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Gather evidence for an OOS investigation.

Bring the original out-of-specification result, preparation records and instrument evidence into a laboratory investigation brief.

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Illustration of a seal examining a circled change in a trace alongside run, sample and procedure records.
Neil reads
  • Original assay result, specification and raw-data links
  • Sample preparation, standard preparation and instrument logs
  • Applicable OOS procedure and any authorised investigation plan
Neil drafts

An OOS laboratory review brief with the original result and a targeted evidence request.

Your team decides

The laboratory supervisor assesses whether an assignable cause is documented; QA approves any invalidation.

Retesting and disposition need their own authorised decisions.

Example conversation

You

Review OOS-101 before the laboratory investigation meeting. What do we know, and what should we request?

Neil

The result is 92.4% against 95–105%. The preparation record lacks its balance printout, and the raw-data review remains open. I would preserve the OOS result and pursue those two evidence gaps separately.

Original assay retained
Original assay retained. : 92.4. Specification 95–105%. Example records.92.4%95%105%

You

Does the missing printout mean the weighing caused the OOS?

Neil

No. Missing evidence does not establish a weighing error. The record says dilution was recorded and suitability passed, but neither closes preparation or acquisition review. I would reconstruct the original calculation and weighing evidence before anyone attributes a cause or considers invalidating the result.

You

Prepare the OOS-101 brief for the investigation meeting.

Neil

Here is the OOS-101 brief: the 92.4% result stands, and the missing balance printout and open raw-data review are requested as two separate lines of evidence.

OOS-101 laboratory investigation briefReview draft · source evidence and assessment

OOS-101 laboratory investigation brief

The assay is 2.6 percentage points below the lower specification limit. Recorded system suitability does not establish that sample preparation was correct, and an absent printout does not establish that it was wrong. Link the original weighing evidence, dilution calculation and acquisition to the same preparation. The investigation can then evaluate a specific explanation without replacing the original result with a preferred outcome.

Source evidence and search scope

OOS-101 (Original assay); PREP-101 (Preparation record); SEQ-101 (Acquisition sequence)

OOS-101 / Original assay

Recorded evidence
92.4%; specification 95.0–105.0%

PREP-101 / Preparation record

Recorded evidence
Dilution recorded; balance printout not attached

SEQ-101 / Acquisition sequence

Recorded evidence
System suitability recorded as passed; raw-data review open
Inputs needed for your own records
  • Original assay result, specification and raw-data links
  • Sample preparation, standard preparation and instrument logs
  • Applicable OOS procedure and any authorised investigation plan

The laboratory supervisor assesses whether an assignable cause is documented; QA approves any invalidation. Retesting and disposition need their own authorised decisions.

Fictional source snapshots. No live query, assignment or approval.

Follow-up work and evidence requests2 proposed tasks · not assigned

Evidence to request

Reconstruct the original preparation
Laboratory investigator
Locate the balance printout, weighing identity, dilution steps and calculation. Record unresolved evidence without backfilling an original observation.
Review the original acquisition
Independent analytical reviewer
Inspect raw data, suitability and processing against the applicable method. Any retest or invalidation requires its own authorised rationale.
Example conversation · prepared replies

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Source excerpt

OOS-101

Original assay

Recorded evidence
92.4%; specification 95.0–105.0%

Selected fictional record, not a live source-system view.

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