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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.
Example from MIL-HDBK-881, which illustrates the first three levels of a typical aircraft system [1] A work-breakdown structure (WBS) [2] in project management and systems engineering is a deliverable-oriented breakdown of a project into smaller components. A work breakdown structure is a key project management element that organizes the team's ...
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.
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 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]
From Wikipedia, the free encyclopedia. Redirect page. Redirect to: Design review (U.S. government)#Preliminary Design Review (PDR) Retrieved from "https: ...
Major system design features are stable and proven in test and evaluation. Materials are available to meet planned rate production schedules. Manufacturing processes and procedures are established and controlled to three-sigma or some other appropriate quality level to meet design key characteristic tolerances in a low rate production environment.