SOPs are all about control – controlling the Who, What, When, and How. But the real “art” of SOPs is determining the degree of control needed and mandating only the “must do’s.”
What are you trying to control? Who does what? Or how a task is performed? Or just the end-result?
Is this an activity where the steps need to be tightly controlled, or do you just need to define who will ensure the activity is done and require some form of checklist or documentation?
Does it really matter how the job is done or can you allow flexibility without compromising quality or compliance, as long as the end-result is achieved?
If you outline a “how,” can it be followed consistently at all times and for all studies?
