1. Ch.2 Pharmaceutical Quality Management
Q.1) What is Quality Management System (QMS) ? (2)
• Ans. - A quality management system (QMS) is a collection
of business processes focused on consistently meeting customer
requirements and enhancing their satisfaction. It is aligned with an
organization's purpose and strategic direction (ISO9001:2015). It is
expressed as the organizational goals and aspirations, policies,
processes, documented information and resources needed to
implement and maintain it.
• Quality management ensures that an organization, product or
service is consistent. It has four main components: quality
planning, quality assurance, quality control and quality
improvement.[1]
Quality management is focused not only on
product and service quality, but also on the means to achieve it.
Quality management, therefore, uses quality assurance and
control of processes as well as products to achieve more
consistent quality.
• ‘A quality management system (QMS) is a set of policies, processes and
procedures required for planning and execution
(production/development/service) in the core business area of an
organization. (i.e. areas that can impact the organization's ability to
meet customer requirements.)’
Q.2) What is Total Quality Management ? what are basic
concept of TQM? (2)
• 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.
• “TQM is a set of systematic activities carried out by the entire
organization to effectively and efficiently achieve company objectives so

2. as to provide products and services with a level of quality that satisfies
customers, at the appropriate time and price”.
• 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 TQM.
• Concept: A successful TQM programme 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. 7. Team work 8. Productivity
improvement 9. Customer satisfaction 10. Reduced costs.
Q.3) What are the quality management tools ?
• Check List - Check lists are useful in collecting data and information easily
.Check list also helps employees to identify problems which prevent an
organization to deliver quality products which would meet and exceed
customer expectations.
• Pareto Chart - The credit for Pareto Chart goes to Italian Economist -
Wilfredo Pareto. Pareto Chart helps employees to identify the problems,
prioritize them and also determine their frequency in the system.
• The Cause and Effect Diagram - Cause and Effect Diagram records causes
of a particular and specific problem .The cause and effect diagram plays a
crucial role in identifying the root cause of a particular problem and also
potential factors which give rise to a common problem at the workplace.
• Histogram - Histogram, introduced by Karl Pearson is nothing but a graphical
representation showing intensity of a particular problem. Histogram helps
identify the cause of problems in the system by the shape as well as width of
the distribution
• Scatter Diagram - Scatter Diagram is a quality management tool which helps
to analyze relationship between two variables. In a scatter chart, data is
represented as points, where each point denotes a value on the horizontal
axis and vertical axis.
• Graphs - Graphs are the simplest and most commonly used quality
management tools. Graphs help to identify whether processes and systems
are as per the expected level or not and if not also record the level of
deviation from the standard specifications.
Q.4) Define Six Sigma. What is the role of sig sigma in QM? (2)

3. • Six Sigma is a method that provides organizations tools to
improve the capability of their business processes. This
increase in performance and decrease in process
variation helps lead to defect reduction and improvement
in profits, employee morale, and quality of products or
services.
• Six Sigma (6σ) is a set of techniques and tools for
process improvement.
• A six sigma process is one in which 99.99966% of all
opportunities to produce some feature of a part are
statistically expected to be free of defects.
• The term "six sigma" comes from statistics and is used
in statistical quality control, which evaluates process
capability. Originally, it referred to the ability of
manufacturing processes to produce a very high
proportion of output within specification. Processes that
operate with "six sigma quality" over the short term are
assumed to produce long-term defect levels below
3.4 defects per million opportunities.
• Role:
• 1. It eliminate waste and inefficiency, thus
increases customer satisfaction by delivering what
the customer is expecting.
2. Six Sigma is strictly structured methodology,
which is very specific for the particular
participants.
3. Six Sigma is statistical data driven methodology
which requires accurate or error-less data to
perfectly analyse the process.
4. Six Sigma put results on financial statements.
5. Six Sigma is a business-driven, multi-
dimensional structured approach for:
• Upgrading Processes
• Decreasing Defects

4. • Diminishing process variability
• Diminishing costs
• Extending customer satisfaction
• Widening profits
Q.5) Describe principle components of TQM. (2.5)
• Leadership commitment
• Customer focus
• Training
• Empowerment and involvement
• Measurement
• Empowerment and involvement
• Recognition and awards
• Communication
1. Leadership : 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.
2. Customer Focus : 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.
3. Training: 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.
4. Empowerment & involvement: After training period the
organization must provide opportunities for employees to

5. 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.
5. Measurement: The 1st step is to define the organization’s
critical performance indicator(CPI). CPI defined as those
measure that contribute to customer’s satisfaction.
6. Recognition and Awards: 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.
7. Communication: 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.
Business goals should be communicated to suppliers.
Q.6) Discuss the concept & give advantages of quality
management system with example. Explain the principle of six
sigma. (10)
• “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.

6. • TQM is a management method in which quality is
required in all manners, to satisfy customer requirements.
It involves every employee’s daily commitment in the
office, which differentiates TQM from other management
systems.
• TQM is not a program. It is “a strategy, a way of doing
businesses, a way of managing, a way of looking at the
organization and its activities” (Anschutz 1995, 13).
Therefore, the success of TQM is measured not only by its
tangible outcome but also by both the way in which the
organizational structure is established and the processes
by which corporate objectives are achieved.
• One of the significant impacts of Japanese TQM is often
explained by describing the development of car industry
during the oil crises in the 1970s. During this period, TQM
was extended to activities for energy conservation and
measures for resource maintenance. It greatly impacted
various industries and became more securely established
as a valuable quality framework for Japanese industrial
development.
• Total quality management ensures that every single
employee is working towards the improvement of work
culture, processes, services, systems and so on to ensure
long term success.
• Total Quality management can be divided into four
categories:
• Plan
• Do
• Check
• Act
• Also referred to as PDCA cycle.
• Planning Phase

7. Planning is the most crucial phase of total quality
management. In this phase employees have to come up
with their problems and queries which need to be
addressed. They need to come up with the various
challenges they face in their day to day operations and
also analyze the problem’s root cause. Employees are
required to do necessary research and collect relevant
data which would help them find solutions to all the
problems.
• Doing Phase
In the doing phase, employees develop a solution for the
problems defined in planning phase. Strategies are
devised and implemented to overcome the challenges
faced by employees. The effectiveness of solutions and
strategies is also measured in this stage.
• Checking Phase
Checking phase is the stage where people actually do a
comparison analysis of before and after data to confirm
the effectiveness of the processes and measure the
results.
• Acting Phase
In this phase employees document their results and
prepare themselves to address other problems
• Advantages: 1. Quality Improvement 2. Productivity
Improvement / Cost Reduction 3. Sales Expansion 4. Profit
Enhancement 5. Ensured Performance of Management
Plan 6. Fulfillment of Top Management’s Ambition 7.
Company-wide Participation 8. Improved Management
and Promotion of Standardization 9. Bottom-up Assembly
and Morale Improvement 10. Establishment of
Management System

8. • Principle of six sigma:
1. Focus on Customer Requirements:
2. Use data to identify the variation in the process
3. Continually improving the process to eliminate the variation:
4. Involve people from different levels of management and process
5. Be flexible and thorough:
1. Focus on Customer Requirements:
The initial phase in Six Sigma process is defining the “quality"
from the point of customers. Every customer defines quality
differently. A business needs to measure quality in a similar way
its customers do. By addressing the needs of the customer
business can define the quality to the customer.
2. Use data to identify the variation in the process
Variations in the process are of two types; Special cause variation and
Natural variation. Special cause variation is caused by external factors.
Natural variation is random variation present in the process. Six Sigma
aims to reduce the special cause variation. To identify the root cause of the
variation, understating the process is necessary. The understanding of the
process should be deep and extensive. Knowledge about the process
cannot be gained unless it is studied. To understand the process clearly,
detailed data about the process is important.
3.Continually improving the process to eliminate the variation:
After identifying root causes, make changes to eliminate variation in the
process. Thus the defects in the process are removed. Additionally,
search for ways to remove steps that do not add value to the customer.
This will eliminate waste in the process. Identify variation and eliminate
it. Don't wait for the variation to show itself. Collect data, talk to people,
and study the data to identify variations in the process. variation may
have become the routine because “that's the way we've always done
things.”
4. Involve people from different levels of management and process
Six Sigma is formed on the foundation of good teams. The good teams
comprise of peoples who take responsibility for the Six Sigma processes.
The people on the team need training in Six Sigma's methods. Forming a
cross-functional team with peoples from different backgrounds will help

9. identify variation. For example, six sigma team from health care project
consists of top management people, doctors, nurses, managers, people
from operations and purchasing.
5. Be flexible and thorough
Six Sigma requires adaptability from various points of view. The business’s
management system needs to acknowledge positive changes. People
should be motivated to accept the changes in the system to eliminate the
variation. To motivate the employee, the benefits of the six sigma system
should be made clear to all levels of employees. This will make the
changes easily acceptable.
Six Sigma also requires reducing variation to be thorough. So understand
all the aspects of a process—the steps, stakeholders, and methods
involved. This will help to ensure that any new or updated process works.
Importance of principles
• Increased Productivity
• Increased Quality
• Reduced Operation Cost
• High Customer Satisfaction
• Improved Employee Morale
• Efficient Work environment