RESPONSIBILITIES

Every SOP needs a responsibilities section. Ideally this section is broken down into identifiable roles and associated high level areas of responsibility. Responsibilities should most definitely not exist only in the responsibilities section. (I feel the same way about references, but this is a little more of a gray area in practice.) There should be at least one sentence in the SOP that clearly defines the responsibility in more detail. For example, the SOP describes a procedure for QA to:

1. create a draft document

2. route it for review in a document management system to specific individuals

3. adjudicate any redlines or comments

4. facilitate workflow to reach a final approved document.

All of these steps can be summarized in the responsibilities section as a QA responsibility to “coordinate document creation and approval.”

Alternatively, the responsibilities section could instead be a RACI (or RASCI if you want to get fancy). Using a RACI table for the responsibilities section has a couple of possible pros and cons:

Pros	Cons
forces author to clearly think through not only responsibilities, but also which roles are ultimately Accountable for, must be Consulted for, or simply Informed of an action	may be over engineered for the scope of the procedure
may make the section easier to scan than sentences or bullets	can also be confusing to users if introduced without training or used inconsistently