QMS Seminar Topic 1

QUALITY MANAGEMENT SYSTEMS
1.INTRODUCTION TO QUALITY
UNDER THE GUIDANCE OF PRESENTED BY:

DR. VARSHA M. JADHAV CHRISTINA VIJU JOHN
M. PHARM, PH. D. (TECH) IN PHARMACY F.Y.M.PHARM (QUALITY ASSURANCE)
Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

OVERVIEW
2
 After this seminar, we will be able to understand the following :
Introduction to Quality:
 What is Quality?
 Definition of Quality
 Evolution of Quality
 Dimensions of Quality
Quality as a strategic decision:
 Meaning of strategy
 Strategy Quality Management
 Mission & Vision Statements

WHAT IS QUALITY?
3
 Quality starts with understanding customer needs and ends when those needs
are satisfied
 Quality is often used to signify ‘excellence’ of a product or service
Quality simply means meeting the customer requirements and this has been
expressed in many ways by some authors:
 “Fitness for purpose or use”- Joseph M. Juran
 “Conformance to specifications”- Philip B. Crosby

WHAT IS QUALITY?
4
Q QUEST FOR EXCELLENCE
U UNDERSTANDING CUSTOMER NEEDS
A ACTION TO ACHIEVE CUSTOMER APPRECIATION
L LEADING IN COMPETITION
I INVOLVING ALL PEOPLE
T TEAMWORK FOR COMMON GOAL
Y YARDSTICKS TO MEASURE PROGRESS

THREE QUALITY GURUS COMPARED
5

DEFINITION OF QUALITY
6
The degree to which a system or process meets:
 Specified requirements, and
 Customer’s needs and expectations
As per ISO 9000:2000:
 “Quality is the degree to which a set of inherent characteristics fulfill
requirements”
Other definitions are:
 Quality is meeting or exceeding customers requirements
 Quality is a measure how closely goods or services confirm to specified standards

EVOLUTION OF QUALITY
7
To know the future, we must know the past

 Industrial Revolution-smaller jobs,more specialization and less responsibility
for the final product
 Early 1900’s-Product inspection introduced-Fredrick Winslow Taylor
 1924-Statistical control charts-W. Shewhart of Bell Laboratories
 1930-Acceptance sampling-H.F. Dodge & H.G. Roming of Bell Labs
 World War II-Statistical methods began to be more widely accepted,especially
in sampling techniques
 1950’s - Quality Assurance,Statistical Quality Control methods introduced to
the Japanese-W.Edward Deming
 “Cost of quality”concepts by Joesph Juran
 1960’s - “Zero Defects” emphasize employee performance-P. Crosby
 1970’s – Quality Assurance methods throughout the entire process

DIMENSIONS OF QUALITY
8
PERFORMANCE
PERCEPTION RELIABILITY
AESTHETICS QUALITY FEATURES
SERVICE CONFORMANCE
DURABILITY

9
1.Performance:
 Performance is often a source of contention between customers and suppliers
 The performance of a product often influences profitability of the end user
2.Features:
 It is important that suppliers designing product or services from performance
specifications are familiar with its intended uses
3.Reliability:
 It is closely related to performance
 It’s a major contributor to the companys image
4.Conformance:
 It confirms whether the product or service possesses as per the specifications

Bharati Vidyapeeth College of Pharmacy, Navi Mumbai 06-03-2021
10
5.Durability:
 It indicates how long the product will be long lasting
 It is closely related to warranty
6.Serviceability:
 It specifies whether it is easy to maintain or repair
 It is one of the most important dimension of quality and criteria for product
selection
7.Aesthetics
 The way the product looks is important to end users
 The aesthetic properties of a product contribute to company’s or brand’s
identity
8.Perception
 It means how the customer views or perceives about a product or service

QUALITY AS A STRATEGIC DECISION
11
 Why do we need a strategic approach ?
 Every organization today faces
challenges like customer

requirements,legislation,technology and
competition
 Quality should be judged for it is
undeniable strategic role in obtaining

performance dominance

MEANING OF STRATEGY
12
 A method or a plan chosen to bring about a desired future, such as
achievement of goal or solution to a problem
 It’s a guide on how to pursue the organization’s mission & vision

STRATEGY QUALITY MANAGEMENT (SQM)
13
 The adoption of a Quality Management System should be a strategic decision
made by the organization’s top management
 Top management must provide evidence and demonstrate their commitment to
the QMS and continual improvement by:
 Communicating the importance of meeting customer and regulatory
requirements
 Ensuring that quality objectives are established
 Performing Management review
 Providing appropriate resources

STRATEGY QUALITY MANAGEMENT (SQM)
14
Leadership
Customer
Improvement
Focus
Core of
SQM
Design
Planning
Quality
Partnership

VISION & MISSION STATEMENTS
15
 Creating your organization’s vision and mission statements are the first two
steps in the action planning process
 Developing a vision and mission statement is crucial to the success of
community initiatives
 These are the statements which explain your groups aspirations in a concise
manner, help your organization focus on what is really important, and provide a
basis for developing other aspects of your strategic plan

WHAT IS A VISION STATEMENT?
16
 Your vision is your dream. Its what the organization believes are the
ideal conditions.
 Whatever the organization’s dream is, it may be well segmented by one
or more vision statements
 Vision statements are short phrases or sentences that convey your
company's hopes for the future.
 By developing a vision statement or statements, the organization
clarifies the beliefs and governing principles of the organization

WHAT IS A VISION STATEMENT?
17
 In general, vision statements should be:

 Understood and shared by members of the community
 Broad enough to include a diverse variety of local perspectives
 Inspiring and uplifting to everyone involved in your effort
 Easy to communicate
Example: Vision
“To emerge as a premier pharmacy college imparting education of high
standards”

WHAT IS A MISSION STATEMENT?
18
 Any organization’s mission statement describes what the group is going
to do and why its going to do that. For example, “Promoting care and
caring at the end of life through coalitions and advocacy”
 Mission statements are similar to vision statements
 However, they are more concrete and they are definitely more “action-
oriented” than vision statements.
 Vision statement should inspire people to dream while
mission statement should inspire them to act accordingly

WHAT IS A MISSION STATEMENT?
19
General guiding principles about mission statements are that they are:
Outcome
Concise Inclusive
Oriented
E.g.: MISSION
1. To produce pharmacy graduates with high ethical standards, capable of providing quality
services to industry, academia, research and mankind at large.
2. To create a centre of excellence for education and research in the field of pharmaceutical
sciences.
3. To provide long-standing learning opportunities in pharmaceutical sciences.

REFERENCES
20
 Juran's Quality Handbook-The Complete Guide to Performance

Excellence, Sixth Edition, Joseph M.Juran,Joseph A. De Feo,ASQ
Publications (Page no. 04-36)
 Book Total Quality Management and Operational Excellence,
Fourth Edition, John S. Oakland (Page no. 19-21)
 https://www.slideshare.net/AmrutaBalekundri/quality-as-a-
strategic-decision
 https://www.slideshare.net/roshankhetade2/quality-introduction-
for-quality-management-system
 https://www.slideshare.net/Dhawal_Raghuvanshi/pharmaceutical-
quality-management-system-83901397

QUESTION/ANSWER SESSION
21

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QUALITY MANAGEMENT SYSTEMS

UNDER THE GUIDANCE OF PRESENTED BY:

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 After this seminar, we will be able to understand the following :

Quality as a strategic decision:

 Strategy Quality Management

 Mission & Vision Statements

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 Quality is often used to signify ‘excellence’ of a product or service

 “Fitness for purpose or use”- Joseph M. Juran

 “Conformance to specifications”- Philip B. Crosby

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

Q QUEST FOR EXCELLENCE

U UNDERSTANDING CUSTOMER NEEDS

A ACTION TO ACHIEVE CUSTOMER APPRECIATION

I INVOLVING ALL PEOPLE

T TEAMWORK FOR COMMON GOAL

Y YARDSTICKS TO MEASURE PROGRESS

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

The degree to which a system or process meets:

 Specified requirements, and

 Customer’s needs and expectations

As per ISO 9000:2000:

 “Quality is the degree to which a set of inherent characteristics fulfill

Other definitions are:

 Quality is meeting or exceeding customers requirements

 Quality is a measure how closely goods or services confirm to specified standards

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

To know the future, we must know the past

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

AESTHETICS QUALITY FEATURES

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 Performance is often a source of contention between customers and suppliers

 The performance of a product often influences profitability of the end user

 It is important that suppliers designing product or services from performance

specifications are familiar with its intended uses

 It is closely related to performance

 It’s a major contributor to the companys image

 It confirms whether the product or service possesses as per the specifications

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 Why do we need a strategic approach ?

 Every organization today faces

challenges like customer

 Quality should be judged for it is

undeniable strategic role in obtaining

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 A method or a plan chosen to bring about a desired future, such as

achievement of goal or solution to a problem

 It’s a guide on how to pursue the organization’s mission & vision

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

 The adoption of a Quality Management System should be a strategic decision

made by the organization’s top management

 Top management must provide evidence and demonstrate their commitment to

the QMS and continual improvement by:

 Communicating the importance of meeting customer and regulatory

 Ensuring that quality objectives are established

 Performing Management review

 Providing appropriate resources

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai 06-03-2021

steps in the action planning process