Quality Related Concepts And Quality Systems PDF

QUALITY-RELATED CONCEPTS AND QUALITY SYSTEMS QUALITY What does quality mean to you?  DEFINITION OF QUALITY QUALITY Websters Dictionary "Degree of Excellence" Turkish Language Association Dictionary "Qualification" Dr. Juran "fitness for use" Dr. Deming "meeting the cu...

QUALITY-RELATED CONCEPTS AND QUALITY SYSTEMS QUALITY What does quality mean to you?  DEFINITION OF QUALITY QUALITY Websters Dictionary "Degree of Excellence" Turkish Language Association Dictionary "Qualification" Dr. Juran "fitness for use" Dr. Deming "meeting the customer's current and future needs" For the development engineer "superior design", For the manufacturing engineer "fitness for a particular design"  DEFINITION OF QUALITY QUALITY is the degree of suitability for purpose. The purpose is determined according to the needs and payment possibilities of the person who will use the goods. pasteurized milk and sterilized milk  DEFINITION OF QUALITY In order to talk about the quality of a product its function or intended use and its price must be taken into consideration.  The degree to which a product meets the needs and wants of a specific consumer group FACTORS - market quality USED TO The degree to which a product meets the DETERMIN potential needs of consumers in general - design quality E THE QUALITY The degree to which the quality of a product at the time of manufacture conforms to the LEVEL OF quality level designed for it - conformity quality THE The degree to which a product has a PRODUCT preference over equivalent products produced by other firms based on consumer experience - consumer preference  Sensory properties of a food product such as appearance, texture, flavor FACTORS Various quality characteristics of food USED TO products DETERMINE Safe use periods of foods - shelf life THE QUALITY Design and manufacturing costs LEVEL OF Production methods and technological THE possibilities PRODUCT Service requirements and costs  QUALITY Quality is the sum of the characteristics of a product or service based on its ability to meet the determined and possible needs (TS-EN-ISO 9000 2008) A product or service is the result of an activity or process (a tangible product, such as canned food or an electronic device; a service is an intangible product, such as a computer program, a design, or a user manual) or an activity or process (a service preparation or a production) Needs usually characteristics within specified criteria (specifications) Needs may include usability, safety, availability, reliability, maintainability, economy and environmental aspects.  QUALITY The concept of quality is generally thought of as a perfect product or service that will meet or exceed expectations. These expectations are generally thought of in terms of intended use and sales price. For example; the characteristics that a consumer wants to have in pasteurized and sterilized milk are different, this is because these foods are produced for different purposes.  QUALITY FORMULA Q=P/E Q = QUALITY P = PERFORMANCE E = EXPECTATIONS If Q ≥ 1; expectations of the customer are met and the quality of the product or service is good  DIMENSIONS OF QUALITY Dimension Meaning and example Performance Primary product characteristics Features Secondary characteristics Conformance Meeting specifications or industry standards Reliability Consistency of performance over time (shelf-life) Durability Useful life, includes repair Service Resolution of problems and complaints Response Human to human interface (courtesy of the dealer) Aesthetics Sensory characteristics Reputation Past performance (such as being ranked first)  DESIGN QUALITY Design quality is designed together with Cost of Quality the quality characteristics and Value of Cost performance features of the product. (TL) Quality Maximum Profit Determining the most appropriate Manufacturer's design quality for a product is carried profit out by finding the optimum point between the value of quality for the Maximum Profit consumer and the cost to the A Q B Quality level manufacturer. QUALITY OF CONFORMANCE Quality of conformance is a concept that shows the degree of compliance with the specifications determined by design quality during production. The measure of conformance quality is also expressed as the percentage of defective goods. As the effectiveness of quality control increases, in other words, as the percentage of parts that comply with the designed quality specifications increases or as the proportion of defective parts decreases, the material and labor losses caused by defective goods, repair costs and consumer complaints also decrease. On the other hand, as the intensity of measurement, evaluation and protection activities increases, their costs also increase.  HISTORICAL DEVELOPMENT OF THE UNDERSTANDING OF QUALITY TOTAL QUALITY MANAGEMENT TOTAL QUALUTY CONTROL STATISTICAL INSPECTION FOREMAN OPERATOR 1900 1918 1937 1960 1980  WHY WAS TOTAL QUALITY CONTROL STAGE NECESSARY ? In statistical quality control stage or up to this stage only the final product was controlled. Even though the quality of the final product could be determined with improved methods there isn’t any solution to change the quality of this product, and it is hard to find a market for this product. However in total quality control stage, control begins with the raw material, it continues throughout the process and it ends when the product is in the hands of the consumer. In the total quality control system control starts with the identification of customer requirements and ends only when the product is placed in the hands of a customer who is satisfied.  TOTAL QUALITY MANAGEMENT SYSTEM After the 1980s, the concept of Total Quality Control began to be called Total Quality Management (TQM) in order to better express the approach of not only controlling quality but also creating, sustaining, producing and managing it. TQM is a company-wide system that covers all areas, from the general manager to the workers and all employees, where everyone is responsible for the quality of their own activities.  One of the most important points in TQM is to train the human factor. For this reason, education is of great importance. TQM is a group effort and is not an activity that can be carried out TOTAL individually. QUALITY MANAGEMEN T SYSTEM In this system, everyone from the top manager to the lowest level works towards the same goal.  TOTAL QUALITY MANAGEMENT SYSTEM TQM is a participatory management style. Employees participate in management, express their ideas, make suggestions and thus problems are solved more quickly. In this way, quality and work safety increase, costs decrease and as a result, the increased company profitability is reflected in the working conditions of the employees and the system develops as a whole. TQM is also consumer-oriented. Here, the main task of the organization is to provide service in line with the needs of the consumer and to produce a product that will satisfy the consumer.  TOTAL QUALITY MANAGEMENT SYSTEM TQM is a quality approach and management method in which planned, programmed, dynamic, knowledge-based, measurement and statistics-based problem-solving techniques are used and in a continuous development process. This continuous development idea called KAIZEN was first put forward by W.A.Shewhart in the form of PDCA (plan- do-check-act) cycle and this idea was transferred to the Japanese by E.Deming in the 1950s. PDCA (plan-do-check-act) cycle  TOTAL QUALITY MANAGEMENT SYSTEM While implementing KAIZEN, the Japanese have shown more development compared to the West, not with the size of the leaps, but with their frequency. The fact that the steps are more frequent and smaller causes the entire organization to integrate with the developments and gains continuity. In the classical management approach, since leaps are dependent on major technological advances, they can only be realized by a limited circle and the developments do not spread to the base.  TOTAL QUALITY MANAGEMENT SYSTEM TOTAL = Everyone must be involved in quality activities from the office level, through the factory floor, warehouse, marketing and sales, suppliers and customers QUALITY = The uniform level of quality to meet the expectations of customers MANAGEMENT = The way we act and work with our employees, our equipment, our processes, our suppliers, our customers and our public TQM “managing the whole to achieve perfection”  TQM includes 6 core concepts: A top management that is ready to provide long- term top-down support Conscious attention to consumer needs TOTAL QUALITY Effective participation of the entire workforce in management MANAGEME Continuous improvement of business and production NT SYSTEM processes Considering suppliers as partners Development of performance measures for operations  TOTAL QUALITY MANAGEMENT SYSTEM The aim of TQM is to provide a quality product to the consumer and in return to increase efficiency while reducing costs. By obtaining a high quality and low cost product, the organization's competitive power in the market will increase and the organization will be able to easily achieve its goals in terms of profit and development. A satisfactory work environment will be created by providing security in terms of work. TQM is a management philosophy that requires a cultural change.  TOTAL QUALITY MANAGEMENT SYSTEM The TQM system is a model that values ​people. It is stated that people are the most important elements that provide benefits in an organization and that all the differences in the world are caused by people. This difference occurs depending on the desires and wishes of the employees in their jobs. People run businesses and produce products that are acceptable to the consumer. 96% of people who need help, guidance and often motivation to progress want to be better. For this purpose, the provision of the right environmental-education services and good management are required.  TOTAL QUALITY MANAGEMENT SYSTEM Within this management approach, an organization that truly wants to be more successful must first help its employees succeed. Total quality management can be likened to a team sport that includes all elements of a business. In this system, “quality is everyone’s job, but the interaction of different talents is necessary for success.” Management must understand the quality technology that includes statistical thinking and also benefit from statistical process control tools.  ISO-9000 QUALITY ASSURANCE STANDARDS The 9001, 9002 and 9003 TS-EN-ISO 9004:2000 was standards revised by ISO in revised by ISO in 2011 and The ISO 9000 Standard 2000 were published as TS- published as TS-EN-ISO series was published in EN-ISO 9001:2000. 9004:2011. 1987. 1987 2000 2011 1991 2009 2015 In 1991, the Turkish Standards Institute prepared The same standard was It was revised as TS-EN-ISO the TS-ISO 9000 standards. revised again by ISO in 2009 9001:2015 in 2015. In 1994, these standards and published as TS-EN-ISO were revised as TS-EN-ISO 9001:2008. 9001:1994 /9002:1994 /9003:1994.  ISO-9000 QUALITY ASSURANCE STANDARDS ISO 9000 quality assurance standards were first implemented in the defense Today, these standards have industry, and later used in successful applications in areas such as aviation, many production and service medical devices, the sectors, including food. automotive industry and nuclear facilities. TS EN-ISO 9000 STANDARDS ARE INTERNATIONAL STANDARDS DEVELOPED FOR QUALITY MANAGEMENT SYSTEM TS EN-ISO 9000 STANDARDS ARE NOT STANDARDS DEVELOPED FOR PRODUCT QUALITY TSE ISO 9000 FINAL SYSTEM PRODUCT STANDARDS STANDARDS  PURPOSES OF USE OF ISO 9000 STANDARDS ISO 9000 standards are the tools used: As a model that can be applied at an international level, As a model for the certification of the quality system, As a condition of the contract,  BENEFITS OF USING ISO 9000 STANDARDS Establishing an effective management system Clearly defining responsibilities and authorities Providing extensive monitoring and control of all activities Optimizing the company structure and process integrity Increasing the efficiency of processes  Improved utilization of time and materials Improved utilization of people, departments BENEFITS and systems OF USING ISO 9000 Improved quality of communication STANDARD Creation of documented systems that include S useful reference and educational tools Improved relationships with consumers and suppliers  TS-EN-ISO 9000 STANDARDS TS-EN-ISO 9000 series of standards consists of four basic standards: TS-EN-ISO 9000:2015 Quality management systems — Fundamentals and vocabulary TS-EN-ISO 9001:2015 Quality management systems — Requirements TS-EN-ISO 9004:2018 Quality management — Quality of an organization — Guidance to achieve sustained success TS-EN-ISO 19011:2018 Guidelines for auditing management systems  TS-EN-ISO 9001:2015 QUALİTY MANAGEMENT SYSTEMS — REQUİREMENTS ISO 9001 is an international certification standard and covers the conditions that an organization's quality management system must contain. When the organization meets the requirements of this standard, it is certified with the ISO 9001 certificate. The ISO 9001 standard aims to evaluate the quality systems of organizations in accordance with ISO Standard Procedures, while ensuring that the quality of the product or service is optimized for the organization and its customers and suppliers. The standard has been prepared to be applicable to all organizations regardless of their type, size and product category.  TS-EN-ISO 9001:2015 QUALITY MANAGEMENT PRINCIPLES The TS-EN-ISO 9001 standard, which is implemented as a certification model in many countries including the European Community countries, is an international quality management standard and is based on 7 quality principles: Customer Focus: Organizations should understand the needs of their customers, comply with customer requests and strive to exceed customer expectations. Leadership: Leaders organize and determine the unity of direction and purpose. The leader should act towards organization and unity of purpose within the company, so that employees can contribute to the achievement of the organization's goals. Engagement of People: Employees at all levels are a value for the organization and the participation of employees at all levels is important for the organization's interests for effectiveness and efficiency.  TS-EN-ISO 9001:2015 QUALITY MANAGEMENT PRINCIPLES Process Approach: When all activities are managed as a process, results can be achieved more successfully and more effectively. PDCA (plan-do-check-act) cycle can be applied to all processes. Improvement: Improvement is important for the organization to maintain its current performance level, to respond to changes in internal and external situations, and to create new opportunities. Evidence-Based Decision Making: Objective and reliable decisions are based on the analysis of data and information. Relationship Management: The organization must manage its relationships with relevant parties for continuous success. Managing relationships has a positive effect on performance.  PCDA CYCLE The standard encourages the process approach, which is one of the 7 quality principles, in the establishment, implementation and improvement of efficiency of quality management to meet customer demands and increase customer satisfaction. The process approach includes the definition of processes within the organization in order to achieve the goal, the implementation, management and interactions of the process system together with their interactions. The management of processes and the system as a whole can be achieved with the risk-based thinking PDCA cycle, which aims to take advantage of opportunities and prevent undesirable results. PCDA CYCLE  TS-EN-ISO 9004:2018 QUALITY MANAGEMENT — GUIDANCE TO ACHIEVE SUSTAINED SUCCESS The standard is a guide standard that provides broader guidance beyond the requirements given in the ISO 9001 standard to take into account the potential of an organization to improve both its effectiveness and efficiency, in other words its performance, for quality management system objectives.  ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEM The ISO 22000 Standard is the implementation of a preventive system in organizations that is developed to prevent consumers from being exposed to foodborne diseases and that keeps all processes in the food chain under control together with all their effects such as infrastructure, personnel and equipment. Food Safety Management System applications in organizations cover production control, product control, equipment control; maintenance and general hygiene practices; personnel and visitor hygiene; transportation, storage, product information; training, supplier selection and evaluation; training, communication and similar issues.  ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEM The main goal is to determine the focal points of intolerable risks that may arise from process errors in the product and to ensure product quality and consumer health. Basically, ISO 22000 plays a role in ensuring not only food safety but also the increase in sensory and nutritional quality, while also forming a fundamental and indispensable part of quality assurance in industrial production, service and maintenance applications.  ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEM Prerequisite Programs (PRPs) are programs that ensure that the Food Safety Management System is built on solid foundations. These conditions and practices, implemented within the framework of GMP, GHP, GLP, GAP and other similar concepts, are now accepted as prerequisites in the preparation and implementation of effective HACCP plans and in the production of safe food.  ISO 22000:2018 FOOD SAFETY MANAGEMENT SYSTEM All food companies that have any place in the food chain (food production, storage and sales, food packaging that comes into contact with food, gloves, etc.) can implement a food safety management system and obtain its documents. HACCP is not a separate document but is a part of the standard requirements in ISO 22000.