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Change Control
Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal—used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. According to the Project Management Institute, change control is a "process whereby modifications to documents, deliverables, or baselines associated with the project are identified, documented, approved, or rejected." Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the 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 and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and 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 not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of disea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standardization
Standardization (American English) or standardisation (British English) is the process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments. Standardization can help maximize compatibility, interoperability, safety, repeatability, efficiency, and quality. It can also facilitate a normalization of formerly custom processes. In social sciences, including economics, the idea of ''standardization'' is close to the solution for a coordination problem, a situation in which all parties can realize mutual gains, but only by making mutually consistent decisions. Divergent national standards impose costs on consumers and can be a form of non-tariff trade barrier. History Early examples Standard weights and measures were developed by the Indus Valley civilization.Iwata, Shigeo (2008), "Weights and Measures in the Indus Valley", ''Encyclopaedia of the History ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 Specificatio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Living Document
A living document, also known as an evergreen document or dynamic document, is a document that is continually edited and updated. An example of a living document is an article in Wikipedia, an online encyclopedia that permits anyone to freely edit its articles; this is in contrast to "dead" or "static" documents, such as an article in a single edition of the ''Encyclopædia Britannica''. A living document may or may not have a framework for updates, changes, or adjustments. This type of document without proper context can change away from its original purpose through multiple uncontrolled edits. This can encourage open collaboration within the network, but in some cases there can also be stagnation if no one takes on the initiative of updating the work. One reason why initiative is not taken to update the document could come from a sense of ambiguity. A living document may evolve through successive updates, be expanded as needed, and serve a different purpose over time. Living ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Changelog
A changelog (also spelled change log) is a log or record of all notable changes made to a project. The project is often a website or software project, and the changelog usually includes records of changes such as bug fixes, new features, etc. Some open-source projects include a changelog as one of the top-level files in their distribution. A changelog has historically included all changes made to a project. An alternative approach has been suggested that the log should instead contain "a curated, chronologically ordered list of notable changes for each version of a project" and should not be a "dump" of a git log "because this helps nobody". Although the GNU ( Automake) canonical naming convention for the file is ''ChangeLog'', it is sometimes alternatively named as ''CHANGES'' or ''HISTORY'' (''NEWS'' is usually a different file reflecting changes between releases, not between the commits). Another convention is to call it a ''CHANGELOG''. Some project maintainers will append ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Version Control
Version control (also known as revision control, source control, and source code management) is the software engineering practice of controlling, organizing, and tracking different versions in history of computer files; primarily source code text files, but generally any type of file. Version control is a component of software configuration management. A ''version control system'' is a software tool that automates version control. Alternatively, version control is embedded as a feature of some systems such as word processors, spreadsheets, collaborative groupware, web docs, and content management systems, e.g., Help:Page history, Wikipedia's page history. Version control includes viewing old versions and enables Reversion (software development), reverting a file to a previous version. Overview As teams develop software, it is common to Software deployment, deploy multiple versions of the same software, and for different developers to work on one or more different versions ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Identifier
An identifier is a name that identifies (that is, labels the identity of) either a unique object or a unique ''class'' of objects, where the "object" or class may be an idea, person, physical countable object (or class thereof), or physical mass noun, noncountable substance (or class thereof). The abbreviation ID often refers to identity, identification (the process of identifying), or an identifier (that is, an instance of identification). An identifier may be a word, number, letter, symbol, or any combination of those. The words, numbers, letters, or symbols may follow an code, encoding system (wherein letters, digits, words, or symbols ''stand for'' [represent] ideas or longer names) or they may simply be arbitrary. When an identifier follows an encoding system, it is often referred to as a code or id code. For instance the ISO/IEC 11179 metadata registry standard defines a code as ''system of valid symbols that substitute for longer values'' in contrast to identifiers wi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Documentation
Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance, and use. As a form of knowledge management and knowledge organization, documentation can be provided on paper, online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, online help, and quick-reference guides. Paper or hard-copy documentation has become less common. Documentation is often distributed via websites, software products, and other online applications. Documentation as a set of instructional materials shouldn't be confused with documentation science, the study of the recording and retrieval of information. Principles for producing documentation While associated International Organization for Standardization (ISO) standards are not easily available publicly, a guide from other sources for this topic may serve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Engineering Change Order
An engineering change order (ECO), also called an engineering change notice (ECN), engineering change (EC), or engineering release notice (ERN), is an artifact used to implement changes to components or end products. The ECO is utilized to control and coordinate changes to product designs that evolve over time. The need for an engineering change may be triggered by a number of events and varies by industry. Typical engineering change categories are: * Product Evolution - a change resulting in applying an existing part to a new application and maintaining backwards compatibility * Cost Reduction - a change resulting in lower overall cost to produce or maintain * Product Performance - a change that improves the capabilities of the item * Safety - a change required to enhance the safety to those using or interacting with the item Usage and contents An ECO is defined as " document approved by the design activity that describes and authorizes the implementation of an engineerin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Change Order
In project management, change orders are also called variations or variation orders. Any modification or change to works agreed in the contract is treated as a variation. Types These modifications can be divided into three main categories # Addition to the work agreed in the contract. # Omission of work agreed in the contract. # Substitution or alteration of work agreed in the contract. Purpose A change order is work that is added to or deleted from the original scope of work of a contract. Depending on the magnitude of the change, it may or may not alter the original contract amount and/or completion date. A change order may force a new project to handle significant changes to the current project. Change orders are common to most projects, and very common with large projects. After the original scope (or contract) is formed, complete with the total price to be paid and the specific work to be completed, a client may decide that the original plans do not best represent his or he ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Change Request
A change request, sometimes called change control request (CCR), is a document containing a call for an adjustment of a system; it is of great importance in the change management process. Purpose and elements A change request is declarative, i.e. it states what needs to be accomplished, but leaves out how the change should be carried out. Important elements of a change request are an ID, the customer (ID), the deadline (if applicable), an indication whether the change is required or optional, the change type (often chosen from a domain-specific ontology) and a change abstract, which is a piece of narrative (Keller, 2005). An example of a change request can be found in Figure 1 on the right. Sources Change requests typically originate from one of five sources: # problem reports that identify bugs that must be fixed, which forms the most common source # system enhancement requests from users # events in the development of other systems # changes in underlying structure and or ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
