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Milestones are tools used in project management to mark specific points along a project timeline. These points may signal anchors such as a project start and end date, or a need for external review or input and budget checks. Some contracts for products include a "milestone fee" that may be paid out when certain points are achieved.
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]
The program evaluation and review technique (PERT) is a statistical tool used in project management, which was designed to analyze and represent the tasks involved in completing a given project. PERT was originally developed by Charles E. Clark for the United States Navy in 1958; it is commonly used in conjunction with the Critical Path Method ...
The phased review process was intended to break up the development of any project into a series of phases that could be individually reviewed in sequence. Review points at the end of each phase required that a number of criteria be met before the project could progress to the next phase. [3] The phased review process consisted of five phases ...
In 2011, consideration of manufacturing readiness and related processes of potential contractors and subcontractors was made mandatory as part of the source selection process in major acquisition programs. [4] [5] MRLs are quantitative measures used to assess the maturity of a given technology, component or system from a manufacturing perspective.
The purpose of a technical peer review is to remove defects as early as possible in the development process. By removing defects at their origin (e.g., requirements and design documents, test plans and procedures, software code, etc.), technical peer reviews prevent defects from propagating through multiple phases and work products and reduce the overall amount of rework necessary on projects.
The IMP is a collection of milestones (called "events") that form the process architecture of the program. This means the sequence of events must always result in a deliverable product or service. This means the sequence of events must always result in a deliverable product or service.