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One objective of a good design review is to examine the results of validation testing, making all product weaknesses visible. This examination involves applying another GD 3 concept, design review based on test results (DRBTR). When applying DRBTR, we must, wherever possible, observe the product test before, during and after completion.
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.
Manufacturing execution systems (MES) are computerized systems used in manufacturing to track and document the transformation of raw materials to finished goods. MES provides information that helps manufacturing decision-makers understand how current conditions on the plant floor can be optimized to improve production output. [ 1 ]
Nowadays, there is software available that combines the flexibility and user friendliness of both, but still some authors have reported that the use of this simulation to design and optimize manufacturing processes is relatively low. [3] [5] One of the most used techniques by manufacturing system designers is the discrete event simulation. [6]
The idea of "digital manufacturing" became prominent in the early 1970s, with the release of Dr. Joseph Harrington's book, Computer Integrated Manufacturing. [5] However, it was not until 1984 when computer-integrated manufacturing began to be developed and promoted by machine tool manufacturers and the Computer and Automated Systems Association and Society of Manufacturing Engineers (CASA/SME).
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.
This gives them the ability to respond rapidly to design changes and innovation, which is a competitive advantage over more traditional manufacturing processes. [13] An area of concern surrounding advanced robotics is the safety and well-being of the human workers who interact with robotic systems.