Amrita bhat Tybms /c 144 Project : total quality managemant

IntroductionTQM is a management philosophy, a paradigm, a continuous improvement approach to doing business through a new management model. The TQM philosophy evolved from the continuous

improvement philosophy with a focus on quality as the main dimension of business. Under TQM, emphasizing the quality of the product or service predominates. TQM expands beyond statistical process control to embrace a wider scope of management activities of how we manage people and organizations by focusing on the entire process, not just simple measurements.

TQM is a comprehensive management system which:

Focuses on meeting owners’/customers’ needs by providing quality services at a cost that provides value to the owners/customers

Is driven by the quest for continuous improvement in all operations

Recognizes that everyone in the organization has owners/customers who are either internal or external

Views an organization as an internal system with a common aim rather than as individual departments acting to maximize their own performances

Focuses on the way tasks are accomplished rather than simply what tasks are accomplished

Emphasizes teamwork and a high level of participation by all employees

Total Quality Administration (TQM) is definitely an approach which seeks to enhance quality as well as performance that will meet or even exceed client expectations. This is often achieved through integrating just about all quality-related features and processes through the company. TQM discusses the general quality measures utilized by an organization including controlling quality style and improvement, quality manage and upkeep, quality enhancement, and high quality assurance. TQM considers all high quality measures taken whatsoever levels as well as involving just about all company work

At its core, Total High quality Management (TQM) is really a management method of long-term achievement through client satisfaction. In the TQM work, all members of the organization take part in improving procedures, products, services and also the culture by which they function. Total Quality Management (TQM) is not a new concept in the Business World; it has been in practice since the development of the traditional management concepts. Although Total Quality Management is taken as an important practice in the manufacturing sector, but reality is that it is equally important for the services sector. Total Quality Management (frequently called as ‘TQM’) is a phenomenon, a management technique, and a process by which an organization ensures that its business operations are carried on in accordance with the set standards of quality (Shim & Siegel, 1999). As the term suggests, Total Quality Management does not only take into account the manufacturing processes, but it includes the quality management at all levels and stages of business operations; from purchase of raw materials to the final distribution of the finished products.

Total quality management plays important role in the production process, as it helps in creating long term relations with customers and result in to sustainability of the company . In the age of technology , with the availability advanced methods of testing available it has become easier to maintain the quality of products in today’s world

It requires the employees to participate in the improvement process and take initiatives that help the organization achieve superior quality in the long run. Several organization the world over have adopted newer quality management practice due to various reasons, as that is what difference them from others in the era of mounting pressures.

Total Quality Management is a widespread and ample theme. Hence, there are found several definitions of TQM in the literature because of different aspects from the authors. Jack Hradesky (1995) gave a good and summarized overview about TQM “Total Quality Management (TQM) is a philosophy, a set of tools, and a process whose output yields customer satisfaction and continuous improvement.”

TQM combines cultural-changing tactics and structured technical techniques whose focus is on satisfying the needs of internal and external customers. TQM requires that the executives are involved and committed, not just interested, and that the focus is on implementation. Results of TQM include error-free processes which deliver products and services fit for use, on time, with competitive pricing and good value.

It is possible to make significant improvement in quality and at the same time make products and services available at lower cost than that offered by the competition. Much of the success enjoyed by Japanese manufactures during the seventies and eighties is attributes to this phenomenon.

QUALITY:-

1. Quality means fitness for use.

2. Quality means productivity, competitive cost, and timely delivery, total customer satisfaction.

3. Quality means conformance to specification and standard.

4. Conformance to requirements.

5. Quality is what the customer says

6. Quality means getting every one to do what they have agreed to do and to do it right the first time and every time.

TOTAL QUALITY :-

It means all the people of the organization are committed to product quality by doing right things right, first time, every time by  employing organization resource to provide value to customer

According to International Organization for standards defined TQM as:

“TQM is 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 the society.

Total = Quality involves everyone and all activities in the company.

Quality = Conformance to Requirements (Meeting Customer Requirements).

Management = Quality can and must be managed.

TQM = A process for managing quality; it must be a continuous way of life; a philosophy of perpetual improvement in everything we do.

Total quality management ensures that every single employee is working towards the improvement of work culture, processes, services, systems and so on to ensure long term success.

Walter Shewart

• In 1920s, developed control charts

• Introduced the term “quality assurance”

W. Edwards Deming

• Developed courses during World War II to teach statistical quality-control techniques to engineers and executives of companies that were military suppliers

• After the war, began teaching statistical quality control to Japanese companies

Joseph M. Juran

• Followed Deming to Japan in 1954

• Focused on strategic quality planning

Armand V. Feigenbaum

• In 1951, introduced concepts of total quality control and continuous quality improvement

Philip Crosby

• In 1979, emphasized that costs of poor quality far outweigh the cost of preventing poor quality

• In 1984, defined absolutes of quality management—conformance to requirements, prevention, and “zero defects

Total Quality Management – A Quality Revolution

Quality is one of the most misunderstood issues in business today, yet it’s central to the survival of even the largest organization .Quality is defined by customer. The perspective of customer isn’t always effective addressed by western companies. In many cases, Japanese competitors have gained an edge over their Western counterparts because they understand the need to satisfy their customer requirements. Markets for home audio and video are cases in points, car and microchip manufacturing are examples where Western busines are facing increasing competition.

Quality isn’t just concerned with whether a product or service meets the claims made for it. Today’s quality is much more than this. The modern concept quality embraces how company meets all its customer requirements including how they are greeted on telephone, how fast sales staff respond to request for quotation , having new products and service when required , and even ensuring the invoice is correct.

The Quality management system (QMS) designed to conform quality system standards is the straight point for Total Quality Management (TQM). The realization that applying quality discipline to all activities would result in more efficient and competitive company led to evolution of TQM. TQM aim is to ensure that each activity contributes to achieving the business’s key objectives and carried out efficiently. The basic philosophy of total quality is “do the right things right first time”

TQM generally requires a change in how company operates. Every department, every activity , every person at every level ,starting at the top of organization, must be wholly committed to the TQM philosophy

TRADITIONAL MANAGEMENT AND TQM COMPARISON

Total quality management has changed the traditional management style forever. It was a very radical movement those days. Some of these changes are radical even today. Few of these changes are discussed below.Traditional way of management focused on internal activities. Quality had a meaning which was totally internally defined. Products or services provided by organization were assumed to be good in quality, if this organization has done its best in producing that product or service. But in total quality management, focus is the customer. So that ultimate decider of the quality is the customer. Fitting to the customer requirement was the least requirement while delighting them is the ultimate goal

Traditionally people thought bad quality products are due to the workers who do not perform their job correctly. One of the major differences between total quality management and traditional management style is the assignment of the responsibility of the quality to the management. Especially responsibility of the quality goes into the middle level management in the operational level.

Total quality management is an organization wide movement. All the organization has to be in unity to apply TQM principles. Total quality management, unlike traditional management calls for high amount of team working. Team building, specially cross functional teams are feature of TQM. These teams will provide the necessary momentum to the implementation process and will propel the system forward, with very less resistance.

TQM believes in quality assurance rather than checking. Quality is inbuilt to the system, so that products are assured to be in good quality.

Some decision like narrowing down the supplier base is total quality management concepts used for this purpose, which is revolutionary still today.Unlike in traditional management style, total quality management makes decisions on facts and figures. Therefore problems are identified correctly. Therefore solutions are well planned.TQM depends on cyclic thinking. Also it is continuous. Therefore improvements are small, stable and continuous in nature. This is also known as Kaizen. These events are used in teambuilding, brain storming and decision making.

There are many other differences between the old or the traditional way of management to the total quality management. In the bigger picture, TQM has basically changed the culture and the thinking patterns of the organization.

The objective of Total Quality management is to satisfy customer requirements as efficiently and profitably as possible. This requires the continuous improvement of performance as fast as developments allow. This is why the commitment to TQM must be both absolute and ongoing.

1) Do the right things. this means that only activities that help a business to satisfy its customers requirements are acceptable. Others activities should be analyzed and, if they re unnecessary be discontinued.

2) Do things right. This means that all activities should be performed correctly, so that the output from the activity conforms to customer’s requirement.

3) Do things right at first time, every time. If this can be achieved, then no more money should be wasted on checking and scrapping output or correcting errors. This type of environment is based on the concept of preventing errors from arising in the first place.

Total quality management is a structured effort by employees to continuously improve the quality of their products and services through

proper feedbacks and research. Ensuring superior quality of a product or service is not the responsibility of a single member. Every individual who receives his /her paycheck from the organization has to contribute equally to design foolproof processes and systems which would eventually ensure superior quality of products and services. Total Quality management is indeed a joint effort of management, staff members, workforce & suppliers in order to meet and exceed customer satisfaction level. One can’t just blame one person for not adhering to quality measures. The responsibility lies on the shoulder of everyone

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 Improvement teams Reducing product and service costs Systems to facilitate improvement Line management ownership Employee involvement and empowerment Recognition and celebration Challenging quantified goals and benchmarking Focus on processes / improvement plans

Total Quality Management Model

TQM requires a new process thinking mindset. We must realize that everything we do is part of a process. Our focus shifts from managing outcomes to managing and improving processes; from what to do to how to do the processes better. Quality performance expands to include how well each part of the process works and the relationship of each part to the process. Also, process improvement focuses on continuously achieving the greatest potential benefit for our customers.

No two organizations have the same TQM implementation. There is no recipe for organization sucess, however, there are a number of great TQM models that organizations can use. These include the Deming Application Prize, the Malcolm Baldrige Criteria for Performance Excellence, the European Foundation for Quality Management, and the ISO quality management standards. Any organization that wants to improve its performance would be well served by selecting one of these models and conducting a self-assessment.

The simplest model of TQM is shown in this above TQM diagram. The model begins with understanding customer needs. TQM organizations have processes that continuously collect, analyze, and act on customer

information. Activities are often extended to understanding competitor's customers. Developing an intimate understanding of customer needs allows TQM organizations to predict future customer behavior. TQM organizations integrate customer knowledge with other information and use the planning process to orchestrate action throughout the organization to manage day to day activities and achieve future goals. Plans are reviewed at periodic intervals and adjusted as necessary. The planning process is the glue that holds together all TQM activity.

TQM organizations understand that customers will only be satisfied if they consistently receive products and services that meet their needs, are delivered when expected, and are priced for value. TQM organizations use the techniques of process management to develop cost-controlled processes that are stable and capable of meeting customer expectations.

TQM organizations also understand that exceptional performance today may be unacceptable performance in the future so they use the concepts of process improvement to achieve both breakthrough gains and incremental continuous improvement. Process improvement is even applied to the TQM system itself

The final element of the TQM model is total participation. TQM organizations understand that all work is performed through people. This begins with leadership. In TQM organizations, top management takes personal responsibility for implementing, nurturing, and refining all TQM activities. They make sure people are properly trained, capable, and actively participate in achieving organizational success. Management and employees work together to create an empowered environment where people are valued.

Total Quality management can be divided into four categories:

Plan

Do Check Act

Also referred to as PDCA cycle.

Planning Phase

Planning is the most crucial phase of total quality management. In this phase employees have to come up with their problems and queries which need to be addressed. They need to come up with the various challenges they face in their day to day operations and also analyze the problem’s root cause. Employees are required to do necessary research and collect relevant data which would help them find solutions to all the problems.

Doing Phase

In the doing phase, employees develop a solution for the problems defined in planning phase. Strategies are devised and implemented to overcome the challenges faced by employees. The effectiveness of solutions and strategies is also measured in this stage.

Checking Phase

Checking phase is the stage where people actually do a comparison analysis of before and after data to confirm the effectiveness of the processes and measure the results.

Acting Phase

In this phase employees document their results and prepare themselves to address other problems.

Total Quality Management Tools There are a wide range of TQM tools. The following is a list of widely used tools. There is no tool that is best for every application; the

knowledgeable practitioner is aware of a rich variety of tools and uses the appropriate one(s).

• Process maps: One of the important keys to understanding how to improve a process is to map the process. While there are several different approaches to process mapping, the key is to determine who does what at each step of the process. Often, the simple drawing of a process map is sufficient to solve many quality problems because the map makes it so obvious where defects can be introduced.

• “Poke-A-Yoke”: This concept of the Japanese management philosophy is to make a process fool proof. The idea is to design the process in such a way that it is self checking or incorporates process steps that cause immediate detection and possible correction of any defect.

Simple examples include color-coding and special keying of parts to ensure that they are assembled the correct way.

• Statistical Tools: One of Deming’s major contributions to the quality movement was the introduction of statistically grounded approaches to the analysis of defects. Without the use of these tools, one can often make incorrect decisions regarding the cause of a problem. This can often lead to exactly the opposite effect of that being sought. Included in this set of tools are statistical process control (SPC) charts, Pareto Charts, and histograms.

• Force Field Analysis: This tool asks one to diagram the forces (policies, culture, and so forth) that are resisting a desired change and the forces that support the change. This assists one in clearly determining the degree of difficulty of making change and exactly where effort will be needed. The supporting forces are places where assistance can be expected.

• Root Cause Analysis (Five Whys): The Japanese popularized this tool. It consists of asking a series of questions (whys) until one uncovers the root cause of a defective product. The objective is to determine why a defective product was produced; this is to be contrasted with the usual approach of just fixing the defective product or replacing it.

• Fishbone Diagram (Ishakawa Diagram): This tool is also called a cause-and effect diagram. It is used in a brainstorming session to examine factors that may influence a given situation or outcome. The causes are often grouped into categories such as people, material, method or process, and equipment. The resulting diagram takes the shape of a fishbone, hence the name.

• Loss Functions: In many manufacturing situations, one creates tolerance limits for a product. Products that fall outside of the limits are defective and those that are inside the limits are deemed good. Several difficulties arise with this approach.

First, there is always the temptation to reclassify products that are just outside the limits into the acceptable category, especially if there is a great push for quantity.

Second, and perhaps more important, the accumulative effect of several parts which are all on the extreme limits of acceptability, may lead to defective performance. The loss function tool is used to recognize that there is a cost associated with any deviation from the ideal value.

• The Plan-Do-Check-Act (PDCA) Cycle: This tool is also known as the Shewhart Cycle. Deming popularized it in Japan; as a result the Japanese refer to it as the Deming Cycle. The tool emphasizes a new plan for change. It carries out tests to make the change on a small scale, observes the effects, and finally, studies the results to determine what has been learned. The cycle is repeated as needed.

• Brainstorming: This process has become a staple of the TQM movement. The concept is to invite participants to suggest “solutions” to a problem without any evaluation of the usefulness or correctness of their ideas. Several approaches are possible, including open suggestions, rotating suggestions, or blind suggestions. There are several computer tools that have been developed to assist in this process. After a fixed period of time, or after all suggestions have been made, there is discussion of the “value” of the suggestions.

• Affinity Diagram: The affinity diagram tool is used to organize large amounts of non-quantitative (ideas, opinions, issues, etc.) information into groupings based on natural relationships between the items. It is largely a creative rather than a logical process. In a very loose sense, the affinity diagram does for ideas what statistics does for numbers, viz. extract meaning from raw data. The affinity diagram process is often used with the results of a brainstorming session to organize the resulting ideas.

Tree Diagram: This tool is used to systematically map out, in increasing detail, the full range of paths and tasks that need to be accomplished to achieve a primary goal and every related sub goal. Graphically, it resembles an organization chart or family tree.

• Prioritization Matrices: Prioritization matrices are one of a group of decision making tools that help to prioritize tasks, issues, or possible actions on the basis of agreed upon criteria. While these tools cannot make decisions, they can help to ensure that all factors are evaluated and that logical decisions are reached.

• Activity Network Diagram: This class of tools includes a wide range of project management tools used to plan the most appropriate schedule for a complex project. Typical examples are Gantt Charts and PERT charts. These tools project likely completion time and associated effects and provide a method for judging compliance with a plan .Several excellent computer programs exist for automating the work associated with this class of tool

7 Important Principles of Total Quality Management

1. Quality can and must be managed

Many companies have wallowed in a repetitive cycle of chaos and customer complaints. They believe that their operations are simply too large to effectively manage the level of quality. The first step in the TQM process, then, is to realize there is a problem and that it can be controlled.

2. Processes, not people, are the problem

If your process is causing problems, it won’t matter how many times you hire new employees or how many training sessions you put them through. Correct the process and then train your people on these new procedures.

3. Don’t treat symptoms, look for the cure

If you just patch over the underlying problems in the process, you will never be able to fully reach your potential. If, for example, your shipping department is falling behind, you may find that it is because of holdups in manufacturing. Go for the source to correct the problem.

4. Every employee is responsible for quality

Everyone in the company, from the workers on the line to the upper management, must realize that they have an important part to play in ensuring high levels of quality in their products and services. Everyone has a customer to delight, and they must all step up and take responsibility for them.

5. Quality must be measurable

A quality management system is only effective when you can quantify the results. You need to see how the process is implemented and if it is

having the desired effect. This will help you set your goals for the future and ensure that every department is working toward the same result.

6. Quality improvements must be continuous

Total Quality Management is not something that can be done once and then forgotten. It’s not a management “phase” that will end after a problem has been corrected. Real improvements must occur frequently and continually in order to increase customer satisfaction and loyalty.

7. Quality is a long-term investment

Quality management is not a quick fix. You can purchase QMS software that will help you get things started, but you should understand that real results won’t occur immediately. TQM is a long-term investment, and it is designed to help you find long-term success.

Before you start looking for any kind of quality management software, it is important to make sure you are capable of implementing these fundamental principles throughout the company. This kind of management style can be a huge culture change in some companies, and sometimes the shift can come with some growing pains, but if you build on a foundation of quality principles, you will be equipped to make this change and start working toward real long-term success.

6c’s of tqm

Commitment If a TQM culture is to be developed, so that quality improvement becomes a normal part of everyone’s job, a clear commitment, from the top must be provided. Without this all else fails. It is not sufficient to delegate ‘quality’ issues to a single person since this will not provide an environment for changing attitudes and breaking down the barriers to quality improvement. Such expectations must be made clear, together with the support and training necessary to their achievement.

2.Culture Training lies at the centre of effecting a change in culture and attitudes. Management accountants, too often associate ‘creativity’ with ‘creative accounting’ and associated negative perceptions. This must be changed to encourage individual contributions and to make ‘quality’ a normal part of everyone’s job.

3.ContinuousimprovementRecognition that TQM is a ‘process’ not a ‘programme’ necessitates that we are committed in the long term to the never-ending search for ways to do the job better. There will always be room for improvement, however small.

4.Co-operationThe application of Total Employee Involvement (TEI) principles is paramount. The on-the-job experience of all employees must be fully utilised and their involvement and co-operation sought in the development of improvement strategies and associated performance measures.

5.CustomerfocusThe needs of the customer are the major driving thrust; not just the external customer (in receipt of the final product or service) but the internal customer’s (colleagues who receive and supply goods, services or information). Perfect service with zero defects in all that is acceptable at either internal or external levels. Too frequently, in practice, TQM implementations focus entirely on the external customer to the exclusion of internal relationships; they will not survive in the short term unless they foster the mutual respect necessary to preserve morale and employee participation.

6.Control Documentation, procedures and awareness of current best practice are essential if TQM implementation are to function appropriately. The need for control mechanisms is frequently overlooked, in practice, in the euphoria of customer service and employee empowerment. Unless procedures are in place improvements cannot be monitored and measured nor deficiencies corrected. Difficulties will undoubtedly be experienced in the implementation of quality improvement and it is worthwhile expounding procedure that might be adopted to minimize them in detailBenefits of Total quality management

1. Reduction of defects because TQM promotes quality awareness and participation of all members of the organization, not just the QA or QC department.2. Total quality management system leads to ease of problem solving. Through measurements such as SPC and other techniques such as failure analysis, defects and failures (even potential failures) can be identified.3. TQM also leads to continuous improvement of processes and products. TQM system should also improve the efficiency of people and machine. 4. TQM leads to quality products, which leads to customer satisfaction. 5. By reducing defects and improving machine and personnel efficiency, TQM should lead to cost savings and profitability improvement (bottomline). 

Total Quality Management is a system of continuous improvement that involves all workers in a business from upper management to production line workers. The focus of the improvement program is to improve customer service and reduce waste in the business. Quality improvement teams use problem-solving techniques and analysis to identify and eliminate weaknesses in the company.

Production DisruptionImplementing a Total Quality Management system in a company requires extensive training of employees. The employee training includes instruction in problem solving techniques and the tools to evaluate a process and identify weaknesses such as statistical process control, Pareto diagrams and brainstorming techniques. During the initial training period, productivity can decline. Meetings for quality improvement teams also take workers away from their duties, which also reduce productivity. While the improvements do reduce lead time, eliminate waste and improve productivity, the beginning stages of implementing Total Quality Management in an organization can reduce worker output.

Lowers Production CostsA Total Quality Management program eliminates defects and waste, which reduces production costs in a business. As teams gather to identify and eliminate weaknesses in the business, the company continues to enjoy reduced costs and higher profit. Quality improvement teams can eliminate defects, reduce lead time and identify redundancies in the production process that can significantly add to the profit the company earns.

Employee ResistanceTotal Quality Management requires change in mindset, attitude and methods for performing their jobs. When management does not effectively communicate the team approach of Total Quality Management, workers may become fearful, which leads to employee resistance. When workers resist the program, it can lower employee morale and productivity for the business. Total Quality Management uses small incremental improvements to move the business forward. It can take years for a company to enjoy the benefits of the program.

Employee ParticipationOnce workers understand their participation and involvement in Total Quality Management is essential to its success, morale and productivity improve. Workers become empowered through participation on quality improvement teams. Businesses can improve morale further by recognizing improvement teams that make meaningful changes in the production process to reduce or eliminate waste.

PHARMACEUTICAL INDUSTRY

INTRODUCTION:

Pharmaceutical company develops, produces, and markets medical drugs These companies can deal in generic or brand medications.

They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

Generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection.

The generic drug may still have a patent on the formulation but not on the active ingredient. Pharmaceutical formulation, in pharmaceutical is the process in which different chemical substances are combined to a pure drug substance to produce a final medicinal products.

PHARMACEUTICAL INDUSTRY IN INDIA:A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 5 - 10 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. It’s playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control. The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and

injectables. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical formulations.

Effect of TQMSurvival of a pharmaceutical organization quality is a major differentiator. TQM implementation is not only a means of organizational growth but a basic requirement for its continued existence. A preliminary step in TQM implementation is to assess the organization's current reality. Relevant preconditions have to do with the organization's history, its current needs, precipitating events leading to TQM and the existing quality of employee 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.Moreover if the organization has a track record of effective responsiveness to the environment, and has been able to successfully change the way it operates when needed, TQM implementation will be easier. On the other hand if it has been historically reactive and has no skill at improving its operating systems, there will be both employee skepticism and a lack of skilled change agents. Under this condition, 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 unstable funding base, weak administrative systems, lack of managerial skill, or poor employee morale, TQM would not be appropriate.

SIGNIFICANCE OF INDIAN PHARMA INDUSTRY

1. Competent workforce:India has a pool of personnel with high managerial and technical competence as also skilled workforce. It has an educated work force and English is commonly used. Professional services are easily available.2. Cost-effective chemical synthesis:Its track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.3. Legal & Financial Framework:India has a 66 year old democracy and hence has a solid legal framework and strong financial markets. There is already an established international industry and business community.4. Information & Technology:It has a good network of world-class educational institutions and established strengths in Information Technology.5. Globalization:The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing.6. Consolidation:For the first time in many years, the international pharmaceutical industry is finding great opportunities in India. The process of consolidation, which has become a generalized phenomenon in the world pharmaceutical industry, has started taking place in India.

FUNCTIONS OF A PHARMACEUTICAL COMPANY:

FOUR MAJOR FUNCTIONS:

1)Research and Development:

Drug Discovery

It is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen and manipulating these pathways using molecular biology or Biochemistry. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.

Drug development:

It refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate formulation as well as to establish safety.

2) Regulators :

This department is responsible for getting approval or license for the particular drugs manufactured by their company. Every drug has to be approved by the central body before it is marketed to the customers. Regulators are doing the following activities in a pharma company

1. Keeping in touch with doctors in the government hospitals regularly

2. Introducing the newly developed drugs to the doctors, then drugs will be given to the patients by doctors’ prescription.

3. Doctors will analyze the patients normalcy, after they have the drugs

4. As per the patients improvements, a separate report will be prepared for the drug and will be given to the regulatory department.

5. These report will be submitted before the DCD (Drug Control Department) by regulatory department

6. As per the doctor’s report drug will be licensed by DCD.

3) Production:Once the drug is approved by the DCD, Regulatory dept will give the MFR (Master Formulation Record) to the Production Department. As per the MFR, following important processes will be taken in a pharmaceutical company to produce tablets.

Dispensing of Raw materials: With the help of R & D, the required raw materials will be purchased by the materials department to the purpose of production.

 Drying: In which chemical component will be completed dried to remove the water contents.

Sifting: Small dust particles will be removed from the raw materials by these process

Slugging: In this process, the chemical components will be made as round shaped particles for further process.

Multimill : Here the round shaped particles will be broken and make it as powder.

Compression: These processed chemical substances will be compressed to get the desired shape such as vowel or round. Now tablets will be ready for packaging process.

 Packaging: There are two types of process

Strip Packing: Here drugs will be packed by Aluminium foils+

Blister Packing: Tables will be covered by PVC (Poly Vinyl Chloride) foils. Then foils will be packed in Carton, each carton will have leaflet with adequate information.

4 Quality:

Quality Assurance: This division will ensure the following things with the help of R&D.

1. Weight,

2. Hardness

3. Thickness

4. Friability ( Tendency to loose weight)

5 Marketing Division:

Every Pharmaceutical company will have their own marketing and sales strategies to introduce the drugs into the market. Drugs will be pushed into the market through doctors normally. Doctors will be approached by sales professionals often. Apart from that they will take care of retail, distributor and wholesale sales

TOTAL QUALITY MANAGEMENT IN INDIAN PHARMA INDUSTRY

The pharmaceutical industry is a vital segment of health care system which is regulated heavily because; any mistake in product design or production can severe, even fetal. The poor qualities of drug are not only a health hazard but also a waste of money for both government and individual consumers. So, the maintenance of the quality with continuous improvement is very important for pharmaceutical industries. From this concept Total Quality Management (TQM) was established. The aim of TQM is prevention of defects rather than detection of defects. So TQM is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of healthcare system and also protect waste of money for both government & individual consumer. Total Quality Management (TQM) acts as an umbrella under which everyone in the organization can strive for customer satisfaction, reduce cost and wastage and increase the efficiency of services. Quality Management practices including ISO implementation in Indian pharmaceutical industries to explore the relationship between Total Quality Management practices and performance of the company. It also attempts to identify and analyze the significant factors affecting Total Quality Management implementation in Indian Pharmaceutical Industries.

The Indian pharmaceutical industry mainly comprises of Indian subsidiaries of Multi National Companies (Glaxo Smithkline, Merck, Pfizer etc.), Indian owned companies (Ranbaxy, Dr. Reddy’s, Cipla, Glenmark, Cadila) and numerous small scale industries scattered in all parts of India. These companies can also be classified on the basis of annual turnover, number of patents, number of employees and number of formulations.

Total quality management (TQM), which was effective in the manufacturing sector, can be used to improve health care

services. However, critical differences should be considered for successful implementation of TQM. These include the professional nature of the medical practice, the difficulty involved in evaluating the process, non-applicability of TQM languages in the health sector and the possible occurrence of conflicts between health care providers and administratorsAnother concept of TQM is continuous improvement or KAIZEN. Traditionally change meant for major organizational restructuring. But Japanese introduced the idea of gradual improvement. The idea behind this was, ‘Small changes can be done quickly, easily and continuously without any significant investment. Small- Proceedings of the 2010 International Conference on Industrial Engineering and Operations Management

Dhaka, Bangladesh, January 9 – 10, 2010

Small changes make big improvements for the organizations, employees and customers’. Japanese called it

‘Kaizen’ A regular habit of thinking new ideas.

There are two approaches adopted by the companies for continuous improvement:

a. The PDCA cycle: Plan-Do-Check-Act and

b. Benchmarking: The ability to learn and study how others do things is an important part of continuous improvement.

ISO 9000 standards:

The International Organization for standardization (ISO) is an international organization whose purpose is to establish agreement on

international quality standards. It has been created to develop and promote quality. ISO 9000 consists of a set of standards and a certification process for companies. By receiving ISO 9000 certification, companies demonstrate that they have met the standards specified by the ISO. The standards are applicable for all types of companies and have gained global acceptance. In many industries ISO certification has become a requirement for doing business.

Effect of substandard Quality:

The Bhopal gas tragedy occurred on December 03rd 1984, when tons of methyl isocyanate, hydrogen cyanide and other lethal gases began spewing from Union Carbide’s pesticide factory in Bhopal. Nobody outside the factory was warned because the safety siren was turned off. By the time the people of Bhopal could realize anything it was too late. Thousands of people lost their lives in this tragedy. The Bhopal disaster was a total failure as described by Lulla S. showing failure of product, process, system and management.

Quality Management and Pharmaceutical Industry:

Apart from safety, the pharmaceutical industry is heavily regulated and the reasons are obvious: mistakes in product design or production can have severe, even fatal, consequences for patients (Gough, 1999).

Examples of recall of the drugs from the market are:

a) VIOXX- Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Vioxx was used to reduce pain, inflammation and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; etc. It got approval from USFDA in 1999. Merck, the manufacturer of Vioxx, voluntarily withdrew it from the

market due to safety reasons- increased risk of Heart attacks. Within this period nearly 28000 or more cases of heart attack or sudden cardiac deaths were caused by Vioxx.

b) Thalidomide (Kevadon) was launched in 1957 as a treatment for morning sickness during pregnancy.

Heavily marketed, its sales soon spread abroad. It took four years before the connection was made between the drug and its side-effects. By which time at least 10,000 children had been born with shortened limbs and other complications. The scandal transformed drug regulation. Drug Research regulations made more stringent.

To ensure quality and safe products, pharmaceutical companies build their quality approach around Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and their In- house Standard Operating Procedures (SOPs).

Thus quality is important for pharmaceutical companies due to

1) Stringent Regulatory requirements;

2) Competitive market;

3) Global competition;

Comparion between Indian and western pharma industry with reference to TQM

An international quality study (IQS) conducted by Ernst & Young for the American Quality Foundation suggested that quality is a crucial factor in major manufacturing organizations in the USA, Canada, Japan and Germany (Sohal and Eddy, 1994). The International Quality Study has made a significant contribution to understanding the link between

quality management practices and business benefits among organizations in the USA, Canada, Japan and Germany. Kim et al. (1997) studied the quality strategies and improvement programs amongst leading manufacturing companies in western economies and found that the most successful firms followed a step-by-step quality staircase to achieve competitive edge. The steps to climb on are conformance, reliability, performance and customization and a sequential follow up of these steps leads to achieving competitive edge. Lassaad Lakhal et al. (2004-2005) conducted a study to find out the relationship between quality management practices and their impact on performance. They collected data from 133 Tunisian companies. The results revealed a positive relationship between Quality Management Practices (QMP) and organizational performance. Calvin London (2005) studied Management effects on Quality policy implementation in pharmaceutical companies and the nature and extent of structured programs for policy implementation. The study revealed that the levels of commitment and involvement shown by management (both senior and middle management) had significant effects on the success of the quality policies. Where the perceived levels of support were lowest, policies took a long time to be implemented, consumed resource and resulted in approved policies that did little to meet their overall objectives for the company.

The role of senior management is one of the most significant factors in creating successful cultural change and policies need to originate from a senior management level.

The picture is, however, different and unclear for developing economies. Quality literature abounds with successful examples and cases of western economies adopting quality initiatives, but very little has been reported on quality issues in developing economies. Only recently,

reports are appearing on quality studies relating to work culture, impacts of government policies, technological diversification, etc. specific to developing countries.

In the case of India, only a few attempts have been made in the past to understand how Indian pharmaceutical companies are competing in domestic and international markets.

Motwani et al. (1994) conducted a study to identify the degree to which quality management practices were present in Indian manufacturing organizations. The study showed that the modern concepts of quality management were practiced by the large Indian manufacturing organizations. Quality certification is becoming an acceptable way of enforcing quality concepts in India. According to a 1995 survey (Confederation of Indian Industries, 1995) among ISO 9000 certified companies, 54 per cent of 330 respondents stated that there had been an improvement in their product and process quality after obtaining certification.

STEPS INVOLVE IN IMPLEMENING TQM

1 Obtaining CEO Commitment

2 Educating Upper-Level Management

3 Creating Steering Committee

4 Outline the Vision Statement, Mission Statement, & Guiding Principles

5 Preparing a Flow Diagram of Company Processes

6 Focus on the Owner/Customer (External) & Surveys

7 Considering the Employee as an Internal Owner/customer

8 Providing a Quality Training Program

9 Establishing Quality Improvement Teams

10 Implementing Process Improvements

11 Using the Tools of TQM

12 Knowing the Benefits of TQM

Continuous Improvement

1 Obtaining CEO Commitment, and

2 Educate Upper-Level Management

The first and second steps are . . .

The first step in implementing TQM is to obtain the total commitment, involvement, and leadership of the CEO and upper-level management.

The second step is to teach the CEO and upper-level management how to conduct the following:

Undergo quality training Commit to TQM and

provide the necessary resources of time and money to permit improvement

Assist in the development of the corporate vision statement, mission statement, guiding principles, and objectives

Serve as a model of expected behavior

Actively lead the way by participating in the activities of the quality steering committee and company training

Drive fear out of the organization

Provide suitable recognition for those who contribute to the quality mission

Drive decision making and problem resolution to the lowest practicable level

3 Creating a Steering Committee

Upon completion of upper management’s commitment and training, a steering committee must be created to guide the company through the process of implementing TQM. The role of the steering committee and the processes the committee follows are listed here.

Steering committee roles are . . .

* Review and evaluate customer surveys.* Determine processes to be improved, based on customer and

employee recommendations, surveys, and a knowledge of existing problems.

* Appoint task process improvement teams and ensure they receive proper training.

4 Outlining the Vision Statement, Mission Statement, & Guiding Principles

In developing the fourth step, important principles to consider including in the company’s vision statement, mission statement, and guiding principles are as follows:

Owner/customer Satisfaction

Improved Safety Elimination of errors and

defects

Doing things right, the first time

Reputation as the best in the field

Continuous Improvement Employee Empowerment

5 Preparing a Flow Diagram of Company Processes

A mechanical contracting firm created the TQM flow diagram illustrated in the figure below to implement quality processes within the company.

6 Focusing on the Owner/Customer (External) & Surveys

Still one of the best ways of accomplishing quality improvement is obtained by focusing on customers’ concerns, and by learning what those concerns are through owner/customer surveys. Much can be provided by studying how your owner/customer feels about your service, your attitude, and whether you would be recommended to another owner/customer

Successful TQM companies ask their owner/customers the following questions.

1. How well do they deliver what they promise?2. How often do they do things right the first time?3. How often do they do things right on time?4. How quickly do they respond to your request?5. How accessible are they when you need to contact us?

7 Considering the Employee as an Internal Owner/Customer

In order to conduct an analysis of the internal processes within the company, the following steps are to be applied to the internal processes within a company.

Listing several of internal owners/customers within your company

Choosing one of these owners/customers to focus on for the application of this technique

Determine the Outputs (products, services, information) that must be provided to this internal owner/customer

Determine the work Processes company uses to produce these output.

8 Providing a Quality Training Program

The successful TQM company provides, training to employees in the order illustrated in the figure below. The training program must begin with upper management & then training must be provided for the remaining management, and the in-house trainers and facilitators. It cannot be emphasized enough that if upper management is not trained and is not a viable, visible participant from the beginning, then the program will not survive.

A Upper Management

B Remaining Management

C In-House Trainers & Facilitators

D Front-Line Supervisors

E Non-Supervisory Employees

F Team Training

G Training of Subcontractors & Suppliers

Continuous Training

9 Establishing quality improvement teams:

In establishing quality improvement teams, a smaller company might assign one quality improvement team. Larger firms might assign several, possibly with one quality lead team as a guide for the other teams. Areas where quality improvement teams could begin investigating for possible improvement are:

Increased Employee Value Informed Employees Technical Training Quality Training

Employee Suggestions Employee Participation Higher Quality of Artistry

10 Implement Process Improvements

Management interest and support Focus on customer satisfaction Identification of areas needing improvement Employee involvement Cooperative attitude between elements of the company Viewing every person who is on the receiving end of a

process as a customer Fear driven from the company Correctly composed teams A system for selecting processes to be improved Training for all employees in quality awareness Training for teams in team procedures and disciplined

problem solving Improved communications outside the company

The structure approach to process improvement1. Problem is brought to the attention of the steering committee2. Steering committee forms a team to examine the process and

make necessary recommendations for improvement3. Team meets, reviews its mission, and determines how often

it will meet4. Training is initiated for team members5. Team meets weekly for an hour or two to analyze the

problem and develop a solution6. Solution is initiated on a pilot basis7. Results of pilot study are examined

Company profile

Wanbury was incorporated in 1990 as a private limited company under the name of Pearl Distributors Private Limited. The name of the company was changed to 'Pearl Organics Private Limited on January 17, 1991 and the company was converted into a public limited company on August 6, 1991.

Wanbury is the fastest growing pharma company amongst top 100 companies in India as per ORG-IMS has strong presence in domestic branded formulations. Wanbury’s major thrust area also lies in Active Pharmaceutical Ingredient (API) and Contract Research and Manufacturing Services (CRAMS). It has a presence in Spain through its branded formulation business - Cantabria Pharma S. L acquired in 2006.

The company is having 3 API manufacturing facilities including 2 US FDA approved multi-product API facilities for regulated markets.

Product range of the company includes:

Coriminic table Cpink table Nock 2 tab Senasof tab Zevanuron Rabiplus cap Folinine Cpink-s Nuture Adtrol 200mg

Milestones:

2008Wanbury opened an office in Zurich, Switzerland for its CRAMS business. Wanbury incorporated Wanbury Global FZE in Middle East for expanding its global business.Wanbury achieved consolidated

turnover of Rs. 630 crore for 18 months period ended 30th September 2008. Rabiplus was awarded ‘Best Brand Launch’ by ORG-IMS as it did sales of Rs.13.8 crores in launch Year. Wanbury is the fastest growing company among top 100 companies in India as per ORG-IMS.

2007Doctor’s Organics Chemicals merged with Wanbury. Wanbury entered into a strategic association with Bravo Healthcare Wanbury incorporated Ningxia Wanbury Fine Chemicals Co to source raw materials from China. Wanbury approved as preferred Vendor by Pfizer (US) for Contract Research and Manufacturing Services (CRAMS). Cpink was awarded ‘Best Brand Launch’ by ORG-IMS as it did sales of Rs. 11 crores in launch year. Wanbury is the fastest growing company among top 100 companies in India as per ORG-IMS.

2006Wanbury achieved 100 crore turnover. Pharmaceutical Products of India (PPIL) merged with Wanbury pursuant to BIFR order. Wanbury acquired Cantabria Pharma S.L. with presence in ethical branded formulations in the Spanish market. Wanbury crossed 1000 employees mark. Wanbury became the world’s largest producer of Metformin with production of 4500 MT.

2005Wanbury acquired Doctor’s Organics and Chemicals, having a US FDA approved facility for manufacturing multi-product API’s.

2004Wander merged with Pearl Organics Limited and Pearl Organics renamed as Wanbury Wanbury set up its R & D center in Navi Mumbai for API. Wanbury started using SAP as a business transaction system.

2002Pearl Organics got US FDA approval for Patalganga plant.

1996Pearl Organics entered into a strategic alliance with Wyckoff Chemicals (US) to market its API in US.

1995Pearl Organics acquired plant of Brij Chemicals Pvt at Patalganga (Maharashtra).

1992Pearl Organics established its first plant in Tarapur for manufacturing API’s.

1991Pearl Distributors Pvt went public and was renamed as Pearl Organics.

1990Incorporated as Pearl Distributors Pvt

Achievements/ recognition:-

Wanbury ranks 47th as per ORG-IMS (Jan-2009)  Cpink awarded “Best Brand Launch' by ORG IMS (06-07)   Rabiplus awarded “Best Brand Launch' by ORG IMS (07-08)  World's largest producer of Metformin Fastest growing company amongst top 100 companies in the

domestic market as per ORG IMS.

What does wanbury do to make continuous improvement in TQM PROCESS

Total Quality Management (TQM) focuses on customer satisfaction through producing high-quality goods and services. To validate that all parts of an organization are functioning well, companies use a number of quantitative measures, such as developing baseline measurements for a process or product. When compared to current performance, the measures are used to determine if improvements are occurring. If a company continues to use quantitative measures over a long period of time, it may bring about "continuous improvement.

Company calculate baselines for the performance of each process. This

is necessary to apply TQM effectively throughout organization. For example, one baseline might be that it takes four days from the time a customer places an order to the time the order is fulfilled and shipped. To improve customer satisfaction, a company might work to reduce this length of time. Another baseline measure is the number of errors made by employees when fulfilling orders.

Company Measure the baseline for defects in goods and services. The goal of company is zero defects. It Determine the causes for the defects and correct them. An example of a defective product would be a flashlight that does not work.

Company redesign the existing process to make it more effective by saving time, money, reducing defects and increasing customer satisfaction. Over the next year, measure the performance of the process and compare it to the baseline to see if improvements are working.

Company periodically reevaluate the process to see what additional changes could be made that would continue to reduce costs, save time,

reduce defects and increase customer satisfaction. Redesign the process as needed.

Company implement the redesigned process and measure the effect of the changes as before. If the poor quality of components or services provided by suppliers is negatively impacting production of goods and services, begin working with the supplier to overcome this problem. This may entail providing new specifications, helping the supplier to find new sources of materials, or finding new suppliers

Company Benchmark the process or goods and services against other companies. When selecting benchmark companies, it use not only those in their own industry but also in other industries. The lessons may be learned from studying the best practices of outside companies.

Company compare their processes to the benchmark processes to determine further areas that may be improved. Redesign their process and implement the changes

It measure the effect of the changes and determine if they are working. Repeat the cycle. To effectively determine if things are improving, measurements must be ongoing. Monthly or quarterly measurements are often used.

Factors affecting TQM process

1. 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.

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.

3. Fear of change. Scepticism 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.

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.

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.

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 mechanisiom Develop commitment, bring about a cultural change, resources will follow suit.

DRAWSBACKS OF TQM

Some Total Quality Management detractors have noted that long-range plans advocated by TQM may limit an organization’s flexibility and agility. TQM teaches that a long-term plan is required to achieve a

complete quality transformation, but a long-term plan that has been pursued for a long period may become an end unto itself. Completion of the plan becomes the ultimate goal. Objectives the plan was designed to accomplish are forgotten; achieving the transformation becomes the most important objective. Instead of maintaining continuous change, the organization may reach a stable point and stagnate. To produce continuously high quality services, an organization must react quickly to changes in the community and not be restricted by its management style.

TQM detractors also argue that although Total Quality Management calls for organizational change, it does not demand radical organizational reform. Real quality improvement requires radical structural change, such as flattening organizational structures. It requires liberation of employees from stifling control systems and the tyranny of functionalism, both of which stifle teamwork.Total Quality Management calls for the elimination of the goals and objectives required by Management-by-Objectives. Critics of TQM claim that this may negatively affect motivation.

 They claim that having established production goals gives employees increasingly higher goals to reach, which motivates them to find new ways to reach the goals. When there are no established production goals, some employees will only produce the minimum required to keep their job. Some maintain that Total Quality Management delegates the determination of quality to quality experts rather than to "real" people.

TQM claims that quality is a complicated entity that is beyond the average employee to comprehend without specialized training in statistical techniques. It takes what is common sense to the ordinary worker and makes it sound complicated by changing the name and dressing it up with technical language

Total Quality Management calls for the elimination of performance assessments that rate employees in relation to each other. Critics fear that without performance assessment managers would have too much

power over employees and may be use it capriciously. Many managers feel performance assessments let them document employee performance for possible reward, but some employees fear the assessments might be used against them in some disciplinary actions. 

Performance assessments may give employees with grievances the documentation they need to prove managers are treating them unfairly. Without them, managers could make unfair accusations about an employee’s performance and the employee would not have the documentation to counter the claims.

Demands change in culture

TQM demands an organizational culture that focuses on continuous process improvement and customer satisfaction. It requires a change of attitude and a reprioritization of daily operations. TQM also requires a long-term management commitment and constant employee involvement. According to Forbes, changing an organization’s culture is a difficult challenge, because culture amalgamates an interlocking set of values, processes, attitudes, communication practices, roles, goals and assumptions, and is often met with resistance by employees, who view it as a threat to their jobs.

Demand time planning and resources

A good TQM system often takes years to implement, and that occurs only after significant planning, time, long-term resource allocation and unwavering management commitment. Lack of proper planning can cause a TQM system to ultimately fail.

Quality is expensive

TQM is expensive to implement. Implementation often comes with additional training costs, team-development costs, infrastructural improvement costs, consultant fees and the like. The system also requires continuous investment in the form of refresher trainings,

process and machine inspections, and quality measurement. TQM is not suitable for very small companies, because its implementation, training and execution costs far supersede its financial gains.

Takes years to show result

TQM is a long-term process that shows results only after years have passed. It requires perseverance, patience, dedication and motivation. Many organizations give up on it after failing to see tangible results quickly. Organizations that function in highly competitive environments cannot afford the luxury of time.

Discourages creativity

TQM’s focus on task standardization to ensure consistency discourages creativity and innovation. It also discourages new ideas that can possibly improve productivity.

Not a quick fix solution

Many companies, in their excessive focus on quality, end up losing financially. Both Xerox, the American document management company, and Federal Express, the cargo airline, suffered significant financial setbacks after winning the Baldrige Quality Awards -- awards that recognize quality performance. According to the book, "Corporate Transformation and Restructuring," two-thirds of companies that embrace TQM fail to experience major performance breakthroughs or improvements in customer satisfaction. According to an Arthur D. Little survey of 500 companies, only 36 percent felt that TQM improved their competitiveness.

1. In your opnion which of this words best define quality?

high cost

satisfy internal and external customer

high profits

2. Do u think Total quality management will work in the organization ?

Yes

No

3. Would TQM program be beneficial to your organization?

Yes

No

4. TQM would used to improve

Project design

Cost estimating

Reduce market share

5.What is your organization perception of quality?

A tool to increase profit

Elimination of defects

A competitive advantage

6.How would u rate importance of service/product quality?

Very important

Somewhat important

Not important

7.do u set your quality to level of ?

the leading company in your field

the competition in general

to level of set internally

8.how does your organization solves quality related problems

A permanent team is available

Assign individual to solve

Set up a multi disciplinary team

9.Do you have system of gathering client suggestion?

No

Yes

10.How do you measure client satisfaction?

Questionnaire survey

By number of complaints

Other method

11.Do you have system of gathering employee suggestion ?

Yes

No

12. Has your organization developed a clear quality policy?

Yes

No.

13.does your organization have quality improvement programs?

A quality improvement program have been implemented recently

Such a plan is under consideration

No

14.what type of quality improvement program do you have ?

Total quality management

Iso 9000

Quality control/ quality assurance

15.Does your quality improvement program gets full support of top management?

Yes

No

16. After implementation of program relationship with your customer have

Improved

Remain the same

Decreased

17. Is formal training in TQM is given to employees?

No training is given

Some training is given

18.Which of the following factors provide the motivation to start TQM?

Pressure from competitors

Demanding customers

Need to reduce cost and improve performance

19.What is estimates profit margin difference before and 3 years after TQM

No difference

Than before 5%

Than before 10%

20. What side effects does your organization suffer with TQM?

Weak morale

High staff turnover

Higher cost