1. TOTAL QUALITY MANAGMENT
BY: Ankit Rana
QualityAssurance Head
Yacca Lifesciences Pvt. Ltd. Bhagwanpur (Roorkee)
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2. TOTAL QUALITY MANAGEMENT (TQM)
 The pharmaceutical industry is a vital segment of health care system which is
regulated heavily because; any mistake in product design or production can be
severe, even fatal.
 The poor qualities of drug are not only a health hazard but also a waste of
money for both the government and the individual customers.
 So, the maintenance of the quality with continuous improvement is very important
for pharmaceutical industries.
 From this concept, Total Quality Management (TQM) was established.
 The aim of TQM is “prevention of defects rather than detection of
defects”.
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3. TQM MEANS:
1. Satisfying customers first time, every time.
2. Enabling the employees to solve problems and eliminate wastage;
3. A style of working, a culture more than a management technique;
4. Philosophy of continuous improvement, never ending, only achievable by/or
through people.
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5. DEFINITION:
 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 requiring 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 (ISO) TQM is defined 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.
 It uses strategy, data and effective communications to integrate the quality discipline
into the culture and activities of the organization.
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6. PRINCIPLES OF TQM:
 Management Commitment
1. Plan (drive, direct)
2. Do (deploy, support, participate)
3. Check (review)
4. Act (recognize, communicate, revise)
 Employee Empowerment
1. Training
2. Suggestion scheme
3. Measurement and recognition
4. Excellence teams
 Fact Based Decision Making
1. SPC (statistical process control)
2. DOE, FMEA
3. The 7 statistical tools
4. TOPS (Ford 8D – team-oriented problem solving)
 Continuous Improvement
1. Systematic measurement and focus on CONQ
2. Excellence teams
3. Cross-functional process management
4. Attain, maintain, improve standards
 Customer Focus
1. Supplier Partnership
2. Service relationship with internal customers
3. Service relationship with internal customers
4. Never compromise quality
5. Customer driven standards
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7. TOTAL QUALITY MANAGEMENT PRINCIPLES:
The 8 Primary Elements of TQM are as follows –
1. Customer-focused
The customer ultimately determines the level of quality. No matter what an organization does to foster
quality improvement—training employees, integrating quality into the design process, upgrading
computers or software, or buying new measuring tools—the customer determines whether the efforts
were worthwhile.
2. Total employee involvement
All employees participate in working toward common goals. Total employee commitment can only be
obtained after fear has been driven from the workplace, when empowerment has occurred, and
management has provided the proper environment. High-performance work systems integrate
continuous improvement efforts with normal business operations. Self-managed work teams are one
form of empowerment.
3. Process-centered
A fundamental part of TQM is a focus on process thinking. A process is a series of steps that take
inputs from suppliers (internal or external) and transforms them into outputs that are delivered to
customers (again, either internal or external). The steps required to carry out the process are defined,
and performance measures are continuously monitored in order to detect unexpected variation.
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8. 4. Integrated system
Although an organization may consist of many different functional specialties often
organized into vertically structured departments, it is the horizontal processes
interconnecting these functions that are the focus of TQM
Micro-processes add up to larger processes, and all processes aggregate into the business
processes required for defining and implementing strategy. Everyone must understand
the vision, mission, and guiding principles as well as the quality policies, objectives, and
critical processes of the organization. Business performance must be monitored and
communicated continuously.
An integrated business system may be modelled after the Baldrige National Quality
Program criteria and/or incorporate the ISO 9000 standards. Every organization has a
unique work culture, and it is virtually impossible to achieve excellence in its products
and services unless a good quality culture has been fostered. Thus, an integrated system
connects business improvement elements in an attempt to continually improve and
exceed the expectations of customers, employees, and other stakeholders.
An integrated business system may be modelled after the Baldrige National Quality
Program criteria and/or incorporate the ISO 9000 standards. Every organization has a
unique work culture, and it is virtually impossible to achieve excellence in its products
and services unless a good quality culture has been fostered. Thus, an integrated system
connects business improvement elements in an attempt to continually improve and
exceed the expectations of customers, employees, and other stakeholders.
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9. 5. Strategic and systematic approach
A critical part of the management of quality is the strategic and systematic approach to
achieving an organization’s vision, mission, and goals. This process, called strategic
planning or strategic management, includes the formulation of a strategic plan that
integrates quality as a core component.
6. Continual improvement
A major thrust of TQM is continual process improvement. Continual improvement
drives an organization to be both analytical and creative in finding ways to become more
competitive and more effective at meeting stakeholder expectations.
7. Fact-based decision making
In order to know how well an organization is performing, data on performance measures
are necessary. TQM requires that an organization continually collect and analyze data in
order to improve decision making accuracy, achieve consensus, and allow prediction
based on past history.
7. Communications
During times of organizational change, as well as part of day-to-day operation, effective
communications plays a large part in maintaining morale and in motivating employees at
all levels. Communications involve strategies, method, and timeliness.
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12. FEATURES OF TQM:
1) Customer-oriented - TQM focuses on customer satisfaction through creation of
better quality products and services at lower costs.
2) Employee involvement and empowerment - Teams focus on quality improvement
projects and employees are empowered to serve customers well.
3) Organization-wide - TQM involves every department or division.
4) Continuous improvement - Quality improvement is a never-ending journey.
5) Strategic focus - Quality is viewed as a strategic, competitive weapon.
6) Process management - TQM adopts the concept of prevention through process
management.
7) Change in corporate culture - TQM involves the creation of a work culture
that is conducive to quality improvement.
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ADVANTAGES OF TQM
The advantages of implementing TQM are:
1. Improves reputation
Faults and problems are spotted and sorted quicker.
2. Higher employee morale
Workers are motivated by extra responsibility, team work and involvement in decisions of TQM.
3. Lower cost
Decrease waste as fewer defective products and no need for separation.

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DISADVANTAGES OF TQM

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