By Everett Larsen
Regulated industries — such as pharmaceuticals, brewing and distilling, or nuclear power — present special challenges for technical writers and information developers. These regulated industries have conflicting usability and compliance requirements, and within all of them the Standard Operating Procedure (SOP) is the primary document that provides both instructional content and regulatory compliance.
Successful SOP writing comes from balancing the competing needs of two groups of users: the regulatory community and the manufacturing process operators. A clear, concise SOP that fully focused on the information needs of its process users would almost certainly generate violations or warnings from its regulators. Conversely, an SOP that fully met a complete set of regulatory guidelines would be almost unreadable by anyone but a regulator, and would be useless for guiding any manufacturing process.
