The old adage that — the only thing constant is change — is true. Within organizations, changes are always occurring due to market drivers, staff changes, new regulations, resource availability, and technological changes. These changes can include changes in policies and procedures, processes, systems, staff, products, services, equipment, materials, emissions, etc. Change management refers to the ability to request, analyze, and decide on a change in a document, process, or object, and then to track the status of that change. Each time a change occurs in the organization, it will impact other areas of the organization and throughout the value chain.
For example, if a new software application is installed within an organization (an audit system), new SOPs will need to be written for the system, training will need to be scheduled, and the auditee may need to be notified that their reports will look different. For an organization to minimize the risk that changes can have on the organization, the organization must identify these potential changes, thoroughly evaluate the impacts of the changes and the risk of not doing them, obtain the necessary approvals, communicate with the affected parties, and create action plans to implement the changes. Change management is not just a matter of best practices, it is the law for most companies.
Under several regulatory standards and guidelines, change control– or controlling or managing change within an organization– must be conducted to ensure that the organization can maintain and improve quality by identifying changes that could improve the product, ensuring proper review and analysis of the changes, and documenting and communicating the changes to the appropriate stakeholders. For example, the ISO regulations, having a continual improvement and document control tone, infer that change should be managed. In addition, the medical device regulations of 21 CFR Part 820, specifically regulate change management.
There are many problems associated with documentation and change control. The most frequent ones are:
Most problems can be solved by developing procedures and having those procedures embedded into the change control process. In addition, a key solution is to ensure the narrower perspective of change control – the formal process ensuring that any changes to elements within the organization are performed in accordance with the change specification—is done within the broader framework of change management. Change management is that broader process that allows for standardization of procedures and activities for all types of changes, and the monitoring of those changes within a continual improvement mindset to minimize change-related impacts and enhance efficiency.
A good automated change control system provides these components:
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