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Nonconformity (quality)
In quality management, a nonconformity (sometimes referred to as a non conformance or nonconformance or defect) is a deviation from a specification, a standard, or an expectation. Nonconformities or nonconformance can be classified in seriousness multiple ways, though a typical classification scheme may have three to four levels, including critical, serious, major, and minor. While some situations allow "nonconformity" and "defect" to be used synonymously, some industries distinguish between the two; a nonconformity represents a failure to meet an intended state and specification, while a defect represents a failure to meet fitness for use/normal usage requirements. This can be seen in the international software engineering standard ISO/IEC 25010 (formerly ISO/IEC 9126), which defines a nonconformity as the nonfulfillment of a requirement and a defect as the nonfulfillment of intended usage requirements. Classifying nonconformity When ensuring quality of a product or a service, cl ...
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Quality Management
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. Evolution Quality management is a recent phenomenon but important for an organization. Civilizations that supported the arts and crafts allowed clients to choose goods meeting higher quality standards than normal goods. In societies where arts and crafts ...
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Specification (technical Standard)
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard. There are different types of technical or engineering specifications (specs), and the term is used differently in different technical contexts. They often refer to particular documents, and/or particular information within them. The word ''specification'' is broadly defined as "to state explicitly or in detail" or "to be specific". A requirement specification is a documented requirement, or set of documented requirements, to be satisfied by a given material, design, product, service, etc. It is a common early part of engineering design and product development processes in many fields. A functional specification is a kind of requirement specification, and may show functional block diagrams. A design or product specification describes the features of the ''solutions'' for the Requirement Specification, ...
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Technical Standard
A technical standard is an established norm or requirement for a repeatable technical task which is applied to a common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. A technical standard includes definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes, and practices. In contrast, a custom, convention, company product, corporate standard, and so forth that becomes generally accepted and dominant is often called a ''de facto'' standard. A techni ...
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Expectation (epistemic)
In the case of uncertainty, expectation is what is considered the most likely to happen. An expectation, which is a belief that is centered on the future, may or may not be realistic. A less advantageous result gives rise to the emotion of disappointment. If something happens that is not at all expected, it is a surprise. An expectation about the behavior or performance of another person, expressed to that person, may have the nature of a strong request, or an order; this kind of expectation is called a social norm. The degree to which something is expected to be true can be expressed using fuzzy logic. Anticipation is the emotion corresponding to expectation. Expectations of well-being Richard Lazarus asserts that people become accustomed to positive or negative life experiences which lead to favorable or unfavorable expectations of their present and near-future circumstances. Lazarus notes the widely accepted philosophical principle that "happiness depends on the background p ...
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ISO/IEC 9126
ISO/IEC 9126 ''Software engineering — Product quality'' was an international standard for the evaluation of software quality. It has been replaced by ISO/IEC 25010:2011. The fundamental objective of the ISO/IEC 9126 standard is to address some of the well known human biases that can adversely affect the delivery and perception of a software development project. These biases include changing priorities after the start of a project or not having any clear definitions of "success". By clarifying, then agreeing on the project priorities and subsequently converting abstract priorities (compliance) to measurable values (output data can be validated against schema X with zero intervention), ISO/IEC 9126 tries to develop a common understanding of the project's objectives and goals. The standard is divided into four parts: * quality model * external metrics * internal metrics * quality in use metrics. Quality The quality model presented in the first part of the standard, ISO/IEC 912 ...
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Product Defect
A product defect is any characteristic of a product which hinders its usability for the purpose for which it was designed and manufactured. Product defects arise most prominently in legal contexts regarding product safety, where the term is applied to "anything that renders the product not reasonably safe".Patricia A. Robinson, ''Writing and Designing Manuals and Warnings'' (2009), p. 234. The field of law that addresses injuries caused by defective products is called ''product liability''. A wide range of circumstances can render a product defective. The product may have a design defect or design flaw, resulting from the product having been poorly designed or tested, so that the design itself yields a product that can not perform its desired function. Even if the design is correct, the product may have a manufacturing defect if it was incorrectly manufactured, for example if the wrong materials are used. A product may also be considered legally defective if it lacks appropriate i ...
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Quality (business)
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or wikt:superiority, superiority of something (goods or service (economics), services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjectivity, subjective attribute and may be understood differently by different people. Consumers may focus on the Acceptance testing, specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the Conformance testing, conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is wikt:reliable, reliable, Maintainability, maintainable, or sustainability, sustainable. In such ways, the subjectivity of quality is rendered objectivity (philosoph ...
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Automotive Industry
The automotive industry comprises a wide range of company, companies and organizations involved in the design, Business development, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industry (economics), industries by revenue (from 16 % such as in France up to 40 % to countries like Slovakia). It is also the industry with the highest spending on research & development per firm. The word ''automotive'' comes from the Greek language, Greek ''autos'' (self), and Latin ''motivus'' (of motion), referring to any form of self-powered vehicle. This term, as proposed by Elmer Ambrose Sperry, Elmer Sperry (1860-1930), first came into use with reference to automobiles in 1898. History The automotive industry began in the 1860s with hundreds of manufacturers that pioneered the Brass Era car, horseless carriage. For many decades, the United States led the world in total automobile production. In 1929, before the Great Depression, ...
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ISO Standards
The International Organization for Standardization (ISO ) is an international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and (as of November 2022) it has published over 24,500 international standards covering almost all aspects of technology and manufacturing. It has 809 Technical committees and sub committees to take care of standards development. The organization develops and publishes standardization in all technical and nontechnical fields other than electrical and electronic engineering, which is handled by the IEC.Editors of Encyclopedia Britannica. 3 June 2021.International Organization for Standardization" ''Encyclopedia Britannica''. Retrieved 2022-04-26. It is headquartered in Geneva, Switzerland, and works in 167 countries . The three official languages of the ISO are English, Frenc ...
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Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ...
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