Concept of quality assurance and TQM

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: to control the sources of product quality variation, namely materials, machines, methods and men. to ensure the correct and most appropriate manufacturing and packaging practices. to assure that the testing results are in compliance with the standards or specifications. 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

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 l ike 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 19 th 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: Satisfying customers first time, every time; Enabling the employees to solve problems and eliminate wastage; A style of working , a culture more than a management technique; 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. Shewhar t -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: · Establish specific goals to be reached (identification of needs to done, focus on specific project etc) · Establish plan for reaching goals (development of structured process to achieve this) · Assign clear responsibility for reaching goals · 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 - w hich 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 !

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. TQM : Transforming an Organization