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To Ensure Workable Procedures, Consult Your Workers, FDA Advises

This article was originally published in The Silver Sheet

Executive Summary

EFFECTIVE QUALITY SYSTEM PROCEDURES begin with listening to employee feedback, FDA quality systems expert Kim Trautman tells device manufacturers. She points out that some firms have too many procedures, while others stuff their SOPs full of extraneous information, which is why it's important for companies to ask workers to sound the alarm when they become overwhelmed. Managers “need to go to the people who are doing the processes and determine what procedures they're utilizing, how they're utilizing them, and whether [the SOPs] are confusing or bouncing them around to too many different places,” Trautman says. Also, officials at Welch Allyn, Thoratec and Philips Consumer Healthcare Solutions discuss their approaches to building strong SOPs.
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