Once the concept is developed, moving from this to a prototype and on to a manufactured product can sometimes lead to details being missed or assumptions being mis-communicated. It is vitally important that details are thought through and communicated to the relevant parties within the organisation and supply chain, to ensure no ambiguity, no errors and that the design is produced exactly as required. The requirements sheet supports definition of the design specification - these requirements will need to be reflected in the detailed design and manufacture/assembly specifications for the device, its components and parts. The RAPAT “Design and Manufacture” worksheet is intended to support this and capture the associated manufacturing assurance evidence for acceptance of the device by end-users.
At the top of the RAPAT “Design & Manufacture” worksheet, the “Design & Manufacture Sheet Completion Status” will initially be set to “Not started”. Use the dropdown list to change this to “In progress”, “Completed” or “Updated” as appropriate. The “Current Development Stage” should also be updated as the project progresses.
Populate the “Design and Manufacture Record” table with design and manufacture details for each component / sub-assembly at an appropriate level of granularity, using the “Add Row” button in the right-click context menu as required. The RAPAT Excel ribbon includes functionality to create supporting datasheet and flowchart worksheets. The dashboard at the top of the “Design & Manufacture” worksheet automatically tracks progress of the items included in the Design and Manufacture Record.
In order to ensure the design intent is clearly presented without ambiguity, details to be specified include:
Requirements provided to the supply chain may also need to include higher level device requirements such as:
The RAPAT “Design and Manufacture” worksheet provides space for summary requirements for each item to be specified, alternatively reference can be made to separate specification documents. Suppliers should be invited to request clarification on the requirements if anything is still unclear.
Design, manufacture and procurement will typically progress through a number of stages, such as conceptual design, prototype development, manufacture set up, certification and production. Prior to full production, demonstration of quality control and compliance may be an important aspect of end-user procurement contracts. There are key stages where quality and compliance should be addressed - these are identified on the RAPAT “Design and Manufacture” worksheet as follows:
Where the manufacturing process includes transition from a prototype or first run manufacture to high speed volume production, checks should be carried out to ensure that product quality, form (geometry) and fit (tolerances) are not adversely affected by the change or that there is no adverse impact on device function or performance.
As part of the design and manufacture specifications it is also important to identify and address any health and safety considerations related to the manufacturing process. These may include exposure of personnel to:
The manufacturer will need to demonstrate compliance with relevant national and international safety regulations
For medical and PPE applications, specific attention needs to be paid to the effects of the manufacturing process on surface roughness, material porosity and any other structural features that can harbour bacteria or viral media, on the ability to sterilise or clean reusable products. All manufacturing processes should be assessed for risks of infection arising from structural features. Due to the specific nature of 3D printing, this process may be particularly susceptible to this risk.
