Keep the result.Follow the phases.Decisions reviewed.
Work through the lab check, the hypothesis test and the manufacturing review, then close with a signed conclusion.
Evidence carried through the investigation.
Follow one investigation
Check the lab first
Interview the analyst, re-check raw data and calculations.
How OOS investigations work: lab check, hypothesis test, manufacturing review and closure
1. Check the lab first
Interview the analyst, re-check raw data and calculations.
Confirm instrument calibration and system suitability.
Verify standards, reagents and sample handling.
- Findings
- Each item records what was checked, what was seen and the evidence reference.
An OOS can also open automatically when an SPC rejection rule fires.
OOS-0019 · Phase IA
Lab investigation
- Result
- Assay 92.1% · spec 95–105
- Analyst interview
- Done
- Calculations
- Re-checked
- Instrument
- In calibration
- Standards
- In date · qualified
Each check needs a written finding.
2. A Hypothesis Test, Planned First
Document the hypothesis-test protocol and sign it first.
Record the result and conclusion.
Conclude Phase I or escalate to Phase II.
- References
- Checklist items reference the FDA OOS guidance sections they follow.
Whether a retest is justified is your lab's decision under your procedure.
OOS-0019 · Phase IB
Hypothesis test
- Protocol
- Signed before testing
- Test
- Fresh preparation
- Result
- 93.0%
- Lab cause
- None found
- Next
- Escalate to Phase II
No testing into compliance.
3. Then look at how it was made
Review the batch or device history record.
Check raw-material CoAs, dispensing records and the bill of materials.
Review process parameters, in-process data and equipment logs.
- Records
- Batch records and dispensing records come from V5 production.
The batch disposition stays with your quality unit.
OOS-0019 · Phase II
Manufacturing review
- Batch record
- WO-3402 reviewed
- Materials
- CoAs · dispensing
- Process
- Dryer temp low
- Root cause
- Assignable
- CAPA
- Corrective + preventive
Evidence from the batch, not memory.
4. A signed conclusion
Choose the outcome: confirmed OOS, invalid result, retest passed or failed.
Record corrective and preventive actions.
Sign the closure with a reason.
- Release
- A confirmed OOS informs the release review in QC release.
Who can sign phase advances and closure is set by your administrators.
OOS-0019 · closure
Quality
- Outcome
- Confirmed OOS
- Cause
- Assignable cause found
- Disposition
- Recommended to QA
- E-signature
- Reason recorded
- Status
- Closed
Closed and signed.
Where OOS fits
A result fails in the lab; the investigation reaches back into production and forward to release.
- Lab & QCSample plans, results against limits and out-of-spec review.See Lab & QC
- This pageOOS investigationsPhase IA, IB and II checklists with signed advancement and closure.
- SPC & TrendingLevey-Jennings charts and Westgard rules on every result.See SPC & Trending
- Release reviewReview exceptions and sign a release or hold decision.See Release review
AI and OOS investigations
An OOS draft is not an investigation result
An OOS draft is not an investigation result
Quality AI can assist a related deviation classification or CAPA draft where configured. Preserve original results and investigate under the approved procedure.
Everything in this feature
What OOS investigations use, and which plan each item needs. Compare plans
Phase IA / IB / II checklists
EnterpriseComplete to advance.
Signed hypothesis protocol
EnterpriseBefore any retest.
Signed phase advancement
EnterpriseE-signature with reason.
Closure outcomes and CAPA
EnterpriseConfirmed, invalid, retest result.
V5 holds the checklist and the evidence. People decide the cause and the disposition.
Explore the sample records.
Open a sample report to review its contents, supporting references and how the record is built.
UltimateSample register
OOS investigation record (CSV)
Test & release
Quality Evidence & Management Review Buyer Guide
A 19-page guide to quality decisions you can show evidence for: management review, lab results, approved suppliers and customer document sharing.
- Management review: inputs to owned decisions, with a worked quarterly review
- Lab results: specifications, out-of-specification investigation and release boundaries
- Approved suppliers: scope, evidence, expiry and a lapsing certificate
- Customer document sharing: approval, revision, withdrawal and portal evaluation
Plus Connected evidence map, RACI, implementation plan, RFP and scored checklist.
Get the quality evidence guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy.
UltimateFree buyer guide
Quality Evidence & Management Review Buyer Guide
Straight answers.
What buyers ask us first about Quality & Laboratory.
Does V5 release product automatically?
No. V5 gathers results and records for review, but a person in quality decides and signs the release.
What does the lab side cover?
Lab and QC covers sampling, instruments, methods, results and out-of-spec handling, with LIMS, lab notebook, stability and SPC on top. These are Enterprise features; see Compare details on the pricing page.
Can we use V5 in a validated environment?
For validation-controlled operations, V5's route is Enterprise private cloud with controlled upgrades and IQ/OQ support. Your team still validates V5 for its intended use.
More of the product
Start with one area. Add the rest when you are ready.
Warehouse & TraceabilityExplore 
Production & PlanningExplore 
This feature's areaQuality & LaboratoryExplore 
Documents & TrainingExplore 
Equipment & PerformanceExplore 
Orders & IntegrationsExplore
Try it with your last OOS.
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