Medical Device Link.

DESIGN AND DEVELOPMENT

A typical design change life cycle comprises four steps. These steps become natural stage-gates to implementation. The change documentation reflects these natural steps in a series of forms. In addition to the forms, documentation includes a work instruction on the process as well as a business process map that identifies the process flow and responsibilities. The process described below shows an example of a design change procedure structure. The design change life cycle flows over the four steps as follows:

• Planning to design.
• Designing and verifying.
• Planning to manufacture (getting ready for manufacture).
• Building.

Planning to Design. In the first phase, the project manager uses management tools to appropriately scope the project. During the scoping period, the manager reviews the forms and internal guidance documents to understand the expectations for the deliverables that will be required to effect the change. Those deliverables should be added to the plan.

Designing and Verifying. The design history file DHF-1 form must be completed and approved in this step. The purpose of the form is to describe the change and to show that design control was adequate and that the company would like to move forward with the change.

Planning to Manufacture. The design history file and launch review (DHF–LR) and the regulatory approval forms (RAFs) must be completed and approved to show that the launch preparations are adequate and that the regulatory approval has been received. To ensure that the appropriate forms are completed, the change forms of the item master (IM) and bill of materials (BOM) become gates. To execute those forms into the materials requirements planning program, the DHF-LR and RAF forms must be approved. The IM and BOM forms become the compliance gates for the system. Once these forms are executed in the manufacturing resource planning (MRP) system, the change is in production and is considered released. This process assumes that all changes to the device master record (DMR), including procedures and forms, can only be made through the MRP system.

Building. The change is monitored, and after the change has been implemented and has become stable (which is dependent on the size and scope of the change), the DHF-2 form is executed in order to close the change. If documents have been updated since the creation of previous summaries (DHF-1, DHF–LR), then those documents that were changed as a result of the design change, but not captured elsewhere, should be listed on the DHF-2 form.

The system design described here contains forms and procedures that serve as the product structure for the design change procedures.