted acci-

dentally between healthcare units.

Using Lean Six Sigma methodologies, we can

find those bits of change and decide which ones

should be fixed/modified and which ones need to

be improved. This process is not meant to be a

quick-fix (silver bullet) approach to the health-

care industry or individual patient care. The

methodical use of the tools over time will save

resources and effort (and lives) in doing our daily

jobs. This book provides an overview of the tools

and processes used in Lean Six Sigma. Detailed

explanations of the use of each tool or process can

10 What Is Lean Six SIgma?

be accessed readily in other references or on the

Internet. For many readers, this book will serve

as a quick reference to what you may already

have in your Practice that can be used by indi-

viduals and teams to improve overall processes.

Your Role in

Lean Six Sigma

n the Lean Six Sigma problem-solving pro-

cess, you may find a number of tools and

methods that you are already familiar with

and a few that are new to you. You may very well

ask, “How is this any different from what we

have done before?” The direct answer will need

to be given by your organization, and it depends

on the various programs that have already been

used. For many Practices, the Lean Six Sigma

effort is part of an ongoing evolution of how they

do their work to improve patient care. One of the

main things that you should notice is that every-

one will be more involved with problem-solving

efforts and with the everyday problems found in

patient care.

As we prepare for this exciting journey, first

look at Figure 4. What would you predict as the

golfer’s next score if you were looking only at

the top box of numbers? Maybe a golf score

within the range 100 to 105 would be a good

12 Your Role in Lean Six Sigma

guess. Could you say anything about the golfer

in general? Now take a look at the graph of the

same numbers (this is called a run chart), and a

lot of information becomes very clear. Your new

estimated score for game number 205 might be

within the range of 92 to 97. You could also say

that up through game 180 the golfer was rela-

tively consistent, scoring around 120. But then

something happened—maybe lessons were

taken, new clubs bought, or a new grip started

to be used—and things began to improve. The

Which provides more insight?

What is your prediction for game number 205?

Game number 180 185 190 195 200 205

Golf score 112 119 102 104 100 ?

Golf Scores

Game number

Score

125

115

105

170 190185180175 195 200 205

Figure 4 More insight.

Your Role in Lean Six Sigma 13

golfer still has not stabilized from whatever hap-

pened and may improve even more. The graph

should be continued to monitor the golfer’s prog-

ress. Thus, as the saying goes, this one picture (a

run chart) is worth a thousand words. Now think

about the large number of “scores”—patient tests

or numerical values—that we have in healthcare

for a patient. The human body is also a system,

and by using some simple graphs we can work

with patients to help improve an individual’s

system (process) of health. One quick note here:

if we record a patient’s vitals in an electronic

system (that is, registry, spreadsheet, database),

then the computer can give us these graphics

with a couple of simple clicks.

During the change process, and while using

this book, you will be able to use the Lean Six

Sigma model for improvement. It has been shown

that by following a model or road map we can

usually accomplish something much quicker

than we can without a guide. Some organizations

today use a model called MAIC (measure, ana-

lyze, improve, control) as a road map. They refer

to this process as being able to do “magic” with-

out the G (garbage) that we find in many activi-

ties. Many organizations have added a D (define)

stage at the beginning of the model to identify

the customer process, resulting in the DMAIC

model (see Figure 5), which is commonly used in

the Lean Six Sigma approach.

14 Your Role in Lean Six Sigma

You may already use run charts, check-

lists, process sheets, standard operating proce-

dures, or any number of other such techniques in

your daily work. The use of the Lean Six Sigma

model for improvement should not replace any-

thing you’re currently doing. It should, however,

help you to review your daily work and look for

areas or methods to improve the process that

customers/patients want and need. Just because

we are doing the same things we have done

before, do our customers/patients still want the

same things from us? How many handwritten or

typed letters, memos, scripts, and so on, do you

Practice strategy

Employee involvement

Team meetings

Verify

Design

MeasureControl

Improve Analyze

Define

Figure 5 The DMAIC base model.

Your Role in Lean Six Sigma 15

see in a typical Practice today? Most work is now

done on computers and sent electronically.

We are beginning a journey of continual

improvement that can be used in our work and our

daily lives. Some of us have been on this journey

for some time while others may just be starting.

The process involves using what Deming (1993)

refers to as profound knowledge: appreciation

for a system, knowledge about variation, theory

of knowledge, and psychology. By following the

Lean Six Sigma methodology for improvement

you should see things around you work better, be

safer, and satisfy your customers more.

(This page intentionally left blank)

What Is Variation?

ariation is the basic principle that no two

things are exactly alike. There are usu-

ally many reasons for things not being

constant. Have you ever noticed while driving

that your vehicle does not stay exactly the same

distance between the white and yellow lines?

What causes this variation? Of course most of

us drive well, and the lines are on the road to

help us get to where we want to go without run-

ning into other vehicles or the ditch. But if we

could measure our vehicle’s distance between the

lines, we would find that minor drifts do occur

on a regular basis (common cause variation). If a

police officer pulls us over, however, some of the

reasons for drifting too far (special cause varia-

tion) might include these: wind velocity with a

high-profile vehicle, alcohol or drug involvement,

cell phone usage, inexperienced driver, poor

weather conditions, worn or damaged tires, or

other factors. The author was once pulled over by

18 What Is Variation?

the police because he was driving too close to the

white line. It seems that in that area, this could

only mean that the driver had been drinking

at the local casino! However, on dark, foggy

nights, the author prefers staying close to the

white line to give oncoming drivers more room on

two-lane country roads.

Similar things happen in healthcare. We have

procedures for how to do the work, but small

variations or personal preferences can and will

cause differences in the output of the process.

A common way to describe this is with the for-

mula Y = f(x), or Y equals the function of the x’s.

Graphically, this is most easily seen when using

the cause-and-effect (fishbone) diagram. The

effect (the head of the fish) is the “Y” of the for-

mula, and the causes (the bones of the fish) are

the x’s. Note that this process will actually help

improve creativity in your Practice as the inputs

will become less varied and the activities can

become more robust for the customer outputs, or

patient care.

The traditional view of quality (sometimes

called the goalpost mentality—see Figure 6)

depicts the way many people regard varia-

tion when dealing with processes (for example,

blood pressure, HDL, LDL). It shows that some

processes (or items that are used) are clearly per-

formed within specifications or tolerances while

others are outside of specifications. There is no

What Is Variation? 19

relationship called out for Y = f(x), but the ques-

tion that should be asked is “What is the ‘real’

difference within the process or between a ser-

vice that is just inside the specification (a) and

another that is just outside the specification (b)?”

(See Figure 7.) Two competing services (say two

overnight delivery services) may be very simi-

lar and probably will function equally well when

used by your Practice. That is one of the reasons

companies who use this traditional model con-

tinue to provide services even if they are just out-

side the spec limits (that is, time of the actual

delivery)—because they think they can get a few

more sales to the customer and the deficiency

will not be noticed. This usually happens during

heavy office workload times when temporaries

are brought in and not trained very well.

No good Good No good

Loss No loss

Target

value

Lower

specification

limit

Upper

specification

limit

Loss

Response

Figure 6 Traditional view of quality.

20 What Is Variation?

A different perspective on variation can be

seen in the Taguchi loss function model (see

Figure 8). This updated view of quality states

that all services (or processes), measured by the

x’s, should aim for a target value that is located

Target

value

Lower

specification

limit

Upper

specification

limit

Figure 7 Part goodness.

Target

Loss

Response

Poor Poor

Fair Fair

Good Good

Best

Figure 8 Taguchi loss function model.

What Is Variation? 21

at the middle of the specification limits (which

reflect customer expectations or healthcare spec-

ifications). In this case, services that are not

centered but similar to each other (for example

how well a report is written or the variation from

the expected wait time for a service) have nearly

the same “loss” to the customer (who may be a

manager or patient) and will not be accepted very

well if at the outer boundaries of the graph. As

the services offered move away from the target

value, the cost to the patient/customer (which

includes internal customers within the health-

care process), and thus society, increases as

issues or problems within the patient or with the

use of that service increase. The goal today is to

reduce variation (both common cause and special

cause—to be discussed later) so that the patient

feels better or the customer will see more service

delivery that is closer to the target value of what

they want versus what we can provide.

Recently, in ordering business cards from a

national office supply chain store, the author expe-

rienced a good example of poor service. The first

order was taken by a very knowledgeable sales-

person and was processed quickly and efficiently.

Then a couple of weeks later at the same store a

second order for a different card was placed. The

logistics manager for the store took the order

the second time and was totally unfamiliar

with the order process. Instead of a pleasant and

22 What Is Variation?

quick experience in ordering a simple item, the

experience was a long, drawn out, grueling effort

that left the author very frustrated and ready to

walk out of the store!

Another service example of the Taguchi loss

function is when people pay money to attend a

public seminar. The seminar is advertised to last

eight hours. If the seminar ends before the eight

hours, people may feel that they did not get their

money’s worth. If the seminar drags on beyond

the eight hours, people become upset because they

could miss their airplane, car pool, kids waiting

to be picked up, and so on. Thus, the seminar

leader must ensure that the attendees’ expecta-

tions are met within the boundaries advertised

and within the attendees’ wants and needs.

A patient may have been coming to a Practice

for a long period of time, and annual blood work

has shown that their HDL and LDL have been

within acceptable limits. Then, all of a sudden,

the numbers are not acceptable and a script is

written to help improve the numbers. However,

the cause of the just-out-of-specification num-

bers may be due to any number of variables rang-

ing from what the patient may have consumed,

contamination of the sample process, reading

of the blood work, or the instruments used to

make the measurements. However, if the annual

values of the HDL and LDL were available to the

What Is Variation? 23

doctor and patient in run chart format, then the

patient’s body process could be reviewed first to

see if there is something going on in the patient’s

life that actually requires medication, or to point

to a potential faulty reading and the need for

retesting.

Note: Be aware of the difference between

variation and variability. Variability comprises

three components: variation (discussed earlier),

instability (when a process has high amounts

of unknown [special cause] variation), and off-

target conditions (which happen when a process

is not centered between the engineering specifi-

cations) (Bajaria and Copp 1991).

(This page intentionally left blank)

Things You Might

Be Involved With

our Practice may be using Six Sigma or

another quality methodology: lean office,

business operating system (BOS), contin-

uous improvement (CI), total quality manage-

ment (TQM), or a system known by some other

name. As a staff worker or supervisor of a pro-

cess, you will be asked by your Practice man-

agement to help implement improvement of the

activities or procedures that you work with. Your

challenge will be to look at the process with an

eye toward both simple improvements, which you

may already know need to be made (cleanliness,

too many signature requirements, information

just sitting around, recording data into a regis-

try, and so on), and how you can measure certain

factors to investigate better ways of performing

the process.

You will be asked to use the tools in this book,

and maybe others, to study your work area and

activities or procedures to look for improvement

26 Things You Might Be Involved With

ideas and ways to implement those ideas. You may

already be familiar with some of these tools; the

challenge will be in learning how to use them in

new ways to help your Practice to meet up coming

rule changes by payers, insurance programs, and

state or national programs or regulations.

Many of us find that by using a model or frame-

work we can do things more simply—“a picture

is worth a thousand words.” This is also true

when trying to improve processes. Dr. Kaoru

Ishikawa (the man who created the fishbone dia-

gram—see Figure 13, page 80) gave us a road

map to follow when first looking at a process that

needs to be improved. The words may not make

much sense right now, but as you work with pro-

cess improvement, you will come to understand

the importance of what is said here.

POINTERS IN

EXPRESSING QUALITY

1. Determine the assurance unit. (What is

to be measured?)

2. Determine the measuring method.

(How will we measure it?)

3. Determine the relative importance of

quality characteristics. (Is this key to

our process?)

Things You Might Be Involved With 27

4. Arrive at a consensus on defects and flaws.

(Does everyone agree on what is good

and bad?)

5. Expose latent deficiencies. (Look at the

process over time.)

6. Observe quality statistically. (Use process

behavior charting.)

7. Distinguish between “quality of design”

and “quality of conformance.” (Ishikawa

1976)

After we know what we can change (quality of

conformance) versus what we can not change

right now (quality of design—this is left to the

Design for Six Sigma [DFSS] process), we can

start working on our processes. Many Practice

personnel start out viewing this effort as only

more work, but many find that doing these stud-

ies actually saves them a lot of time and grief in

the future as things start to improve, work flows

better, and patients actually see results and

feel better. One question to ask yourself right

now is “How often does my process slow down or

stop because something is not working the way

it should?” Or “Is the output ever significantly

changed or even disregarded by someone down

the line (including my external customer/patient)

because something did not happen right at my

activity?” Note that this last question does not

28 Things You Might Be Involved With

ask if the business needs changed, which may

have caused the instance of variation. Working

on things that no one uses happens a lot for staff,

and dealing with this and the changing business

needs is also part of DFSS.

The next section discusses the DMAIC model,

where you will learn when to most appropri-

ately use the methods and tools presented in

this book to improve your or the patient’s pro-

cesses. As we proceed, please continue to keep an

open mind and be willing to experiment with the

tools. Be willing to look for ways to apply them in

your activities and procedures to learn as much

as you can about how a process operates. Also,

you may be expected to show patients, by use

of the graphical tools, how their health is being

affected, given the measurements that have been

taken over time. You will then be able to mod-

ify your work or instruct the patient as appropri-

ate and give your organization and your patients/

customers the best possible outcome.

The DMAIC Model

hroughout this book, you’ll find a number

of approaches and/or steps to assist you

in applying the tools or methods being

discussed. For the implementation of Lean Six

Sigma, a model has emerged that is well recog-

nized and which you’ll need to use in your Prac-

tice to show customers that Lean Six Sigma is

being used. The DMAIC model (see Figure 9)

stands for define, measure, analyze, improve, and

control, and is very similar to the PDSA (plan, do,

study, act) or PDCA (plan, do, check, act) models

that you may have heard of or are already using.

A key factor in each step of DMAIC is keep-

ing the focus of the Practice strategy in mind so

that all of the healthcare staff can work with the

methodology and focus the time and resources

to accomplish each of the phases and strive for

continual improvement. This is one of several

driving forces that make Lean Six Sigma differ-

ent from other quality improvement programs.

30 The DMAIC Model

Other driving forces include getting everyone in

the healthcare system involved (patients, pay-

ers, employers, and so on), getting the informa-

tion technology group to assist in supplying data

more quickly to everyone, and getting finan-

cial data in the form of cost-of-quality analysis.

Research (Stamatis 1996) is showing that many

organizations are finding more opportunity for

improvement to the bottom line in the office

than currently exists on many plant production

floors.

Practice strategy

Employee involvement

Team meetings

Verify

Design

SDCA SDCA

PDSAPDSA

PDSA

MeasureControl

Improve Analyze

Define

Figure 9 The DMAIC model.

The DMAIC Model 31

Staff personnel at all levels will be asked to

get involved with the Lean Six Sigma model and

look for continual improvement opportunities in

work areas. Basically, you will do the following:

Define Identify the issue causing

decreased customer satisfaction.

Measure Collect data from the process.

Analyze Study the process and data for

clues to what is going on.

Improve Act on the data to change the

process for the better.

Control Monitor the system to sustain

the gains.

An example:

1. Select one important problem that you

have in the Practice.

2. Draw a flow diagram, or similar tool, of

the issue—how does it currently work?

3. Get concurrence from everyone who is

involved in that process that the flow

diagram is accurate. This in itself can

be a painful process of getting concurrence

and may actually solve some of the issues

as this process gets people aligned.

32 The DMAIC Model

4. Look over the flow diagram and ask

“Given what we know today, is this the

most effective way to do this?”

5. Make changes to the process as necessary

and update the process flow diagram

(note: this tool now becomes a simple job

aid, reminder, or training tool on how

that process works). Caution: be careful

about throwing technology at problems.

The process must work well first before

you computerize it. Otherwise, you

will only get the same problems as before—

only faster.

6. Now review the process and ask “What

could this process be?” or “How could this

process be more effective?”

7. Seek management approval and funding

for future changes.

8. Update the process flow diagram to match

the new flow. Train everyone in the new/

updated process flow using the flow

diagram/chart.

See Figure 10.

A number of tools and methods can be used in

the steps of the DMAIC model. This book gives

a quick overview of many of these items as they

relate to potential areas for improvement. More

The DMAIC Model 33

detailed information can be found in quality

control/assurance books, on the Internet, or in

quality improvement magazines or journals. The

DMAIC model uses the following tools:

Define

Advanced practice quality planning

(healthcare APQP)

Auditing (sampling, sampling plans)

Brainstorming

Business operating system (BOS)

Cause-and-effect diagram (fishbone

diagram, Ishikawa diagram)

Look for

opportunities

for

improvement

Get staff

concurrence

Create

flowchart

Select

issue

Update

system

and train

staff

Future

improvements

Ask key

questions

Update

flowchart

Figure 10 Process improvement flowchart.

34 The DMAIC Model

Cost–benefit analysis (cost of quality,

quality cost, cost of poor quality, return

on investment)

Cycle time analysis

Failure mode and effects analysis (FMEA)

Flowcharts

Lessons learned—review

Practice strategy

Process behavior charts

Process identification—storyboards

SDCA (standardize, do, check, adjust)

SIPOC (supplier, input, process, output,

customer) diagram

Systems thinking

Team development

Team meetings (huddles)

Value stream mapping

Voice of the customer (patient feedback)

Walkaround/walkthrough/waste walk

Measure

The DMAIC Model 35

Auditing (sampling, sampling plans)

Benchmarking—start by setting the

current baseline for the process

Business operating system (BOS)

Cause-and-effect diagram (fishbone

diagram, Ishikawa diagram)

Cost–benefit analysis—start collecting

information

Cycle time analysis

Data collection—check sheets, histograms,

Pareto charts, run charts, scatter

diagrams

Identifying a data collection plan

Identifying variability—instability,

variation, off-target, cause-and-effect

diagram, process capability

Measurement systems analysis (MSA)

PDSA (plan–do –study/check–act)

Practice strategy

SIPOC (supplier, input, process, output,

customer) diagram

Stratification

Team meetings (huddles)

36 The DMAIC Model

Value analysis

Walkaround/walkthrough/waste walk

Analyze

Auditing (sampling, sampling plans)

Benchmarking—how others do things

Brainstorming

Business operating system (BOS)

Cause-and-effect diagram (fishbone

diagram, Ishikawa diagram)

Check sheets

Continual improvement

Cost–benefit analysis (cost of quality,

quality cost, cost of poor quality, return

on investment)

Flowcharts

Practice strategy

Scatter diagrams

Stratification

Team meetings (huddles)

The DMAIC Model 37

Value analysis

Walkaround/walkthrough/waste walk

Improve

Auditing (sampling, sampling plans)

Brainstorming alternatives

Business operating system (BOS)

Continual improvement

Cost–benefit analysis (cost of quality,

quality cost, cost of poor quality, return

on investment)

Cycle time analysis

Flowcharts

Failure mode and effects analysis (FMEA)

Kanban (wait time, patient pull-through)

Lessons learned

Mistake-proofing

PDSA (plan–do–study/check–act)

Practice strategy

Problem solving

38 The DMAIC Model

Process improvement

Scatter diagrams

Standard operating procedures (SOPs)

Stratification

Systems thinking

Team meetings (huddles)

Variation reduction

Visual controls, aids

Walkaround/walkthrough/waste walk

Control

Auditing (sampling, sampling plans)

Business operating system (BOS)

Continual improvement

Cost–benefit analysis (cost of quality,

quality cost, cost of poor quality, return

on investment)

Cycle time analysis

FMEA—update

Kanban

The DMAIC Model 39

Lessons learned—update

Measurement systems analysis (MSA)

Mistake-proofing

PDSA (plan–do–study/check–act)

Practice strategy

Process behavior charts

Run charts

Standard operating procedures

(SOPs)—update

Standardization (SDCA—standardize, do,

check, adjust)

Team meetings (huddles)

Value analysis

Variation reduction

Visual controls, aids

Voice of the customer (patient feedback)

Walkaround/walkthrough/waste walk

Most Practice staff members will find this pro-

cess very exciting as they will have the tools and

methods to demonstrate the improvements that

they are helping the organization to achieve.

There are times when a staff worker tries to tell

40 The DMAIC Model

a supervisor that something is wrong with a pro-

cess. Now we have the means to not only tell but

also show and demonstrate what needs to be

done. Following this process creates a road map

for continual improvement and, once started,

it is a never-ending journey. These tools and

methods have proven themselves useful every-

where: from shop floors to office settings, from

schools to hospitals, and even from churches to

the home. Also, if your Practice is currently plan-

ning on achieving ISO 9001 registration, Patient-

Centered Medical Home status, the Malcolm

Baldrige National Quality Award (or related

state-level award), or any number of other qual-

ity improvement–based awards or recognitions,

one of the baseline requirements is the ability to

demonstrate that continual improvement is actu-

ally being achieved.

Teams

he first thing we need to look at with respect

to teams is the difference between a team

and a group. A group (as in a natural work

group or department within the Practice) is a col-

lection of individuals who may be working toward

a common goal but who are not necessarily inter-

dependent. A team is a group of people who have

come together for a specific common purpose—

often to be accomplished within a specific time

frame—and has established a common definition

of what the members will be doing. Each person

understands and can discuss the common objec-

tive. Many philosophies and books are available

on teams, team building, and how to create effec-

tive teams. For example, the American Society

for Quality’s Team and Workplace Excellence

Forum has a lot of material.

An important problem many managers (those

who direct or run the Practice) face with respect

to teams is failing to ask individuals in the group

42 Teams

what they want from their experience on the

team! Lack of communication within the team

and between it and management thus causes a

vast number of failures. Finding a solution to

this should be the manager’s number one con-

cern any time groups of people come together.

Just saying the words one time is not enough for

effective communication to take place.

The second-most-important issue has to do

with the team itself. The members must be able

to answer three basic questions before they can

start and continue the process of teaming. These

questions are summed up in the acronym MCG.

M stands for “Who will be the members on the

team and why?” C stands for “Who will handle

what roles and responsibilities, and who is in

control?” G represents “What are the goals of the

team?” and ensuring that those goals are com-

municated to everyone who interacts with the

team. Each team needs to ask these three ques-

tions and ensure that its members share a com-

mon purpose.

MCG can be expanded by using another acro-

nym, SGRPI: systems, goals, roles, procedures,

and interpersonal relationships. The term systems

refers to thinking about how the team fits into

the structure of your Practice. Goals, as in MCG,

refers to what the team wants to accomplish

and communicating that to others. Roles, as in

the C of MCG, refers to the various roles involved

Teams 43

in a well-operating team and who will fill each.

Procedures refers to agreed-to and communi-

cated ground rules and logistical agreements

that the team has made with itself. Interpersonal

relationships refers to the relationships that any

team must work out in advance, as this becomes

a major issue if things are not resolved early.

People need to know how to relate to each other

and agree that they are all working for a common

purpose.

The following are some rationales for team

building from the National Training Laborato-

ries Institute (1984):

The Obvious

Goal clarity and

commitment

Surfacing control or

influence issues

Inclusion/cohesion

needs

Exploration of

working norms

Control/management

of destructive

competition

The Less Obvious

Identifying wants and

needs

Support needs

Creative

interdependence

(synergy)

Discovery of intrinsic

needs

44 Teams

Every team must go through a series of stages

toward group actualization. Five states com-

monly involved are: forming, storming, norming,

performing (producing), and ending. This process

usually takes a lot of time, and if at any point

something changes (for example, new managers,

new team members, economic conditions, a sig-

nificant emotional event experienced by one of

the existing members, and so on), the team as a

whole may need to go back to some prior stage

and repeat their efforts in order to become a top-

performing unit. Failure to follow these basic

stages is the most common reason why some

teams never achieve their full potential.

You should keep in mind several points at each

stage. Forming involves the people on the team

getting to know and trust each other. There can

be many frustrations here (for example, lack of

action, no clear assignment, poor communication,

and so on), and there is a lot for the team to work

through leading to the ultimate goal of accep-

tance and commitment of the group to becoming

a team. In storming, team members need to work

out their differences with each other. Because of

the forming activities, team members should feel

they are able to talk things out with each other

without hurting feelings or risking rejection just

because they see things differently. The pri-

mary outcome of this stage should be to clarify

the team’s major activities and develop members’

Teams 45

sense of belonging to the team. Norming occurs

when the team sets its boundaries and members

become more sensitive to each other and to the

goal or goals of the team. The team is now ready

to work on projects and enjoy a level of internal

support. In the performing stage the team can

work to full capacity to achieve its goals with

the pride that develops from performing well.

The last phase is ending. We all at various times

in our lives must deal with something coming to

an end. At the end of a team, or on losing a team

member, we want to be able to have satisfaction

with, and recognition of, a job well done.

Many managers want teams to immediately

jump into the performing stage of teamwork,

but this usually causes friction and a discon-

nect within the group, which has not been given

the opportunity to form into a team. Each team,

ideally during its formation phase, will identify

what its goal or purpose is for existing. There are

a number of team structures or types of teams:

• Cross-functional team. Members come

from various functional areas of the

organization and/or customers and

suppliers to achieve the goals of the team.

• Improvement team. Has a specific assigned

task of making one or more operational

improvements (cost, cycle time, quality) in

the Practice.

46 Teams

• Self-directed team. Operates with virtually

no management or supervisor involvement.

Its members have been given the time and

resources to accomplish the tasks assigned

to them.

• Quality circle. A team with the specific

assigned task of improving the quality of

an operation, service, or product. These

groups are commonly called improvement

teams today.

• Project team. A project-focused team that

has a specific goal to accomplish. It could

be a start-up of new activities, the launch

of a new product or service, a preventive

maintenance or cleaning program, or

other goal that may not involve a continual

improvement issue.

A team is far more than just a group of peo-

ple who happen to work in a given area. Well-

functioning teams take time to form and arrive

at their level of functionality, but once that has

taken place such teams have a lot of fun and take

pride in what they accomplish. Your overall goal

should be to develop well-functioning teams in

your Practice to achieve customer satisfaction

and continual improvement.

The Lean Six Sigma Road

Map for the Practice

s you prepare for the Lean Six Sigma

journey, you’ll do well to take a look at

the following suggested road map:

1. Develop a flowchart (or similar tool) of

a current significant process—“as is”—in

your Practice.

2. Recognize that variation exists in

everything you do—standardize the

process throughout the Practice.

3. Develop/refine measures of work for

customer satisfaction in the process.

4. Identify what the patient/customer wants

and needs—reduce variation around

this target.

5. Develop a “should be” or “preferred state”

process flow map.

48 The Lean Six Sigma Road Map for the Practice

6. Use a problem-solving methodology to

plan improvements.

7. Follow the PDSA model to deploy the

improvement.

8. Monitor the process using run charts or

process behavior charts.

9. Incorporate new technology where

appropriate.

10. Update standard operating procedures

or policies and lessons learned.

11. Celebrate successes.

12. Repeat the road map for continual

improvement—PDSA/SDCA.

Summary

e are starting a journey of continual

improvement in your Practice. The way

may be familiar to a lot of you as you

have been using the tools and methods for some

time. Others of you may be new to this path, and

through this book the author hopes to assist you

along the way. This book is designed to be a guide

rather than a detailed description of each tool

used. Follow the process, and use what seems

to be appropriate at each step. Every tool and

method will not be used each time a new study

starts. You may even find uses for these tools and

methods in different phases of the DMAIC model,

and that is encouraged. The goal of all this work

is to continually improve your procedures and

activities to satisfy your patients and customers

(both internally and externally) and increase the

effectiveness of your total Practice.

50 Summary

Here are some other points that healthcare

professionals should remember when using this

process:

1. If the method seems to be getting too

complicated, it probably is, and you should

step back to see if you can simplify what

you’re trying to study!

2. Asking patients to wait for long periods of

time is waste! Find a better way.

3. Most problems can be solved without using

designed experiments. If the process is

an old, established one and it used to work

okay, then keep asking why it isn’t now

until you find the problem!

4. Remember the KISS principle: keep it

simple (keep it simple staff, keep it simple

statistician, or keep it statistically simple)!

5. Sometimes all you need is an updated

histogram or flowchart to see the problem!

6. Never give up!

7. Have fun!

At times, your Practice might run into problems

that seemingly can not be solved, or you just don’t

have enough time and resources to handle every-

thing. It will be during those times that con-

sultants or other specialists may be called in to

Summary 51

assist with the issues at hand. Many times such

people will have advanced training in the tools

and methodologies discussed in this book. We

usually call these people “Lean Six Sigma Black

Belts,” and they may ask your team to start a

“Green Belt project.” Since that is what you are

doing with this book—Lean Six Sigma Green

Belt projects—you will be able to call yourself a

Lean Six Sigma Green Belt.

If you would like to earn a formal title in this

arena, check with a local quality practitioner or

contact the American Society for Quality (ASQ)

about the Certified Quality Improvement Asso-

ciate (CQIA) or other certification processes or

examinations for healthcare professionals. ASQ

can be reached at 800-248-1946 or http://www.

asq.org for more information.

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Tools

Define

Measure

AnalyzeImprove

Control

An old Japanese quality auditing technique,

after the initial greetings in the front office, is

to visit a rest room in the hourly working area

before conducting the rest of the audit. The

purpose of this detour, rather than to use the

facility, is to check for the cleanliness of the rest

room. The belief is that if management can not

54 7S

provide clean facilities for staff, then a number

of other processes may be at issue in the organi-

zation. Have you ever used a dirty restroom at a

gas station or a restaurant? What did you think

about how that organization handled other activ-

ities on the property?

How organized is your Practice and work

area? Is there dust, grease, food scraps, eye irri-

tants, trash, or other unclean issues in the work

space? An unclean office setting hides safety

hazards, health risks, and equipment problems,

shows a lack of pride in work, and signals a host

of other issues. If your office does look clean on

the surface, how about the way paperwork is

stored in your Practice? Does the doctor have all

of the correct files available at a single glance, or

is everything stored in patient files so that each

packet is different? How much time do patients

have to wait in the various waiting rooms in your

Practice? How about other personnel that work in

the Practice? Is everything available in a timely,

orderly manner, or is information typically miss-

ing or hard to find when needed to accomplish

the tasks at hand?

It has been researched and proven that

cleanliness/orderliness at home and work leads

to much more productive settings and more pride

in what we do. Some people feel that far too much

time is spent talking about uncleanliness and

7S 55

disorder; however, it has been shown to be one

of the more important factors contributing to

why things do not always work the way they are

supposed to. When things are not organized and

clean, the likelihood of something going wrong

increases exponentially.

The Japanese created a process referred to as

the 5S method, which work groups use to ensure

a clean, organized, and safe work environment

(see Table 1). Many work teams spend a specific

amount of time each day to ensure that their

work areas are cleaned. This has the added ben-

efit of allowing the staff who use the work area

to take a close look at their environment for signs

of future trouble.

The classic 5S includes sort, set in order, shine,

standardize, and sustain. For 7S, we are adding

safety, oversight.

Table 1 5S chart.

Japanese (S) Translation English (S)

Seiri Cleaning up Sort

Seiton Organizing Set

Seiso Cleaning Shine

Seiketsu Standardizing Standardize

Shitsuke Training & discipline Sustain

56 7S

The 5S method was created for a manufactur-

ing setting. In a medical Practice, we must also

be on high alert to ensure the safety of staff and

patients as well as the oversight of our processes.

Thus, we now have what can be called the 7S for

the healthcare Practice. These sets include:

• Sort. Review and sort work tools and

materials to ensure that all unnecessary

items are removed and to ensure

workplace organization. Look for

unnoticed dangers: unprotected moving

objects (such as file drawers), exposed

or damaged electrical wires, and other

issues that might get in the way of doing

the work safely.

• Set in order. Have a place for everything

and keep everything in its place when not

in use. People need to know where things

are supposed to be. Also, apply ergonomics

to help prevent movement injuries.

• Shine. Clean everything in the work area

inside and out regularly, inspecting each

item for signs of defects or wear or other

signs of future trouble.

• Standardize. Using the first three S’s,

establish a pattern of how things are to

be done. This is not meant to reduce

creativity, but to help ensure that things

7S 57

are done in a way that helps to reduce

variation in the process. Continually

maintain what has been accomplished

and ensure that standards are lived up to.

• Safety. The process of avoiding injuries to

patients from the care that is intended

to help them.

• Oversight. Medical oversight is the

process of reviewing care that is provided

to patients, to ensure their safety.

• Sustain. Reinforce all of the above to

ensure that this process becomes a part

of your daily work.

The task for you and your fellow staff is to clean

your work areas, address any unsafe issues that

currently exist, and prevent those that may occur

in the future. Put a red tag or other identification

on anything that should be addressed. If there is

a safety officer in your organization, ask him or

her to periodically check your work space to help

ensure a safe and clean working environment.

58 Advanced Practice Quality Planning (Healthcare APQP)

Define

Measure

AnalyzeImprove

Control

ADVANCED PRACTICE QUALITY

PLANNING (HEALTHCARE APQP)

Have you ever heard the old saying “a stitch in

time saves nine” or “an ounce of prevention is

worth a pound of cure”? How about “measure

twice, cut once”? What do these sayings mean?

Most people will answer by saying that if you

plan ahead of time, you can save time, money,

resources, and sometimes frustration. In my own

experience I have sometimes started a project

only to have the parameters change later and

have to redo work that was already done. The

idea that we can plan, as best as possible, ahead

of time to help prevent surprises and save valu-

able resources works in our jobs as well as in our

homes. Anything that is to be done can be thought

out first, or written plans can be completed to

lay out a blueprint of what we are going to do.

Advanced Practice Quality Planning (Healthcare APQP) 59

This concept is referred to as advanced practice

quality planning, or healthcare APQP.

APQP is a process whereby we first look at

the parameters of what we are going to do. Do we

have the right amount of resources or material

available? Do we have the right people to do the

job or provide the service? Do we have the right

tools or training to do the job well? Do we know

the correct way of using everything we have to

provide a safe environment for ourselves, our

patients, and other customers? All these ques-

tions, and many more, should be answered before

we start work! One of several tools you can use to

ensure that you have thought of all the elements

(causes) that will give you the desired output or

effect is the cause-and-effect diagram (see page

79). You can also think of APQP as the first step

of the PDSA cycle, where you are going to plan

before you do something.

In planning to meet future medical require-

ments, such as those espoused by the Committee

on Quality of Health Care in America in Crossing

the Quality Chasm (2001), we must ensure that

the six aims for improvement are addressed:

• Safe. Avoiding injuries to patients from

the care that is intended to help them.

• Effective. Providing services based on

scientific knowledge to all who could

benefit, and refraining from providing

60 Advanced Practice Quality Planning (Healthcare APQP)

services to those not likely to benefit

(avoiding underuse and overuse,

respectively).

• Patient-centered. Providing care that is

respectful of and responsive to individual

patient preferences, needs, and values,

and ensuring that patient values guide

all clinical decisions.

• Timely. Reducing waits and sometimes

harmful delays for both those who receive

and those who give care.

• Efficient. Avoiding waste, including waste

of equipment, suppliers, ideas, and energy.

• Equitable. Providing care that does not

vary in quality because of personal

characteristics such as gender, ethnicity,

geographic location, and socioeconomic

status.

Your organization may very well use some of

the traditional quality tools (check sheets, run

charts, Pareto diagrams, and so on) to ensure

that the elements of APQP are being done in

your organization prior to starting a new proj-

ect or job. Tools such as check sheets can take

on many forms and can be designed using the

cause-and-effect diagram as a guide to help

ensure completeness. You can and should use the

various tools reviewed in this guidebook to help

Advanced Practice Quality Planning (Healthcare APQP) 61

ensure that the work you are going to do is of

the best quality and reduces the greatest amount

of time and wasted effort possible. The typical

APQP model shown in Figure 11 incorporates a

lot of the tools and strategies found in this book.

Your role in this process is to ensure that the

work you will be doing is the best given the tools

and resources provided by management.

Act Plan

StudyDo

Take appropriate

action and

follow up

Determine

goals and

targets

Determine

methods of

reaching goals

Engage in

education and

training

Implement

work

Study the effects of

implementation

Figure 11 The APQP model.

62 Auditing (Sampling, Sampling Plans)

Define

Measure

AnalyzeImprove

Control

AUDITING (SAMPLING,

SAMPLING PLANS)

Most people have heard of certified public accoun-

tants, or CPAs. A CPA maintains and checks

financial records to ensure accuracy of the num-

bers. We need to work with our management in

checking the working processes in our organiza-

tions to ensure that the processes are doing what

they are designed to do.

This checking process is sometimes called

quality auditing, and it is commonly done in orga-

nizations that are ISO 9001 registered or have

applied for a quality award (Baldrige or state-

level awards). Many customers require their sup-

pliers to check their products and services before

they are delivered. This is one reason your orga-

nization may have personnel designated to review

items in the Practice for accuracy. This is com-

Auditing (Sampling, Sampling Plans) 63

monly called inspection. Quality auditing is sim-

ilar to inspection in that we are looking at how

the process is doing instead of looking at specific

parts or services that have been provided. Some

organizations (as medical device manufactur-

ers and pharmaceutical companies) use supplier

quality engineers to visit their suppliers and/or

perform incoming inspection to check products

as parts are received from their suppliers.

The first thing you need to know if asked to

audit something is “What is the standard that

I will be auditing against?” If you are going to

conduct a process audit in another department,

you must ensure that there are standard operat-

ing procedures (SOPs) or some other form of pro-

cess sheets that are used to ensure that things

are being done in a standardized manner. If you

were to conduct a safety audit, then having the

written safety rules would be important. As you

are starting to see, there are a number of things

that can be audited. Some others are cleanliness,

quality of product, quality of service, knowledge

of the system, and emergency procedures. If your

Practice is ISO 9000 or ISO 14000 registered,

you already know a number of things that can

be audited. If you have not seen either of these

standards, you may wish to ask your supervisors

about getting a copy.

As organizations move to become registered

to national or international standards such as

64 Auditing (Sampling, Sampling Plans)

ISO 9001 or ISO 14001, they will train some of

their internal people to conduct quality system

audits. This is to ensure that the system that the

management has established is in fact working

the way it was intended to. As an employee in a

Practice you would be trained in auditing tech-

niques and assigned to auditing teams that will

periodically check the processes of other activi-

ties within your organization. This process of

quality auditing is very different from what the

Internal Revenue Service (IRS) does when they

call taxpayers in for a financial review. When

you are asked to be part of an audit team, you

need to be aware of some basic guidelines:

• Bepleasanttothepersonbeingaudited.

You are not a cop looking to catch him or

her doing something wrong.

• Befactualinwhatyouobserve.Hiding

things does not help the company improve,

and being too critical may harm personal

objectivity.

• Bethoroughinlookingattheprocess

as it relates to the standard. If you

miss something, customer satisfaction

may suffer or, worse yet, someone might

get hurt.

• Askquestionsforclarity.Youwanttobeas

positive as possible given the situation.

Auditing (Sampling, Sampling Plans) 65

• Recordyourobservationsfortherecordand

the next person who will audit the area.

• Followwhattheinternalleadauditor

directs you to do.

Being an internal auditor for your organization

can be both challenging and informative. We

usually get a better view of what our company is

doing if we have a chance to look at its activities.

For some of us, it breaks up our everyday routine

and gives us a chance to see how others might

be doing things and to benchmark (see the next

section) that against what we do.

Sampling is a methodology that reviews/

inspects a small segment of some larger pro-

cess/population to make a judgment/inference

about the entire process. This idea works in part

based on the central limit theorem, which basi-

cally states that over time, things tend to follow

patterns. An example of this would be to simply

flip a coin. Your basic assumption is that a coin is

fair and that for any group (say 10 to 50) of flips

that you should get roughly 50 percent heads and

50 percent tails. This is not always true, so we

could do samples of flipping a coin to verify how

“fair” the coin really is.

A sampling plan is a structured, planned

sequence of samples that are to be taken on a

given activity or process to verify the state of

goodness of the process.

66 Benchmarking

Define

Measure

AnalyzeImprove

Control

BENCHMARKING

Benchmarking is the process of looking at a

system and applying some or all of its concepts

to another system. Granite Rock, a Malcolm

Baldrige National Quality Award–winning com-

pany located in California, has used benchmark-

ing in a dramatic way. Its processes had been the

same as those of nearly any gravel yard in

the United States. Any time a customer wanted

some road materials it sent a truck and driver

to the yard. The driver then placed the order at

the front office and waited for a Granite Rock

employee to get a front-end loader, go into the

yard to obtain the material, and fill the truck

with the appropriate amount. Then Granite

Rock decided to capitalize on the technology of

the ATM, the automated banking machine that

Benchmarking 67

allows a customer to walk up and, by inputting

some basic data, handle any number of banking

transactions. The new process that Granite Rock

developed allows the truck driver to pull into an

area with overhead filling stations (instead of

going to an office first) and punch in their cus-

tomer codes and the materials desired. The mate-

rial is automatically loaded into the truck. This

new process cuts wait time to minutes instead

of hours and allows customers to get materials

24 hours a day, seven days a week, year-round.

Some managers think benchmarking is only

about taking trips to competing organizations

and trying to copy something they do that is felt

to be better than what is currently being done in

their own organizations. During the late 1970s

and early 1980s many managers went to Japan

to learn what was being done there and to see

why Japanese quality was so much better than

that in the United States. Most of those trips

resulted in disappointment as you can’t always

see a physical difference in activities. Sometimes

it is the small, subtle things that Practice staff

have learned over time and shared with fellow

workers that make the big difference.

Here are the basic process steps of bench-

marking:

1. Flowchart the current process.

2. Identify the areas to be improved.

68 Benchmarking

3. Brainstorm ideas (blue sky—this term is

discussed under “Brainstorming”).

4. Investigate how others (internal and

external) do similar processes.

5. Develop plans for application of ideas.

6. Pilot test ideas.

7. Initiate the new process.

8. Evaluate the new process.

Before starting a benchmarking project, you are

advised to make sure you know exactly how your

current process works. That may sound funny,

but it has been shown that when people attempt

to flowchart a process (see “Flowchart” section),

there is often a lot of disagreement about the

exact steps and/or the order of those steps. Thus,

any time there is more than one person who per-

forms a task in or around your Practice, the

process should be flowcharted.

Once everyone agrees on how a process oper-

ates, you can start looking at the process for

bottle necks or other things that may not work or

flow as well as you might wish. This could be any-

thing about the current process from wanting to

reduce the amount of variation in one part of the

process to changing certain things about it that

may help employees’ ergonomics. In looking at

the process, it sometimes helps to get as creative

Benchmarking 69

as you can and ask, “What if ?” This is the “blue

sky” part of benchmarking. What might this

process look like in an ideal world? If money and

technology were no object, how might it work? If

we had the technology, what could happen?

Now it is time to do some research about how

others, internal or external to your organization,

may do similar things. By becoming internal

auditors (discussed in “Auditing”), we sometimes

get to see how others do similar things in our

own organizations. Also, as in the case of Granite

Rock (see “Auditing”), sometimes going outside

the industry helps give you ideas about a differ-

ent way of doing things. Say you need to move

something from one place to another; maybe

looking at mail service or delivery organizations

would help.

Once you have seen other ways of doing things,

it is time to figure out how you can do things

differently in your own operation. Establish a

plan for the changes, and acquire the needed

resources from management. The plan should

list the materials needed, when and where new

activities will be initiated, any training that may

be needed and when it will take place, and other

details that allow for the changeover to the new

idea. Then prepare and run a pilot test to ensure

that the plan will work. Generally it is unwise to

just jump right in with the new idea without test-

ing it first. Even the best-laid plans may have

70 Benchmarking

unforeseen bugs that can cause problems, so run

a small test first.

As you move forward into the new operation,

you should monitor it carefully to ensure that it

lives up to your hopes for the new process. Some-

times changeovers will be conducted in stages

instead of all at once. Either way, watch and eval-

uate the process to ensure that you are still meet-

ing the customer’s wants and needs—and doing

it faster, better, and/or cheaper than before.

A point to remember: Walt Disney was well

known for showing any carnival company exactly

how Disneyland was set up and operated. One day,

after being criticized for this, Walt said, “I hope

they copy me. That way as I create new things,

they will always be playing catch-up, while I

have the newest and greatest.” Benchmarking

is not just about copying something; it is about

looking at our processes for ways of doing things

better overall. The challenge is to distance your-

self from the way that it has always been done

to see if other methods or technologies now exist

that might help you in your work areas.

Brainstorming 71

Define

Measure

AnalyzeImprove

Control

BRAINSTORMING

Brainstorming is the process whereby an indi-

vidual, group, or team develops as many ideas

about a topic as possible using various creativity

techniques or methods. Two basic phases make

up brainstorming: the creative phase, which is

used to generate a large number of ideas, and

the evaluation phase, where the ideas generated

are evaluated for usefulness or practicality. Note

that the team should take a break time between

the two phases, as different parts of the brain are

used in each phase. At a minimum, a 10-minute

stretch break should be taken instead of going

directly into the evaluation mode after being

creative.

It is very important that during the creative

phase no criticism or other distractions are

allowed. Team members should keep their minds

72 Brainstorming

open to all possibilities, no matter how wild the

idea. One method here is to call for “blue sky”—

that is, if anything were possible, what might it

be? During this phase of brainstorming, the goal

is to generate as many ideas as possible. If ideas

are being put on a flip chart with a large group,

you should have two or more recorders available

to capture all the ideas as they develop. Other-

wise you can have each person say what he or she

is thinking and have him or her or another group

member record the idea on a sticky note and put

it on the wall. Facilitation can be used during the

creative phase, but freewheeling also works well.

Here are some basic guidelines for the creative

phase of brainstorming:

• Nocriticism,compliments,orquestions

allowed

• Wildideasarewelcome

• Don’twait

• Quantityisimportant(versusquality,at

this stage)

• Hitchhike—buildonpreviousideas

• Thinkbeyondthecurrentwayofdoing

things

• Thinkhowthingsmightbedone30years

from now

Brainstorming 73

During the evaluation phase it is best to have a

facilitator work with the group to look over the

ideas in a sequence. There are many ways to go

about evaluating the ideas you have generated.

One good starting point is to organize the list of

ideas into like groups or categories to help in the

evaluation process. The caution here is not to get

overly critical, as there may be something in one

of those “crazy” ideas that might actually work for

the given situation. This is often true because of

new technology or different ways of doing things

that are not common in your organization.

The brainstorming process can be fun and

hard work at the same time. The main purpose

is to “think outside the box” to get a new per-

spective on doing your own job. If you are unsure

what “outside the box” means, try this exer-

cise: In Figure 12, try connecting all the dots by

drawing four consecutive straight lines without

Figure 12 Nine dot exercise.

74 Brainstorming

lifting the pencil (or pen) off of the paper. One

possible answer appears on page 216.

The brainstorming technique can be very

helpful in looking at a process from all angles.

It is also helpful if the group working on the

project is cross-functional to the Practice, that

is, comprising people who work in different parts

of the healthcare community. And, optimally,

people from various areas and levels of respon-

sibility should be included in the brainstorming

group. But during this exercise there should be

no rank or level of employee recognized. Every-

one has an equal right to say what he or she

thinks, from the floor sweeper to the president.

However, a few comments to watch out for are

listed here as idea stoppers—they are warning

signals that the brainstorming process may not

be working as well as it could. If any of these idea

stoppers come up during the meeting, stop and

address them right away so the group or session

can move forward in a positive manner:

Brainstorming 75

Idea Stoppers

Don’t be ridiculous.

Let’s shelve it for

right now.

It won’t work here.

Our business is

different.

Let’s think about

it some more.

We did all right

without it.

It’s too radical

a change.

Management won’t

like it.

Where did you dig

up that idea?

It’s not practical.

It’s too expensive.

You can’t be serious.

You can’t do that.

The technology will

not allow that.

Where did you get . . .

We’ve never done it

before.

I have something

better.

It’s too risky.

Let’s be sensible.

We’ll never get it

approved.

They won’t like it.

It’s good, but . . .

Let’s check on it later.

Too much work.

Let’s get back to

reality.

That’s been tried

before.

That’s not my job.

You do not know

how we do things

around here.

That’s too high-tech

for us.

It will never work.

76 Business Operating System (BOS)

Define

Measure

AnalyzeImprove

Control

BUSINESS OPERATING SYSTEM

(BOS) FOR HEALTHCARE

ORGANIZATIONS

BOS (AIAG 2007) is a process that aims to aid in

the development or improvement of a fundamen-

tal management system for healthcare organi-

zations that provides for continual improvement,

emphasizing error or adverse- event prevention

and the reduction of variation and organizational

waste.

The BOS process focuses on the objectives of:

• Providingprocessimprovementsto

increase the value added to the

organization, customers, and stakeholders

• Improvingdeliveredhealthcare

quality and safety to complement

existing accreditation, or to aid in

Business Operating System (BOS) 77

achieving accreditation, certifications,

or registrations

• Improvingtheimageoftheorganization,

increasing customer confidence, and

having a tool to reward results

• Developing/incorporatingaprocessthat

is actionable

• Minimizingburdenonhealthcare

organizations

• AligningwiththeMalcomBaldrige

National Quality Award Program’s

Healthcare Criteria for Performance

Excellence to help the organization prepare

for state, national, or international

award programs.

The Healthcare Criteria are built on the follow-

ing set of interrelated core values and concepts:

• Visionaryleadership

• Patient-focusedexcellence

• Organizationalandpersonallearning

• Valuingstaffandpartners

• Agility

• Focusonthefuture

• Managingforinnovation

78 Business Operating System (BOS)

• Managementbyfact

• Socialresponsibilityandcommunity

health

• Focusonresultsandcreatingvalue

• Systemsperspective

Cause-and-Effect Diagram 79

Define

Measure

AnalyzeImprove

Control

CAUSE-AND-EFFECT DIAGRAM

(FISHBONE DIAGRAM,

ISHIKAWA DIAGRAM)

Originally developed in the 1940s by Kaoru

Ishikawa in Japan, the cause-and-effect diagram

is a graphical analysis tool that allows the user

to display the factors involved in a given situa-

tion. “Cause-and-effect diagrams are drawn to

clearly illustrate the various causes (x) affecting

product quality by sorting out and relating the

causes. Therefore, a good cause-and-effect dia-

gram is one that fits the purpose, and there is no

one definite form” (Ishikawa 1976). The causes

can be any item or occurrence that is related to

the effect (Y) being studied. Thus, the effect is a

function of the causes: Y = f(x). This tool is some-

times called an Ishikawa diagram (for its origi-

nator) or a fishbone diagram, or even a feather

80 Cause-and-Effect Diagram

diagram, given the shape of the graphic (see

Figure 13).

Reminder: Ask the five W’s and H: what, why,

when, where, who, and how.

When creating this diagram, it is best to try

to keep an open mind and to work as a team to

view and discuss what the system or process is

doing. You want to capture everything you can

about the process, looking for all the actual activ-

ities in the process, not just what you think is

happening. Besides using the five W’s and H

in creating the cause-and-effect diagram, some

people use brainstorming, but many people start

by reviewing some of the eight M’s:

• Man(people—Practicestaff)

• Machine(equipment)

Causes

Effect

Man Machine Methods

Materials Mother Nature Measurement

Figure 13 A basic cause-and-effect diagram.

Cause-and-Effect Diagram 81

• Methods(operatingprocedures)

• Materials

• Measurement

• MotherNature(environment)

• Management(person[s]whorunsor

directs the Practice)

• Money

This tool is relatively simple to use, yet it is very

powerful. Once completed, it graphically portrays

the factors of the process to management and

other teams. Imagine you want to have donuts

at your next team meeting. What are some of the

factors that would be involved? You first need to

decide where the donuts will come from, what

type you want, who will make or buy them, and

other issues. A simple cause-and-effect diagram

for this appears in Figure 14.

As the team works on the process, more detail

can be added to the diagram. Let’s say that in

our donut example the team wants to look at

the measurement stem of the diagram to see

how the amount of cream in the donut could

vary. Some factors you might add are consis-

tency of the cream, types of cream used, size of

insertion equipment, cooking temperature effect

on cream, and so on (see Figure 15). This allows

the team to get as detailed as needed to ensure

82 Cause-and-Effect Diagram

Cooking

location

Room temp.

Amount

jelly filled

Good

donuts

Man Machine Methods

Materials Mother Nature Measurement

Training Deep fryer model Convenience store

bought

Care

Individual mastery

Equipment

placement

Donut shop

Homemade

Type of

oil

Fresh dough

Room humidity

Age of donuts

Amount

cream filled

Light

intensity

Measurement

plan

Figure 14 Cause-and-effect diagram for donuts.

Measurement

Amount of cream filled

Consistency of cream

Types of cream used

Size of insertion equipment

Cooking temperature effect on cream

Figure 15 Cause-and-effect stem: measurement

breakdown.

Cause-and-Effect Diagram 83

that it understands the process and can show the

causes and effects of the given situation. Once

completed, the cause-and-effect diagram can

be shown to other groups (for example, accoun-

tants, maintenance, administrators, other Prac-

tice staff, management, customers, suppliers)

as a visual aid or training aid so that everyone

involved in the activity understands what the

process is doing.

84 Check Sheets

Define

Measure

AnalyzeImprove

Control

CHECK SHEETS

A check sheet (sometimes called a checklist) is

any set of words, tally lists, or graphics designed

to assist us in conducting a planned review or

observation of our process or system. An air-

craft pilot, before taking off or landing a plane,

is required to use a check sheet to ensure proper

operation of the airplane (see Figure 16). For

us in the healthcare Practice, check sheets can

either be a list of things to do or a data collection

method that allows us to tally the issues/items

being monitored on a list or on a pictorial image.

As can be seen in Figures 17 and 18, these

check sheets are designed to collect data for

analytical purposes from our work areas. Prac-

tice staff need to have simple tools that allow

for quick and easy collection of data. During the

Check Sheets 85

Preflight Inspection: Cessna 152

1) CABIN

1. Control Wheel Lock—Remove

2. Ignition Switch—OFF

3. Master Switch—ON

4. Fuel Quantity Indicators—CHECK

QUANTITY

5. Fuel Shutoff Valve—ON

2) EMPENNAGE

1. Rudder Gust Lock—REMOVE

2. Tail Tie-Down—DISCONNECT

3. Control Surfaces—CHECK freedom

of movement and security

3) RIGHT WING Trailing Edge

1. Aileron—CHECK freedom of movement

and security

4) RIGHT WING

1. Wing Tie-Down—DISCONNECT

2. Main Wheel Tire—CHECK for proper

inflation

3. Before first flight of the day and after

each refueling, use sampler cup and

drain small quantity of fuel from fuel tank

sump quick-drain valve to check for

water, sediment, and proper fuel grade.

4. Fuel Quantity—CHECK VISUALLY for

desired level

5. Fuel Filler Cup—SECURE

5) NOSE

1. Engine Oil Level—CHECK, do not

operate with less than four quarts. Fill to

six quarts for extended flight.

Figure 16 Cessna 152 checklist.

86 Check Sheets

Game day: 6/1/09

Opponent: Falcons Game Stats Tally

Final score: 4 to 2 W

Fielder

Strike Walk 1st 2nd 3rd Home RBI out Other

Pitcher l l ll

Catcher ll l

1st base l l l

2nd base l l l l

Short l l l l l

3rd base ll l l

Left field ll l

Center

field l l l

Right

field l ll

Other 1 ll l l

Other 2 l ll

Other 3 ll

Other 4 ll

Other 5 ll

Totals 11 5 3 4 2 1 3 16

Figure 17 Traditional check sheet.

Check Sheets 87

collection of data on a check sheet, it is common

to see developing patterns or trends that may

affect the outcome of a process. This is especially

true in healthcare settings where we do not see

repetitive activities on a daily basis. You want

to make this data collection as easy as possible;

otherwise the information you obtain may not be

as reliable as you need or the time it takes you to

collect the data may be prohibitive. Here are the

basic steps in making a check sheet:

1. Identify and agree on the causes or

conditions that are to be collected.

Game day: 6/1/09

Opponent: Falcons

Final score: 4 to 2 W

Game Stats Tally

Walks

l l l l

Out by fielder

l l l l l l l l l l l l l

Strikeouts

l l l l l l l l l

Home runs

l l l l

x = On-base hits

s = Stranded

o = Field location of "out"

ooo o

oooo

xxxx

ssss ss

xxx

sss

oooo

Figure 18 Pictorial check sheet.

88 Check Sheets

2. Decide who will collect the data, over what

time period or periods, and how the data

will be collected.

3. Create a check sheet that will work in the

area where it is to be used.

4. Collect the data as designed to ensure

consistency and accuracy of the

information.

Check sheets can be the basis for other analyt-

ical tools and are often incorporated into attri-

bute process behavior charts (discussed under

“Process Behavior Charts”). It is sometimes sur-

prising how just creating and using a check sheet

can help you focus on continual improvement and

how changes may occur just because of the use

of the check sheet. As you strive to improve your

organization using the tools of Lean Six Sigma,

check sheets become a powerful tool.

Continual Improvement (Kaizen, Kaizen Events) 89

Define

Measure

AnalyzeImprove

Control

CONTINUAL IMPROVEMENT

(KAIZEN, KAIZEN EVENTS)

Continual improvement (CI) is the process of keep-

ing an open mind and looking for ways to make

the things that you do better, do them less expen-

sively, or do them faster. As the Industrial Revo-

lution progressed into the early 1900s, Frederick

Taylor developed a method of work specializa-

tion that many organizations still use today. It

was during this time that workers first stopped

checking their own work, and specialized inspec-

tors were employed in inspection teams. This

process developed for several decades, and pro-

fessional organizations were born that focused

on doing inspection better.

During the late 1920s Walter Shewhart devel-

oped the first control chart, and statistical pro-

cess control (SPC) was born (some now call this

90 Continual Improvement (Kaizen, Kaizen Events)

process behavior charting). Many organizations

continued to rely on inspectors, but the use of

charting, which could bring the staff back into

the process of looking at the quality of their work,

became a requirement in the United States dur-

ing World War II. It was in 1951 that Armand

Feigenbaum first published his book Total Qual-

ity Control, and the TQM (total quality manage-

ment) age commenced.

During the 1960s and 1970s the use of qual-

ity circles and employee involvement became the

next evolutionary phase in continual improve-

ment. This was followed by a major resurgence

of SPC during the 1980s. During the 1990s the

International Organization for Standardiza-

tion’s quality management system (QMS) ISO

9000, and the Malcolm Baldrige National Qual-

ity Award were the major advances in continual

improvement. With the turn of the century, Six

Sigma started receiving a lot of attention.

Other terms used of late include value

analysis/value engineering, lean manufacturing/

lean office, kaizen, poka-yoke, and others. Lean

Six Sigma is the latest wave in the ongoing con-

tinual improvement movement and is bringing

together many fields of study and putting them

in the hands of the people doing the work.

Some people refer to these various methods

as continuous improvement because they feel

Continual Improvement (Kaizen, Kaizen Events) 91

we should always make breakthrough strides

in everything we do. Unfortunately, nature and

human beings do not work that way. Even in evo-

lution, things have to step back or level off every

now and then. As we learn new things, some-

times humans have to relearn old knowledge.

Thus Dr. Deming changed the term continuous

to continual.

Concurrent with this change, Dr. Deming also

developed a system he called profound knowledge.

This concept involves the following: appreciation

for a system, knowledge about variation, theory

of knowledge, and psychology. By using each of

these aspects of profound knowledge, continual

improvement can and will become a reality in

our organizations. Our goal is always to main-

tain and improve the quality of the products or

services we provide to customers, both internal

and external.

One common way of implementing continual

improvement is to use the PDSA cycle (see) and

SDCA cycle (see “Standardization”) together (see

Figure 19): the Practice staffer will see a com-

plete process for identifying processes, improving

those processes, and applying lessons learned.

The two cycles working together with the other

tools in this book will help the Practice worker to

continually improve the work that is done with

an eye to satisfying the customer.

92 Continual Improvement (Kaizen, Kaizen Events)

Kaizen is a Japanese terms that literally

means continuous improvement.

A kaizen event is a preplanned activity or

sequence of actions to be taken over a short period

of time to make/allow for a desired outcome to

occur. An example of a kaizen event could be the

planned rearrangement of the Practice furni-

ture based on studies conducted to improve the

workflow to better satisfy patients or the work-

flow of the Practice. Another example might be

a special one- or two-day effort to load patient

chart data into a registry to allow for better

utilization of information and for preplanning of

patient visits.

Figure 19 PDSA and SDCA working together.

Cost–Benefit Analysis 93

Define

Measure

AnalyzeImprove

Control

COST–BENEFIT ANALYSIS

(COST OF QUALITY, QUALITY

COST, COST OF POOR QUALITY,

RETURN ON INVESTMENT)

Cost–benefit analysis is a financial tool that

reports how quality levels are being sustained in

the Practice and its patient base. Many costs

in the Practice can be classified into one of four cat-

egories: prevention costs, appraisal costs, internal

failure costs, or external failure costs. However,

not all expenses of the company are used for the

cost–benefit analysis, only those that relate in

some way to products or services that we deliver

to our customers (see Table 2). The real power of

this tool is not so much in our using the exact or

“right” measures for each expense, but in looking

at trends over time to see how the organization

94 Cost–Benefit Analysis

Table 2 Costs of quality.

Prevention costs Appraisal costs Internal failure costs External failure costs

Marketing/customer/ Purchasing appraisal Product/service design Complaint investigations/

user costs failure costs (internal) customer or user service

Product/service/ Operations (manufacturing Purchasing failure Returned goods

design development or service) appraisal costs costs

Purchasing External appraisal Operations (product Retrofit costs

prevention costs costs or service) failure costs

Operations Review of test and Other internal Warranty claims

(manufacturing or inspection data failure costs

service) prevention

costs

Quality Miscellaneous quality Liability costs

administration evaluations

Other prevention costs Penalties

Customer/user goodwill

Lost sales

Other external failure costs

Source: ASQ Quality Costs Committee, Jack Campanella, editor. 1999. Principles of Quality Costs: Principles,

Implementation, and Use. 3rd ed. Reprinted with permission of ASQ Quality Press, Milwaukee, Wisconsin.

Cost–Benefit Analysis 95

is doing. We want to look at what the total

cost is to provide our customers with products

and services.

Traditionally, when cost of quality is first cal-

culated for an organization, a picture such as that

in Figure 20 will emerge. This is partly because

many accountants and managers have not been

taught about this tool in their formal education,

nor does any government or professional organi-

zation require the reporting of financial data in

this format.

Organizations that have learned to use the

cost–benefit analysis of quality costs typically

are very surprised at the amount of waste that

they’re producing. By focusing on prevention and

Dollars $

Prevention Appraisal Internal

failure

External

failure

Figure 20 Traditional quality costs.

96 Cost–Benefit Analysis

appraisal activities, the failure costs will slowly

start to come down. This will not happen over-

night, and it may take years in some stubborn

cases to show improvement as the old proce-

dures work their way out of your organization’s

system.

No one should be blamed for the poor results

of the first measurement. It is important to look

at those numbers as a benchmark against which

to measure improvement. The results of the first

measurement should be made available to every-

one in the Practice so that people can start to

generate ideas about what can be done and how

to go about doing it. There’s an old adage: “What

gets measured, gets done!” Thus, if everyone

knows that management is watching the num-

bers of the cost–benefit analysis, things should

start to improve.

The ultimate goal is to change the overall pic-

ture to look like the one in Figure 21. As an orga-

nization continually improves its operations, it

will see an overall reduction in the total cost to

provide its products and services.

Cost–Benefit Analysis 97

Dollars $

Prevention Appraisal Internal

failure

External

failure

Figure 21 Quality costs—moving to continual

improvement.

98 Cycle Time Analysis

Define

Measure

AnalyzeImprove

Control

CYCLE TIME ANALYSIS

Once you identify the boundaries of your process

(see “SIPOC Diagram” and “Process Identifica-

tion”), you can now set a starting benchmark for

what is being done. Knowing what is happen-

ing currently will give you a base from which to

evaluate the effect of future improvements. It is

surprising to note that many healthcare organi-

zations do not know what their cycle times are

nor what the yield of the process is. Yield can be

defined as the total number of units handled cor-

rectly (with no rework or rechecking) through the

process step(s).

In using the cycle time or yield tool, one com-

mon approach is to look at the value added for

each step in the process. Do items, people, or

information sit around in holding patterns

Cycle Time Analysis 99

waiting for something to be done? Are multiple

reviews or signatures required where no value is

added(doestheitemreallyneedtheVP’ssigna-

ture, which in reality is only a rubber stamp)?

How long is it currently taking to accomplish

all the process steps versus how long it should

take the information or item to go through the

system? A common suggestion is to imagine

yourself as the object or item going through your

system and see what is really going on. From this

perspective, you can then look for possible areas

of improvement.

The four basic principles of cycle time reduc-

tion are: eliminate, combine, simplify, and change.

Can certain steps be eliminated? These could

be sorting, storage, or movement of the item or

information. Can some of the steps be combined?

This could be having the same person do mul-

tiple activities at the same time or having the

customer speak to only one person instead of

several. Can the steps or information be simpli-

fied in some way? Is a complicated form really

necessary or is it just the way things are done?

Finally, should things or the process be changed?

The “current state,” “could be,” and “should be”

flowchart maps are useful at this point to look at

ways to make changes (see “Flowchart”).

Your manager or supervisor may have you

collect information about the cycle times in

100 Cycle Time Analysis

your process to calculate something call rolled

throughput yield. This is a measure used to track

the overall process as to the quality output of your

system. It is a good metric to use to evaluate your

success in how the process is being improved.

A cycle time analysis was conducted at a

Practice where a quality improvement coach

(QIC) noted that a lot of billing errors were being

returned from the payer. In following the trail

back through the various personnel in the

Practice, the root cause was discovered to be the

poor handwriting of the doctor and the first per-

son to have to input the information into the com-

puter system for billing purposes. Since it was

so hard to track down the doctor each time the

person had a question (which was happening

many time each day), the person had to guess

at what they thought the doctor intended. The

data clerk was able to guess correctly only some

of the time. Thus the Practice was forced to hire

two people (one data entry clerk and one person

to chase down the errors for correcting billing

issues) to handle the workload. Finding a better

way for the doctor to communicate his/her intent

to the computer system would allow for one full-

time person to be better utilized to add value to

the Practice instead of chasing down errors.

Failure Mode and Effects Analysis (FMEA) 101

Define

Measure

AnalyzeImprove

Control

FAILURE MODE AND

EFFECTS ANALYSIS (FMEA)

The failure mode and effects analysis (FMEA)

was first extensively used in the aerospace indus-

try in the 1960s to look at all the possible effects

of failure of a given piece of equipment. (The con-

cept of FMEA was first developed in 1949.) These

documents typically have been created by engi-

neers or the quality officer and often do not get

down to the shop floor or to the work areas where

they are needed. Sometimes three versions of

the FMEA are created during the design, devel-

opment, and implementation of a new service.

The system FMEA looks at the concept of creat-

ing a new service, what the effects on the service

might be, and what Practice staff may need to go

through to be able to provide the service. Design

engineers use the design FMEA to determine

102 Failure Mode and Effects Analysis (FMEA)

how the service should be offered. The process

FMEA (the one staff should have available to

them) looks at how the service actually is pro-

vided and the various effects that can arise.

The process FMEA is useful because it ana-

lyzes the operation to determine what could go

wrong if things are not controlled, maintained,

and set up properly, and what to do about each

issue. If done well, the FMEA should predict

what could happen if something goes wrong in

the process and assign a priority number for each

issue raised. One of the more famous FMEAs

was done on O-rings used in the space shuttle

program. Engineers predicted that if a certain

series of environmental circumstances occurred,

the shuttle would blow up on takeoff. Sadly, we

all know what eventually happened.

If you have never seen an FMEA for your oper-

ation (see Figure 22), you should ask your super-

visor or local expert if one exists. Otherwise, you

might ask whether someone could work with

you to create a process FMEA for your work

area. The process of developing this document

will assist you in a number of ways: it will help

ensure that the processes in your work area are

running as smoothly as they can given the cur-

rent environment, and it will help you look for

initial areas of improvement in your Practice.

The FMEA is a matrix of process issues that

could happen in the system. A numerical scale

Failure Mode and Effects Analysis (FMEA) 103

System FMEA

Failure

mode Effect Cause

The problem The The

ramifications cause(s)

of the of the

problem problem

Design FMEA

Failure

mode Effect Cause

The causes The effect New root

of the from the causes for

problem system FMEA the design

from the with perhaps failure

system FMEA a better modes

definition

Process FMEA

Note: It is not unusual to have an iteration of the causes in a

process FMEA. The flow of the iteration is demonstrated. The

iteration stops when the RPN is sufficiently low—less than 50 in

a 1 to 10 guideline scale.

Failure

mode Effect Cause

The causes The same Specific

of the effect as the root causes

problem design for the

from the FMEA process

design FMEA failure

modes

Figure 22 Relationships of a process FMEA in an

iteration mode of failure identification.

Source: Stamatis, D. H. 2003. Failure Mode and Effect Analysis:

FMEA from Theory to Execution, 2nd ed. Reprinted with

permission of ASQ Quality Press, Milwaukee, Wisconsin.

104 Failure Mode and Effects Analysis (FMEA)

has been developed to look at the severity of an

issue, the likelihood of occurrence, and the pos-

sibility of detecting an issue during the current

operation before it gets downstream. One typical

set of scores is shown in Figures 23 through 25.

(Granted that these are manufacturing exam-

ples; adaptation will have to be made to your

Practice setting.)

The three scores in the tables are then mul-

tiplied across the matrix to get a single number

called the risk priority number (RPN), which is

used by management to decide what issues, if

any, need to be addressed further. This document

should give the Practice worker a clear picture

of the operation and how the service should be

provided.

Failure Mode and Effects Analysis (FMEA) 105

Rank Resolution

1 Minor: Unreasonable to expect Unreasonable to expect that If the numerical value falls

that the minor nature of this failure the minor nature of the failure between two numbers,

would cause any real effect on would cause any noticeable always select the higher

the product and/or service. effect on the product and/or number.

Customer will probably not even the service. Customer most If the team has a

notice the failure. likely will not be able to disagreement in the ranking

detect the failure. value, the following

may help:

2–3 Low: Low severity ranking due Low severity ranking due to 1. If the disagreement

to nature of failure causing only slight annoyance of the is an adjacent category,

a slight customer annoyance. failure. Customer probably average out the

Customer probably will notice a will notice a very minor difference. For example,

slight deterioration of the product deterioration of the product if one member says 2

and/or service, a slight and/or service. and someone else says

inconvenience in the next 6, the ranking in this

process, or minor rework action. case should be 4 (2

and 6 are adjacent

categories. Therefore

2 + 6 = 8, 8/2 = 4).

Figure 23 Severity process and/or service guideline.*

*All of the above guidelines and rankings may be changed to reflect specific situations.

Source: Stamatis, D. H. 2003. Failure Mode and Effect Analysis: FMEA from Theory to Execution, 2nd ed.

Reprinted with permission of ASQ Quality Press, Milwaukee, Wisconsin.

106 Failure Mode and Effects Analysis (FMEA)

Rank Resolution

4–6 Moderate: Moderate ranking Moderate failure causes 2. If the disagreement

because failure causes some customer dissatisfaction. jumps one category,

dissatisfaction. Customer is made Customer is made then consensus must

uncomfortable or is annoyed by uncomfortable and/or be reached. Even with

the failure. May cause the use of annoyed by the failure. Some one person holding out,

unscheduled repairs and/or degradation of performance total consensus must

damage to equipment. is noticeable. be reached. No average,

no majority. Everyone

in the team must have

ownership of the

ranking. They may not

agree 100 percent, but

they can live with it.

Figure 23 Continued.

Failure Mode and Effects Analysis (FMEA) 107

Rank Resolution

7–8 High: High degree of customer High degree of customer If the numerical value falls

dissatisfaction due to the nature of dissatisfaction due to the between two numbers,

the failure, such as an inoperable nature of the failure. No always select the higher

product or inoperative safety or government number.

convenience. Does not involve regulations issues. If the team has a

safety issues or government disagreement in the ranking

regulations. May cause value, the following

disruptions to subsequent may help:

processes and/or services.

1. If the disagreement

is an adjacent category,

average out the

difference. For example,

if one member says 2

and someone else says

6, the ranking in this

case should be 4 (2

and 6 are adjacent

categories. Therefore

2 + 6 = 8, 8/2 = 4).

Figure 23 Continued.

108 Failure Mode and Effects Analysis (FMEA)

Rank Resolution

9–10 Very high: Very high severity is Very high severity ranking 2. If the disagreement

when the failure affects safety or when safety issues are jumps one category,

involves noncompliance with involved or compliance to then consensus must

government regulations. government regulations is be reached. Even with

ignored. one person holding out,

total consensus must

In this scale 9–10 is reserved be reached. No average,

only for safety and government no majority. Everyone

compliance requirements. All in the team must have

other rankings may be used as ownership of the

they seem applicable. ranking. They may not

agree 100 percent, but

they can live with it.

Figure 23 Continued.

Failure Mode and Effects Analysis (FMEA) 109

Resolution

If the numerical value falls

between two numbers,

always select the higher

number.

If the team has a

disagreement in the ranking

value, the following

may help:

1. If the disagreement

is an adjacent category,

average out the

difference. For example,

if one member says 2

and someone else says

6, the ranking in this

case should be 4 (2

and 6 are adjacent

categories. Therefore

2 + 6 = 8, 8/2 = 4).

Rank

1 Failure is unlikely. C

greater than or equal to

1.67 (<1 in 10

or ≈ ±5s)

2 Very low: Process in statistical

control. Isolated failures exist.

is greater than or equal

to 1.33 (1 in 20,000 or ≈ ±4s)

3 Low: Process in statistical

control. Isolated failures

occur sometimes. C

greater than or equal to

1.00 (1 in 4000 or ≈ ±3.5s)

4–6 Moderate: Process in

statistical control with

occasional failures but not in

major proportions. C

is less

than or equal to 1.00 (1 in

1000 or 1 in 80 or ≈ ±3s)

Rank

1 Remote probability of

occurence. Capability shows

at least X-bar ±3s within

specifications (1/10,000).

2–5 Low probability of

occurrence. Process in

statistical control. Capability

shows at least X-bar ±3s

within specifications

(1/5000–1/500).

6–7 Moderate probability of

occurrence. Process in

statistical control with

occasional failures, but not

in major proportions.

Capability shows more

than X-bar ± 2.5s within

specifications (1/20–1/200).

Figure 24 Occurrence process and/or service guideline.*

*All of the above guidelines and rankings may be changed to reflect specific situations.

Source: Stamatis, D. H. 2003. Failure Mode and Effect Analysis: FMEA from Theory to Execution, 2nd ed.

Reprinted with permission of ASQ Quality Press, Milwaukee, Wisconsin.

110 Failure Mode and Effects Analysis (FMEA)

Resolution

2. If the disagreement

jumps one category,

then consensus must

be reached. Even with

one person holding out,

total consensus must

be reached. No average,

no majority. Everyone

in the team must have

ownership of the

ranking. They may not

agree 100 percent, but

they can live with it.

Rank

7–8 High: Process not in

statistical control. Have

failures often (1/40–1/20).

9–10 Very high: Failures are

inevitable.

Rank

8–9 High probability of

occurrence. Process in

statistical control with

failures often occurring.

Capability shows X-bar

±1.5s (1/100–1/20)

10 Very high probability of

occurrence. Failure is

almost certain. (1/10+)

Note: To use a criteria scale such as this, one must have a substantial amount of data to support

statistical control and C

values. This is a very powerful scale if one has the data; if not, do not try to

generate the data to support the scale. Use a theoretical scale that is more qualitative but through the

synergy of the team becomes just as powerful.

Figure 24 Continued.

Failure Mode and Effects Analysis (FMEA) 111

Resolution

If the numerical value falls

between two numbers,

always select the higher

number.

If the team has a

disagreement in the ranking

value, the following

may help:

1. If the disagreement

is an adjacent category,

average out the

difference. For example,

if one member says 2

and someone else says

6, the ranking in this

case should be 4 (2

and 6 are adjacent

categories. Therefore

2 + 6 = 8, 8/2 = 4).

Rank

Remote likelihood that the product

or service will be delivered

(1/10,000). The defect is

functionally obvious and readily

detected. Detection reliability at

least 99.99 percent.

Low likelihood that the product

would be delivered with the defect.

The defect is obvious

(1/5000–1/500). Detection

reliability at least 99.80 percent.

Moderate likelihood that the

product will be delivered with the

defect. The defect is easily

identified (1/200–1/50). Detection

reliability at least 98.00 percent.

Rank

1 Very high: Controls almost

certainly will detect the

existence of a defect.

2–5 High: Controls have a good

chance of detecting the

existence of a failure.

6–8 Moderate: Controls may

detect the existence of

a defect.

Figure 25 Detection process and/or service guideline.*

*All of the above guidelines and rankings may be changed to reflect specific situations.

Source: Stamatis, D. H. 2003. Failure Mode and Effect Analysis: FMEA from Theory to Execution, 2nd ed.

Reprinted with permission of ASQ Quality Press, Milwaukee, Wisconsin.

112 Failure Mode and Effects Analysis (FMEA)

Resolution

2. If the disagreement

jumps one category,

then consensus must

be reached. Even with

one person holding out,

total consensus must

be reached. No average,

no majority. Everyone

in the team must have

ownership of the

ranking. They may not

agree 100 percent, but

they can live with it.

Rank

High likelihood that the product

would be delivered with the defect.

The defect is subtle (1/20).

Detection reliability greater than

90 percent.

Very high likelihood that the

product and/or service will be

delivered with the defect. Item is

usually not checked or not

checkable. Quite often the defect

is latent and would not appear

during the process or service

(1/10+). Detection reliability

90 percent or less.

Rank

9 Low: Controls more than

likely will not detect the

existence of a defect.

10 Very low: Controls very

likely will not detect the

existence of a defect.

Figure 25 Continued.

Flowchart 113

Define

Measure

AnalyzeImprove

Control

FLOWCHART (FLOW MAP,

PROCESS MAP, CURRENT STATE/

COULD BE/SHOULD BE MAP)

When you create a flowchart, you are creating

a picture of the steps in a process or system as

it actually operates or is supposed to operate.

Given the old adage that a picture is worth a

thousand words, this tool allows you to commu-

nicate, using standard symbols (see Figure 26),

how your process works (see Figure 27). The flow-

chart is very useful when looking at a process

that you want to improve (note that it is included

in the control plan—if done in your Practice). By

actually creating three flowcharts—1) what you

think it is (before you check reality), 2) what it

actually is, and 3) what you would like it to be

(see Figure 28)—you can analyze what changes

114 Flowchart

need to be made and study whether the changes

are doable given your training and resources.

Each organization should decide for itself

what symbols to use, as there are many versions

available today. After you decide what symbols

to use, you can follow some basic steps to create

the flowchart:

Bad

Good

Scrap

Warehouse

Figure 27 Basic flowchart structure.

Process step or operation

Delay

Quality check, inspection, or measurement

Storage

Decision

Movement of material

Figure 26 Typical flowchart symbols.

Flowchart 115

1. Create the boundaries of the process that

you intend to flowchart. This might involve

identifying the inputs and outputs of the

process or identifying who the suppliers

and customers are for the process.

2. Determine the various steps in the process.

Do not worry about sequence here, but

do collect all the steps. The foundation

material from a failure mode and effects

analysis (FMEA) or control plan can

be used if available to help start this

process. If a group is brainstorming ideas,

What you think it is… What it actually is…

What you would

like it to be…

Figure 28 Three versions of a process.

116 Flowchart

you could list each idea on a flip chart or

a wall using sticky notes.

3. Build the sequence of the process, putting

everything into the appropriate order.

4. Draw the flowchart using the symbols

appropriate for your organization.

 5.Verifythattheflowchartiscompleteand

appropriate for the given operation. This

can be very important if more than one

group is working on similar processes.

Overlaps or deletions may otherwise occur

between processes.

Flowcharts are a good analytical tool for moni-

toring a process over time and also in conducting

training for new Practice staff or supervisors. By

referencing the flowcharts on a regular basis, you

can use them as visual standards to help ensure

that things are still running as they are supposed

to. Note that if a change is made to the process,

it is important to update the flowchart to reflect

the change. Regular audits may be done in your

area for any number of issues (safety, quality,

environmental, and so on), so having the flow-

charts readily available helps everyone involved.

Tip: Some organizations like to start with the

“what you think it is” flowchart to get a sense of

what is happening in the Practice. Other groups

Flowchart 117

like to start with “what you would like it to be”

so that they can set the vision for the future.

The challenge for many organizations is to final-

ize the “what it actually is” flowchart, as there

are often many viewpoints within the Practice as

to how and why things work the way they do.

118 Histogram

Define

Measure

AnalyzeImprove

Control

HISTOGRAM

A histogram is a frequency distribution that

graphically displays the measurements taken

from a process and shows how those data are dis-

tributed and centered over a measurement scale

(usually horizontally—see Figure 29). Histo-

grams give us a picture of what a process is pro-

ducing over a specified period of time and how

much variation exists. This picture can then

be compared with our expectations of the pro-

cess, or older histograms, to see if it is operating

within specifications and to the desired plan for

that particular process. Sometimes you will see a

normal bell-shaped curve included with the his-

togram to show the theoretical placement of the

numbers as compared with the actual measure-

ments taken from the process (see Figure 30).

Histogram 119

Value—measurement

Count #

Figure 29 Basic histogram.

Figure 30 Histogram with bell-shaped curve.

120 Histogram

A histogram is usually quick and easy to con-

struct and is typically one of the first tools you

will use in looking at the output of a process. It

can be created by hand or with the aid of a com-

puter. Given that some test equipment can now

be tied directly to computers, a wealth of infor-

mation becomes available very quickly using the

histogram as the base. Using the histogram,

calculations can be made on the process’s mean

(average), median (middle number), and stan-

dard deviation (measure of how the numbers

are distributed in the data, sometimes compared

with the normal curve expectations).

If the Practice staffer needs to make a histo-

gram by hand, here are the basic steps:

• Setupachecksheettocollectthe

data—this could be the histogram

graph itself.

• Collectthemeasurementsastheyoccur

and record them on the check sheet.

• Orderthedataonthehistogramgraph,

if not already done through the check

sheet.

• Postthehistogramwhereotherscansee

the process.

• Interpretthedata.

Histogram 121

Since the histogram is made up of individual

numbers, it is possible to show the specification

limits for the parts on the histogram. This is

done to look for shifts in the process or the over-

all capability of the process.

122 Kanban (Wait Time, Patient Pull-Through)

Define

Measure

AnalyzeImprove

Control

KANBAN (WAIT TIME,

PATIENT PULL-THROUGH)

A system is best controlled when material, people,

and information flow into and out of the process

in a smooth and rational manner (without peri-

ods of waiting). If process inputs (patients, staff

members, supplies, and so on) arrive before they

are needed, unnecessary confusion, inventory,

wasted time, and costs generally occur. If process

outputs are not synchronized with downstream

processes, delays, disappointed customers/

patients, and associated costs may occur.

A properly administered kanban system will

improve system control by assuring timely move-

ment of products, people, and information. This

method is used in a process to signal an upstream

supplier (internal or external) that more material

or product is needed downstream. Originally, it

Kanban (Wait Time, Patient Pull-Through) 123

was just a manual card system, but has evolved

into more sophisticated signaling methods for

some organizations (by use of patient charts, col-

ored lighting systems, and so on). It is referred to

as a pull system because it serves to pull mate-

rial or product from a supplier rather than rely-

ing on a scheduling system to push the material

or product forward at predetermined intervals.

It is said that the kanban method was inspired

by Toyota’s Taiichi Ohno visiting a United States

supermarket.

In the past, many Practices were designed

with large patient waiting rooms and areas

where needed supplies were stored. If you see the

patient waiting area filled with people on a daily

basis (versus once in a while), then this is an indi-

cation of a systemic problem. The physical layout

of the office area may need to be discussed in the

Lean Six Sigma team meeting to brainstorm pos-

sible rearrangements to the way we approach the

scheduling of patients and how we move patients

and staff around the office, to allow doctors and

other staff to better utilize everyone’s time. Ask-

ing anyone (patients, doctors, staff members, and

so on) to wait is a form of waste and needs to be

minimized.

124 Lessons Learned

Define

Measure

AnalyzeImprove

Control

LESSONS LEARNED

We have all learned to do things through our

experiences, the people we have met, and the

articles or books we have read. We now apply this

learning to the work that we do every day. Some

things are repetitive, while others take thought

to accomplish. Either way, there is a standard

process that we use to accomplish our work. If we

were to take a vacation day or be out sick, could

the work be done reasonably well without us?

We are not talking about replacing ourselves

here; however, there should be a way for someone

else to be able to figure out how to do our work if

we are not there. Some companies rely on stan-

dard operating procedures (SOPs) to tell new or

replacement staff what to do. But those rarely

tell the whole truth about a job. Lessons learned

is a system that allows for the collection, storage,

Lessons Learned 125

retrieval, and distribution of knowledge—the

important learnings—to other people to use when

needed. This could be used for many purposes: to

do someone’s job in his or her absence, to conduct

internal benchmarks, or to look for better ways of

doing another job in the organization.

Learning just to gather knowledge is part

of what a learning organization is all about. In

lessons learned, companies formally establish a

system for collecting important learnings about

particular customers, activities, or processes

for use at a later time. The author’s dentist,

after each checkup, records what he has talked

about with the patient on cards that stay with

the patient’s dental records. This allows him

to review what has been or is happening in the

patient’s life prior to the next dental visit. This

process could be captured for use by any service

organization. A process should exist for collect-

ing and using these “Aha!” insights, for example,

the Ritz Carlton is well known for greeting

returning guests with personalized service

learned from prior visits. “What are we going

to do differently in this Practice regarding this

process, and for our customers, based on what we

have learned?” Thus, we learn to not repeat our

past mistakes.

In the ideal setting, the culmination of lessons

learned should lead your Practice to becoming

the best healthcare organization that it can be.

126 Management Involvement

Define

Measure

AnalyzeImprove

Control

MANAGEMENT INVOLVEMENT

In the study of economics, one finds the theories

of bubble up (worker taking the lead to do things)

and trickle down (management taking the lead

to do things). In either case, as we have seen in

the Practice, we need to have management’s buy-

in and support to ensure that things last over

time. Management involvement, then, is the way

that supervisors and managers support employ-

ees through time and resource allowances to not

only do the job well, but to study how to do an

even better job for the customer. Merely asking

staff to work harder or work better will not be

enough over time to make a real difference for

the customer.

To demonstrate management involvement,

managers and leaders need to operate with

integrity and be guided by moral principle. To be

Management Involvement 127

involved, they must be courageous, be willing to

ask the tough questions (even if they do not like

the answers), be willing to defend the decisions

of teams and employees who work for them, and

be willing to instruct upper managers to do what

is right. Employees must know that the environ-

ment is safe, that the system is being well taken

care of, and the business is being managed fairly.

Also, the managers and leaders must be willing

to uphold processes and principles that say, in

effect, that this organization will be successful

and people will be proud to work here.

Dr. J. M. Juran (1989) points out in his Juran

on Leadership for Quality that managers should:

• Establishqualitygoals

• Provideresources

• Reviewprogress

• Giverecognition

• Revisetherewardsystem

• Serveonprojectteams

• Faceuptoemployeeapprehensions

This is an area where you will “know it when you

see it.” If supervisors continually try to push staff

to only work harder to make their numbers, then

you know that quality and customer concerns are

minimal. On the other hand, if supervisors care

128 Management Involvement

that the services and products that are presented

to customers are the best they can be, and they

show concern for satisfying or delighting the cus-

tomer, then managers are showing commitment

to quality and how work is being done.

For Lean Six Sigma to work well in your orga-

nization, management must be committed during

all phases of the process to ensure that adequate

time and resources are allocated to achieve

continual improvement. Practice staff will notice

that managers are not cutting corners to save

costs, that safety remains a prime concern, and

that they, the Practice staff, are being treated

fairly. Also, Practice staff will see workload dis-

tribution and expectations being managed in an

equitable fashion and that employment agree-

ments are managed equitably.

Peter Senge’s comment on the subject is worth

repeating here: “Top management buy-in is a poor

substitute for genuine commitment and learning

capabilities at all levels in an organization. In

fact, if management authority is used unwisely,

it can make such commitment and capability less

likely to develop” (Senge 1990).

Measurement Systems Analysis (MSA) 129

Define

Measure

AnalyzeImprove

Control

MEASUREMENT SYSTEMS

ANALYSIS (MSA)

In healthcare environments, we do not often

think about analyzing the equipment or pro-

cesses we use to study or verify work that has

been done according to a standard or specifi-

cation. Whenever we measure anything with a

gage or a scale, we typically assume that it will

give us a true reading or measurement. Have

you ever put an envelope on a postage scale and

then put the same envelope back on again to see

if you get the same postage reading? Usually you

will, but more often than you might think,

you can actually get a different reading. This is

especially true if you are just between two differ-

ent rate codes. Or have you stepped on a bath-

room scale only to try it again a little later to see

if you get the same reading? Depending on the

130 Measurement Systems Analysis (MSA)

scale (some newer electronic scales have blockers

in them to prevent variation) you may very well

see different readings. What is happening?

Any form of measurement has variation in it.

Even if a gage or scale is being used, results can

be different. If you have multiple people review-

ing data entry information, the odds are that

incorrect information will get through! That is

why many accounting processes have so many

rework and rechecking loops in them. Why does

this happen? It is a well proven fact that inspec-

tion is only about 80 percent effective. Also, even

if you have a standard to work to (say, a written

procedure that is to be followed for some out-

come), there is always a chance for something

to not be evaluated the same way by different

people. Ask almost any police officer who has had

to take eyewitness testimony of a traffic accident

from a number of people. The officer will prob-

ably tell you that there were as many versions of

the story as people interviewed!

Each of us relies on measurement processes

(visual inspection, verification loops, actual

testing equipment, and so on) to measure our

processes and the outcomes of our work. The

question measurement systems analysis (MSA)

addresses is “How effective are those measure-

ment processes?” It is surprising how quickly

a measurement process can get out of calibra-

tion or otherwise give poor readings. Even after

Measurement Systems Analysis (MSA) 131

installing the measurement system properly and

using it the way that it was designed, things can

still go wrong with how the measurement pro-

cess performs. Sometimes we will see two identi-

cal processes that will give different outcomes for

the same thing being studied. In other cases, two

or more Practice staff will use the same or simi-

lar processes but get different results.

Measurement systems analysis is a method

of checking how well people are using a measure-

ment process and judging whether the mea-

surement system is effective and efficient, in

order to provide your customers with the services

they want. The process of testing is sometimes

called gage repeatability and reproducibility

(GR&R), and through the use of software we

can look at the gage’s accuracy, repeatability,

reproducibility, and stability. If the MSA shows

problems, then you must take action to ensure

that the service you provide will meet customer

requirements.

One common MSA method involves a group

of people (two or more) using the same or simi-

lar measurement processes and testing a blind

set of numbered samples (around 10 or so). The

test items (reports, financial information, timed

events, and so on) are given to the people ran-

domly with only the tester knowing which item

is which. Each person tests each item a total of

three times in a random order so that the person

132 Measurement Systems Analysis (MSA)

will not know what outcome the item may have

had on a prior test. After all items have been

measured the appropriate number of times, the

data can be put into any of a number of computer

software programs for analysis.

Other methods of MSA are used for processes

that can only be checked once for each item. The

main point here is that checking processes can

vary, and our methods of verifying or validating

what is done must be understood so that deci-

sions can be made on the overall effectiveness of

how things are being evaluated. With this infor-

mation, we can start studying the variation of

the processes with confidence that we know the

variation of the measurement system.

Mistake-Proofing (Error-Proofing, Poka-Yoke) 133

Define

Measure

AnalyzeImprove

Control

MISTAKE-PROOFING (ERROR-

PROOFING, POKA-YOKE)

Mistake-proofing (also called error-proofing or

poka-yoke) is the process of either ensuring that

there is only one way (or limited ways) to do any

given task in a process or ensuring that any mis-

take is very obvious as soon as it happens. Such

efforts help reduce variation in the process and

help prevent nonconformity issues from arising

in the process downstream or when a customer

uses the product or service. Have you ever noticed

that when you try to plug an electrical appliance

into an electrical outlet, the plug can go in only

one way (this is true for either two- or three-

pronged plugs)? This is an example of mistake-

proofing that allows the electronics industry to

ensure proper usage of appliances in the office

or home.

134 Mistake-Proofing (Error-Proofing, Poka-Yoke)

Jobs in your organization can be looked at in

the same way. Is it possible for a process to be

completed in more than one way? Can the process

be done in a different order than what the pro-

cess design states (or worse yet, does each person

develop their own method for doing the work)? If

any of these issues or any number of others exist,

you should help ensure that things are done more

consistently to help reduce variation in the pro-

cess. Note: We are not talking about reducing or

stopping independent thought or creativity here!

Some things can be done differently with little to

no impact on the outcome of the process. What

we want to look at is how to give customers more

consistency in what they see.

You may need to get quality assurance or man-

agement involved with some changes to your pro-

cesses; however, some changes you can do with

the help of your natural work groups. If there is

a series of similar processes that comes through

your area, look over the paperwork that accom-

panies these processes. Is everything arranged

logically for your work space? Is the paperwork

aligned to show similar steps in the same order

or sequence? Do some reports sit in in-boxes for

long periods of time with no value added? If you

could change anything about your work area,

what would it be? Tell your supervisor or team

your ideas.

Mistake-Proofing (Error-Proofing, Poka-Yoke) 135

The originator of this method was a Japanese

engineer named Shigeo Shingo, and there is now

a yearly prize (Shingo Prize) in the United States

to promote the use of mistake-proofing and other

world-class operational excellence strategies.

136 Pareto Chart

Define

Measure

AnalyzeImprove

Control

PARETO CHART

Dr. J. M. Juran applied the concept of the Pareto

principle (based on the work of a 19th-century

economist and priest named Vilfredo Pareto)

to industry during the 1950s. Basically, the

Pareto principle, or 80/20 rule, states that 80

percent of effect(s) are the result of 20 percent

of causes. The result of this work is a graphi-

cal tool—called a Pareto chart—that shows fre-

quency of occurrences (or ranks the effects of

problems). See Figure 31.

The Pareto chart organizes data to show

which items or issues have the greatest fre-

quency in the process, system, or service. The

chart stratifies the data to show the ranking of

the groups, starting with the largest and work-

ing across to the smallest group (see Figure 32

Pareto Chart 137

for a pictorial version of the Pareto chart). The

idea is that by organizing the data in this format,

we can develop a plan to work on problems that

will give us the biggest return on our process

improvement efforts.

A Pareto chart is easy to develop by hand; how-

ever, there are computer software programs that

can do this as well. Here are the basic steps:

• Collectthedata—thePracticestaffercan

again start with the check sheet to collect

information.

Count

Defect

Count 49 13 75433

Element 7

Element 6

Element 3

Element 1

Element 8

Element 2

Others

Figure 31 Pareto chart.

138 Pareto Chart

• Organizeandgroupthedatafromhighest

frequency to lowest frequency.

• DrawtheParetochart.

• Analyzethedata.

• Workontheissues.

Once the Pareto chart has been created, the

Practice staffer and team can start develop-

ing plans and actions (use a problem-solving

method) for improving the process, starting with

the most frequently occurring issue or problem.

As that problem is improved (you may not be able

to totally eliminate the problem, but you still

Patient: ___________

Address: ___________

___________

Phone: ___________

Email: ___________

BackFront

Figure 32 Pictorial Pareto chart—patient

chart audit.

Pareto Chart 139

try), the team can go to the next most frequently

occurring problem and work on that, and so on.

When creating multiple Pareto charts over

time for the same process, it is helpful to main-

tain the same scale (see Figures 33 and 34). If

a computer is used, the Practice staffer may

have to manually set the scale. This will allow

for easier comparisons to demonstrate continual

improvement.

100

Count

Percent

Defect

Before Improvement

Addition error

Wrong city

Customer not verified

Spelling error

Wrong $ value

Customer info wrong

Wrong state

Wrong salesperson

Other

Count 24 15 6 5 4 3 2 2 1

Figure 33 “Before” Pareto chart.

140 Pareto Chart

Count

Percent

Defect

Wrong city

Customer not verified

Spelling error

Wrong $ value

Customer info wrong

Wrong state

Wrong salesperson

Additional error

Other

Count 15 6 5 4 3 2 2 1 1

100

After Improvement

Figure 34 “After” Pareto chart.

PDSA Cycle (Plan–Do–Study–Act) 141

Define

Measure

AnalyzeImprove

Control

PDSA CYCLE

(PLAN–DO–STUDY–ACT)

PDSA is a strategy intended to be a guiding light

for the way we work and do our jobs. Building on

the work of Walter Shewhart in the 1930s, Dr. W.

Edwards Deming changed the PDCA improve-

ment model (plan–do–check–act) to PDSA (plan–

do–study–act). The latter model is the foundation

for various methods such as advanced quality

planning, problem solving, Lean Six Sigma, and

process improvement (see Figure 35).

The PDSA cycle is used as a road map to work

through a process to identify possible aspects

that can be improved. First, a plan is estab-

lished regarding what is to be worked on. In the

do phase, we do the work of the process. Then

we can study the process and outputs of the pro-

cess to identify possible improvements. Finally,

142 PDSA Cycle (Plan–Do–Study–Act)

we take some actions on what we have seen and

observed. This cycle should be repeated until

the process is as good as it can be given the cur-

rent process parameters and materials. The

challenge is that as new methods, materials, and

technology become available, we keep open minds

to allow for changing the way we do our work.

Another view of the PDSA cycle is represented

by the data–knowledge–action cycle (see Figure

Figure 35 PDSA cycle.

PDSA Cycle (Plan–Do–Study–Act) 143

36). This may allow the Practice staffer or man-

ager to understand PDSA by starting with the

basic building blocks of the process. You need

to have knowledge about the process, have data

from the process, and be willing and able to take

action to make necessary changes. Without all

three components, nothing will change. Just as

a three-legged stool will give solid support, once

all three parts are present, you can work with

the process to understand what it is doing. Then

you can work to improve it.

A fascinating point that the author has noted

while observing people such as Deming, Juran,

and Feigenbaum is that each of them applied the

Knowledge

Action

Data

Figure 36 Continuous improvement model.

Source: Cutcher-Gershenfeld, J., and K. Ford. 2005. Valuable

Disconnects in Organizational Learning Systems. New York:

Oxford University Press. Used with permission.

144 PDSA Cycle (Plan–Do–Study–Act)

PDSA technique to his own life and work. Each

of them continually challenged their beliefs and

training to look for new and better ways of doing

any work or assignment. The point is to continu-

ally improve everything that we do, both on the

job and in our life.

Practice Strategy (Future State) Project Planning 145

Define

Measure

AnalyzeImprove

Control

PRACTICE STRATEGY (FUTURE

STATE) PROJECT PLANNING

Building a practice strategy involves a lot of proj-

ect planning to ensure that the desired goals

and outcomes of the Practice will be achieved.

The old adage that “failing to plan is planning

to fail” applies to medical Practices as much as

anywhere else. If we give little to no forethought

to how we run our Practice to deliver quality and

safe healthcare for our patients, then the out-

comes can not be predicted. In the books Curing

Health Care (Berwick, Godfrey, and Roessner

1990) and Crossing the Quality Chasm (Commit-

tee on Quality Healthcare in America 2001), a

bleak picture is presented on how well, or poorly,

we in the United States as a society design and

deliver our healthcare to patients. The challenge

here is for Six Sigma team members to utilize

146 Practice Strategy (Future State) Project Planning

the tools outlined in this pocket guide to set a

strategic plan in place to help ensure that your

Practice is delivering the very best quality and

safest healthcare available to your patients.

Project planning is the disciplined monitor-

ing of how and when a practice strategy will

be accomplished. If you want to go on a long

trip, do you just jump in the car and go? Some

people do because they like the spontaneity of

adventure. Most of us, however, would rather

plan the trip, some in more detail than others.

We do so to know what needs to be taken, how

long we will be gone, and any number of other

details. Those of you with young children know

that this is very important.

Too often, Practice staff use the tools and pro-

cesses listed in this book as independent events

to satisfy some issue of the moment. Using project

planning, you should look at the entire system and

strive for synergy as you use communication

and the tools and processes to contribute to con-

tinual improvement. Project planning becomes

the tracking system to ensure that all the

elements, tools, processes, communications, and

so forth, are brought together as a whole system

for doing the work that you do in your Practice.

Effective project planning requires skills in

the following areas (Kerzner 1995):

• Informationprocessing

Practice Strategy (Future State) Project Planning 147

• Communication

• Resourcenegotiations

• Securingcommitments

• Incrementalandmodularplanning

• Assuringmeasurablemilestones

• Facilitatingtopmanagementinvolvement

At times Practice staff may become part of proj-

ect plans that are developed in your Practice or

aligned healthcare units. Working with such

plans should help ensure the successful demon-

stration of continual improvement and the satis-

faction of customer’s wants and needs.

148 Problem Solving

Define

Measure

AnalyzeImprove

Control

PROBLEM SOLVING

Some of the more successful attempts to solve

problems have been accomplished through the

use of a model or strategy that outlines the steps

that should be followed in investigating and con-

taining issues, and fixing the problems so that

they will not return. Unfortunately, many of us

have seen situations in which a problem has been

fixed, only for the same issue to crop up again in

a week, month, or year. The question is “How do

we permanently solve problems?”

One common approach to problem solving

is called the eight discipline (8D) approach

( Stamatis 1996). The steps commonly followed in

this process are:

1. Use a team approach. Organize a small

group of people (note that we did not say

Problem Solving 149

that you have a team at this point—this

is just a starting group) with knowledge

of the process/product, authority to make

changes in the Practice, and skill in the

technical disciplines required to solve

the problem and implement corrective

actions. The group must have a designated

Champion.

2. Describe the problem. Specify the internal/

external customer problem by identifying

the quantifiable terms—the who, what,

when, where, why, how, and how many

(five W’s and two H’s) for the problem.

Use SIPOC, brainstorming, flowcharts,

and any other methods that the group

feels is appropriate.

3. Start and check interim (containment)

actions. Define and implement

containment actions to isolate the

effect or issue from the problem “right

now.”Verifytheeffectivenessofthis

containment action to ensure that the

internal or external customer does not

see further problems.

4. Define and check root causes. Identify

all potential causes of the problem

(a cause-and-effect chart is useful here).

Isolate and verify the root causes by

150 Problem Solving

testing each potential cause (sampling is

used here) against the problem description

and test data (individual test or a DOE

if needed). Identify alternative corrective

actions to eliminate root causes, using a

process behavior chart to ensure that

the process remains stable.

5. Check corrective action. Through a

sampling plan, quantitatively confirm

that the selected corrective actions will

resolve the problem for the customer and

will not cause undesirable issues (FMEA

and control plans).

6. Start permanent corrective action.

Once a corrective action is verified to

be working, update all procedures

and processes to incorporate the new

process. This should include training

where appropriate.

7. Stop future problems. Modify the

management systems, operating systems,

preventive maintenance, processes,

and procedures and documentation to

prevent recurrence of this and all similar

problems. Note: If similar processes are

found in the Practice, look closely at them

also to ensure that they do not develop the

same issue.

Problem Solving 151

8. Congratulate your team. Improvements

happen only because many people work

together. Everyone deserves credit.

Your external customers may have a prescribed

problem- solving methodology other than 8D that

they want your organization to use. Other meth-

ods that can be used in problem solving are the

PDSA cycle and, although not recommended, the

scientific method that you probably learned in

high school.

152 Process Behavior Charts (Statistical Process Control)

Define

Measure

AnalyzeImprove

Control

PROCESS BEHAVIOR CHARTS

(STATISTICAL PROCESS CONTROL)

The foundation for process behavior charts was

laid by Walter Shewhart (called the father of

modern-day quality control) in the late 1920s.

The charts were originally called control charts

as they were thought to help control the pro-

cess. Today, more than 30 different charts can be

used; however, we typically use only six or seven

on a regular basis; Practice staff will find the

IMR, p, and u the most useful. These charts fol-

low the premise of creating a picture of the pro-

cess variation while the work is being done (see

“Run Chart”). This allows the Practice staffer

to ensure that the process is stable and continu-

ing to operate within the process boundaries (not

necessarily specification limits) that have been

established for that process. If something does

Process Behavior Charts (Statistical Process Control) 153

start to deteriorate or change in the process,

the process behavior chart will give the Practice

staffer an early warning that something needs

to be adjusted or changed to bring the process

back into control. Note: the healthcare worker

should remember that in pursuing continual

improvement, you want the process to change for

the better; thus, instead of a stable process you

should see the variation on the process behav-

ior chart follow the standard out-of-control rules

(found in many texts)!

This book will not go into the details of creat-

ing and maintaining process behavior charts as

you can find many references on the subject (see

“control charts” in most texts). We will discuss in

general the basic charts and some of the ways to

use them. Table 3 lists these basic charts.

The “Data type” column in Table 3 indicates

twodifferenttypesofdata.Variabledataareinfor-

mation in number format that comes from scales

(for example, length measures, weighing devices,

temperature controls, distance measures, or time

measures). Attribute data are information on the

goodness of something (for example, pass/fail cri-

teria, acceptance standards, accuracy of proce-

dure, or accuracy of counts).

Variable data are usually considered more

valuable in understanding process behavior than

attribute data as more information is available

and trends and patterns are more easily and

154 Process Behavior Charts (Statistical Process Control)

Table 3 Process behavior chart types.

Chart name Data type Measure* Description

X-bar and R Variable Averages of Subtract the smallest sample value

variable data from the largest to identify the range

X-bar and s Variable Averages of Use a computer to identify the

variable data standard deviation

Individual moving Variable Individual variable Used when averages are not

range (IMR) data available

p Attribute Fraction of Percentage of all units checked

nonconforming units

np Attribute Number of total Number of units found to have issues

nonconforming units

c Attribute Number of Number of issues found

nonconforming

u Attribute Number of Average number of issues found per

nonconforming per unit the number of units checked

Some references refer to nonconforming as “defect” or “defective.” Your industry may have a product liability

issue with the terms “defect” or “defective,” so “nonconforming” is used in this text.

Process Behavior Charts (Statistical Process Control) 155

more quickly seen in the variables. The home gas

usage run chart (see Figure 37) is an example of

plotting using variable data.

In either type of process behavior chart (vari-

able or attribute), the healthcare worker or super-

visor needs to ensure that the measurements

from the process are recorded, calculated, and

plotted appropriately. In variable data charts the

healthcare worker should ensure that the process

average is calculated and then refer to an appro-

priate table to calculate the upper (UCL) or lower

(LCL) control limits (see Figure 38), which can

be found in most SPC books (Stamatis 1997).

100

Units

May

Mar

Jan

Nov

Month

Figure 37 Home gas usage.

156 Process Behavior Charts (Statistical Process Control)

When working with attribute charts, calculat-

ing the control limits with a handheld calculator

can be relatively simple. See Figures 39 and 40

for the steps to follow on the calculator for the p

and u charts (most commonly used in the Practice

setting) without having to learn the technical

formulas found in many reference books.

T he mo st i mp or t a nt t h i n g a bout p r o c es s b eh av-

ior charts is that you actually use them to under-

stand what your process is doing. Just ma king the

charts and posting them on the wall is often sar-

castically called statistical process display (SPD)

and does little to help the healthcare worker

monitor or improve the process. Learning to use

and read the charts can go a long way toward

helping your Practice maintain and/or improve

the quality of services that you provide. The term

“being in statistical control” refers to the plot

points on the chart following a random pattern

between the upper and lower control limits.

First add up all the x’s and divide by the total num-

ber; this equals x

–

. Record this number. The UCL

and LCL can be calculated using a standardized

table that can be found in many control chart refer-

ences or in SPC software.

Figure 38 Calculating process average, UCL, and

LCL for variable data.

Process Behavior Charts (Statistical Process Control) 157

First add up all the u’s and divide by the total num-

ber; this equals u

–

On your calculator, follow these steps:

1. Enter u

–

into the display.

2. Divide by the total number of u’s.

3. √

_____

4. Times 3 equals some value; record this

value.

5. Add the value to u

–

for UCL.

6. Subtract the value from u

–

for LCL.

Figure 40 u chart control limit calculations.

First add up all the p’s and divide by the total num-

ber; this equals p

–

. Record this number.

On your calculator, follow these steps:

1. 1 minus p

–

2. Times p

–

3. Divide by the total number of p’s.

4. √

_____

5. Times 3 equals some value; record this

value.

6. Add the value to p

–

for UCL.

7. Subtract the value from p

–

for LCL.

Figure 39 p chart control limit calculations.

158 Process Identification

Define

Measure

AnalyzeImprove

Control

PROCESS IDENTIFICATION

Anything we do can be defined in terms of a pro-

cess or system. Many of the tools discussed in

this book can be used to help identify causes and

effects, frequency and distribution of measures,

most frequently occurring data, process flow as

it is occurring, and other aspects of the process.

If you plan to study a process, it is very impor-

tant that you first identify the boundaries that

you will work within. Many books talk about the

basic “input, process, output” model for process

identification (shown earlier in Figure 2, page

6). Today, some people use the SIPOC model (see

Figure 3, page 8)—supplier, input, process, out-

put, customer—which gives defined boundaries

to the old model.

In any sporting event, besides knowing the

rules of the game, you must know the boundaries

Process Identification 159

of the game field. This does not prevent us from

thinking outside the box (boundaries), but it does

give us guidelines for what we are dealing with

as we go about our daily tasks and endeavors.

Taking the time to actually list or draw compo-

nents of the process will help us find issues more

quickly than might otherwise be possible.

One common method of identifying the pro-

cess is called the storyboard method. This tool is

similar to flowcharting but involves drawing pic-

tures of the various tasks instead of just using

words. This technique is used by movie produc-

ers to sequence scenes of a film prior to shooting

to ensure that everyone on the set (actors, sound

technicians, cinematographer, support person-

nel, and so on) knows what is supposed to happen

ahead of time. The same scenario can be used in

the Practice to lay out a pictorial sequence of the

process as it should happen. This technique can

be especially useful if you have customers from

different cultures visiting your Practice who may

not speak your language as their native tongue.

160 Process Improvement (PI)

Define

Measure

AnalyzeImprove

Control

PROCESS IMPROVEMENT (PI)

Process improvement is the method of making

a system work better to satisfy customer wants

and needs. It is vital if continual improvement is

to become a reality. In process improvement you

should look at reducing overall variability, not

just the variation. Variability is made up of three

components: instability, variation, and off-target

conditions.

In dealing with variability, most practitio-

ners traditionally have addressed only the varia-

tionquestion.Variationisimportant,andweuse

the tools listed in this book to help reduce it as

much as possible. But the other two components

are also important. Without knowledge of these

two—instability and off-target conditions—

Process Improvement (PI) 161

we could miss some very important factors and

even cause major problems in the Practice.

Instability is the lack of a stable operating pro-

cess; common cause and special cause variation

are unchecked and not responded to. Without a

stable process, capability values are not worth

calculating and customers can, and do, see any

number of issues come and go without rhyme or

reason. The best method for monitoring a pro-

cess is to use process behavior charts, but far too

often the charts either are not kept up-to-date or

are not used at all. Practice staff play a big role

in monitoring the processes to ensure that the

jobs they perform are stable and in control.

Whether a process is off target is often deter-

mined by the managers who design the operation

or services. The Practice staffer can only mon-

itor whether the process is centered within the

specifications and/or control limits. Even though

today we talk about the Taguchi loss func-

tion and how processes should be centered with

regard to what the customer wants and needs,

many jobs we work in today were designed years

ago when managers put the target wherever it

made the most economic sense for the company

at that time, instead of for the customer. In other

cases, we have done something the same way for

so long that it is now assumed that there is a rule

162 Process Improvement (PI)

or even a governmental law that it must be done

that way. So the Practice staffer should moni-

tor the process and be ready to give up-to-date

information to managers when processes are to

be redesigned, so that the new thinking becomes

a reality in your Practice.

Run Chart 163

Define

Measure

AnalyzeImprove

Control

RUN CHART

A run chart is a graph that shows measurements

from an operation or process in relationship to

time.Virtually no calculations are required for

this chart, and it is very useful in monitoring

process variation for patterns, trends, and shifts.

The run chart, sometimes called a trend chart or

line graph, is the basis for a number of the pro-

cess behavior charts and can be used almost

anywhere (try tracking the utility usage of your

home, and then look for ways to cut energy usage

to save cost—see Figure 41).

The run chart is created by setting up a time-

line and a measurement scale. Then, as mea-

surements are taken from the process during

production runs, the data can be plotted on the

grid to form a graph of the process. The health-

care worker can then monitor the process as it is

164 Run Chart

running to see the process variation and deter-

mine whether the process is changing with

sudden shifts (spikes) or moving up or down over

time (trends). The home gas usage run chart

was made with actual numbers for a northern

state. Notice the general trend of summer versus

winter usage. The winter of 1998 used less energy

than either the winters of 1999 or 2000 because

an elderly father came to live in the home during

the last two years. You can also see a spike in

February 2000, which was caused by an esti-

mated bill being generated instead of an actual

gas reading taken during January. During the

summer months, the furnace is not used very

100

Units

May

Mar

Jan

Nov

Month

Figure 41 Home gas usage.

Run Chart 165

much, but the gas dryer is being used more and

more to handle additional laundry needs.

Other uses of the run chart show the health-

care worker if there are cycles (as in the gas

usage example above) or how events around the

work area may be affecting the operation or pro-

cess. Sometimes we work with an operation for so

long that we don’t notice little things happening

around us that may have an impact on how the

process works. By monitoring a run chart, we can

get a picture of what is going on in the system.

166 Scatter Diagram

Define

Measure

AnalyzeImprove

Control

SCATTER DIAGRAM

The scatter diagram is a graphic display used to

identify a relationship or association between two

variables, cause and effect, and so on. To create

the diagram, you plot the intersection of the two

data points, maintaining one variable on the

x-axis and the other variable on the y-axis. Once

all of the data is on the graph, the observer can

eyeball a line of best fit (which can also be calcu-

lated on a computer for accuracy). The plot pat-

tern (line of best fit) identifies whether there is a

positive, negative, or no correlation in the data.

There is also the possibility for a nonlinear rela-

tionship between the variables (see Figure 42).

One caution in the use of this tool is to ensure

that the two variables being compared actu-

ally are related to each other. By accident, you

Scatter Diagram 167

–1.0

–1.5

–2.0

–2.5

–3.0

–3.5

–4.0

100 200 300

Scatter plot

400 500

No correlation:

Strong negative correlation:

–1

–2

–3

–4

–3 –2 –1 0

Scatter plot

21 3

Figure 42 Scatter diagrams.

168 Scatter Diagram

Strong positive correlation:

Quadratic relationship:

4.0

3.5

3.0

2.5

2.0

1.5

1.0

100 200 300

Scatter plot

400 500

100 200 300

Scatter plot

400 500

Figure 42 Continued.

Scatter Diagram 169

could show that there is a relationship between

two variables when there may be a third factor

in play. An example of this would be to say that

drowning is caused by increased ice cream sales.

On the graph, it might be noted that as drown-

ings go up, so do ice cream sales. However, as

everyone could guess, both of these events occur

more frequently during summer months versus

winter. So drowning and ice cream sales are actu-

ally factors of warmer weather, versus having a

causal relationship to each other.

170 SIPOC Diagram

Define

Measure

AnalyzeImprove

Control

SIPOC DIAGRAM

The SIPOC (supplier–input–process–output–

customer) diagram can be a flowchart, quasi–

value stream map, turtle diagram, and so on,

that shows the variables involved in a given pro-

cess (see Figure 43). Traditionally, we would

have mapped the IPO (inputs, process, out-

puts) of a process, which could be the entire

Practice or one aspect of the Practice. Today,

we typically include the items, people/patients,

or processes that are needed at the beginning

of the process flow and then list the items,

people, or processes that are a result of what is

being done/studied in the core event. One of the

primary uses of the SIPOC diagram is to ensure

that everyone in the system has a clear, visual

reference for what is to be done in the process (a

road map of how things are supposed to work).

SIPOC Diagram 171

Suppliers

Providers of the required inputs/

resources to ensure that the process

executes as planned.

Inputs

Resources required by the process to

obtain the intended output.

Process

Top-level description of activity.

Outputs

Deliverables from the process.

Note: deliverables can be hardware,

software, systems, services, data,

information, and so on.

Customers

Any organization that receives an

output or deliverable from the process.

Note: can also capture systems/

databases that receive outputs,

information, data, and so on.

Input

boundaries

Process being

reviewed

Output

boundaries

Figure 43 Basic SIPOC diagram.

172 SIPOC Diagram

This is a method of aligning everyone to a com-

mon goal (what is to be accomplished).

To develop a SIPOC diagram, start by defin-

ing the process and its boundaries. Next, iden-

tify the outputs of the process, including data,

services, products, information, records, and so

on. For each identified output, identify all of the

associated inputs. Then move on to the internal

and external customers—those that receive the

identified outputs. Finally, move back to the sup-

plier column to identify the internal and external

suppliers for each identified input. Although it

may seem odd to bounce back and forth from side

to side on the chart, this is done to help stimulate

thinking. For example, new outputs are often

identified when discussing inputs or customers.

External suppliers to a process are those out-

side the enterprise that provide process inputs,

including materials, purchased parts, contracted

services, electrical power, and so on. Internal sup-

pliers to a process are departments or processes

inside the enterprise that provide process inputs.

Similarly, a process’s external customers are

those outside the enterprise who receive process

outputs while internal customers are those inside

the enterprise who receive process outputs. Sup-

pliers of either type are responsible for meeting

the requirements of their customers. Customers

of either type are responsible for communicating

their requirements to their suppliers.

Standard Operating Procedures (SOPs) 173

Define

Measure

AnalyzeImprove

Control

STANDARD OPERATING

PROCEDURES (SOPs)

Standard operating procedures (SOPs) are known

by many names: work instructions, level three

ISO 9001 documentation, operating guides, job

aids, standard job procedures, and more. Your

Practice may already have a policy and proce-

dures manual (sometimes called a quality man-

ual) that can include at least some of the SOPs

for your Practice. In your Practice, what do you

call the step-by-step description of how to carry

out a task? These descriptions should give the

details of how you do your various jobs. They

should address such things as: What is the job?

Where does the SOP apply? When does the SOP

apply? Who is responsible? And so on.

Practice staff are responsible for following

SOPs as written. If any deviations are made,

174 Standard Operating Procedures (SOPs)

the healthcare worker needs to document what

was done and why (either in the patient charts

or other designated area for such information).

This will be a big help if at a later date a problem

arises and an investigation is done in the health-

care worker’s area. Documented evidence will

go a long way toward preventing finger-pointing

or faultfinding and the healthcare worker being

blamed for something out of his or her control.

The SOP should be a living document, chang-

ing as Practice staff change the work that they

do. If something changes in the system, the

healthcare worker should ensure that the SOP

is updated. Once something changes in the pro-

cess, and a new, desirable level is achieved, the

healthcare worker should help update all docu-

ments relating to that process appropriately and

destroy the old documents.

Standardization (SDCA) 175

Define

Measure

AnalyzeImprove

Control

STANDARDIZATION

(SDCA—STANDARDIZE–DO–

CHECK–ADJUST)

Standardization is the process of locking in the

gains that you have made during the improve-

ment process. It is commonly referred to as the

SDCA cycle (standardize–do–check–adjust). This

tool is generally used once a process has been

improved, to update the control plans, FMEA,

process sheets, and other process documentation

to lock in the improvements and standardize the

changes throughout the organization (see Figure

44). Thus, everyone who is involved with the pro-

cess in question will provide the service in the

same basic way.

The SDCA cycle involves updating (standard-

izing) any documentation related to the process

that has been improved, then doing the work

176 Standardization (SDCA)

to ensure that it runs smoothly. The process is

then checked or inspected to ensure accuracy

and, finally, adjusted to ensure that the pro-

cess output satisfies the customer’s wants and

needs. This cycle should be used any time that

improvements have been achieved and the Prac-

tice wants to ensure that the lessons learned will

become part of everyday work.

Figure 44 Standardization cycle.

Systems Thinking 177

Define

Measure

AnalyzeImprove

Control

SYSTEMS THINKING

Systems thinking is recognition/identification

and consideration of all the various individual

elements that interrelate with a common pur-

pose toward the whole function of a unit (Rice

1997). Many of us are so busy doing our daily jobs

that we have little time to think about what we

are actually doing. In systems thinking, you use

all the tools and methods around you to look at

what is being done in a given operation. You must

examine the operation as it is for aspects of the

process, equipment, methods, procedures, envi-

ronment, or other factors, that could be changed

to give faster, better, and cheaper service to cus-

tomers (internal and external). Often, however,

we notice that someone (maybe even yourself)

has made a change in one part of an operation

only to cause new problems somewhere else.

178 Systems Thinking

Using systems thinking, you can understand

the process and know that if one factor is changed

or influenced in some particular way, then some-

thing different might happen downstream in the

process. For example, if a computer glitch occurs

in one Practice, will that prevent other tasks in

other healthcare units from being completed?

If one healthcare worker changes something in

the way data is collected, but does not let others

know, what might happen to the integrity of the

information downstream? If programming is

changed on a database with little or no updated

training provided, how long will it take to get

accurate and reliable information? All of this is

part of systems thinking.

You should constantly be looking at the vari-

ability in the system for opportunities for con-

tinual improvement. As the author has noted

in other sections of this guide, variability is

made up of three factors: instability, variation,

and off- target conditions. Instability of a pro-

cess says that you can not be sure what it will

do at any given time. Process behavior charts

are useful tools to graphically show how the pro-

cess is operating and whether the process is in

a state of statistical control. However, instabil-

ity goes beyond just statistical control. A process

can become unstable for any number of reasons.

Some of these include lack of poor housekeeping

disciplines, poor materials from suppliers, vague

Systems Thinking 179

or unknown customer requirements, inadequate

procedure definition, or equipment shortages.

Learning about your process and how it fits into

the overall activities in your Practice is the foun-

dation of systems thinking.

Variation is discussed in the “What Is Vari-

ation” section of this book, so let’s look at off-

target conditions. Given today’s views on quality

processes, process designers should always set

target values of characteristic measurements.

With tools such as quality function deployment

(not discussed in this book), specialists should be

able to center the target values according to what

the customer wants and needs. But this has not

always been the case.

A service call recently experienced by the

author may be a good example of a lack of systems

thinking. In making an appointment, I was told

to expect a wait of a couple of hours. I arrived at

the organization a little early with a book to read.

A person took the order and sent the information

to the back for the service to be performed. After

three hours of not hearing anything (the first

person had noted that I was waiting on the prem-

ises), I went to check on how things were going.

I was told that things were not right and that I

must have done something, but that the service

should be completed shortly. After another hour,

I again went to check on the service to find that

things had been completed, but I had not been

180 Systems Thinking

called yet. It seems that there was some need to

transfer paperwork between a number of people

before I could be called. A couple of days later,

a quality representative called me to see how I

liked the service. After recounting the above

story, the rep repeatedly apologized and said

that she would look into what might have caused

the long delay, which should not have occurred.

It turned out that part of the delay was due to

someone taking a lunch break and my paperwork

being buried on their desk. After they returned

from lunch, the person started from the top of

the pile and they worked their way down to my

file at the bottom.

Team Meetings (Huddles) 181

Define

Measure

AnalyzeImprove

Control

TEAM MEETINGS (HUDDLES)

Useful and productive team meetings are struc-

tured events with a purpose. Just meeting for

the sake of meeting wastes time and energy that

could be used more productively in other areas.

Many of us do not think much about meetings

since we attend so many of them that it seems

almost second nature. We rarely ask if the meet-

ing is necessary and a valuable use of the attend-

ees’ time. Any time two or more people come

together to conduct business, we should remem-

ber that time, energy, and resources are being

spent. For an in-depth study of the topic, see How

to Make Meetings Work by Michael Doyle and

David Straus (1976).

The first question should always be, “Why

are we having this meeting?” There are actually

many good reasons to hold meetings, and there

182 Team Meetings (Huddles)

are different meeting types. Five of the most

basic are problem solving, information sharing

(both gathering and/or giving), planning and

coordination, decision making, and reaction or

feedback. Any meeting can be a combination

of these types. Each type of meeting may require

different roles, more or fewer people, and a vari-

ety of meeting methods. It is important to be

clear about the type of meeting you want and

to plan accordingly. Be sure everyone who will

be attending knows the type of meeting it will be

and why it’s being held so that they can arrive

with a common set of expectations.

You should always set an agenda because:

• Itisanessentialstepindetermining

whether a meeting is needed and, if it is,

to building a successful one

• Ithelpsdefinewhatneedstobe

accomplished (outcomes)

• Itspellsouthowtheoutcomescanbe

accomplished (process)

• Anagendaestablishesatimeframe

• Ithelpsidentifywhoneedstobepresent

Here are some rules to ensure that you have a

good meeting:

1. Treat others as equals, not as inferiors.

Team Meetings (Huddles) 183

2. Be sincere, not manipulative and sneaky.

3. Genuinely care about others; don’t be

indifferent.

4. Keep an open mind rather than being

certain and dogmatic.

5. Be descriptive and specific, not evaluative

and vague.

6. Concentrate on solving problems, not

blaming others.

7. Assume that others have good intentions

rather than assuming that they are

devious.

8. Explain the what and the why; don’t

assume that your intentions or purpose

are automatically understood.

9. Listen for the other person’s point of view;

we don’t always share the same reality.

10. Encourage everyone to give their input;

don’t dominate.

11. Accept and appreciate the differences in

others; don’t let stereotypes run your life.

12. Watch and respond to the way people

interact at every meeting; how people work

together affects the outcome and the

meeting’s effectiveness.

184 Team Meetings (Huddles)

Here are the typical roles of meeting

participants:

• Leader

• Facilitator

• Timekeeper

• Recorder

• Teammember

• Historian—lessonslearned

Planned and handled properly, meetings do not

have to be a waste of time and energy. Ensuring

that there is a good reason to hold the meeting

and establishing a good agenda are the best ways

to use everyone’s time well.

Teams 185

Define

Measure

AnalyzeImprove

Control

TEAMS (EMPLOYEE

INVOLVEMENT, IMPROVEMENT,

SELF-DIRECTED)

Employee Involvement Teams

Some companies call their employees their most

valuable assets. When this is true, managers

spend time and resources to coach and train

the employees to be better at whatever they do.

This is especially true when it comes to allowing

employees to become more involved with the work

that is done in healthcare. Employee involvement

is about encouraging and allowing all employees

to do better work by using their minds as well as

their hands to do the job. This notion is feared

by many managers who were trained in classical

management theory—they may think they will

lose control over the work environment. By using

186 Teams

the whole person instead of having the employee

check his or her brain at the door when they enter

work, managers actually can have more produc-

tive processes and better activities. Going from

“do what I say” to “what will it take to satisfy our

customers?” will go a long way toward developing

an environment where continual improvement is

a way of life.

Thus, a basic definition of employee involve-

ment is the process of including employees at

a variety of levels and across functional areas

for the purpose of having meaningful input/

involvement in the business (Rice 1998). This is

different from prior business models (for exam-

ple, Theory X, Taylorism) where managers sat in

their offices and dictated their wisdom to employ-

ees and directed them to “just go do it” or “do it

exactly as I told you.” Empowerment is about

personal responsibility and having personal and

organizational goals aligned.

Evidence that employee involvement is alive

in your Practice includes but is not limited to

the following: no surprise decisions are made,

as input is sought from many people; instead

of managers ordering employees what to do,

an atmosphere of cooperation is evident in the

Practice; if something does go wrong, groups of

people work on fixing the issue versus the man-

ager or supervisor assigning blame; employees

are not afraid to approach managers or even the

Teams 187

owner of the organization. Every Practice needs

to define employee involvement given its culture,

its organizational goals, and its customer base.

Just as real teams take a long time to become

efficient operating units, so too it takes time to

build employee involvement into the culture of

the Practice. But the personal and productivity

rewards for doing so can be outstanding.

Improvement Teams

An improvement team consists of a group of

appropriate individuals who have been chosen to

work on a specific process to find ways of improv-

ing the operation (cost, cycle time, quality of

product or service). These teams are meant to be

active for a certain time frame, working on spe-

cific processes, and then report to management

their findings and recommendations.

This is the team that works to make the big

changes (what Juran calls managerial break-

throughs) in processes for continual improve-

ments. These changes usually will be on the

order of a factor of 10 or more change in the pro-

cess as measured in process capability or in cus-

tomer delight (versus satisfaction). It is important

for members of this team to keep an open mind

and think out of the box, and not be afraid to call

in experts as needed to make the big improve-

ments. Use of the “could be” process map is

188 Teams

useful here to help with brainstorming ideas of

what is possible.

The improvement team’s members usually

will be highly trained in the use of the tools and

methodologies surveyed in this book (as well as

in other techniques) and probably will be some

of the teachers of these tools to other Practice

personnel. Practice staff and improvement team

members do not need to be certified to be able

to use these tools, and because of their work-

ing every day with the process, they can some-

times solve problems better than those who are

certified. When more expertise is needed, some

of the highest mastery certifications that exist

for using these tools are the Lean Six Sigma

Master Black Belt and the ASQ Certified Six

Sigma Black Belt.

Self-Directed Teams

A self-directed team is a group of people who

have been authorized by management to work on

a process or to improve a process using all the

resources available to them and to manage their

own time and energy, as a self-operating unit,

for the good of the organization. Self-directed

teams tend to share leadership equally among

the group members; thus, rather than one person

being the leader, they are all responsible for the

output of the team.

Teams 189

These teams tend to be more important in a

company that has evolved into a lean manufac-

turing or lean Practice organization. Whereas

the old system of mass review does not require

people to be prepared to change anything

quickly, in a lean organization changeover of pro-

duction must be quick and often, and sometimes

occurs many times each shift. Mass customiza-

tion has become a new buzzword for manufactur-

ing, given customer demand for large quantities

of service transactions made to individual cus-

tomers’ requirements.

In lean Practice organizations, natural work

cells or groups are usually formed around a cer-

tain service area. These groups are ideal candi-

dates to become self-directed teams as they work

closely together and can work as a single unit to

satisfy customers instead of as individual staff.

The team then is able to provide its own reward

and recognition to each of its members. The team

members have shared goals and take respon-

sibility for communication with the rest of the

organization.

Team Basics

Remember the famous quote, “There is no ‘I’

in ‘team’”? The essence of this idea is to imply

that a team is a collective effort of individuals.

To harness the best of each individual, the

190 Teams

team members need to understand each other’s

strengths, roles, responsibilities, and the scope

of the task. There are a number of books that go

into detail about how to form a team, organize

meetings, manage projects, and accomplish the

desired goals. In the context of Six Sigma, we

will cover areas important to a Green Belt. Pro-

tocols such as setting the team agenda, record-

ing the minutes of the meeting (with proposed

actions), sticking to the set meeting time, and

enforcing meeting attendance need to be fol-

lowed for an effective team meeting. An initial

meeting to kick off the team with introductions

and high-level discussion on the goals, objectives,

milestones, and so on, will provide an opportu-

nity for the team to get to know each other and

understand the expectations. A team agenda can

be flexible but you need to have one.

Some teams have their team goals, objectives,

and scope/boundaries visibly displayed at every

meeting to keep the members on track. Man-

agement presence during kickoff and at regu-

lar intervals during the project helps enforce the

importance of the team objective.

Team Formation

A team usually comprises five to nine members

(seven is considered an ideal size) with comple-

mentary skills to achieve the goals and objectives

Teams 191

of the team. Team composition should be driven

by the size and scope of the project; it is possible

to have a team of one or two for a smaller project

and a large team with sub-teams for a big project.

The team includes subject matter experts and

stakeholders. Subject matter experts sometimes

remain outside the team as resources or extended

team members. Stakeholders are always part of

the team. The team will not be able to implement

their ideas and solutions without having stake-

holders represented on the team. Teams smaller

than five reduce the opportunity for interaction

problems and are easier to manage, whereas

teams greater than nine produce a lot of inter-

action that can be counterproductive to a team’s

progress. Teams with greater diversity tend to

produce better interaction between team mem-

bers. Some teams also bring in individuals who

are neither subject matter experts nor stakehold-

ers but are outsiders to the team. The outsider

helps the team ask questions that might never be

explored by the team members closer to the pro-

cess. This needs to be moderated as the outsider

might ask too many questions and frustrate the

core members. Typically, Six Sigma teams are

cross-functional so as to address the issues from

every angle.

192 Value Analysis

Define

Measure

AnalyzeImprove

Control

VALUE ANALYSIS

A value analysis is a review of a process to iden-

tify what parts or steps of a process actually add

value for interested parties that need access to

that portion of the healthcare system. The issue

here is that our current tasks and assignments

take a certain amount of time. What if we could

eliminate some of the steps that are deemed

unnecessary so that more time could be spent

doing the things that really mean something to

the patients, clients, stakeholders, and so on, of

the Practice? One of many possible ideas here

would be to eliminate the need to constantly go

to a fax machine (which could be at the other end

of a long hallway) to receive information that

could just as easily be sent directly to the com-

puter that the person is working on.

Value Analysis 193

To do a value analysis, it helps to imagine your-

self as the thing going through a process (such

as information, blood test results, or some other

patient evaluation). What happens from the very

first thought of getting the process accomplished?

If a doctor orders a blood work request, what are

the steps that are actually needed to allow the

doctor to discuss the results with the patient?

To start this analysis, create a list of all of the

actions/steps that need to be accomplished and

the amount of time each takes from the view-

point of the thing going through the process (for

example, blood test—doctor’s request, script,

patient goes to have blood drawn, waiting time,

actual blood draw event, samples labeled prop-

erly, travel to laboratory, tests conducted, results

recorded, records sent to doctor, wait for next

patient visit, doctor remembers to discuss results

with patient, any follow-up actions needed).

Once the process has been mapped and times

recorded, review each entry to see which ones

meet all three criteria below to say that the step

actually adds some value:

• Doesacustomer(patient,stakeholder,

other important person) recognize the step

as being important?

• Doesthestepaddvaluetothethinggoing

through the process? (For example,

signatures do not add value.)

194 Value Analysis

• Wasthestepdonerightthefirsttime?

Only when an item meets all three criteria (you

can say yes to each) is that step considered a

value-add to the process. All of the other items

are non-value-added steps and need to be con-

sidered for elimination or at least diminished

impact as they relate to the process.

Please note that we are “leaning” the pro-

cess with the value analysis instead of trying to

make the Practice staff work harder or longer

hours to complete the tasks as we have them cur-

rently established. There are many process steps

in every Practice, which have developed for any

number of reasons, that do not add value to the

process. Eliminating as many of the non-value-

added steps as possible will free up a lot of time

of the Practice staff and allow them to do the

most important work. It has been estimated that

many offices can eliminate 50 percent to 80 per-

cent of their current time requirements in doing

nearly any task by conducting a value analy-

sis. This is typically one of the first places (low-

hanging fruit) for the Six Sigma team to look

when analyzing a Practice for possible improve-

ment efforts.

Value Stream Map (VSM) 195

Define

Measure

AnalyzeImprove

Control

VALUE STREAM MAP (VSM)

A value stream is the series of activities that an

organization performs, such as scheduling, orga-

nizing, ordering, counseling, record keeping, and

accounting, to provide the healthcare services. A

value stream often starts with a first contact with

a patient or supplier’s supplier and ends with the

payment for services or customer’s customer (as

the SIPOC diagram will show). Wastes are both

explicit and hidden along this value stream.

The three main components of a value stream

are:

1. Flow of information/materials, from

receipt of supplier material to delivery of

finished goods and services to customers.

Examples:

196 Value Stream Map

• Schedulingpatientsforofficevisitsand

then ensuring that they are checked in

when they arrive

• Rawmaterial/suppliesshippedweekly

from a supplier to the organization

by truck

• Movementofmaterialfromrawmaterial

storage to areas where it is needed in

the Practice

• Shippingoffinishedgoodstoan

overseas customer via customs

2. The transformation of raw materials/

information into completed services, or

inputs into outputs. Examples:

• Gettingthepatientroutedaroundthe

Practice to ensure that a full evaluation

is completed

• Sendingpatientstoaspecialistifneeded

for further testing/consultations

3. The flow of information required to

support the flow of information/material

and transformation of goods and services.

Examples:

• Patientchartsupdatedproperlyand

stored in an appropriate location (not

being left on desks)

Value Stream Map 197

• Billingdoneappropriatelyandall

payments timely received

This concept is visually illustrated via a lean

tool called the value stream map. This map uses

simple graphics and icons to illustrate the move-

ment of material, information, inventory, work-

in-progress, operators, and so on. Value stream

mapping is a very powerful tool. The analy-

sis subsequent to value stream mapping, called

value stream analysis, can help uncover hidden

wastes within the organization. An organization

that effectively uses lean thinking and applies

lean tools to reduce waste throughout the value

stream and offer value to their customers is a

lean enterprise organization.

Figure 45 shows a quasi value stream map

(VSM) without the time allocations inserted in

each box. The time is an important factor in com-

pletingafullVSM,andeachprocess,onceflow-

charted, needs to be studied to understand the

actual time averages and variation found at each

step in the process. This will allow you to under-

stand the bottlenecks better and to see the pro-

cess as a whole functioning system.

198 Value Stream Map

Hospital

Insurance

organizations

Billing

Fee collection

Patient

repeats cycle

as needed

Pharmas

Pharmacy

Home self care

Family member care

Medical

devices

Office

supplies

Medical

supplies

Wellness

Quality healthcare

of patient

Patient

visits

practice

Patient

PCMH

Education

and learning

Practice

scheduling

Tests Nurse Doc Tests

• Optometry

• Dentistry

• Podiatry

Specialist

• Cardiology

• Neurology

• Pathology

• Radiology

• Laboratory services

• Pharmaceutical

Specialist

Figure 45 Total quality assurance management value stream map.

Variation Reduction 199

Define

Measure

AnalyzeImprove

Control

VARIATION REDUCTION

Variation is a fact of life. If the measurement

instrument (gage) or process that you are using

does not show that the process is varying, then it

is not sensitive enough and needs to be replaced.

If you get one complaint about something, you

can be assured that there are probably 10 more

complaints that your system did not pick up. The

author is aware of one organization who thinks

that it provides pretty good service to customers.

But one long-time customer (nearly 20 years) has

recently become very upset about the overall ser-

vice being received, and on one particular order

was triple-charged for a wrong product sent that

took an excessive amount of time to arrive. It

wasn’t until the author made a call to the presi-

dent of the organization that the vice president

of customer service got involved in trying to

200 Variation Reduction

straighten things out. The organization still does

not have a good method to accurately collect cus-

tomer concerns, and the customer in question is

still very unhappy.

Since all processes vary, the question becomes

how to improve the process by reducing the

amount of variation that is currently present

(see Figure 46). This book lists various tools and

methods to help identify variation. In variation

reduction, you use those same tools to identify

and monitor your progress toward improving

what you do. Does the run chart show a reduction

in variation? What can be seen in the cause-and-

effect diagram, the histogram, the Pareto chart,

or other tools? These and many other questions

should be answered to understand the process as

well as possible.

Just buying a new electronic instrument may

actually cause more variation in the system due to

UCL LCL UCL LCL

Improvement

Figure 46 Variation reduction curves.

Variation Reduction 201

measurement error (see “Measurement Systems

Analysis”). Throwing money at the system (say, a

gift certificate for a future purchase) rarely helps

improve the process. Studies will need to be done

to understand all aspects of the process varia-

tion (for example, equipment, Practice supplies,

people, communications, or paperwork), and you’ll

need to work to reduce the causes in the system.

The key is to identify and provide what the cus-

tomer wants and needs from your process to the

best of your abilities, given any limitations of

the process.

202 Visual Controls, Aids

Define

Measure

AnalyzeImprove

Control

VISUAL CONTROLS, AIDS

When you drive a motor vehicle, what visual con-

trols help you get to where you are going? This

could be a great thought starter in asking Prac-

tice staff what would help them accomplish their

tasks better. In an automobile, we have vari-

ous monitoring devices inside the vehicle. Then

there are numerous street signs, traffic lights,

construction barriers or other warning devices,

law enforcement personnel, and signals (hope-

fully) from other drivers on their intentions. In

our Practice, we can include any number of tech-

niques (some very simple) and ways to help our

fellow staff to know what is coming through the

Practice or what is going to happen next.

Remember the old adage “a picture is worth

1000 words?” The author has a copy of one of the

first Toyota manuals used in the United States

Visual Controls, Aids 203

for what is called the Toyota Production System.

It contains mostly pictures! Why might this

be? If you were to go to Japan, or any other coun-

try where you could not speak the language, how

would you communicate with others? Now think

about your patients. Do they speak the medical

language that you do? The odds are, they do not,

and some of our patients may even feel threat-

ened by all of the medical terminology that they

hear in the Practice even though it is in English.

Many of our Practices already have models

and pictures in the examination rooms to help

clinicians explain to patients how the body

works. Can this be expanded? Using computers

any number of things can be done to show how

the body is or should be functioning. There are

even high-end holographic devices today that can

show the actual organs of the body in real time.

How about simpler techniques—pictures or mod-

els that a patient can touch and feel to get the

information to them as needed?

The challenge then is to set up a system that

allows anyone to quickly see where information,

people, supplies/materials, and so on, belong and

where they are going next. Use pictures, direc-

tional indicators (how do you feel when you walk

into a new hospital for the first time), and any

other indicators to assist everyone in knowing

how things work or how to get from point A to

point B.

204 Voice of the Customer (Patient Feedback)

Define

Measure

AnalyzeImprove

Control

VOICE OF THE CUSTOMER

(PATIENT FEEDBACK)

Customer feedback is a method or process of find-

ing out what the customer actually thinks of your

products or services. It is said that for every cus-

tomer who actively complains to you, there are

at least 10 others who for one reason or another

will speak badly to others of your products and

services. Finding out what the customer thinks,

wants, and needs is a time-consuming effort, and

many customers are getting tired of filling out

surveys. Sometimes when customers (internal or

external) do tell us something, we can not do any-

thing about it, we do not want to hear what they

are saying, or they expect something other than

what we offer.

There traditionally have been many tech-

niques for talking with customers, and with the

Voice of the Customer (Patient Feedback) 205

advent of e-mail and the Internet, even more

exist today. The problem with many surveys is

that we really do not know what proportion of

our customers or which of our customers actually

bothered to send them back. Also, paper surveys

tend to have a very low return rate overall; thus,

they really do not give us a very good picture. The

point is that we must keep trying to talk with

customers as often as possible to ensure that we

know what their wants and needs are.

The most effective method still seems to be

actually getting out into the world with your

customers to experience what they experience

and to interact with them as they use your prod-

ucts and services. Have you ever thought about

what you do? What is it like for the next person in

the organization to use your work? For Practice

staff, finding this out should be a lot easier than

it is for shop floor personnel, as staff can simply

communicate with the next person in the health-

care chain. Practice staff might want to talk

with that person directly, observe how he or she

uses the information supplied to him or her, and

study the data that are collected in the process

to look for better ways to do work to make things

easier for the internal customer.

A good starting point for collecting customer

feedback is to set up a display for all employees

and visitors to see. On that display, have sam-

ples of the ultimate products/services that are

206 Voice of the Customer (Patient Feedback)

produced in your Practice. It has often been noted

that employees work all day yet do not know

how their work is used. Once the display is up,

employees can point out their work to others and

take pride in what they do. Some of this infor-

mation may not relate to the services provided

by your Practice, so it should be passed along to

an immediate customer who buys the services.

Doing this well will allow your Practice to pro-

vide additional services to your immediate cus-

tomers that they did not ask or pay for, giving

you an advantage over your competition.

Walkaround/Walkthrough/Waste Walk 207

Define

Measure

AnalyzeImprove

Control

WALKAROUND/WALKTHROUGH/

WASTE WALK

If you attended grade school in the United States,

somewhere in the early grades you probably had

a teacher play the telephone game with the class.

The telephone game involves the teacher put-

ting the class in a semicircle and whispering a

short phrase to the first student. Then each stu-

dent in turn whispers what they heard (or think

that they heard) into the ear of the next student

in line. By the time the last student received the

message and repeated what they heard, it usually

sounded nothing like what the teacher started

with. Note: the author has done the same with

degreed engineers and they still can not keep the

phrase consistent.

So, given this scenario, think about your own

work area. Are things being done the same way

208 Walkaround/Walkthrough/Waste Walk

as they were a year ago, two, five, or even 10?

Small things are changing all of the time. Unless

some form of standard (visual, written, and so on)

is employed, the odds are that things will change

over time. The purpose of the walkaround is to

identify these areas of change or to highlight

areas or things that should be or could be changed

to improve the operation of the Practice.

Avedis Donabedian (2003) defined quality

assurance as “all actions taken to establish, pro-

tect, promote, and improve the quality of health

care.” With this in mind, walk around your

Practice and start asking the question, “What

if?” We are often limited by our perceptions of

money, time, physical surroundings, and so on.

What if we could change something? How would

that impact the staff’s ability to provide a better

experience for the patient?

One primary challenge with this technique is

to be able to view your work area with an open

mind and stay out of the mind-set that we do

things this way because of some preconceived

notion that it must be that way. Continually ask

yourself, “If we could do this better for the custo-

mer (internal or external), how might the cus-

tomer appreciate the better service?” If a doctor

could open any patient folder in the Practice and

find everything in the same order, with sum-

mary run charts at the front giving an overview

Walkaround/Walkthrough/Waste Walk 209

of the patient’s health, how might that affect the

doctor’s work and the patient’s experience?

During the walkaround of the Practice, one

thing to keep in mind is elimination of what the

Japanese call muda, or waste.

Eight Categories of Muda

1. Overproduction above demand

2. Waiting for processing, use, work

3. Material and/or information movement

4. Overprocessing

5. Excess inventory

6. Unnecessary motion

7. Inaccurate work (defectives)

8. Underutilized people

Causes of Waiting Waste

• Unbalancedworkload

• Waitingforinformation

• Queuingdelays

• Latedeliveries

• Upstreamqualityproblems

210 Walkaround/Walkthrough/Waste Walk

• Unleveledscheduling

Causes of Processing Waste

• SOPchangeswithoutcommunication

• Just-in-caselogic

• Truecustomerrequirementsundefined

• Overprocessingtoaccommodatedowntime

• Lackofcommunication

• Redundantapprovals

• Extracopies/excessiveinformation

211

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New York: Jove.

If Japan Can, Why Can’t We . . . 1980. VHS.

Washington, DC: CC-M Productions.

(To purchase a videocassette, go to

http:www.managementwisdom.com/ifjapan

canwhyc.html.)

Ishikawa, K. 1976. Guide to Quality Control.

Tokyo: Asian Productivity Organization.

Juran, J. M. 1964. Managerial Breakthrough:

A New Concept of the Manager’s Job. New

York: McGraw-Hill.

———. 1989. Juran on Leadership for Quality:

An Executive Handbook. New York: The Free

Press.

Kerzner, H. 1995. Project Management: A

Systems Approach to Planning, Scheduling,

and Controlling. 5th ed. New York: Van

Nostrand Reinhold.

Munro, R.A. 2000. “Linking Lean Six Sigma

with QS-9000.” Quality Progress (May).

———. 2002. Six Sigma for the Office: A Pocket

Guide. Milwaukee: ASQ Quality Press.

214 References

National Demonstration Project on Quality

Improvement in Healthcare. 1990. Curing

Health Care: New Strategies for Quality

Improvement. San Francisco: Jossey-Bass.

National Training Laboratories Institute. 1984.

Team-Building Readings. Arlington, VA:

NTLI.

Quality or Else. 1980. VHS. Washington,

DC: CC-M Productions. (To purchase a

videocassette, go to http:www.management

wisdom.com/qualityorelse.html.)

Rice, E. J. 1984. A Quick Reference Guide for

Team Building: Which Path Is Your Team

Taking. Dearborn, MI: Ford Motor Company.

(Note: The June 1999 issue of Quality

Progress was dedicated to teams. Also the

American Quality and Participation [AQP],

an affiliate of ASQ, has much available on

teams and team building).

———. 1997. “Automotive Excellence: Know the

History of Training to Promote Learning.”

ASQ Automotive Division 3, no. 4 (Fall):

12–15.

———. 1998. “Are You Listening?” Quality

P r o g r e s s 31, no. 5 (May): 25.

Senge, P. M. 1990. The Fifth Discipline: The Art

and Practice of the Learning Organization.

New York: Jove.

References 215

Stamatis, D. H. 1996. Total Quality Service:

Principles, Practices, and Implementation.

Delray Beach, FL: St. Lucie Press.

———. 1997. TQM Engineering Handbook. New

York: Marcel Dekker.

———. 2003. Failure Mode and Effect Analysis:

FMEA from Theory to Execution. 2nd ed.

Milwaukee: ASQ Quality Press.

Time: The Next Dimension of Quality. 1993.

VHS. CRM Films. http://www.crmlearning.

com/time-the-next-dimension-of-quality.

Wheeler, D. J., and S. R. Poling. 1998. Building

Continual Improvement: A Guide for

Business. Knoxville, TN: SPC Press.

Womack, J. P., and D. T. Jones. 1996. Lean

Thinking. New York: Simon & Schuster.

216 Answer from puzzle on page 73.

Start

Figure 46 Nine dots exercise solved.

217

Index

advanced practice quality planning (healthcare APQP),

58–61

analyze, phase of DMAIC, tools used in, 36–37

Art of Living, The, xiii

attribute data, 153–56

auditing, 62–65

benchmarking, 66–70

Black Belt, Lean Six Sigma, xxi, 51

brainstorming, 71–75

breakthrough improvement, 187

business operating system (BOS), for healthcare

organizations, 76–78

cause-and-effect diagram, 18, 79–83

check sheets, 84–88

checklist, 84–88

common cause variation, 17

continual improvement, 89–91

versus continuous improvement, 90–91

continual improvement process, tips, 50

218 Index

continuous improvement, versus continual improvement,

90–91

control, phase of DMAIC, tools used in, 38–39

cost of quality, 93

cost of poor quality, 93

costs, categories of, 93–96

could be map, 113–17, 187–88

cross-functional team, 45

current state map, 113–17

customer, definition, 8

customer feedback, 204–6

cycle time analysis, 98–100

cycle time reduction, principles, 99

data collection, with check sheets, 84–87

data–knowledge–action cycle, 143

define, phase of DMAIC, tools used in, 33–34

Deming, W. E., 91, 141, 144

design FMEA, 101–2

Design for Six Sigma (DFSS), 27–28

Disney, Walt, 70

DMAIC (define–measure–analyze–improve–control)

matrix guide, 2–4

model, 1, 13, 29–40

driving forces of, 29–30

problem-solving steps, 31–32

eight discipline (8D) problem solving process, 148–51

eight M’s, in cause-and-effect diagram, 80–81

80/20 rule, 136

employee involvement teams, 185–87

failure mode and effects analysis (FMEA), 101–4

in flowcharting, 115

Feigenbaum, Armand, 90, 144

Index 219

fishbone diagram, 18, 79–83

5S method, 53, 55–56

five W’s and H, in cause-and-effect diagram, 80

five W’s and two H’s, 149

flow map, 113–17

flowchart, 113–17

in benchmarking, 68

gage repeatability and reproducibility (GR&R), 131

goalpost mentality, 18–19

Granite Rock, 66–67

Green Belt, Lean Six Sigma, xxi, 51

group, versus team, 41

histogram, 118–21

idea stoppers, in brainstorming, 74–75

improve, phase of DMAIC, tools used in, 37–38

improvement teams, 45, 187–88

inspection, 62–63

instability, in variability, 23, 160–61, 178–79

internal audit, guidelines, 63–65

International Organization for Standardization (ISO), 90

Ishikawa, Kaoru, 26, 79

Ishikawa diagram, 18, 79–83

ISO 9001 registration, 40

job aids, 32, 173

Juran, J. M., 127, 136, 143

kaizen, 89–91

220 Index

kaizen events, 89–91

kanban, 122–23

lean organization, 197

structure, 189

Lean Six Sigma

Black Belt, xxi, 51

definition, 5–6

Green Belt, xxi, 51

in Practice, xxi–xxii, 6–10

road map for Practice, 47–48

your role in, 11–15

Lean Six Sigma for Healthcare, 7

lessons learned, 124–25

line graph, 163–65

loss function, 20, 22, 161

lower control limit, 155-157

MAIC (measure–analyze–improve–control) improvement

model, 13

Malcolm Baldrige National Quality Award (MBNQA),

40, 90

Healthcare Criteria for Performance Excellence, 77–78

MCG (members–control–goals), and teams, 42

measure, phase of DMAIC, tools used in, 34–36

measurement systems analysis (MSA), 129–32

meetings, team, 181–84

mistake-proofing, 133–35

muda, 209–10

off-target conditions, in variability, 23, 160–62, 179

Ohno, Taiichi, 123

output, of process (Y = f/x), 18, 79

Index 221

p chart, control limit calculations, 157

Pareto, Vilfredo, 136

Pareto chart, 136–39

patient feedback, 204–6

Patient-Centered Medical Home, 40

PDCA (plan–do–check–act) cycle, 141

PDSA (plan–do–study–act) cycle, 59

in continual improvement, 91

poka-yoke, 90, 133

practice strategy (future state) project planning, 145–47

problem solving, 148–51

steps in DMAIC, 31–32

process

in healthcare, 7

output of, (Y = f/x), 18, 79

process behavior charting, 89–90

process FMEA, 102

process improvement, 160–62

process map, 113–17

process model, 6

profound knowledge, Deming’s, 15, 91

project planning, 146–47

project team, 46

pull concept, in lean Practice, 6

quality

expressing, 26–27

traditional view of, 18–19

quality auditing, 62–63

quality circle, 46

quality improvement, in the Practice, 25–26

six aims of, 59–60

quality of care and services, healthcare, xiv

quality of conformance, 27

quality of design, 27

quality system audit, guidelines, 63–65

222 Index

risk priority number (RPN), 104

Ritz Carlton, 125

road map for Practice, Lean Six Sigma, 47–48

rolled throughput yield, 99–100

run chart, 12–13, 163–65

scatter diagram, 166–69

SDCA (standardize–do–check–adjust) cycle, 175–76

in continual improvement, 91

self-directed teams, 46, 188–89

Senge, Peter, 128

7S method, 53–57

SGRPI (systems–goals–roles–procedures–interpersonal

relationships), 42–43

Shewhart, Walter, 89, 141, 152

Shingo prize, 135

Shingo, Shigeo, 135

should be map, 133–17

SIPOC diagram, 170–72

SIPOC (supplier–input–process–output–customer) model,

8, 158

special cause variation, 17

specifications, and quality, 19, 20–21

standard operating procedures (SOPs), 173–74

standardization, 175–76

standards, in auditing, 63–64

statistical process control (SPC), 89–90

statistical process display (SPD), 156

storyboard method, of process identification, 159

systems FMEA, 101

systems thinking, 177–80

Taguchi loss function, 20–21, 22

Taylor, Frederick, 89

Index 223

team building, rationales, 43

team meetings, 181–84

teams, 41–46, 185–91

formation, 190–91

versus a group, 41

stages of, 44–45

types of, 45–46

thinking outside the box, in brainstorming, 73–74

tools, Lean Six Sigma, 53–210

advanced practice quality planning, 58–61

auditing, 62–65

benchmarking, 66–70

brainstorming, 71–75

business operating system (BOS) for healthcare

organizations, 76–78

cause-and-effect diagram, 79–83

check sheets, 84–88

continual improvement, 89–91

cost of poor quality, 93–96

cost of quality, 93–96

cost–benefit analysis, 93–96

current state/could be/should be map, 113–17

cycle time analysis, 98–100

employee involvement teams, 185–87

error-proofing, 133–35

failure mode and effects analysis (FMEA), 101–4

fishbone diagram, 79–83

flow map, 113–17

flowchart, 113–17

healthcare APQP, 58–61

histogram, 118–21

huddles, 181–84

improvement teams, 187–88

Ishikawa diagram, 79–83

kaizen, 89–91

kaizen events, 89–91

kanban, 122–23

lessons learned, 124–25

line graph, 163–65

management involvement, 126–28

224 Index

measurement systems analysis (MSA), 129–32

mistake-proofing, 133–35

Pareto chart, 136–39

patient feedback, 204–6

patient pull-through, 122–23

PDSA (plan–do–study–act) cycle, 141–44

poka-yoke, 133–35

practice strategy (future state) project planning, 145–47

problem solving, 148–51

process behavior charts, 152–56

process identification, 158–59

process improvements, 160–62

process map, 113–17

quality cost, 93–96

return on investment, 93–96

run chart, 163–65

sampling, 62–65

sampling plans, 62–65

scatter diagram, 166–69

SDCA (standardize–do–check–adjust) cycle, 175–76

self-directed teams, 188–89

7S method, 53–57

SIPOC diagram, 170–72

standard operating procedures (SOPs), 173–74

standardization, 175–76

statistical process control (SPC), 152–56

systems thinking, 177–80

team meetings, 181–84

teams, 185–91

trend chart, 163–65

used in analyze phase of DMAIC, 36–37

used in control phase of DMAIC, 38–39

used in define phase of DMAIC, 33–34

used in improve phase of DMAIC, 37–38

used in measure phase of DMAIC, 34–36

value analysis, 192–94

value stream map, 195–97

variation reduction, 199–201

visual aids, 202–3

visual controls, 202–3

Index 225

voice of the customer, 204–6

wait time, 122–23

walkaround/walkthrough/waste walk, 207–10

trend chart, 163–65

u chart, control limit calculations, 157

upper control limit, 155–57

value analysis, 192–94, 197

value stream map, 195–97

variability, 160–61, 178

versus variation, 23

variable data, 153–56

variation, 160

description and definition, 17–23

versus variability, 23

variation reduction, 199–201

visual aids, 202–3

visual controls, 202–3

voice of the customer, 204–6

wait time, 122–23

walkaround, 207–10

walkthrough, 207–10

waste, 209–10

in Lean Practice, 6

waste walk, 207–10

yield, definition, 98

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