Alert limits and action limits are one of the fastest ways to make a monitoring program defendable. They also prevent the two failure modes auditors see all the time: dashboards with no decisions, and decisions with no thresholds.

What good looks like

  • Alert limit = investigate signal and document assessment
  • Action limit = execute a defined response (change control,CAPA,rollback,process controls)

Starter checklist

1) Define the baseline (validated reference) 2) Pick acceptance metrics (what “acceptable” means) 3) Separate signals (data drift,concept drift,performance drift) 4) Set limits by risk (patient impact drives tightness+SLA) 5) Assign owner+backup (named accountability) 6) Define response SLAs (review,escalation,closure) 7) Document decisions (review minutes matter) 8) Link actions to change control (threshold updates,retraining,rollback)

Visual checklist

Alert+Action limits starter checklist

If you want an editable template version,reach out via the contact page.