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Design Control Snapshot: Advice About Design Change, Files, Inputs And More

This article was originally published in The Gray Sheet

Executive Summary

From our digital archives: Device changes and design history files are integral aspects of design control that work hand-in-hand and should not be overlooked by manufacturers, industry experts said. Firms should keep copious records of design changes that can later be reviewed in a design history file (DHF); otherwise they could encounter what one expert dubbed “change creep.” This happens when a manufacturer makes numerous changes to a product, “and then all of a sudden we have a design that doesn’t even look like the original device,” John Gagliardi of MidWest Process Innovation said in December 2012. Further, firms should ensure that human factors are taken into consideration when design inputs are gathered.

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