This is a ready-to-use scribe log. It is the single most valuable artifact a live inspection produces: a timestamped, factual record of everything that happened in the front room. It drives the back room request list, the daily debrief, and the eventual response to observations, and it tells you exactly what the inspector saw. Replace every <<FILL: ...>> placeholder, keep it under front room control, and reconcile it with the back room request tracker at every break. A filled specimen follows.
How to use this log
- Two scribes where possible: one types the record, one listens for nuance and watches the inspector’s reactions. Reconcile at breaks.
- Capture the request wording exactly. “Calibration records for the autoclave” is a different scope than “all calibration records for sterilization equipment.” Scope errors here cause over-disclosure.
- Flag, do not editorialize. Write “v5 still cited in training matrix,” not “training matrix is wrong, we are in trouble.”
- The scribe writes; the scribe does not answer questions or join the discussion.
- Time-stamp every row. Reconstructing the day depends on it, especially when mapping observations back to what was said and provided.
Log header
| Field | Entry |
|---|---|
| Inspection reference | <<FILL: internal inspection ID>> |
| Authority | <<FILL: FDA / EMA-coordinated / national competent authority / MHRA / PMDA>> |
| Inspector(s) | <<FILL: names / IDs>> |
| Inspection day | <<FILL: Day n of the inspection>> and date <<FILL>> |
| Scribe(s) | <<FILL>> |
| Front room host | <<FILL>> |
| Page | <<FILL: n of m>> |
Scribe record
| Time | Topic | Inspector question (verbatim where possible) | Who answered | Documents requested (scope) | Documents provided (ID, version, time) | Commitment made | Note / concern (flag only) |
|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: none / detail>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Continue on additional pages; keep pages numbered and in sequence.
Field definitions
- Time: local time the exchange occurred, to the minute.
- Topic: the system, process, or record area under discussion.
- Inspector question: the exact wording where you can capture it; the scope of a request lives in the wording.
- Who answered: name and function of the SME or host who responded.
- Documents requested (scope): exactly what was asked for, at the scope confirmed by the host, no broader.
- Documents provided: the document ID, version, and the time it was handed over, so you know precisely what the inspector holds.
- Commitment made: any timeline or action the host committed to; only the host should make commitments, and every one must be captured here.
- Note / concern: a neutral flag for the back room to work, never a judgment or an admission.
End-of-day reconciliation
At the close of each day, the scribe and back room lead reconcile this log against the master request tracker:
| Reconciliation check | Confirmed |
|---|---|
| Every document request in the log appears on the request tracker | <<FILL: Y/N>> |
| Every document provided is logged with ID, version, and time | <<FILL>> |
| Every commitment made is captured and assigned an owner | <<FILL>> |
| Open requests carried to tomorrow are listed | <<FILL>> |
| Flagged concerns are on the debrief parking lot | <<FILL>> |
Filled specimen
| Time | Topic | Inspector question | Who answered | Documents requested (scope) | Documents provided | Commitment | Note / concern |
|---|---|---|---|---|---|---|---|
| 09:14 | Batch record review | ”Show me how a second person verifies the line clearance entry.” | J. Doe, Mfg QA | SOP for second-person verification of line clearance | SOP-QA-014 v6, 09:31 | None | Training matrix still cites v5; flag for debrief |
| 09:40 | Deviation handling | ”What is your timeline to close a major deviation?” | A. Smith, QA | Deviation log, Q1, major only | Filtered deviation report, 09:52 | None | One open >90 days; justification memo staged |
| 10:05 | CAPA | ”Show me the CAPA for DEV-2026-118.” | A. Smith, QA | CAPA record DEV-2026-118 | In progress | None | Effectiveness check pending; prep CAPA owner as SME |
In this specimen the scribe captured the exact request wording, logged the version and time of each document handed over, flagged the training-matrix inconsistency neutrally for the back room, and noted an open deviation without editorializing. That record is what the response team uses later to map each observation back to what was actually said and provided.
Common inspection findings this log helps prevent
- The site finishes the inspection with no clean list of what was provided, so the response team guesses at what the inspector saw.
- A commitment was made by an SME and never tracked, then missed.
- A document was handed over at a broader scope than requested, and nobody noticed until it opened a new line of questioning.
- Answers drifted between SMEs because there was no contemporaneous record to align to.
How to adapt this log
- Set the inspection reference and authority in the header; keep one continuous log per inspection with numbered pages.
- Assign two scribes where staffing allows and define how they reconcile at breaks.
- Wire this log directly into your back room master request tracker so requests and provisions cross-check.
- Feed the completed log into your post-inspection response drafting as a controlled output.
- Keep the log factual; the discipline of flag-not-editorialize is what keeps it useful and safe.