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Total quality management

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Total quality management

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Total quality management (TQM) has been defined as an
integrated organizational effort designed to improve quality at
every level.
The process to produce a perfect product by a series of measures
require an organized effort by the entire company to prevent.
According to international organization for standards defined
tqm as, “TQM is a management approach for an organization,

Total quality management (TQM) has been defined as an
integrated organizational effort designed to improve quality at
every level.
The process to produce a perfect product by a series of measures
require an organized effort by the entire company to prevent.
According to international organization for standards defined
tqm as, “TQM is a management approach for an organization,

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Total quality management

  1. 1. TOTAL QUALITY MANAGEMENT PRODIPTA CHAKRABORTY DEPT. OF PHARMACEUTICS HIMALAYAN PHARMACY INSTITUTE
  2. 2. Various Definitions Total quality management (TQM) has been defined as an integrated organizational effort designed to improve quality at every level.   The process to produce a perfect product by a series of measures require an organized effort by the entire company to prevent or eliminate errors at every stage in production is called total quality management.  According to international organization for standards defined tqm as, “TQM is a management approach for an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction and benefits to all members of the organization and to the society. 5
  3. 3. Principles of tqm 1. Produce quality work the first time and every time. 2. Focus on the customer. 3. Have a strategic approach to improvement. 4. Improve continuously. 5. Encourage mutual respect and teamwork TOTAL QUALITY MANAGEMENT 9
  4. 4. Characteristics of TQM Committed management.  Adopting and communicating about total quality management. Closer customer relations. Closer provider relations. Benchmarking. Increased training. Open organization Employee empowerment. Flexible production. Process improvements. Process measuring          6
  5. 5. The three aspects of TQM Tools, techniques, and training inCounting their use for analyzing, understanding, and solving quality problems Quality for the customer as a driving force and central concern. Customers Shared expressed values and beliefs, define Culture by leaders, that and support quality. TOTAL QUALITY MANAGEMENT 8
  6. 6. The key elements of the TQM  Focus on the customer.  Employee involvement  Continuous improvement TOTAL QUALITY MANAGEMENT 10
  7. 7. Focus on the customer • It is important to identify the organization’s customers. • External customers consume the organization’s product or service. • Internal customers are employees who receive the output of other employees. TOTAL QUALITY MANAGEMENT 11
  8. 8. Employee Involvement • Since the quality is considered the job of all employees, employees should be involved in quality initiatives. • Front line employees are likely to have the closest contact with external customers and thus can make the most valuable contribution to quality. • Therefore, employees must have the improve quality. authority to innovate and TOTAL QUALITY MANAGEMENT 12
  9. 9. CONTINUOUS IMPROVEMENT The quest for quality is a never-ending process in which people are continuously working to improve the performance, speed and number of features of the product or service. • • Continuous improvement means that small, incremental improvement that occurs on a regular basis will eventually add up to vast improvement in quality. TQM is the management process used to make continuous improvements to all functions. TQM represents an ongoing, continuous commitment to improvement. The foundation of total quality is a management philosophy that • • • supports meeting customer requirements through continuous improvement. TOTAL QUALITY MANAGEMENT 15
  10. 10. Continuous Process Improvement.  View all work as process – production and business.  Process – purchasing, design, invoicing, etc.  Inputs – process – outputs.  Process improvement – increased customer satisfaction.  Improvement – 5 ways:  reduce resources, reduce errors, meet expectations of downstream customers, make process safer, make process more satisfying to the person doing TOTAL QUALITY MANAGEMENT 16
  11. 11. THE TQM SYSTEM Continuous ImprovementObjective Principles Leadership Education and structure Training SupportiveElements Communications recognition Measurement Reward and TOTAL QUALITY MANAGEMENT 17 Custom er Focus Process Improvem ent Total Involvem ent
  12. 12. BENEFITS OF TQM: • • • • • • • • • • Improved quality. Employee participation. Team work. Working relationships. Customer satisfaction. Employee satisfaction. Productivity. Communication. Profitability. Market share. TOTAL QUALITY MANAGEMENT 18
  13. 13. 1. Leadership 2. Customer Satisfaction 3. Employee Involvement 4. Continuous Process Improvement 5. Supplier Partnership 6. Performance Measures
  14. 14.  Top management must realize importance of quality  Quality is responsibility of everybody, but ultimate responsibility is CEO  Involvement and commitment to CQI(continuous quality improvement)  Quality excellence becomes part of business strategy  Lead in the implementation process
  15. 15. 1. Give attention to external and internal customers 2. Empower, not control subordinates. Provide resources, training, and work environment to help them do their jobs 3. Emphasize improvement rather than maintenance 4. Emphasize prevention 5. Encourage collaboration rather than competition 6. Train and coach, not direct and supervise 7. Learn from problems – opportunity for improvement 8. Continually try to improve communications 9. Continually demonstrate commitment to quality 10. Choose suppliers on the basis of quality, not price 11. Establish organisational systems that supports quality efforts
  16. 16. Must begin from top management, most important CEO commitment Cannot be delegated (indifference, lack of involvement cited as principle reason for failure) Top/senior management must be educated on TQM philosophy and concepts, also visit successful companies, read books, articles, attend seminars Timing of implementation – is the org ready, re-organization, change in senior personnel, current crisis – then need to postpone to favourable time Need a roadmap/framework for implementation Formation of Quality Council – policies, strategies, programmes
  17. 17. Quality council job– 1. Develop core values, vision statement, mission statement, and quality policy statement 2. Develop strategic long-term plan with goals and annual quality improvement program with objectives 3. Create total education and training plan 4. Determine and continually monitor cost of poor quality 5. Determine performance measures for the organization, approve them for functional areas, and monitor them. 6. Continually determine projects that improve processes, particularly those affect external and internal customer satisfaction 7. Establish multifunctional project and departmental or work group teams and monitor progress 8. Establish or revise the recognition and reward system to account new way of doing business. Must begin from top management, most important CEO commitment
  18. 18. Customer is always right – in Japan customer is “King” Customer expectations constantly changing – 10 years ago acceptable, now not any more! Delighting customers Satisfaction is a function of total experience with organization Must give customers a quality product or service, reasonable price, on-time delivery, and outstanding service Need to continually examine the quality systems and practices to be responsive to ever – changing needs, requirements and expectations – Retain and Win new customers
  19. 19. Checklist for both internal and external customers 1. Who are my customers? 2. What do they need? 3. What are their measures and expectations? 4. Does my product/service exceed their expectations? 5. How do I satisfy their needs? 6. What corrective action is necessary?
  20. 20. To focus on customer, an effective feedback program is necessary, objectives of program are to: 1. Discover customer dissatisfaction 2. Discover priorities of quality, price, delivery 3. Compare performance with competitors 4. Identify customer’s needs 5. Determine opportunities for improvement
  21. 21.  Warranty cards/Questionnaire  Telephone/Mail Surveys  Focus Groups  Customer Complaints  Customer Satisfaction Index Good experience are told to 6 people while bad experience are repeated to 15 people
  22. 22. People – most important resource/asset Quality comes from people Deming – 15% operator errors, 85% management system Project teams – Quality Control Circles (QCC), QIT Education and training – life long, continuous both knowledge and skills Suggestion schemes; Kaizen, 5S teams Motivational programmes, incentive schemes Conducive work culture, right attitude, commitment
  23. 23. View all work as process – production and business Process – purchasing, design, invoicing, etc. Inputs – PROCESS – outputs Process improvement – increased customer satisfaction Improvement – 5 ways; Reduce resources, Reduce errors, Meet expectations of downstream customers, Make process safer, make process more satisfying to the person doing
  24. 24. Inputs – processing – outputs Input Materials Info, Data People Money Process Work methods Procedures Tools Production – Cutting, Welding, etc. Bank – deposit/withdrawal process, Kad Pintar Application Process at NRD Outputs Products Delivered service In-process jobs – forms signed, drawing completed Others Also by-products, wastes Conditions feedback
  25. 25.  Identify the opportunity (for improvement)  Analyze the current process  Develop the optimal solution(s)  Implement changes  Study the results  Standardize the solution  Plan for the future
  26. 26.  40% product cost comes from purchased materials, therefore Supplier Quality Management important  Substantial portion quality problems from suppliers  Need partnership to achieve quality improvement – long-term purchase contract  Supplier Management activities
  27. 27. Managing by fact rather than gut feelings Effective management requires measuring Use a baseline, to identify potential projects, to asses results from improvement E.g. Production measures – defects per million, inventory turns, on-time delivery Service – billing errors, sales, activity times Customer Satisfaction Methods for measuring Cost of poor quality  Internal failure  External failure  Prevention costs  Appraisal costs
  28. 28.  Award Models (MBNQA, EFQM, PMQA)  Benchmarking – grade to competitors, or best practice  Statistical measures – control charts, Cpk  Certifications ISO 9000:2000 Quality Mgt System ISO 14000 Environmental Mgt System, Underwriters Lab (UL), GMP QS 9000, ISO/TS 16949
  29. 29. Importance of TQM in pharma/TM industry Handling: • Containers should be opened carefully and subsequently resealed in an approved manner. Highly sensitising material should be handled in separate production areas • • • TOTAL QUALITY MANAGEMENT 20
  30. 30. Storage: • Secure storage facilities should be designated for use to prevent damage or deterioration of materials. • These should be kept clean and tidy and subject to appropriate pest control measures. • Environmental conditions should be recorded. • The condition of stored material should be assessed at appropriate intervals. • Storage conditions for api should be based upon stability studies light etc taking into account time, temperature, humidity, TOTAL QUALITY MANAGEMENT 21
  31. 31. Packaging: • Labelling and packaging processes should be defined and controlled to ensure that correct packaging materials are used correctly and other specified requirements are met. • Printed labels should be securely stored to avoid mix-ups arising. • Marking and labelling should be legible and durable, provide sufficient information, for accurate identification and indicate, if appropriate, and/or expiry date. required storage conditions, retest 22
  32. 32. Facilities and equipment: • The location, design, and construction of buildings should be suitable for the type and stage of manufacture involved, protecting the product from contamination (including cross-contamination) and protecting operators and the environment from the product. • Equipment surfaces in contact with materials used in api manufacture should be non-reactive. TOTAL QUALITY MANAGEMENT 23
  33. 33. Sterile area • Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should avoid API. activities which could compromise the quality of • Smoking, eating, drinking, chewing and storage of food should be restricted to designated areas separated from production or control areas. TOTAL QUALITY MANAGEMENT 24
  34. 34. Computerised systems • . Computer systems should be designed and operated to prevent unauthorised entries or changes to the programme. • In the case of manual entry of quality should be a second independent check of the initial entry. critical data there to verify accuracy • A back-up system should be provided of all quality critical data. TOTAL QUALITY MANAGEMENT 26
  35. 35. Labelling • Each container should be identified by an appropriate label, showing at least the product identification and the assigned batch code, or any combination of both. other easily understandable • . Containers for external distribution may require additional labels. TOTAL QUALITY MANAGEMENT 25
  36. 36. Advantages of tqm • Improves reputation- faults and problems are spotted and sorted quicker. • Higher employee morale- workers motivated by extra responsibility ,team work tqm. and involvement indecisions of • Lower cost. • Decrease waste as fewer defective products and no need for separate. Helps to face competition Reduction in Customer complaintsTOTAL QUALITY MANAGEMENT 27
  37. 37. Disadvantages of tqm • Initial introduction cost. • Benefits may not be seen for several years. • Workers may be resistant to change. TOTAL QUALITY MANAGEMENT 28
  38. 38. A model for organization management. TOTAL QUALITY MANAGEMENT 29
  39. 39. Models of tqm TOTAL QUALITY MANAGEMENT 30
  40. 40. BENEFITS OF TOTAL QUALITY MANAGEMENT Financial benefits include lower costs, higher returns on sales and• investment, and the competitive prices. ability to charge higher rather than • Improved access to global markets, higher customer retention levels, less Time required to develop new innovations, and a reputation as a quality firm. Total quality management (tqm) is one such approach that seeks to improve quality and Performance which will meet or exceed customer expectations. • • • TOTAL QUALITY MANAGEMENT 31
  41. 41. CONCLUSION: • TQM encourages participation amongst employees, managers and organization as whole. Using Quality management reduces rework nearly to zero in an achievable goal .The responsibilities either its professional, social, legal one that rest with the pharmaceutical manufacturer for the assurance of quality of product are tremendous and it can only be achieved by well organised. Work culture and complete engagement of the employees at the work place. It • • should be realised that national & international regulations must be implemented systematically and process. Control should be practiced rigorously. Thus quality is critically important ingredient to organisational success today which can be achieved by TQM, an organisational approach that focusses on quality as an over achieving goals, aimed at aimed at the prevention of defects rather than detection of defects.. • • TOTAL QUALITY MANAGEMENT 32

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