Total quality management (TQM) is a management approach that seeks to continuously improve processes and products. It focuses on preventing mistakes by identifying causes and implementing changes. The key elements of TQM include focusing on customers, analyzing processes, working in quality teams, and using data to identify problems and solutions. TQM has advantages like increased innovation, productivity, customer satisfaction and profitability when implemented successfully in an organization. In the pharmaceutical industry, TQM and quality by design (QBD) help ensure consistent, safe and effective drug products by building quality into every stage of product and process design based on scientific understanding and risk management.
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TOTAL QUALITY MANAGMENT.pptx
1. TOTAL QUALITY MANGMENT
By: Radhika soni(48)
Industrial Pharmacognostical Technology
Faculty of Pharmacy
M.Pharm
(pharmacognosy) sem-I
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2. Contents:
Introduction OF TQM
Key elements of TQM
Advantages of TQM
TQM in drug industry
Quality by design
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3. Introduction
Quality: The degree to which a set of inherent characteristics fulfills the requirements
Quality is a term that is widely used when talking about how good or poor a product or
service is.
What is TQM?
TQM is a structured approach to organizational management with a process focused on
improving the quality of outputs of an organization, including services and goods, by the
constant improvement of its internal practices.
or
TQM is an organizational management philosophy seeking to continuously improve the
quality of processes and products.
Using a set of management and quality tools, TQM approach seeks to increase business even
as it reduces loss due to improper practices. Being a highly adaptable concept, it has been
widely applied in several industries in the production and service sectors.
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4. The main components of TQM include:
Focus on consumer
Analysis of process
Work in quality teams
Systematic analysis of problems
Implement planned changes and evaluate results
Use data to identify problems and solutions
Implement changes
TQM is also based on the main principle that mistakes are often a result of faulty processes
and systems. By identifying the causes of such mistakes, it is possible to eliminate them
through three mechanisms:
Prevent errors from occurring.
Where prevention is not possible, early detection to prevent the mistake causing damage
down the chain.
Immediate correction of process if mistakes recur.
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5. Key elements of TQM
There are eight key elements on which an organization must focus to implement TQM with
success:
(a) Ethics
(b) Integrity
(c) Trust
(d) Training
(e) Teamwork
(f) Leadership
(g) Recognition
(h) Communication
These eight elements are further clubbed into four groups as based on their function.
(a)Group I Foundation (c) Group III Binding Mortar
(b)Group II Building Bricks (d) Group IV Roof
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7. 1. Foundation:
A foundation of ethics, integrity and trust helps to create an open and fair environment that
fosters involvement by everyone in the organization.
Ethics deals with what is good and bad in a given situation, both at the individual and the
organizational levels.
Integrity refers to the honesty with which one adheres to facts.
When ethics are followed with integrity, it leads to development of trust, the third element
of the foundation, which creates an environment of cooperativeness.
2. Building Bricks:
Employees need to be trained in performing their duties right and in problem solving.
They must also be trained in interacting with others, to do their job better through
teamwork.
Any team is only as good as its leader and so here has to be inspirational leadership by
someone who understands TQM and is committed to it in daily practice.
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8. 3. Binding Mortar:
The link which binds all elements of TQM is communication which refers to a common
understanding of the message by both the sender and receiver.
Openness in communication between members of an organization and with vendors and
customers is key to the success of TQM.
4. Roof:
Recognizing the contributions of people in an organization, whether for teams or for
individuals, is the final element in TQM.
When employees receive recognition, it brings about a leap in their self-esteem and such
employees are more motivated which ultimately leads to better productivity and quality of
work they do.
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9. Advantages of TQM:
Innovation in processes
Greater productivity
Reduced defects in product
Increased customer satisfaction
Higher profitability and
reduced costs
Higher employee morale
Better adaptability to changing
market conditions
Increased competitiveness
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10. TQM in drug industry:
As time evolved pharmaceutical processes grew more complex, it gradually came to be
realized that no process is perfect all the time, and there are drifts from the normal
functioning.
According to regulatory bodies across the world, high quality drug products are those that
can be relied upon to deliver the desired clinical effects with consistency.
Consumers of medicines need to know for sure that the drug product they are consuming are
of good quality, safe for consumption, and will be effective in relieving them of their
ailment.
This quality can be guaranteed only if the products have it built into them right from the
very first stage of design of the product and process.
Realization of this basic principle led to the International Conference on Harmonization
(ICH) in 2002, introducing a unheard term in the drug processing field the concept of
Quality by Design or QbD.
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11. Quality By Design
The ICH guideline Q8 Pharmaceutical Development defines QbD as, A systematic
approach to development that begins with predefined objectives, emphasizes product,
process understanding and process control based on sound science and quality risk
management.
To achieve the objective of QbD, it is important to understand product characteristics and
study process characteristics using a combination of prior knowledge and experimental
studies.
From this data generated during product development, it becomes possible to decide which
quality parameters in starting materials are the most important and which critical processing
factors need to be controlled to achieve a product with all the desired quality attributes.
Developing such pharmaceutical quality systems is the key to meeting patient requirements
in an efficient manner. Because they deliver consistent quality, these systems also serve to
increase the confidence of regulatory bodies about the organizations commitment to quality.
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15. References:
A. R. Kashi, B. Sukumaran, P. Venna ; A Text Book of Pharmaceutical Quality Assurance;
Nirali Prakashan; 1st Edition; 2020: 2.1-2.6.
D. Ranjan, R. B. Bodla; QbD: Key To Quality Pharmaceuticals; Scholars Academic
Journal Of Pharmacy; 260-265. https://saspublishers.com/media/articles/SAJP-76-260-265-c.pdf
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