Process Flow

Device Master Record Management enables Design Engineers, Manufacturing Engineers, Senior Design Engineers, and Senior Manufacturing Engineers to manage the engineering design process for life science apps.

This page discusses:

Creating Objects

You can create these types of objects:

  • Parts
  • Process documents can be material specifications, CAD drawings, servicing manuals, or any other reference document needed in the device design.
  • Reference lists include supporting information that can be associated with a part or change order.

Associating Objects with the Device Master Record

You can use the DMR View to see all of the objects associated with the engineering design (listed above) in one hierarchical list. The list shows which items are related to which other items and lets you add, remove, and reorganize items as needed.

The DMR lists all of the specifications and other documentation, raw materials, sub-assemblies, components, parts, effectivity dates, and quantities required to manufacture a part or final product. This view ensures a consistent manufacturing process by associating product documents, and reference lists within the DMR/BOM. The DMR View lets you specify which plants use a particular part, document, or reference list.

Initiating and Implementing Changes

You can use change orders (COs) to:

  • Add new objects to the BOM
  • Change existing objects
  • Obsolete objects

The Proposed Changes page for the CO lists all the objects affected by that specific CO. The change process controls how the CO moves from being created, to being reviewed and implemented.