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Quality Audit
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001. Purpose Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria. With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS. Audits can also be used for safety pu ...
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Quality System
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 ( ISO 9001:2015). 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. ...
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Quality Costs
In process improvement efforts, quality costs or cost of quality (sometimes abbreviated CoQ or COQ) 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. Prior to its introduction, the general perception was that higher quality requires higher costs, either by buying better materials or machines or by hiring more labor. Furthermore, while cost accounting had evolved to categorize financial transactions into revenues, expenses, and changes in shareholder equity, it had not attempted to categorize costs relevant to quality, which is especially important given that most people involved in manufacturing never set hands on the product. By classifying quality-related entries from a company's general ledger, management and quality practitioners can evaluate investments in quality based on cost improvement and profit enhancement. Definitions Feigenbaum defined the follo ...
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TÜV Rheinland
TÜVs (; short for , ) are internationally active, independent service companies from Germany and Austria that test, inspect and certify technical systems, facilities and objects of all kinds in order to minimize hazards and prevent damages. The TÜV companies are organized into three large holding companies, TÜV Nord, TÜV Rheinland and TÜV SÜD (with TÜV Hessen), along with the smaller independent companies TÜV Thüringen, TÜV Saarland and TÜV Austria. History With the increasing number and efficiency of steam engines during the Industrial Revolution, there had been more and more accidents caused by exploding (or more precisely, bursting) boilers. After the explosion of the boiler at the Mannheim Aktienbrauerei in January 1865, the idea was pursued there to subject boilers to regular inspections on a voluntary basis, as was already the case in Great Britain. Twenty boiler owners in Baden joined in the plans and finally founded the ''Gesellschaft zur Überwachung und Ver ...
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SGS S
SGS may refer to: Acronym usage * ISO 639-3 code for the Samogitian dialect * ISO 3166 trigram for South Georgia and the South Sandwich Islands * FAA location identifier for South St. Paul Municipal Airport Companies and organizations * SGS Essen, a German multi-sports club * SGS S.A. (formerly ''Société Générale de Surveillance''), a Swiss company providing inspection, verification, testing and certification services * SGS-ATES (''Società Generale Semiconduttori – Aquila Tubi E Semiconduttori''), a former Italian company now merged into STMicroelectronics * SGS/SCN, regional television stations in Australia * Saudi Geological Survey, the national geological survey of the Kingdom of Saudi Arabia * Serbian Genealogical Society, a learned society that is engaged in genealogical research * Sisters of the Good Samaritan, a Roman Catholic congregation of religious women * Styling Garage, a German automobile tuner and coachbuilder active in the 1980s Entertainment * Sahaba ...
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Quality Management
Total quality management, Total Quality management (TQM), ensures that an organization, product, or service consistently performs as intended, as opposed to Quality Management, which focuses on work process and procedure standards. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Customers recognize that quality is an important attribute when choosing and purchasing products and services. Suppliers can recognize that quality is an important differentiator of their offerings, and endeavor to compete on the quality of their products and the service they offer. Thus, quality management is focused both on product and service quality. Advancement In earlier periods, arts and crafts were led by Master craftsman, master craftspeople or artists who supervised studios, trained apprentices, and oversaw the product development process. With the advent of the Industrial Revolution, steam engines, and mass production, the role of crafts ...
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Final Quality Audit
The final quality audit (FQA) process, in the electronic hardware manufacturing world, is the last process flow before shipping a product. This process is established to ensure the unit has gone through and passed all the manufacturing or test process and is in good quality. This process not only includes visual checking of the unit (i.e. labels has been placed properly, no scratches, no dents, all LED/lights are functional) but also checks that the correct firmware and version plus configuration has been loaded properly. It must power up according to specs as well. There are cases where a separate out of the box audit (OBA) process is defined, but most of the time this can be combined as well. OBA is just a visual check making sure that the unit has, again, the correct labels plus all the manuals or other parts that needs to ship with it is also inside the box. Labels from the unit should also match the ones outside the box. Besides checking good quality of the unit, this proc ...
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DQS-UL
DQS Holding GmbH based in Frankfurt am Main is the holding company of the worldwide DQS Group. The group provides assessments and certifications of management systems and processes of any type. History DQS was founded in 1985 in Berlin and was the first German certification body.Wolfgang Hansen: ''Zertifizierung und Akkreditierung von Produkten und Leistungen der Wirtschaft'', Carl Hanser Verlag München Wien, 1993, p. 155, .Walter Masing: ''Handbuch der Qualitätssicherung'', Carl Hanser Verlag, 2nd ed., 1988, p. 972, . The aim of the founding partners, Deutsche Gesellschaft für Qualität, DGQ (Deutsche Gesellschaft für Qualität, German Society for Quality) and DIN (German Institute for Standardization), was mainly to promote the German economy. The foundation overlapped with the publication of the first drafts of the ISO 9000 series of standards, which also include the most important quality standard worldwide today: ISO 9001. In 1986 DQS became the first certification ...
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Cost Of Poor Quality
Cost of poor quality (COPQ), poor quality costs (PQC), cost of nonquality, Cost of Quality (QOQ), Cost of Current Quality (COCQ) are costs that would disappear if systems, processes, and products were perfect. COPQ was popularized by IBM quality expert H. James Harrington in his 1987 book ''Poor-Quality Cost''. COPQ is a refinement of the concept of quality costs. In the 1960s, IBM undertook an effort to study its own quality costs and tailored the concept for its own use. While Feigenbaum's term "quality costs" is technically accurate, it's easy for the uninitiated to jump to the conclusion that better quality products cost more to produce. Harrington adopted the name "poor quality costs" to emphasize the belief that investment in detection and prevention of product failures is more than offset by the savings in reductions in product failures. Harrington breaks down COPQ into the following elements: Examples White collar COPQ Harrington noted that expanding cost analyses ...
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Code Of Federal Regulations
In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulatory law, regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation. The CFR annual edition is published as a special issue of the ''Federal Register'' by the Office of the Federal Register (part of the National Archives and Records Administration) and the Government Publishing Office. In addition to this annual edition, the CFR is published online on the Electronic CFR (eCFR) website, which is updated daily. Background Congress frequently delegates authority to an executive branch agency to issue regulations to govern some sphere. These statutes are called "authorizing statute" or "enabling statute" (or "authorizing legislation"). Authorizing statutes typically have two parts: (1) a substantive sc ...
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Quality Management System
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 ( ISO 9001:2015). 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. ...
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Quality System Regulation
Quality may refer to: Concepts *Quality (business), the ''non-inferiority'' or ''superiority'' of something *Quality (philosophy), an attribute or a property *Quality (physics), in response theory *Energy quality, used in various science disciplines *Logical quality, philosophical categorization of statements *Service quality, comparison of expectations with performance in a service *Vapor quality, in thermodynamics, the ratio of mass of vapor to that of vapor and liquid *Data quality, refers to the condition of a set of values of qualitative or quantitative variables Practices *Quality assurance (QA) *Quality control (QC) *Quality management system (QMS) *Quality Management (QM) Places *Quality, Kentucky, an unincorporated community Brands and enterprises *Quality Comics, an American comic book publisher between 1939 and 1956 *Quality Communications, a British comic book publisher between 1982 and 2008 *Quality Records, a Canadian entertainment company Music * ''Quality'' (CDQ ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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