Quality assurance and quality management concepts.pptx

UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies

1. Quality assurance and quality management concepts unit I Present By- Gayatri K. Bahatkar Assistant professor

2. INDEX Definition concept of Quality control Quality assurance and GMP Total Quality Management (TQM): Definition Elements Philosophies

3. 1.1 CONCEPT OF QUALITY The dictionary meaning of 'Quality' is 'the standard of something when it is compared to other things.  ISO (International Organization for Standardization) defines quality as 'the totality of features and characteristics of a product or service that bears on its ability to meet a stated or implied need. The meaning of the quality could be understood from two perspectives: Manufacturer's perspective and Consumer's perspective. From the Manufacturer's Perspective, the quality is to conform to the specifications. The consumer's perspective is to consider quality characteristics with price considerations. Getting maximum quality features while having a price as the focus point is the motto of maximum consumers.

4. Historical Philosophies of Quality Walter A. Shewhart , W. Edwards Demin , Joseph M. Juran , Armand Feigenbaum , Philip Crosby, Genichi Taguchi, Kaoru Ishikawa have been identified as making a significant contribution to improving the quality of goods and services. All these have put their philosophies of quality with some common points below: ✓ Inspection is never the answer to quality improvement, nor is "policing". ✓ Involvement of leadership and top management is essential to the necessary culture of commitment to quality. ✓ A program for quality requires organization-wide efforts and long term accompanied by the necessary investment in training. ✓ Quality is first and schedules are second. As per Philip Crosby, Quality is defined as conformance to requirements, neither a ‘goodness’ nor ‘Elegance’.

5. Crosby’s Five Absolutes of Quality: Quality is defined as conformance to requirements, not as ‘goodness’ or ‘elegance’ There is no such thing as a quality problem. It is always cheaper to do it right the first time. The only performance measurement is the cost of quality. The only performance standard is zero defects Crosby suggests that 80 percent of quality problems are within the control of management.

6. Methods for Quality Improvement: Step 1 Establish management commitment. Step 2 Form quality improvement teams.. Step 3 Establish quality measurements. Step 4 Evaluate the cost of quality. Step 5 Raise quality awareness. Step 6 Take actions to correct problems Step 7 Zero defects planning.

7. Step 8 Train supervisors and managers. Step 9 Hold a ‘Zero Defects’ day to establish the attitude and expectation within the company. Step 10 Encourage the setting of goals for improvement. Step 11 Obstacle reporting. Step 12 Recognition for contributors. Step 13 Establish Quality Councils. Step 14 Do it all over again.

8. As per Armand V. Feigenboum , Quality is simply a way of managing a business organization. Four Steps to Quality: Step 1 Set quality standards. Step 2 Appraise conformances to standards. Step 3 Act when standards are not met. Step 4 Plan to make improvements.

9. Feigenbaum’s 10 benchmarks for total quality success: Quality is a company-wide process. Quality is what the customer says it is. Quality and cost are a sum, not a difference. Quality requires both individual and team zealotry. Quality is a way of managing. Quality and innovation are mutually dependent. Quality is an ethic. Quality requires continuous improvement. Quality is the most cost-effective, least capital-intensive route to productivity. Quality is implemented with a total system connected with customers and suppliers.

10. As per Kaoru Ishikawa who is a ‘Father of Quality Circles’ and as a founder of the Japanese quality movement quality approaches include ; An atmosphere where employees are continuously looking to resolve problems Greater commercial awareness; A change of shop floor attitude is aiming for ever-increasing goals.

11. Seven tools of Quality control by Kaoru Ishikawa: TOOL 1 Pareto charts: Used to identify the principal causes of problems. TOOL 2 Ishikawa/fishbone diagrams: Charts of cause and effect in processes. TOOL 3 Stratification Layer charts which place each set of data successively on top of the previous one. TOOL 4 Check sheets: To provide a record of quality TOOL 5 Histograms Graphs used to display the frequency of various ranges of values of quality. TOOL 6 Scatter graphs Used to help determine whether there is a correlation between two factors. TOOL 7 Control charts Used as a device in statistical Process Control.

12. 1.2 QUALITY ASSURANCE Quality Assurance (QA) is a management method that is defined as “all those planned and systematic actions needed to provide adequate confidence that a product, service or result will satisfy given requirements for quality and be fit for use”. As per WHO (World Health Organization), QA is a wide-ranging concept consisting all matters that individually or collectively, directly or indirectly 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. QA, therefore, Pharmacy incorporates GMP (Good Manufacturing Practices) and other factors, including product design and development.

13. Components of Quality Assurance: Strategic or Organizational Level: This level deals with the quality policy, objectives and management and usually produced as the Quality Manual. Tactical or Functional Level: This deals with general practices such as training, facilities, operation of QA. Operational Level: This deals with the Standard Operating Procedures (SOPs), worksheets and other aspects of day to day operations.

14. Quality Assurance, therefore, incorporates GMP and other factors such as product design and development. Quality Assurance applicable for manufacturing should ensure that: All pharmaceutical products developed as per GMP, GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) requirements. Production and control operations comply with GMP. Job responsibilities are clearly defined. Material management and appropriate controls for the same are in place. Finished product release is done in compliance with GMP requirements and with authorized approvals.

15. Quality of the product is maintained throughout the shelf life. Good documentation practices are implemented and followed. SOPs for self-inspections, handling deviations, rejects, recalls etc. are in place. Investigation processes are followed properly. Regular evaluation of products is done to ensure consistent quality products and continuous improvement .

16. The manufacturer should own the responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of The marketing authorization without any adverse or unwanted reactions on a patient. Though the senior management is responsible for the implementation of GMP for attaining good quality products, commitments from the staff of all levels, suppliers, as well as distributors, also are also very important aspects. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. It should be fully documented and its effectiveness should be monitored.

17. 1.3 GOOD MANUFACTURING PRACTICES (GMP) FOR PHARMACEUTICAL PRODUCT As per WHO, Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are followed to eliminate the risks associated with the quality of the product ex. Cross-contaminations, mix-ups as well as reasons causing the same. 

18. A. Clearly defined and systematically reviewed manufacturing processes: All batch documentation All Quality specification All relevant SOPs

19. B. Critical steps of production processes are validated: Process design Identification of process variables Control strategy Process qualification Process monitoring need for improvement PROCESS VALIDATION

20. C. Appropriate resources: personnel, buildings, equipment, and materials are available to produce a quality product: This means that the company has evaluated all of the elements It needs to produce a product and has sufficient resources of the right quality for its production. D. Manufacturing is based on clearly written procedures: The procedures referred to here include the batch manufacturing and testing instructions and the SOPs needed for every department. E. Operators are trained: A company can have “all the documentation in the world” but if its operators are not properly trained to carry out the tasks that they are supposed to perform then the company will not be successful.

21. 1.4 QUALITY CONTROL (QC) As per WHO, “QC is the part of GMP concerned with sampling, specifications, testing, organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out and that the materials are neither released for use nor products released for sale or supply until their quality has been satisfactory. QC is not confined laboratory operations but must be involved in all decisions concerning the quality of the product” Each manufacturing company should have a separate quality control department. The independence of quality control from production is considered fundamental. The quality control department should be independent of other departments and under the authority of a person with appropriate qualifications and experience.

22. The QC department must have adequate resources such as adequate laboratory facilities or access to them e.g. government or contract laboratories, appropriately qualified, trained and experienced personnel and approved written procedures ex. Specifications QC labs should have minimum following departments: Chemical testing laboratory with adequate chemicals and glassware. Instrument analysis lab with adequate type and number of analytical instruments. Microbiology laboratory with facility for microbial testing and sterility testing it required.  Documentation room. Retained sample room with suitable environmental conditions.

23. Components of QC Department: QC department is responsible for inspecting, analytical testing, monitoring of all materials and environmental conditions in the factory, releasing or rejecting materials for production use and finished products related to starting materials, packaging materials, intermediates, bulk products, and finished products. Sampling should be undertaken by methods and personnel approved by the QC department in accordance with approved SOP. QC personnel must have access to the production area to undertake to sample when necessary. All test methods applied for testing should be validated for accuracy, precision, linearity, repeatability, robustness, specificity. Records for sampling, inspecting, testing of materials, intermediates and bulk and finished products need to be kept for traceability .

24. The QC department should review and evaluate the relevant production documentation in terms of quality. All documents should be approved by QC to ensure manufacturing documentation and quality assurance documentation in harmony. Records for deviations and failure investigations should be generated wherever necessary and should be reviewed by the QC department. Deviations hampering product quality need to properly investigated and appropriate action needs to be taken. The finished product should comply with the qualitative and quantitative composition of the product and should be in appropriate container closure as mentioned in marketing authorization. Assessment of finished products should embrace all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packing), documentation, compliance with the specification for the finished product, and an examination of the finished pack

25. Successful quality control also requires that: Materials used for manufacturing are of the required purity. Proper containers are used for finished product packing. Labeling of in-house materials and the finished product is correct. Batches are released by the authorized person.  Samples of starting materials and products and retained.

26. In addition to those already mentioned, the QC department has other duties to carry out, including: Establishing, validating and implementing all QC procedures. Evaluating, maintaining, storing reference standards  Ensuring correct labeling of containers of materials and products.  Stability testing of active ingredients and finished products. Participating in complaint investigations. Participating in environmental monitoring

27. TOTAL QUALITY MANAGEMENT (TQM ) Quality management is defined as “the aspect of management function that determines and implements the ‘quality policy,’ i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management”. Quality cannot be built just by testing, but it should be ensured at every stage of manufacturing i.e. starting from purchasing the right material to its manufacturing and storage. For building quality in product, controls need to be implemented at each stage related to manufacturing activity. Below are some basic elements of quality management: ✓ The infrastructure supporting quality management i.e. Quality system. ✓ Systemic plan and actions to execute planning for manufacturing quality product.

28. Objectives of Quality Management To provide quality medicine. To minimize defects in product which may lead to recall or rejection. To increase productivity keeping quality intact. To handle all changes in manufacturing facility without affecting the quality of the product.

29. Quality Management System (QMS) is defined as “the process of systems of an organization with regard to its quality related activities for enhancing customer satisfaction and also taking care of all other interested parties such legislative and regulatory bodies, shareholders, suppliers, employees etc.” With the respect to QMS, the ISO 9000 is a family of standards comprising: ISO 9000: 2000 provides fundamentals and vocabulary for QMS. ISO 9001: 2000 introduces QMS and its requirements to address customer satisfaction. Provides requirements for compliance with standards. 1S0 9004:2000 provides guidelines for continuous performance improvements for QMS ISO 9001: 2000 is the most comprehensive standard in the series: It specifies system requirements in purchase, design and development, production, installation and servicing ISO 9000: 2000 and 1S0 9004 2000 provide guidelines for the achievement the standards. Certificates to the organizations are issued based on this standard.

30. Quality Management which is one of the five sections of ISO 9001: 2000 has below Objectives: To consistently meet customer requirements. To achieve customer satisfaction. To enhance market share. To sustain market share. To improve communications and morale in the organization. To reduce costs and liabilities. To increase confidence in the production system.

31. Total Quality Management (TQM ) Total quality management (TQM) is a management approach towards quality for long term success through customer satisfaction. In a TQM effort, all members of an organization participate in improving processes, products, services, and the culture in which they work . Total Quality Management is mainly concerned with continuous improvement in all work It is a long term planning. It is the consistent improvement in quality. It is a never-ending process . Total Quality Management consists of three words : Total: Make up of the whole . Quality: Degree of excellence a product or service provides . Management: Process of planning, organizing, directing and controlling.

32. TQM is relatively new concept of quality control. It is basically, a management function involving the direction of top management and co-ordination of all quality-related activities throughout the company to achieve Zero defects and customer satisfaction. Since quality is a measure of the users satisfaction provided by the product, it should include   Functional efficiency Appearance. Ease of installation and operation . Safety . Reliability. Maintainability. Running and maintenance cost . In TQM quality awareness begins at the very conception of the product and continues throughout the various stages of its development and manufacture and even its usage to provide feedback from the users which is essential for quality improvement.

33. Elements of TQM : Total quality is a description of culture, attitude and organization of a company that strives to provide customers product and services that satisfy their needs . To successful implementation of TQM an organization must concentrate on 8 key Elements : ✓ Ethics ✓ Integrity Trust Training Team work Leadership ✓ Recognitions ✓ Communications

34. TQM Approach : TQM can be summarized as a management system for a customer-focused organization that involves all employees in continual improvement. It uses strategy, data, and effective communications to integrate the quality discipline into the culture and activities of the organization . Below are three major elements for the TQM approach . Customer-focused: The customer ultimately determines the level of quality so it is always beneficial to recognize customer requirements toward product quality . Total employee involvement: Building quality in product is not single persons job, all employees should participate in working toward common goals. Management has to provide a favorable environment at workplace to achieve every employee’s commitment towards common goal.

35. Continual improvement: This is very important and large concept of TOM Continual improvement drives an organization to become more competitive and more effective at meeting customer expectations . Other than these elements, effective communication, strategic and systematic approach facts based decision making also can be of help for implementing TQM . Total quality management helps in higher productivity, strengthening competitive Position, cost reduction, higher profitability, cost management, increased customer focus etc. Six Sigma, ISO 9001, lean manufacturing are some of the examples of the strategies of TQM.

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