So let’s get down to it. The three topics in this blog will be; Design and development planning; Design and development inputs; Design and development outputs.
Design and development planning; you must plan and control the design and development of product through staging, review, verification and validation of each stage, assign responsibilities, manage the interface between responsibilities and groups, with any resultant design plan being updated as needed concerning the process. I have seen one page plans, 200 page plans. Simple Gantt charts and very complex MS Project type one. Just remember the above elements and have a plan.
Design and development inputs; inputs will include functional and performance requirements, applicable statutory and regulatory requirements, where applicable, information derived from previous similar designs, and other requirements essential for design and development. Yes, the ‘other’ requirements. Now here is the easy bit. These inputs are to be reviewed for adequacy, will be complete, unambiguous and not in conflict with each other. So easy. Just keep the above in mind when developing your plan.
And finally, design and development outputs are to be provided in a form that enables verification against the design and development input and approved prior to release. These outputs should meet the input requirements for design and development, provide appropriate information for purchasing, production and for service provision, contain or reference product acceptance criteria, and specify the characteristics of the product that are essential for its safe and proper use.
My head hurts. Just keep these as components of your plan and all should be good. Part 3 next fortnight.
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