Engineering Change Management (ECM)

CUSTOMER’S CHALLENGE

The organization is a global pharmaceutical manufacturing company with multiple sites. The organization has one program to manage all changes (GMP and non-GMP changes). The need to differentiate GMP changes (Engineering Change Control) and non-GMP changes (Engineering Change Management) is crucial. Not all changes require control, some changes only require documentation and management. When an audit commences, the organization would manually filter through all the Engineering Change Controls to remove non-critical changes. Non-critical changes would bog down the Change Control System, causing months of delay.

HOW WE HELPED

Cheme Engineering worked collaboratively with the organization to implement a fully integrated Engineering Change Management Program. This program utilized applications that the organization already owned, such as Remedy, to support the process. The ECM program was built to ensure that only non-SISPQ impacting changes would be accepted.

CUSTOMER’S SUCCESS

Since the project was completed, the pharmaceutical organization has seen the following improvements to their process.

• Average Change Control Requests take 1.5 months to complete – ECM requests significantly reduced this duration – with some ECM requests taking less than 15 minutes to complete, and on average, less than 3 days.
• Minimal disruption to operations
• Visibility of all changes (GMP and Non-GMP)
• User-friendly process that eliminated the need for any guessing – the system is designed to only accept non-GMP impacting changes with minimal training
• This program requires minimal administration