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In 21CFR820.3(h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems". The FDA also specifies that a design review should include an independent reviewer.
The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team.
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The preliminary design review was originally planned to be completed by June 2017. [5] While NASA received three inquiries for its August 2017 request for proposals, Lockheed was the sole bidder. [6] On April 2, 2018, NASA awarded Lockheed Martin a $247.5 million contract to design, build and deliver in late 2021 the Low-Boom X-plane.
One objective of a good design review is to examine the results of validation testing, making all product weaknesses visible. This examination involves applying another GD 3 concept, design review based on test results (DRBTR). When applying DRBTR, we must, wherever possible, observe the product test before, during and after completion.
The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...
The Preliminary Design Review took place in August 2017. [10] It was concluded that "The Power Processing Unit successfully demonstrated stable operation of the propulsion system and responded appropriately to all of our planned contingency scenarios." [11]
General Dynamics has conducted design review work using the input of soldiers and bringing the ASCOD 2 Chassis in line with the British requirements. The Ajax programme passed the "Preliminary Design Review" (PDR) initial design point in December 2012. At this stage of development, system maturity and preliminary system design were reviewed.