The Engineering Change Document Change Control Procedure outlines the steps and responsibilities to request changes to products or processes and the implementation of those changes to assure an orderly, controlled, and a 100% effective change to all aspects of the manufacture of a device and all related documentation.

The Control of changes to devices, processes, and the associated master records is one of the most important elements of a quality assurance system. Therefore, it is company policy that all changes must be made according to approved Engineering Change/Document Change Control Notices.

The Engineering Change Document Change Control Procedure applies to all manufacturing processes and products manufactured by the company. Specifically, Change Control applies to: components, including software; labeling and packaging; devices; processes; production equipment; manufacturing materials; and all associated documentation such as standard operating and quality assurance procedures, data forms, and product-specific documentation. These documents constitute the Device Master Record. Therefore much of the discussion herein is centered around the Device Master Record.

The procedures are to be followed from the time the master record is first released for production of a device for all changes to the in-process device or the associated manufacturing processes through implementation of changes to all appropriate documents. (8 pages, 1332 words)

Engineering Change Responsibilities:

All Personnel need to supply as much detail as they can with ENG102-1.

The Engineering Manager and the President will determine whether to schedule a management review of the proposal.