B.

Pharm- Third Year

Pharmaceutical Quality Assurance

(PQA)

U1.2: Total Quality Management

(TQM)
UNIT – I

1.2 Total Quality Management (TQM): Definition, elements, philosophies

U1- 1.2-TQM
CONTENT

 Introduction
 Practice before TQM
 Benefits
 Disadvantages
 Components
 6C’s Implementation of TQM
 Elements
 Philosophies of TQM
 Conclusion

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U1- 1.2-TQM
INTRODUCTION

Total Quality Management

Made up of
whole/complete
Degree of Excellence a product or service provides
to the customer in present and future

Manner of handling, controlling, directing, etc

TQM is the art of managing the whole to achieve excellence.

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U1- 1.2-TQM
INTRODUCTION

TQM is defined by the International Organization for Standards (ISO) as "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 society."

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U1- 1.2-TQM
INTRODUCTION

Pharmaceutical companies play significant role in the healthcare sector and for this; these
firms are also regulated by regulatory bodies. In India, it is regulated by CDSCO (Central
Drugs Standard Control Organization) and in US- US FDA (United States Food And Drug
Administration).

Any mistake in the manufacturing process can lead to unwanted consequences. So to clear
the regulatory requirements, pharma firms need to continuously bring improvement in their
manufacturing process by implementing TQM.

TQM stands for "to fulfil the customer's quality expectations."

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U1- 1.2-TQM
Practices Before TQM

Before TQM, traditional quality management techniques only included final product quality
control (FPQC). If all of the criteria of the final product were found to be within the
acceptable range, it was considered a quality product; however, if the findings were found
to be outside of the acceptable range, the product was deemed to be of low quality and was
rejected.

Traditional systems had a number of flaws, one of which was that they did not include any
procedure or stages for product quality management during the manufacturing process.

Only the quality control department was responsible for the product's quality; other
departments were unconcerned about it, resulting in batch-to-batch fluctuation.
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U1- 1.2-TQM
Benefits of TQM In Pharma Industry

Increase in Profit

BENEFITS Accelerate
Cost Saving OF TQM Innovations

Facilitate Entry
to Global Market

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U1- 1.2-TQM
Disadvantages of TQM

Change may be The cost of the

resisted by initial
employees introduction.

DISADVANTAGES
OF
TQM

Benefits may take

several years to
manifest.
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U1- 1.2-TQM
COMPONENTS OF TQM

1. Customer Centric:- The organization's most important responsibility is to identify its

customers (internal and external). Customers of the drug product may be external
customers, while workers of the company may be internal customers. Organizations should
think about and focus on each and every customer's expectations, with customer happiness
as the primary goal.

2. Employee Involvement:- Providing employees with the tools they need to solve problems
and reduce waste.
Quality is the responsibility of every employee, the organisation must utilise each
employee's experience and knowledge in the process of quality improvement.
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U1- 1.2-TQM
COMPONENTS OF TQM

3. Continuous Improvement:- Improving quality and maintaining it is a never-ending

process in which each person consistently contributes to the improvement of company
performance, process yield, and product or service attributes.

The goal of continuous improvement is to increase quality at regular intervals and sustain it.
This will, in turn, serve to improve the overall quality of the product or service, as well as
the overall performance of the business.

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U1- 1.2-TQM
6Cs For Implementation of TQM

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U1- 1.2-TQM
6Cs For Implementation of TQM

1. Commitment to quality improvement is required by all the employees

2. The organization must embrace modern quality improvement culture
3. From time to time new reforms in all policies, procedures and activities are required for
continuous improvement
4. Harness employees expertise and cooperation for the improvement of strategies
5. Focus on customer requirements for staying relevant in the market
6. Control, monitor and measure of performance

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U1- 1.2-TQM
ELEMENTS OF TQM

KEY ELEMENTS OF TQM

In each scenario, ethics is concerned with the good-bad or right-wrong.
Organizational ethics are set of rules that all employees must follow
A Ethics
when performing their jobs. Personal ethics refers to personal rights
and wrongs.
Honesty, principles, values, fairness, commitment to the facts, and
B Integrity sincerity are all examples of integrity. It is the internal or external
expectations of the client, and it deserves to be met
Integrity and ethical behaviour are the foundations of trust. Trust
C Trust encourages complete engagement from all members, and TQM cannot
be implemented without it.

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U1- 1.2-TQM
ELEMENTS OF TQM
KEY ELEMENTS OF TQM
Employee training focuses on improving interpersonal skills,
teamwork, problem solving, decision making, job management
D Training
performance analysis and improvement, business economics, and
technical abilities
Teamwork is a fundamental component of TQM for a successful
business, and as a result, problems will be solved faster and more
E Teamwork effectively. Quality improvement teams or excellence teams (QITS),
problem solving teams (PSTS), and natural work teams are the three
types of teams used by TQM enterprises (NWTS).
It is the most crucial aspect of TQM. To give focus, clarity, and
F Leadership direction to increase quality, a supervisor must grasp TQM and present
an inspiring vision, strategies, philosophies, beliefs, and goals.
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U1- 1.2-TQM
ELEMENTS OF TQM

KEY ELEMENTS OF TQM

Communication is defined as the proper and complete understanding
of ideas among all members of a company, suppliers, and customers.
• Downward communication (the most common form of
communication in an organisation, such as presentations and
discussions so supervisors can explain TQM to employees),
G Communication
• Upward communication (lower level employees can provide
suggestions to upper management to provide insight to correct
the situation that arises from the use of TQM) (it breaks down
barriers between departments and allows dealing with customers
and suppliers in a more professional manner).

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U1- 1.2-TQM
ELEMENTS OF TQM

KEY ELEMENTS OF TQM

The last and final component of the system is recognition, which is given
for both team and individual suggestions and accomplishments.
H Recognition Good performers can be recognised in front of departments, on
performance boards, or in front of top management in a variety of ways
(award, trophies).

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U1- 1.2-TQM
PHILOSOPHIES OF TQM

Quality Gurus- Individuals who have been identified as making a significant contribution to
improving the quality of goods and services
1. W. Edwards Deming
2. Joseph M. Juran
3. Armand Feigenbaum
4. Philip Crosby
5. Kaoru Ishikawa

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U1- 1.2-TQM
PHILOSOPHIES OF TQM

1. W. Edwards Deming:
• The theory of Statistical Quality Control was created by Dr. W. Edwards Deming (SQC).
• He proposed that while each item cannot be checked individually, a sample should be tested for
quality and decisions made based on statistical methods.
• He proposed that a change in the routine and fixed manufacturing process would affect the
quality of the final pharmaceutical product. As a result, if variation in the process is eliminated,
the chances of quality change are reduced.
• The 14 quality management concepts were proposed by Dr. Deming. Top management
commitment to quality, effective communication between higher level employees and lower
level employees, continuous search for and rectification of quality problems, and company-
wide training and education in quality are just a few of them. 18
U1- 1.2-TQM
PHILOSOPHIES OF TQM

2. Joseph Juran:

• Quality, according to Joseph Juran, is "fitness for use."

• Juran is also credited with coining the phrase "Cost of Quality."
• He is the one who came up with the concept of the Quality Trilogy, i.e. Quality assurance,
quality control, and quality improvement are all aspects of quality management.

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U1- 1.2-TQM
PHILOSOPHIES OF TQM

3. Armand V. Feigenbaum:
Quality is simply a way of managing a business organization
Four Steps to Quality: (SAAP)

Appraise Act when

Set quality Plan to make
conformances standards are
standards improvements
to standards not met

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U1- 1.2-TQM
PHILOSOPHIES OF TQM

3. Armand V. Feigenbaum:
10 benchmarks for total quality success:
• Is a Company wide process
• Is What the customer says it is
• & cost are a sum, not a difference
• Requires both individual & team enthusiasm
• Is a way of managing
Quality • and innovation are mutually dependent
• Is an ethic
• Requires continuous improvement
• Is the most cost effective, least capital- intensive route to
productivity
• Is implemented with a total system connected with customers &
suppliers 21
U1- 1.2-TQM
PHILOSOPHIES OF TQM

4. Philip B. Crosby:

Crosby’s Absolutes of Quality

Quality is the
The only The only
Conformance to It is always
performance performance
requirements, not cheaper to do it
measurement is standard is zero
as a ‘goodness’ or right first time
the cost of quality defects
‘elegance’

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U1- 1.2-TQM
PHILOSOPHIES OF TQM

5. Kaoru Ishikawa:

Father of Quality Circles- Quality circle is a voluntary group of employees who work on
similar tasks.

Number of
Focus Meeting Generate Structure
members
• 3-12 people • Is on specific • Once a week • Mutual respect • Top
issues to • To analyze & trust as they management
resolve work related work on • Steering
problem problems solutions committee
• Proposes • Co-ordinator
solutions to • Facilitator
management • Leader
and
• Members
implementatio
n of solutions • Non-members
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U1- 1.2-TQM
CONCLUSION

• TQM is the most effective method for pharmaceutical quality control.

• Many regulatory bodies strongly advise it, but it is still not fully applied in all businesses,
particularly in India. Because India is one of the world's top exporters of pharmaceutical
items, thorough TQM adoption is critical in the Indian setting.
• The manufacturer needs to be able to,
1) manage the causes of variance in product quality, such as materials, machinery, and
processes as well as men
2) ensure that the best manufacturing and packaging methods are used.
3) ensure that the findings of the testing are in accordance with the standards or specifications

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THANK YOU

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