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Total Quality
Management
TOTAL QUALITY MANAGEMENT IN
PHARMACEUTICALS
 The pharmaceutical is a vital segment of the health care system which
is regulated heavily because; any mistake in product design or
production can be serve, even fatal.
 The poor qualities of drug are not only a health hazards but also a
waste of money for both the government and the individual customers.
 So, the maintenance of the quality with the continuous improvement is
very important for the pharmaceutical industry.
 From this concept, Total Quality Management (TQM) was established.
 The aim of the 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 the health care
system also protect waste of money for the government and the
individuals customers.
 The basis of this approach is that the organizational units should be
working harmoniously to satisfy the customer.
• 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 the continuous improvement, never ending, only achievable by/or
through people.
1. TQM has been defined as an integrated organizational effort
designed to improve quality at every level.
2. The process to procedure a perfect product by a series of the
measures requiring an organised effort by the entire company
to prevent or eliminate errors at every stage in the production
is called Total Quality Management.
1. According to International Organization for Standards (ISO)
TQM is defined 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.
2. It uses strategy, data and effective communications to
integrate the quality discipline into the culture and activities of
the organization.
TQM MODEL
The 8 Elements of TQM
To be successful implementing TQM, an organization must
concentrate on the eight key elements:
1. Ethics.
2. Integrity.
3. Trust.
4. Training.
5. Teamwork.
6. Leadership.
7. Recognition.
8. Communication.
 TQM has been coined to describe a philosophy that makes quality the
driving force behind the 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:-
1. Foundation – It includes: Ethics, Integrity and Trust.
2. Building Bricks – It includes: Training, Teamwork and Leadership.
3. Binding Mortar – It includes Communication.
4. Roof – It includes: Recognition.
 TQM is built on a foundation of ethics, integrity and
thrust.
 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.
1.Ethics:
 Ethics is the discipline concerned with good and bad in
any situation.
 It is a two-faceted subjected 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.
 Individuals ethics include personal rights or wrongs.
2. Integrity:
 Integrity implies honesty, morals, values, fairness, and
adherence to the facts and sincerity.
 The characteristic is what customers (internal or
external) except and deserve to receive.
 People see the opposite of integrity as duplicity.
 TQM will not work in an atmosphere of duplicity.
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,
foster individuals risk-taking for continuous improvement and helps
to insure 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 for TQM.
 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 the implementing TQM
within their departments, and teaching their employees the
philosophies to TQM.
• During the creation and the formation of TQM, employees are
trained so that they can become effective employees for the
company.
5. Team work:
A. To become successful in business, teamwork is also a key
element of TQM.
B. With the use of teams, the business will receive quicker and
better solutions of the problems.
C. Teams also provide more permanent improvements in
processes and the operations.
D. In teams, people feel more comfortable bringing up
problems that may occurs, and can get help from other
workers to find a solution and put into place.
6. Leadership:
 It is possibly the most important element in the TQM.
 It appears everywhere in the organization.
 Leadership in the TQM requires the manager to provide an
inspiring vision, make strategic directions that are understood by
all and to and to instil values that guides 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.
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 communications with and among
all the organization members, suppliers and customers.
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.
 Recognition comes in its best form when it is immediately
following an action that an employee has performed.
TQM Philosophy – What’s Different?
• TQM attempts to embed quality in every aspects of the
organization.
• Focus on Customer:
1. Identify and meet customer needs.
2. Stay tuned to changing needs, e.g., fashion styles.
• Continuous Improvement:
1. Continuous learning and problem solving, e.g., Kaizen, 6
sigma.
• Quality at the Source:
1. Inspection vs. prevention & problem solving.
• Employee Empowerment:
1. Empower all employees; external and internal customers.
2. Team approach, quality circle.
• Understanding Quality Tools:
1. Ongoing training on analysis, assessment, and correction,&
implementation of quality tools.
• Team Approach:
1. Teams formed around processes – 8 to 10 people.
2. Meet weekly to analyze and solve problems.
• Benchmarking:
1. Studying practices at “best in class” companies.
• Managing Supplier Quality:
1. Certifying suppliers vs. receiving inspection.
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.
Tqm

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Tqm

  • 2. TOTAL QUALITY MANAGEMENT IN PHARMACEUTICALS  The pharmaceutical is a vital segment of the health care system which is regulated heavily because; any mistake in product design or production can be serve, even fatal.  The poor qualities of drug are not only a health hazards but also a waste of money for both the government and the individual customers.  So, the maintenance of the quality with the continuous improvement is very important for the pharmaceutical industry.  From this concept, Total Quality Management (TQM) was established.
  • 3.  The aim of the 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 the health care system also protect waste of money for the government and the individuals customers.  The basis of this approach is that the organizational units should be working harmoniously to satisfy the customer.
  • 4. • 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 the continuous improvement, never ending, only achievable by/or through people.
  • 5. 1. TQM has been defined as an integrated organizational effort designed to improve quality at every level. 2. The process to procedure a perfect product by a series of the measures requiring an organised effort by the entire company to prevent or eliminate errors at every stage in the production is called Total Quality Management.
  • 6. 1. According to International Organization for Standards (ISO) TQM is defined 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. 2. It uses strategy, data and effective communications to integrate the quality discipline into the culture and activities of the organization.
  • 7.
  • 9. The 8 Elements of TQM To be successful implementing TQM, an organization must concentrate on the eight key elements: 1. Ethics. 2. Integrity. 3. Trust. 4. Training. 5. Teamwork. 6. Leadership. 7. Recognition. 8. Communication.
  • 10.
  • 11.  TQM has been coined to describe a philosophy that makes quality the driving force behind the 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:- 1. Foundation – It includes: Ethics, Integrity and Trust. 2. Building Bricks – It includes: Training, Teamwork and Leadership. 3. Binding Mortar – It includes Communication. 4. Roof – It includes: Recognition.
  • 12.  TQM is built on a foundation of ethics, integrity and thrust.  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.
  • 13. 1.Ethics:  Ethics is the discipline concerned with good and bad in any situation.  It is a two-faceted subjected 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.  Individuals ethics include personal rights or wrongs.
  • 14. 2. Integrity:  Integrity implies honesty, morals, values, fairness, and adherence to the facts and sincerity.  The characteristic is what customers (internal or external) except and deserve to receive.  People see the opposite of integrity as duplicity.  TQM will not work in an atmosphere of duplicity.
  • 15. 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, foster individuals risk-taking for continuous improvement and helps to insure 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 for TQM.
  • 16.  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 the implementing TQM within their departments, and teaching their employees the philosophies to TQM. • During the creation and the formation of TQM, employees are trained so that they can become effective employees for the company.
  • 17. 5. Team work: A. To become successful in business, teamwork is also a key element of TQM. B. With the use of teams, the business will receive quicker and better solutions of the problems. C. Teams also provide more permanent improvements in processes and the operations. D. In teams, people feel more comfortable bringing up problems that may occurs, and can get help from other workers to find a solution and put into place.
  • 18. 6. Leadership:  It is possibly the most important element in the TQM.  It appears everywhere in the organization.  Leadership in the TQM requires the manager to provide an inspiring vision, make strategic directions that are understood by all and to and to instil values that guides 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.
  • 19. 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 communications with and among all the organization members, suppliers and customers.
  • 20. 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.  Recognition comes in its best form when it is immediately following an action that an employee has performed.
  • 21.
  • 22. TQM Philosophy – What’s Different? • TQM attempts to embed quality in every aspects of the organization. • Focus on Customer: 1. Identify and meet customer needs. 2. Stay tuned to changing needs, e.g., fashion styles. • Continuous Improvement: 1. Continuous learning and problem solving, e.g., Kaizen, 6 sigma. • Quality at the Source: 1. Inspection vs. prevention & problem solving. • Employee Empowerment: 1. Empower all employees; external and internal customers. 2. Team approach, quality circle.
  • 23. • Understanding Quality Tools: 1. Ongoing training on analysis, assessment, and correction,& implementation of quality tools. • Team Approach: 1. Teams formed around processes – 8 to 10 people. 2. Meet weekly to analyze and solve problems. • Benchmarking: 1. Studying practices at “best in class” companies. • Managing Supplier Quality: 1. Certifying suppliers vs. receiving inspection.
  • 24. 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.