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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.
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 ...
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 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.
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.
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