This is a ready-to-use form for any laboratory determination that is a trained person’s reading of a physical thing, a colony count, a visual clarity or particulate check, a turbidity or color-match call, rather than a number derived from an instrument data file. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Purpose
To record two genuinely independent readings of the same physical article by two different qualified people, within a window short enough that the article has not changed, and to document the disagreement rule and its outcome, so the second-person review is a real verification rather than one person’s number being initialed by someone who only glanced at it.
When to use
Complete one record for every result of this kind that a procedure designates as requiring second-person verification: colony counts, too-numerous-to-count and estimated-count plates, visual clarity or particulate observations, turbidity calls, color or appearance matches against a reference, and any comparable subjective or observational determination with no retained instrument raw-data file. Pair with the manual integration justification form for the separate, instrument-based manual-integration case, and with second-person review of analytical and QC laboratory data for the underlying method.
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Sample / article ID | Text (plate ID, vial ID, sample ID) | Yes | Reader 1 | At first reading |
| Method / test | Method ID and determination type | Yes | Reader 1 | At first reading |
| Maximum time window for the second reading | Duration, set from how fast the article changes | Yes | Method owner | Defined in advance |
| Reader 1 identity and reading | Name/ID + recorded value or observation | Yes | Reader 1 | At first reading, recorded before Reader 2 sees it |
| Reader 1 date/time | Timestamp | Yes | Reader 1 | At first reading |
| Reader 2 identity and reading | Name/ID + recorded value or observation | Yes | Reader 2 (independent of Reader 1) | Within the defined window, before seeing Reader 1’s value |
| Reader 2 date/time | Timestamp | Yes | Reader 2 | At second reading |
| Elapsed time between readings | Duration, compared against the maximum window | Yes | Either | At reconciliation |
| Agreement within defined tolerance? | Yes / No, against the method’s stated tolerance | Yes | Either | At reconciliation |
| If No: adjudication path followed | Third reading, or defined escalation, per method | Conditional | Supervisor / QA | On disagreement |
| Final recorded value and basis | Value + one-line basis for which reading, or the adjudicated result, was accepted | Yes | Reconciler | At reconciliation |
| Retained evidence | Photograph, retained article, or “none retained, technique does not support it” | Yes | Either | At reading or shortly after |
| Reader 1 signature and date | Signature + date | Yes | Reader 1 | At first reading |
| Reader 2 signature and date | Signature + date | Yes | Reader 2 | At second reading |
| Reconciler / QA signature and date (if adjudicated) | Signature + date | Conditional | Supervisor / QA | On disagreement |
Acceptance criteria
The record is acceptable when both readings were made independently, Reader 2 did not see Reader 1’s value before recording their own, the second reading occurred within the defined maximum window, any disagreement outside tolerance followed the defined adjudication path rather than an informal override, and the final value carries a stated basis.
References
21 CFR 211.194(a)(8) (second-person review for accuracy, completeness, and compliance). MHRA GxP Data Integrity Guidance and Definitions; PIC/S PI 041 (contemporaneous, attributable observation).
Confirm the current version of each reference before issue.
Filled specimen
| Field | Entry |
|---|---|
| Sample / article ID | EM plate EM-2026-3391, incubator 2, position C-14 |
| Method / test | Environmental monitoring, settling plate, TSA, 5-day incubation read |
| Maximum time window for the second reading | 30 minutes from Reader 1’s reading (method MIC-SOP-009) |
| Reader 1 identity and reading | J. Abara, 4 CFU, individual colonies, no overlap |
| Reader 1 date/time | 2026-09-14, 08:05 |
| Reader 2 identity and reading | D. Okafor, 4 CFU, recorded before seeing Reader 1’s value |
| Reader 2 date/time | 2026-09-14, 08:21 |
| Elapsed time between readings | 16 minutes, within the 30-minute window |
| Agreement within defined tolerance? | Yes, exact match |
| If No: adjudication path followed | N/A |
| Final recorded value and basis | 4 CFU, both independent readings agreed |
| Retained evidence | Photograph taken at 08:22, filed with the EM record |
| Reader 1 signature and date | J. Abara, signed, 2026-09-14 |
| Reader 2 signature and date | D. Okafor, signed, 2026-09-14 |
A second specimen row for a disagreement: Reader 1 reads a related plate, EM-2026-3392, as 12 CFU at 08:30; Reader 2 reads it independently at 08:48 as 15 CFU, a 3-colony spread outside the method’s stated tolerance of plus-or-minus one colony for counts under 20. The supervisor performs a documented third reading at 08:55, counts 15, and the final recorded value is 15 CFU with the basis “third reading by supervisor per MIC-SOP-009 section 6.4, two independent counts and the adjudicating count agreed at 15; Reader 1’s count is attributed to two closely adjacent colonies read as one.” Both original readings and the adjudication are retained; nothing is overwritten.
Common inspection findings this form prevents
- A “second reviewer” who looks at the first reader’s recorded count and initials agreement, rather than independently counting or reading the same article.
- A second reading performed so long after the first that the plate or sample has visibly changed, making independent verification meaningless even though a second signature exists.
- Disagreements resolved informally, “the senior analyst’s count wins,” with no documented rule and no record of the discrepancy.
- Too-numerous-to-count or estimated plates handled by eye-matching the first reader’s estimate rather than an independent one.
How to adapt this form
- Set the maximum reading window from the actual rate of change of the article your method covers, a fast-growing organism needs a shorter window than a stable visual reference.
- State your method’s numeric tolerance for colony counts, or the qualitative criteria for a visual or color-match disagreement, in the method itself, and reference it here rather than inventing a threshold on the form.
- Point the adjudication path to your real escalation procedure.
- If your technique genuinely supports no retained evidence at all, state that explicitly rather than leaving the field blank, so a reviewer later knows it was considered, not overlooked.