M.Pharm sem-1 QA 102T

1. Total Quality Management
&
Six Sigma
Prepared by: Dhruti Sudani

2. Introduction:
• Total – Made up of the whole(or) Complete.
• Quality – Degree of Excellence of a product or
service provides to the customer in present and
future.
• Management – Act , art, or manner of handling ,
controlling, directing, etc.
TQM is the art of managing the whole to achieve
excellence.

3. Definition
• “TQM is a set of systematic activities carried out by the entire organization to
effectively and efficiently achieve company objectives so as to provide products and
services with a level of quality that satisfies customers, at the appropriate time and
price.”
• Total Quality Management is commonly expressed in conjunction with business
excellence.
• It is a scientific management methodology that values the quality of companies and
organizations—quality not only in products, but also in their processes and in their
organization for quality management.
• According to the TQM Committee, in the 21st century a company is to seek quality
establishing respectable existence and a co-delighting relationship with stakeholders.
• In order to accomplish this, the committee continues, “it is crucial that the company
achieve competitive and praised ability, technology, speed and flexibility, and vitality.”
And TQM has a significant role to play to meet those requirements.

4. A successful TQM programe requires the following six basic
concepts:
1. Top management commitment
2. Focus on the customer
3. Effective involvement and utilization of the entire work
4. Continuous improvement
5. Treating suppliers as partners
6. Establishing performance measures for the processes.

5. TQM Tools
1.Quality Improvement Teams
These are small groups of employees who work on solving specific problems related
to quality and productivity, often with stated targets for improvement. Quality
improvement teams are proving to be highly successful at tracking down the causes of
poor quality as well as taking remedial action.
Benchmarking
This is the process of identifying the best practices and approaches by comparing
productivity in specific areas within ones' own company to other organisations both
within and outside the industry.
2. statistical process control
This is a statistical technique that uses periodic random samples taken during actual
production to determine whether acceptable quality levels are being met or whether
production should be stopped in order to take remedial action. Because most
processes produce some variation, statistical process control uses statistical tests to
determine when variations fall outside a narrow range around the acceptable quality
level. The emphasis when using SPC is on defect prevention rather than trying to
inspect the quality into the product.

6. COMMITMENT
In order for the Eye on the Future Model to be a success, each member in an
organisation must be committed to the change process. If necessary inspirational speakers should be
employed to enthuse staff to a new attitude of commitment. Once again, people are led by example.
it appears that management is not committed to the change process, this is the attitude the people
develop.
TRAINING
Training must be a part of the organisation succession planning. In today's business
environment any training which is less than visionary will not help the organisation
meet its' future goals and objectives. Training objectives must be supportive of the
company's vision and mission. In order to identify training, the employees must be
involved. The results of the training must be evaluated to ensure that effective improvement has been
achieved and that employees are competent to use the skills acquired.

7. Management must promote the need for continuous training,
as it will facilitate the
following:
1. Employees will be more confident and motivated in their
work
2. Reduce staff turnover
3. Reduce errors
4. Improve productivity
5. Improve the organisation competitiveness.
Training must help each individual in the organisation to
maintain a growing knowledge of their business environment.
It must be implemented to each individual,
from the directors to the cleaners.

8. TQM which means Total Quality Management, which focuses on improvement in the
quality of product to satisfy the customers. Managerial activities of TQM are,
1. Continuous improvement of skills :
• Organization should continuously improve the culture of skills. They should develop
their skills in the specific department. For this, the organization should give effective
trainning and program to make employee skilled one. Creative and innovation skill
makes the quality of a product which satisfy the customers and also helps to develop
overall working efficiency of the organization.
2. Use of Teamwork:
• Use of teamwork is the important part of TQM. It helps to solve problems of any part of
the organization. Team co-operates between each other and one encourages another
for making process. All member comes together for taking decision related to
procedure and working method.

9. 3. Improving processes, product and service:
• TQM is continuous improvement in processes, product & service. It
should be done by considering customers need and wants .New
technology is improving the taste and demand of customers due to
the mode, design and structure. So, management should
employees in such improvement of planning.
4. Focus on customer satisfaction:
• All the business organizations main objective is to earn profit and
wealth through customers satisfaction. If we make customer satisfy
the market area, then it will increase the volume of business. So,
customers are the source of revenue in an organization. Essential
measure to satisfy the customers are: taking their view, identifying
potential customers, studying the measures for satisfying customers
and supplying goods and services on the basis of their needs and
demand.

10. The Continous
Improvement
Customer focus
Process
development
Total involvement
Objective
Principles
Leadership
Education Training
Communications
Measurement
Reward and Recognition
Elements

11. Principles of TQM

12. • Leaders establish unity of purpose and direction of
the organization. The should create and maintain
the internal environment in which people can
become fully involved in achieving the
organization’s objectives.
1. Leadership
• Leadership is an important factor for Total Quality
Management. An effective and dynamic leader can
lead a successful team and subsequently make a
profitable organization.

13. • The main objective for a product or service design is to meet or
exceed the customers’ expectation and thus to satisfy the customer
while making a reasonable profit.
• Customers are the driving force for product and service design.
• A customer oriented or customer focused organization maintains its
competitive advantage.
2. Customer Focus
• The organization must access the current skill level & awareness of the total
quality principles of all employees.
• Employee training is an important factor of quality management. Training is an
efficient way to increase employees’ ability to perform better
3. Training
• An organization which fully utilizes the skills of its workers’ ability is on its
way to achieve organizational objectives

14. 4.Empowerment & involvement
• After training period the organization must provide
opportunities for employees to apply what they have
learnt. They check their skills .
• People at all levels are the essence of an organization, and
their full involvement enables their abilities to be used for
the organization’s benefit.
• The 1st step is to define the organization’s critical
performance indicator(CPI).
• CPI defined as those measure that contribute to customer’s
satisfaction
5. Measurement

15. • The form of recognition should fit the accomplishment in
other words, the value of the recognition should be
common ensurate with the value of the accomplishment.
5. Recognition
• The organization must communicate with work force, their
supplier and their customers all are interface.
• With in the organization, employees at all level need
information on continuous improvement project so they can
become aware of progress their contribution and the effect.
6. Communication

16. • Management commitment is found to be the most significant factor
affecting the implementation of Total Quality Management.
• Management of the respondent companies assumed responsibility for
quality.
• Primary role of management is to provide employees to meet the goals
of the organization.
7. Management’s Role
• Each stage of the production process is seen as being a link in the
chain right down to the relationship between one worker in the
process and another.
• It is the teamwork from which the business will receive quicker and
better solutions to problems.
8. Quality chains and Teamwork

17. • Quality control includes a system which accepts or
rejects any activities which affects the quality and
prevents quality deficiency and imparts consistency
in the quality of product or service.
• It focuses on product defect detection through post-
production inspection.
• It is concerned with the adherence to standards and
sorting rejects.
Quality Control

18. • It is the totality of the arrangements made with the
object of ensuring that pharmaceutical products
are of the quality required for their intended use.
• Quality assurance is a wide-ranging concept
covering all matters that individually or collectively
influence the quality of a
product.
Quality Assurance

19. • In other words, it is an independent review undertaken from time to
time to check whether quality performance conforms to pre-
determined standards in respect of quality plan systems, policies
specifications, etc.
Quality Audit
1.‘Internal audit’ carried out by the executives nominated by
the management for specific areas such as system audit,
product audit, etc.
2. ‘External audit’ assigned to external independent agencies

20. 1. Plan
Identify
problem and
develop plan
for
improvement.
2. Do
Implement
plan on a test
basis.
3. Study/Check
Assess plan; is it
working?
4. Act
Institutionalize
improvement;
continue cycle.
There are two approaches:
A. The PDCA cycle: Plan-Do-Check-Act cycle
Continuous improvement

21. B. Benchmarking:
•The ability to learn and study how others do
things is an important part of continuous
Improvement.
•It is used to compare an organization’s activity
against that of a recognized leader in the market.
•This will identify opportunities for quality
improvement and will lead to competitive
advantage in the market place

22. • A measure of goodness in quality management system.
• It is a methodology to manage process variations that cause
defects.
• Six Sigma identifies and prevents defects in manufacturing and
service-related processes.
Six Sigma
• It is a disciplined, data-driven methodology focused on
eliminating defects.
• Six Sigma is a reference to a statistical measuring system,
equivalent to just 3.4 defects per every million opportunities.

23. Sigma and % accuracy
Defects per Million % Accuracy
Opportunities (DPMO)
One Sigma 691,500 30.85%
Two Sigma 308,500 69.15%
Three Sigma 66,810 93.32%
Four Sigma 6,210 99.38%
Five Sigma 233 99.977%
Six Sigma 3.4 99.9997%
Seven Sigma 0.020 99.999998%

24. • Six Sigma strength is its ability to turn a practical problem into a
statistical problem, generate a statistical solution and then
convert that back into a practical solution by using,
> DMAIC process (Define, Measure, Analyze, Improve, and Control)
> DMADV process (Define, Measure, Analyze, Design, Verify).
Philosophy of six sigma
• DMAIC is used to improve an existing business process.
• DMADV is used to create new product designs or process
designs in such a way that it results in a more predictable,
mature and defect free performance.

25. DMAIC:
• The DMAIC method is used primarily for improving
existing business processes. The letters stand for:
•Define the problem and the project goals.
•Measure in detail the various aspects of the current
process.
•Analyze data to, among other things, find the root defects
in a process.
•Improve the process.
•Control how the process is done in the future.

26. DMADV:
• The DMADV method is typically used to create new processes
and new products or services. The letters stand for:
•Define the project goals.
•Measure critical components of the process and the product
capabilities.
•Analyze the data and develop various designs for the process,
eventually picking the best one.
•Design and test details of the process.
•Verify the design by running simulations and a pilot program,
and then handing over the process to the client.

27. • A gauge of quality and efficiency, Six Sigma is also a measure of
excellence. Embarking on a Six Sigma program means delivering
top-quality service and products while virtually eliminating all
internal inefficiencies.
• A true Six Sigma organization produces not only excellent product
but also maintains highly efficient production and administrative
systems that work effectively with the company's other service
processes.
• The primary factor in the successful implementation of a six sigma
project is to have the necessary resources, the support and
leadership of top management.
Conclusion