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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). I ...
s (QMS) and
information technology Information technology (IT) is the use of computers to create, process, store, retrieve, and exchange all kinds of data . and information. IT forms part of information and communications technology (ICT). An information technology syste ...
(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. Change control is used in various industries, including in IT, software development, the pharmaceutical industry, the medical device industry, and other engineering/manufacturing industries. For the IT and software industries, change control is a major aspect of the broader discipline of
change management Change management (sometimes abbreviated as CM) is a collective term for all approaches to prepare, support, and help individuals, teams, and organizations in making organizational change. It includes methods that redirect or redefine the use ...
. Typical examples from the
computer A computer is a machine that can be programmed to carry out sequences of arithmetic or logical operations ( computation) automatically. Modern digital electronic computers can perform generic sets of operations known as programs. These prog ...
and
network Network, networking and networked may refer to: Science and technology * Network theory, the study of graphs as a representation of relations between discrete objects * Network science, an academic field that studies complex networks Mathematic ...
environments are patches to software products, installation of new
operating system An operating system (OS) is system software that manages computer hardware, software resources, and provides common daemon (computing), services for computer programs. Time-sharing operating systems scheduler (computing), schedule tasks for ef ...
s, upgrades to network
routing Routing is the process of selecting a path for traffic in a network or between or across multiple networks. Broadly, routing is performed in many types of networks, including circuit-switched networks, such as the public switched telephone netw ...
tables, or changes to the
electrical power Electric power is the rate at which electrical energy is transferred by an electric circuit. The SI unit of power is the watt, one joule per second. Standard prefixes apply to watts as with other SI units: thousands, millions and billion ...
systems supporting such
infrastructure Infrastructure is the set of facilities and systems that serve a country, city, or other area, and encompasses the services and facilities necessary for its economy, households and firms to function. Infrastructure is composed of public and priv ...
. Certain portions of
ITIL The Information Technology Infrastructure Library (ITIL) is a set of detailed practices for IT activities such as IT service management (ITSM) and IT asset management (ITAM) that focus on aligning IT services with the needs of business. ITIL de ...
cover change control.


The process

There is considerable overlap and confusion between
change management Change management (sometimes abbreviated as CM) is a collective term for all approaches to prepare, support, and help individuals, teams, and organizations in making organizational change. It includes methods that redirect or redefine the use ...
,
configuration management Configuration management (CM) is a process for establishing and maintaining consistency of a product's performance, functional, and physical attributes with its requirements, design, and operational information throughout its life. The CM proc ...
and change control. The definition below is not yet integrated with definitions of the others. Change control can be described as a set of six steps: # Plan / scope # Assess / analyze # Review / approval # Build / test # Implement # Close


Plan / scope

Consider the primary and ancillary detail of the proposed change. This should include aspects such as identifying the change, its owner(s), how it will be communicated and executed, how success will be verified, the change's estimate of importance, its added value, its conformity to business and industry standards, and its target date for completion.


Assess / analyze

Impact and risk assessment is the next vital step. When executed, will the proposed plan cause something to go wrong? Will related systems be impacted by the proposed change? Even minor details should be considered during this phase. Afterwards, a risk category should ideally be assigned to the proposed change: high-, moderate-, or low-risk. High-risk change requires many additional steps such as management approval and stakeholder notification, whereas low-risk change may only require project manager approval and minimal documentation. If not addressed in the plan/scope, the desire for a backout plan should be expressed, particularly for high-risk changes that have significant worst-case scenarios.


Review / approval

Whether it's a change controller, change control board, steering committee, or project manager, a review and approval process is typically required. The plan/scope and impact/risk assessments are considered in the context of business goals, requirements, and resources. If, for example, the change request is deemed to address a low severity, low impact issue that requires significant resources to correct, the request may be made low priority or shelved altogether. In cases where a high-impact change is requested but without a strong plan, the review/approval entity may request a full
business case A business case captures the reasoning for initiating a project or task. It is often presented in a well-structured written document, but may also come in the form of a short verbal agreement or presentation. The logic of the business case is that ...
may be requested for further analysis.


Build / test

If the change control request is approved to move forward, the delivery team will execute the solution through a small-scale development process in test or development environments. This allows the delivery team an opportunity to design and make incremental changes, with
unit Unit may refer to: Arts and entertainment * UNIT, a fictional military organization in the science fiction television series ''Doctor Who'' * Unit of action, a discrete piece of action (or beat) in a theatrical presentation Music * ''Unit'' (a ...
and/or
regression testing Regression testing (rarely, ''non-regression testing'') is re-running functional and non-functional tests to ensure that previously developed and tested software still performs as expected after a change. If not, that would be called a '' regre ...
. Little in the way of testing and validation may occur for low-risk changes, though major changes will require significant testing before implementation. They will then seek approval and request a time and date to carry out the implementation phase. In rare cases where the solution can't be tested, special consideration should be made towards the change/implementation window.


Implement

In most cases a special implementation team with the technical expertise to quickly move a change along is used to implement the change. The team should also be implementing the change not only according to the approved plan but also according to organizational standards, industry standards, and quality management standards. The implementation process may also require additional staff responsibilities outside the implementation team, including stakeholders who may be asked to assist with troubleshooting. Following implementation, the team may also carry out a post-implementation review, which would take place at another stakeholder meeting or during project closing procedures.


Close

The closing process can be one of the more difficult and important phases of change control. Three primary tasks at this end phase include determining that the project is actually complete, evaluating "the project plan in the context of project completion," and providing tangible proof of project success. If despite best efforts something went wrong during the change control process, a post-mortem on what happened will need to be run, with the intent of applying lessons learned to future changes.


Regulatory environment

In a
good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...
regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept. As a common practice, the activity is usually directed by one or more SOPs. From the
information technology Information technology (IT) is the use of computers to create, process, store, retrieve, and exchange all kinds of data . and information. IT forms part of information and communications technology (ICT). An information technology syste ...
perspective for
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
s, it has been guided by another U.S.
Food and Drug Administration 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 ...
document.


See also

*
Change request A change request (aka Change Control Request, or 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 state ...
*
Change order Change or Changing may refer to: Alteration * Impermanence, a difference in a state of affairs at different points in time * Menopause, also referred to as "the change", the permanent cessation of the menstrual period * Metamorphosis, or change, ...
*
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 contro ...
*
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 manageme ...
*
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, physical countable object (or class thereof), or physical noncountable ...
*
Version control In software engineering, version control (also known as revision control, source control, or source code management) is a class of systems responsible for managing changes to computer programs, documents, large web sites, or other collections o ...
*
Changelog A changelog 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 in ...
* Living document *
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 specificati ...
*
Standardization Standardization or standardisation 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. Standardizatio ...
* Scope management


References

{{Authority control Information technology management Project management Software project management