UNIT – I Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP Total Quality Management (TQM): Definition, elements, philosophies

1. QUALITY ASSURANCE AND
QUALITY MANAGEMENT
CONCEPTS
UNIT I
Present By- Gayatri K. Bahatkar
Assistant professor

2. INDEX
 Definition
 concept of Quality control
 Quality assurance and GMP
Total Quality Management (TQM):
 Definition
 Elements
 Philosophies

3. 1.1 CONCEPT OF QUALITY
 The dictionary meaning of 'Quality' is 'the standard of something
when it is compared to other things.
 ISO (International Organization for Standardization) defines
quality as 'the totality of features and characteristics of a product
or service that bears on its ability to meet a stated or implied
need.
 The meaning of the quality could be understood from two
perspectives: Manufacturer's perspective and Consumer's
perspective.
 From the Manufacturer's Perspective, the quality is to conform to
the specifications.
 The consumer's perspective is to consider quality characteristics
with price considerations.
 Getting maximum quality features while having a price as the

4. Historical Philosophies of
Quality
 Walter A. Shewhart, W. Edwards Demin, Joseph M. Juran,
Armand Feigenbaum, Philip Crosby, Genichi Taguchi, Kaoru
Ishikawa have been identified as making a significant
contribution to improving the quality of goods and services. All
these have put their philosophies of quality with some common
points below:
 ✓ Inspection is never the answer to quality improvement, nor is
"policing".
 ✓ Involvement of leadership and top management is essential to
the necessary culture of commitment to quality.
 ✓ A program for quality requires organization-wide efforts and
long term accompanied by the necessary investment in training.
 ✓ Quality is first and schedules are second.
As per Philip Crosby, Quality is defined as conformance to
requirements, neither a ‘goodness’ nor ‘Elegance’.

5. Crosby’s Five Absolutes of
Quality:
 Quality is defined as conformance to
requirements, not as ‘goodness’ or ‘elegance’
 There is no such thing as a quality problem.
 It is always cheaper to do it right the first time.
 The only performance measurement is the cost
of quality.
 The only performance standard is zero defects
 Crosby suggests that 80 percent of quality
problems are within the control of management.

6. Methods for Quality
Improvement:
 Step 1 Establish management commitment.
 Step 2 Form quality improvement teams..
 Step 3 Establish quality measurements.
 Step 4 Evaluate the cost of quality.
 Step 5 Raise quality awareness.
 Step 6 Take actions to correct problems
 Step 7 Zero defects planning.

7.  Step 8 Train supervisors and managers.
 Step 9 Hold a ‘Zero Defects’ day to establish
the attitude and expectation within the
company.
 Step 10 Encourage the setting of goals for
improvement.
 Step 11 Obstacle reporting.
 Step 12 Recognition for contributors.
 Step 13 Establish Quality Councils.
 Step 14 Do it all over again.

8. As per Armand V. Feigenboum, Quality is simply a
way of managing a business organization.
Four Steps to Quality:
 Step 1 Set quality standards.
 Step 2 Appraise conformances to standards.
 Step 3 Act when standards are not met.
 Step 4 Plan to make improvements.

9. Feigenbaum’s 10 benchmarks for
total quality success:
 Quality is a company-wide process.
 Quality is what the customer says it is.
 Quality and cost are a sum, not a difference.
 Quality requires both individual and team zealotry.
 Quality is a way of managing.
 Quality and innovation are mutually dependent.
 Quality is an ethic.
 Quality requires continuous improvement.
 Quality is the most cost-effective, least capital-intensive
route to productivity.
 Quality is implemented with a total system connected
with customers and suppliers.

10. As per Kaoru Ishikawa who is a ‘Father of
Quality Circles’ and as a founder of the
Japanese quality movement quality
approaches include ;
 An atmosphere where employees are
continuously looking to resolve problems
 Greater commercial awareness;
 A change of shop floor attitude is aiming for
ever-increasing goals.

11. Seven tools of Quality control by
Kaoru Ishikawa:
 TOOL 1 Pareto charts: Used to identify the principal
causes of problems.
 TOOL 2 Ishikawa/fishbone diagrams: Charts of cause
and effect in processes.
 TOOL 3 Stratification Layer charts which place each set
of data successively on top of the previous one.
 TOOL 4 Check sheets: To provide a record of quality
 TOOL 5 Histograms Graphs used to display the
frequency of various ranges of values of quality.
 TOOL 6 Scatter graphs Used to help determine whether
there is a correlation between two factors.
 TOOL 7 Control charts Used as a device in statistical
Process Control.

12. 1.2 QUALITY ASSURANCE
 Quality Assurance (QA) is a management method
that is defined as “all those planned and systematic
actions needed to provide adequate confidence that
a product, service or result will satisfy given
requirements for quality and be fit for use”.
 As per WHO (World Health Organization), QA is a
wide-ranging concept consisting all matters that
individually or collectively, directly or indirectly
influence the quality of a product. It is the totality of
the arrangements made with the object of ensuring
that pharmaceutical products are of the quality
required for their intended use. QA, therefore,
Pharmacy incorporates GMP (Good Manufacturing
Practices) and other factors, including product
design and development.

13. Components of Quality Assurance:
 Strategic or Organizational Level: This level
deals with the quality policy, objectives and
management and usually produced as the
Quality Manual.
 Tactical or Functional Level: This deals with
general practices such as training, facilities,
operation of QA.
 Operational Level: This deals with the Standard
Operating Procedures (SOPs), worksheets and
other aspects of day to day operations.

14. Quality Assurance, therefore, incorporates
GMP and other factors such as product
design and development.
 Quality Assurance applicable for manufacturing
should ensure that:
 All pharmaceutical products developed as per
GMP, GLP (Good Laboratory Practices) and GCP
(Good Clinical Practices) requirements.
 Production and control operations comply with
GMP.
 Job responsibilities are clearly defined.
 Material management and appropriate controls for
the same are in place.
 Finished product release is done in compliance
with GMP requirements and with authorized
approvals.

15.  Quality of the product is maintained throughout
the shelf life.
 Good documentation practices are
implemented and followed.
 SOPs for self-inspections, handling deviations,
rejects, recalls etc. are in place.
 Investigation processes are followed properly.
 Regular evaluation of products is done to
ensure consistent quality products and
continuous improvement.

16.  The manufacturer should own the responsibility for the
quality of the pharmaceutical products to ensure that they are
fit for their intended use, comply with the requirements of The
marketing authorization without any adverse or unwanted
reactions on a patient.
 Though the senior management is responsible for the
implementation of GMP for attaining good quality products,
commitments from the staff of all levels, suppliers, as well as
distributors, also are also very important aspects.
 To achieve the quality objective reliably there must be a
comprehensively designed and correctly implemented
system of quality assurance incorporating GMP and quality
control. It should be fully documented and its effectiveness

17. 1.3 GOOD MANUFACTURING PRACTICES
(GMP) FOR PHARMACEUTICAL PRODUCT
 As per WHO, Good manufacturing practice is that part of
quality assurance which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by the marketing authorization.
 GMP are followed to eliminate the risks associated with
the quality of the product ex. Cross-contaminations, mix-
ups as well as reasons causing the same.

18. A. Clearly defined and systematically
reviewed manufacturing processes:
All batch
documentatio
n
All Quality
specification
All relevant
SOPs

19. B. Critical steps of production processes are
validated:
Process
design
Identification of
process
variables
Control
strategy
Process
qualification
Process
monitoring need
for improvement
PROCESS
VALIDATIO
N

20.  C. Appropriate resources: personnel, buildings,
equipment, and materials are available to produce a
quality product: This means that the company has
evaluated all of the elements It needs to produce a
product and has sufficient resources of the right quality
for its production.
 D. Manufacturing is based on clearly written
procedures: The procedures referred to here include the
batch manufacturing and testing instructions and the
SOPs needed for every department.
 E. Operators are trained: A company can have “all the
documentation in the world” but if its operators are not
properly trained to carry out the tasks that they are
supposed to perform then the company will not be
successful.

21. 1.4 QUALITY CONTROL (QC)
 As per WHO, “QC is the part of GMP concerned with sampling,
specifications, testing, organization, documentation and release
procedures which ensure that the necessary and relevant tests
are carried out and that the materials are neither released for
use nor products released for sale or supply until their quality
has been satisfactory. QC is not confined laboratory operations
but must be involved in all decisions concerning the quality of
the product”
 Each manufacturing company should have a separate quality
control department.
 The independence of quality control from production is
considered fundamental. The quality control department should
be independent of other departments and under the authority of
a person with appropriate qualifications and experience.

22.  The QC department must have adequate resources such as
adequate laboratory facilities or access to them e.g. government
or contract laboratories, appropriately qualified, trained and
experienced personnel and approved written procedures ex.
Specifications
QC labs should have minimum following departments:
 Chemical testing laboratory with adequate chemicals and
glassware.
 Instrument analysis lab with adequate type and number of
analytical instruments.
 Microbiology laboratory with facility for microbial testing and
sterility testing it required.
 Documentation room.
 Retained sample room with suitable environmental
conditions.

23. Components of QC
Department:
 QC department is responsible for inspecting, analytical
testing, monitoring of all materials and environmental
conditions in the factory, releasing or rejecting materials
for production use and finished products related to starting
materials, packaging materials, intermediates, bulk
products, and finished products.
 Sampling should be undertaken by methods and
personnel approved by the QC department in accordance
with approved SOP. QC personnel must have access to
the production area to undertake to sample when
necessary.
 All test methods applied for testing should be validated for
accuracy, precision, linearity, repeatability, robustness,
specificity.
 Records for sampling, inspecting, testing of materials,
intermediates and bulk and finished products need to be
kept for traceability.

24.  The QC department should review and evaluate the relevant
production documentation in terms of quality. All documents
should be approved by QC to ensure manufacturing
documentation and quality assurance documentation in
harmony.
 Records for deviations and failure investigations should be
generated wherever necessary and should be reviewed by the
QC department. Deviations hampering product quality need to
properly investigated and appropriate action needs to be taken.
 The finished product should comply with the qualitative and
quantitative composition of the product and should be in
appropriate container closure as mentioned in marketing
authorization.
 Assessment of finished products should embrace all relevant
factors, including the production conditions, the results of in-
process testing, the manufacturing (including packing),
documentation, compliance with the specification for the finished
product, and an examination of the finished pack

25. Successful quality control also
requires that:
 Materials used for manufacturing are of the
required purity.
 Proper containers are used for finished product
packing.
 Labeling of in-house materials and the finished
product is correct.
 Batches are released by the authorized
person.
 Samples of starting materials and products and
retained.

26. In addition to those already mentioned, the
QC department has other duties to carry out,
including:
 Establishing, validating and implementing all QC
procedures.
 Evaluating, maintaining, storing reference
standards
 Ensuring correct labeling of containers of
materials and products.
 Stability testing of active ingredients and
finished products.
 Participating in complaint investigations.
 Participating in environmental monitoring

27. TOTAL QUALITY MANAGEMENT (TQM)
 Quality management is defined as “the aspect of
management function that determines and implements the
‘quality policy,’ i.e. the overall intention and direction of an
organization regarding quality, as formally expressed and
authorized by top management”.
 Quality cannot be built just by testing, but it should be
ensured at every stage of manufacturing i.e. starting from
purchasing the right material to its manufacturing and
storage. For building quality in product, controls need to be
implemented at each stage related to manufacturing activity.
 Below are some basic elements of quality management:
✓ The infrastructure supporting quality management i.e. Quality
system.
✓ Systemic plan and actions to execute planning for
manufacturing quality product.

28. Objectives of Quality
Management
 To provide quality medicine.
 To minimize defects in product which may lead
to recall or rejection.
 To increase productivity keeping quality intact.
 To handle all changes in manufacturing facility
without affecting the quality of the product.

30.  Quality Management System (QMS) is defined as “the process
of systems of an organization with regard to its quality related
activities for enhancing customer satisfaction and also taking
care of all other interested parties such legislative and regulatory
bodies, shareholders, suppliers, employees etc.”
With the respect to QMS, the ISO 9000 is a family of standards
comprising:
 ISO 9000: 2000 provides fundamentals and vocabulary for QMS.
 ISO 9001: 2000 introduces QMS and its requirements to address
customer satisfaction.
 Provides requirements for compliance with standards.
 1S0 9004:2000 provides guidelines for continuous performance
improvements for QMS
 ISO 9001: 2000 is the most comprehensive standard in the
series: It specifies system requirements in purchase, design and
development, production, installation and servicing
 ISO 9000: 2000 and 1S0 9004 2000 provide guidelines for the
achievement the standards. Certificates to the organizations are
issued based on this standard.

31. Quality Management which is one of the five
sections of ISO 9001: 2000 has below
Objectives:
 To consistently meet customer requirements.
 To achieve customer satisfaction.
 To enhance market share.
 To sustain market share.
 To improve communications and morale in the
organization.
 To reduce costs and liabilities.
 To increase confidence in the production system.

32. Total Quality Management
(TQM)
 Total quality management (TQM) is a management approach
towards quality for long term success through customer
satisfaction. In a TQM effort, all members of an organization
participate in improving processes, products, services, and
the culture in which they work.
 Total Quality Management is mainly concerned with
continuous improvement in all work It is a long term planning.
It is the consistent improvement in quality. It is a never-ending
process.
 Total Quality Management consists of three words:
 Total: Make up of the whole.
 Quality: Degree of excellence a product or service provides.
 Management: Process of planning, organizing, directing and
controlling.

34.  TQM is relatively new concept of quality control. It is basically,
a management function involving the direction of top
management and co-ordination of all quality-related activities
throughout the company to achieve Zero defects and
customer satisfaction.
 Since quality is a measure of the users satisfaction provided
by the product, it should include
 Functional efficiency
 Appearance.
 Ease of installation and operation.
 Safety.
 Reliability.
 Maintainability.
 Running and maintenance cost.
 In TQM quality awareness begins at the very conception of
the product and continues throughout the various stages of its
development and manufacture and even its usage to provide
feedback from the users which is essential for quality
improvement.

36. Elements of TQM:
 Total quality is a description of culture, attitude and organization of a
company that strives to provide customers product and services
that satisfy their needs.
 To successful implementation of TQM an organization must
concentrate on 8 key
Elements:
 ✓ Ethics
 ✓ Integrity
 Trust
 Training
 Team work
 Leadership
 ✓ Recognitions
 ✓ Communications

37. TQM Approach:
 TQM can be summarized as a management system for a
customer-focused organization that involves all employees in
continual improvement. It uses strategy, data, and effective
communications to integrate the quality discipline into the
culture and activities of the organization.
Below are three major elements for the TQM approach.
 Customer-focused: The customer ultimately determines the
level of quality so it is always beneficial to recognize
customer requirements toward product quality.
 Total employee involvement: Building quality in product is
not single persons job, all employees should participate in
working toward common goals. Management has to provide a
favorable environment at workplace to achieve every
employee’s commitment towards common goal.

38.  Continual improvement: This is very important
and large concept of TOM Continual improvement
drives an organization to become more
competitive and more effective at meeting
customer expectations.
 Other than these elements, effective
communication, strategic and systematic
approach facts based decision making also can
be of help for implementing TQM.
 Total quality management helps in higher
productivity, strengthening competitive Position,
cost reduction, higher profitability, cost
management, increased customer focus etc. Six
Sigma, ISO 9001, lean manufacturing are some of
the examples of the strategies of TQM.

39.  THANK YOU