Rush requests in regulatory submissions

Classes should reflect cost of delay and risk, not who shouts. Proposed: Expedite for patient-safety or regulatory stop-sale issues, one active at a time, named sponsor, four-hour response, daily review. Fixed Date for trade shows and campaign launches, with an external date and a published entry cutoff; reserve capacity. Standard for normal marketing material, target 10 working days, first-in-first-out within class. Intangible for low-value updates, best effort, may be batched. Policies: all requests enter intake; a triage role assigns class using written criteria; no director can reclassify by email, and escalation goes to the service manager; expedite limit is one or two; ready criteria before review include complete source data, approved claims, and a reviewer checklist. Publish a class matrix showing lead-time target, entry criteria, WIP allocation, and escalation path. Last month 31% Rush means the class is meaningless. Cap expedite and show displaced work. Review class mix weekly with stakeholders. This turns priority into a transparent policy rather than an interruption contest.

Calculate capability first. Demand is 95 per month, about 4.3 per day; peaks of 140 are about 6.4 per day. Review capacity is four reviewers, but interruptions reduce effective capacity; assume each can do five reviews per day, or 20 per day, so review is not the only constraint. Current lead time is 19 days at 4.3 per day, implying roughly 82 items in the system. To hit 10 days, target total WIP of about 43. Set stage limits: Intake/ready 8, Draft 10, Review 10, Sign-off 6, Publish 4, totaling 38, plus a review queue limit of 8-10. Allocate review capacity: 15% expedite reserve, 25% fixed-date, 60% standard. Do not raise limits during peak; instead reduce intake or extend standard lead time. Use a pull signal: a reviewer pulls only when below limit and the item meets ready criteria. Track queue age daily. The 35-50 review queue is a symptom of pushing work into review; limiting upstream drafting is the lever.

Make the cost of expediting visible. Publish a weekly 'expedite tax' view: number of expedites, standard items displaced, and lead-time impact. Require a named sponsor and a written reason for each expedite, and log it. Cap active expedite at one, or two during trade show season. Route director requests to the service manager, not reviewers, so the queue is protected. Train directors on classes and publish cutoff dates for fixed-date work. In the weekly service review, show class mix and whether the 31% Rush rate is real demand or gaming. If it is genuine, raise capacity or negotiate scope; if it is gaming, enforce criteria. Add a rule that reclassification after intake requires a trade-off decision. Measure expedite percentage, standard lead time, and fixed-date on-time performance. The goal is not zero expedites but intentional, limited, and visible ones. Reviewers then regain the ability to finish work instead of constantly switching.