What controls ensure formal approval of SOP revisions before implementation?

• A. Post-implementation review by staff.
• B. Formal approval by the designated approver and versioning in the document control system.
• C. No approval required.
• D. Only an email from the author.

Answer: (B)

Formal change control and document control are what ensure SOP revisions are properly vetted before they’re used. The designated approver is someone authorized to review changes for accuracy, safety, and compliance, and their formal sign-off provides accountability. Versioning in the document control system creates a precise record of what changed, when, and who approved it, and ensures the current revision is the one in use. This combination prevents unauthorized or outdated procedures from being implemented and keeps an auditable trail for audits and reviews.

Post-implementation review happens after changes are in place and cannot stop unapproved updates from being used. No approval at all leaves the system vulnerable to unmanaged changes and regulatory risk. An email from the author lacks the formal authorization, traceability, and controlled distribution needed for reliable SOP governance.