Activity

  • alexandrabuga replied to the topic SOP: how much detail before too much detail? in the forum Device Documentation 7 years, 1 month ago

    I agree with @hm243 that SOPs should be very detailed and descriptive laying out the instructions on how to create a specific product. As Dr. Simon mentions in lecture it should be written at a HS level so that anyone can pick up the SOP and understand it and create the product. It should be written in such a way that you could just provide the SOP and someone who hasn’t done it before, would be able to create it. So a little more descriptive than an Ikea manual. SOPs are usually written during or before the Design Transfer, and training must take place on SOPs which is usually done during the Design Transfer. In order to perform an SOP you need to be trained on it and it must be recorded/logged in a validated training system. A general format includes; Purposes, Scope, References, Responsibilities, Definitions, Procedure, Approvals, and Appendices.