Change Control

 Change control is a process used to manage changes to a system, process, or product. The purpose of change control is to ensure that changes are made in a controlled manner, and that any potential risks associated with the change are identified and managed appropriately. Change control is an important part of quality management systems, and is used to maintain the integrity and consistency of products and processes.

The steps involved in the change control process typically include the following:

1.    Initiation: A change is initiated by a person or department responsible for the system, process, or product. The change request should include a description of the change, the reason for the change, and the potential impact of the change.

2.    Assessment: The change is assessed to determine the potential impact on the system, process, or product. This may involve reviewing documentation, conducting risk assessments, or consulting with subject matter experts.

3.    Approval: The change is approved or rejected based on the assessment. If the change is approved, the approval may be given by a change control board or a designated individual.

4.    Implementation: The change is implemented, and appropriate documentation is updated to reflect the change.

5.    Verification: The change is verified to ensure that it has been implemented correctly and that it has achieved the desired outcome.

6.    Closure: The change control process is closed out, and appropriate documentation is filed for future reference.

Change control is important because it helps to ensure that changes are made in a controlled and consistent manner. This helps to reduce the risk of errors, deviations, or failures that can impact product quality or process performance. Change control also helps to ensure that changes are made in compliance with applicable regulations and industry standards.

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