This is a ready-to-use log for an inspection front room and back room. Replace every <<FILL: ...>> placeholder with your own specifics and pair it with your inspection management SOP. A filled sample follows. This log is the company’s contemporaneous memory of an inspection and the source record for the observation response, so it must be complete and honest.
Purpose
To record every document and record requested during a health authority inspection, what was provided, when, in what form, whether the back room reviewed it first, and every commitment made to the investigator, so that the inspection is controlled in real time and can be reconstructed afterward.
When to use
Open one log per inspection, at the opening meeting, and keep it live until every commitment is closed. One coordinator or scribe owns entries; the back room owns the review linkage.
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Request number | Sequential integer | Yes | Scribe | As each request lands |
| Date / time received | Date + 24h time | Yes | Scribe | On request |
| Requested by | Investigator name or “lead / 2nd” | Yes | Scribe | On request |
| Request description | Free text, specific | Yes | Scribe | On request, spoken back to confirm scope |
| System / source | System or file location | Yes | Runner | On retrieval |
| Back room reviewed | Yes / No + reviewer initials | Yes | Back room | Before hand-off |
| Provided date / time | Date + 24h time | Yes | Coordinator | On hand-off |
| Format | PDF / paper / screen demo / export | Yes | Coordinator | On hand-off |
| Copies (investigator / file) | Y/N + Y/N | Yes | Document control | On hand-off |
| SME involved | Name / role | If applicable | Coordinator | On hand-off |
| Commitment made | None, or text + due date + owner | Yes | Coordinator | If a commitment is given |
| Commitment status | Open / Met (date) | Yes | QA | Until closed |
| Notes | Free text | No | Any | As needed |
The log
| Req # | Date/time | Requested by | Description | System / source | Back room reviewed | Provided | Format | Copies (Inv/File) | SME | Commitment (text / due / owner) | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Y + initials>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: none / text>> | <<FILL: Open/Met>> |
Instructions
- Assign the next sequential request number to every request, including verbal ones; do not skip or reuse numbers.
- Speak the request back to the investigator to confirm scope before logging it, so the description is exactly what was asked.
- The back room must review every retrieved record and initial the “Back room reviewed” field before the record crosses the table. A blank in that field means the record has not yet been cleared to provide.
- Record the format precisely; a screen demonstration is logged as a demonstration, not a document provided.
- Any commitment (a time to provide a record, an action promised) is entered with text, a due date, and a named owner, and is not closed until QA marks it Met with a date.
- At the close, reconcile the log: every provided record has a back room review, and every commitment has a status.
Retention
Retain the completed log as part of the inspection file for not less than <<FILL: retention period, e.g. the site records retention schedule>>. It is a quality record and supports the observation response and any later reconstruction.
Acceptance criteria
- Every request, including verbal, carries a unique sequential number and a specific description.
- Every provided record has a back room review entry before hand-off.
- Every commitment has an owner, a due date, and a closure status.
- The log reconciles at the close with no gaps.
Filled sample
Illustrative rows from an inspection day. Names and numbers are examples.
| Req # | Date/time | Requested by | Description | System / source | Back room reviewed | Provided | Format | Copies | SME | Commitment | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 014 | 08-12 09:42 | Inv. (lead) | Audit trail config record, HPLC-07 CDS | CDS admin export | Y (SA) | 08-12 10:15 | PDF + screen demo | Y / Y | QC lab lead | None | n/a |
| 015 | 08-12 10:05 | Inv. (lead) | Last 3 OOS for Product B, 2026 | QMS / LIMS | Y (SA) | 08-12 11:30 | Y / Y | Lab supervisor | Provide closure package for the open OOS by 08-13 12:00 (owner: QA) | Met 08-13 10:20 | |
| 016 | 08-12 13:20 | Inv. (2nd) | Training records, 4 named analysts | LMS export | Y (MO) | 08-12 14:00 | Y / Y | Training lead | None | n/a |
Row 015 shows the pattern that matters: the back room reviewed the OOS records first, noticed one was still open, the SME was ready to show its status, and the commitment to provide the closure package was logged with a due time and owner and then closed the next morning. Nothing was left to memory.
Common findings this log prevents
- No contemporaneous record of what the investigator requested or received, so the response cannot reconstruct the inspection.
- A record handed over without back room review, surfacing a problem the company could have been ready to explain.
- A verbal commitment to the investigator that was never tracked and never met, resurfacing at the next inspection.
- Uncertainty at the close about what was and was not provided.
How to adapt this log
- Add or remove columns to match your front room and back room roles, but keep the request number, back room review, and commitment fields.
- Decide whether you keep it on paper, in a controlled spreadsheet, or in your QMS, and validate the tool if electronic.
- Set the retention period from your records retention schedule.
- Pair it with your inspection management SOP.