This document discusses Total Quality Management (TQM). It defines TQM as comprising of three elements: total, quality, and management. It then outlines some key characteristics of TQM including committed management and communication. It also discusses reasons for TQM failure such as lack of commitment from top management. Finally, it highlights benefits of TQM such as financial benefits, improved access to markets, and improved quality and performance.

1. Presented by :- Rutik Janardhan Jadhav
Roll no :- 06
Department :- Pharmaceutics
TOTAL QUALITY MANAGEMENT (TQM )
19-Dec-23
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2. SR. NO CONTENT
1
INTRODUCTION
2 CHARACTERISTICS OF TQM
3 REASONS FOR TQM FAILURE
4
IMPORTANCE OF TQM IN PHARMA INDUSTRY
4 ADVANTAGES & DISADVANTAGES
5
BENEFITS OF TOTAL QUALITY MANAGEMENT
19-Dec-23
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INTRODUCTION
TOTAL QUALITY MANAGEMENT (TQM)
Comprises of three words
1. Total = Whole
2. Quality = Degree of excellence
3. Management = Act of planning

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• Total quality management increases the
customer satisfaction by boosting the quality.
• It does by motivating the work force and
improving the way company operates.
INTRODUCTION

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CHARACTERISTICS OF TQM
 Committed Management :
The management of the company should be committed to-word
the productions of quality product.
 Communication :
The Communication between various department and management
should be there to maintain the quality of product.

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THE KEY ELEMENTS OF THE TQM
Focus on the customer.
Employee involvement.
Continuous improvement.

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 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.
 Since the quality is considered the job of all employees,
employees should be involved in quality initiatives.

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 Continuous improvement :
The mission for quality is a never-ending process in which
people are continuously working to improve the
• Performance
• Speed
• Number of features of the product or service.

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PRINCIPLES
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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TQM fails because :
Top management sees no reasons for change
Top management is not concerned for its staff.
Top management is not committed to the TQM programmer.
The company loses interest in the programmer after six months.
Reasons for TQM failure

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IMPORTANCE OF TQM IN PHARMA INDUSTRY
 Handling
 Storage
 Packaging
 Facilities and equipment
 Sterile Area and labelling

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 Handling:
 Containers should be opened carefully and subsequently
resealed in an approved manner.
 Highly sensitive materials such as penicillin's and
cephalosporin's should be handle in separate production
area.
 Highly active should be manufacture in a dedicate area
and using delectated reagent.
 Pure and API should be handle in an environmental
giving the adequate protection against contamination.
IMPORTANCE OF TQM IN PHARMA INDUSTRY

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 Storage:
Secure storage facilities should be designated for use to
prevent damage of materials.
These Should be kept clean and neat to the appropriate pest
control measurement.
Environmental conditions should be recorded.
The Storage conditions for API should be based upon stability
studies taking into account time.
Temperature
Humidity
Light etc…

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 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 store to avoid mix-ups
arising.
 Marking and labelling should be readable and durable,
provide sufficient information for identification and
indication require accurate storage conditions retest and
expiry date.

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 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
and protecting operators and the environment from the
product.
Equipment surfaces in contact with materials used in
API manufacturing should be non reactive.

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 Sterile Area and labelling :
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, and Storage of food should
be restricted to designated areas separated from
production or control areas.
 LABELLING:
Each container should be identified by an appropriate
label ,showing at least the product identification and
assigned batch code, or any other easily understandable
combination of both.

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 Advantages of TQM :
 Improves reputation- Faults & Problems are spotted and shorted
quicker.
 Higher employee morale- Workers motivated by extra responsibility,
teamwork and involvement indecisions of TQM
 Lower cost.
 Decrease waste as fewer defective products and no need for
separate.
ADVANTAGES

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 Disadvantages of TQM:
 Initial introduction cost is high.
 Benefits are not long lasting.
 Workers may be resistant to change.
DISADVANTAGES OF TQM:

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BENEFITS OF TOTAL QUALITY
MANAGEMENT :
 Financial benefits include lower costs, higher returns on sales
and investment, and the ability to charge higher rather than
competitive prices.
 Improved access to global markets, higher customer retention
levels.
 improve quality and Performance

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TOTAL QUALITY MANAGEMENT (TQM )