UNIVERSITI TEKNIKAL MALAYSIA, MELAKA

QUALITY IMPROVEMENT USING SIX SIGMA CONCEPTS IN INJECTION MOULDING MANUFACTURING

Thesis submitted in accordance of with the requirement of the Universiti Teknikal Malaysia Melaka for the Degree of Bachelor of Engineering (Honours)

Manufacturing (Manufacturing Process)

By
SURESH S/O VASU B050510019

Faculty of Manufacturing Engineering April 2008

ABSTRACT

This thesis has focused on the quality improvement of major defect injection moulding assembly line in the ALPS MALYSIA Sdn.Bhd. The objectives of this thesis were to identify current quality problem and to improve major quality problem in the 30 tone injection moulding operation department using Six-Sigma DMAIC methodology. In order to analyze the data some of Statistical Quality Control (SQC) tools were used such as pareto chart, histogram, cause and effect diagram and control chart. The main defects in the assembly line determined and proper tool is used to analyze the quality problem. Major defects were highlighted and analyzed. Root causes for the problems were determined and suggestions for improvement were suggested. After the improvement stage, suggestions for control the quality also were suggested.

ABSTRAK

Tesis ini bertujuan untuk memperbaiki kualiti pada produk yang di hasilkan melaui proses injection moulding di ALPS MALAYSIA Sdn.Bhd. Objektif tesis ini adalah, untuk mengenalpasti masalah kualiti yang dihadapi pada masa kini di kawasan kajian dan seterusnyamemperbaiki masalah tersebut dengan menggunakan metodologi enam-sigma(DMAIC). Untuk menganalisa data yang diperbaiki, beberapa komponen-komponen kawalan kualiti secara statistik (SQC) seperti rajah pareto, histogram, rajah sebeb dan akibat dan rajah kawalan. Masalah-masalah kualiti yang wujud pada produk yang dihasilkan dikesan. Daripada masalah-masalah ini masalah utama akan dikenalpasti dan dianalisis. Sebab-sebab utama masalah tersebut berlaku dan cadangan untuk memperbaiki masalah tersebut akan dicadangkan. Selepas itu, cadangan untuk mengawal kualiti pada produk siap juga akan dicadangkan.

CHAPTER 1
INTRODUCTION

1.1

Project Background

Quality has become one of the most important competitive strategic tools which many organizations have realized it as a key to develop products and services in supporting continuing success. Quality system is designed to set a clear view for organization to follow enabling understanding and involvement of employees proceeding towards common goal.

The aim of business is long term profitability. Over a considerable length of time, earning is achieved by pleasing customers with good products or services while keeping production cost at a minimum. The use of quality tools and technique provides long term dividends through lower costs and productivity improvements.

As competition increases and changes occur in the business world, one should need to have a better understanding of quality. Quality concerns affect the entire organization in every competitive environment. Consumer demands high quality level of product or services at reasonable prices to achieve value and customers satisfaction.

There is an increasing focus on quality throughout the world. With increased competition, companies have recognized the importance of quality system implementation in maintaining effectiveness in a volatile business environment. Specifically meeting the needs and desired of the customers is critical and must be done much better and efficiently than it has done in the past.

Total Quality Management (TQM) is one of the most common quality management practices in todays industrial environment. TQM refer to the broad set of management and control processes designed to focus an entire organization and all of its employees on providing products or services that do the best possible job of satisfying the customer. According to Sashkin and Kiser (1993), TQM means that the organizations culture is defined by, supports, the constant attainment of customer satisfaction through an integrated system of tools, techniques, and training. This involves the continuous improvement of organizational process, resulting in high quality products and services.

Thus, the TQM philosophy of management is customer-focused. TQM incorporates the concepts of product quality, process control, quality assurance, and quality improvement. Some advise that customer satisfaction is the driving force behind quality improvement; other suggest quality management is achieved by internal productivity or cost improvement programs; and still others consider TQM as mean to introduce participatory management. In general, the Japanese concentrate on customer satisfaction with a particular focus on understanding customer needs and expectations.

Besides TQM there are other quality system used to improve quality such as Lean and Six Sigma. These two are related, but distinct. Among the several quality management concepts that have been developed, the lean concept, as in lean manufacturing, lean production, etc. is one of the more wide-spread and successful attempts. Briefly, lean is about controlling the resources in accordance with the customers needs and to reduce unnecessary waste (including the waste of time). The concept was introduced at a larger scale by Toyota in the 1950s, but not labeled lean manufacturing until the now famous book about the automobile appeared in 1990 (Womack et al., 1990). While there are many formal definitions of the lean concept, it is generally understood to represent a systematic approach to identifying and eliminating elements not adding value to the process. Consequences of this are striving for perfection and a customer-driven pull of the process.

Meanwhile, most recent quality philosophy to be adopted by businesses around the world is known as Six Sigma. The founder of the Six Sigma philosophy is Mikel Harry (Harry and Schroeder, 2000). Mikel Harry developed and implemented his Six Sigma philosophy with the Motorola Corporation and the philosophy has had great success at the GE Corporation (Harry and Schroeder, 2000). Six sigma focuses on the reduction and removal of variation by the application of an extensive set of statistical tools and supporting software. This powerful business management strategy has been exploited by many world class organizations such as General Electric (GE), Motorola, Honeywell, Bombardier, ABB, Sony, to name a few from the long list. Six sigma applications in the service sector are still limited although it has been embraced by many big service oriented companies such as J P Morgan, American Express, Lloyds TSB, Egg, City Bank, Zurich Financial Services, BT, etc.

Six sigma today has evolved from merely a measurement of quality to an overall business improvement strategy for a large number of companies around the world. The concept of six sigma was introduced by Bill Smith in 1986, a senior engineer and scientist within Motorolas communication Division, in response to problems associated with high warranty claims. The success of the efforts at Motorola was not just achieving six sigma quality level rather the focus was on reducing defect rate in processes through the effective utilization of powerful and practical statistical tools and techniques. This would lead to improved productivity, improved customer satisfaction, enhanced quality of service, reduced cost of operations or costs of poor quality, and so on.

This thesis mainly focused on six sigma quality philosophy and other related philosophy that would be implemented in these studies in order to identify the current problem or rejection criteria facing by the company. The Six Sigma philosophy used because, it provides a step-by-step quality improvement methodology that uses statistical methods to quantify variation. An extensive on related literature reviews was carried in order to enhance more knowledge on the related study field.

1.2

Problem Statement

Currently in Alps Electric Parts Production Department which produce Plastic product for Electronic Component especially Remote Control as main business facing many rejection problem. The main defect cause this rejection is Black dot on the appearance of the product. There are also some other causes that lead to rejection such as part breakage, scratches, oily surface, white mark silver mark, parting burr and etc. In order to study the problem a research has carried out with help of an engineer by study the literature review on TQM, Six Sigma and PDCA philosophies and other reference for this analysis and research method.

1.3

Objectives

The objectives of this thesis are: To utilize six sigma methodology in performing the study. To study the black dot rejects utilizing QC tools at the identified assembly lines. To identify the root causes of the black dot rejects To recommend actions to improve the black dot rejects and sigma level.

1.4

Scope Of Project

The scope of the study is limited to part production 30 tone assembly lines only and the analysis is focused on major defect only. Six Sigma DMAIC methodologies will be used where DMA is applied and IC will be suggested to the company. The data will be collected for the assembly line for six month period from May 07 to October 07.

1.5

Report outline

Chapter 1 gives an introduction to the projects which are including objectives, scope, and background. In this chapter, it describes the background of quality problem as the case study of Company.

Chapter 2 presents the literature review on concepts of TQM, Six-Sigma Quality, and what the correlation about DMAIC with other Quality Improvement approaches (PDCA). It also presents some quality tools that incorporate with the study.

Chapter 3 describes the company background and the description of the methodology used in this project.

Chapter 4 presents the data analysis using Six-Sigma methodology. In this chapter the collected data from the case Study Company was analyzed stage by stage. First, the analysis starts with Define stage, which is continued with Measurement stage and then followed by Analyze stage. After analyze the problem based on the data collected, and then we go to the Improve stage and culminate with Control stage.

Chapter 5 presents the conclusions of the whole project and suggestions for future work.

CHAPTER 2
LITERATURE REVIEW

2.1

Introduction

Literature review includes study and research of published materials like journals, thesis, case studies, technical documents and online library. Generally, the purpose of a review is to analyze critically a segment of a published body of knowledge through summary, classification and comparison of prior research studies, reviews of literature, and theoretical articles. This chapter will describe topics that related to quality such as Total Quality Management, Quality Management Philosophies, SixSigma methodology, ISO 9000, Lean manufacturing, concept of quality, quality tools and other relevant quality topics. Emphasizes is more on six sigma methodology since the study conducted in a Six Sigma manner.

Besides that, this chapter also includes review on injection moulding process which currently applied by the studied company and the types of defects that frequently occurs in the production line.

2.2

Definitions of quality

In the Websters New World Dictionary, quality is defined as physical or nonphysical characteristic that constitutes the basic nature of a thing or is one of its distinguishing features.

Shewhart (1980), mention that there are two common aspects of quality; one of these has to do with the consideration of the quality of a thing as an objective reality independent of the existing of man. The other has to do with what we think, feel or sense as a result of the objective reality. This subjective side of quality is closely linked to value. It is convenient to think of all matters related to quality of manufactured product in terms of these three functions of specification, production and inspection. (Grant and Leavenworth, 1988).

Quality is fitness for use, (Juran, 1989). Quality is conformance to requirements (Crosby, 1986) and quality should be armed at the needs of the customer present and future (Deming, 1986).

Feigenbaum (1983) said that quality is the total composite product and service characteristics of marketing, engineering, manufacture and maintenance through which he product and service in use will meet the expectations of the customer. Mizuno (1988) mention that product quality encompasses those characteristics which the product most posses if it is to be used in the intended manner. Actually, quality can take many forms. All the definitions mentioned above can be classified into three types. They are quality of design, quality of conformance and quality of performance. Quality of design means that the product has been designed to successfully fill a consumer need, real or perceived. Quality of conformance refers to the manufacture of the product or the provision of the service that meets the specific requirements that set by customer. Finally, quality of performance brings out the definitions that the product or service performance its intended function as identified by the customer.

2.3

Quality Management Philosophies

More managers than ever before are focusing on quality as a way of increasing productivity, reducing costs, and meeting customer needs. These managers are

beginning to understand the importance of continuously improving the quality of their services and products as a means of achieving these goals. Those who begin to learn about quality quickly become familiar with the names of Philip B. Crosby, W.Edwards Deming, and Joseph M. Juran--renowned quality experts--who have been carrying forth the message of quality for more than 30 years. At an age when most people have retired, Philip B. Crosby and Joseph M. Juran continue an untiring pace of work conducting seminars, consulting with clients, and writing new texts. They have devoted their lives to helping organizations improve the quality of their products and services. Their influence is now worldwide and their accomplishments are legendary in the discipline.

2.3.1 The Deming Philosophy

W. Edwards Deming was originally trained as a statistician, and much of his philosophy can be traced to these roots. He worked for Western Electric during its pioneering era of statistical quality control development in the 1920s and 1930s. During World War II, he taught quality control courses as part of the national defense effort. Deming began teaching statistical quality control in Japan shortly after Word War II a is credited with having been an important contributor to the Japanese quality improvement programs. In fact, the highest award for quality improvement in Japan is called the Deming Prize. While Japan embraced his methods for 30 years, he was virtually unknown in the United States until 1980.

Deming focuses on the improvement of product and service conformance to specifications by reducing uncertainty and variability in the design and manufacturing process. In Deming's view, variation is the chief culprit of poor quality. In mechanical assemblies, for example, variations from specifications for part dimensions lead to inconsistent performance and premature wear and failure. Likewise, inconsistencies in service frustrate customers and hurt the reputation of the company. To achieve reduction of variation refines a never-ending cycle of product design, manufacture, test, and sales, followed by market surveys, then redesign, and

so forth. Deming claims that higher quality leads to higher productivity, which in turn leads to long-term competitive advantage. The Deming "chain reaction" theory summarizes this view; the theory states that process improvements lead to lower costs due to less rework, fewer mistakes, delays and snags, and more efficient use of materials. Lower costs, in turn, lead to productivity improvements. With better quality and lower prices, the firm can achieve a greater or larger market share and remain competitive and provide more meaningful and rewarding jobs. Upper management needs to recognize the benefits of quality as a strategic factor and strive to create a culture that supports empowerment, continuous improvement and customer satisfactions. Deming stresses that top management has the overriding responsibility for quality improvement (Deming, 1986)

2.3.1.1 Deming's 14 Points for Management

1. Create and publish to all employees a statement of the aims and purposes of the company or other organization. Management must demonstrate constantly their commitment to this statement 2. 3. Learn the new philosophy throughout all areas everybody. Understand the purpose of inspection. It should evaluate process improvements and cost reductions. 4. 5. 6. 7. 8. 9. End the practice of awarding business on the basis of price alone Improve constantly and forever the system of production and service Institute training Teach and institute leadership Drive out fear. Create trust. Create a climate for innovation Optimize all efforts toward the aims and purposes of the company.

10. Eliminate exhortations for the work force 11. (a) Eliminate numerical quotas for production Instead learn and institute methods for improvement (b) Eliminate management by objectives (MBO). Instead, learn the capabilities of processes, and how to improve them.

12. Remove barriers that rob people of pride of workmanship. 13. Encourage education and self-improvement for everyone. 14. Take action to accomplish the transformation

2.3.2 Jurans Quality Trilogy

Dr. J. M. Juran, whose impact on the quality movement in Japan, was second only to Demings, developed a useful framework to what referred to as "a universal thought process-a universal way of thinking about quality, which fits all functions all levels, all product lines. He called it the "quality trilogy: The underlying concept of the quality trilogy is that managing for quality consists of three basic quality oriented processes: Quality planning Quality control Quality improvement

The starting point is quality planning which involves creating a process that will be able to established goals. Once the process is turned over to the operating forces, their responsibility is to run the process at optimal effectiveness and take corrective action when the process or product does not conform to established specifications.

Finally, quality improvement is "the process for breaking through to unprecedented levels of performance. But quality improvement does not happen of its own accord. It results from purposeful action taken by upper management to introduce a new managerial approach throughout the organization of quality improvement process. This quality improvement process is super-imposed on the quality control process. It is implemented in addition to quality control, not instead of it. Juran's approach is essentially the same as Demings. Quality is a management responsibility that needs to be performed systematically to achieve continuous improvement over time.

This is the same basic idea behind the so-called PDCA cycle, known in Japan as the Deming wheel, which is considered to be the essence of the Japanese approach to total quality control:

Plan: The basic planning process described by Juran. Do: The implementation of the plan. Check: Evaluation of performance according to critical measures appropriate methods

Act: Quality improvement efforts based on the lessons learned from experiences. These experiences feed into the new plan, since PDCA is a cyclical process (Costin, 1994)

2.3.3 The Crosby philosophy

Philip B. Crosby was corporate vice president for quality at International Telephone and Telegraph (ITT) for 14 years after working his way up from line inspector. After that he e established Philip Crosby Associates in 1979 to develop and offer training programs related to quality. He is also the author of several popular books. His first book, Quality is Free published in 1979, sold about one million copies.

The essence of Crosby's quality philosophy is embodied in what he calls the "Absolutes of' Quality Management and the Basic Elements of Improvement." Crosby's Absolutes of Quality Management areas follow: Quality means conformance to requirement, not elegance There is no such thing as quality problem only opportunities to improve. There is no such thing as the economics of quality; it always cheaper to do the job right the first time. The only performance measurement is the cost of quality approach. The only performance standard is Zero Defect

Crosby's Basic Elements of Improvement include determination, education, and implementation. By determination, Crosby means that top management must be serious about quality improvement. The Absolutes should be understood by everyone; this can be accomplished only through education. Finally, every member of the management team must understand the implementation process. (Evans & Lindsay,1993).

2.4

Introduction and Implementation of Total Quality Management

(TQM)
Total Quality Management is a management approach that originated in the 1950's and has steadily become more popular since the early 1980's. Total Quality is a description of the culture, attitude and organization of a company that strives to provide customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company's operations, with processes being done right the first time and defects and waste eradicated from operations.

Total Quality Management, TQM, is a method by which management and employees can become involved in the continuous improvement of the production of goods and services. It is a combination of quality and management tools aimed at increasing business and reducing losses due to wasteful practices. Some of the companies who have implemented TQM include Ford Motor Company, Phillips Semiconductor, SGL Carbon, Motorola and Toyota Motor Company (Gilbert, 1992).

2.4.1

TQM Definination

TQM is a management philosophy that seeks to integrate all organizational functions such as marketing, finance, design, engineering, and production, customer service, etc. to focus on meeting customer needs and organizational objectives.

TQM views an organization as a collection of processes. It maintains that organizations must strive to continuously improve these processes by incorporating the knowledge and experiences of workers. The simple objective of TQM is "Do the right things, right the first time, every time". TQM is infinitely variable and adaptable.

Although originally applied to manufacturing operations, and for a number of years only used in that area, TQM is now becoming recognized as a generic management tool, just as applicable in service and public sector organizations. There are a number of evolutionary strands, with different sectors creating their own versions from the common ancestor.

TQM is the foundation for activities, which include commitment by senior management and all employees, meeting customer requirements, reducing development cycle times, Just In Time/ Demand flow manufacturing and improvement teams. This shows that all personnel, in Manufacturing, Marketing, Engineering, R&D, Sales, Purchasing, HR, etc must practice TQM in all activities. (Hyde,1992).

2.4.2 Implementation Principles and Processes of TQM

A preliminary step in TQM implementation is to assess the organization's current conditions. Relevant preconditions have to do with the organization's history, its current needs, precipitating events leading to TQM, and the existing employee quality of working life. If the current reality does not include important preconditions, TQM implementation should be delayed until the organization is in a state in which TQM is likely to succeed.

If an organization has a track record of effective responsiveness to the environment, and if it has been able to successfully change the way it operates when needed, TQM will be easier to implement. If an organization has been historically reactive and has

little skill at improving its operating systems, there will be both employee skepticism and a lack of skilled change agents. If this condition prevails, a comprehensive program of management and leadership development may be instituted. A management audit is a good assessment tool to identify current levels of organizational functioning and areas in need of change. An organization should be basically healthy before beginning TQM. If it has significant problems such as a very unstable funding base, weak administrative systems, lack of managerial skill, or poor employee morale, TQM would not be appropriate (Tichey, 1993).

However, a certain level of stress is probably desirable to initiate TQM. People need to feel a need for a change. Kanter (1983) addresses this phenomenon as building blocks, which are present in effective organizational change. These forces include departures from tradition, a crisis or galvanizing event, strategic decisions, individual "prime movers," and action vehicles. Departures from tradition are activities, usually at lower levels of the organization, which occur when entrepreneurs move outside the normal ways of operating to solve a problem. A crisis, if it is not too disabling, can also help create a sense of urgency, which can mobilize people to act. In the case of TQM, this may be a funding cut or threat, or demands from consumers or other stakeholders for improved quality of service. After a crisis, a leader may intervene strategically by articulating a new vision of the future to help the organization deal with it. A plan to implement TQM may be such a strategic decision. Such a leader may then become a prime mover, who takes charge in championing the new idea and showing others how it will help them get where they want to go. Finally, action vehicles are needed and mechanisms or structures to enable the change to occur and become institutionalized (Smith, 1999).

2.4.3 Summary for TQM

TQM encourages participation amongst shop floor workers and managers. There is no single theoretical formalization of total quality, but Deming, Juran and Ishikawa provide the core assumptions, as a:

"...discipline and philosophy of management which institutionalizes planned and continuous improvement ... and assumes that quality is the outcome of all activities that take place within an organization; that all functions and all employees have to participate in the improvement process; that organizations need both quality systems and a quality culture."

2.5

Six-Sigma Quality

Six-Sigma refers to the philosophy and methods companies such as General Electric and Motorola use to eliminate defects in their products and processes. A defect is simply any component that does not fall within the customers specification limits. Each step or activity in a company represents an opportunity for defects to occur and Six-Sigma programs seek to reduce the variation in the processes that lead to these defects. Indeed, Six-Sigma advocates see variation as the enemy of quality and much of the theory underlying Six-Sigma is devoted to dealing with this problem. A process that is in Six-Sigma control will produce no more than 3.4 defects out of every million units.

One of the benefits of Six-Sigma thinking is that it allows managers to readily describe the performance of a process in terms of its variability and to compare different processes using a common metric. This metric is defects per million opportunities (DPMO). (Raisinghani,M.S 2005).This calculation requires three pieces of data: Unit: The item produced or being serviced. Defect: Any item or event that does not meet the customers requirements. Opportunity: A chance for a defect to occur.

A straightforward calculation is made using the following formula:

DPMO =

Number of defects X 1,000,000 Number of opportunities for error per unit x Number of unit

2.5.1 Six-Sigma methodology

Six Sigmas methods include many of the statistical tools that were employed in other quality movements, Six-Sigma is employed in a systematic project-oriented fashion through define, measure, analyze, improve, and control (DMAIC) cycle. The DMAIC cycle is a more detailed version of the Deming PDCA cycles, which consists of four steps Plan, Do, Check, and Act within continuous improvement.

Continuous improvement, also called Kaizen, seeks continual improvement of machinery, materials, labor utilization, and production methods through application of suggestions and ideas of company teams. Like Six Sigma, it also emphasizes the scientific method, particularly hypothesis testing about the relationship between process inputs (Xs) and outputs (Ys) using design of experiments (DOE) methods. The availability of modern statistical software has reduced the drudgery of analyzing and displaying data and is now part of the Six-Sigma tool kit. The overarching focus of the methodology, however is, understanding and achieving what the customer wants, since that is seen as the key to profitability of a production process. In fact, to get across this point, some use the DMAIC as an acronym for Dumb Managers Always Ignore Customers.

The standard approach to Six-Sigma projects is the DMAIC methodology developed by General Electric (G.E). The DMAIC methodology is central to Six Sigma process improvement projects. The following phases provide a problem-solving process in which specific tools are employed to turn a practical problem into a statistical problem, generate a statistical solution and then convert that back into a practical solution (Henderson, Evans and et al, 2000).

2.5.1.1 Define (D)

The purpose of the Define phase is to clearly identify the problem, the requirements of the project and the objectives of the project. The objectives of the project should focus on critical issues, which are aligned with the companys business strategy and the customers requirements. The Define phase includes: Define customer requirements as they relate to this project. Explicit customer requirements are called Critical-to-Quality (CTQ)

characteristics; Develop defect definitions as precisely as possible; Perform a baseline study (a general measure of the level of performance before the improvement project commences); Create a team charter and Champion; Estimate the financial impact of the problem; and Obtain senior management approval of the project

Some of the key questions addressed in this stage are: What matters to the customers? What Defect are we trying to reduce? By how much and by when? What is the current Cost of defects? Who will be in the project team? Who will support us to implement this project? The most applicable tools in this phase are the following: Project Charter - this document is intended to clearly describe the problem, defects definitions, team information and deliverables for a proposed project and to obtain agreement from key stakeholders. Trend Chart - to see (visually) the trend of defect occurrence over a period of time. Pareto Chart - to see (visually) how critical each input is in contributing negatively or positively to total output or defects.

 Process Flow Chart - to understand how the current processes functions and the flow of steps in current process

2.5.1.2 Measure (M)

The purpose of the Measure phase is to fully understand the current performance by identifying how to best measure current performance and to start measuring it. The measurements used should be useful and relevant to identifying and measuring the source of variation. This phase includes:

Identifying the specific performance requirements of relevant Critical-toQuality

(CTQ) characteristics; Map relevant processes with identified Inputs and Outputs so that at each process step, the relevant Outputs and all the potential Inputs (X) that might impact each Output are connected to each other;

Generate list of potential measurements Analyze measurement system capability and establish process capability baseline;

Identify where errors in measurements can occur; Start measuring the inputs, processes and outputs and collecting the data; Validate that the problem exists based on the measurements; Refine the problem or objective (from the Analysis phase)

Some of the key questions addressed in this stage are: What is the Process? How does it function? Which Outputs affect CTQs most? Which Inputs affect Outputs (CTQs) most? Is our ability to measure/detect sufficient? How is our current process performing? What is the best that the process was designed to do?

The most applicable tools at this phase include the following: Fishbone Diagram to demonstrate the relationships between inputs and outputs Process Mapping - to understand the current processes and enables the team to define the hidden causes of waste. Preliminary Failure Mode & Effect Analysis (FMEA) - using this in the Measure phase helps to identify and implement obvious fixes in order to reduce defects and save costs as soon as possible. Gauge Repeatability & Reproducibility (GR&R) - used to analyze the variation of components of measurement systems so minimize any unreliability in the measurement systems.

2.5.1.3 Analyze (A)

In the Analyze phase, the measurements collected in the Measure phase are analyzed so that hypotheses about the root causes of variations in the measurements can be generated and the hypothesis subsequently validated. It is at this stage that practical business problems are turned into statistical problems and analyzed as statistical problems. This includes: generate hypotheses about possible root causes of variation and potential critical Inputs (Xs); identify the vital few root causes and critical inputs that have the most significant impact; and Validate these hypotheses by performing Multivariate analysis.

Some of the key questions addressed in this stage are: Which Inputs actually affect our Critical to qualitys most (based on actual data)? By how much?

 Do combinations of variables affect outputs? If input is changed, does the output really change in the desired way? How many observations are required to draw conclusions? What is the level of confidence? The Analyze phase offers specific statistical methods and tools to isolate the key factors that are critical for a comprehensive understanding of the causes of defects: Tests for normality (Descriptive Statistics, Histograms) this is used to determine if the collected data is normal or abnormal so as to be properly analyzed by other tools. Correlation/Regression Analysis - to identify the relationship between process inputs and outputs or the correlation between two different sets of variables. Analysis of Variances (ANOVA) - this is an inferential statistical technique designed to test for significance of the differences among two or more sample means. FMEA (Failure Mode and Effect Analysis) - applying this tool on current processes enables identification of sufficient improvement actions to prevent defects from occurring. Hypothesis testing methods - these are series of tests in order to identify sources of variability using historical or current data and to provide objective solutions to questions, which are traditionally answered subjectively. Cause & Effect Matrix - to quantify how significant each input is for causing variation of outputs.

2.5.1.4 Improve (I)

The Improve phase focuses on developing ideas to remove root causes of variation, testing and standardizing those solutions. This involves:



identify ways to remove causes of variation; verify critical Inputs; discover relationships between variables; establish operating tolerances which are the upper and lower specification limits (the engineering or customer requirement) of a process for judging acceptability of a particular characteristic, and if strictly followed will result in defect-free products or services;

Optimize critical Inputs or reconfigure the relevant process.

Some of the key questions addressed in this stage are: Once we know for sure which inputs most affect our outputs, how do we control them? How many trials do we need to run to find and confirm the optimal setting/procedure of these key inputs? Who should the old process be improved and what is the new process? How much have Defects per Millions Opportunities (DPMO) decreased? The most applicable tools at this phase are: Process Mapping - this tool helps to represent the new process subsequent to the improvements. Process Capability Analysis (Cpk) - in order to test the capability of process after improvement actions have been implemented to ensure we have obtained a real improvement in preventing defects. DOE (Design of Experiment) - This is a planned set of tests to define the optimum settings to obtain the desired output and validate improvements.

2.5.1.5 Control (C)

The Control phase aims to establish standard measures to maintain performance and to correct problems as needed, including problems with the measurement system. This includes:



validate measurement systems; verify process long-term capability; Implement process control with control plan to ensure that the same problems dont reoccur by continually monitoring the processes that create the products or services.

Some of the key questions addressed in this stage are: Once defects have been reduced, how do we ensure that the improvement is sustained? What systems need to be in place to check that the improved procedures stay implemented? What do we set up to keep it going even when things change? How can improvements be shared with other relevant people in the company?

Most applicable tools at the Control phase include: Control Plans this is a single document or set of documents that outlines the actions, including schedules and responsibilities, which are needed to control the key process inputs variables at the optimal settings. Operating Flow Chart(s) with Control Points - this is a single chart or series of charts that visually display the new operating processes. Statistical Process Control (SPC) charts - these are charts that help to track processes by plotting data over time between lower and upper specification limits with a center line. Check Sheets - this tool enables systematic recording and compilation of data from historical sources, or observations as they happen, so that patterns and trends can be clearly detected and shown (Hagemeyer and Gershenson, 2005).

2.6

Analytical tools for Six-Sigma and continuous improvement

The analytical tools of Six-Sigma have been used for many years in traditional quality improvement programs. What makes their application to Six-Sigma unique is the integration of these tools in a corporate wide management system. The tools common to all quality efforts, including Six-Sigma, are flowcharts, run charts, Pareto charts, histograms, check sheets, cause-and-effect diagrams, and control charts. Examples of these, along with an opportunity flow diagram, are shown in Figure 2.1 to Figure 2.5 arranged according to DMAIC categories where they commonly appear.

1. Flow charts. There are many types of flow charts. The one shown in figure 2.1 depicts the process steps as part of a SIPOC (supplier, input, process, output and customer) analysis. SIPOC in essence is a formalized input-output model, used in the define stage of a project.

Figure 2.1: An example of SIPOC analysis diagram for Define stage (Hagemeyer,C. and Gershenson, J.K. (2005))

2. Run charts shown in the Figure 2.2A. They depict trends in data over time, and thereby help to understand the magnitude of a problem at the define stage. Typically, they plot the median of a process.

3. Pareto charts shown in the Figure 2.2C. These charts help to break down a problem into the relative contributions of its components. They are based on the common empirical finding that a large percentage of problems are due to a small percentage of causes. In the example, 80 percent of customer complaints are due to late deliveries, which are 20 percent of the causes listed.

4. Check sheets shown in Figure 2.2B. These are basic forms that help standardize data collection. They are used to create histograms such as shown on the Pareto chart.