M Pharmacy (PQA)

1. 12/7/20181
Prepared by
Miss Unnati .M. Patel
F.Y.M PHARM (PQA)
Guided by
Mr. Ajinkya Kurhe
M pharm(Pharmaceutics)
Sanjivani College of Pharmaceutical Education and
Research, Kopargaon

2. 12/7/20182
CONTENT
1. Strategic Quality Management.
2. Mission and Vision Statements.
3. Quality Policy and Quality Objective.
4. Strategic Planning and Implementation.
5. Mckinsey 7s Model.
6. Competitive Analysis
7. Management commitment to quality

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Strategic Quality Management
• Strategy: It is a guide on how to pursue the organization’s
mission and vision. Strategies set direction by identifying the
activities that help develop specific goals and plans.
•
Aim of
strategies
Operational
effectiveness
Achieving a
competitive
advantage

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• Strategic Quality Management(SQM) is a process of
continous improvement.It involves all of organizational
elements i.e. inputs,process,outcomes,customer satisfaction.
Phases of SQM
Establishing Quality Mission
Developing Quality Profile
Declaring Quality Policy
Listing/Modifying long term and annual
quality objective.
Designing for Quality

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6. Mission Statements
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• It is statement of organization’s purpose and scope of its
operation.
• It describes the present position of organization that reveal
what an organization wants.
• This statement is essential for effective establishing
objectives and formulating stratergies.
• Mission statement focus on “what our business is now”.

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Vision Statement
• It describes the desired future position of organization.
• It can be viewed as ultimate goal that may take 5 years/ more
to achieve.
• Vision statement emphasize on “what our business will be
later”.

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Quality Policy
• It is one of clause of 5.3 section in ISO 9001:2008.
• It is document developed by management to express
directive of top management with respect to quality.
• It provides guidelines for
a) Planning the overall quality program.
b) what is to be done and how it is to be done.
c) provides a framework for establishing and reviewing
quality objective.
• It should be communicated and understood within the
organization.

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Quality Objective
• It is one of clause of ISO 9001:2015 in section 5.4.1
• It is method used by industries to focus goal from quality policy
into plans for improvement.
• Quality Objective effective in addressing what needs to be
improved .It is directly linked to the customers.
• Requirements of Quality Objective
1. Specific
2. Measurable
3. Agreed
4. Realistic
5. Time-Based

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Strategic Planning and Implementation
Startegic Management is concerned with making decision about
an organization ‘s future decision for growth, renewal and
implementing those policies.
Strategic Planning Strategic Implementation
Strategic
Management

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Strategic Planning
• It is making decision about determining the organization mission.
• Formulating the policies to guide the organization in establishing
objective, choosing a strategy and implementing the same.
• Establishing long range and short range objectives to achieve the
mission of organization.
• SWOT Analysis is strategic planning technique used to help
organization to identify the competition.

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SWOT
Analysis
Strength
Weakness
Opportun
ities
Threats

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Strategic Implementation
• It is a term used to describe the activities within an organization
to manage excecution of strategic plan.
• To bring action to the chosen strategy so as to achieve strategic
goal and objective.
Vision Strategy
Implementation
plan

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Steps of Implementation
1. Project Implementation
2. Procedural Implementation
3. Resources Allocation
4. Structural Implementation
5. Functional Implementation
6. Behavioral Implementation
• It deals with those aspects of strategy implementation
that have impact on behavior of people in
organization.

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1. Project Implementation
• It include 2 phases : Project Activation
Project Operation
2. Procedural Implementation
• Licensing Procedures
• Foreign Collaboration Procedure
• Import and Export Requirement
• Capital issues and Control Requirement
3. Resources Allocation
• It is process of allocating resources among the project /plan.
Basic
Allocation
Decision
Contingency
Mechanism

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4.Structural Implementation
Structural
Implement
ation
Design of
System
Specific
Grouping
Identifies
Formal
Relationship
5.Functinal Implementation: It is carried out in different areas
• Marketing Plans and Policies
• Financial Plans and Policies
• HR management policies:
a) Organizational Characteristic
b) Personnel System

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Marketing Plans and Policies
Pricing
Promotio
n
Product
Financial Plans and Policies
Sources of
Funds
Usage of
Funds
Management
of Funds

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Mckinsey 7s Model
Origin
• It was first mentioned in “The Arts of Japanese Management” by
Richard Pascale and Anthony Athos in 1981.
• At the same time Tom Peter and Robert Watermann were in
same condition.
• The 7s model was born at meeting of these 4 authors.
What is the Model
• It describes 7 Factors to organize a company in effective way.
• It aslo determines way in which a organization operates.
• Managers should take into account all 7 factors to be
implemented the same.

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7s
Elements
Hard Elements
• Strategy
• Structure
• System
Soft Elements
• Shared Values
• Skills
• Style
• Staff

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Competitive Analysis
 It is analysis of competitors of organization .
 Analysis include evaluating the strength, weakness of
organization.
• Identify the current and potential
Competition.
Step 1
• Determine 5 Strategic areas in of
competitiveness.
Step 2
• Create a Competition Matrix.Step 3
Step 4
Step 5
• Create separate matrices.
• Review of matrices to determine
vulnerable areas of company.

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Management commitment to quality
• It is one of the subclause of ISO 9001:2008 under section 5.1.
• Top management shall provide evidence of its commitment to
development and implementation of quality management system and
continually improving its effectiveness by:
a) Communicating to organization the importance of meeting
customer as well as statutory and regulatory requirements.
b) Establishing the Quality Policy .
c) Establishing the Quality Objective .
d) Ensuring the Availability of Resources.
e) Conducting the Mangement Review.

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References
1. Juran’s Quality Planning and Analysis for Enterprise Quality
by Frank M. Gryna, Richard G.H. Ghua, Joseph A. Defeo
Fifth Edition , published by McGraw Hill Education Pvt Ltd
Pg no.424,216,243-247,249,255.
2. www.iosrequirement.com

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