2. The quality of something depends on the criteria being applied to it.
Something might be good because it is useful, because it is beautiful,
or simply because it exists
Quality can refer to:
•Technical interpretation - A specific characteristic of an object (the
qualities of ice - i.e. its properties)
•Philosophical interpretation - The essence of an object (the quality of ice
- i.e. "iceness")
•Practical interpretation - The achievement or excellence of an object
(good quality ice - i.e. not of inferior grade)
•Metaphysical interpretation - The meaning of excellence itself
•Scientific interpretation - In physics, the range of frequencies over which
something will characteristically respond.
3. Quality assurance (QA)
• QA is the activity of providing evidence needed to establish confidence among
all concerned, that quality-related activities are being performed effectively.
• All those planned or systematic actions necessary to provide adequate
confidence that a product or service will satisfy given requirements for quality.
• Quality Assurance is a part and consistent pair of quality management proving
fact-based external confidence to customers and other stakeholders that a
product meets needs, expectations, and other requirements.
• QA assures the existence and effectiveness of procedures that attempt to
make sure - in advance - that the expected levels of quality will be reached.
4. QUALITY ASSURANCE IN
PHARMA INDUSTRY
It is a measure of high degree of
managerial, scientific, technical functions
by sophisticated design and development.
Implement of quality assurance Is the
most vital function of total quality
management in pharmaceutical industry
and is considered as an internal part of
business and market.
5. QUALITY OBJECTIVES
For any industry or organization functional
objective should be well defined and quantified.
It help management to stimulate action and allow
companies to perform against defined objectives.
A large company has to establish on
interdepartmental mechanism to identify important
objective of the company / organization which need
to work assess their economic and other efforts and
fix priorities of action.
6.
The inputs given below can help in identifying quality objectives
Pareto analysis of repeated external alaram signals
(Eg:complaints returns)
Pareto analysis of repeated internal alarm signals ( eg: rejection
reprocessing etc)
Proposal key persons in the organization ie managers ,supervisors,
professionals etc.
Proposal from suggestion schemes.
Data from field study of user’s needs ,costs.
Comparison data on performance of the product versus
compititor’s product.
Comments of key people out side organization.
ie customers, vendors, press etc.
7. QUALITY OBJECTIVES &
QUANTIFIED GOALS
NATURE OF OBJECTIVE
Product improvement.
Training.
Cost reduction
QUANTIFIED GOALS
To make a tablet for with
reduced disintegration time
of less then one minute .
To conduct G L P training
for analyst with in 30 days.
To reduce cost of packing
material of product X by
the first half of the
financial year.
8. DESIGN /SPECIFIC ENGINEERING
PRODUCT DEVELOPMENT
MARKETING &
MARKET
RESEARCH
DISPOSAL AFTER
USE
PROCUREMENT
QUALITY LOOP
TECHNICAL
ASSISTANCE
MAINTENANCE
PROCESS PLANNING &
DEVELOPMENT
PRODUCTION
INSTALLATION &
OPERATION
INSPECTION TESTING
AND EXAMINATION
SALES AND
DISTRIBUTION
PACKING AND STORAGE
9. QUALITY MANAGEMENT SYSTEM (QMS)
APPROACH
An approach for developing and implementing a quality management system
consist of several steps
Determining the needs and expectations of customers and other interested
parties.
Establishing the quality policy and quality objective of the organization.
Determining the processes and responsibilities necessory to attain the quality
objectives.
Establishing methods to measure the effectiveness and efficiency of each
process.
Applying these measures to determine the effectiveness and efficiency of each
process.
Establishing and applying a process for continually imparting the existing
management practices.
10. ANALYTICAL LABORATORY PROCESS
FOR QUALITY CONTROL
PROCESS PARAMETER
ANALYSIS USING APPROPRITE
REPRESENTITIVE
SAMPLE
STANDARDS
CALIBERATED INSTRUMENT
ANALYTICAL
REPORT
11. WHERE FROM THE
QUALITY COMES
The quality comes from a process.
A process is the transformation of set of
inputs ,which can include actions ,
materials an operations into desired out put
in the form of products, information
,services or results are to be analyzed by
examination of its inputs and outputs .this
will determine the actions which will be
necessory to improve quality.
13. FITNESS FOR USE
quality of concept
market research
Quality of design
quality of specification
Quality of conformance
Assurance
Field
Technology
Man power
Management
Reliability
Maintainability
Logistical support
Promptness
Competence
Integrity
14. FITNESS FOR USE
A difference in the quality of grade
(which include level of fitness of the
product for use and level of
purchasing power of the customer)
will determine the quality & design of
the product.
15. A SPIRAL OF PROGRESS IN QUALITY
SALE
RESEARCH
TEST
PROCESS
CONTROL
DEVELOPMENT
RESEARCH
DESIGN
SPECIFICATION
PRODUCTION
PLANNING FOR
MANUFACTURE
INSTRUMENTATION
VENDER
