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The manufacturing readiness level (MRL) is a measure to assess the maturity of manufacturing readiness, similar to how technology readiness levels (TRL) are used for technology readiness. They can be used in general industry assessments, [ 1 ] or for more specific application in assessing capabilities of possible suppliers.
Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
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 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 ...
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]
A Technology Readiness Level Calculator was developed by the United States Air Force. [6] This tool is a standard set of questions implemented in Microsoft Excel that produces a graphical display of the TRLs achieved.
Furthermore, many of the IMP events are fixed by customer-defined milestones (e.g., Preliminary or Critical Design Review, Production Deliver, etc.) while intermediate events are defined by the Supplier (e.g., integration and test, software build releases, Test Readiness Review, etc.).
Operations readiness is the process of preparing the custodians of an asset under construction, and their supporting organisation, to be fully ready to assume ownership of the asset at the point of delivery/handover, and to be able to take responsibility for performing the safe and efficient operation of that asset in a sustainable and environmentally-friendly manner.