Operational SOP Review Template

SOP weaknesses often appear when instructions are clear enough for routine use but not strong enough for handoffs, deviations, escalation, or inspection pressure.

Designed primarily for QA, compliance, documentation, and operational managers involved in SOP review or process ownership. It may also support document authors, reviewers, trainers, auditors, and cross-functional personnel who work with GMP procedures.

Use this template to review whether an SOP clearly defines:

• What action personnel are expected to take

• When routine conditions become non-routine

• When QA, management, or deviation pathways should be involved

• Who owns execution, review, approval, and follow-up

• Where unclear instructions could create deviation risk

• Whether the SOP can realistically be followed during operations

Includes review prompts, example weakness patterns, and space to capture observations, potential concerns, and follow-up actions.