Managing change in a regulated or controlled environment:

Managing change in a regulated or controlled environment

Continuous improvement and innovation are vital to ensure a product continues to deliver incremental value to its customer. Without change all competitive products eventually offer the same feature set and customers make purchase decision strictly based on price. Change allows a company to differentiate their products and focus on delivering incremental value their clients are willing to pay a premium for.

Managing the change process for a product that is regulated by an outside agency requires collaboration traceability and accountability. This ensures the change delivers the anticipated benefit to the customer, does not void a certification and is properly coordinated.

Collaboration can be a complex process involving people across multiple departments, or facilities. Collaboration is required to manage the creation of new part numbers, changes to bill of material, creation/update of documents, updates to routings, and management of projects. These tasks usually take place outside of the live production ERP system to eliminate the chance that unapproved changes don’t make their way into manufacturing.

Each task needs an approval or notification step to provide; status on the change, visibility in the event the task is rejected or notification when all steps are completed. Notification may also be required from individuals that are not assigned specific task, yet may need to be notified of pending change. By tracking the individuals connected to the change process a true sense of accountability exists.

After all steps in the change process are completed and approved, the update is ready for implementation. In this step new parts are added, new bill of material (possibly with an effectivity date) are released, routings changes are implemented, and drawings signed off.

Some companies utilize a paper or manual process, which may be effective for small organizations that do not have to report to an outside agency. The challenge of managing change with a manual process in a regulated or complex environment is significantly more difficult due to the lack of a formal mechanism for traceability and accountability. A better way to manage this process is to utilize a software tool to manage the Engineering Change Order (ECO) process. An ECO tool facilitates the creation of a framework for the change and attaches tasks associated with that change outside of the live production environment. As each task is approved or rejected history is maintained listing who completed each tasks and when they did it. As the tasks are approved the software should allow the user to automatically update all impacted areas (Parts, BOM’s, Routings, Documents, etc.) in the live production environment.

A professional and automated ECO process allows a company to more effectively manage their change process reduce the amount of time it takes to implement change and reduce the overall cost of incorporating customer suggestions or innovate new features.