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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements".
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
ISO 14000 is a family of standards by the International Organization for Standardization (ISO) related to environmental management that exists to help organizations (a) minimize how their operations negatively affect the environment ; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance, and an occupational safety and health management system enables an organization to control its occupational health and safety risks.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place to ensure consistent checking. Inspections are usually non-destructive.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.
Software quality assurance (SQA) is a means and practice of monitoring all software engineering processes, methods, and work products to ensure compliance against defined standards. It may include ensuring conformance to standards or models, such as ISO/IEC 9126, SPICE or CMMI.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Material in the standard also forms the basis for accreditation from an accreditation body.
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
IATF 16949:2016 is a technical specification aimed at the development of a quality management system which provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
Corrective and preventive action consists of improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. It is usually a set of actions, laws or regulations required by an organization to take in manufacturing, documentation, procedures, or systems to rectify and eliminate recurring non-conformance. Non-conformance is identified after systematic evaluation and analysis of the root cause of the non-conformance. Non-conformance may be a market complaint or customer complaint or failure of machinery or a quality management system, or misinterpretation of written instructions to carry out work. The corrective and preventive action is designed by a team that includes quality assurance personnel and personnel involved in the actual observation point of non-conformance. It must be systematically implemented and observed for its ability to eliminate further recurrence of such non-conformation. The Eight disciplines problem solving method, or 8D framework, can be used as an effective method of structuring a CAPA.
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.
CSA CAN3-Z299 is a series of quality assurance standards developed by the Canadian Standards Association in the 1970s. It is an alternative to the ISO 9000 series of standards. The stated objectives of the Z299 series of standards are:
In process improvement efforts, quality costs or cost of quality is a means to quantify the total cost of quality-related efforts and deficiencies. It was first described by Armand V. Feigenbaum in a 1956 Harvard Business Review article.
Acceptance sampling uses statistical sampling to determine whether to accept or reject a production lot of material. It has been a common quality control technique used in industry.
The Allied Quality Assurance Publications (AQAP) are standards for quality assurance systems developed by NATO.
References
- ↑ "Receiving Inspection Procedure ISO 9001 2015 | QP1210". Bizmanualz Blog. Retrieved 2022-08-08.
- ↑ "Exploring ISO 9000 - Part 16 Control of Quality Records". www.moldmakingtechnology.com. 5 July 2022. Retrieved 2022-08-09.
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