Contents

◼ TQM in Pharmaceuticals
◼ Definition
◼ History
◼ Categories
◼ Principles
◼ Elements
◼ Managing TQM
◼ Advantages

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TOTAL QUALITY MANAGEMENT IN
PHARMACEUTICALS

➢ The pharmaceutical industry is a vital segment of health care
system which is regulated heavily because; any mistake in
product design or production can be severe, even fatal.

➢ The poor qualities of drug are not only a health hazard but
also a waste of money for both the government and the
individual customers.

➢ So, the maintenance of the quality with continuous
improvement is very important for pharmaceutical industries.

➢ From this concept, Total Quality Management (TQM) was
established.

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➢ 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 health care system and also protect waste of money for
both government and individual customers.

➢ The basis of this approach is that the organizational units
should be working harmoniously to satisfy the customer.

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➢ Therefore, total quality management (TQM) means:

1. Satisfying customers first time, every time;

2. Enabling the employees to solve problems and eliminate
wastage;

3. A style of working, a culture more than a management
technique;

4. Philosophy of continuous improvement, never ending, only
achievable by/or through people.

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Definition:

➢ TQM has been defined as an integrated organizational
effort designed to improve quality at every level.

➢ The process to produce a perfect product by a series of
measures requiring an organised effort by the entire
company to prevent or eliminate errors at every stage in
production is called Total Quality Management.

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➢ According to International Organization for Standards (ISO)
TQM is defined as, TQM is a management approach for an
organization, centred 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.

➢ It uses strategy, data and effective communications to
integrate the quality discipline into the culture and activities
of the organization.

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TQM Model:

Customer
Focus

Total
TQM Planning

Participation MODEL Process

Process Process
Improvement Management

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History of TQM:

➢ The need for improved product quality emerged in the 1980s,
when it became apparent that the United States was logging
behind some industrial countries, most notably Japan, in the
area of product quality.

➢ Many of the tools and techniques that were used to identify
quality problems and take corrective action.

➢ The exact origin of the term “total quality management” is
uncertain.

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➢ It is almost certainly inspired by Armand V. Feigenbaum’s
multi-edition book Total Quality Control and Kaoru
Ishikawa’s “What is Total Quality Control? The Japanese
Way”.

➢ It may have been first coined in the United Kingdom by the
Department of Trade and Industry during its 1983 “National
Quality Campaign” or, it may have been first coined in the
United States by the Naval Air Systems Command to describe
its quality-improvement efforts in 1985.

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Categories of TQM

◼ 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.

◼ Total Quality management can be divided into four
categories:

◼ Plan
◼ Do
◼ Check
◼ Act
◼ Also referred to as PDCA cycle.

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Planning Phase

◼ Planning is the most crucial phase of total quality
management.

◼ In this phase employees have to come up with their
problems and queries which need to be addressed.

◼ They need to come up with the various challenges they face
in their day to day operations and also analyze the
problem’s root cause.

◼ Employees are required to do necessary research and
collect relevant data which would help them find solutions
to all the problems.

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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.

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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.

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Principles of TQM:-

The principles of the TQM approach are:

1. Focus on the Customer:

➢It is important to identify the organization’s customers.

➢External customers consume the organization’s product or
service.

➢Internal customers are employees who receive the output of
other employees.

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2. Employee Involvement:

➢Since quality is considered as the job of all employees,
employees should be involved in quality initiatives.

➢Front line employees are likely to have the closest contact
with external customers and thus can make the most valuable
contribution to quality.

➢Therefore, employees must have the authority to innovate

and improve quality.

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3. Process-centred:

➢A fundamental part of TQM is a focus on process thinking.

➢A process is a series of steps that take inputs from suppliers
(internal or external) and transforms them into outputs that
are delivered to customers (either internal or external).

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4. Integrated System:

➢Every organization has a unique work culture, and it is
virtually impossible to achieve excellence in its products and
services unless a good quality culture has been fostered.

➢Thus, an integrated system connects business improvement
elements in an attempt to continually improve and exceed
the expectations of customers, employees and other
stakeholders.

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5. Strategic and Systematic Approach

➢A critical part of the management quality is the strategic
and systematic approach to achieving an organization’s
vision, mission and goals.

➢This process, called strategic planning or strategic
management, includes the formulation of a strategic plan
that integrates quality as a core component.

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6. Continuous Improvement:

➢The quest for quality is a never ending process in which
people are continuously working to improve the
performance, speed and number of features of the product
or service.

➢Continuous improvement means that small, incremental
improvement that occurs on a regular basis will eventually
add to a vast improvement in quality.

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7. Fact-based Decision Making:

➢In order to know how well an organization is performing,
data on performance measures are necessary.

➢TQM requires that an organization continually collect and
analyse data in order to improve decision making accuracy,
achieving consensus, and allow prediction based on past
history.

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8. Communications:

➢During times of organizational change, as well as part of
day to day operation, effective communications plays a
large part in maintaining morale and in motivating
employees at all levels.

➢Communications involve strategies, method and timelines.

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The 8 Elements of TQM

To be successful implementing TQM, an organization must
concentrate on the eight key elements:

◼ Ethics
◼ Integrity
◼ Trust
◼ Training
◼ Teamwork
◼ Leadership
◼ Recognition
◼ Communication

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Key Elements
➢ TQM has been coined to describe a philosophy that makes

quality the driving force behind leadership, design, planning,
and improvement initiatives.

➢ For this, TQM requires the help of those eight key elements.
These elements can be divided into four groups according to
their function.

➢ The groups are:
I. Foundation – It includes: Ethics, Integrity and Trust.
II. Building Bricks – It includes: Training, Teamwork and

Leadership.
III. Binding Mortar – It includes: Communication.
IV. Roof – It includes: Recognition.

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I. Foundation

◼ TQM is built on a foundation of ethics, integrity and
trust.

◼ It fosters openness, fairness and sincerity and allows
involvement by everyone.

◼ This is the key to unlocking the ultimate potential of
TQM.

◼ These three elements move together, however, each
element offers something different to the TQM concept.

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1. Ethics –
◼ Ethics is the discipline concerned with good and bad in

any situation.
◼ It is a two-faceted subject represented by organizational

and individual ethics.
◼ Organizational ethics establish a business code of ethics

that outlines guidelines that all employees are to adhere
to in the performance of their work.

◼ Individual ethics include personal rights or wrongs.

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2. Integrity
◼ Integrity implies honesty, morals, values, fairness, and

adherence to the facts and sincerity.
◼ The characteristic is what customers (internal or

external) expect and deserve to receive.
◼ People see the opposite of integrity as duplicity.
◼ TQM will not work in an atmosphere of duplicity.

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3. Trust
◼ Trust is a by-product of integrity and ethical conduct.
◼ Without trust, the framework of TQM cannot be built.
◼ Trust fosters full participation of all members.
◼ It allows empowerment that encourages pride ownership and it

encourages commitment.
◼ It allows decision making at appropriate levels in the

organization, fosters individual risk-taking for continuous
improvement and helps to ensure that measurements focus on
improvement of process and are not used to contend people.

◼ Trust is essential to ensure customer satisfaction.
◼ So, trust builds the cooperative environment essential for TQM.

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II. Bricks
◼ Basing on the strong foundation of trust, ethics and integrity,

bricks are placed to reach the roof of recognition.
◼ It includes:

4. Training
◼ Training is very important for employees to be highly

productive.
◼ Supervisors are solely responsible for implementing TQM

within their departments, and teaching their employees the
philosophies of TQM.

◼ During the creation and formation of TQM, employees are
trained so that they can become effective employees for the
company.

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5. Teamwork
◼ To become successful in business, teamwork is also a key

element of TQM.
◼ With the use of teams, 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.

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◼ There are mainly three types of teams that TQM
organizations adopt:

A. Quality improvement teams or excellence teams (QITs)
◼ These are temporary teams with the purpose of dealing

with specific problems that often recur.
◼ These teams are set up for period of three to twelve

months.
B. Problem solving teams (PSTs)
◼ These are temporary teams to solve certain problems and

also to identify and overcome causes of problems.
◼ They generally last from one week to three months.

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C. Natural work teams (NWTs)
◼ These teams consist of small groups of skilled workers

who share tasks and responsibilities.
◼ These teams use concepts such as employee

involvement teams, self-managing teams and quality
circles.

◼ These teams generally work for one to two hours a week.

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6. Leadership
◼ It 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 instil 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.

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III. Binding Mortar

7. 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.

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◼ There are different ways of communication such as:
A. 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.
B. Upward communication
◼ By this the lower level of employees are able to provide

suggestions to upper management of the affects of TQM.

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◼ 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.

C. 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.

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IV. Roof

8. Recognition
◼ Recognition is the last and final element in the entire system.
◼ It 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.

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◼ Recognition comes in its best form when it is immediately
following an action that an employee has performed.

◼ 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 etc.
◼ Places – Good performers can be recognized in front of

departments, on performance boards and also in front of top
management.

◼ Time – Recognition can given at any time like in staff meeting,
annual award banquets, etc.

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Employee Materials Technology Methods
Involvement

Managing Total Quality

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Managing Total Quality:

The major ingredients in TQM are discussed below:-

1. Strategic Commitment

➢ The start point for TQM is a strategic commitment by the
management.

➢ Firstly, the organizational culture must change to recognise
that quality is not just an ideal but is instead an objective
goal that must be pursued.

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➢ Secondly, a decision to pursue the goal of quality carries
with it some real costs- for expenditures such as new
equipment and facilities.

➢ Thus, without a commitment from the top
management, quality improvement will prove to be just
a slogan or gimmick.

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2. Employee Involvement

➢Employee involvement is another critical ingredient in
TQM.

➢Virtually all successful quality enhancement programs
involve making the person responsible for doing the job
responsible for making sure it is done right.

➢By definition, then employee involvement is critical
component in improving quality.

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3. Materials

➢Another important part of TQM is improving the quality of
the materials that organizations use.

4. Technology

➢New forms of technology are also useful in TQM
programs.

➢Investing in higher grade machine capable of doing jobs
more precisely and reliably often improves quality.

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5. Methods

➢ Improved methods can improve product and service
quality.

➢ Methods are operating systems used by the
organization during the actual transformation process.

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TQM Tools

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Advantages of TQM:
The advantages of implementing TQM are:

1. Improves reputation

Faults and problems are spotted and sorted quicker.

2. Higher employee morale

Workers are motivated by extra responsibility, team work
and involvement in decisions of TQM.

3. Lower cost

Decrease waste as fewer defective products and no need for
separation.