1. Quality As A Strategic Decision
Presenter:
Amruta Balekundri
M.Pharm 1st semester,
Department of Pharmaceutical
Quality Assurance,
KLE College of Pharmacy,
Belagavi.
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2. CONTENTS:
• Meaning of Strategy
• Strategic quality management
• Vision & Mission Statement
• Quality policy
• Quality Objectives
• Strategic Planning & Implementation
• McKinsey 7s Model
• Competitive analysis
• Management commitment to Quality
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3. Meaning of Strategy:
• A method or plan chosen to bring about a desired future, such
as achievement of a goal or solution to a problem.
• The art and science of planning and marshalling resources for
their most efficient and effective use. The term is derived from
the Greek word for generalship
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4. Strategic quality management:
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 any
regulatory requirements.
• Ensuring that quality objectives are established.
• Performing Management review.
• Providing appropriate resources.
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5. Vision & Mission Statements:
• 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 statements explain your group's 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.
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6. WHAT IS A VISION STATEMENT?
• Your vision is your dream. It's what your organization
believes are the ideal conditions.
• Whatever your organization's dream is, it may be well
articulated 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, your
organization clarifies the beliefs and governing principles
of your organization, first for yourselves, and then for the
greater community.
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7. WHAT IS A VISION STATEMENT?
• 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 .
Some examples of vision statements that meet the above
criteria:
• Caring communities.
• Good food good life.
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8. WHAT IS A MISSION STATEMENT?
• An organization's mission statement describes what the group is
going to do and why it's 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, in that they,
too, look at the big picture. However, they're more concrete, and
they are definitely more "action-oriented" than vision
statements. Your vision statement should inspire people to
dream; your mission statement should inspire them to action.
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9. WHAT IS A MISSION STATEMENT?
General guiding principles about mission statements are that they
are:
• Concise: While not as short as vision statements, mission
statements generally still get their point across in one sentence.
• Outcome-oriented: Mission statements explain the fundamental
outcomes your organization is working to achieve.
• Inclusive: While mission statements do make statements about
your group's key goals, it's very important that they do so very
broadly. Good mission statements are not limiting in the
strategies or sectors of the community that may become
involved in the project.
• E.g.: Promoting community health and development by
connecting people, ideas and resources."
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10. Quality Policy:
• The quality policy is the only true definition of quality that
counts in your organization .
• Make sure the policy builds on current corporate objectives
and values.
• It must be fully integrated with those concepts.
• Part of the reason why you need a well written quality policy
is to make your employees understand that their job affects
product quality, and therefore the success of the company.
Employees must be made aware that their individual
contribution is important to the company’s overall success.
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11. Establishing the Quality Policy:
• This requirement is comparable to the requirements of ISO
9001:2008 Clause 5.3 – Quality Policy. You should check that
there is evidence that Top management have participated in the
creation of the quality policy, and are reviewing and maintaining
it.
• You should review the quality policy to determine whether the
quality policy is appropriate to the context of the organization and
its purpose, that there is a commitment to continually improving
the QMS, and the quality objectives are consistent with the quality
policy. Top management should demonstrate that the quality
policy is compatible with the strategic direction and context of the
organization, as required by Clause 5.1.1b.
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12. Establishing the Quality Policy:
Top management must ensure that the quality policy:
• Is appropriate to the organization.
• Includes a commitment to requirements and continual
improvement.
• Provides a basis for establishing and quality objectives.
• Is communicated and understood within the organization.
• Is periodically reviewed for suitability.
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13. Quality Objectives:
• Quality objectives are requirements of the
ISO 9000 standard.
• The quality objectives are the main method used by companies
to focus the goal(s) from the Quality Policy into plans for
improvement.
• The Quality Policy is created with the Customer Requirements
in mind, then quality objectives are linked back to the
Customer Requirements through the Quality Policy. The
quality objectives take the goal(s) stated in the Quality Policy
and turned these into statements for improvement against
which plans can be made
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14. Quality Objectives:
After deciding which things to monitor, measure
and improve, the important thing is to make the
Quality Objectives effective in addressing what
needs to be improved.
The objectives should be designed to be S.M.A.R.T
• S-Specific
• M- Measurable
• A- Agreed
(Achievable)
• R- Realistic
• T-Time based
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15. 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.
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16. Measurable:
• If an objective can’t be measured, how will we know if it has
been obtained?
• In order to make a Quality Objective effective, it needs to be
measurable.
• So to improve quality of the products we must be able to
measure the defects being made, and therefore make plans to
reduce the number of defects.
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17. Agreed:
• For an objective to be agreed it first needs to be created and
approved by top level management.
• Once management agrees on the objective it needs to be
communicated to each level of the organization that will be
required to implement the plans to achieve the objective, and
the people at these levels of the organization need to agree that
the plan is achievable.
• Without this buy-in they may not fully work towards the goal
and the plan may be doomed to failure.
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18. Realistic:
• Being realistic with an objective will make selling it within
your organization easier.
• If you tell your employees that you want to reduce defects
from 50% to 2%, they will not be able to see how this is
possible, especially if the plans around the object do not
support the improvement.
• It is better to set realistic goals and overachieve than it is to set
unrealistic goals and always fall short of the expectation.
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19. Time based:
• To be truly effective, an objective needs to have a time
associated with it.
• Since a plan needs to have dates in order to be properly
tracked.
• Again, having the time associated will allow you to monitor
how close you expect to be in achieving your goals.
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20. Strategic planning & implementation:
1.Clarify your vision
2. Gather and Analyze Information
3. Formulate a Strategy
4. Implement Your Strategy
5. Evaluate and Control
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21. 1.Clarify your vision :
• The purpose of goal-setting is to clarify the vision for your
business. This stage consists of identifying three key facets:
First, define both short- and long-term objectives.
• Second, identify the process of how to accomplish your
objective.
• Finally, customize the process for your staff, give each person
a task with which he can succeed. Keep in mind during this
process your goals to be detailed, realistic and match the
values of your vision
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22. 2. Gather and Analyze Information:
• The focus of the analysis should be on understanding the needs
of the business as a sustainable entity, its strategic direction
and identifying initiatives that will help your business grow.
• Examine any external or internal issues that can affect your
goals and objectives.
• Make sure to identify both the strengths and weaknesses of
your organization as well as any threats and opportunities that
may arise along the path.
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23. 3. Formulate a Strategy:
• The first step in forming a strategy is to review the information
gleaned from completing the analysis.
• Determine what resources the business currently has that can
help reach the defined goals and objectives.
• Identify any areas of which the business must seek external
resources. The issues facing the company should be prioritized
by their importance to your success.
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24. 4. Implement Your Strategy:
• Successful strategy implementation is critical to the success of
the business venture. This is the action stage of the strategic
management process.
• If the overall strategy does not work with the business' current
structure, a new structure should be installed at the beginning
of this stage.
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25. 5. Evaluate and Control:
• Strategy evaluation and control actions include performance
measurements, consistent review of internal and external
issues and making corrective actions when necessary.
• Any successful evaluation of the strategy begins with defining
the parameters to be measured. These parameters should
mirror the goals set in Stage 1.
• Determine your progress by measuring the actual results
versus the plan.
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26. McKinsey 7s Model:
 McKinsey 7-S framework. Developed in the early 1980s by
Tom Peters and Robert Waterman, two consultants working at
the McKinsey & Company consulting firm, the basic premise
of the model is that there are seven internal aspects of an
organization that need to be aligned if it is to be successful.
 The McKinsey 7-S model can be applied to elements of a
team or a project as well.
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27. McKinsey 7s Model:
The 7-S model can be used in a wide variety of situations where
an alignment perspective is useful, for example, to help you:
• Improve the performance of a company.
• Examine the likely effects of future changes within a company.
• Align departments and processes during a merger or
acquisition.
• Determine how best to implement a proposed strategy.
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28. McKinsey’s seven elements:
• The McKinsey 7-S model involves seven interdependent
factors which are categorized as either "hard" or "soft"
elements:
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Hard
elements
Strategy
Structure
System
Soft
Elements
Shared
values
Skills
Style
Staff

29. McKinsey’s seven elements:
 Hard elements are easier to define or identify and management
can directly influence them: These are strategy statements;
organization charts and reporting lines; and formal processes
and IT systems.
 Soft elements, on the other hand, can be more difficult to
describe, and are less tangible and more influenced by culture.
However, these soft elements are as important as the hard
elements if the organization is going to be successful
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30. McKinsey’s seven elements:
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31. McKinsey’s seven elements:
Hard elements:
• Strategy: the plan devised to maintain and build competitive
advantage over the competition.
• Structure: the way the organization is structured and who
reports to whom.
• Systems: the daily activities and procedures that staff members
engage in to get the job done
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32. McKinsey’s seven elements:
Soft Elements:
• Shared Values: called "super ordinate goals" when the model
was first developed, these are the core values of the company
that are evidenced in the corporate culture and the general
work ethic.
• Style: the style of leadership adopted.
• Staff: the employees and their general capabilities.
• Skills: the actual skills and competencies of the employees
working for the company.
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33. McKinsey’s seven elements:
• Placing Shared Values in the middle of the model emphasizes
that these values are central to the development of all the other
critical elements. The company's structure, strategy, systems,
style, staff and skills all stem from why the organization was
originally created, and what it stands for.
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34. Competitive analysis:
• Competitive analysis or competitive research is a field of
strategic research that specializes in the collection and review
of information about rival firms. It's an essential tactic for
finding out what your competitors are doing and what kind of
threat they present to your financial well-being.
• Competitive research is completely legal, it's simply collecting
bits of information available in the public domain.
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35. How to Conduct Competitive Analysis?
1. Identify Your Competitors.
2. Categorize the competitors.
3. Analyze and Compare Competitor Content.(S.W.O.T)
Analysis.
4. Determine Your Competitive Position in the Marketplace.
5. Identify Areas for Improvement.
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36. 1.Identify Your Competitors:
• Every company has those dreaded competitors they cannot
stand, no matter what you do they are always using your ideas
and taking your potential customers.
• Whether you are a local, national, or international company
there is probably someone in your company, specifically the
sales and marketing teams, that can quickly rattle off your top
competitors as well as what differentiates them from you.
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37. 2.Categorize the competitors:
• Primary Competition: These are your direct competitors,
which means they’re either targeting the same audience or
have a similar product — or both.
• Secondary Competition: These competitors may offer a high-
or low-end version of your product, or sell something similar
to a completely different audience.
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38. 3.Analyze and Compare Competitor
Content.(S.W.O.T) Analysis :
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39. 4.Determine the competitive position in
the market place:
• Gather Competitive Information Secondary sources of
information are recommended as an excellent starting point for
developing a competitive and industry analysis.
• Secondary sources include information developed for a
specific purpose but subsequently made available for public
access and thus alternative uses. For example, books are
secondary sources of information as are articles published in
journals.
• And even the s.w.o.t analysis is helpful in deciding the
competitive position.
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40. 5.Identify Areas for Improvement:
• After the analysis of the above competitive analysis the areas
which are to be improved can be analyzed.
• The analysis can guide to improve the position at the
marketplace.
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41. Management commitment to quality:
Direct participation by the highest level executives in a specific
and critically important aspect or program of an organization. In
quality management it includes
1) Setting up and serving on a quality committee
2) Formulating and establishing quality policies and objectives
3) Providing resources and training.
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42. Management commitment to quality:
4) overseeing implementation at all levels of the organization
5) evaluating and revising the policy in light of results achieved.
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43. References:
• https://essayswriters.com/essays/Management/strategic-quality-
management.html
• https://www.beckershospitalreview.com/strategic-planning/strategic-
planning-framework-the-importance-of-mission.html)
• https://ctb.ku.edu/en/table-of-contents/structure/strategic-
planning/vision-mission-statements/main
• https://www.iso-9001-checklist.co.uk/5.2-quality-policy.htm
• https://advisera.com/9001academy/knowledgebase/how-to-write-
good-quality-objectives/
• https://www.iso-9001-checklist.co.uk/tutorial/5.1-management-
commitment.htm
• https://www.mindtools.com/pages/article/newSTR_91.htm
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