Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP

Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP

1. Quality Assurance & Quality Management concepts Dr Bindiya Chauhan Pharmaceutical Quality Assurance SGT University

2. Quality is: Fitness for use Conformance to requirements Degree of excellence Performance exceeding expectations ‘The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs’ Quality Assurance – One can define quality assurance in variety of ways. In simple term Quality Assurance is nothing but checking of quality at each and every stages of manufacturing starting from raw material procurement to the finished product distribution with reviewing each and every type of fine documents of the same.

3. Quality systems are methodologies in which a manufacturer must establish and follow a system to ensure that their products consistently meet applicable requirements and specifications. Uncommon/rare definition of Quality: excellence Product-based definition: quantities of product attributes User-based definition: fitness for intended use ; meeting or exceeding user expectations Value-based definition: quality vs. price Manufacturing-based definition: conformance to specifications

4. Quality Management concepts Quality Control Quality Assurance Inspection/ Audit Total Quality Management

5. BASIC COMPONENTS OF Quality Management Quality management ensures that an  organization , product or service is consistent. It has  four  main components: Quality planning Quality assurance Quality control Quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it.

6. Total Quality Management (TQM)

7. BASIC CONCEPTS OF TOTAL QUALITY MANAGEMENT What is TQM? A system of management based on the principle that every member of staff must be committed to maintaining high standards of work in every aspect of a company's operations. Total Quality Management is a management framework based on the belief that an organization can build long-term success by having all its members, from low-level workers to its highest ranking executives, focus on quality improvement and, thus, delivering customer satisfaction. In a TQM effort, all members of an organization participate in improving processes, products, services, and the culture in which they work.

8. Total Quality Management is an enhancement of the traditional way of doing business. It is a proven technique to guarantee survival in world class competition .. The words Total Quality Management stand for- Total – Made up of the whole; Quality – Degree of excellence a product or service provides; Management – Act, art or manner of handling, controlling, directing etc. Total quality management can be summarized as a management system for a customer-focused organization that involves all employees in continual improvement . BASIC CONCEPTS OF TOTAL QUALITY MANAGEMENT

9. BASIC CONCEPTS OF TOTAL QUALITY MANAGEMENT Therefore total quality management is the art of managing the whole to achieve excellence . It is defined as both a philosophy and a set of guiding principles that represent the foundation of a continuously improving organization. It is the application of quantitative methods and human resources to improve all the processes within an organization and exceed customer needs now and in the future. It combines fundamental management techniques, existing improvement efforts and technical tools under a disciplined approach.

10. T he 8 Primary Elements of TQM It uses strategy, data and effective communications to integrate the quality discipline into the culture and activities of the organization. Here are the 8 principles of total quality management: 1. Customer focused 2. Total employee involvement 3. Process-centered 4. Integrated system 5. Strategic and systematic approach 6. Continual improvement 7. Fact-based decision making 8. Communications

11. T he 8 Primary Elements of TQM 1. Customer-focused The customer ultimately determines the level of quality . No matter what an organization does to foster quality improvement—training employees, integrating quality into the design process, upgrading computers or software, or buying new measuring tools—t he customer determines whether the efforts were worthwhile. 2. Total employee involvement All employees participate in working toward common goals . Total employee commitment can only be obtained after fear has been driven from the workplace, when empowerment has occurred, and management has provided the proper environment. High-performance work systems integrate continuous improvement efforts with normal business operations. Self-managed work teams are one form of empowerment.

12. T he 8 Primary Elements of TQM 3. Process-centered A fundamental part of TQM is a focus on process thinking . A process is a series of steps that take inputs from suppliers (internal or external) and transforms them into outputs that are delivered to customers (again, either internal or external). The steps required to carry out the process are defined, and performance measures are continuously monitored in order to detect unexpected variation. 4. Integrated system (the process of bringing together the component sub system into one system) Although an organization may consist of many different functional specialties often organized into vertically structured departments , it is the horizontal processes interconnecting these functions that are the focus of TQM. Every organization has a unique work culture, and it is virtually impossible to achieve excellence in its products and services unless a good quality culture has been fostered. Thus , an integrated system connects business improvement elements in an attempt to continually improve and exceed the expectations of customers, employees, and other stokeholders .

13. T he 8 Primary Elements of TQM 5. Strategic and systematic approach A critical part of the management of quality is the strategic and systematic approach to achieving an organization’s vision, mission, and goals. This process, called strategic planning or strategic management, includes the formulation of a strategic plan that integrates quality as a core component. 6. Continual improvement A major thrust of TQM is continual process improvement. Continual improvement drives an organization to be both analytical and creative in finding ways to become more competitive and more effective at meeting stakeholder expectations.

14. T he 8 Primary Elements of TQM 7. Fact-based decision making In order to know how well an organization is performing, data on performance measures are necessary. TQM requires that an organization continually collect and analyze data in order to improve decision making accuracy, achieve consensus, and allow prediction based on past history. 8. Communications During times of organizational change, as well as part of day-to-day operation, effective communications plays a large part in maintaining morale and in motivating employees at all levels . Communications involve strategies, method, and timeliness. These elements are considered so essential to TQM

15. 7 PRINCIPLES OF TQM 1. Quality can and must be managed The base of TQM is quality that intern affect customer satisfaction. The quality must be managed throughout the process. 2. Processes, not people, are the problem If your process is causing problems, it won’t matter how many times you hire new employees or how many training sessions you put them through. Correct the process and then train your people on these new procedures. 3. Don’t treat symptoms, look for the cure If you just patch over the underlying problems in the process, you will never be able to fully reach your potential. If, for example, your shipping department is falling behind, you may find that it is because of holdups in manufacturing. Go for the source to correct the problem.

16. 7 PRINCIPLES OF TQM 4 . Every employee is responsible for quality Everyone in the company, from the workers on the line to the upper management, must realize that they have an important part to play in ensuring high levels of quality in their products and services. Everyone has a customer to delight, and they must all step up and take responsibility for them. 5. Quality must be measurable A quality management system is only effective when you can quantify the results . You need to see how the process is implemented and if it is having the desired effect . This will help you set your goals for the future and ensure that every department is working toward the same result.

17. 7 PRINCIPLES OF TQM 6. Quality improvements must be continuous Total Quality Management is not something that can be done once and then forgotten. It’s not a management “phase” that will end after a problem has been corrected. Real improvements must occur frequently and continually in order to increase customer satisfaction and loyalty. 7. Quality is a long-term investment Quality management is not a quick fix. You can purchase QMS software that will help you get things started, but you should understand that real results won’t occur immediately. TQM is a long-term investment, and it is designed to help you find long-term success.