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  • Luisa Gutierrez replied to the topic SOP: how much detail before too much detail? in the forum Device Documentation 8 years, 1 month ago

    I agree with the comments above that an SOP is a step by step process that provides guidance to the person reading the procedures. In addition, the type of detail that goes into the SOP is crucial to accommodate any worker so if for instance you bring a person from outside the company with no prior knowledge, they can read through the SOP and be able to still provide a consistent product. One side to the SOP’s that I see that detail can provide an issue is having tight tolerances. For example, if the medical device requires to have a specific length with the tight tolerance and the employee keeps getting the wrong tolerance. It can provide that confusion of the device failing a verification step due to that tight tolerance while in reality the part is still usable. In addition, the goal of SOP’s is to also go to the point on how to do something. There are times that there are sections providing detail on why it works or any other unnecessary details that ultimately can be removed to provide a simplified SOP that gets straight to the point.