This presentation include QUALITY AS STRATEGIC DESIGN of subject Quality Management System for both B. Pharmacy and M. Pharmacy(pharmaceutical quality assurance).

1. QUALITY AS A STRATEGIC
DECISION
PRESENT BY: HEALY LAD
FIRST YEAR M. PHARM
PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT

2. CONTENTS:
• Definitions of Strategy
• Strategic Quality Management
• Mission and Vision Statement
• Quality Policy
• Quality Objective
• Strategic Planning & Implementation
• McKinsey 7s Model
• Competitive Analysis
• Management Commitment to Quality

3. DEFINITIONS OF STRATEGY:
Henry Mintzberg: Defines strategy as a pattern in a stream of
direction.
Max McKeown: defines strategy as strategy is about shaping
the future and is the human attempt to get a desirable ends
with available norms.
Henrik von Scheel: defines the essence of strategy as the
activities to deliver a unique mix of value choosing to perform
activities differently or to perform different activities than rivals.
Alfred D. Chandler: defines strategy as the determination of the
basic long-term goals and objectives of an enterprise and the
adoption of courses of action and the allocation of resources
necessary for carrying out these goals.

4. CONTIN…
Dr. Vladimir Kvint: defines strategy as a system of finding,
formulating and developing a doctrine that will ensures long-
term success if followed faithfully.
Arthur Sharplin: defines strategy as a plan or a course of action
which is of vital pervasive or continuing importance to the
organization as a whole.

5. STRATEGIC QUALITY MANAGEMENT(SQM)
• SQM is process of continuous improvement. It involves all organizational
elements i.e. inputs, process, outcomes and customer satisfaction.
• The adoption of Quality Management Strategic decision is made by top
management of the organization by;
Ensures Quality Objectives
Performing Management Review
Communicating Importance of Need of Customer and
regulatory requirement
Providing Appropriate Resources

6. CONTIN…
 Ensures Quality Objectives:
Quality objectives are measurable goals relevant to enhancing customer
satisfaction and are consistent with the quality policy. These objectives
are initially established when planning your QMS and redefined in
management reviews as needed.
 Examples can include goals to improve on time delivery, defects, or
scrap

7. CONTIN…
 Performing Management Review:
It include Human resource planning, Recruitment and selection,
Training and development, Career planning and development,
Compensation programs, Internal employee relations and
Assessment of employee potential.
 Providing Appropriate Resources:
Pharmaceutical products are intended for human consumption, the
regulatory authorities are very particular about the grade of water
that is used. There are waters at various grades of purification that
are required for specific operations in the plant.

8. VISION AND MISSION STATEMENTS
VISION STATEMENTS:
It describes the long-run objectives of your company, usually for a time
frame of five to ten years or even longer.
MISSION STATEMENTS:
It describes how to achieve goals set in your vision statement. It defines
purpose of the organization.

9. WHAT IS VISION
STATEMENT?
• Your vision is your dreams. It`s what your organization
believes are the ideal condition.
• Vision statements are short phrases or sentences that
convey company`s hopes for future. By developing a
visions statement/s organization clarifies the beliefs and
principles of the organization.
• It generally emphasize on “what our business will be
later”.

10. Contin…
• In general vision statements should be;
Understood and shared by members of community.
Broad enough to include a diverse variety of local perspective.
Inspiring and uplifting to everyone involved in your effort.
Easy to communicate.
EXAMPLE:
• Lupin pharma: Lupin Pharmaceuticals, Inc is committed to bringing
innovative products for healthcare professional to improve the
health and well being of individuals.

11. WHAT IS MISSION STATEMENT?
• Mission statement describe what an organization is
going to do and why its going to do for that.
• For example one of the pharmaceutical industry states
its mission statement as “ Is to become a transnational
pharmaceutical company through the development and
introduction of wide portfolio of branded and generic
products in key market”
• Mission statement are similar to vision statements, but
they are more concrete and definitely more “action-
oriented” than vision statement.

12. CONTIN…
Mission statement describe why an organization exists, what
its overall goal is, identifying the goal of its operations: what
kind of product or service it provides, its primary customers
or market, and its geographical region of operation.
It may include a short statement of such fundamental matters
as the organization's values or philosophies, a business's main
competitive advantages, or a desired future state.
 The purpose of a mission statement is:
To communicate the organisation's purpose and direction to its
employees, customers, vendors, and other stakeholders.

13. CONTIN…
A mission statement also creates a sense of identity for its
employees. Organizations normally do not change their mission
statements over time, since they define their continuous,
ongoing purpose and focus.

14. GENERAL GUIDING PRINCIPLE OF
MISSION STATEMENT:
• Concise: While not as short as vision statements, mission statements
generally still get their point across in one sentence.
• Outcome-oriented: Mission statement explain the fundamental outcomes
which organization is working to achieve.
• Inclusive: Mission statements do make statements about organization key
goals, its very important that they do very broadly. Good mission statement
are not limiting in strategies of the community that become involved in
project.

16. QUALITY POLICY:
• It is one of the clause of 5.3
section in ISO 9000:2004 that
quality policy is a document
developed by management to
express the directive of top
management with respect to
Quality.
• Quality policy is requirement of
any formalized Quality
Management System(QMS) and
its purpose is to set framework
for commitment of the scope of
QMS
QUALITY
POLICY
QUALITY
SERVICE
INNOVATIO
N
INCREASE
EFFICIENCY
CLIENT
STAISFACTI
ON

17. CONTIN…
Quality policy is a statement or principle of action which describes
an organization's commitment to quality operations and products.
The quality policy isn’t the same as the quality manual, quality
management system (QMS), or standard operating procedures
(SOPs). Instead, the policy is a declaration of why your company is
committed to a quality-driven culture quality system.
Executive management will probably determine who writes &
Policies should contain:
Minimal information on specific procedure edits the individual
quality policies. detailed information about structure,
responsibility,

18. CONTIN:
 Definitions within policies are important to ensure that all
parties are speaking the same language review.
 The policy should define the responsibilities of individual
department implementing the policy are understanding.
should ensure that adequate resources & structure exist for
successful implementation.

19. WHY WE NEED QUALITY POLICY ?
• For planning of overall Quality Program.
• Provides framework for establishing and reviewing quality
object.
• Gives idea about “what to be done” and “how to be done”
• Ensures consistency in practice and help to maintain product
quality.

20. QUALITY OBJECTIVE:
• Quality Objective are requirement of ISO
9000 standard.
• Quality Objective are the main method used by the company to
focus goals from the quality policy into plans for improvement.
• The quality policy is created with the Customer requirement in
mind while quality objective linked back to quality policy.
• Quality objective takes goal stated in quality policy and turned
these into statement for improvement against which plan can
be made.

21. Contin…
• After deciding which thing to be monitored, measured and improved
the important thing is to make Quality Objectives in effective in
addressing what need to be improved.
• The objective should be designed to be S.M.A.R.T.
S- Specific
M- Measurable
A- Attainable
R- Realistic/ Relevant
T- Time based

23. 1. SPECIFIC:
For the best results, an objective needs to be clear and specific.
Instead of saying “to improve non-conforming product” a
specific Quality Objective would be “to reduce non-
conformances”.
Make your goals specific and narrow for
more effective planning.

24. 2. MEASURABLE:
If an Objective can be measure, then how will be know if it is
been obtain?
In order to make Quality Objective effective, it needs to be
measurable.
So to improve the Quality of Product we must able to measure
the defects being made and therefore make plans to reduce
the number of defects.
It provide a way of evaluation with use of data or metric
targets.

25. 3. ATTAINABLE / ACHIEVABLE:
For an Objective to be achieved it first need to be created and
approved by top level management.
Once the management agree on the objective it need to be
communicated to each level of organization that will be
implement the plans to be achieved the objective and the people
at these level of organization need to agree that plan is
achievable.
Without this buy-in they may not fully work towards the goal
and plan may doomed to failure.

26. 4. REALISTIC:
Being realistic with objective will make selling it within your
organization easier.
It describe the goal relevant to the overall mission and vision of
your values and long term objectives.
It is always best to set a realistic goals than to set unrealistic
goals as it fall of short of expectation.

27. 5. TIME BASED:
To be effective in objective need to have time
associated with it. Since plan needs to have
dates in order to be properly tracked.
Time associated work will allows to monitor
how close you expect to be in achieving
goals during manufacturing.

28. STRATEGIC PLANING AND
IMPLEMENTATION:
Strategic management is
concerned with making
decision about
organization`s future
growth, renewal and
implementing those policy.
It is an ongoing process in
which
Strategic
Management
Strategic
Planning
Strategic
Implementation

29. STRATEGIC PLANNING:
The process of developing and maintaining a strategic fit
between the organization goals and capabilities and changing
marketing opportunities.
Strategy planning guides the organization in establishing
objective, choosing strategy and implementing the same.
It establish long range and short range objectives to achieve
the mission of the organization.
SWOT analysis is the strategic planning techniques used to
help organization to identify the competition.

30. SWOT ANALYSIS:
SWOT Analysis is a simple but
useful framework for
analyzing your organization's
strengths, weaknesses,
opportunities, and threats.
It helps the organization to
build on what you do well, to
address what you're lacking,
to minimize risks, and to take
the greatest possible
advantage of chances for
success.

31. To help decision makers share and compare ideas.
To provide linearity to the decision making process allowing
complex ideas to be presented systematically.
To bring a clearer common purpose and understanding of
factors for success.
To analyze issues that have led to failure in the past.

32. 1. S- STRENGTH:
Growing treatment naive patient population.
 Low cost of innovation, manufacturing and operations.
 Higher GDP growth leading to increased disposable income in the
hands of general public and their positive attitude towards spending
on healthcare.
Low-cost, highly skilled set of English speaking labour force and
proven track record in design of high technology manufacturing
devices.
Beneficial aspects of the organization or the capabilities of an
organization, which includes human competencies, process
capabilities, financial resources, products and services, customer
goodwill and brand loyalty.

33. 2. W- WEAKNESS
Stringent pricing regulations affecting the profitability of
pharma companies.
Poor all-round infrastructure is a major challenge.
Presence of more unorganized players versus the organized
ones, resulting in an increasingly competitive environment,
characterized by stiff price competition.
Poor health insurance coverage.
Weaknesses are the factors which do not meet the standards
we feel they should meet. However, weaknesses are
controllable. They must be minimized and eliminated.

34. REASONS:
Limited financial resources
 Weak spending on R & D
 Very narrow product line
Limited distribution
 Higher costs
 Out-of-date products / technology
 Weak market image,
Poor marketing skills
Limited management skills
 Under-trained employees.

35. 3. O- OPPURTINITIES:
Global demand for generics rising.
Rapid OTC and generic market growth.
Increased penetration in the non - metro markets.
Large demand for quality diagnostic services.
Significant investment from MNCs.
Organization should be careful and recognize the opportunities
and grasp them whenever they arise. Opportunities may arise
from market, competition, industry/government and
technology.

36. EXAMPLES:
 Rapid market growth,
 Rival firms are complacent,
 Changing customer needs/tastes,
 New uses for product discovered,
 Economic boom,
 Government deregulation,
 Sales decline for a substitute product.

37. 4. T- THREATS:
External elements in the environment that could cause trouble
for the business - External factors, beyond an organization’s
control, which could place the organization’s mission or
operation at risk.
Arise when conditions in external environment jeopardize the
reliability and profitability of the organization’s business.
. Threats are uncontrollable. When a threat comes, the stability
and survival can be at stake.

38. EXAMPLES:
Entry of foreign competitors,
Introduction of new substitute products,
 Product life cycle in decline,
Changing customer needs/tastes,
Rival firms adopt new strategies,
Increased government regulation,
Economic downturn

39. STRATEGIC IMPLEMENTATION:
It is a term used to describe the activities within an
organization to manage execution of strategic plan.
To bring action to the chosen strategy so as to achieve strategic
goal and objective.
VISION STRATEGY IMPLEMENTATION
OF PLAN

40. STEPS OF IMPLEMENTATION:
1. Project Implementation
2. Procedural Implementation
3. Resource Allocation
4. Structural Implementation
5. Functional Implementation
6. Behavioral Implementation

41. 1. PROJECT IMPLEMENTATION:
 Project implementation is a process whereby “project inputs
are converted to project outputs”.
It may be looked at as Putting in action the activities of the
project.
Consists of carrying out the activities with the aim of delivering
the outputs and monitoring progress compared to the work
plan.
Its objective is to keep the project on track and achieve the end
results of the project.

42. CONTIN…
Project Implementation include II phases:
1. Project Activation:
 This means making arrangements to have the project started. It
involves coordination and allocation of resources to make
project operational.
2. Project Operation:
 This is practical management of a project. Here, project inputs
are transformed into outputs to achieve immediate objectives.

43. 2. PROCEDURAL IMPLEMENTATION:
 A procedure refers to a series of the related task which
make-up a chronological sequence. It is an established way
of performing the work to be accomplished.
Procedural implementation level concerned with the
completion of all statutory and other formalities which have
been prescribed by the Government both at Central and
State.
The major procedural requirements involved in the strategy
implementation process are discussed as under:

44. 1. Licensing Procedures
2. Foreign Collaboration Procedure
3. Import and Export Requirement
4. Capital issues and Control Requirement
 LICENSING PROCEDURE:
 The licensing provisions have been provided under the Industries
(Development and Regulation) Act, 1951. In many industries, an
industrial license is required particularly in those industries which
are perceived to be injurious to public health.

45. FOREIGN COLLABORATION
PROCEDURES:
The emergence of joint venture projects with foreign
collaborators brings technology and participation in equity
Besides, joint ventures, Indian companies may enter technology
agreements for the import of technical know-how.
In the case of a joint venture and technology agreement, prior
approval has to be received from the Central Government.

46. IMPORT AND EXPORT REQUIREMENTS:
Import and Export requirements differ in two types of goods i.e.
which are under the list of open general license and those under
the restrictive list.
There are fewer requirements for items falling under open
general license except that the companies going for
import/exports have to inform the Reserve Bank of India.
However, an import and export license is required to be procured
from the Ministry of Commerce in the case of items falling under
the restrictive list.

47. CAPITAL ISSUE REQUIREMENTS:
Under the provisions of the Securities Exchange and Board of
India Act, 1992, SEBI exercises some controls over capital issues
to the public in the form of adherence to disclosure norms.
For this purpose, SEBI scrutinizes the prospectus of the company
intending to enter the capital market to ensure that relevant
information has been provided in the prospectus on the basis of
which the public can analyze the worth of issue of shares or
debentures.
For raising funds from abroad by way of Global Depository
Receipts, American Depository Receipts, and long term loans,
prior permission of the Central Government is required.

48. 3. RESOURCES ALLOCATION:
Resources Allocation is a process of allocating resources
among the project /plan.
It is process of assigning and scheduling available resources in
the most effective and economical way possible.
The three most basic resources are Land, Labor and Capital.
The other resources include Energy, Entrepreneurship,
Information, Expertise, Management and Time.
Resources in Project Management anything used up to execute
the project are Budget, People, Technology, Time, Space, Tools,
Equipment etc.

49. Resource allocation is used to assign the available resources in
an economic way.
In project management, resource allocation is the scheduling of
activities and the resources required by those activities while
taking into consideration both the resource availability and the
project time.

50. 4. STRUCTURAL IMPLEMENTATION:
Structural implementation is an arrangement of tasks
and sub tasks required to implement a strategy.
Structural strategy has 3 key components
1. Identifies Formal Relationships, including span of
control, no of levels in hierarchy.
2. It specifies grouping of individuals in departments.
3. Design of system to ensure effectiveness,
coordination and integration of efforts across
Departments.

51. TYPES OF STRUCTURAL IMPLEMENTATION:
VERTICAL STRUCTURE:
Process of differentiation
Involves division of labor and specialization.
Dominates: specialized tasks , hierarchy of authority, rules and
regulation, vertical communication, centralized decision making
and emphasis on efficiency
Also called as tall structure.
Best suited for standardized products and services in large
volumes.
Established technologies, wide market, seeking customer on
undifferentiated items.

52. HORIZONTAL STRUCTURE:
Process of Integration among members in an organization,
cross functional systems and teamwork.
Dominates:
 SHARED TASKS.
 FLEXIBLE RULES AND REGULATION.
 HORIZONTIAL COMMUNICATION.
 DECENTRAILISATION DECISION MAKING.
 EMPHASIS ON LEARNING
Its also called lean and mean organization or flat structure. Liberal
exchange of information among different layers and across
departments.

53. 5. FUNCTIONAL STRATEGY:
Functional strategy is the approach, a functional area takes to achieve
corporate and business unit objectives and strategies by maximizing
resource productivity.
It helps managers in focusing company’s major functional areas of
activity.
Objectives:
 Profitability - Product quality
 Market share - Innovation
 Human talent
 Cost efficiency

54. TYPES OF FUNCTIONAL STRATEGIES:
1. MANUFACTURING STRATEGY
2. MARKETING STRATEGY
3. HUMAN RESOURCE STRATEGY
4. RESEARCH AND DEVELOPMENT STRATEGY
5. FINANCIAL MANAGEMENT STRATEGY

55. McKINSEY 7S MODEL:
The model was developed in the
late 1970s by Tom Peters and Robert
Waterman, former consultants at
McKinsey & Company
The McKinsey 7S Model is an
organizational tool that assesses
the well-being and future success
of a company. It looks to seven
internal factors of an organization
as a means of determining whether
a company has the structural
support to be successful.

56. CONTIN…
The model categorizes the
seven elements as either "hard"
or "soft“
The three "hard" elements are
strategy, structures (such as
organization charts and
reporting lines), and systems
(such as formal processes and IT
systems.)
These are relatively easy to
identify, and management can
influence them directly.
HARD ELEMENTS SOFT ELEMENTS
STRATEGY SHARED VALUES
STRUCTURE SKILLS
SYSTEMS STAFF
STYLE

57. SOFT ELEMENTS:
The four "soft" elements, on the other hand, can be harder to
describe, less tangible, and more influenced by your company
culture.
But they're just as important as the hard elements if the
organization is going to be successful.

58. 1. STRUCTURE:
Ways in which task and people are specialized and divided and authority is
distributed i.e. who is accountable to whom in the organization.
It is the organizational chart of the firm.
One of the most visible and easily changeable element of the framework.
This Element discribe how your company is organized (that is, how
departments and teams are structured, including who reports to whom)
Main structures are:
 Functional based
 Divisional based
 Team based
 Project based

59. 2. STRATEGY:
Blueprint or the actions which gives direction to mangers to achieve the
organizational goals.
Blueprint or the actions which gives direction to mangers to achieve the
organizational goals.
Bridges a gap between where we are and where we want to be in
future
Various strategies are there which a company may opt according to its
needs like :
 Market penetration
 Product development
 Market development
 Diversification

60. 3. SYSTEMS:
 Systems are the resources and procedures that people use
to perform their tasks.
Formal and informal processes and procedures are followed
to manage the organization.
Ensures that all employees are working in proper direction
as per the manager.
Examples:
 Performance measurement system
 Reward system
 Resource allocation

61. 4. STYLE:
Represents the style of leadership adopted in the organization.
 Leadership of top management and overall operating style of
organization.
Impacts norms followed by people, how they work and
interact with each other and customers.
Leadership styles like:
 Autocratic
 Democratic
 Laissez-faire

62. 5. STAFF:
Human resources and their competencies.
Concerns with what type of and how many employees will be
required by the organization.
It includes:
 Recruitment
 Selection
 Training and development
 Motivation

63. 6. SKILLS:
Distinctive competencies in the organization.
Refers to those activities that an organization does best and for
which they are known.
These concern both the skills of organization as well as those of
the employees.
Organization should provide training to improve the skills of
the employees.
It includes:
 What skill does a company posses?
 What skills is the company lacking?

64. 7. SHARED VALUES:
They are the norms and standards that guide employees
behavior and company's action.
Common values, guiding principles that unites the organization
in one direction.
Determines the way we work and the way in which problems
are solved in the organization.
Placing shared values in the middle emphasizes that these
values are central to the development of all the other critical
elements.
The company’s other 6s stem from why the organization was
originally created and what it stands for.
The original vision of the company was formed from the values
of the creators. As the values changes, so does all the other
elements.

65. REFERENCES:
Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph
A.De Feo, ASQ Publications.
The Quality Management Sourcebook: An International Guide to
Materialsand Resources By Christine Avery; Diane Zabel, Routledge,
1997
https://www.iso-9001-checklist.co.uk/free-iso-downloads.htm
https://simplicable.com/new/quality-objectives
https://the9000store.com/iso-9001-2015-requirements/iso-2015-
requirements-for-qms-planning/quality-
objectives/#:~:text=Quality%20objectives%20are%20measurable%20goals
,delivery%2C%20defects%2C%20or%20scrap.