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
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
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
Editor's Notes
Plan:Evaluate current process
Collect procedures, data, identify problems
Develop an improvement plan, performance objectives
Do: Implement the plan – trial basis
Study: Collect data and evaluate against objectives
Act: Communicate the results from trial. If successful, implement new process .
Create constancy of purpose towards improvement of product and service
Adopt the new philosophy. We can no longer live with commonly accepted levels of delay, mistakes
and defective workmanship
Cease dependence on mass inspection. Instead, require statistical evidence that quality is built in
End the practice of awarding business on the basis of price
Find problems. It is management’s job to work continually on the system
Institute modern methods of training on the job
Institute modern methods of supervision of production workers, The responsibility of foremen must
be changed from numbers to quality
Drive out fear, so that everyone may work effectively for the company
Break down barriers between departments
Eliminate numerical goals, posters and slogans for the workforce asking for new levels of productivity without providing methods
Eliminate work standards that prescribe numerical quotas
Remove barriers that stand between the hourly worker and their right to pride of workmanship
Institute a vigorous program of education and retraining
Create a structure in top management that will push on the above points every day
Based on these premises Crosby has developed a 14- step methodology which is presented below: 1. Management commitment: Clarify and demonstrate management’s commitment to quality. 2. Quality improvement team: Guide the quality improvement programme. 3. Quality measurement: Display current and potential non-conformance problems in a manner that permits objective evaluation and corrective action. 4. Cost of quality: Define the ingredients of the cost of quality and explain its use as a management tool. 5. Quality awareness: Develop awareness about quality throughout the company towards the conformance of the product or service through effective communication channels. 6. Corrective action: Provide a systematic method of resolving forever the problem that is identified through previous action steps. 7. Zero defects planning: Examine the various activities that must be conducted in preparation for formally launching the zero defects (ZD) programmed. 8. Employee education: Define the type of training that the employees need in order to actively carry out their part of the quality improvement programme. Employee education process, according to Juran, comprises the following dimensions: · Comprehension · Commitment · Competence · Communication · Correction
· Continuance 9. Zero defects day: Mark a day in the year as zero defects day. An event that will let all employees realize, through a personal experience, that there has been a change. 10. Goal setting: Set targets-turn pledges and commitments into action by encouraging individuals to establish improvement goals for themselves and their groups. 11. Error-cause removal: Give the individual employee a method of communicating to the management, the situations that make it difficult for them to meet the target and improve. It focuses on permanent removal of common causes of errors. 12. Recognition: Appreciate those who participate. 13. Quality councils: Bring together all quality professionals for planned communication on a regular basis. 14. Do it over again: Emphasize that the quality improvement is a never ending journey.
Dr. Genichi Taguchi one of the best known Japanese quality experts, four times recipient of the coveted Deming prize, developed techniques of industrial optimization. His revolutionary concept of quality as the loss imparted by the producer to the society from the time the product is shipped. Taguchi’s approach focused on a statistical method that zeros in rapidly on the variations in a product that distinguish the bad parts from good. He calls it the concept of robust design. His contributions have acquired the title of Taguchi methods. In a nutshell Taguchi’s 8-point approach towards quality may be listed as follows: · Identify the main function, side effects and failure.
Bhaskar Mazumder et al
/Int.J. PharmTech Res.2011,3(1) 370
· Identify noise factors and testing conditions for evaluating quality loss. · Identify the quality characteristics to be observed and the objective function to be optimized. · Identify the control factors and define the data analysis procedure. · Conduct the matrix experiment and define the data analysis procedure. · Analyze the data, determine optimum levels for the control factors, and predict performance under these levels. · Conduct the verification experiment and plan future action.