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Total Quality Management (TQM) :

Total Quality Management (TQM) gvrr416@gmail.com

TQM - Three paradigms:

TQM - Three paradigms Total: Made up of the whole (Involving the entire organization, supply chain, and/or product life cycle) Quality : degree of excellence a product or service provides Management : Act, art or manner of system with steps like Plan, Organize, Control, Direct, etc Therefore, TQM is the art of managing the whole to achieve excellence

Definition :

Definition The International Organization for Standards (ISO 8402:1994 ) defines TQM: A management approach for an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society

Quality Throughout:

Quality Throughout A Customer’s impression of quality begins with the initial contact with the company and continues through the life of the product Customers look to the total package - sales, service during the sale, packaging, deliver, and service after the sale Quality extends to how the receptionist answers the phone, how managers treat subordinates, how courteous sales and repair people are, and how the product is serviced after the sale

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Some of the definitions of Quality by researchers are:- Quality is fitness for use (Juran, 1974) Quality is conformance to requirements (Crossby. 1984) Quality means best for certain customer conditions These conditions are: The actual use and the selling price of the product. (Feigenbaum, 1961) Quality is the capability of products or services to knowingly satisfy those preconceived composite wants of the user(s) that are intelligently related to the characteristics of performance, and do not cause major overt or covert reactions or actions by other people (Johnson, 1987)


Quality… The totality of features and characteristics of products or services that bears on its ability to satisfy given needs. (ANSI and ASAC, 1978) It’s a immense field which can be seen by eyes, felt by touch, listen by ear and also can be tasted by tongue Hence quality is both a user-oriented and a production oriented expression

Quality therefore :

Quality therefore Defined by the customers A measure of achievement of customer satisfaction. Fulfilling the customer’s need/requirement Value for money Keeping one’s word Ensuring zero defects An object which lies in the eyes of the beholder. Ensuring fitness for use Image of the company and costumer confidence in the organization A precise and measurable variable Utility to the society


Management The American Management Association defines management as "the process of getting work done through people." The verb manage comes from the Italian maneggiare (to handle — especially a horse), which in turn derives from the Latin manus (hand). The French word mesnagement (later ménagement) influenced the development in meaning of the English word management in the 17th and 18th centuries.

Theories of management:

Theories of management Management theories can also be divided into two sets One is the set that concentrates mainly on efficiency and another is the set that concentrates mainly on effectiveness Efficiency is about doing things the right way It involves eliminating waste and optimizing processes Effectiveness is about doing the right things A good management style is a blend of both efficiency and effectiveness There is no point in acting efficiently if what you are doing will not have the desired effect Management techniques can be viewed as either bottom-up, top-down, or collaborative processes

Scenario in India:

Scenario in India In India, largely the top down approach is popular In the top-down approach, the management makes the decisions, which the employees have no choice but to accept On the other hand, in the bottom-up approach, employees submit proposals to their managers who, in turn, funnel the best ideas further up the organization However the bottom up approach is not a very popular approach in India as most of the Indian businesses are family run businesses

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TQM is a management-oriented strategy TQM acts as an umbrella under which everyone in the organization can strive for customer satisfaction reduce costs and wastage increase the efficiency of services

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Aims at embedding awareness of quality in all organizational processes TQM, which originally hails from the Japanese, saw the 1980's bring it to the healthcare domain In the 1950s, the Japanese asked W. Edwards Deming, an American statistician and management theorist, to help them improve their war torn economy By implementing Deming's principles of total quality management (TQM), Japan experienced dramatic economic growth

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In the 1980s, when the United States began to see a reduction in its own world market share in relation to Japan, American business rediscovered Deming Dr. Deming's teachings and philosophy can be seen through the results they produced when they were adopted by the Japanese Ford Motor Company was simultaneously manufacturing a car model with transmissions made in Japan and the United States

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Soon after the car model was on the market, Ford customers were requesting the model with Japanese transmission over the USA-made transmission, and they were willing to wait for the Japanese model As both transmissions were made to the same specifications, Ford engineers could not understand the customer preference for the model with Japanese transmission It delivered smoother performance with a lower defect rate. Finally, Ford engineers decided to take apart the two different transmissions

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The American-made car parts were all within specified tolerance levels On the other hand, the Japanese car parts had much closer tolerances than the USA-made parts - e.g. if a part was supposed to be one foot long, plus or minus 1/8 of an inch - then the Japanese parts were within 1/16 of an inch This made the Japanese cars run more smoothly and customers experienced fewer problems

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Ford Motor Company was one of the first American corporations to seek help from Deming In 1981, Ford's sales were falling Between 1979 and 1982, Ford had incurred $3 billion in losses Dr. Deming to help jump-start a quality movement at Ford To Ford's surprise, Deming talked not about quality but about management He told Ford that management actions were responsible for 85% of all problems in developing better cars.

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In 1986 Ford came out with a profitable line of cars, the Taurus-Sable line By 1986, Ford had become the most profitable American auto company For the first time since the 1920s, its earnings had exceeded those of arch rival General Motors (GM) Its earnings continued to exceed GM and Chrysler's

What’s the goal of TQM?:

What’s the goal of TQM? “Do the right things right the first time, every time.” gvrr416@gmail.com

Two main objectives:

Two main objectives 1.Total client satisfaction through quality products and services 2.Continuous improvements to processes, systems, people, suppliers, partners, products, and services

Productivity and TQM:

Productivity and TQM Traditional view Quality cannot be improved without significant losses in productivity TQM view Improved quality leads to improved productivity gvrr416@gmail.com

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To achieve this level of performance requires more than a good philosophy - the organization must change its behavior and adopt new ways of doing business This is what Dr. Deming preached to the Japanese in 1950, and in the 1980s and 90s until his death, in America Deming's approach was amply summed up in his famous 14 Points

1. Constancy of purpose:

1. Constancy of purpose Create constancy of purpose for continual improvement of products and service to society, allocating resources to provide for long range needs rather than only short term profitability, with a plan to become competitive, to stay in business, and to provide jobs. gvrr416@gmail.com

2. The new philosophy :

2. The new philosophy Adopt the new philosophy. We can no longer live with commonly accepted levels of delays, mistakes, defective materials, and defective workmanship. Transformation of Western management style is necessary to halt the continued decline of business and industry.

3. Cease dependence on mass inspection:

3. Cease dependence on mass inspection Eliminate the need for mass inspection as the way of life to achieve quality by building quality into the product in the first place. Require statistical evidence of built in quality in both manufacturing and purchasing functions.

4 . End lowest tender contracts:

4 . End lowest tender contracts End the practice of awarding business solely on the basis of price tag. Instead require meaningful measures of quality along with price. Reduce the number of suppliers for the same item by eliminating those that do not qualify with statistical and other evidence of quality. The aim is to minimize total cost, not merely initial cost, by minimizing variation. This may be achieved by moving toward a single supplier for any one item, on a long term relationship of loyalty and trust. Purchasing managers have a new job, and must learn it. gvrr416@gmail.com

5. Improve every process :

5. Improve every process Improve constantly and forever every process for planning, production, and service. Search continually for problems in order to improve every activity in the company, to improve quality and productivity, and thus to constantly decrease costs. Institute innovation and constant improvement of product, service, and process. It is management’s job to work continually on the system (design, incoming materials, maintenance, improvement of machines, supervision, training, retraining).

6. Institute training on the job:

6. Institute training on the job Institute modern methods of training on the job for all, including management, to make better use of every employee. New skills are required to keep up with changes in materials, methods, product and service design, machinery, techniques, and service.

7. Institute leadership :

7. Institute leadership Adopt and institute leadership aimed at helping people do a better job. The responsibility of managers and supervisors must be changed from sheer numbers to quality. Improvement of quality will automatically improve productivity. Management must ensure that immediate action is taken on reports of inherited defects, maintenance requirements, poor tools, fuzzy operational definitions, and all conditions detrimental to quality.

8. Drive out fear :

8. Drive out fear Encourage effective two way communication and other means to drive out fear throughout the organization so that everybody may work effectively and more productively for the company

9. Break down barriers :

9. Break down barriers Break down barriers between departments and staff areas. People in different areas, such as Leasing, Maintenance, Administration, must work in teams to tackle problems that may be encountered with products or service. gvrr416@gmail.com

10. Eliminate exhortations :

10. Eliminate exhortations Eliminate the use of slogans, posters and exhortations for the work force, demanding Zero Defects and new levels of productivity, without providing methods. Such exhortations only create adversarial relationships; the bulk of the causes of low quality and low productivity belong to the system, and thus lie beyond the power of the work force.

11. Eliminate arbitrary numerical targets:

11. Eliminate arbitrary numerical targets Eliminate work standards that prescribe quotas for the work force and numerical goals for people in management. Substitute aids and helpful leadership in order to achieve continual improvement of quality and productivity.

12. Permit pride of workmanship:

12. Permit pride of workmanship Remove the barriers that rob hourly workers, and people in management, of their right to pride of workmanship. This implies, among other things, abolition of the annual merit rating (appraisal of performance) and of Management by Objective. Again, the responsibility of managers, supervisors, foremen must be changed from sheer numbers to quality.

13. Encourage education :

13. Encourage education Institute a vigorous program of education, and encourage self improvement for everyone. What an organization needs is not just good people; it needs people that are improving with education. Advances in competitive position will have their roots in knowledge.

14. Top management commitment & action :

14. Top management commitment & action Clearly define top management’s permanent commitment to ever improving quality and productivity, and their obligation to implement all of these principles. Indeed, it is not enough that top management commit themselves for life to quality and productivity. They must know what it is that they are committed to—that is, what they must do. Create a structure in top management that will push every day on the preceding 13 Points, and take action in order to accomplish the transformation. Support is not enough: action is required!

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W. Edwards Deming : (1900-1993)], the Father of Modern Quality based much of his work on earlier work done by Walter Shewhart on statistical quality control (SQC) Shewhart is considered the father of quality control. SQC uses control charts to identify and control sources of variation in manufacturing processes In TQM, we apply the principles of controlling the quality of machine-based factory operations to controlling the quality of people-based management operations

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The Plan-Do-Study-Act (PDSA) cycle developed by Dr. Walter Shewhart helps us manage the effects of variation This is the scientific method applied to problem solving which has us plan and test our improvements, make adjustments, and then standardize them to prevent recurrence PDSA or PDCA (check) is fundamental to TQM

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“Quality should be built into the product, and testing alone cannot be relied on to ensure product quality .”

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Quality management plays a key role in the pharmaceutical industry . To ensure that products are safe and effective, manufacturing processes are subject to strict legal conditions. National and international authorities constantly monitor the manufacturers' adherence to regulations. Directives and procedural instructions for validation require companies in the industry to document the entire logistics chain in full - from goods inwards to delivery, and from the development of new preparations to the maintenance of mixers and packaging lines gvrr416@gmail.com

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Because the pharmaceutical industry has traditionally focused upon the application of Good Manufacturing Practice (GMP) It has been slow to consider the potential benefits to be gained by implementing an EN ISO 9001 Quality Management System (QMS)

Difference Between GMP & ISO 9001:

Difference Between GMP & ISO 9001 EN-ISO 9001 is a generic, business focused, standard which supports the effective management of quality to an internationally recognized level of best practice It is flexible in that it specifies what is to be achieved, but allows each company freedom to determine, and justify, how these requirements are achieved. In contrast, GMP is an industry-specific standard prescribing what must be done to ensure product safety and efficacy.

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Thus, EN-ISO 9001 benefits the business by ensuring the quality of the management system, while GMP ensures that regulatory requirements are met. Although there is inevitably some overlap between the requirements of a QMS and GMP they are, in fact, highly complementary

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In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative In that announcement, the FDA explained the Agency’s intent to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies gvrr416@gmail.com

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The CGMPs for the 21st Century Initiative steering committee created a Quality System Guidance Development working group (QS working group) to compare the current CGMP regulations, which call for some specific quality management elements, to other existing quality management systems. The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations and various quality system models

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Such as the Drug Manufacturing Inspections Program (i.e., system-based inspectional program), the Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases. The QS working group determined that, although the CGMP regulations do provide great flexibility, they do not incorporate explicitly all of the elements that today constitute most quality management systems.

Difference Between CGMP & TQM:

Difference Between CGMP & TQM CGMP regulations & other quality management systems differ somewhat in organization & in certain constituent elements; however, they are very similar and share underlying principles Ex : the CGMP regulations stress quality control Recently developed quality systems stress quality management, quality assurance, and the use of risk management tools, in addition to quality control QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufacturing world

Quality Management System - integrating GMP into ISO :

Quality Management System - integrating GMP into ISO To be effective the QMS should have the visible and ongoing support of top management. To take full benefit for company the QMS should involve all staff whose activities influence quality, have a clear and unambiguous continuous improvement focus, and incorporate relevant, realistic performance measures with emphasis on reducing failure costs, and satisfying (internal and external) customer needs. The quality manual occupies the highest level in the document hierarchy. It overviews and acts as a directory to the QMS, capturing the unique character of the company.

Key Elements :

Key Elements To be successful implementing TQM, an organization must concentrate on the 8 key elements: TRUST

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Ethics Integrity Trust Training Teamwork Leadership Recognition Communication gvrr416@gmail.com

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TQM has been coined to describe a philosophy that makes quality the driving force behind leadership, design, planning, and improvement initiatives. For this, TQM requires the help of those eight key elements. These elements can be divided into four groups according to their function.

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The groups are: Foundation – It includes: Ethics, Integrity and Trust Building Bricks –It includes: Training, Teamwork and Leadership. Binding Mortar –It includes: Communication. Roof –It includes: Recognition.

Barricade in executing TQM:

Barricade in executing TQM Lack of understanding of the TQM concept: The top and senior executives should develop full understanding, conviction and faith in the concept and should be committed to extend whole hearted support. The training programs at the beginning and also periodically, as well as continuous stress on benefits to the organization and individual help developing loyal and committed work force to the cause of TQM.

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2. Absence of visible support from senior and top management:- The management should make sincere efforts to let know their commitment by way of frequent visits to quality improvement team’s meeting and story sessions. They should have informal talks with the members of QIT’s. Providing facilities, resources, finance for TQM activities and attending presentation and participating in steering committee meeting will make the commitment visible.

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3. Fear of change. Skepticism in the minds of management that TQM will reveal their deficiencies and dilute their authority & importance- These misconceptions need to the eradicated by being advised by the top management suitably In fact, successful implementation of TQM would result in better opportunities and harmonious relations. More exposures to the concept of TQM would help people to appreciate the gain of TQM.

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4 . Many layers of existing organization structure – TQM requires a flat organizational structure with large span control. A change in organizational structure to meet this is required. 5. Poor internal communication – Exchange of ideas, by participation of members of different departments in QIT’s. Periodic visit of one department employees to another. Seminars, group discussions, news letters expressing the view. Breaking the barriers to communications.

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6. Heavy workloads- TQM does not require any extra time and effort on the part of management. A conscious expression of interest in day to day work is sufficient. 7. Nature of organization TQM is a philosophy and suits any organization. Committed, continuous, conscious efforts towards customer’s satisfaction need to be the way of life.

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8 . Lack of adequate education and training:- Provide education about TQM. Organize regular training programs. Emphasize on “Learning to learn” 9. Limited resources:- Get experts from outside to train and educate senior and top management. Develop internal training mechanism Develop commitment, bring about a cultural change, resources will follow.

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10. Irregularity of the meetings:- Holding of steering committee and QIT’s meeting on specified time and day should be ensured by the management. Use committed work leaders. 11. Delay in implementation of the recommendation of QIT’s. Implement suggestion immediately If not possible, communicate. 12. Measurement difficulties:- Set objectives and standards in verifiable mode. Use standard questionnaire. Carry out periodic survey

Current State of Pharmaceutical Manufacturing:

Current State of Pharmaceutical Manufacturing Not state-of-art compared to other industries Achieve reasonable quality –but at great effort and cost Manufacturing is 25% of expenses –equal to R&D investment Factory/equipment utilization rate about 15% Product waste up to 50% for some products Inability to predict effects of scale-up Lack of agility –usually takes years to bring up a new production site Operations fragmented around globe Inability to understand reasons for manufacturing failures

Consequences of State :

Consequences of State High cost and low efficiency of manufacturing Drug shortages due to inability to manufacture Slowed development/access for investigational drugs Partly due to lack of clarity about IND stage regulatory requirements Need for intensive regulatory oversight

Characteristics of Desired State:

Characteristics of Desired State Manufacturers have extensive knowledge about critical product and process parameters and quality attributes Manufacturers strive for continuous improvement FDA role: Initial verification, subsequent audit No manufacturing supplements needed

Barriers to Desired State:

Barriers to Desired State Lack of trust Lack of scientific knowledge Upfront investment requirements Legacy products Bureaucratic resistance (in firms)

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Total Quality Management In Pharmacy Education – Potentials- Dr.G. Vidya Sagar http://www.pharmainfo.net/reviews/total-quality-management-pharmacy-education-potentials gvrr416@gmail.com

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