Change Management

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 advances.  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. 

Change management is not just a matter of best practices, it is the law for most companies.  In accordance with many 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 stakesholders.  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.

Organizations seeking to embed change management into their processes and culture find that they must move beyond the more narrow perspective of change control – the formal process ensuring that any changes to elements within the organization are performed in accordance with the change specification—to a broader framework of change management.  Change management is that broader process which 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.

Web-based eQCM allows organizations to consistently follow best practices to initiate a change request, follow a risk-based approach to assess the change impacts, create action plans, obtain the appropriate approvals and sign-offs, and provide communication and collaboration throughout all stages of the change cycle.  With the Processes-In-Control dashboard, the managers can see the status of current processes, identify bottlenecks and review critical indicators in order to optimize