First, an SOP must be written for the end user. The technical writer should observe the individuals performing a process and make sure the SOP is reflective of the process. This is especially important when another department (e.g., Quality or Document Control) is asked to write a procedure for a production group. It is not possible to write an effective procedure without having extensive, first-hand knowledge of how a process is actually performed.

Second, an SOP must be easy to follow. An SOP should not sound like a re-reading of a regulation or a quality standard. If end users cannot tell what they are required to know or do after reading an SOP, than the SOP has failed. Objectives should be clearly stated. Responsibilities should be clearly defined. Deliverables should be clearly called out.

Lillian Erickson, MasterControl’s global quality manager