Who is the primary owner of an SOP?

• A. Approver authorizes.
• B. User executes.
• C. Owner creates and maintains.
• D. Custodian controls distribution.

Answer: (C)

Ownership of an SOP centers on accountability for the document’s content and its lifecycle. The primary owner is the person or role responsible for creating the SOP and keeping it current, accurate, and aligned with policy and practice. This means they oversee updates, revisions, and version control, set review intervals, approve changes, and ensure proper archiving when a procedure becomes obsolete. In short, the owner drives the document from draft to ongoing maintenance, making sure it reflects actual practices and remains compliant.

The other roles support the process but don’t carry the same overarching responsibility. The approver signs off on changes, confirming they meet requirements. The custodian handles distribution and access control, ensuring the right people can view or edit the SOP as appropriate. The user executes the procedure, following the documented steps.