Enabling effective scale-up manufacturing

In the scale-up production the products are made according a fixed DMR, the Device Master Record. The DMR contains the “what to make” and the “how to make” (“drawings and instructions”).

Individuals tasked with operating the production line need to be trained to execute the production job. In the lead up to released production, the line needs to be validated, meaning that the line needs to constantly perform as expected.

It is very valuable to have a clear view on batch and/or production targets, such as quantities, cost, and yield, in the early stages.