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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.
The IMP documents the key events, accomplishments, and the evaluation "criteria" in the development, production and/or modification of a military system; moreover, the IMS provides sequential events and key decision points (generally meetings) to assess program progress. Usually the IMP is a contractual document.
An important design principle for work breakdown structures is called the 100% rule. [19] It has been defined as follows: The 100% rule states that the WBS includes 100% of the work defined by the project scope and captures all deliverables – internal, external, interim – in terms of the work to be completed, including project management.
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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]
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