ALLAMA IQBAL OPEN UNIVERSITY ISLAMABAD (Department of Business Administration) ASSIGNMENT No.

1 Course: Total Quality Management (890) Level: MBA 100 Q. 1 Discuss the concept of Total Quality Management and its importance in the business Semester: Spring 2011 Marks:

management. Critically discuss the role of gurus in the development of Total Quality Management The concept of quality has existed for many years, though its meaning has changed and evolved over time. In the early twentieth century, quality management meant inspecting products to ensure that they met specifications. In the 1940s, during World War II, quality became more statistical in nature. Statistical sampling techniques were used to evaluate quality, and quality control charts were used to monitor the production process. In the 1960s, with the help of so-called quality gurus, the concept took on a broader meaning. Quality began to be viewed as something that encompassed the entire organization, not only the production process. Since all functions were responsible for product quality and all shared the costs of poor quality, quality was seen as a concept that affected the entire organization. The meaning of quality for businesses changed dramatically in the late 1970s. Before then quality was still viewed as something that needed to be inspected and corrected. However, in the 1970s and 1980s many U.S. industries lost market share to foreign competition. In the auto industry, manufacturers such as Toyota and Honda became major players. In the consumer goods market, companies such as Toshiba and Sony led the way. These foreign competitors were producing lowerpriced products with considerably higher quality. To survive, companies had to make major changes in their quality programs.Many hired consultants and instituted quality training programs for their employees. A new concept of quality was emerging. One result is that quality began to have a strategic meaning. Today, successful companies understand that quality provides a competitive advantage. They put the customer first and define quality as meeting or exceeding customer expectations. Since the 1970s, competition based on quality has grown in importance and has generated tremendous interest, concern, and enthusiasm. Companies in every line of business are focusing on improving quality in order to be more competitive. In many industries quality excellence has become a standard for doing business Companies that do not meet this standard simply will not survive. 1

Quality Gurus To fully understand the TQM movement, we need to look at the philosophies of notable individuals who have shaped the evolution of TQM. Their philosophies and teachings have contributed to our knowledge and understanding of quality today. Walter A. Shewhart was a statistician at Bell Labs during the 1920s and 1930s. Shewhart studied randomness and recognized that variability existed in all manufacturing processes. He developed quality control charts that are used to identify whether the variability in the process is random or due to an assignable cause, such as poor workers or miscalibrated machinery. He stressed that eliminating variability improves quality. His work created the foundation for todays statistical process control, and he is often referred to as the grandfather of quality control. W. Edwards Deming is often referred to as the father of quality control. He was a statistics professor at New York University in the 1940s. After World War II he assisted many Japanese companies in improving quality. The Japanese regarded him so highly that in 1951 they established the Deming Prize, an annual award given to firms that demonstrate outstanding quality. It was almost 30 years later that American businesses began adopting Demings philosophy. A number of elements of Demings philosophy depart from traditional notions Deming outlined his philosophy on quality in his famous 14 Points. These points are principles that help guide companies in achieving quality improvement. The principles are founded on the idea that upper management must develop a commitment to quality and provide a system to support this commitment that involves all employees and suppliers. Deming stressed that quality improvements cannot happen without organizational change that comes from upper management. Joseph M. Juran After W. Edwards Deming, Dr. Joseph Juran is considered to have had the greatest impact on quality management. Juran originally worked in the quality program at Western Electric. He became better known in 1951, after the publication of his book Quality Control Handbook. In 1954 he went to Japan to work with manufacturers and teach classes on quality. Though his philosophy is similar to Demings, there are some differences. Whereas Deming stressed the need for an organizational transformation, Juran believes that implementing quality initiatives should not require such a dramatic change and that quality management should be embedded in the organization. One of Jurans significant contributions is his focus on the definition of quality and the cost of quality. Juran is credited with defining quality as fitness for use rather than simply conformance to specifications. As we have learned in this chapter, defining quality as fitness for use takes into 2

account customer intentions for use of the product, instead of only focusing on technical specifications. Juran is also credited with developing the concept of cost of quality, which allows us to measure quality in dollar terms rather than on the basis of subjective evaluations. Juran is well known for originating the idea of the quality trilogy: quality planning, quality control, and quality improvement. The first part of the trilogy, quality planning, is necessary so that companies identify their customers, product requirements, and overriding business goals. Processes should be set up to ensure that the quality standards can be met. The second part of the trilogy, quality control, stresses the regular use of statistical control methods to ensure that quality standards are met and to identify variations from the standards. The third part of the quality trilogy is quality improvement. According to Juran, quality improvements should be continuous as well as breakthrough. Together with Deming, Juran stressed that to implement continuous improvement workers need to have training in proper methods on a regular basis. Armand V. Feigenbaum Another quality leader is Armand V. Feigenbaum, who introduced the concept of total quality control. In his 1961 book Total Quality Control, he outlined his quality principles in 40 steps. Feigenbaum took a total system approach to quality. He promoted the idea of a work environment where quality devel opments are integrated throughout the entire organization, where management and employees have a total commitment to improve quality, and people learn from each others successes. This philosophy was adapted by the Japanese and termed companywide quality control. Philip B. Crosby is another recognized guru in the area of TQM. He worked in the area of quality for many years, first at Martin Marietta and then, in the 1970s, as the vice president for quality at ITT. He developed the phrase Do it right the first time and the notion of zero defects, arguing that no amount of defects should be considered acceptable. He scorned the idea that a small number of defects is a normal part of the operating process because systems and workers are imperfect. Instead, he stressed the idea of prevention. To promote his concepts, Crosby wrote a book titled Quality Is Free, which was published in 1979. He became famous for coining the phrase quality is free and for pointing out the many costs of quality, which include not only the costs of wasted labor, equipment time, scrap, rework, and lost sales, but also organizational costs that are hard to quantify. Crosby stressed that efforts to improve quality more than pay for themselves because these costs are prevented. Therefore, quality is free. Like Deming and Juran, Crosby stressed the role of management in the quality improvement effort and the use of statistical control tools in measuring and monitoring quality. 3

Kaoru Ishikawa is best known for the development of quality tools called cause-and-effect diagrams, also called fishbone or Ishikawa diagrams. These diagrams are used for quality problem solving, and we will look at them in detail later in the chapter. He was the first quality guru to emphasize the importance of the internal customer, the next person in the production process. He was also one of the first to stress the importance of total company quality control, rather than just focusing on products and services. Dr. Ishikawa believed that everyone in the company needed to be united with a shared vision and a common goal. He stressed that quality initiatives should be pursued at every level of the organization and that all employees should be involved. Dr. Ishikawa was a proponent of implementation of quality circles, which are small teams of employees that volunteer to solve quality problems. Dr. Genichi Taguchi is a Japanese quality expert known for his work in the area of product design. He estimates that as much as 80 percent of all defective items are caused by poor product design. Taguchi stresses that companies should focus their quality efforts on the design stage, as it is much cheaper and easier to make changes during the product design stage than later during the production process. Taguchi is known for applying a concept called design of experiment to product design. This method is an engineering approach that is based on developing robust design, a design that results in products that can perform over a wide range of conditions. Taguchis philosophy is based on the idea that it is easier to design a product that can perform over a wide range of environmental conditions than it is to control the environmental conditions. Taguchi has also had a large impact on todays view of the costs of quality. He pointed out that the traditional view of costs of conformance to specifications is incorrect, and proposed a different way to look at these costs. Lets briefly look at Dr. Taguchis view of quality costs. Recall that conformance to specification specifies a target value for the product with specified tolerances, say 5.00 _ 0.20. According to the traditional view of conformance to specifications, losses in terms of cost occur if the product dimensions fall outside of the specified limits. This is shown in Figure 5-4. However, Dr. Taguchi noted that from the customers view there is little difference whether a product falls just outside or just inside the control limits. He pointed out that there is a much greater difference in the quality of the product between making the target and being near the control limit. He also stated that the smaller the variation around the target, the better the quality. Based on this he proposed the following: as conformance values move away from the target, loss increases as a quadratic function. This is called the Taguchi loss function and is shown in Figure 5-5. According to the function, smaller differences from the target result in smaller costs: the larger the differences, the larger the cost. The Taguchi loss function has had a significant impact in changing the view of quality cost. What characterizes TQM is the focus on identifying root causes of quality problems and correcting them at the source, as opposed to 4

inspecting the product after it has been made. Not only does TQM encompass the entire organization, but it stresses that quality is customer driven. TQM attempts to embed quality in every aspect of the organization. It is concerned with technical aspects of quality as well as the involvement of people in quality, such as customers, company employees, and suppliers. Here we look at the specific concepts that make up the philosophy of TQM.

Q. 2

Define and discuss the concept of Deming philosophy and its importance in TQM.

Critically discuss the 14 point of Deming philosophy and their main themes keep in view the financial sector of Pakistan. A core concept in implementing TQM is Demings 14 points, a set of management practices to help companies increase their quality and productivity: 1. . Create a constant purpose toward improvement.

Plan for quality in the long term. Resist reacting with short-term solutions. Don't just do the same things better find better things to do. Predict and prepare for future challenges, and always have the goal of getting

better. 2. Adopt the new philosophy.

Embrace quality throughout the organization. Put your customers' needs first, rather than react to competitive pressure and

design products and services to meet those needs.

Be prepared for a major change in the way business is done. It's about leading,

not simply managing.

Create your quality vision, and implement it.

3. Stop depending on inspections.

Inspections are costly and unreliable and they don't improve quality, they

merely find a lack of quality.

Build quality into the process from start to finish. Don't just find what you did wrong eliminate the "wrongs" altogether. 5

Use statistical control methods not physical inspections alone to prove that

the process is working. 4. Use a single supplier for any one item.

Quality relies on consistency the less variation you have in the input, the less

variation you'll have in the output.

Look at suppliers as your partners in quality. Encourage them to spend time

improving their own quality they shouldn't compete for your business based on price alone.

Analyze the total cost to you, not just the initial cost of the product. Use quality statistics to ensure that suppliers meet your quality standards.

5. Improve constantly and forever.

Continuously improve your systems and processes. Deming promoted the Plan-

Do-Check-Act approach to process analysis and improvement.

Emphasize training and education so everyone can do their jobs better. Use kaizen as a model to reduce waste and to improve productivity,

effectiveness, and safety. 6. Use training on the job.

Train for consistency to help reduce variation. Build a foundation of common knowledge. Allow workers to understand their roles in the "big picture." Encourage staff to learn from one another, and provide a culture and

environment for effective teamwork. 7. Implement leadership.

Expect your supervisors and managers to understand their workers and the

processes they use.

Don't simply supervise provide support and resources so that each staff

member can do his or her best. Be a coach instead of a policeman.

Figure out what each person actually needs to do his or her best. Emphasize the importance of participative management and transformational

leadership. 6

Find ways to reach full potential, and don't just focus on meeting targets and

quotas. 8. Eliminate fear.

Allow people to perform at their best by ensuring that they're not afraid to

express ideas or concerns.

Let everyone know that the goal is to achieve high quality by doing more things

right and that you're not interested in blaming people when mistakes happen.

Make workers feel valued, and encourage them to look for better ways to do

things.

Ensure that your leaders are approachable and that they work with teams to act

in the company's best interests.

Use open and honest communication to remove fear from the organization.

9. Break down barriers between departments.

Build the "internal customer" concept recognize that each department or

function serves other departments that use their output.

Build a shared vision. Use cross-functional teamwork to build understanding and reduce adversarial

relationships.

Focus on collaboration and consensus instead of compromise. Get rid of unclear slogans.

10.

Let people know exactly what you want don't make them guess. "Excellence

in service" is short and memorable, but what does it mean? How is it achieved? The message is clearer in a slogan like "You can do better if you try."

Don't let words and nice-sounding phrases replace effective leadership. Outline

your expectations, and then praise people face-to-face for doing good work. 11.

Eliminate management by objectives. Look at how the process is carried out, not just numerical targets. Deming said

that production targets encourage high output and low quality.

Provide support and resources so that production levels and quality are high and

achievable. 7

Measure the process rather than the people behind the process.

12.

Remove barriers to pride of workmanship. Allow everyone to take pride in their work without being rated or compared. Treat workers the same, and don't make them compete with other workers for

monetary or other rewards. Over time, the quality system will naturally raise the level of everyone's work to an equally high level. 13.

Implement education and self-improvement. Improve the current skills of workers. Encourage people to learn new skills to prepare for future changes and

challenges.

Build skills to make your workforce more adaptable to change, and better able

to find and achieve improvements. 14.

Make "transformation" everyone's job. Improve your overall organization by having each person take a step toward

quality.

Analyze each small step, and understand how it fits into the larger picture. Use effective change management principles to introduce the new philosophy

and ideas in Deming's 14 points.

Q. 3

Discuss the concept customers feedback in continuous quality improvement. Critically

discuss the role of comments card and focus group in getting the customers feedback with reference to the manufacturing organization Serving your customers, whether they are internal or external to your organization, is central to your success. Some of the most important components of customer service are:

Customer satisfaction - a process that involves extending exceptional courtesy and service to our customers. Customer Feedback and Research - a process that requires an organization to consistently solicit feedback from its customers in order to improve services and products. Continuous Quality Improvement - a process of continuous learning in order to help organizations work to improve their services and products. Individual Responsibility - a process that acknowledges that each person in the organization is responsible when it comes to customer service.

COMMENT CARD A carefully planned and well-written customer comment card allows the customer to express their opinion and provide valuable feedback. This form of store evaluation not only helps measure customer satisfaction, but also shows the retailer what areas of operation may need additional resources. The customer comment card is a great way to collect testimonials. It can also be a great tool for receiving complaints. Disgruntled customers generally need an outlet to express their dissatisfaction. A conveniently placed customer comment card could prevent the unhappy customer from complaining to a thirdparty. Now the retailer can receive the complaint and act quickly to resolve the issue. Not only do we get to keep that customer, but it may also prevent any negative word-of-mouth. Customer Comment Card Tips:

Use a professional printer to print the comment cards. Ask only about things you are willing to change. Add the ability for customers to mail in the cards, not just a drop-box. Ask if the customer would like to be contacted regarding comments. Offer an incentive or reward to customers who fill out the comment card. Act quickly to resolve any complaints.

Keep a stack of customer comment cards near your cash registers. Remember, in-store comment cards are only one method for soliciting feedback. Get creative in your methods of soliciting customer feedback. Use an online version of the customer comment card on the store's website. If you have developed a mailing list, consider sending the cards to select customers. You may be surprised to know what people think about your shop! What do your customers think about your business? What do they think about the kinds of marketing you try and the types of items you stock in your shelves? Do they like the service you provide, the prices you offer, or the policies you employ?

Well, theyre shopping at your store, so they must like it at least a little, right? Id wager that they do, but that doesnt always mean much. Are they shopping with you because they really like what youre doing, or are they just with you until a better option comes along?

Really knowing what your customers want and what they think about your business should be a very big concern. A person giving you businesses isnt always the best indicator that theyll continue to do so for years to come. A single new store opening might be all it takes to draw away a lot of your customer base if youve been ignoring them and dont really know what they want. Having survey cards printed is a simple form of color printing that can have a big impact on the future of your company. This allows you to get some basic information from the people actually shopping in your store and lets you know what needs to be improved.

You can either have cards printed that already have some basic questions listed on it, or have a link on the cards to online surveys with more extensive questions. 10

In order to encourage people to take part in a longer online survey you can offer them a ten-dollar gift certificate for completing it. This helps you out in multiple ways. Not only do you gain additional information from your customers, but you can help ensure theyll keep coming back in. Another bonus of using color printing to hand out survey cards is that it shows people that you care about what they have to say. People like to know that a company cares about what they think, and this will generate more interest in your store. If you think about it, this is the best means of gathering research about your customers that you could hope for. These are the very people youre trying to market to telling you what they most want. Use this information to tailor your color printing material to an advertisement that will appeal specifically to them. The costs of getting survey cards printed along with the cost of having a website set up for the survey is well worth the marketing benefits youll gain. Now youll never have to worry that people are only going to stick around until they find something better. If people can see a business willing to listen to their advice and change to keep them happy, theyll be much more likely to stick around for years. FOCUS GROUP Market research: Small number of people (usually between 4 and 15, but typically 8) brought together with a moderator to focus on a specific product or topic. Focus groups aim at a discussion instead of on individual responses to formal questions, and produce qualitative data (preferences and beliefs) that may or may not be representative of the general population Using Focus Groups Effectively Focus groups are managed like any other project; they require defining the objectives, creating a work plan, conducting the group discussions and, most important, completing insightful analysis and developing recommendations. There are several lessons-learned, namely:

Complete detailed background research on what you need to learn from the groups. The facilitator must understand the group participants to be able to draw out the essential information the client needs to learn and understand. 11

Involve the end-user in the design of the group so he/she can verbalize and visualize success. This is an opportunity to expose the end-user to the process and to discuss what they should expect.

The physical layout needs to encourage participants to feel free to express themselves and interact with each other. Free dialogue starts with the arrangement of chairs and tables. Assigned seating with first-name tags can encourage discussions.

Follow-up a week after the event allows the facilitator time to think over what he/she experienced and to draw better conclusions. It is important to leave a period-of-time for the wonderment of focus groups to wear off.

Q. 4

Define and discuss the term team in the view of Total Quality Management. Critically

discuss the role of teams in the continuous quality improvement process with reference to commercial organization. WHAT ARE THE STEPS IN THE CONTINUOUS QUALITY IMPROVEMENT PROCESS?

Step 1 Identify a need/issue/problem and develop a problem statement Step 2 Define the current situation - break down problem into component parts, identify major problem areas, develop a target improvement goal Step 3 Analyze the problem - identify the root causes of the problem and use charts and diagrams as needed. Step 4 Develop an action plan - outline ways to correct the root causes of the problem, specific actions to be taken, identify who, what, when and where Step 5 Look at the results - confirm that the problem and its root causes have decreased, identify if the target has been met and display results in graphic format before and after the change

Step 6 Start over - go back to the first step and use the same process for the next problem

WHAT IS THE CONTINUOUS QUALITY IMPROVEMENT TEAM STRUCTURE? The Department of Children & Family Services/Office of Community Services' Continuous Quality Improvement process involves two levels of teams. There is a state level Continuous Quality Improvement team and a Continuous Quality Improvement team in each region statewide. The teams 12

include staff from all levels within the agency representing all programmatic service areas as well as community stakeholders. WHAT ARE CONTINUOUS QUALITY IMPROVEMENT TEAM ROLES?

Chair/Facilitator - facilitates Continuous Quality Improvement meetings, champions the Continuous Quality Improvement process and coordinates input and feedback to staff. Scribe - takes detailed meeting minutes, schedules meeting room. Member - participates in review of issues referred to the Continuous Quality Improvement team; provides feedback to peers, stakeholders and consumers

Implementing total quality management: role of team management. Introduction Globalization in the business theater is driving companies toward a new view of quality as a necessary tool to compete successfully in worldwide markets. A direct outcome of this new emphasis is the philosophy of total quality management (TQM). In essence, TQM is a company-wide perspective that strives for customer satisfaction by seeking zero defects in products and services. The TQM Philosophy Implementing a total quality management system has become the preferred approach for improving quality and productivity in organizations. TQM, which has been adopted by leading industrial companies, is a participative system empowering all employees to take responsibility for improving quality within the organization. Instead of using traditional bureaucratic rule enforcement, TQM calls for a change in the corporate culture, where the new work climate has the following characteristics:

An open, problem-solving atmosphere; Participatory design making; Trust among all employees (staff, line, workers, managers); A sense of ownership and responsibility for goal achievement and problems solving; and, Self-motivation and self-control by all employees.

The TQM approach involves more than simply meeting traditional rejection rate standards. The end result of TQM is the efficient and effective use of all organizational processes in providing consistent 13

quality at a competitive price. The TQM philosophy is a long-term endeavor that links people and processes in a system that alters the corporate culture to become one where quality is the core aspect of business strategy. The effective use of quality improvement teams, and the TQM system as a whole, can be reinforced by applying basic principles of motivation. In particular, the recognition of team accomplishments as opposed to those of individuals, and the effective use of goal setting for group efforts, are important in driving the TQM system. The HR department is in a position to help institutionalize team approaches to TQM by designing appraisal and reward systems that focus on team performance. For many companies, the philosophy of TQM represents a major culture shift away from a traditional production-driven atmosphere. In the face of such radical operational makeovers, a determined implementation effort is vital to prevent TQM from becoming simply platitudinal and the team approach just another management fad. Senior management must take the lead in overt support of TQM. Senior Management and TQM To be successful, a TQM system must be wholeheartedly accepted by top management, who, in turn, must convey their commitment to all organizational members.(9) The policy for implementation and maintenance of the TQM system should be set forth in writing and incorporated into the organization's mission and goals statements. The key elements of senior management's role in implementing TQM are: * Institutionalizing the TQM structure as established by stated goals and formal policies and procedures; and * Providing leadership as demonstrated by top management's explicit expectations and behavior in everyday activities. In summary, top management's responsibilities in the TQM implementation process include: 1. Initiating agreement on goals and measures that cascade throughout the organization; 2. Providing the agreed resources (people, money, training, machines, etc.); 3. Assigning authority and establish deadlines to put resources into motion; 14

4. Monitoring progress in achieving goals, not to apportion blame, but to aim for improvement; and, 5. Measuring improvement and reward both the achievement of goals and the ways they are achieved Obtaining cooperation from other departments in the use of surveys largely depends on their perception of HRM's role in the survey process. The challenge is to establish that HRM is not usurping departmental prerogatives, but is instead a helpful collaborator assisting each department in making their own quality improvements. Emphasizing HRM's collaborator role can be accomplished in the participative spirit of the TQM philosophy by involving other departments in the development of the survey instrument itself. This involvement begins the process of helping each department own the TQM program which will follow. Thus, using a corss-functional TQM survey development team provides an early opportunity for HRM to exemplify the TQM team philosophy and dispel territorial fears about how survey results will be used. TQM and Training and Development In general, HRM is responsible for providing training and development. With their background, HR departments are well-positioned to take the leading role in providing such programs consistent with the TQM philosophy. HR managers have an important Beyond communicating the TQM philosophy, the specific training and development needs for making TQM a practical reality must be assessed. Basically HR professionals must decide the following: What knowledge and skills must be taught? How? What performance (behaviors) will be recognized, and how will we reward them? HRM has faced these questions before and can best confront them in the TQM process. Training and development that does not fit within the realm of these questions will more than likely encounter heavy resistance. However, training and development does fall within the realm of these questions probably will be accepted more readily.

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Q. 5

Discuss the different improvement strategies used in continuous quality improvement

management. Critically discuss the primary improvement strategies with examples in the light of business organization. Which one strategy is better in your view and why? Quality Improvement Strategies More than 40 years ago, Donabedian proposed measuring the quality of health care by observing its structure, processes, and outcomes. Structure measures assess the accessibility, availability, and quality of resources, such as health insurance, bed capacity of a hospital, and number of nurses with advanced training. Process measures assess the delivery of health care services by clinicians and providers, such as using guidelines for care of diabetic patients. Outcome measures indicate the final result of health care and can be influenced by environmental and behavioral factors. Examples include mortality, patient satisfaction, and improved health status. Twenty years later, health care leaders borrowed techniques from the work of Deming in rebuilding the manufacturing businesses of post-World War II Japan. Deming, the father of Total Quality Management (TQM), promoted constancy of purpose and systematic analysis and measurement of process steps in relation to capacity or outcomes. The TQM model is an organizational approach involving organizational management, teamwork, defined processes, systems thinking, and change to create an environment for improvement. This approach incorporated the view that the entire organization must be committed to quality and improvement to achieve the best results. In health care, continuous quality improvement (CQI) is used interchangeably with TQM. CQI has been used as a means to develop clinical practice and is based on the principle that there is an opportunity for improvement in every process and on every occasion. Many inhospital quality assurance (QA) programs generally focus on issues identified by regulatory or accreditation organizations, such as checking documentation, reviewing the work of oversight committees, and studying credentialing processes. There are several other strategies that have been proposed for improving clinical practice. For example, Horn and colleagues discussed clinical practice improvement (CPI) as a multidimensional outcomes methodology that has direct application to the clinical management of individual patients . CPI, an approach lead by clinicians that attempts a comprehensive understanding of the complexity of health care delivery, uses a team, determines a purpose, collects data, assesses findings, and then translates those findings into practice changes. From these models, management and clinician commitment and involvement have been found to be essential for the successful implementation of change. From other quality improvement strategies, 16

there has been particular emphasis on the need for management to have faith in the project, communicate the purpose, and empower staff. Quality improvement is defined as systematic, data-guided activities designed to bring about immediate improvement in health care delivery in particular settings A quality improvement strategy is defined as any intervention aimed at reducing the quality gap for a group of patients representative of those encountered in routine practice Shojania and colleagues developed a taxonomy of quality improvement strategies , which infers that the choice of the quality improvement strategy and methodology is dependent upon the nature of the quality improvement project. The lack of scientific health services literature has inhibited the acceptance of quality improvement methods in health care, but new rigorous studies are emerging. It has been asserted that a quality improvement project can be considered more like research when it involves a change in practice, affects patients and assesses their outcomes, employs randomization or blinding, and exposes patients to additional risks or burdensall in an effort towards generalizability for participants, securing informed consent, and ensuring scientific value Plan-Do-Study-Act (PDSA) Quality improvement projects and studies aimed at making positive changes in health care processes to effecting favorable outcomes can use the Plan-Do-Study-Act (PDSA) model. This is a method that has been widely used by the Institute for Healthcare Improvement for rapid cycle improvement. One of the unique features of this model is the cyclical nature of impacting and assessing change, most effectively accomplished through small and frequent PDSAs rather than big and slow ones, before changes are made systemwide. Six Sigma Six Sigma, originally designed as a business strategy, involves improving, designing, and monitoring process to minimize or eliminate waste while optimizing satisfaction and increasing financial stability. The performance of a processor the process capabilityis used to measure improvement by comparing the baseline process capability (before improvement) with the process capability after piloting potential solutions for quality improvement. There are two primary methods used with Six Sigma. One method inspects process outcome and counts the defects, calculates a defect rate per 17 Regardless of whether the project is considered research, human subjects need to be protected by ensuring respect

million, and uses a statistical table to convert defect rate per million to a (sigma) metric. This method is applicable to preanalytic and postanalytic processes (a.k.a. pretest and post-test studies). The second method uses estimates of process variation to predict process performance by calculating a metric from the defined tolerance limits and the variation observed for the process. This method is suitable for analytic processes in which the precision and accuracy can be determined by experimental procedures. Six Sigma and PDSA are interrelated. The DMAIC methodology builds on Shewharts plan, do, check, and act cycle. The key elements of Six Sigma is related to PDSA as follows: the plan phase of PDSA is related to define core processes, key customers, and customer requirements of Six Sigma; the do phase of PDSA is related to measure performance of Six Sigma; the study phase of PDSA is related to analyze of Six Sigma; and the act phase of PDSA is related to improve and integrate of Six Sigma. Toyota Production System/Lean Production System Application of the Toyota Production Systemused in the manufacturing process of Toyota cars resulted in what has become known as the Lean Production System or Lean methodology. This methodology overlaps with the Six Sigma methodology, but differs in that Lean is driven by the identification of customer needs and aims to improve processes by removing activities that are nonvalue-added (a.k.a. waste). Steps in the Lean methodology involve maximizing value-added activities in the best possible sequence to enable continuous operations. This methodology depends on root-cause analysis to investigate errors and then to improve quality and prevent similar errors. Factors involved in the successful application of the Toyota Production System in health care are eliminating unnecessary daily activities associated with overcomplicated processes, workarounds, and rework involving front-line staff throughout the process, and rigorously tracking problems as they are experimented with throughout the problem-solving process. Root Cause Analysis Root cause analysis (RCA), used extensively in engineering and similar to critical incident technique, is a formalized investigation and problem-solving approach focused on identifying and understanding the underlying causes of an event as well as potential events that were intercepted. The Joint Commission requires RCA to be performed in response to all sentinel events and expects, based on the results of the RCA, the organization to develop and implement an action plan consisting of 18

improvements designed to reduce future risk of events and to monitor the effectiveness of those improvements. RCA is a technique used to identify trends and assess risk that can be used whenever human error is suspected with the understanding that system, rather than individual factors, are likely the root cause of most problems. A similar procedure is critical incident technique, where after an event occurs, information is collected on the causes and actions that led to the event. Due the breadth of types of adverse events and the large number of root causes of errors, consideration should be given to how to differentiate system from process factors, without focusing on individual blame. The notion has been put forth that it is a truly rare event for errors to be associated with irresponsibility, personal neglect, or intention, a notion supported by the IOM.4, Yet efforts to categorize individual errorssuch as the Taxonomy of Error Root Cause Analysis of Practice Responsibility (TERCAP), which focuses on lack of attentiveness, lack of agency/fiduciary concern, inappropriate judgment, lack of intervention on the patients behalf, lack of prevention, missed or mistaken MD/healthcare providers orders, and documentation error may distract the team from investigating systems and process factors that can be modified through subsequent interventions. Even the majority of individual factors can be addressed through education, training, and installing forcing functions that make errors difficult to commit.

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