Design Verification is the next required step in the design process. Verification is literally an examination of evidence to prove the predetermined requirements have been met. This is an exercise done on paper, where you take all of the design inputs (specifications, regulations, knowledge from previous designs, and any information required for proper function of the device) and compare them to the design outputs (drawings, assembly instructions, design files, test instructions, etc.). The goal is to verify that the product is actually designed as it was intended. Also, you will need to verify that the design is safe and will not cause harm to the end user.
A Design Verification can be performed at each stage of development. In the beginning, the verification is a key quality assurance step. As the process evolves, the activities will become more detailed and comprehensive. Towards the end of the design stage, the interaction of the various factors will need to be considered. According to the FDA, “the basis of verification is a three-pronged approach involving tests, inspections and analyses.” Any combination of approaches can be used including (but not limited to) fault tree analysis of a design or process, failure mode and effects analysis, and comparison of a design to a previous product or package integrity tests.
A Statement of Compliance can be created to document the outcome of each verification. Identified in this document is the design being evaluated, the method of verification used, what date this was performed on, and the individuals involved in the verification. This document will list every requirement for the design, note if the design is in compliance or not, and list the evidence of this compliance. The Statement of Compliance should be filed in the Design History File.
Some manufacturers have confused production testing with verification – the two are not the same. Production testing will tell you if the device being tested has been manufactured correctly, whereas verification testing will establish the correlation between design input and design output.
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