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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.
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. [1]
Work breakdown structures that subdivide work by project phases (e.g. preliminary design phase, critical design phase) must ensure that phases are clearly separated by a deliverable also used in defining entry and exit criteria (e.g., an approved preliminary or critical design review).
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Download as PDF; Printable version; In other projects Appearance. ... Redirect page. Redirect to: Design review (U.S. government)#Preliminary Design Review (PDR)
The preliminary design review evaluates the adequacy of the preliminary design. In the following phase, detailed design is drawn and coded for the system as a whole and all the subsystems, and a critical design review is performed where it is evaluated whether the design is sufficiently detailed to fabricate, integrate, and test the system. [1] [2]
The primary objective of the IMP is a single plan that establishes the program or project fundamentals. It provides a hierarchical, event-based plan that contains: Events; Significant accomplishments; Entry and exit criteria; however it does not include any dates or durations.
[Entry evaluation]: The review leader uses a standard checklist of entry criteria to ensure that optimum conditions exist for a successful review. 1. Management preparation: Responsible management ensure that the review will be appropriately resourced with staff, time, materials and tools, and will be conducted according to policies, standards ...