A brief introduction about quality, quality assurance and total quality management.

1. Concept of Quality
Assurance
and
Total Quality
Management
By: Y.Akhila Swarnalatha Lakshmi,
15IS1S0402,
M.Pharm(PAQA)., JNTUK.

2.  The professional, social and legal responsibility
that rest with the pharmaceutical manufacturers
for the assurance of product quality are
tremondous.
 The manufacturer should be in a position:
a) to control the sources of product quality variation,
namely materials, machines, methods and men.
b) to ensure the correct and most appropriate
manufacturing and packaging practices.
c) to assure that the testing results are in compliance
with the standards or specifications.
d) to assure product stability and to perform other
activities related to product quality through a well-
organized total quality assurance system.

3.  Implementation of an effective quality assurance
policy is the most important goal of pharmaceutical
industry. The concept of quality assurance and
quality control together develops towards assuring
the quality, safety and efficacy of pharmaceutical
products.
 The pursuit of quality being approached through the
concept of total quality management (TQM) system
which is aimed at prevention of defects rather than
detection of defects.
 Although the responsibilities for assuring product
quality belong primarily to quality assurance
personnel, it involves many department and
disciplines within a pharmaceutical company. To be
effective, it must be supported by a team effort.

4. Quality assurance
 Quality assurance is a wide ranging concept covering all
matters that individually or collectively 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.(WHO definition)
 QA is the heart and soul of quality control
QA = QC + GMP
QA GMP QC
Quality Management
Quality Assurance
GMP
Quality Control

5. 5
FACTORS IN DRUG QUALITY
ASSURANCE
DRUG
PRODUCT
QUALITY
LABELLING &
PRODUCT
INFROMATION
IMPORT
& EXPORT
CONTROL
RAW
MATERIALS-
ACTIVE &
INACTIVE
MANUFACURING
PROCESSES
& PROCEDURES
STORAGE
TRANSPORT
DISTRIBUTION
DISPENSING
& USE
QC &
ANALYSIS
HUMAN
RESOURCES-
PROFESSIONALS
LEGISLATIVE
FRAMEWORK
-REGULATIONS PACKAGING

6. Primary Functions of QA:
Quality Control
Analytical testing of products
Active and Non active material control
Sampling, inspecting and testing of incoming raw
materials
 Packaging and labeling components
Bottles, caps, foils, labels, measures, cartons
Physical inspection of product and operations
at critical intermediate stages
In-process controls, HHACCP
Control of product through its distribution
GSP, GDP ETC

7. 7
Elements of the Quality Assurance Cycle in
Pharmaceutical Manufacturing:
 Research
 Development
 Prototyping
 Documentation
 Raw Materials
 Facilities
 Equipment
 Personnel and Supervision
 Monitoring, Feedback, Follow-up
Quality Assurance Cycle
Research
Development
Raw Materials
Facilities
Documentation
Equipment
Personnel

8. 8
A Guiding Philosophy for Quality Assurance in the
Pharmaceutical Industry:
Poor Quality Medicines:
 Are a health hazard
 Waste money for governments and consumers.
 May contain toxic substances that have unpredictable,
unintended consequences.
 Will not have a desired therapeutic effect.
 Does not save anyone any money in the long term.
 Hurt everyone – patients, health care workers, policy
makers, regulators, manufacturers

9. 9
CONSEQUENCES OF Q.A.
BREACHES:
Poor Treatment outcomes
High Health Bills
Treatment Failures & Deaths
Loss of Confidence in the Health
Services
Enormous Economic Losses
National Security Issue

10. QUALITY
 The concept and vocabulary of quality are elusive.
 Different people interpret quality differently.
 It is a matter of feeling and the definition varies from person to
person depending on the perspective in which defined.
 Quality has been defined in different ways by the quality gurus as
–
 conformance to standards or specifications;
 fitness for use;
 meeting customer’s requirements or expectations;
 delighting the customer etc.

11. Eight dimensions of quality:
 Performance: Product’s primary operating characteristics.
 Features: Supplements to a product’s basic functioning
characteristics.
 Reliability: A probability of not malfunctioning during a specified
period.
 Conformance: The degree to which a product’s design and
operating characteristics meet established standards.
 Durability: A measure of product life.
 Serviceability: The speed and ease of repair.
 Aesthetics: How a product looks, feel, tastes and smells.
 Perceived quality: As seen by a customer.

12. Ways of Improving Quality:
 Plan-Do-Study-Act Cycle (PDSA)
Also called the Deming Wheel after originator.
Circular, never ending problem solving process.
 Seven Tools of Quality Control: Tools typically taught to
problem solving teams.
 Cause-and-Effect Diagrams
 Flowcharts
 Checklists
 Control Charts
 Scatter Diagrams
 Pareto Analysis
 Histograms
PDSA Cycle

13. 7 tools of quality control:
1.Cause-and-Effect
Diagrams: also called
Fishbone Diagram. Focused
on identifying the causes of
quality problem
2.Flow-Charts:Used to
document the detailed steps
in a process
Often the first step in Process
Re-Engineering.

14. 3.Checklist:Simple data
check-off sheet designed to
identify type of quality problems
at each work station; per shift, per
machine, per operator.
4.Control charts:
Important tool used in Statistical Process
Control . The UCL and LCL are
calculated limits used to show when
process is in or out of control.

15. 5.Scatter Diagrams:A graph that
shows how two variables are related to one
another. Data can be used in a regression
analysis to establish equation for the
relationship.
6.Histograms:
A chart that shows the frequency
distribution of observed values of a variable
like service time at a bank drive-up
window. Displays whether the distribution is
symmetrical (normal) or skewed .
7.Pareto Analysis:Technique that displays the
degree of importance for each element
Named after the 19th century Italian economist
Often called the 80-20 Rule
Principle is that quality problems are the result of only a
few problems e.g. 80% of the problems caused by 20% of
causes.
5
6
7

16. TOTAL QUALITY MANAGEMENT
 TQM is the integration of all functions and processes within an
organization in order to achieve continuous improvement of the
quality of goods and services.
 The goal is customer satisfaction.
 Integrated organizational effort designed to improve quality of
processes at every business level.

17.  TQM may also be defined as performance superiority in delighting
customers. The means used are people, committed to employing
organizational resources to provide value to customers, by doing
the right things right the first time, every time.
 Total quality management (TQM) means:
1. Satisfying customers first time, every time;
2. Enabling the employees to solve problems and eliminate wastage;
3. A style of working, a culture more than a management technique;
4. Philosophy of continuous improvement, never ending, only achievable
by/or through people.
Key elements of TQM:
 Focus on the customer
 Employee involvement
 Continuous improvement

18. Measurement
Measurement
Measurement
Measurement
Empowerment/
Shared Leadership
Process
Improvement/
Problem
Solving
Team
Management
Customer
Satisfaction
Business
Results
The Continuous Improvement Process
. . .

19. GURU’S OF TQM:
 Walter. A. Shewhart -TQC &PDSA(Plan- Do- Study- Act)
 W.Edwards Deming- 14 Points & PDCA(Plan- Do- Control- Act)
 Joseph Juran- Juran’s Trilogy
 Armand Feigenbaum: Developed the concept of total quality control
(TQC). One of his important contributions has been that of cost of
quality.
 Philip. B. Crosby: Four Absolutes-Quality requirement, Prevention of
NC,Zero Defects & Measure of NC.
 Genichi Taguchi- Quality as Loss Function. Proposed 8-point approach.
 Kaoru Ishikawa-Disciple of Juran & Feigenbaum: TQC in Japan, SPC,
Cause &Effect Diagram, QC.
 Frederick W. Taylor wrote Principles of Scientific Management in 1911.
 W. Edwards Deming and Joseph M. Juran, students of Shewhart, went
to Japan in 1950; began transformation from “shoddy” to “world class”
goods.
 In 1960, Dr. K. Ishikawa formalized “quality circles” - the use of small
groups to eliminate variation and improve processes.

20. W. Edwards Deming:
The best known of the “early” pioneers, is credited with
popularizing quality control in Japan in early 1950s.
Today, he is regarded as a national hero in that country and
is the father of the world famous Deming prize for quality.
 He realized that in regard to stability and variations of
industrial processes the special causes (assignable causes)
amounted to only 15 % of all causes and may be controlled
by the work force.
The rest 85% of causes could be dealt with by the
management!
Among his many contributions is the famous Deming Wheel
.
Amongst his many pioneering contribution his 14-point
achieving organizational excellence is the best.

21. Joseph Juran
 Juran, like Deming was invited to Japan in 1954 by the union of Japanese
Scientists and engineers.
 Juran defines quality as fitness for use in terms of design, conformance,
availability, safety and field use.
 He focuses on top-down management and technical methods rather than
worker pride and satisfaction.
 He recommends a set of four important stages as: ·
I. Establish specific goals to be reached (identification of needs to done,
focus on specific project etc) ·
II. Establish plan for reaching goals (development of structured process to
achieve this) ·
III. Assign clear responsibility for reaching goals ·
IV. Give rewards/awards on the basis of result achieved (development of
feedback system, utilization of lessons learned from feedbacks etc).
 His famous quality trilogy the main components of which are: · Quality
planning · Quality control and · Quality improvement

22. Philip Crosby
He is the author of popular book “Quality is Free”.
He developed a 14-step methodology.
His absolutes of quality are:
• Quality is defined as conformance to requirements,
not “goodness”.
• The system for achieving quality is prevention, not
appraisal.
• The performance standard is zero defects, not
“that’s close enough”.
• The measurement of quality is the price of non-
conformance, not indexes.

23. •He believed it is preferable to design product
that is robust or insensitive to variation in the
manufacturing process, rather than attempt to
control all the many variations during actual
manufacture.
•“Taguchi methodology” is fundamentally a
prototyping method that enables the designer
to identify the optimal settings to produce a
robust product that can survive manufacturing
time after time, piece after piece, and provide
what the customer wants.
Taguchi

24. He was the originator of “total quality control”, often referred to
as total quality.
He defined it as:
“An effective system for integrating quality
development, quality maintenance and quality
improvement efforts of the various groups within an
organization, so as to enable production and
service at the most economical levels that allow full
customer satisfaction”.
He saw it as a business method and proposed three steps to
quality:
• Quality leadership
• Modern quality technology
• Organisational commitment
Armand V Feigenbaum

25. He made many contributions to quality, the most noteworthy being his total
quality viewpoint, company wide quality control, his emphasis on the
human side of quality, the Ishikawa diagram and the assembly and
use of the “seven basic tools of quality”:
 Pareto analysis - which are the big problems?
 Cause and effect diagrams - what causes the problems?
 Stratification - how is the data made up?
 Check sheets - how often it occurs or is done?
 Histograms - what do overall variations look
like?
 Scatter charts - what are the relationships
between factors?
 Process control charts - which variations to control and
how?
Dr .Kaoru Ishikawa

26. Total Quality Management (TQM)
Beyond 2000:
 As the 21st century begins, the quality movement has matured..
 The new quality systems have evolved beyond the foundations laid by
Deming, Juran and the early Japanese practitioners of quality.
 In 2000, the ISO 9000 series of quality management standards was revised to
increase emphasis on customer satisfaction.
 Sector-specific versions of the ISO 9000 series of quality management
standards were developed for such industries as automotive (QS-9000),
aerospace (AS9000) and telecommunications (TL 9000 and ISO/TS 16949)
and for environmental management (ISO 14000).
 Six Sigma, a methodology developed by Motorola to improve its
business processes by minimizing defects, evolved into an
organizational approach that achieved breakthroughs – and
significant bottom-line results.
 When Motorola received a Baldrige Award in 1988, it shared its quality
practices, like Toyota Motor Corporation, with others.

27. What is Six Sigma?
• A goal of near perfection in meeting customer
requirements
• A sweeping culture change effort to position a company for
greater customer satisfaction, profitability and competitiveness
• A comprehensive and flexible system for achieving, sustaining
and maximizing business success; uniquely driven by close
understanding of customer needs, disciplined use of facts, data, and
statistical analysis, and diligent attention to managing, improving
and reinventing business processes.
•The objective of Six Sigma quality is 3.4 defects per million
opportunities!
(Number of Standard Deviations) 3 Sigma 4 Sigma 5 Sigma 6 Sigma
0.0 2700 63 0.57 0.002
0.5 6440 236 3.4 0.019
1.0 22832 1350 32 0.019
1.5 66803 6200 233 3.4
2.0 158,700 22800 1300 32

28. Six Sigma Improvement Methods
DMAIC vs. DMADV
Define
Measure
Analyze
Design
Validate
Improve
Control
Continuous Improvement Reengineering

29. Six Sigma DMAIC Process
Measure
Control
Define
Analyze
Improve
Customers
requirements,
team goals,
project
boundaries,
process to
improve
Collect data, customer
reviews, defect types and
their frequency. Eliminate
assumptions
Organize data, look for
process problems and
opportunities. Helps to
prioritize opportunities,
improve, identify
sources of variation
and root causes of
problems in the
process.
Generate both obvious
and creative
solutions(innovation,
technology & discipline)
to fix and prevent
problems.
Insure that the process
improvements, once
implemented, will “hold the
gains” rather than revert to the
same problems again.Statistical
tools are used .

30. Six Sigma DMADV Process
Measure
Validate
Define
Analyze
Design
Develop detailed design for new
process. Determine and evaluate
enabling elements. Create
control and testing plan for new
design. Use tools such as
simulation, benchmarking, DOE,
Quality Function Deployment
(QFD), FMECA analysis, and
cost/benefit analysis.
Test detailed design with a pilot
implementation. If successful,
develop and execute a full-scale
implementation. Tools in this step
include: planning tools,
flowcharts/other process
management techniques, and work
documentation.

31. Obstacles for TQM:
 Top management commitment
 Improper planning
 Organization Structure & Departments
 Lack of a genuine quality culture
 Lack of top management support and commitment
 Over- and under-reliance on SPC methods
 Data’s & Facts For Effective Decisions
 Internal & External Customers-Dissatisfaction

32. Methods to overcome obstacles:
Continuous Improvement
Continuous Training & Education
Empowerment
Teamwork
Changing organisation culture
© 2005 Wiley 32

33. BENEFITS OF TQM:
Improved quality
Employee participation
Team work
Internal and external customer
satisfaction
Productivity
Communication
Profitability
Market share
33

34. From
Motivation through fear and loyalty
To
Motivation through shared
vision
Attitude: “It’s their problem” Ownership of every problem
affecting the customer
Attitude: “the way we’ve always
done it”
Continuous improvement
Decisions based on assumptions/
judgment calls
Decisions based on data and
facts
Everything begins and ends with
management
Everything begins and ends with
customers
TQM: Transforming an Organization