Total Quality Management (TQM) is a management approach focused on quality that involves participation from all organization members aiming for long-term success through customer satisfaction. TQM aims to prevent defects rather than detect them after the fact. It has objectives like decreasing mistakes, early mistake recognition, and flexibility. TQM provides benefits like higher customer retention, less time, improved quality, and a competitive edge. It has characteristics like committed management, closer customer/supplier relations, benchmarking, training, and employee empowerment. Key elements include ethics, integrity, trust, training, teamwork, leadership, communication, and recognition. TQM draws from philosophies like Deming's 14 points and Crosby's 14 steps. It can be applied

1. TOTAL QUALITY
MANAGEMENT (TQM)
SUBJECT: PHARMACEUTICAL QUALITY ASSURANCE
PREPARED BY: MS. ASHWINI U. BHOIR
ASSISTANT PROFESSOR
IN PHARMACEUTICS

2. Introduction
Quality
QMS
The word Total Quality Management means???
• Total: Made up of the whole
• Quality: Degree of excellence a product or service provides;
• Management: Art, act or manner of handling , controlling, directing
etc.
Aim: Prevention of defects rather than detection

3. Introduction
Fig 1. Quality Management System

4. TOTAL QUALITY
MANAGEMENT (TQM)
OBJECTIVES Decrease of mistakes in all operating areas.
Early mistake recognition.
Mistake prevention as a preventive step.
Avoidance of wastes.
Reduction of the lead time.
Increase of the flexibility and profitability.
Better capture and conversion of the consumer’s need.
Contented position of the consumers.

5. DEFINITONS:
Total Quality Management (TQM) refers to management methods used to
enhance quality, based on the participation of all members & aiming all
long term success through customers satisfaction & benefits to all
organizations.
As per 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 the society.”
Plays a vital role in improving productivity, product quality and reduce
manufacturing cost by reducing rework and scrape.

6. BENEFITS:
• Financial
• Higher customer retention
levels
• Less time required
• Improve quality
SIGNIFICANCE:
• Encourage innovation
• Motivates people for the better
quality
• Integrates the business
• Provide a valuable and distinctive
competitive edge.
• Adaptability for organization

7. CHARACTERISTICS
• Committed management
• Adopting and communicating about total quality management.
• Closer customer relations.
• Closer provider relations.
• Benchmarking.
• Increased training.
• Open organization
• Employee empowerment.
• Flexible production.
• Process improvements.
• Process measuring.

8. Initial
introduction
cost.
Benefits
may not
be seen
for
several
years.
Workers
may be
resistant
to
change.
PRINCIPLE
Focus on
customer
Employee
involvement
Process
centered
Integrated
system.
Strategic
and
systematic
approach
Decision-
making
based on
facts. Communication

9. Elements of TQM
Ethics
Integrity
Trust
Training
Teamwork
Leadership
Communication
Recognition
• Communicati
on
• Recognition
• Training
• Teamwork
• Leadership
• Ethics
• Integrity
• Trust
Foundation Bricks
Binding
mortar
Roof

10. Ethics
Integrity
Trust
• Organizational
• Personal
• Implies honesty, moral
• Duplicity
• By product of integrity and ethics
1. Foundation
Training
High productivity
Improve skills
Teamwork
Key element
1.1. QITs 2. PSTs
2.3. NWTs
Leadership
Leader with
inspiring vision,
strategic
directions
2. Bricks

11. 3. Binding mortar
Communication
Binds everything
a)Downward
b)Upward c) Sideways
4. Roof
Recognition
Final element
a) Ways b) Places c) Time

12. QUALITY MANAGEMENT PHILOSOPHIES
Dr. W. Edwards Deming: (1900-1993) is considered to be Father of
Modern Quality.
Dr. Deming preached that to achieve the highest level of performance
requires more than a good philosophy the organization must change its
behavior and adopt new way of doing business.
Deming’s and his
famous 14 Points

13. QUALITY MANAGEMENT PHILOSOPHIES
CROSBY
• Philip Bayard Phil Crosby was a businessman and Author who
contributed to management theory and quality management
practices.
• Crosby’s approach revolves around the zero defects program.
Doing things right the first time is always cheaper than trying to fix
defects after they have been created. Thus, quality is free.

14. QUALITY MANAGEMENT PHILOSOPHIES
CROSBY’s 14 steps to quality:
 Management Commitment
 From Quality Improvement Team
 Management Perspective
 Determine Quality Measures
 Evaluate the Cost of Quality
 Quality Awareness
 Correction Action
 Ad hoc Committees and Zero Defects
Programs Training of Supervisors and
Managers
 Zero Defect Day
 Goal Settings
 Error cause removal
 Recognition
 Quality Councils
 Do it over again
CROSBY’s TRIANGLE:

15. Application of TQM in Pharmaceutical Industry
In Handling
Process
Storage
Packaging
Facilities and
equipment
Sterile area
Labelling
Computerised
systems

16. REASONS OF FAILURES IN IMPLEMENTATION OF TQM
APPROACH
• Interfering of managers in teamwork.
• Disordered / Untidy procedures and processes.
• Lack of Understanding of TQM approach.
• Many Layers in the organizational structure.
• Lack of adequate training and education.
• Limited resources.