Sunday, June 11, 2006

GE's Wealth of Free Advice

By Steven Pearlstein
Wednesday, June 7, 2006; Page D01

Five years ago, Warren Coopersmith's family-owned distribution firm in Takoma Park was at one of those crucial "grow-or-die" junctures. Its biggest customers, movie theaters and video-rental outlets, were consolidating and looking for suppliers big enough to provide all popcorn, candy, soda pop and cleaning supplies to their expanding empires.

Coopersmith decided that his company, Marjack, was going to be a survivor. He began by recruiting experienced professionals to his management team. He made a few acquisitions, expanded his business with such existing customers as Regal Cinema, and developed new lines, such as providing candy and snacks to Office Depot and Kinko's outlets. He even embarked on a bit of vertical integration, buying his own popcorn company.

But as Marjack's revenue grew toward $150 million, five times what it had been, Coopersmith and his team realized that there were problems. Their profit margins weren't what they should have been and their systems weren't up to handling the increase in volume. A small but annoying number of orders were going out incomplete or incorrect.

That's when the folks at General Electric's Commercial Finance unit, which had just financed Marjack's new warehouse in Landover, knocked on Coopersmith's door with an unusual offer: Would he be interested in having a team of GE's famed Six Sigma management experts come out, perform their rigorous statistical analyses of warehouse operations, and find ways to cut costs and improve quality? And here's the thing: It would be absolutely free, with no strings attached.

You might well ask why a $25 billion division of a global corporate behemoth would want to go through the time, hassle and money of helping Marjack pick and pack Milk Duds and red licorice. The answer is pretty simple: For the $15 million that Six Sigma costs a year, GE Commercial Finance buys a ton of customer loyalty and sets itself apart in what is otherwise a commodity-service business. Perhaps even more important, the program increases the odds that the mid-size firms to which GE is lending money will not only stay in business long enough to pay back the loans, but will be more likely to grow in the future -- as will their need for capital. "We know instinctively that the benefits to us are substantial," said Sharon Garavel, who heads up the program. "Our customers have told us that they intend to give us a larger share of their business." By her reckoning, it has already generated 350,000 hours of free consulting services to more than 3,000 customers since 2002, saving them collectively more than $1.2 billion.

In fact, under chief executive Jeffrey Immelt, who started offering Six Sigma assistance to customers when he ran GE's medical equipment division, all of General Electric's units have an "At the Customer, for the Customer" program. It is a brilliant example of how a company has taken an internal skill -- in this case, change management and continuous improvement, for which it is world-renowned -- and turned it into a marketable product.

Among those who sing the program's praises are Mike Woods, chief knowledge officer at Red Robin Gourmet Burgers, a Denver-based restaurant chain. Red Robin uses GE for 80 percent of its franchisee financing. Woods, who became part of the Six Sigma cult after spending a week at GE's Crotonville, N.Y., management training center, invited GE's gurus in to solve one of the chain's most vexing problems: getting patrons their milkshakes within four minutes of their orders.

This had long been a goal of a company catering to families with young children, but it was meeting it only 36 percent of the time. When the staff at restaurants was asked why, they said there weren't enough mixers or enough bartenders (yes, that's who makes the milkshakes). But after a GE team analyzed the problem, more important facts turned out to be that the first orders in weren't necessarily the first ones out, and that because of uneven workload among the wait staff, shakes were sitting undelivered for longer than they should have. The purchase of a minor piece of equipment, and introduction of procedures requiring any waiters passing by the bar to deliver finished drinks to any table, got the success rate up to 77 percent.

Another happy customer is Stephen Carter, president of the American subsidiary of Komori, a Japanese maker of printing presses. An important part of Komori's business involves getting replacement parts to customers when their machines are down, which they had been doing within 24 hours for 87 percent of their customers. GE's Six Sigma "black belts" saw that most of the orders that took longer involved items that were out of stock. After analyzing more than a decade of parts orders, they found a way of ensuring that the most-sought items, or those with long lead times, were never out of stock, while reducing inventory for slow-moving and less hard-to-replace components. The result: 95 percent of orders now go out on time.

At Marjack, GE's experts meticulously analyzed the steps taken by the warehouse staff members as they moved their carts up and down the aisles, filling the weekly orders from movie theaters and retail outlets. As is often the case, there weren't any major fixes -- just a whole bunch of little things, like collecting all the used carts in one place, clustering all the most-used items near the packing stations, dispatching forklift drivers with walkie-talkies. But in the end, according to in-house strategist Chris Paladino, the warehouse staff improved productivity by 35 percent while cutting in half the number of customer complaints. As a result, Marjack now dispatches 500 boxes to customers each day with almost the same size staff that used to send out 350.

Coopersmith says that as a result of the culture change and confidence that GE's collaboration has generated, he'll invest heavily in new scanning and truck routing technology that will further enhance productivity while allowing the company to push into new product lines.

"The process with GE was a real catalyst in getting our brains going again," he said -- a fact he says he won't forget the next time Marjack's inventory financing goes out to bid.

Saturday, June 10, 2006

Mumbai's Dabbawalas

Rajen Nair (rajennair)

Published 2006-06-11 00:16 (KST)


A colorful assortment of dabbas

A dabbawala is a person whose job is to collect lunch boxes from homes, which are packed in an aluminum container, known locally as dabba, which they deliver to customers in their respective offices. How it came into existence was a matter of necessity for the British during the Raj, who, for want of good hygienic food scarcely available on the streets of Mumbai, had to depend on meals prepared at home. They would hire locals to carry the lunch boxes from home to their workplace. Since then, these lunch box carriers have become popularly known as dabbawalas.

Mumbai is densely populated, and traffic fairly bursts out at its seams. It is the financial hub of India and has a large number of corporate offices, concentrated in south Mumbai. The working class, residing in far-off suburbs and who relish homemade dishes, patronize the dabbawalas.

This wide network, a unique human chain, is instrumental in bringing mother's recipe to the worker's desk. Every morning the dabbawala visits each home client, collects the lunch boxes, and then transports them through the suburban rail network. They are then handed over to another group of dabbawalas assembled at different railway stations. Each container of lunch boxes bears a distinguishing number and is then sorted out, allocated to each pick-up man for the onward journey, and handed out to the rightful owners.



Balancing wooden cart on a dabbawala's head

©2006 Rajen Nair
It is a common sight to see the dabbawalas attired in their traditional white kurta (pajama) and a topi (hat), wheeling a bicycle with loads of cylindrical aluminum containers tucked on either side. These lunch boxes are delivered on every working day without fail, despite deluges during the monsoon season or a strike announcement made by a political party. Again, in the evening the empty containers are collected from offices and delivered back to homes for another round of errands the next day morning.

More than 200,000 lunch boxes are transported to and fro every day by a dabbawala force of about 5,000 strong. In today's globalization that boasts of modern transport systems, this unique human feat of delivering lunch boxes, using a non-polluting and cost-effective primitive mode of transport like bicycles and pullers of wooden carts, is unparalleled anywhere in the world.

The dabbawalas may be semi-literate, but their efficient delivery and time management skills would shame some professionally managed corporations. The American business magazine Forbes has given a six-sigma performance rating to them. The dabbawalas were also featured in a BBC documentary.

The dabbawalas achieved worldwide fame when Prince Charles, during one of his visits to Mumbai, paid a special visit to them and evidenced keen interest in how they worked. He was so impressed with them that later, during his wedding, he extended an invitation to these dabbawalas. In a way, the dabbawala does yeoman service in maintaining healthy food habits for workers in Mumbai by keeping them away from fast food joints.

Fundamentals of Six Sigma

Fundamentals of Six Sigma

Date: Jun 9, 2006 By David M. Levine. Sample Chapter is provided courtesy of Financial Times Prentice Hall.

Six Sigma management is a quality improvement system originally developed by Motorola in the mid-1980s. Six Sigma offers a prescriptive and systematic approach to quality improvement and places a great deal of emphasis on accountability and bottom-line results. Many companies all over the world use Six Sigma management to improve efficiency, cut costs, eliminate defects, and reduce product variation. This chapter offers an introduction to Six Sigma.

Introduction
1.1 What Is Six Sigma?
1.2 Roles in a Six Sigma Organization
1.3 Statistics and Six Sigma
1.4 Learning Statistics for Six Sigma Using This Book

Summary

References

Learning Objectives
After reading this chapter, you will be able to

Know what the acronym DMAIC stands for.
Understand the difference between the role of a Six Sigma green belt, black belt, and master black belt.
Understand the role of statistics in Six Sigma management.

Introduction
Six Sigma management is a quality improvement system originally developed by Motorola in the mid-1980s. Six Sigma offers a prescriptive and systematic approach to quality improvement and places a great deal of emphasis on accountability and bottom-line results. Many companies all over the world use Six Sigma management to improve efficiency, cut costs, eliminate defects, and reduce product variation.

1.1 What Is Six Sigma?

The name Six Sigma comes from the fact that it is a managerial approach designed to create processes that result in no more than 3.4 defects per million. One of the aspects that distinguishes Six Sigma from other approaches is a clear focus on achieving bottom-line results in a relatively short three- to six-month period of time. After seeing the huge financial successes at Motorola, GE, and other early adopters of Six Sigma management, many companies worldwide have now instituted Six Sigma management programs [see References 1, 2, 3, and 5].

The DMAIC Model
To guide managers in their task of improving short- and long-term results, Six Sigma uses a five-step process known as the DMAIC model, named for the five steps in the process: Define, Measure, Analyze, Improve, and Control.

Define. The problem is defined along with the costs, benefits, and impact on the customer.

Measure. Operational definitions for each critical-to-quality (CTQ) characteristic are developed. In addition, the measurement procedure is verified so that it is consistent over repeated measurements.

Analyze. The root causes of why defects occur are determined, and variables in the process causing the defects are identified. Data are collected to determine benchmark values for each process variable.

Improve. The importance of each process variable on the CTQ characteristic are studied using designed experiments (see Chapter 8, "Design of Experiments"). The objective is to determine the best level for each variable.

Control. The objective is to maintain the benefits for the long term by avoiding potential problems that can occur when a process is changed.

1.2 Roles in a Six Sigma Organization
The roles of senior executive (CEO or president), executive committee, champion, process owner, master black belt, black belt, and green belt are critical to the Six Sigma management process.

The senior executive provides the impetus, direction, and alignment necessary for Six Sigma’s ultimate success. The most successful, highly publicized Six Sigma efforts have all had unwavering, clear, and committed leadership from top management. Although it may be possible to initiate Six Sigma concepts and processes at lower levels, dramatic success will not be possible until the senior executive becomes engaged and takes a leadership role.

The members of the executive committee are the top management of an organization. They should operate at the same level of commitment for Six Sigma management as the senior executive.

Champions take a very active sponsorship and leadership role in conducting and implementing Six Sigma projects. They work closely with the executive committee, the black belt assigned to their project, and the master black belt overseeing their project. A champion should be a member of the executive committee or at least a trusted direct report of a member of the executive committee. He or she should have enough influence to remove obstacles or provide resources without having to go higher in the organization.

A process owner is the manager of a process. He or she has responsibility for the process and has the authority to change the process on his or her signature. The process owner should be identified and involved immediately in all Six Sigma projects relating to his or her own area.

Master Black Belt
A master black belt takes on a leadership role as keeper of the Six Sigma process and advisor to senior executives or business unit managers. He or she must leverage his or her skills with projects that are led by black belts and green belts. Frequently, master black belts report directly to senior executives or business unit managers. A master black belt has successfully led many teams through complex Six Sigma projects. He or she is a proven change agent, leader, facilitator, and technical expert in Six Sigma management. It is always best for an organization to develop its own master black belts. However, sometimes it is impossible for an organization to develop its own master black belts because of the lead time required to become a master black belt. Thus, circumstances sometimes require hiring master black belts from outside the organization.

Black Belt
A black belt is a full-time change agent and improvement leader who may not be an expert in the process under study [see Reference 4]. A black belt is a quality professional who is mentored by a master black belt, but who may report to a manager for his or her tour of duty as a black belt.

Green Belt
A green belt is an individual who works on projects part-time (25%), either as a team member for complex projects or as a project leader for simpler projects. Most managers in a mature Six Sigma organization are green belts. Green belt certification is a critical prerequisite for advancement into upper management in a Six Sigma organization.

Green belts leading simpler projects have the following responsibilities:

Refine a project charter for the project.
Review the project charter with the project’s champion.
Select the team members for the project.
Communicate with the champion, master black belt, black belt, and process owner throughout all stages of the project.
Facilitate the team through all phases of the project.
Schedule meetings and coordinate logistics.
Analyze data through all phases of the project.
Train team members in the basic tools and methods through all phases of the project.
In complicated Six Sigma projects, green belts work closely with the team leader (black belt) to keep the team functioning and progressing through the various stages of the Six Sigma project.

1.3 Statistics and Six Sigma
Many Six Sigma tools and methods involve statistics. What exactly is meant by statistics, and why is statistics such an integral part of Six Sigma management? To understand the importance of statistics for improving quality, you can go back to a famous 1925 quote of Walter Shewhart, widely considered to be the father of quality control:

The long-range contribution of statistics depends not so much upon getting a lot of highly trained statisticians into industry as it does in creating a statistically minded generation of physicists, chemists, engineers, and others who will in any way have a hand in developing and directing the production processes of tomorrow.

This quote is just as valid today as it was more than 75 years ago. The goal of this book is not to make you a statistician. The goal is to enable you to learn enough so that you will be able to use the statistical methods that are involved in each phase of the DMAIC model. Using Minitab and/or JMP statistical software will help you achieve this goal while at the same time minimize your need for formulas and computations.

Table 1.1 summarizes the statistical methods that are commonly used in the various phases of the DMAIC model.

Table 1.1 Phases of the DMAIC Model, Statistical Methods Used, and Chapters in This Book
Phase of DMAIC Model
Statistical Methods
Chapters

Define Tables and Charts 3
Descriptive Statistics 4
Statistical Process Control Charts 11

Measure Tables and Charts 3
Descriptive Statistics 4
Normal Distribution 5
Analysis of Variance 6, 7, 8
Statistical Process Control Charts 11

Analyze Tables and Charts 3
Descriptive Statistics 4
Analysis of Variance 6, 7, 8
Regression Analysis 9, 10
Statistical Process Control Charts 11

Improve Tables and Charts 3
Descriptive Statistics 4
Analysis of Variance 6, 7, 8
Regression Analysis 9, 10
Design of Experiments 8

Control Statistical Process Control Charts 11


1.4 Learning Statistics for Six Sigma Using This Book
This book assumes no previous knowledge of statistics. Perhaps you may have taken a previous course in statistics. Most likely, such a course focused on computing results using statistical formulas. If that was the case, you will find the approach in this book very different. This book provides the following approach:

Provides a simple nonmathematical presentation of topics. Every concept is explained in plain English with a minimum of mathematical symbols. Most of the equations are separated into optional boxes that complement the main material.
Covers statistical topics by focusing on the interpretation of output generated by the Minitab and JMP software.

Includes chapter-ending appendices that provide step-by-step instructions (with screenshots of dialog boxes) for using Minitab Version 14 and JMP Version 6 for the statistical topics covered in the chapter.
Provides step-by-step instructions using worked-out examples for each statistical method covered.

Summary
Six Sigma management is used by many companies around the world. Six Sigma uses the DMAIC model that contains five phases: Define, Measure, Analyze, Improve, and Control. Many different roles are important in a Six Sigma organization. Statistics is an important ingredient in such an organization. The purpose of this book is to enable you to learn enough so that you will be able to use statistical methods as an integral part of Six Sigma management.

References

Arndt, M., "Quality Isn’t Just for Widgets," Business Week, July 22, 2002, 72–73.
Gitlow, H. S., and D. M. Levine, Six Sigma for Green Belts and Champions, (Upper Saddle River, NJ: Financial Times Prentice Hall, 2005).
Hahn, G. J., N. Doganaksoy, and R. Hoerl, "The Evolution of Six Sigma," Quality Engineering, 2000, 12, 317–326.
Hoerl, R., "Six Sigma Black Belts: What Do They Need to Know?" Journal of Quality Technology, 33, 4, October 2001, 391–406.
Snee, R. D., "Impact of Six Sigma on Quality," Quality Engineering, 2000, 12, ix–xiv.

Summary
Six Sigma management is used by many companies around the world. Six Sigma uses the DMAIC model that contains five phases: Define, Measure, Analyze, Improve, and Control. Many different roles are important in a Six Sigma organization. Statistics is an important ingredient in such an organization. The purpose of this book is to enable you to learn enough so that you will be able to use statistical methods as an integral part of Six Sigma management.

Monday, June 05, 2006

Pursuing Pharmaceutical Quality and Economy

Forward-looking pharmaceutical companies build continuous improvement techniques into their processes from day one.

Jun 1, 2006
By: Bikash Chatterjee
BioPharm International


Bikash Chatterjee

The pharmaceutical industry's recent emphasis on continuous improvement, operational excellence, and process analytical technology has motivated us to evaluate the basic tenets of our approach to quality. Historically, the ability to ensure that a drug meets its intended form, fit, and function has been achieved through the application of the quality infrastructure, i.e., standard operating procedures, policies, specifications; qualification or validation, i.e., commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), process validation; and testing, i.e., in-process and final release. However, despite these processes, the number of drug recalls continues to rise, escalating from 176 in 1998 to 354 in 2002, according to the US Center for Drug Evaluation and Research.1

The use of regulations as a primary means of ensuring product quality began to decline in early 2000, when industry pushed back on FDA's Part 11 compliance requirements for electronic signatures and electronic data exchange, challenging the cost and effort associated with implementation, versus the actual benefit to product quality. Today, however, industry and regulatory agencies are moving toward a more scientific approach to ensuring product quality.

The International Conference on Harmonization (ICH) Q8 and Q9 guidance documents2,3 , for example, define a scientific approach to process characterization, advocating a quality by design framework. Risk management is an integral part of this approach.

Similarly, the US FDA's "GMPs for the Twenty-First Century" initiative focused on quality by design, risk management, continuous process improvement, and quality systems. Rolled out in 2004, this initiative challenged industry's traditional approaches to ensuring product quality by encouraging employees to look beyond traditional inspection methodologies for ensuring product performance. The early process and product characterization emphasized in the quality-by-design and risk-management approaches do not inherently conflict with validation. On the contrary, by deepening the level of scientific understanding of a manufacturing process, the approaches ensure that a process is well understood before it is considered "validated." Methods that involve continuous improvement and real-time control, however, do pose a significant question: Are these quality methods inconsistent with the basic tenets of validation that have served as the backbone of the industry's quality structure for so many years? Once you have "validated" a manufacturing process, how much can you improve it—through real-time control or any sort of continuous improvement step incorporated into Lean, Six Sigma, etc.—without having to file manufacturing supplements with FDA? How much of an impediment are those filing requirements?

THE VALIDATION PARADIGM

The challenge of validation is that it has been viewed as a necessary evil—a regulatory activity that cannot be avoided when manufacturing regulated products. The effort and cost associated with validation continue to escalate as industry and regulatory groups increase their understanding of pharmaceutical processes and identify an increasing number of process variables that must be controlled. Biotech adds another layer of complexity by introducing the qualified pilot or intermediate-scale model as an integral component of the validation equation.4

The prohibitive cost of characterization studies at full scale requires us to establish clear, scientific arguments to show how process development studies relate to full-scale validation lots. The complexity of biotech processes demands an even higher level of scientific argument. As we increase our understanding of biopharmaceutical processing, the value associated with traditional validation diminishes, and industry responds accordingly.

The integration of equipment validation and process validation provided incentive to measure the capability of our processes and analytical methods. However, somewhere along the way, the incentive for validation shifted from a need to measure processes, to a need to satisfy a regulatory requirement as quickly and as cheaply as possible.

Over time, industry came to believe that validation had to include a broader range of equipment and processes and a greater level of detail, and as a result, validation costs went up. In response, the industry attempted to distribute the responsibility for validation among participants in the quality process. For example, industry suddenly decided that validation had to include commissioning activities and engineering pre-cursor activity to equipment qualification, so they started requiring that contractors and subcontractors test and document various aspects of IQ. The approach of requiring increased involvement from vendors also extended to factory acceptance tests. Such tests—which have ranged from simple vendor testing and certification to constructing simulator panels to mimic the actuation of automated components—have also ranged in their true relevance to the validation process.

Market drivers completely unrelated to the field of validation often have determined the amount of effort put into validation. For example, when equity markets dried up in the late 1990s, emerging biotech companies shifted their emphasis from scientific investigation to bringing product to market as quickly as possible. The industry looked for cheaper and faster ways to push through the validation process to move programs forward quickly. The result was simpler process validation studies that focused on building three validation lots to demonstrate process predictability, rather than focusing on true process understanding. Likewise, companies began buying more equipment from suppliers who offered "canned" validation protocols that could be purchased and implemented, rather than developing their own protocols to challenge the equipment and thus increase the probability the equipment would meet the needs of the process. The implication of these shifts was that validation was necessary, but not essential to sound process development.

This short-cut approach to validation resulted in processes that were less stable at the commercial scale. FDA's recent revelations about high-profile, approved products that may be unsafe, such as Vioxx and Serevent, and Congress's pressure on industry to find ways to reduce the cost of drugs to the general public, have impacted both Big Pharma and biotech. In response, the industry has recognized the need for a better way to reduce process and product risk.

The answer was a shift to a more scientifically driven development approach, often referred to as "Operational Excellence," or "Process Excellence." This approach integrates process, quality, and business requirements to promote the science of development.

These quality initiatives integrate Six Sigma, Lean Manufacturing, Kepner-Tregoe, Theory of Constraints, Design of Experiments, and Balanced Scorecards to establish process understanding. These methodologies emphasize the need to objectively define, measure, and characterize critical variables that affect a process. While testing and data collection are integral components, verification is the final culmination of the quality assessment—not the basis of quality.

Looking closely at these approaches, however, reveals that they based in a large part upon an approach that has been integral to our quality systems for over 70 years—Walter Shewhart's cycle of Plan, Do, Check, Act (PDCA).

PLAN, DO, CHECK, ACT


Figure 1. PDCA "The Shewhart Cycle"

Walter Shewhart, an enterprising statistician who worked at Bell Laboratories in the US during the 1930s, developed the science of Statistical Process Control. An offshoot was the PDCA Cycle, often referred to as "the Shewhart Cycle." This tool was adopted and promoted from the 1950s on, by W. Edwards Deming, the renowned quality management authority, and as a result the tool also became known as "the Deming Wheel" (Figure 1).

The PDCA Cycle was the first tool broadly adopted as a framework for continuous improvement. PDCA is a four-step quality improvement cycle that promotes continuous improvement based on the method of design (plan), execution (do), analysis (check), and evaluation (act). Sometimes referred to as plan/do/study/act, the cycle emphasizes the constant attention and reaction to factors that affect quality.

The chief advantage of the PDCA cycle—flexibility in moving through each phase of the cycle—is also its biggest challenge, because it left the door open for subjectivity. Subjectivity has long been the downfall of our industry. Without a clear vision for success or a defined method for evaluation, the potential exists to rely on unscientific process development and characterization activities, which can lead to incorrect or incomplete conclusions. For example, univariate analysis methods—often called One-Factor-at-a-Time (OFAT) studies5 —have been the backbone of the small-molecule pharma industry, as well as the biopharm industry. Such studies, however, do not possess the power to fully characterize a process. The result is a false sense of security that the process characteristics are understood.


Figure 2. Cube Plot for Protein Recovery

An analogy would be that of trying to solve the popular "Rubik's Cube" puzzle. It may be relatively simple to get one side of the cube all one color, thus providing the impression of progress towards your goal. However, the reality is that you are actually further from success than when you started the exercise (Figure 2). Because of these limitations, other industries abandoned the OFAT approach 30 years ago, deeming it ineffective for process characterization and verification.

The biopharmaceutical industry, too, has come to recognize that the OFAT approach is insufficient. The industry has also realized that to be successful in combining quality, technical, and business requirements in the drug development lifecycle, it must realign not only its scientific approach to process understanding, but also its thinking within the organization. As a result, Operation Excellence initiatives have moved to frameworks such as Six Sigma to provide a roadmap that can meet this need.

SIX SIGMA AND ITS ROADMAP


Figure 3. Six Sigma as an organizational development and leadership tool

In 1986, Motorola established a framework designed to integrate quality, process, and business requirements into the product development lifecycle. Motorola recognized that variation is the death knell of any process, so the company set out to establish a methodology to identify and eliminate variation. They called this approach Six Sigma6 (Figure 3).


Figure 4. The DMAIC Roadmap

In the late 1990s, CEOs Jack Welch from GE and Larry Bossidy from Allied Signal adapted the Motorola model to a set methodology called the DMAIC roadmap. DMAIC is an acronym for Define, Measure, Analyze, Improve and Control. These are the five phases necessary to measure, characterize, and control a process (Figure 4).

Within each step of the road-map, a defined set of tools is applied. Each phase in the DMAIC process is intended to guide the members of an improvement team through the project in a manner that provides relevant data and in-depth process understanding. The DMAIC project management approach allows businesses to make the best possible decisions with the available data and resources. The five-steps of the DMAIC process are as follows:

1. Define: Clearly define the problem and relate it to the customer's needs (generally, with a cost benefit to the organization identified).

2. Measure: Measure what is key to the customer and know that the measurement is good.

3. Analyze: Search for and identify the most likely root causes.

4. Improve: Determine the root causes and establish methods to control them.

5. Control: Monitor and make sure the problem does not come back.

Within each DMAIC phase, there is a set of deliverables that must be completed to ensure all project requirements are met. A summary of the deliverables and typical activities for each phase of the DMAIC process is shown in Table 1.

Looking closely at the tools within the DMAIC methodology reveals elements that have been part of the quality toolkit since its inception. Cause and effect diagrams, Failure Mode and Effects Analysis (FMEA), and process capability analysis, among others, have been used broadly by process and quality engineers in multiple industries for years. What separates the DMAIC roadmap from the isolated application of these individual tools is the methodology around the application of the tools. In DMAIC, the process evaluation is based on the objective acquisition and analysis of data, in lieu of representative testing and inference.

LEAN MANUFACTURING

Although Six Sigma and the DMAIC toolkit focused on eliminating process variability, there still remained the need to bring products to market faster and more cheaply. As a result, the biopharmaceutical industry has turned to the principles of Lean Manufacturing to increase the efficiency of our processes. The ideas of Lean Manufacturing are based on the Toyota Production System approach of eliminating waste in every aspect of a company's operation. Lean focuses on time variability, in contrast to Six Sigma's focus on process variability. In their book Lean Thinking, Jim Womack and Daniel Jones7 recast the principles of Lean into five principles:
1. Value: Every company needs to understand the value customers place on their products and services. It is this value that determines how much money the customer is willing to pay for them. This analysis leads to a top-down, target-costing approach that has been used by Toyota and others for many years. Target costing focuses on what the customer is willing to pay for certain products, features, and services. From this, the required cost of these products and services can be determined. It is the company's job to eliminate waste and cost from the business processes so that the customer's price can be achieved at great profit to the company. In the biopharmaceutical and pharmaceutical world, value is often associated with quality and data, rather than with standard cost.

2. Value Stream: The value stream is the entire flow of a product's lifecycle, from the origin of the raw materials used to make the product through to the customer's cost of using, and ultimately disposing of, the product. Only by studying and obtaining a clear understanding of the value stream (including its value-added and waste) can a company truly understand the waste associated with the manufacture and delivery of a product or service.

3. Flow: One significant key to the elimination of waste is flow. If the value chain stops moving forward for any reason, then waste occurs. The trick is to create a value stream in which the product (or its raw materials, components, or sub-assemblies) never stops in the production process, because each aspect of production and delivery is in harmony with the other elements. Carefully designed flow across the entire value chain will minimize waste and increase value to the customer. Achieving this kind of flow is a challenge in our industry because many of our processes are batch processes. Even so, within the context of the total value stream, there are significant opportunities to move towards continuous flow.

4. Pull: A traditional Western manufacturer uses a style of production planning and control whereby production is "pushed" through the factory based upon a forecast and a schedule. A pull approach dictates that we do not make anything until the customer orders it. To achieve this requires great flexibility and very short cycle times of design, production, and delivery of the products and services. It also requires a mechanism for informing each step in the value chain what is required of them today, based on customers' needs.

5. Perfection: A lean manufacturer sets perfection as a target. The idea of total quality management is to systematically and continuously remove the root causes of poor quality from the production processes so that the plant and its products move toward perfection. This relentless pursuit of the perfect is the key attitude of an organization that is "going for lean."

Lean has been enthusiastically embraced by our industry because the tools are simple and improvement can be realized quickly. Although Lean is often initiated because of cost or efficiency reasons, there is another perspective to Lean that is often overlooked: quality.


Figure 5. DMAIC and Lean tools deployed in the Shewhart Cycle

Our industry should think of Lean as a quality initiative—not a business-driven one. While it is true that the basis for Lean is to eliminate waste and maximize the value-added activities of a process, another benefit of Lean is the way it simplifies and standardizes the process. The result is improved predictability. If you map the DMAIC and Lean tools together against the Shewhart PDCA Cycle, you find they follow the same framework; the tools within both toolkits are designed to address the same basic requirements of the PDCA cycle (Figure 5).

VALIDATION AND PLAN, DO, CHECK, ACT


Table 1a. Summary of DMAIC phase deliverables (continued)

Mapping validation, as applied by the biopharmaceutical industry today, may seem inconsistent with the principles of the Shewhart PDCA Cycle, DMAIC, and Lean. The basis of traditional validation is verification against predetermined acceptance criteria. How-ever, if we divide the validation process into its components, there is more similarity than difference between validation and these improvement methods. The steps of the validation life cycle map well to the Control, Measure, and Analyze phases of the DMAIC roadmap. What is missing is the Improve stage.


Table 1b. DMAIC phase deliverables

Six Sigma and Lean principles are predicated on the absolute requirements of demonstrating that the process is in control. By building on an efficient and objective framework for characterizing, measuring, and optimizing a process, it is possible to achieve a level of confidence that the process will be predictable and reproducible. No amount of testing will ever approach this level of confidence; heightened testing and large sampling can still only infer the process is in control. (As many have said, you cannot test quality into the product.) The irony in applying validation to the PDCA model is that its efficacy is only as good as one's understanding of the key process input variables that steer the process. In the absence of this, validation degenerates to a paper exercise.

CONCLUSION


Quick Recap

The twenty-first century GMP initiative advocates the need for building process understanding throughout the process development lifecycle. Tools such as Six Sigma, DMAIC, and Lean Manufacturing provide a framework for objective characterization and analysis of a process's key parameters. This knowledge, coupled with a quality system framework for specification, in-process, and release testing, can significantly elevate the level of quality built into the final product or process. While at first glance validation might appear to be inconsistent with these improvement initiatives, the elements of the validation lifecycle map to the control, measure, and analysis phases of the PDCA lifecycle. The most effective application of validation is achieved by using these optimization tools in the process characterization and development phases of a process long before validation. Until characterization and evaluation frameworks are more fully integrated into the drug development lifecycle, validation will remain a costly and time-consuming exercise capable only of providing limited assurance of process and product stability.

Bikash Chatterjee is the chief operating officer of Pharmatech Associates, 1098 Foster City Blvd., Foster City, CA 94404; tel 650.227.0177 fax 650-227-0176; bchatterjee@pharmatechassociates.com


REFERENCES

1. US Food and Drug Administration, Center for Drug Evaluation and Research, http://fda.gov/CDER.

2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8, November 2005.

3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline, Quality Risk Management Q9, November 2005.

4. Gibson M. Technology Transfer: An International Good Practice Guide for Pharmaceutical and Allied Industries. Illinois: DHI Publishing, 2005.

5. Schmidt SR, Launsby RG. Understanding Industrial Designed Experiments, 4th Ed. Colorado: Air Academy Press, 2000.

6. Brefogle FW. III. Implementing Six Sigma. New Jersey: Wiley and Sons, 1999.

7. Womack JP, Jones DT. Lean Thinking. New York: Simon & Schuster, 1996.

Snuffing Out Scrap

Realistically, scrap is difficult if not impossible to eliminate. But manufacturers that acquiesce to scrap are missing opportunities to cut wasteful material and save on labor costs.

By Jonathan Katz
June 1, 2006 -- Plant operators frequently play the role of garbage collectors at the expense of manufacturers. Instead of producing, they're gathering scrapped parts and materials to be recycled, reused or discarded. Facing foreign competitors who already are able to produce parts and materials at a significantly lower cost, U.S. manufacturers cannot afford the additional labor costs incurred from handling excess scrap.

Although manufacturers expect some scrap will be generated during the production process, truly lean operations strive for little or no scrap. These companies employ a variety of continuous-improvement methodologies, including Six Sigma, Multivariable Testing (MVT) and simple chart analyses, to reach their scrap-reduction goals.

Manufacturers tend to be more successful in their scrap-reduction efforts when they use some type of scientific approach rather than basing their plans of action on experience, says Ralph Rio, research advisor, ARC Advisory Group, Dedham, Mass. "Unfortunately, most manufacturers are going by tribal knowledge, meaning someone has an opinion about how to fix a particular operation or to reduce scrap and, by dominance of their personality, has a change implemented," he says. "Sometimes it works, but usually it doesn't."

Instead, Rio says manufacturers should depend on fact-based knowledge, often derived from information entered into databases by plant-floor operators that is then represented on a simple Pareto chart -- a bar graph with values plotted in descending order starting from the left-hand side.

The quick and simple approach to solving scrap problems is what David Cochran, vice president of operations for QualPro Inc., an MVT training and consulting firm based in Knoxville, Tenn., stresses to his clients. MVT involves a brainstorming process in which several people with different roles throughout the company and plant operations list ideas to address inefficiencies. Manufacturers then narrow down the list based on which ideas are the most practical to implement, usually depending on how costly or time consuming the project will be, says Cochran, who co-authored with Charles Holland "Breakthrough Business Results with MVT."

"If something is not easy to test and implement, we set that aside because what we found is that these easy and quick and inexpensive changes very often can create these big breakthrough results," he says. The next step with MVT is to test the ideas in live situations. The ones that produce positive results are implemented while the ones that fail are dropped.

Using these tools to analyze processes at the operations level is a common way to measure and identify scrap problems, but material waste also can be prevented by implementing changes at the engineering stage. In the auto industry the first line of attack against scrap often is taken at the engineering stage, says Ron Krupitzer, vice president of automotive applications for the American Iron and Steel Institute.

For instance, stamping plants sometimes use steel blanks that are larger than needed to ensure there's enough workable material during the tryout process. Over time, auto manufacturers have found ways to fine-tune the engineering process so they can use the smallest-size blank possible. One way Tier One auto parts suppliers have trimmed blank sizes is by using more computer modeling applications to predict and simulate the stamping operation, Krupitzer says. This gives them a better idea of what steel grade will produce the least amount of scrap.

Auto manufacturers also have experimented with stronger steel to reduce scrap, sometimes in the assembly of inner-door panel hinges where the need for additional reinforcement parts results in more waste. Now automakers can use laser-welded blanks, or blanks made from higher-strength steel to eliminate the need for hinge supports, Krupitzer says. Higher-grade steel may also be used in the stamping process to prevent splitting and lower defect rates.

For the Hexacomb division of Pregis Corp., an $850 million protective packaging company based in Lake Forest, Ill., the scrap problem was paper and glue used to create die-cut packaging. When Hexacomb President Bill McBee joined the division in 2003, he was looking for ways to reduce costs. He started by focusing on the most obvious cost-cutting opportunity: waste. During the process of converting paper into die-cut packaging, Hexacomb was scrapping the equivalent of approximately one out of every four rolls of paper it purchased, according to McBee. He estimated the cost of wasted paper, glue and labor at $4.5 million.

McBee started his scrap-reduction initiative by selecting Hexacomb's top-performing plant in Trenton, Ill., for an MVT experiment. A brainstorming session with all the plant's hourly and salaried employees resulted in 350 to 400 ideas. McBee says it's critical to involve the people who are most familiar with the plant-floor processes in these sessions. "You start off by shooting all the engineers -- they don't really have the answers," jokes McBee. "Then you get all the operators and material handlers and everyone you can who really understands what's going on in the process . . . and you go through four days of SPC (statistical process control) training, using statistics from the plant that you're going to work with."

From there, the plant staff narrowed the 350 or so ideas down to 24 variables to test by eliminating duplicate suggestions and less-practical ideas. Over a 48-hour period, plant-floor operators conducted the tests and recorded the results. The plant found three factors that reduced scrap, three that increased waste and 15 that had no effect at all, McBee says.

The changes that worked -- replacing old glue rollers with new ones, setting scheduled speeds for the machines that make the cores and tweaking the speed of the saws that cut the paper -- reduced scrap at the Trenton facility by half.

Hexacomb has extended MVT to other plants and achieved further scrap savings. In 2005, the company conducted an MVT of 17 machines at eight different plants, but McBee cautions that the method is more effective when it's narrowly focused. "MVT works best if you have a situation where you focus on one process -- for example, one machine, one plant," he says. "When you try to combine all of them, you get a lot of averaging, so you don't get nearly the impact when you do a whole bunch of them with the same factors on the same days."

About six years ago, Cummins Inc., a Columbus, Ind.-based manufacturer of large diesel engines, began making Six Sigma part of the company culture. One of Cummins' goals with Six Sigma was to reduce the amount of scrap at its fuel systems plant. Through the Six-Sigma process of defining, measuring and analyzing, the company found several opportunities to reduce material waste. One of the key people in implementing these improvement projects was account manager Ginger Lirette. In 2005, Lirette received one of the company's first J. Irwin Miller awards -- named after the company's former CEO -- for completing 13 quality improvement projects that saved the company nearly $14 million.

One project headed by Lirette was to analyze the gauging on the fuel systems injector line where the company was experiencing a high defect rate. Using the Six Sigma methodology, Lirette discovered that the gauging was not accurately simulating an operating engine. "Based on that study, we were able to rework our gauge to be more real-world like, and we were able to save quite a bit of time, scrap and labor," Lirette says.

Another Six-Sigma project the company undertook revealed that one of the operations intended to improve the roundness of injector plungers actually was causing defects. By removing this step from the process, the company was able to improve the quality of the plungers and reduce scrap. "How often does that happen?" Lirette asks, then answers: "[It's] probably not very often that you actually get to take an operation out, so you're reducing your inventory, you're reducing your labor time and getting a quality improvement."

In 1999, General Cable Corp.'s 56,000-square-foot Moose Jaw, Saskatchewan, Canada, plant was operating at approximately 4% gross waste, according to plant manager Ray Funke. At the time, the factory, which was a winner of IndustryWeek's 2005 Best Plants award program, was using some rudimentary tools to measure scrap, but it wasn't providing the detail that was needed to produce significant results. So the plant developed detailed metrics of every cause of scrap from every workstation in the plant using several lean tools.

The plant utilized a Pareto-analysis chart to engage its workforce in its scrap-reduction efforts by showing them where scrap was occurring. Funke says getting production workers involved in the scrap-reduction process was a key turning point for the plant. "It was a major initiative because our company in 1999 wasn't in a very good position from a financial standpoint with the market downturn in wire and cable, and we were obviously trying to cut costs in any way possible, and scrap was clearly a big opportunity for every plant within our company," Funke explains.

By using the charts and involving employees in the process, the plant was able to significantly cut scrap at its extrusion line, reducing approximately $140,000 of wasted material in 1999 to between $12,000 and $15,000 in 2005. The plant ended 2005 with a gross scrap rate of about 1.1%. Its 2006 goal is 0.85% and as of April was on track to reach that mark, according to Funke.

"I think the big thing is we have frequent metrics that get in front of the people who run the equipment at least once a week, so they see these metrics as far as what are the major drivers, they understand what the cost of a quality defect is or what the inherent scrap is, and we use the Pareto 80/20 rule -- that we'll just focus on the big hitters until we can't theoretically drive anything out any further," Funke says.

The World According to TRIZ

By Reena Jana

The World According to TRIZ
Blue-chip American companies are embracing a 60-year-old innovation theory pioneered by a Russian inventor

With "innovation" such a hot buzzword in business circles these days, companies are scrambling to find the magic formula for creating inventive products and services. One method that's gaining converts -- and breeding skeptics -- is a 60-year-old theory known as TRIZ.

TRIZ is the brainchild of late Russian inventor Genrich Altshuller (1926-98), who worked as a patent inspector. In the process of observing invention after invention, Altshuller sought to identify a consistent formula for innovation. In 1946, he published an article laying out his theory of structured innovation, which he titled "Teoriya Resheniya Izobretatelskikh Zadatch." That translates roughly into "Theory of Inventive Problem Solving," or TRIZ, for short.

Fast-forward to 2006. The list of American companies that have applied Altshuller's recipe for innovation includes Boeing (BA ), Hewlett Packard (HPQ ), IBM (IBM ), Motorola (MOT ), Raytheon (RTN ), and Xerox (XRX ), among others.

HAPPY OUTCOMES. In the U.S., one of the main evangelists for TRIZ has been Brooklyn (N.Y.)-based futurist and innovation consultant Andrew Zolli of Z + Partners, who has advised such blue-chip companies as General Electric (GE ). The TRIZ gospel is also being spread through a newly published book, Insourcing Innovation, by innovation coach David Silverstein, author Neil De Carlo, and TRIZ Journal editor and scientist Michael Slocum.

Here's a brief tutorial on TRIZ. Begin by defining your ideal outcome -- what function you want the product or process to perform. The next step is to figure out how to best utilize your organization's resources to work toward that goal. Next, run scenarios and devise models to try to achieve the desired outcome.

To help guide the process, Altshuller devised a matrix of 39 basic problems and 40 possible solutions. The former includes such tech-y considerations as "energy spent by non-moving object" or "tension, pressure." But others are more general, like "speed" or "level of automation." The list of possible fixes include categories such as "pneumatics and hydraulics," but also more common-sense principles such as "other way around" (as in, why not try the opposite of the approach that isn't working?).

MIX AND MATCH. One company that successfully applied TRIZ to arrive at an innovative product is San Diego-based OnTech. In 2004, OnTech debuted a single-serving, self-heating container that can be used as packaging for soup, coffee, tea, or even baby formula. Among the brands that have licensed the technology are a line of gourmet coffees produced by celebrity chef Wolfgang Puck and Hillside soups and coffees.

OnTech's product developers faced more than 400 technical and engineering dilemmas in trying to devise a sturdy, yet portable container that could warm drinks and stews, but could also contain and withstand the chemical reaction used to generate heat. The team surveyed TRIZ's list of 39 problems and identified those that applied, and then selected fixes from the parallel list of 40 inventive principles.

For example, they chose No. 14 from the first list -- "temperature" -- and applied No. 30 from the second list, "use of composite materials," as well as No. 40, "flexible shells and thin films." By using TRIZ's mix-and-match lists as a springboard, the engineers quickly arrived at a suitable material for their container: a ceramic and carbon-fiber composite that's both durable and conducts heat efficiently. Presto, a new product was born.

ASIAN ACCEPTANCE. Although TRIZ has been around for half a century, it's only in the past decade that it began to infiltrate the research & development departments of American companies. Silverstein recalls that he first learned of TRIZ six years ago, during a consulting gig with Navistar International (NAV ), a manufacturer of heavy-duty trucks. "One of their PhDs introduced me to a Russian group in Detroit, and they told me about TRIZ. And I thought, 'This could be a parallel to Six Sigma,'" he says, referring to the system for gauging defects and boosting quality pioneered by Motorola (MOT ) in the mid-1980s and later popularized by companies like GE.

Silverstein acknowledges that TRIZ has found greater acceptance in Asia than in the U.S. His Asian client base has more than doubled in the past 18 to 24 months, he says. "It's hard for some companies to see innovation as something that can be structured," he says. "People want to think that innovations occur as the result of really smart people's ideas. When you structure that and say anyone can innovate, well, this idea becomes threatening."

Still, TRIZ is making inroads stateside. Davin Stowell, founder and chief executive of New York-based Smart Design, a leading product-design firm, only recently discovered TRIZ. Although he has yet to put the theory into practice, Stowell admits that he sees its merits. "When I first read about TRIZ, I found it a little offputting at first. I was a slight skeptic," he says. "Then I saw that it wasn't that different from what we do in product design."

COOKIE-CUTTER SOLUTION? According to Stowell, the main difference between TRIZ and the methods used by design-cum-business-strategy firms such as Smart Design, Palo Alto (Calif.)-based IDEO, or Boston's Design Continuum, though, is that they also rely heavily on another trendy concept: ethnography (see BW, 6/5/06, "The Science of Desire"). In other words, they engage in intensive consumer research to figure out whether their inventions will be well-received or not.

When asked if "structured innovation" à la TRIZ is a contradiction in terms, Stowell defends the general idea. "You need structure to step out of the box. While TRIZ is clearly much more applicable for engineering and science, its core principles are helpful. Innovation absolutely needs to be structured to finish a project. Or else you wander all over the place," he says.

Some product-design firms approach TRIZ with caution. One of them is Design Continuum. "It seems to me that TRIZ is trying to create an equation for innovation," says Harry West, the company's vice-president of strategy & innovation. "I think it's a great aspiration. But if there's an equation for innovation out there, your competitor can do the same -- which means the competitive challenge can easily be lost."

TRIZ's proponents contend that they aren't trying to sell a modern-day version of snake oil. Says Silverstein: "Look, TRIZ is not the answer to everything. It's just one approach to innovation." And it's an approach more companies are turning to.

Zeroing In On The Customer: IW Best Plants Profile - 2004

To improve its products, Northrop Grumman's flagship Defensive Systems Division plant goes to war -- literally.

By Tonya Vinas
Oct. 1, 2004 -- Northrop Grumman Corp. Defensive Systems Division, Rolling Meadows, Ill.

At a Glance


Total square feet: 1 million

Start-up: 1967

Achievements: With ongoing process improvements, the Rolling Meadows operation achieved $13 million in cost savings in 2003 and a 39% increase in cash flow over the past three years. Additionally, it has reduced average time-to-market for new products by more than 50%.

Benchmarking Contact: Tom Fallon, 847/259-9600, Ext. 5681, tom.fallon@ngc.com

Talk about customer service.

It's not unusual for engineers to visit customers in the field, especially these days with manufacturers focusing on service as a strategic advantage. But when your customer is a soldier, preparing for war or in live combat, customer service takes on a whole new meaning.

"I'd like you to assume that this land mass over here is the United States -- good guys," says Jim Cameron, a man whose streamlined language and patient explanations come in handy when explaining the intricacies of war on a faux map. "This land mass over here is some bad guy. Unfortunately, the nature of man is such that there are always good guys and bad guys. The only thing that's common is that we're always the good guys."

Cameron, vice president and general manager of the Defensive Systems Division (DSD) of Northrop Grumman Corp., uses the map to explain what his division manufactures -- complex defense electronic systems that give soldiers the ability to find hidden dangers, confuse enemies and their "smart" weapons, and zero in on precise targets when using their own weapons.

The DSD division is headquartered at a sprawling, million-square-foot compound in Rolling Meadows, Ill., one of this year's IW Best Plant's winners. The plant's 2,000 employees use a variety of methods to achieve world-class status, but all are driven by a focus on the customer that's as sharp as the sensors of the products they produce.

"What discriminates us is that we believe if we can understand our customer's mission as well as they do, we can help them be more effective," says Cameron, who has held his current post for six months and previously worked at ITT Industries. "We don't wait for our customer to say, 'Will you give us this?' We find out what our customer is trying to do, and then we develop solutions. As a result of that, we get out ahead of the competition and give our customers the things that are the most beneficial for them to execute their mission."

The crux of this customer interaction takes place in the field through user conferences, extensive testing at customer sites, training at customer sites and, at times, during war.

"The field service engineer is out there to maintain and service our products in the field," explains Greg Schmidt, vice president of engineering and manufacturing at Rolling Meadows. "By maintaining and supporting that product, they are working hand-in-hand with the user. Sometimes we don't have enough field service engineers to go everywhere they need to be at the same time. So we actually have [design] engineers and our operations test engineers volunteer to go into theater to support our products."

These engineers are deployed in teams and include people who've been with the products "from the electrons on our IT system to the real hardware," Schmidt says. "They take that experience and learning and bring it back for the next program."

DSD's customer focus is apparent throughout the high-mix, low-volume Rolling Meadows plant. Rather than focus on one omnipresent improvement philosophy -- such as lean or Six Sigma or value-stream mapping -- Rolling Meadows using all of these and more techniques, all with an eye toward customers, customers, customers.

To please customers, DSD must develop innovative, mission-critical products and manufacture them faster and cheaper. DSD's achievements in this area enabled the division to win 80% of proposals submitted in 2003 and maintain a 100% repeat-business rate.

Sure, the wars in Iraq and Afghanistan have increased demand for the plant's products, but Rolling Meadows has customers other than U.S. armed forces and has been laying the building blocks for the past five years that gave it an advantage when the U.S. declared war. Some of those building blocks include:

Adding automated testing and other process improvements that reduced overall manufacturing cycle time by 62%.

Establishing the Operator Self-Acceptance and Product Assessment Program, which empowered production workers to make accept/reject decisions about products throughout the manufacturing process. "This approach helps build quality into the product rather than trying to inspect quality into the product," the plant management stated in its Best Plants application. On one of its complex electronic devices, the plant has seen a 300% increase in first-pass yield improvement.

Deploying 17 Six Sigma black belts to use their tools throughout the plant to make singular-but-significant improvements in business practices and engineering processes. In the case of one infrared sensing system, Six Sigma techniques allowed for a tripling of units produced annually by adding fewer than five employees and a nominal increase in production. On the same product, engineers used Six Sigma to determine that using a different method to apply a drop of reactive liquid during production reduced drying time from 24 hours to 3.5 hours, cutting 20 hours out of cycle time.

Emphasizing modular design and agility. For instance, in its Litening targeting system line -- which was used in the rescue of Pvt. Jessica Lynch from an Iraqi hospital -- engineers can customize each pod with a few software programming changes. The hardware remains largely the same.

So the pods going to one branch of the military are different than those going to another, but the customization takes minimal time and overhead. (The pods, shaped like bloated missiles the length of a large surf board, attach to the underbelly of aircraft.)

Using IT to integrate product design and manufacturing and to track process improvements. The Rolling Meadows plant was an early adopter of product lifecycle management (PLM) software and uses it to communicate design plans and changes immediately to manufacturing staff so that they can begin planning for capacity, raw materials and other needs. PLM also enables intense supplier/partner collaboration. Additionally, a robust, home-grown portal runs on top of all applications and gives team leaders and managers a real-time view of significant metrics across the plant and its market segments via a variety of charts and graphics. The entire system is integrated and updates simultaneously.

"The information is not added again and again," says Lisa Strama, manager of operations systems at the plant. "It flows automatically so that people can focus on strategies."

Cameron meets monthly with managers to review the metrics point-by-point via the portal. He insists upon the meetings and a manager's report, although he could review the data himself, because he sees it as a learning experience and a way to ensure that managers know their knitting.

The data is not only used for tracking improvements but for planning, e.g., capital equipment purchases. In that way, Cameron says there's a "closed-loop" system from the engineers in the field with the customer to the executive decisions he and his staff make.

"It gets that guy-who-is-closest-to-the-customer's current view of the world that helps us focus on where we're going in the future," Cameron says. "It's a very powerful thing."

Six Sigma In A Small Business

Tony Jacowski
Expert Author
Published: 2006-06-01

As a small business owner, you will eventually sense the need for Six Sigma implementation in your business.

Typically, yours is a 3-5 year old company on the threshold of expanding your operations to meet the growing customer expectations but is cornered to optimize your resources on generating more sales than anything else. Small companies in the bracket of 50-100 employees (most of them being non technical) and revenue of $10-15 million find themselves in this fix. The predicament at this stage is one of a person who is caught between a tiger and cliff.

Finding A Way Out Of The Jam

The situation needs to be given a rational thought concerning how many resources can be afforded and whether the time has really come for Six Sigma. The cost of hiring consultants being hardly affordable, you have to explore options like hiring a Black Belt and having some of your employees trained in-house for Green Belt positions.

What you probably don't want to miss out on in hiring an experienced Black Belt, although expensive, are the benefits you get because of her/his domain knowledge and experience. Her proven track record will have the best chances of outweighing the initial cost benefit of grooming in-house Black Belts. An experienced Black Belt helps by bringing the focus immediately into a pressing issue on hand which is crucially important to the organization. Alternately, your best man with brilliant analytical and leadership skills may be trained as a Black Belt, and you may enroll in a Champion Session.

The trouble with this kind of an arrangement is whether you can afford to lose your best person from his current job. Enrolling Black Belts, can be an option for you, but you must realize that it takes some time before the new Black Belts get acclimatized with your scheme of things. At the same time, Green Belts, most often being part-time, don't need to be of high skill. Choosing a few reasonable persons from your organization will suffice. A great Black Belt can take minor shortcomings of Green Belts in stride and things will eventually balance out.

Resolving The Issue Of The Master Black Belt

Even an experienced Black Belt will need the support of a Master Black Belt. The vacuum can be felt typically when the Black Belt finds herself in a logjam. A typical case could be one of technical or organizational reasons. But hiring Master Black Belts is a costly proposal. Secondly, growing and training Master Black Belts in house is also impractical. You will have to hire a consulting Master Black Belt.

But getting a professional is not easy, especially when many of them are more interested in increasing 'their-hours-in-work' than in the task. You can consult your state's 'Manufacturing Extension Programs' or a trusted contact to refer you to a consulting Master Black Belt. In any case, with you at the helm of affairs, you will know when to pull the plug when something is not working out.

Caution Is The Word

Probably you would want to go one project at a time. Assessing your progress at intervals should direct the course of action. Brainstorm with your internal team to decide on activities to go for Six Sigma and which of the activities are measurable. Establishing measurability and metrics beforehand is important.

Foundations of Six Sigma Management

Date: Jun 2, 2006 By Howard S. Gitlow, David M. Levine, Edward A. Popovich. Sample Chapter is provided courtesy of Prentice Hall.

This chapter is about getting you comfortable with Six Sigma management. It accomplishes this objective by providing you with strong anecdotal evidence that Six Sigma is a very successful style of management, explaining how it must be emphatically led from the top of the organization, and, finally, introducing you to the Six Sigma models for improving and inventing/innovating products, services, or processes. This chapter could serve as a brief introduction to Six Sigma management for any stakeholder of your organization.
Sections

Introduction
1.1 Successful Applications of Six Sigma Management
1.2 Key Ingredients for Success with Six Sigma Management
1.3 Benefits of Six Sigma Management
1.4 Fundamentals of Improving a Product, Service, or Process
1.5 Fundamentals of Inventing–Innovating a Product, Service, or Process
1.6 What Is New about Six Sigma Management?
1.7 Six Sigma in Non-Manufacturing Industries

Summary
References

Learning Objectives

After reading this chapter, you will be able to:

Present strong evidence of the value of Six Sigma style of management.
Understand the key ingredient for success with Six Sigma management.
Appreciate the benefits of Six Sigma management.
Review the fundamentals of improving a product, service, or process.
Appreciate the DMAIC model for improvement.
Introduce the fundamentals of inventing and innovating a product, service, or process.
Appreciate the DMADV model for invention and innovation.
Know what is new about Six Sigma management.
Appreciate the significance of Six Sigma management in non-manufacturing industries.
Introduction

This chapter is about getting you comfortable with Six Sigma management. We accomplish this objective by providing you with strong anecdotal evidence that Six Sigma is a very successful style of management, explaining how it must be emphatically led from the top of the organization, and, finally, introducing you to the Six Sigma models for improving and inventing/innovating products, services, or processes. This chapter could serve as a brief introduction to Six Sigma management for any stakeholder of your organization.

1.1 Successful Applications of Six Sigma Management
Manufacturing organizations have experienced great success with Six Sigma management. Selected manufacturing organizations that use Six Sigma management include the following:

Asea-Brown-Boveri
AT&T
Bombardier
Eli Lilly
Foxboro
General Electric
Honeywell/Allied Signal
IBM–UK
Lockheed Martin
Motorola
Raytheon
Seagate
Texas Instruments

Additionally, non-manufacturing organizations have had excellent results with Six Sigma management. A few non-manufacturing organizations using Six Sigma management include the following:

Allstate Insurance
Amazon.com
American Express
Bank of America
Bankers Life and Insurance
Capital One Services
Intuit
J. P. Morgan Chase
Merrill Lynch
Microsoft
United Health Group
University of Miami

Jack Welch, Chairman emeritus and CEO of General Electric, was so committed to and impressed with Six Sigma that he stated:

"Six Sigma GE Quality 2000 will be the biggest, the most personally rewarding, and, in the end, the most profitable undertaking in our history."

"...we plunged into Six Sigma with a company-consuming vengeance just over three years ago. We have invested more than a billion dollars in the effort and the financial returns have now entered the exponential phase." (GE’s letter to shareowners, February 12, 1999)

1.2 Key Ingredients for Success with Six Sigma Management
The key ingredient for a successful Six Sigma management process is the commitment of top management. Executives must have a burning desire to transform their organizations. This means total commitment from the top of the organization to the bottom of the organization. An executive’s commitment is shown in part by how she or he allocates time and resources, and by the questions she or he asks of others. Many Six Sigma executives spend at least 25% of their time on Six Sigma matters and allocate major organizational resources to drive the Six Sigma style of management. If an executive asks: "What was yesterday’s production volume?," she or he is saying: "I care about quantity, not quality." If an executive asks: "What is happening with the Production Department’s Six Sigma projects to increase production volume?," she or he is saying: "I care about quality and quantity."

1.3 Benefits of Six Sigma Management
There are two types of benefits from Six Sigma management: benefits to the organization and benefits to stakeholders. Benefits to an organization are gained through the continuous reduction of variation and, where applicable, the centering of processes on their desired (nominal) levels. The benefits are as follows:

Improved process flows
Reduced total defects
Improved communication (provides a common language)
Reduced cycle times
Enhanced knowledge (and enhanced ability to manage that knowledge)
Higher levels of customer and employee satisfaction
Increased productivity
Decreased work-in-progress (WIP)
Decreased inventory
Improved capacity and output
Increased quality and reliability
Decreased unit costs
Increased price flexibility
Better designs
Decreased time to market
Faster delivery time

Increased ability to convert improvements and innovations into hard currency
In essence, Six Sigma is a roadmap for an enterprise to become more effective and efficient. An "effective" enterprise is one that does the "right" things "right" the first time, and an "efficient" enterprise is one that uses minimum resources to accomplish the "right" thing. The "right" thing is judged by the perception of customers and the marketplace. Simply put, the Six Sigma enterprise focuses on providing a value-added experience to current and future customers through its processes, products, and services. Processes that do not add value to the customer’s experience are candidates for elimination by management. A value-added process is a process that the customer is willing to pay for, does not involve rework or fixes, is done "right" the first time, and is not wasteful to the enterprise.

Louis Schultz, President of Process Management International, a consulting firm in Minneapolis, Minnesota, states that:

"The perception and performance of an enterprise determines its value. Six Sigma management focuses on driving effective and efficient performance across the total enterprise to increase the perception of the marketplace of its ability to deliver value-added processes, products, and services. The perception of the marketplace of the value of an enterprise is indirectly measured by market share, shareholder value, and the willingness of customers to recommend these processes, products, and services to other potential customers."

Benefits to stakeholders are a by-product of the organizational benefits. The benefits to stakeholders include the following:

Shareholders receive more profit due to decreased costs and increased revenues.
Customers are delighted with products and services.
Employees experience higher morale and more satisfaction from joy in work.
Suppliers enjoy a secure source of business.

1.4 Fundamentals of Improving a Product, Service, or Process
Process Basics (Voice of the Process [VoP])

Definition of a Process
A process is a collection of interacting components that transform inputs into outputs toward a common aim, called a mission statement. The job of management is to optimize the entire process toward its aim. This may require the sub-optimization of selected components of the process. Sometimes a particular department in an organization may have to give up resources in the short run to another department to maximize profit for the overall organization. This is particularly true when one department expends effort to correct the failings or omissions of another department working on the same process. Inspection, signature approvals, rework areas, complaint-resolution areas, etc. are all evidence that the process was not done effectively and efficiently the first time. The consumption of resources utilized in correcting the failings and omissions would have been avoided if the process was done "right."

The transformation, as shown in Figure 1.1, involves the addition or creation of value in one of three aspects: time, place, or form. An output has "time value" if it is available when needed by a user. For example, you have food when you are hungry. Or material inputs are ready on schedule. An output has "place value" if it is available where needed by a user. For example, gas is in your tank (not in an oil field), or wood chips are in a paper mill. An output has "form value" if it is available in the form needed by a user. For example, bread is sliced so it can fit in a toaster, or paper has three holes so it can be placed in a binder.


Figure 1.1 Basic Process

Processes exist in all facets of organizations, and our understanding of them is crucial. Many people mistakenly think only of production processes. However, administration, sales, service, human resources, training, maintenance, paper flows, interdepartmental communication, and vendor relations are all processes. Importantly, relationships between people are processes. Most processes can be studied, documented, defined, improved, and innovated.

An example of a generic assembly process is shown in Figure 1.2. The inputs (component parts, machines, and operators) are transformed in the process to make the outputs (assembled product).


Figure 1.2 Production Process

An organization is a multiplicity of micro sub-processes, all synergistically building to the macro process of that organization. All processes have customers and suppliers; these customers and suppliers can be internal or external to the organization. A customer can be an end user or the next operation downstream. The customer does not even have to be a human; it could be a machine. A supplier could be another organization supplying sub-assemblies or services, or the prior operation upstream.

Variation in a Process
The outputs from all processes and their component parts may be measured; the measurements invariably fluctuate over time, creating a distribution of measurements. The distribution of measurements of the outputs from a process over time is called the "Voice of the Process (VoP)." Consider a process such as getting ready for work or for class in the morning. Some days you are busier than usual, while on other days you have less to do than usual. Your process varies from day to day to some degree. This is common variation. However, if a construction project begins on the highway you take to work or school, you might drastically alter your morning routine. This would be special variation because it would have been caused by a change external to your "driving to work or school" process. If the traffic patterns had remained as they were, your process would have continued on its former path of common variation.

The design and execution of a process creates common causes of variation. In other words, common variation is due to the process itself. Process capability is determined by inherent common causes of variation, such as hiring, training, or supervisory practices; inadequate lighting; stress; management style; policies and procedures; or design of products or services. Employees working within the process cannot control a common cause of variation and should not be held accountable for, or penalized for, its outcomes. Process owners (management) must realize that unless a change is made in the process (which only they can make), the capability of the process will remain the same. Special causes of variation are due to events external to the usual functioning of the process. New raw materials, a drunken employee, or a new operator can be examples of special causes of variation. Identifying the occurrence of special and common causes of variation is discussed extensively in References 2 and 3.

Because unit-to-unit variation decreases the customer’s ability to rely on the dependability and uniformity of the outputs of a process, managers must understand how to reduce and control variation. Employees use statistical methods so that common and special causes of variation can be differentiated; special variation can be resolved and common variation can be reduced by management action, resulting in improvement and innovation of the outputs of a process.

The following fictionalized case history demonstrates the need for management to understand the difference between common and special causes of variation to take appropriate action. In this case history, an employee comes to work intoxicated. His behavior causes productivity, safety, and morale problems. You, as the supervisor, speak to the employee privately, try to resolve the situation, and send the employee home with pay. After a second instance of intoxication, you speak to the employee privately, try to resolve the problem again, and send the employee home without pay. A third instance causes you to refer the employee to an Employee Assistance Program. A fourth offense results in you terminating the employee. As a good manager, you document the employee’s history to create a paper trail in case of legal action. All of the above is necessary and is considered to be good management practice.

The thought process behind the preceding managerial actions assumes that the employee is the problem. In other words, you view the employee’s behavior as the special cause of variation from the desired sober state. However, this is true only if there is a statistically significant difference between the employee in question and all other employees. If the employee’s behavior is part of a process that allows such behavior to exist, then the problem is not a special cause, but rather a common cause; it requires a different solution. In the latter case, the employee must be dealt with as before; but, additionally, organizational policies and procedures (processes) must be changed to prevent future incidents of intoxication. This new view requires a shift in thought. With the new thought process, if existing organizational policies and procedures allow employees with drinking problems to be present in the workplace, an intoxicated employee must be dealt with according to the original solution, and policies and procedures must be improved to prevent future incidents of such behavior on the job.

Feedback Loops
An important aspect of any process is a feedback loop. A feedback loop relates information about outputs from any stage(s) back to other stage(s) to make an analysis of the process. Figure 1.3 depicts the feedback loop in relation to a basic process.


Figure 1.3 Feedback Loop

The tools and methods discussed in this book provide vehicles for relating information about outputs to other stage(s) in the process. Decision making about processes is aided by the transmission of this information. A major purpose of quality management is to provide the information (flowing through a feedback loop) needed to take action with respect to a process.

There are three feedback loop situations: no feedback loop, special cause only feedback loop, and special and common cause feedback loop. A process that does not have a feedback loop is probably doomed to deterioration and decay due to the inability of its stakeholders to rejuvenate and improve it based on data from its outputs. An example of a process without a feedback loop is a relationship between two people (manager and subordinate, husband and wife, or buyer and seller) that contains no vehicle (feedback loop) to discuss issues and problems with the intention of establishing a better relationship in the future. A process in which all feedback information is treated as a special cause will exhibit enormous variation in its output. An example of a process with a special cause only feedback loop could be a relationship between two people; but in this case, the relationship deteriorates through a cycle of successive overreactions to problems that are perceived as special by both members of the relationship. In fact, the problems are probably repetitive in nature due to the structure of the relationship itself and to common causes of variation. Finally, in a process in which feedback information is separated into common and special causes—special causes are resolved and common causes are reduced—products, services, or processes will exhibit continuous improvement of their output. For example, the relationship problems between a superior and a subordinate can be classified as either due to special and/or common causes; statistical methods are used to resolve special causes and to remove common causes, thereby improving the relationship in the future.

Consider the following example. Paul is a 40-year-old, mid-level manager who is unhappy because he wants his boss to give him a promotion. He thinks about his relationship with his boss and wonders what went wrong. He determines that over a period of 10 years, he has had about 40 disagreements with his boss (one per quarter).

Paul thinks about what caused each disagreement. Initially, he thought each disagreement had its own special cause. After studying the pattern of the number of disagreements per year, Paul discovered that it was a stable and predictable process of common causes of variation. Subsequently, he wrote down the reason for as many of the disagreements as he could remember (about 30). However, after thinking about his relationship with his boss from the perspective of common causes, he realized his disagreements with his boss were not unique events (special causes); rather, they were a repetitive process, and the reasons for the disagreements could be classified into common cause categories. He was surprised to see that the 30 reasons collapse down to four basic reasons—poor communication of a work issue, a process failure causing work not to be completed on schedule, unexcused absence, and pay-related issues—with one reason, poor communication of a work issue, accounting for 75% of all disagreements. Armed with this insight, he scheduled a discussion with his boss to find a solution to their communication problems. His boss explained that he hates the e-mails that Paul is always sending him and wished Paul would just talk to him and say what is on his mind. They resolved their problem; their relationship was greatly improved, and, eventually, Paul received his promotion.

Definition of Quality (Voice of the Customer [VoC])Goal Post View of Quality
Quality is a concept whose definition has changed over time. In the past, quality meant "conformance to valid customer requirements." That is, as long as an output fell within acceptable limits (called specification limits) around a desired value or target value (also called the nominal value, denoted by "m"); it was deemed conforming, good, or acceptable. We refer to this as the "goal post" definition of quality. The nominal value and specification limits are set based on the perceived needs and wants of customers. Specification limits are called the Voice of the Customer. Figure 1.4 shows the "goal post" view of losses arising from deviations from the nominal value. That is, losses are minimum until the lower specification limit (LSL) or upper specification limit (USL) is reached. Then, suddenly, losses become positive and constant, regardless of the magnitude of the deviation from the nominal value.


Figure 1.4 Goal Post View of Losses Arising from Deviations from Nominal

An individual unit of product or service is considered to conform to a specification if it is at or inside the boundary (USL or LSL) or boundaries (USL and LSL). Individual unit specifications are made up of a nominal value and an acceptable tolerance from the nominal. The nominal value is the desired value for process performance mandated by the customer’s needs and/or wants. The tolerance is an allowable departure from a nominal value established by designers that is deemed non-harmful to the desired functioning of the product or service. Specification limits are the boundaries created by adding and/or subtracting tolerances from a nominal value; for example:

USL = upper specification limit = nominal + tolerance

LSL = lower specification limit = nominal – tolerance

A service example of the goal post view of quality and specification limits can be seen in a monthly accounting report that must be completed in 7 days (nominal), no earlier than 4 days (lower specification limit—not all the necessary data will be available), and no later than 10 days (upper specification limit—the due date for the report at the board meeting). Therefore the "Voice of the Customer" is that the report must be completed ideally in 7 days, but no sooner than 4 days or no later than 10 days.

Another example of the goal post view of quality and specification limits is to insert a medical device into the chest of a patient that is 25 mm in diameter (the nominal value). A tolerance of 5 mm above or below the nominal value (25 mm) is acceptable to the surgeon performing the operation. Thus, if a medical device’s diameter measures between 20 mm and 30 mm (inclusive), it is deemed conforming to specifications. It does not matter if the medical device is 21 mm or 29 mm; they are both conforming units. If a medical device’s diameter measures less than 20 mm or more than 30 mm, it is deemed as not conforming to specifications and is scrapped at a cost of $1,000.00 per device. Therefore, the "Voice of the Customer" states that the diameters of the medical devices must be between 20 mm and 30 mm, inclusive, with an ideal diameter of 25 mm.

In this section, you assumed that there is a reasonable target from which deviations on either side are possible. For situations in which there is only one specification limit—such as time to deliver mail in hours, with the target of 0 hours and an upper specification limit of 5 days—the objective is not to exceed the upper specification, and to deliver the mail on a very consistent basis (little variation) to create a highly predictable mail delivery process. In other words, whether there are two-sided specifications or a one-sided specification, the goal is to have increased consistency, implying minimal variation in performance and, thus, increased predictability and reliability of outcomes.

Continuous Improvement View of Quality
A more modern definition of quality states that: "Quality is a predictable degree of uniformity and dependability, at low cost and suited to the market" [see Reference 1]. Figure 1.5 shows a more realistic loss curve in which losses begin to accumulate as soon as a quality characteristic of a product or service deviates from the nominal value. As with the "goal post" view of quality, once the specification limits are reached, the loss suddenly becomes positive and constant, regardless of the deviation from the nominal value beyond the specification limits.

The continuous improvement view of quality was developed by Genichi Taguchi [see Reference 10]. The Taguchi Loss Function, called the Loss curve in Figure 1.5, expresses the loss of deviating from the nominal within specifications: the left-hand vertical axis is "loss" and the horizontal axis is the measure, y, of a quality characteristic. The loss associated with deviating (y – m) units from the nominal value, m, is:

L(y) = k(y – m)2 = Taguchi Loss Function (1.1)

where

y = the value of the quality characteristic for a particular item of product or service.

m = the nominal value for the quality characteristic.

k = a constant, A/d2.

A = the loss (cost) of exceeding specification limits (e.g., the cost to scrap a unit of output).

d = the allowable tolerance from the nominal value that is used to determine specification limits.


Figure 1.5 Continuous Improvement View of Losses of Deviations from Nominal

Under this Taguchi Loss Function, the continuous reduction of unit-to-unit variation around the nominal value is the most economical course of action, absent capital investment (more on this later). In Figure 1.5, the righthand vertical axis is "Probability" and the horizontal axis is the measure, y, of a quality characteristic. The distribution of output from a process before improvement is shown in Curve A, while the distribution of output after improvement is shown in Curve B. The losses incurred from unit-to-unit variation before process improvement (the lined area under the loss curve for Distribution A) is greater than the losses incurred from unit-to-unit variation after process improvement (the hatched area under the loss curve for Distribution B). This definition of quality promotes continual reduction of unit-to-unit variation (uniformity) of output around the nominal value, absent capital investment. If capital investment is required, then an analysis must be conducted to determine if the benefit of the reduction in variation in the process justifies the cost. The capital investment for a process improvement should not exceed the single lined area under the Taguchi Loss Function in Curve A, but not in Curve B, in Figure 1.5. This modern definition of quality implies that the Voice of the Process should take up a smaller and smaller portion of the Voice of the Customer (specifications) over time, rather than just being inside of the specification limits. The logic here is that there is a loss associated with products or services that deviate from the nominal value, even when they conform to specifications.

To illustrate the continuous definition of quality, return to the example of the medical device that is to be inserted into a patient’s chest. Every millimeter higher or lower than 25 mm causes a loss that can be expressed by the following Taguchi Loss Function:

L(y) = k(y – m)2 = (A/d2)(y – m)2 = ($1,000/[52])(y – 25mm)2 = (40)(y – 25mm)2

if 20 ≤ y ≤ 30

L(y) = $1,000 if y <> 30

Table 1.1 shows the values of L(y) for values of the quality characteristic (diameter of the medical device).

Table 1.1 Loss Arising from Deviations in Diameters of the Medical Device

Diameter of the Medical Device (y)
Value of Taguchi Loss Function (L[y])

18
1,000

19
1,000

20
1,000

21
...640

22
...360

23
...160

24
...40

25
...0

26
..40

27
...160

28
...360

29
...640

30
1,000

31
1,000

32
1,000



Under the loss curve shown in Table 1.1, it is always economical to continuously reduce the unit-to-unit variation in the diameter of medical devices, absent capital investment. This will minimize the loss of surgically inserting medical devices.

If a Taguchi Loss Function has only one specification limit, such as an upper specification limit, the preceding discussion applies without loss of generality. For example, if in the opinion of customers, 30 seconds is the maximum acceptable time to answer phone calls at a customer call center and the desired time is 0 seconds, any positive deviation will result in loss to the customer. Moreover, the greater the process variation (above the nominal time of 0), the greater the loss to the customer. In the case where there is no natural nominal value (e.g., 0 seconds), deviation between the process average and the desired time results in a process bias. The loss function can be used to show in these cases that the loss is a function of the bias squared plus the process variation. This implies that the goal is to eliminate the bias (i.e., move the process average toward the desired time) and to reduce process variation. For example, customer call centers not only wish to reduce their time to answer phone calls from their customers, but they want to have uniformly short answer times. Why? When management determines staffing requirements for the customer call center, it needs to be able to have enough staff to meet its specification for time-to-answer. The more variation in the time-to-answer per call, the more unpredictable the process, and the less confidence management will have in its staffing model. Management may actually overstaff to ensure it meets its specifications. This introduces more cost to the customer call center, which is indirectly passed on to the customer.

Definitions of Six Sigma Management (Relationship Between VoC and VoP)
Non-Technical Definitions of Six Sigma Management
Six Sigma management is the relentless and rigorous pursuit of the reduction of variation in all critical processes to achieve continuous and breakthrough improvements that impact the bottom line and/or top line of the organization and increase customer satisfaction. Another common definition is that Six Sigma management is an organizational initiative designed to create manufacturing, service, and administrative processes that produce a high rate of sustained improvement in both defect reduction and cycle time (e.g., when Motorola began its effort, the rate it chose was a 10-fold reduction in defects in two years, along with a 50% reduction in cycle time). For example, a bank takes an average of 60 days to process a loan with a 10% rework rate in 2004. In a Six Sigma organization, the bank should take no longer than an average of 30 days to process a loan with a 1% error rate in 2006, and no more than an average of 15 days to process a loan with a 0.10% error rate by 2008. Clearly, this requires a dramatically improved/innovated loan process.

Technical Definitions of Six Sigma Management
The Normal Distribution. The term Six Sigma is derived from the normal distribution used in statistics. Many observable phenomena can be graphically represented as a bell-shaped curve or a normal distribution [see Reference 3], as illustrated in Figure 1.6.


Figure 1.6 Normal Distribution with Mean (μ) and Standard Deviation (σ)

When measuring any process, its outputs (services or products) vary in size, shape, look, feel, or any other measurable characteristic. The typical value of the output of a process is measured by a statistic called the mean or average. The variability of the output of a process is measured by a statistic called the standard deviation. In a normal distribution, the interval created by the mean plus or minus 2 standard deviations contains 95.44% of the data values; 45,600 data values per million are outside of the area created by the mean plus or minus 2 standard deviations (45,600 = 1,000,000 x [4.56% = 100% – 95.44%]). In a normal distribution, the interval created by the mean plus or minus 3 standard deviations contains 99.73% of the data; 2,700 defects per million opportunities are outside of the area created by the mean plus or minus 3 standard deviations (2,700 = 1,000,000 x[0.27% = 100% – 99.73%]). In a normal distribution, the interval created by the mean plus or minus 6 standard deviations contains 99.9999998% of the data; 2 data values per billion data values are outside of the area created by the mean plus or minus 6 standard deviations (2 = 1,000,000,000 x [0.0000002% = 100% – 99.9999998%]).

Relationship Between VoP and VoC. Six Sigma promotes the idea that the distribution of output for a stable normally distributed process (Voice of the Process) should be designed to take up no more than half of the tolerance allowed by the specification limits (Voice of the Customer). Although processes may be designed to be at their best, you assume that the processes may increase in variation over time. This increase in variation may be due to small variation with process inputs, the way the process is monitored, changing conditions, etc. The increase in process variation is often assumed to be similar to temporary shifts in the underlying process mean. In practice, the increase in process variation has been shown to be equivalent to an average shift of 1.5 standard deviations in the originally designed and monitored process. If a process is originally designed to be twice as good as a customer demands (i.e., the specifications representing the customer requirements are 6 standard deviations from the process target), then even with a shift in the Voice of the Process, the customer demands are likely to be met. In fact, even if the process mean shifted off target by 1.5 standard deviations, there are 4.5 standard deviations between the process mean and closest specification limit, resulting in no more than 3.4 defects per million opportunities (dpmo). In the 1980s, Motorola demonstrated that in practice, a 1.5 standard deviation shift was what was observed as the equivalent increase in process variation for many processes that were benchmarked.

Figure 1.7 shows the "Voice of the Process" for an accounting function with an average of 7 days, a standard deviation of 1 day, and a stable normal distribution. It also shows a nominal value of 7 days, a lower specification limit of 4 days, and an upper specification limit of 10 days. The accounting function is referred to as a 3-sigma process because the process mean plus or minus 3 standard deviations is equal to the specification limits; in other terms, USL= μ + 3σ and LSL = μ – 3σ. This scenario will yield 2,700 defects per million opportunities, or one early or late monthly report in 30.86 years [(1/0.0027)/12].


Figure 1.7 Three Sigma Process with 0.0 Shift in the Mean

Figure 1.8 shows the same scenario as in Figure 1.7, but the process average shifts by 1.5 standard deviations (the process average is shifted down or up by 1.5 standard deviations [or 1.5 days] from 7.0 days to 5.5 days or 8.5 days) over time. This is not an uncommon phenomenon. The 1.5 standard deviation shift in the mean results in 66,807 defects per million opportunities at the nearest specification limit, or one early or late monthly report in 1.25 years [(1/.066807)/12], if the process average moves from 7.0 days to 5.5 days or from 7.0 days to 8.5 days. In this discussion, only the observations outside the specification nearest the average are considered.


Figure 1.8 Three Sigma Process with a 1.5-Sigma Shift in the Mean

Figure 1.9 shows the same scenario as Figure 1.7, but the Voice of the Process takes up only half the distance between the specification limits. The process mean remains the same as in Figure 1.7, but the process standard deviation has been reduced to one half-day through application of process improvement. In this case, the resulting output will exhibit two defects per billion opportunities, or one early or late monthly report in 41,666,667 years [(1/.000000002)/12].

Figure 1.10 shows the same scenario as Figure 1.9, but the process average shifts by 1.5 standard deviations (the process average is shifted down or up by 1.5 standard deviations [or 0.75 days = 1.5 x 0.5 days] from 7.0 days to 6.25 days or 7.75 days) over time. The 1.5 standard deviation shift in the mean results in 3.4 defects per million opportunities at the nearest specification limit, or one early or late monthly report in 24,510 years [(1/.0000034/12]. This is the definition of 6-sigma level of quality.

Another Look at the 1.5-Sigma Shift in the Mean. The engineer responsible for creating the concept of Six Sigma at Motorola was Bill Smith. Bill Smith indicated that product failures in the field were shown to be statistically related to the number of product reworks and defect rates observed in production. Therefore, the more "defect and rework free" a product was during production, the more likely there would be fewer field failures and customer complaints. Additionally, Motorola had a very strong emphasis on total cycle time reduction. A business process that takes more steps to complete its cycle increases the chance for changes/unforeseen events, and the opportunity for defects. Therefore, reducing cycle time is best accomplished by streamlining the process, removing non-value added effort, and as a result, reducing the opportunities for making mistakes (defects). What a concept! Reducing cycle time by simplifying a process will result in fewer defects, lower remediation/warranty/service costs, and ultimately increased customer satisfaction with the results. This last concept is not new to those who are familiar with Toyota production system concepts, Just-In-Time philosophy, or what many call "Lean Thinking." Six Sigma practitioners concern themselves with reducing the defect or failure rate while Lean practitioners concern themselves with streamlining processes and reducing cycle time. Defect reduction and lean thinking are "flip sides" of the "same coin." The integrated strategy of considering both sides at the same time was the basis of the original work in Six Sigma.