Concept of Quality Assurance and Total Quality Management

By: Y.Akhila Swarnalatha Lakshmi, 15IS1S0402, M.Pharm(PAQA)., JNTUK.

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.

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.

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

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FACTORS IN DRUG QUALITY ASSURANCE

DRUGPRODUCTQUALITY

LABELLING &PRODUCT

INFROMATION

IMPORT& EXPORTCONTROL

RAW MATERIALS-

ACTIVE &INACTIVE

MANUFACURINGPROCESSES

& PROCEDURESSTORAGE

TRANSPORTDISTRIBUTIONDISPENSING

& USE

QC &ANALYSIS

HUMANRESOURCES-

PROFESSIONALS

LEGISLATIVE FRAMEWORK

-REGULATIONS PACKAGING

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

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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

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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

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CONSEQUENCES OF Q.A. BREACHES:Poor Treatment outcomesHigh Health BillsTreatment Failures & DeathsLoss of Confidence in the Health

ServicesEnormous Economic LossesNational Security Issue

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.

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.

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

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 processOften the first step in Process Re-Engineering.

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.

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 elementNamed after the 19th century Italian economistOften called the 80-20 RulePrinciple is that quality problems are the result of only a few problems e.g. 80% of the problems caused by 20% of causes.

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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.

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

Measurement

Mea

sure

men

tM

easurement

Measurement

Empowerment/ Shared Leadership

Process Improvement/

Problem SolvingTeam

Management

Customer Satisfaction

Business Results

The Continuous Improvement Process

. . .

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.

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.

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

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.

•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

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 andservice 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

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

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.

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 Sigma0.0 2700 63 0.57 0.0020.5 6440 236 3.4 0.0191.0 22832 1350 32 0.0191.5 66803 6200 233 3.42.0 158,700 22800 1300 32

Six Sigma Improvement MethodsDMAIC vs. DMADV

Define

Measure

Analyze

Design

Validate

Improve

Control

Continuous Improvement Reengineering

Six Sigma DMAIC Process

Measure

Control

Define

Analyze

Improve

Customers requiremen

ts, 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 .

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.

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

Methods to overcome obstacles:

Continuous ImprovementContinuous Training & EducationEmpowermentTeamworkChanging organisation culture

© 2005 Wiley 32

BENEFITS OF TQM: Improved quality Employee participation Team work Internal and external customer

satisfaction Productivity Communication Profitability Market share

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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