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In completing the Product Requirements Document (PRD) from Stage 1, you have defined the requirements for the product.
The industrial design team now has the parameters it needs to develop your product design.
Obviously, there will be many checks along the way (design reviews) to ensure the product is true to the requirements but also to allow for updates to the PRD when additional requirements are discovered either by the design team or through research on the technology or the customer application.
Updating the PRD will allow for a controlled way to change the direction of the design and will keep everyone on the same page.
The PRD will also indicate how the requirements will be verified, whether by testing, inspection, or other means.
The deliverable for this stage, the output of the design process, can be in many forms, but the minimum design output must be a set of documentation and design database information to repeatably and reliably manufacture the product.
The design process must also be controlled so that you can determine if the design output met the design input and has addressed all the design challenges that were discovered along the way. The design process must also have a risk management process to identify and mitigate any critical risks to safety, and to product function.
The design process is also iterative, with prototypes of different scope and complexity built along the way to verify the technology and the design approach. The simplest prototypes might be a 3D printed part to show that tab A fit into slot B, but prototypes of the final product, covered in the next Checklist, are suitable for Verification and Validation should be production ready versions, perhaps even Pilot Production.
Design Control Process
The design control process is a series of checkpoints that are necessary at major and minor design points. All design output should be reviewed before being released for manufacturing. One way to think about this – if you publish a document, a schematic, a part drawing, a procedure, etc. – it’s time for a design review.
Risk Management Process
The risk management process is required for Medical Devices and we highly recommend them for all products. This is more than a series of FMEAs (Failure Mode and Effects Analysis), but those are a good start. Sometimes products are so simple that the risks seem obvious, but you’d be surprised.
Product Resources uses ISO 9001, ISO 13485, and ISO 80079-34 as a basis for our quality system to cover Design Management and Risk Management.
Learn more about Product Resources’ approach to the manufacturing process. Just fill out the form to the left to download our FREE Manufacturing Checklists for this stage or any of the six stages in the manufacturing process.
We also provide relevant templates and tools you can use in your own manufacturing process.
Here’s what we’ll cover in Stage 2 – Design: