TQM : The key elements for its successful implementation in the business organization
Mr. Bhavin P. Marolia
Traditionally, in the pharmaceutical industry the word
‘Quality’ is usually referred to
‘conformance to specification’; that is to
inspection and servicing of products. Due to overriding concern for
quality from all manufacturing industries, the definition of quality
has been expanded to the service extended to customer to obtain
‘Total Quality’ represents a competitive strategy.
In other words, ‘Quality’ in terms of
‘Total Quality’ is everything an organization does
in the eyes of its customers, which will determine whether they buy
from this company or from its competitor. ‘Total
Quality’ provides an umbrella under which everyone in the
organization can strive and create customer satisfaction.
TQM has emerged as a new and different way of managing business that
allows it to provide quality goods and services at the lowest cost in
order to achieve customers’ satisfaction and, at the same
time, to ensure satisfactory business development by continuous
improvements. TQM, thus eyes the triple targets of gaining maximum
productivity, profitability and customer loyalty.
Total Quality Management ( TQM )
→ Quality involves everyone and all activities in the company
→ Conformance to requirements ( Meeting customer requirements
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.
As defined by ISO :
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 society.
The reasons for all the business organizations
adopting TQM concept are as follows :
· Overriding concern for quality.
· Achieving certification from national and
international organization regarding quality assurance in all facets in
· Gaining competitive advantage over its rivals.
· Achieving customer satisfaction
· Overall growth of the business.
· Reducing losses due to wasteful practices.
Continuous improvement with respect to improving results and
more importantly with improving capabilities to produce better results
There exist extensive numbers of examples of failed or badly
performed implementation processes of TQM. The relatively frequent
occurance of failed or badly performed implementation processes is a
problematic phenomenon, which negatively affects organizations,
irrespective of size, in their development towards business excellence
and ultimately survival in a competitive environment.
However, following are the key elements which can lead a
foundation for the successful implementation of TQM in the business
Quality Planing :
Planning quality improvement, implementing the plan,
analyzing the results and re-planning is a continuous cycle (
Plan-Do-Check-Act ). Inter-related improvement plans are deployed at
all levels of the organization ( corporate, department, process,
individual ). Following are the steps for quality planing :
· Quality policy is formulated.
· Quality policy is adopted by the management
explicitly, stating its commitment and intentions with respect to
· Quality plans are established annually based on
· The feedback on quality problems encountered in
the past or expected in the future is collected.
· Based on this feedback, quality objectives
involving every function are set.
· Quality objectives are set in regard to
procedures, training, quality costs, documents, tools and gauges,
preventive maintanence, development of new products, etc.
· Quality plans are monitored quarterely by the
quality council, reporting directly to the chief executive.
Leadership and Management commitment :
Leadership is possibly the most important element in TQM. It
appears everywhere in organization. Leadership in TQM requires the
manager to provide an inspiring vision, make strategic directions that
are understood by all and to instill values that guide subordinates.
For TQM to be successful in the business, the supervisor must be
committed in leading his employees. A supervisor must understand TQM,
believe in it and then demonstrate their belief and commitment through
their daily practices of TQM. The supervisor makes sure that
strategies, philosophies, values and goals are transmitted down through
out the organization to provide focus, clarity and direction. A key
point is that TQM has to be introduced and led by top management.
The philosophy of TQM is applicable to any organization,
which is customer oriented and is committed to quality. Management
commitment to Total Quality is essential for the organization to
achieve excellence. The commitment to quality must be conveyed to all
levels and activities of the organization. Commitment and personal
involvement is required from top managemet in creating and deploying
clear quality values and goals consistent with the objectives of the
company and in creating and deploying well defined systems, methods and
performance measures for achieving those goals. Furthermore, management
commitment involves every department, function and process in the
organization and the active commitment of everyone in the organization
to meeting customer needs and seeking continuous improvement.
Training is very important for employees to be highly
productive. Training programs are important in creating and maintaining
an environment for quality improvement. All laboratory personnel,
including the highest levels of management, should receive training and
· To enable them to perform their individual
processes and functions.
· To be aware of the relationship with the various
· To understand the importance of customer
satisfaction and the corporate laboratory objectives.
· To be able to contribute effectively to the
continuous improvement programme.
Supervisors are solely responsible for implementing TQM
within their departments, and teaching their employees the philosophies
of TQM. Training that employees require are …
· Interpersonal skills,
· The ability to function within teams,
· Problem solving,
· Decision making,
· Job management,
· Performance analysis and improvement,
· Business economics,
· TQM awareness and
· Technical skills.
During the creation and formation of TQM, employees are
trained so that they can become effective employees for the company.
Quality chains and Teamwork :
Each stage of the production process is seen as being a link
in the chain right down to the relationship between one worker in the
process and another. This will foster teamwork. It is the teamwork from
which the business will receive quicker and better solutions to
problems. Teams also provide more permanent improvements in processes
and operations. In teams, people feel more comfortable bringing up
problems that may occur, and can get help from other workers to find a
solution and put into place. There are mainly three types of teams that
TQM organizations adopt :
temporary teams with the purpose of dealing with specific problems that
often re-occur. These teams are set up for period of three to twelve
temporary teams to solve certain problems and also to identify and
overcome causes of problems. They generally last from one week to three
teams consist of small groups of skilled workers who share tasks and
responsibilities. These teams use concepts such as employee involvement
teams and quality circles. These teams generally work for one to two
hours a week.
Quality control is defined as the operational techniques and
activities that are used to fulfill the requirements for the quality.
It focuses on product defect detection through post-production
inspection. It is concerned with the adherence to standards and sorting
rejects. Quality is regarded as an ‘end-of-line’
function where attention is given more to the end product than the
processes themselves. Variation is studied through a decision making
process based on acceptable or unacceptable standards. Quality control
phase makes use of techniques ( including statistical ) to achieve,
maintain and improve quality standards of products and services. In
other words, Quality control includes a system which accepts or rejects
any activities which affects the quality and prevents quality
deficiency and imparts consistency in the quality of product or
Quality Assurance Unit :
Quality assurance is a wide-ranging concept covering all
matters that individually or collectively influence the quality of a
product. It is the totality of the arrangements made with the object of
ensuring that pharmaceutical products are of the quality required for
their intended use.
A quality assurance unit assures the management that all the
activities are being performed as designed in the organization and the
products are of quality required for their intended use. QA unit at
pharmaceutical product manufacturing establishment has following
principal duties :
· To establish control procedures and revise them
· To prepare specifications for raw material,
packaging materials and finished products.
· To devise system for identification, segregation
of test samples to avoid mix-up and cross contamination.
· To prepare SOPs for each test or analysis.
· To evaluate adequacy of manufacturing conditions
by monitoring environment and validation of equipments.
· To reject or release raw materials and
intermediate products on the basis of results of examination, test or
· To reject or release containers, closures, other
packaging materials and labeling materials on the basis of results of
examination, test or analysis.
· To reject or release each lot of finished
· To evaluate storage conditions of raw materials,
intermediates and finished products.
· To carry out stability studies on finished
· To establish date of expiry of potency under
specified storage conditions.
Quality Audit :
Quality Audit is a systematic and independent examination to
determine whether quality activities and related results comply with
planned arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives. In other words, it
is an independent review undertaken from time to time to check whether
quality performance conforms to pre-determined standards in respect of
quality plans, systems, policies, specifications, etc. It could be
· ‘Internal audit’ carried out
by the executives nominated by the management for specific areas such
as system audit, product audit or sub-contractor audit , etc
· ‘External audit’ assigned to
external independent agencies.
Quality circles :
Quality circle is a small group of employees in the same work area or
doing a similar type of work who voluntarily meet regularly for about
an hour every week to idientify, analyze and resolve work-related
problems, leading to improvement in their performanace, and enrichment
for their work life. It can be seen that the concept of quality circles
is just one segment of TQM. TQM is not complete without quality circles
nor quality circles alone would be adequate for necessary quality
culture in the whole organization. The basic aims of quality circles
· To contribute to the improvement and development
of the enterprise.
· To respect humanity and build a better workshop.
· To satisfy the higher human needs of recognition
Natural Work Team ( NWT ) is sometimes reffered to as Quality
Effective communication :
It binds everything together. Starting from foundation to
roof of the TQM house, everything is bound by strong mortar of
communication. It acts as a vital link between all elements of TQM.
Communication means a common understanding of ideas between the sender
and the receiver. The success of TQM demands communication with and
among all the organization members, suppliers and customers.
Supervisors must keep open airways where employees can send and receive
information about the TQM process. Communication coupled with the
sharing of correct information is vital. For communication to be
credible the message must be clear and receiver must interpret in the
way the sender intended.
There are different ways of communication such as :
· Downward communication - This is the dominant
form of communication in an organization. Presentations and discussions
basically do it. By this the supervisors are able to make the employees
clear about TQM.
· Upward communication - By this the lower level
of employees are able to provide suggestions to upper management of the
affects of TQM. As employees provide insight and constructive
criticism, supervisors must listen effectively to correct the situation
that comes about through the use of TQM. This forms a level of trust
between supervisors and employees. This is also similar to empowering
communication, where supervisors keep open ears and listen to others.
· Sideways communication - This type of
communication is important because it breaks down barriers between
departments. It also allows dealing with customers and suppliers in a
more professional manner.
Recognition of staff :
Recognition should be provided for both suggestions and
achievements for teams as well as individuals. Employees strive to
receive recognition for themselves and their teams. Detecting and
recognizing contributors is the most important job of a supervisor. As
people are recognized, there can be huge changes in self-esteem,
productivity, quality and the amount of effort exhorted to the task at
hand. Reward and recognition systems emphasizing the achievement of
quality objectives truly motivates the work force to fully participate
in quality improvement activities. Recognition comes in its best form
when it is immediately following an action that an employee has
Recognition comes in different ways, places and time such as,
· Ways – It can be by way of personal
letter from top management. Also by award banquets, plaques, trophies,
· Places – Good performers can be
recognized in front of departments, on performance boards and also in
front of top management.
· Time – Recognition can be given at any
time like in staff meeting, annual award banquets,etc.
Customer satisfaction and customer feedback :
TQM has a customer-first orientation. The customer, not
internal activities and constraints, comes first. Customer satisfaction
is seen as the company's highest priority. The company believes it will
only be successful if customers are satisfied. The TQM company is
sensitive to customer requirements and responds rapidly to them. In the
TQM context, `being sensitive to customer requirements' goes beyond
defect and error reduction, and merely meeting specifications or
reducing customer complaints. The concept of requirements is expanded
to take in not only product and service attributes that meet basic
requirements, but also those that enhance and differentiate them for
An internal customer is a member of the organization, which
is a part of the process and undertakes, the performance of a specific
task. The ‘supplier’ to this internal customer is
again a member of the organization that transfers his/her product or
service to the next member of the chain ( his/her customer ). To do
things ‘right first time’ and on time, and achieve
( external ) cutomer satisfaction the internal suppliers and internal
customers must always work in perfect coordination.
Measures of customer satisfaction includes using market
research and focus groups to identify customer needs, to build these
into the process and to collect customer feedback. Besides customer
surveys; survey of competing products, routine inspection, customer
complaints, etc. also play vital role to implement TQM successfully.
Statistical monitoring :
Trends ( data ) are displayed by measurements; interpreted
statistically and numerical targets established. This data and
statistics are used to monitor and evaluate production processes and
quality. A variety of data, either numerical or non-numerical can be
gathered in a systematic fashion for a clear and objective picture of
the facts. This can be done by Data Collection Form. Statistical tools
for quality improvement includes :
· Affinity diagram which
includes recording the individual ideas in small cards and then
grouping the related cards together.The information from the cards is
then transferred onto paper outlined by groupings.
· Benchmarking is used to
compare an organization’s activity against that of a
recognized leader in the market. This will identify opportunities for
quality improvement and will lead to competitive advantage in the
· A scatter diagram shows
how two variables are related and is thus used to test for cause and
· A cause and effect diagram
( fish bone diagram ) describes a relationship between variables. The
undesirable outcome is shown as an effect, and related causes are shown
as leading to, or potentially leading to, this effect.
· A flowchart is a
pictorial representation of the steps in a process and is useful for
investigating opportunities for improvement by gaining a detailed
understanding of how the process actually works.
· A control chart displays
statistically determined upper and lower limits drawn on either side of
a process average. This chart shows if the collected data are within
upper and lower limits previously determined through statistical
calculations of raw data from earlier trials.
· A histogram ’s
shape shows the nature of the distribution of the data, as well as
central tendency ( average ) and variability. Specification limits can
be used to display the capability of the process.
· The Pareto diagram
displays, in decreasing order, the relative contribution of each cause
to the total problem.
Zero defects concept :
Philip B. Crosby is an internationally known quality expert.
He is best known for popularizing the ‘Zero defects
concept’ and the four absolutes for quality management that
originated in the United States at the Martin Marietta Corporation
where Crosby worked during the 1960s. The four absolutes of Quality
Management are as follows :
· Quality equals conformance to requirement.
· Prevention causes quality
· Zero defects
· The measurement of Quality is the price non
He believed that it is essential for an organization to make
products right first time without any flaws or defects. Any problems in
the production process must be filtered out before they get anywhere
near to the customer.
A central principle of TQM is that mistakes may be made by
people, but most of them are caused, or at least permitted, by faulty
systems and processes. This means that the root cause of such mistakes
can be identified and eliminated, and repetition can be prevented by
changing the process.
There are three major mechanisms of prevention:
– proofing ).
early to prevent them being passed down the value added chain
(Inspection at source or by the next operation).
can be corrected, to prevent the production of more defects. (Stop in
Lal H.; Total Quality Management – A Practice
Approach, New Delhi, New Age International Publishers, 1995.
Rao A. L.; Bharani M.; Madhu Y.; Sankar G.G.; Total Quality
Management : The Need of New Era. Indian J.Pharm. Educ. Res.
39 ( 4 ) Oct – De
Hashmi K.; Introduction and Implementation of Total Quality
Management ( TQM ). http://www.isixsigma.com/me/tqm/
Total Quality Management from Wikipedia, the free
1 Bhavin P. Marolia*,
2 Bhanubhai N. Suhagia, 1
Dineshbhai R. Shah, 1 Nilesh K. Patel and
1 Ashish D. Mishra
1 Department of Quality
Assurance, Maliba Pharmacy College, Tarsadi, Surat-394350, Gujarat,
2 Department of Quality
Assurance, L.M. College of Pharmacy, Navarangpura, Ahmedabad-380009,
Mr. Bhavin P. Marolia
Lecturer, Department of Quality Assurance, Maliba
Pharmacy College, Tarsadi, Surat-394350, Gujarat, India
e-mail : firstname.lastname@example.org
Dr. Bhanubhai N. Suhagia
M.Pharm., Ph. D., F.I.C., L.L.B. Professor,
Department of Quality Assurance, L.M. College of Pharmacy,
Ahmedabad, Gujarat, India
Dr. Dinesh R. Shah
M.Pharm., Ph. D., Professor, Department of Quality
Assurance, Maliba Pharmacy College, Tarsadi, Surat-394350,
Mr. Nilesh K. Patel
M.Pharm.,Lecturer, Department of Quality Assurance,
Maliba Pharmacy College, Tarsadi, Surat-394350, Gujarat,
e-mail : email@example.com
Mr. Ashish D. Mishra
M.Pharm. Asst. Professor, Department of Quality
Assurance, Maliba Pharmacy College, Tarsadi, Surat-394350,
e-mail : firstname.lastname@example.org