TQM i.e. Total Quality Management plays an very important role in pharmaceutical industries in world-wide as it is very feasible and time saving and improves product quality at a great extent.

1. TQM: Total Quality Management
Sinhgad Technical Education Society’s
Sinhgad Institute of Pharmacy, Narhe.
Guided By:
Ms. Ashwini. A. Bhosale.
Asst. Professor,
M.Pharm ,
Pharmaceutical Chemistry
Presented by:
Mr. Saurabh. D. kalkate
M.Pharm (First Year)
Quality Assurance Techniques.
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2. Content
 Introduction
 History
 The Concept Of TQM
 Various Definitions
 Characteristics of TQM
 Traditional approach & TQM
 The Three Aspects Of TQM
 Need Of TQM
 Principles Of TQM
 The key elements of the TQM
 Benefits Of TQM
 Importance Of TQM In Pharma Industry 2

3. Continue…
 Advantages Of TQM
 Disadvantages Of TQM
 A Model For Organization Management
 Conclusion
 Reference
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4. Introduction
 Total – Made up of the whole.
 Quality – Degree of excellence a product or service provides.
 Management – act, art or manner of planning, controlling,
directing,….
Therefore, TQM is the art of managing the whole to achieve
excellence.
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5. History
 1920’s – First seed of Quality Management planted.
(By U.S. industry)
 1930’s – Walter Shewhart develop methods for statistical analysis &
control of quality.
 1950’s – Various scientist develops zero defects way for quality
improvement.
 1968 – Japanese named total quality to quality management system arises.
 Today – TQM is a name for a systemic approach to managing
organizational quality.
- It describe organizational quality policy & procedure or
various standards. (ISO 9000)
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6. The Concept Of TQM
 Produce quality work the first time.
 Focus on the customer.
 Have a strategic approach to improvement.
 Improve continuously.
 Encourage mutual respect teamwork.
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7. Various DefinItions
 Total Quality Management (TQM) has been defined as an integrated
organizational effort designed to improve quality at every level.
 According to international organization for standards defined tqm 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”.
 The process to produce perfect product its require an organizational
effect by entire company to prevent or eliminate errors at every stage
is called as Total Quality Management.
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8. Characteristics of TQM
 Committed management.
 Adopting & Communicating about total quality management.
 Closer customer relations.
 Closer provider relations.
 Benchmarking.
 Increased training.
 Open organization.
 Employee empowerment.
 Process improvement.
 Flexible production.
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9. Traditional approach & TQM
Quality element Previous state TQM
Definition Product-oriented Customer-oriented
Decisions Short-term Long-term
Emphasis Detection Prevention
Errors Operations System
Responsibility Quality control Everyone
Problem solving Managers Team
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10. The Three Aspects Of TQM
 Counting – Tools, techniques, & training in their use
for analyzing, understanding, and solving
quality problems.
 Customers – Quality for the customer as a driving force
& central concern.
 Culture – Shared values and beliefs, expressed by
leaders, that define & support quality.
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11. Need Of TQM
The benefits of TQM include:-
 Less product defects.
 Satisfied customers.
 Lower costs.
 Well- defined cultural values.
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12. Principles Of TQM
TQM
Focus on
Customer
Employee
Involvement
Process
Centered
Integrated
system
Strategic &
Systemic
Approach
Decision-
making Based
on Facts
Communication
Continuous
Improvement
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13. The key elements of the TQM
 Focus on the customer.
 Employee involvement.
 Continuous improvement.
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14. 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
employee.
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15. 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 & thus can make the most valuable contribution to quality.
 Therefore, employees must have the authority to innovate & improve
quality.
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16. Continuous Improvement
TQM Mission
Continuous Quality
Improvement
Quality
Improvement
Team
Total
Participation
Customer
Focus
Systematic
Problem
Solving
Focus
Statistical
Quality
Control
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17. 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 upto vast improvement in
quality.
 TQM is the management process used to make continuous improvement to
all functions.
 TQM represents an ongoing, continuous commitment to improvement. 17

18. Benefits Of TQM
 Improved quality.
 Employee participation.
 Team work.
 Working relationship.
 Customer satisfaction.
 Communication.
 Productivity.
 Profitability.
 Market share.
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19. Importance Of TQMIn Pharma Industry
 Handling –
 Containers should be opened carefully and subsequently resealed in an
approved manner.
 Highly sensitising material such as penicillins and cephalosporins
should be handled in separate production area.
 Highly active or toxic API (e.g. steroids) should be manufactured in a
dedicated area and using dedicated equipment.
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20. Storage –
 Secure storage facilities should be designated for use to prevent
damage or deterioration of materials.
 Environmental conditions should be recorded.
 Storage condition for API should be based upon stability studies
taking into account time, temperature, humidity, light, etc.
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21. Packaging –
 Labelling and packaging processes should be defined and
controlled to ensure that correct packaging materials are used and
other specified requirements are met.
 Printed labels should be securely stored to avoid mix-ups arising.
 Marking and labelling should provide sufficient information, for
accurate identification and indications, if appropriate, required
storage conditions, retest and/or expiry date.
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22. 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).
 Equipment surfaces in contact with materials used in API
manufacture should be non-reactive.
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23. Advantages Of TQM
 Improves reputation – Faults & problems are spotted and sorted
quicker.
 Higher employee morale – Workers motivated by extra responsibility,
team work & involvement indecisions of TQM.
 Lower cost.
 Decrease waste as fewer defective products and no need for separate.
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24. Disadvantages Of TQM
 Initial introduction cost.
 Benefits may not be seen for several years.
 Workers may be resistant to change.
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25. A Model For Organization Management
TQM Model
Customer Focus
Planning
Process
Process
Management
Process
Improvement
Total
Participation
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26. Conclusion
 TQM encourages participation amongst employees, managers and
organization as whole.
 Using quality management reduces rework nearly to zero in an
achievable goal.
 We conclude that TQM is a very important concept use to apply in an
organization or company daily operations.
 Example; McDonald use these techniques in effective manner.
 It mainly focus or aimed at the prevention of defects rather than
detection of defects.
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27. References
 Suganthi L. & Samuel A.(2005). Text book of Total Quality Management.
2nd edition, Page no. 49-61.
 Nagarajan R., Arivalanagar A.(2009). Total Quality Management, New age
international publishers. 1st edition, Page no. 21.
 Justin K.(2015). Total Quality Management. First year M.Pharm Analysis,
Published on Dec 14, 2015. (www.slideshare.com)
 www.slideshare.com/tqm in pharma industry, accessed on 06/03/2021
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28. Continue…
 https://asq.org/quality-resources/total-quality-management/tqm-history,
accessed on 08/03/2021
 https://www.slideshare.net/mobile/justinsolin/total-quality-management-
56112246, accessed on 08/03/2021
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29. Question & Answer
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