Outline the standard change-management steps that should be followed when an SOP is revised.

• A. Propose change, perform impact/risk assessment, draft revision, obtain approvals, train affected personnel, issue the new version, and archive the old version.
• B. Propose change, do nothing, issue the new version.
• C. Fire staff.
• D. Delete old SOP.

Answer: (B)

When revising an SOP, the process is a controlled sequence that ensures any change is justified, understood by those affected, and fully traceable. Start with proposing the change and evaluating its impact and risk on operations, safety, compliance, and quality. This impact assessment helps determine whether the revision is warranted and what resources or controls are needed. Next, draft the revision with the necessary edits, clearly reflecting what changes and why they’re needed. Obtain formal approvals from the appropriate authority to authorize the modification and to establish accountability for the update. Once approved, train the personnel who will be affected by the change so they understand the new requirements and how to apply them in practice. Then issue the new version as the official SOP and archive the old version to preserve a historical record and enable traceability or rollback if needed. This sequence protects consistency, regulatory compliance, and operational integrity. Skipping risk assessment, approvals, or training, or simply deleting or ignoring the old version, would undermine control, history, and accountability.