In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedure. I am going to describe this change control procedure in this post.
A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:
The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data.