1.
TOTAL QUALITY MANAGEMENT
PRODIPTA CHAKRABORTY
DEPT. OF PHARMACEUTICS
HIMALAYAN PHARMACY INSTITUTE

2.
Various Definitions
Total quality management (TQM) has been defined as an
integrated organizational effort designed to improve quality at
every level.

 The process to produce a perfect product by a series of measures
require an organized effort by the entire company to prevent or
eliminate errors at every stage in production is called total
quality management.
 According to international organization for standards defined
tqm as, “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. 5

3.
Principles of tqm
1. Produce quality work the first time and every time.
2. Focus on the customer.
3. Have a strategic approach to improvement.
4. Improve continuously.
5. Encourage mutual respect and teamwork
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4.
Characteristics of TQM
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
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6

5.
The three aspects of TQM
Tools, techniques, and training inCounting
their use for analyzing,
understanding, and solving quality
problems
Quality for the customer as a
driving force and central concern.
Customers
Shared
expressed
values and beliefs,
define
Culture
by leaders, that
and support quality.
TOTAL QUALITY MANAGEMENT 8

6.
The key elements of the TQM
 Focus on the customer.
 Employee involvement
 Continuous improvement
TOTAL QUALITY MANAGEMENT 10

7.
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 employees.
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8.
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
improve quality.
authority to innovate and
TOTAL QUALITY MANAGEMENT 12

9.
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.
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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10.
Continuous Process Improvement.
 View all work as process – production and business.
 Process – purchasing, design, invoicing, etc.
 Inputs – process – outputs.
 Process improvement – increased customer satisfaction.
 Improvement – 5 ways:
 reduce resources, reduce errors, meet expectations of
downstream customers, make process safer, make process
more satisfying to the person doing
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11.
THE TQM SYSTEM
Continuous
ImprovementObjective
Principles
Leadership
Education and
structure
Training SupportiveElements
Communications
recognition
Measurement
Reward and
TOTAL QUALITY MANAGEMENT 17
Custom
er
Focus
Process
Improvem
ent
Total
Involvem
ent

12.
BENEFITS OF TQM:
•
•
•
•
•
•
•
•
•
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Improved quality.
Employee participation.
Team work.
Working relationships.
Customer satisfaction.
Employee satisfaction.
Productivity.
Communication.
Profitability.
Market share.
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13.
1. Leadership
2. Customer Satisfaction
3. Employee Involvement
4. Continuous Process Improvement
5. Supplier Partnership
6. Performance Measures

14.
 Top management must realize importance of quality
 Quality is responsibility of everybody, but ultimate responsibility is CEO
 Involvement and commitment to CQI(continuous quality improvement)
 Quality excellence becomes part of business strategy
 Lead in the implementation process

15.
1. Give attention to external and internal customers
2. Empower, not control subordinates. Provide resources, training, and work
environment to help them do their jobs
3. Emphasize improvement rather than maintenance
4. Emphasize prevention
5. Encourage collaboration rather than competition
6. Train and coach, not direct and supervise
7. Learn from problems – opportunity for improvement
8. Continually try to improve communications
9. Continually demonstrate commitment to quality
10. Choose suppliers on the basis of quality, not price
11. Establish organisational systems that supports quality efforts

16.
Must begin from top management, most important CEO
commitment
Cannot be delegated (indifference, lack of involvement cited as
principle reason for failure)
Top/senior management must be educated on TQM philosophy
and concepts, also visit successful companies, read books, articles,
attend seminars
Timing of implementation – is the org ready, re-organization,
change in senior personnel, current crisis – then need to postpone
to favourable time
Need a roadmap/framework for implementation
Formation of Quality Council – policies, strategies, programmes

17.
Quality council job–
1. Develop core values, vision statement, mission statement, and quality policy
statement
2. Develop strategic long-term plan with goals and annual quality improvement
program with objectives
3. Create total education and training plan
4. Determine and continually monitor cost of poor quality
5. Determine performance measures for the organization, approve them for
functional areas, and monitor them.
6. Continually determine projects that improve processes, particularly those affect
external and internal customer satisfaction
7. Establish multifunctional project and departmental or work group teams and
monitor progress
8. Establish or revise the recognition and reward system to account new way of
doing business. Must begin from top management, most important CEO
commitment

18.
Customer is always right – in Japan customer is “King”
Customer expectations constantly changing – 10 years ago
acceptable, now not any more!
Delighting customers
Satisfaction is a function of total experience with organization
Must give customers a quality product or service, reasonable price,
on-time delivery, and outstanding service
Need to continually examine the quality systems and practices to be
responsive to ever – changing needs, requirements and expectations
– Retain and Win new customers

19.
Checklist for both internal and external customers
1. Who are my customers?
2. What do they need?
3. What are their measures and expectations?
4. Does my product/service exceed their expectations?
5. How do I satisfy their needs?
6. What corrective action is necessary?

20.
To focus on customer, an effective feedback program is necessary, objectives of
program are to:
1. Discover customer dissatisfaction
2. Discover priorities of quality, price, delivery
3. Compare performance with competitors
4. Identify customer’s needs
5. Determine opportunities for improvement

21.
 Warranty cards/Questionnaire
 Telephone/Mail Surveys
 Focus Groups
 Customer Complaints
 Customer Satisfaction Index
Good experience are told to 6 people while bad experience are
repeated to 15 people

22.
People – most important resource/asset
Quality comes from people
Deming – 15% operator errors, 85% management system
Project teams – Quality Control Circles (QCC), QIT
Education and training – life long, continuous both
knowledge and skills
Suggestion schemes; Kaizen, 5S teams
Motivational programmes, incentive schemes
Conducive work culture, right attitude, commitment

23.
View all work as process – production and business
Process – purchasing, design, invoicing, etc.
Inputs – PROCESS – outputs
Process improvement – increased customer satisfaction
Improvement – 5 ways; Reduce resources, Reduce errors,
Meet expectations of downstream customers, Make
process safer, make process more satisfying to the person
doing

24.
Inputs – processing –
outputs
Input
Materials
Info, Data
People
Money
Process
Work methods
Procedures
Tools
Production – Cutting,
Welding, etc.
Bank –
deposit/withdrawal
process,
Kad Pintar Application
Process at NRD
Outputs
Products
Delivered service
In-process jobs –
forms signed, drawing
completed
Others
Also by-products,
wastes
Conditions
feedback

25.
 Identify the opportunity (for improvement)
 Analyze the current process
 Develop the optimal solution(s)
 Implement changes
 Study the results
 Standardize the solution
 Plan for the future

26.
 40% product cost comes from purchased materials, therefore Supplier Quality
Management important
 Substantial portion quality problems from suppliers
 Need partnership to achieve quality improvement – long-term purchase contract
 Supplier Management activities

27.
Managing by fact rather than gut feelings
Effective management requires measuring
Use a baseline, to identify potential projects, to asses results
from improvement
E.g. Production measures – defects per million, inventory
turns, on-time delivery
Service – billing errors, sales, activity times
Customer Satisfaction
Methods for measuring
Cost of poor quality
 Internal failure
 External failure
 Prevention costs
 Appraisal costs

28.
 Award Models (MBNQA, EFQM, PMQA)
 Benchmarking – grade to competitors, or best practice
 Statistical measures – control charts, Cpk
 Certifications
ISO 9000:2000 Quality Mgt System
ISO 14000 Environmental Mgt System,
Underwriters Lab (UL), GMP
QS 9000, ISO/TS 16949

29.
Importance of TQM in pharma/TM industry
Handling:
•
Containers should be opened carefully and subsequently
resealed in an approved manner.
Highly sensitising material should be handled in separate
production areas
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•
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30.
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.
• Environmental conditions should be recorded.
• The condition of stored material should be assessed at
appropriate intervals.
• Storage conditions for api should be based upon stability
studies
light etc
taking into account time, temperature, humidity,
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31.
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,
and/or expiry date.
required storage conditions, retest
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32.
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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33.
Sterile area
• Personnel suffering from an infectious disease or having
open lesions on the exposed surface of the body should
avoid
API.
activities which could compromise the quality of
• Smoking, eating, drinking, chewing and storage of food
should be restricted to designated areas separated from
production or control areas.
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34.
Computerised systems
• . Computer systems should be designed and operated to
prevent unauthorised entries or changes to the
programme.
• In the case of manual entry of quality
should be a second independent check
of the initial entry.
critical data there
to verify accuracy
• A back-up system should be provided of all quality critical
data.
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35.
Labelling
• Each container should be identified by an appropriate
label, showing at least the product identification and the
assigned batch code, or any
combination of both.
other easily understandable
• . Containers for external distribution may require
additional labels.
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36.
Advantages of tqm
• Improves reputation- faults and problems are spotted and
sorted quicker.
• Higher employee morale- workers motivated by extra
responsibility ,team work
tqm.
and involvement indecisions of
• Lower cost.
• Decrease waste as fewer defective products and no need
for separate.
Helps to face competition
Reduction in Customer complaintsTOTAL QUALITY MANAGEMENT 27

37.
Disadvantages of tqm
• Initial introduction cost.
• Benefits may not be seen for several years.
• Workers may be resistant to change.
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38.
A model for organization management.
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39.
Models of tqm
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40.
BENEFITS OF TOTAL QUALITY
MANAGEMENT
Financial benefits include lower costs, higher returns on sales and•
investment, and the
competitive prices.
ability to charge higher rather than
• Improved access to global markets, higher customer retention
levels, less
Time required to develop new innovations, and a reputation as a
quality firm.
Total quality management (tqm) is one such approach that seeks
to improve quality and
Performance which will meet or exceed customer expectations.
•
•
•
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41.
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.
Work culture and complete engagement of the employees at the work place. It
•
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should be realised that national & international regulations must be
implemented systematically and process.
Control should be practiced rigorously.
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..
•
•
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