Inspection Day Playbook: Who Talks, What Opens, What Waits

Inspection day is not the time for improvisation. Conflicting answers, missing

SMEs, or over-sharing beyond scope can turn a manageable visit into a 483. The

best teams treat inspection day like a live performance backed by a rehearsed

script.

This playbook choreographs the room. You will clarify roles, stage document

routing, define how to defend scope without sounding defensive, and establish

communication protocols that keep the inspector informed without exposing

unnecessary risk.

Inspection day truths you should plan for

Inspectors arrive with hypotheses. Every answer either confirms or dispels

them. Consistency is vital.

Time evaporates. Without predefined roles, requests pile up and anxiety spikes.
Scope creep is inevitable. If you cannot diplomatically redirect, the visit

expands and findings multiply.

Documentation errors appear when no one verifies the package before it leaves

the backroom.

Build the team: who talks and who supports

Core front-room roles

Inspection lead: Owns scope management, decides who speaks, and closes

each session with a recap.

Primary spokesperson: Delivers strategic statements, aligns with the lead,

and keeps responses succinct.

Scribe: Logs every question, document request, commitment, and follow-up in

real time. Captures timestamps and responsible owners.

Escort: Manages inspector movement, coordinates breaks, and ensures

facility rules are followed.

Backroom engine

Document control coordinator: Receives requests from the scribe, routes to

system owners, confirms version, and packages documents with cover sheets.

Technical SME bench: Prepped experts standing by, entering the front room

only when invited.

Quality reviewer: Reviews every document before release and confirms it

matches the request.

Runner: Delivers evidence from backroom to front room and collects

signatures or acknowledgments.

Create role cards with responsibilities, escalation paths, and backup contacts.

Distribute cards a week before the inspection and rehearse together.

Engineer a precise document routing workflow

Request capture: Scribe records request ID, description, deadline, and the

inspector’s phrasing.

Backroom intake: Document coordinator logs the request in the tracking tool

and assigns retrieval to the content owner.

Quality review: QA checks content, redacts sensitive information if needed,

and ensures alignment with approved versions.

Packaging: Prepare a cover sheet summarizing the request, document ID,

revision, and owner verification signature.

Delivery: Runner brings the package to the front room. The lead verifies it

fulfills the request before handing it to the inspector.

Close-out: Scribe marks the request as delivered and notes any follow-up or

inspector comments.

Set target turnaround times (e.g., 5 minutes for controlled SOPs, 15 for batch

records) and monitor during the inspection. Conduct daily stand-ups to address

bottlenecks.

Control the scope without confrontation

Equip the inspection lead and spokesperson with respectful redirection phrases:

“We can gather that information for you, but it falls outside the agreed scope.

Would you like to log it as a potential follow-up?”

“To stay within the focus of this inspection, may we note that question and

revisit if time allows?”

“That system is managed by our partner site. I can have the liaison provide a

written update if you would like.”

Log every scope-challenge request. If the inspector insists, escalate to

leadership quickly so the decision is deliberate and documented.

Communication protocols in the room

Answers should be brief, factual, and linked to source documents.
If you do not know, say so: “I do not have that detail in front of me. May I

confirm and return with the exact information?”

SMEs speak only when invited by the inspection lead. Before entering, they

receive a quick brief on the context.

Summarize each session: “Today we provided X documents and committed to Y

follow-ups. Tomorrow we will cover Z.”

Metrics to monitor in real time

Average response time for document requests.
Number of scope challenges raised and resolved.
Accuracy of the scribe log (validated during end-of-day backroom reviews).
Volume of last-minute SME call-ins (indicator of preparation gaps).
Commitments logged versus commitments closed on time.

30-day preparation plan

Day 0-7: Review transcripts from the last inspection. Identify where

answers deviated or scope ballooned. Update role cards accordingly.

Day 8-14: Build or refresh the document routing tracker, test the workflow

with a mock request cycle, and confirm all stakeholders can access the tool.

Day 15-21: Host a 60-minute rehearsal covering opening meeting, key

process walkthrough, and scope challenge scenarios.

Day 22-30: Finalize talking points, distribute logistics (badges, room

layout, contact lists), and conduct a final readiness check.

Frequently asked questions

How detailed should role cards be? One page each. Include responsibilities,

contact numbers, escalation chain, and reminders (e.g., scribe logs requests in

real time, do not paraphrase).

What tools work for tracking? Excel, Smartsheet, or your QMS request module

all work—choose what the team already uses daily.

How do we handle virtual inspections? Replicate roles in a digital control

room. Use secure screen-sharing, breakout rooms for SMEs, and a chat channel

dedicated to backroom coordination.

When should leadership join? Opening meeting for tone, closing meeting for

commitments. Otherwise they stay on standby unless escalation is required.

Sustain the win

Debrief within 48 hours after every inspection. Update scripts, role cards, and

routing workflows based on what worked and what did not. Rotate inspection leads

to build depth and prevent burnout. With a rehearsed playbook, inspection day

feels controlled—and inspectors leave impressed by your discipline.