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RAJ QMS 1.pptx
- 1. Basics Of QualityManagement. Total Quality Management. Principles Of Six Sigma SUBMITTED BY, RAJ PATIL QUIDED BY, FIRST YEAR M.PHARMACY ( QAT ) K.V.DHAMAK DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE PRAVARA RURAL COLLEGE OF PHARMACY SEMESTER 1 ROLL NO : 13 PRAVARA RURAL COLLEGE OF PHARMACY
- 2. Contents Quality ManagementSystem Basics Of Quality Management System Dimension Of Quality Scope Of Pharmaceutical QMS Introduction Of Total Quality Management (TQM) Total Quality Management and Continuous Improvement:- Six SIGMA Principal OF Six SIgma
- 3. Quality Management System(QMS) Quality Management System (QMS) is an important aspect for the pharmaceutical industry for maintaining the quality and safety for their products and services. QMS relies on the regulations and guidelines to maintain the effective quality in pharmaceutical industries. According to US FDA, the international harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry. This guidance is referred as ICH (International Council for Harmonization) guideline. Quality:- Quality can be defined according to US FDA as; "A measure of a product's or service's ability to satisfy the customer's stated or implied needs."
- 4. Basics of qualitymanagement system Quality word oriented from Latin word 'Qualitus' it means General excellence OR distinctive feature. Quality- a standard of how good something is as measured against other similar things.(by OXFORD dictionary) If we try to analyse definition some common words like...
- 5. 1. Standard 2. Measurement 3. Goodness 4. comparison Most simple definition of quality is 'fitness for use' The customer or user is at focus. if customer or user is happy and satisfied with our product or service then product or service is called good quality. It must be remember that the quality is not the job of only a single person or single department but, it is responsibility of whole organization. Quality of Product and service is measurable, managerial, technological and stastical feature of organization.
- 6. Dimension Of Quality Performance Feature Reliability Key Dimensions of Quality Perceived quality Aesthetics Durability Conformance Serviceability
- 7. Quality Assurance(QA):- According to WHO, QA 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. Quality assurance therefore incorporates GMP and other factors. including those outside the scope of this guide such as product design and development. Quality Control (QC):- QC is that part of GMP concerned with sampling, specification, testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining its quality.
- 8. Scope of PharmaceuticalQMS:- 1. Phamaceutical Development:- Drug substance development. Formulation development (including container/closure system). Manufacture of investigational products. Delivery system development (where relevant). Manufacturing process development and scale-up. Analytical method development. 2. Technology Transfer: New product transfers during development through manufacturing. Transfers within or between manufacturing and testing sites for marketed product
- 9. Introduction:- Total-Made upof the whole (or) Complete. Quality-Degree of Excellence a product or service provides to the customer in present and future. Management -Act, art, or manner of handling, controlling, directing, etc. TQM is the art of managing the whole to achieve excellence Definition:- "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 society."
- 11. Characteristics : •Technological strength, hardness, •Time - oriented, Reliability, maintainability - availability •Contractual Guarantee Six basic concepts of TQM:- 1. A committed and involved management to provide long term top - to - bottom organization support. 2. An unwavering focus on the customer, both internally and externally. 3. Effective involvement and utilization of the entire work force. 4. Continuous improvement of the business and production 5. Treating suppliers of the business and production process. 6. Establishing the performance measures
- 12. Total Quality Managementand Continuous Improvement:- 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.
- 13. What is sixsigma..???? Six sigma is a business statistical Strategy. Is to identifying defects and removing them from the process of products to improve quality. A defect is defined as any process output that does not meet customer specifications. Statistical measure to objectively evaluate processes.
- 14. History of sixsigma The Six sigma was founded by Motorola in the 1970s. Out of senior executive Art Sundry's criticism of Motorola's bad quality. They founded a connection between increases in quality and decreases in costs of production. Bill Smith, "Father of six sigma" introduce this quality improvement Methodology to Motorola
- 15. Six Sigma Definition Quality management program developed by Motorola in the 1980s. • Management philosophy focused on business process improvements to: ✓Eliminate waste, rework, and mistakes ✓Increase customer satisfaction ✔Increase profitability and competitiveness
- 16. Six Sigma Methods DEFINE DEFINE MEASURE MEASURE ANALYZE ANALYZE IMPROVE DESIGN CONTROL VERIFY DMAIC DMADV
- 17. Objective Of SixSigma
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- 19. Six Sigma Technique Define process goals in terms of key critical parameters (i.e. critical to quality or critical to production) on the basis of customer requirements or Voice Of Customer (VOC) Measure the current process performance in context of goals Analyze the current scenario in terms of causes of variations and defects Improve the process by systematically reducing variation and eliminating defects Control future performance of the process
- 20. Principles of SixSigma There are 5 key principles of Six Sigma:
- 21. 1. Focuson Customer Requirements: The initial phase in Six Sigma process is defining the "quality" from the point of customers. Every customer defines quality differently. A business needs to measure quality in a similar way its customers do. By addressing the needs of the customer business can define the quality to the customer.
- 22. 2. Use datato identify the variation in the process: Variations in the process are of two types; Special cause variation and Natural variation. Special cause variation is caused by external factors. Natural variation is random variation present in the process. Six Sigma aims to reduce the special cause variation. To identify the root cause of the variation, understating the process is necessary. The understanding of the process should be deep and extensive. To collect detailed data:
- 23. Define thegoals for data collection clearly Identification of the data. Define the reason for the data collection Define the expected insight Define the data collection method Eliminate the error in the data collection Data collection in the Six Sigma process includes interviewing with people, taking observations, and asking questions. Once the data collection is finished, check whether the collected data gives the required knowledge to meet the objectives which were set up. If not, repeat the data collection plan and get more information
- 24. The processis repeated to find answers. Identify the potential root causes for the variation in the process and try to eliminate it with the help of collected data. After identifying the potential root causes, analyze it. To identify the significant root cause that makes the variation, use Statistical analysis.
- 25. 3. Continually improvingthe process to eliminate the variation: After identifying root causes, make changes to eliminate variation in the process. Thus the defects in the process are removed. Additionally, search for ways to remove steps that do not add value to the customer. This will eliminate waste in the process. Identify variation and eliminate it. Don't wait for the variation to show itself. Collect data, talk to people, and study the data to identify variations in the process. variation may have become the routine because "that's the way we've always done things."
- 26. 4. Involve peoplefrom different levels of management and process: Six Sigma is formed on the foundation of good teams. The good teams comprise of peoples who take responsibility for the Six Sigma processes. The people on the team need training in Six Sigma's methods. Forming a cross- functional team with peoples from different backgrounds will help identify variation. For example, six sigma team from health care project consists of top management people, doctors, nurses, managers, people from operations and purchasing.
- 27. 5. Be flexibleand thorough: Six Sigma requires adaptability from various points of view. The business's management system needs to acknowledge positive changes. People should be motivated to accept the changes in the system to eliminate the variation. To motivate the employee, the benefits of the six sigma system should be made clear to all levels of employees. This will make the changes easily acceptable. Six Sigma also requires reducing variation to be thorough. So understand all the aspects of a process the steps, stakeholders, and methods involved. This will help to ensure that any new or updated process works.
- 28. Importance of SixSigma Principles: Six Sigma is such a popular approach for process management as it forms a way through which one can improve their processes. It is centrally a customer and product-driven approach. The main purpose of this approach is to avoid waste and delivering the product by meeting all the requirements of the customer thereby increasing customer satisfaction To accurately analyze the process, Six Sigma requires precise data. The below goals also known as business success facts can be achieved by implementing Six Sigma in a company.
- 29. Importance of SixSigma Principles Increased Quality Increased Productivity Reduced Operation Cost High Customer Satisfaction Improved Employee Morale Efficient Work environment
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