2. Content
Introduction
What does TQM mean?
Components of TQM
The principles of quality management
The Elements of TQM
Advantages of total quality management
The Disadvantages of TQM
Conclusion
References
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Total Quality Management (TQM)
3. Focus on QC,QA & TQM
QC
QA
TQM
Product
Product
&
Process
Product,
Process,
Peoples,
Organization
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Total Quality Management (TQM)
4. Introduction
Total Quality Management or TQM is an
integrative philosophy of management for
continuously improving the quality of products and
processes.
It is used around the world.
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Total Quality Management (TQM)
5. What does TQM mean?
Total Quality Management means that the
organization's culture is defined by and supports the
constant attainment of customer satisfaction through an
integrated system of tools, techniques, and training.
This involves the continuous improvement of
organizational processes, resulting in high quality
products and services.
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Total Quality Management (TQM)
6. According to International organization for
Standards defined TQM as ,
“ TQM is a management approach for an
organization, cantered 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.”
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Total Quality Management (TQM)
7. The Concept of TQM
Produce quality.
Focus on the customer.
Have a strategic approach to improvement.
Improve Continuously.
Encourage mutual respect and teamwork.
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Total Quality Management (TQM)
10. Principle of TQM
Top management
Training needs
Customer orientation
Involvement of employees
Techniques and tools
Corporate culture
Continues improvements
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Total Quality Management (TQM)
11. Elements of TQM
Focus on the customer.
Employee involvement.
Continuous improvement.
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Total Quality Management (TQM)
12. Focus on 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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Total Quality Management (TQM)
13. Employee involvement
Since the quality is considered 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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Total Quality Management (TQM)
14. 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 up to vast improvement in quality.
TQM is the management process used to make continuous
improvements to all functions.
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Total Quality Management (TQM)
15. TQM represents an ongoing, continuous
commitment to improvement.
The foundation of total quality is a management
philosophy that supports meeting customer
requirements through continuous improvement.
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Total Quality Management (TQM)
16. Importance of TQM in
Pharma- Industry
Handling:-
Containers should be opened carefully and
subsequently resealed in an approved manner.
Highly sensitizing material such as penicillin's and
cephalosporins should be handled in separate
production areas.
Highly active or toxic API (e.g. certain steroids,
cytostatic substances) should be manufactured in a
dedicated area and using dedicated equipment.
Pure and final API should be handled in an
environment giving adequate protection against
contamination.
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Total Quality Management (TQM)
17. Packaging-
Labelling and packaging processes should be
defined and controlled to ensure that correct
packaging materials are used correctly and
other specified requirements are met.
Printed labels should be securely stored to
avoid mix-ups arising.
Marking and labelling should be legible and
durable, provide sufficient information, for
accurate identification and indicate, if
appropriate, required storage conditions, retest
and/or expiry date.
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Total Quality Management (TQM)
18. Storage:
Secure storage facilities should be designated
for use to prevent damage or deterioration of
materials.
These should be kept clean and tidy and subject
to appropriate pest control measures.
The condition of stored material should be
assessed at appropriate intervals.
Storage conditions for API should be based
upon stability studies taking into account time,
temperature, humidity, light etc
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Total Quality Management (TQM)
19. Facilities and equipment:
The location, design, and construction of buildings
should be suitable for the type and stage of
manufacture involved, protecting the product from
contamination (including cross-contamination) and
protecting operators and the environment from the
product.
Equipment surfaces in contact with materials used
in api manufacture should be non-reactive.
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Total Quality Management (TQM)
20. Sterile area :-
Personnel suffering from an infectious disease or
having open lesions on the exposed surface of the
body should avoid activities which could
compromise the quality of API.
Smoking, eating, drinking, chewing and storage of
food should be restricted to designated areas
separated from production or control areas.
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Total Quality Management (TQM)
21. Labelling:-
Each container should be identified by an
appropriate label, showing at least the product
identification and the assigned batch code, or any
other easily understandable combination of both.
Containers for external distribution may require
additional labels
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Total Quality Management (TQM)
22. Computerized systems:-
Computer systems should be designed and operated
to prevent unauthorized entries or changes to the
programme.
In the case of manual entry of quality critical data
there should be a second independent check to
verify accuracy of the initial entry.
A back-up system should be provided of all quality
critical data.
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Total Quality Management (TQM)
24. Advantages of TQM:-
1. Improves reputation- faults and problems are
spotted and sorted quicker.
2. Higher employee morale- workers motivated by
extra responsibility ,team work and involvement
indecisions of tqm.
3. Lower cost.
4. Decrease waste as fewer defective products and
no need for separate.
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Total Quality Management (TQM)
25. Disadvantages of TQM:-
1. Initial introduction cost.
2. Benefits may not be seen for several years.
3. Workers may be resistant to change.
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Total Quality Management (TQM)
26. Conclusion
Total Quality Management is practiced by many
business organizations around the world.
It is a proven method for implementing a quality
conscious culture across all the vertical and
horizontal layers of the company.
Although there are many benefits, one should take
the cost into the account when implementing
TQM.
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Total Quality Management (TQM)
