Change controls in the quality management system (SMM) and information technology (IT) systems is a process - both formal and informal - is used to ensure that changes to products or systems are introduced in control and coordinated ways. This reduces the likelihood that unnecessary changes will be introduced to the system without prior thinking, introduces errors into the system or undo changes made by other software users. The objectives of the change control procedure typically include minimal service disruption, reduction of back-out activities, and effective resource utilization in the implementation of change.
Change controls are used in a variety of industries, including in IT, software development, pharmaceutical industry, medical equipment industry, and other engineering/manufacturing industries. For the IT industry and software, change control is a key aspect of the broader change management discipline. Common examples of computer and network environments are patches for software products, installation of new operating systems, upgrades to network routing tables, or changes to power systems that support the infrastructure.
Certain sections of the Information Technology Infrastructure Library include control changes.
Video Change control
Prosesnya
There is a lot of overlap and confusion between change management, configuration management and change control. The definitions below are not yet integrated with other definitions.
Change control can be described as a series of six steps:
- Plan/Coverage
- Value/Analysis
- Reviews/Approvals
- Create/Test
- Apply
- Close
Plan/Scope
Consider the main and additional details of the proposed changes. It should include aspects such as identifying change, owner (s), how it will be communicated and implemented, how success will be verified, estimates of change from importance, added value, conformity with business and industry standards, and target date to complete.
Value/Analysis
Impact and risk assessment are the next important step. When executed, will the proposed plan cause something to be wrong? Will the system be affected by the proposed changes? Even small details should be considered during this phase. Thereafter, the risk category should ideally be assigned to proposed changes: high, medium, or low risk. High-risk changes require many additional steps such as management approval and stakeholder notifications, whereas low-risk changes may require only minimal project manager approval and documentation. If not addressed in the plan/scope, the desire for the backout plan should be disclosed, especially for high-risk changes that have the worst worst-case scenarios.
Review/Approval
Whether it's a change controller, change control boards, steering committees, or project managers, a review and approval process is usually required. The plan/scope and impact/risk assessment are considered in the context of business objectives, requirements, and resources. If, for example, a change request is deemed to address low-level and low-impact issues that require significant resources to be corrected, the request can be either low-priority or suspended altogether. In cases where high impact changes are requested but without a strong plan, the review/approval entity may request that a complete business case be requested for further analysis.
Build Build/
If a change control request is approved to move forward, the sending team will execute the solution through a small-scale development process in a test or development environment. This allows the delivery team the opportunity to design and make additional changes, with unit and/or regression testing. Few ways of testing and validation can occur for low-risk changes, although major changes will require significant testing before implementation. They will then seek approval and request time and date to implement the implementation phase. In rare cases where the solution can not be tested, special consideration must be made to the change/implementation window.
Implement
In many cases, specialized implementation teams with technical expertise to move changes quickly are used to implement change. The team should also apply changes not only in accordance with approved plans but also to organizational standards, industry standards, and quality management standards. The implementation process may also require additional staff responsibilities outside the implementation team, including those stakeholders who may be asked to assist in troubleshooting. After implementation, the team may also conduct post-implementation reviews, which will take place at other stakeholder meetings or during project closure procedures.
Close
The closing process can be one of the more difficult phase of control changes. The three main tasks in this final phase include determining that the project is completely completed, evaluating the "project plan in the context of project completion," and providing concrete evidence of project success. If in spite of the best efforts there is something wrong during the change control process, a post-mortem on what happens needs to be done, with the intent of applying learning for future changes.
Maps Change control
Regulatory environment
In the industry of Good Manufacturing Practice Settings, this topic is often encountered by its users. Various industry guidelines and comments are available for people to understand this concept. As a general practice, these activities are usually directed by one or more SOPs. From an information technology perspective for clinical trials, has been guided by other US Food and Drug Administration documents.
See also
- Documentation
- Identifier
- Version control
- Changelog
- Guest Documents
- Specifications (technical standards)
- Standardization
References
Source of the article : Wikipedia
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