total quality management in the pharma industry has been covered in this presentation.

1. CONCEPT OF TOTAL
QUALITY MANAGEMENT
 More Pratiksha Sanjay
 M Pharm First Year
 Department Of Pharmaceutics
 Roll No -8
 Guided By-Dr. A.D.Kulkarni
Sir

2. CONTENT
 INTRODUCTION
 WHAT IS QUALITY
 QUALITY CONTROL
 QUALITY ASSURANCE
 EVOLUTION OF TQM
 DEFINITION OF TQM
 GOAL OF TQM
 TQM IN PHARMACEUTICALS
 PRINCIPLES OF TQM
 6Cs OF TQM
 KEY ELEMENTS OF TQM
 BENEFITS OF TQM
 ADVANTAGES OF TQM
 DISADVANTAGES OF TQM
 CONCLUSION
 REFERENCE

3. INTRODUCTION
 TQM is philosophy whose underlying premises
are continual improvements and efforts to be
made by all employees in an organization to
understand ,meet and exceed requirements ,
needs and expectations of client .
 It is also a learning system and set of methods,
techniques and tools aimed at achieving the
satisfaction of users , employees, business
partners.

4. Total- Made up of the whole.
Quality- Degree of excellence a product or service
provides to the customer in present and future.
Management- Act,art,or manner of handling,
controlling, directing, etc.
 TQM is the art of managing the whole to achieve
excellence.

5. QUALITY
Quality is “fitness for use”
( Joseph Juran)
Quality is ‘conformance to requirements”
( Philip B. Crosby)
Quality of a product or service is its ability
to satisfy the need and expectations of the
customer.

6. QUALITY
 Quality is generally referred to a parameter which
decides the inferiority or superiority of a product
service. It is a measure of goodness to understand
how a product meets its specifications. Usually, when
the expression “quality” is used , we think in the
terms of an excellent product or service that meets or
even exceeds our expectations. This expectations are
based on the price and the intended use of the goods
or services.

7. QUALITY CONTROL
 It is that part of Quality Management focused on
fulfilling requirements of the Customers for the
quality products.
 “The operational techniques and activities that
are used to fulfil requirements for quality”.
 Quality control protocols may help you lower
your inspection costs and use your resources in a
more cost-effective manner, too.
 Quality control is limited to looking at products .
 Quality control is testing the final product
against product quality standards.

8. QUALITY ASSURANCE
 “All planned and systemic activities necessary to
provide adequate confidence that a product or
service will satisfy given requirements for
quality’.
 Quality assurance is more concerned with the
processes that produce the final product, and
making sure that quality is part of each phase. QA
is about maturing the process towards minimum
defect. It is about balancing methodology,
leadership, and technology. It is about taking into
account human factors as well as technological
ones

10. EVOLUTION OF TOTAL QUALITY
MANAGEMENT

11. DEFINITION OF TQM
 Systematic activities of operating the whole units of a
company effectively and efficiently to supply goods and
services of quality satisfactory to customers at right time and
at right price, thus contributing to attaining Business Purposes.
 According to 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.”
 Total Quality Management (TQM) is a management strategy
aimed at embedding awareness of quality in all organizational
processes.

12. GOAL OF TQM
“Do the right things right the first
time, every time.”

13. TOTAL QUALIY 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.

14. CONT
 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.

15. PRINCIPLE OF TQM

16. CONT
 FOCUS ON THE CUSTOMER-
 External customers consume the organization’s product or
service.
 Internal customers are employees who receive the output
of other employees.
 EMPLOYEES INVOLVMENT.
 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
 CONTINUOUS IMPROVMENTS-
 TQM is the management process used to make continuous
improvements to all functions.
 TQM represents an ongoing, continuous commitment to
improvement

17. CONT
 PROCESS CENTERED- A fundamental part of TQM is
its focus on the process thinking. A process is a series of
step that take inputs from supplier and transfer them into
outputs that are delivered to customer
 INTEGRATED SYSTEM-An organization should have
an integrated system that provides effective TQM.
 EVALUATED DECISION-In order to know how well
an organization is operating data on performance measure
is mandatory,
 COMMUNICATION-During day o day operation and
time of organizational change effective communication
plays a significant part in maintaining morale and
motivating employees at all levels.

18. 6CS OF TQM

19. STEPS IN IMPLEMENTING 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.

20. CONT…
 PLAN- Define and Analyze a problem and
identify the root cause.
 DO- Devise a solution
Develop detailed action
Plan and implement it systematically
 CHECK- Confirm outcomes against plan
Identify deviation and issues.
 ACT- Standardize solution
Review and define next issues.

21. KEY 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

22. BENEFITS OF TQM
 Improved quality.
 Employee participation.
 Team work.
 Working relationships
 Customer satisfaction.
 Employee satisfaction.
 Productivity.
 Communication.
 Profitability.
 Market share

23. ADVANTAGES OF TQM
o Improves reputation- faults and problems are
spotted and sorted quicker.
o Higher employee morale- workers motivated by
extra responsibility ,team work and involvement
in decisions of total quality management.
o Lower cost.
o Decrease waste as fewer defective products and
no need for separate.

24. DISADVANTAGES OF TQM
o Initial introduction cost.
o Benefits may not be seen for several years.
o Workers may be resistant to change.
o It can be lead to too much attention.
o Extremely demanding of management and staff.
o It is not a quick fix. TQM takes to implement.

25. CONCLUSION
 TQM encourages participation amongst employees,
managers and organization as whole.
 Using Quality management reduces rework nearly to
zero in an achievable goal .The responsibilities either
its professional, social, legal one that rest with the
pharmaceutical manufacturer for the assurance of
quality of product are tremendous and it can only be
achieved by well organised.
 Thus quality is critically important ingredient to
organisational success today which can be achieved
by TQM, an organisational approach that focusses on
quality as an over achieving goals, aimed at aimed at
the prevention of defects rather than detection of
defects.

26. REFERENCE
 Pharmaceutical Quality Assurance By Swarali
Paul and Mrs.Gunjan Jesvani Page No-1624
 K.Wolters ; “Remington The science and
practice of pharmacy”;21st edition volume -
2005;published in Philadelphia College of
Pharmacy and science”
 https://asq.org/quality-resources/total-quality-
management