Amrita bhat

Tybms /c
144
Project : total quality managemant

















Introduction
TQM 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 todays 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 its central to the survival of even the largest organization .Quality is
defined by customer. The perspective of customer isnt 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 isnt just concerned with whether a product or service meets the
claims made for it. Todays 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 businesss 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
customers 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 cant 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 problems
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 Demings 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 wont 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. Dont 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. Its 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 wont 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.






6cs of tqm


Commitment
If a TQM culture is to be developed, so that quality improvement
becomes a normal part of everyones 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 everyones job.


3.Continuousimprovement
Recognition 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-operation
The 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.Customerfocus
The 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 customers (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 detail
Benefits 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 Disruption
Implementing 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 Costs
A 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 Resistance
Total 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 Participation
Once 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. Its 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 TQM
Survival 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 doctors 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 ad
equate 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. Reddys, 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
administrators
Another 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 Carbides 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 managements 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 companys 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 improvement
1. Problem is brought to the attention of the steering committee
2. Steering committee forms a team to examine the process and
make necessary recommendations for improvement
3. Team meets, reviews its mission, and determines how often
it will meet
4. Training is initiated for team members
5. Team meets weekly for an hour or two to analyze the
problem and develop a solution
6. Solution is initiated on a pilot basis
7. 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. Wanburys 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.
2007Doctors 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 worlds largest producer of Metformin with
production of 4500 MT.
2005Wanbury acquired Doctors Organics and Chemicals, having a US
FDA approved facility for manufacturing multi-product APIs.
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 APIs.
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 teams meeting and
story sessions. They should have informal talks with the members of
QITs. 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 QITs.
? 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 customers 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 organizations 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
employees 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 organizations 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
TQMs 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