Record: OOS Investigation Report (Phase 1 and Phase 2)

This is a ready-to-use investigation record. Replace every <<FILL: ...>> placeholder with your own specifics, and complete every field at the phase it belongs to, contemporaneously and signed. Phase 1 must be completed and signed before Phase 2 begins. Sections marked “complete only if applicable” are left N/A with a reason when not used. A worked filled specimen follows so you can see how a completed record reads. Verify each cited regulation against the current source before you rely on it.

Document control header

Section A: Event identification and triage

Triage actions confirmed before any rerun:

Section B: Phase 1 laboratory assessment

Performed by the analyst and QC supervisor under QA oversight, before Phase 2, evaluating execution only. Document each area as checked with the specific evidence reviewed. “Checked” with no evidence is not acceptable.

Phase 1 conclusion (select exactly one):

Section C: Retest / resample plan (complete only if applicable)

Approved by QA before any new result is generated. Leave N/A with a reason if neither is used.

Section D: Phase 2 full investigation (complete when Phase 1 finds no assignable laboratory cause)

Led by QA with manufacturing, process, and, where relevant, supplier quality and validation.

Section E: Assignable cause and invalidation decision

If no assignable cause was identified, the OOS is confirmed and attributable to the material. Record “Result invalidated: No” and proceed to disposition on that basis.

Section F: Batch disposition

Section G: CAPA and closure

References

This record satisfies the documentation requirements of the governing OOS SOP and the following sources. Confirm the current version and clause numbers of each before issue.

21 CFR 211.192 (production record review and investigation of any unexplained discrepancy or failure of a batch or component to meet specifications, whether or not the batch has been distributed). 21 CFR 211.165(f) (rejection of batches that fail to meet specifications). 21 CFR 211.194 (laboratory records and the supporting raw data). FDA Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (Level 2 revision, May 2022). ICH Q7, section 8.15 (deviations) and section 2.2 (responsibilities of the quality unit(s), covering review of deviations and investigations) for active pharmaceutical ingredients. ICH Q10 (pharmaceutical quality system) for the systemic handling and trending of quality events. EU GMP Chapter 6 (quality control) and Chapter 1 (pharmaceutical quality system); MHRA GxP Data Integrity Guidance and Definitions. ISO 13485:2016 clause 8.3 (control of nonconforming product), incorporated by reference under the harmonized QMSR, for finished-device testing.

Filled specimen

The following shows the record completed for an example finished-product assay closed at Phase 1 on a documented integration error. The company, system, and numbers are illustrative; replace them with your own.

Section A (extract):

Section B (extract):

Section E and F (extract):

Section G (extract):

Change one fact and the record runs differently. Had the chromatogram been clean, SST passed, calculation right, and nothing in the preparation explaining the number, Phase 1 would close with no cause, the 93.4 percent would stand, and Section D Phase 2 would open: a long granulation hold time in the batch record and two adjacent lots trending low (97.8 and 96.9 percent against a 95.0 floor) would give the OOS a product-side story, widen the scope to those lots, and force a disposition that confronts a real assay shortfall. The two records start with the identical number; the investigation, not the number, decides what it means.

Common inspection findings this record prevents

• Phase 1 documented as “no error found” with no evidence behind each assessment area.
• A result invalidated with no documented assignable cause recorded in Section E.
• Retest or resample performed without a QA-approved plan and predefined acceptance rule signed before results were seen.
• The original OOS omitted from the final evaluation, or an outlier test used to discard a failing assay.
• The analyst who generated the result recorded as the person who invalidated it.
• Phase 2 root cause stated as “human error” with no specific error and no scope assessment of related lots.
• Disposition that does not follow from the findings, or a batch released over a confirmed OOS.
• Closure past the committed timeline with no justification on file.

How to adapt this record

1. Set the form number and the governing SOP in the header to match your OOS procedure.
2. Add or remove Phase 1 assessment rows in Section B to fit your test types (for example microbiological identity, growth promotion, and incubation controls for a sterility OOS; standard curve and controls for a bioassay).
3. Keep the one-conclusion rule in Phase 1; do not add an in-between option.
4. Point Section D and F cross-references to your real recall, stability, and batch release procedures, and add the QP signature line only where Annex 16 release applies.
5. Tie Section G to your CAPA system so the CAPA-ID and effectiveness check are traceable.
6. Confirm every regulation cited in the governing SOP against the current published version before issue.