What this is
What is an out of specification report?
What is an out of specification report?
An out of specification report records a laboratory or test result that falls outside its specification limits, and phases the response into a laboratory investigation and, if that does not explain the result, a process investigation. It is raised the moment the result is confirmed, not reconstructed afterwards.
Who completes an out of specification report?
The laboratory that produced the result, working with quality. The analyst and any reviewing chemist supply the phase one detail; quality owns the decision on whether a process investigation is required and signs the conclusion alongside the laboratory manager.
What is the difference between an OOS report and incoming material inspection?
Incoming material inspection is the routine check performed on receipt of material, before it enters stock. An OOS report is the investigation raised when a specific test result, wherever it was generated, falls outside specification, and it can be triggered by a result recorded during an incoming inspection as much as by in-process or release testing.
Scope
When is an out of specification report required?
This report covers a confirmed laboratory or test result outside its limits. Where the result was never confirmed, or where the nonconformance is in the product or process rather than the test itself, a different record applies.
Use this template when
- A laboratory or test result has come back outside its specification limits and has been confirmed by the analyst
- A decision is needed on whether the result reflects a laboratory error or a genuine failure before any retest is run
- The result may affect other batches tested by the same method, equipment or analyst and those need identifying
- A retest is being considered and needs a documented justification and a protocol defined in advance
- The investigation needs to route into a root cause analysis or a hold on other product
Do not use it for
- Product Nonconformance Report, which records product that does not meet specification for reasons other than a laboratory test result.
- Process Deviation Report, which records a process running outside its set limits even where the product still passed.
- Incoming Material Inspection, which is the routine receipt check that may generate the result this report investigates.
- Hold and Release Record, which places the affected batches on hold and records the disposition decision once the OOS investigation is complete.
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Compliance mapping
Which ISO 17025 requirements does this satisfy?
Neither ISO 17025 nor FDA OOS guidance prescribes a report format, but both are specific about sequence: laboratory competence must be demonstrated before a result is doubted, and a result must be investigated before it is retested away.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 17025 cl.7.10 | Nonconforming work identified, evaluated for significance, and corrective action taken before results are released or acted on | Phase one, laboratory investigation |
| ISO 17025 cl.6.4 | Equipment used for testing shown to be calibrated and fit for the method at the time of test | Phase one, laboratory investigation |
| ISO 17025 cl.7.2 | Method validated and followed as specified, with deviations recorded and justified | Phase one, laboratory investigation |
| FDA OOS guidance, phase I | Laboratory investigation completed before retesting, covering calculation, method, equipment and analyst error | Retest decision |
| FDA OOS guidance, phase II | Manufacturing and process investigation where the laboratory phase does not explain the result | Phase two, process investigation |
| ISO 17025 cl.7.11 | Records controlled and retained to demonstrate the basis for the conclusion reached | Conclusion |
What it does not cover
- Incoming Material Inspection, the routine receipt check, run at the supplier's sampling rate, that this report's triggering result may have come from.
- Hold and Release Record, which records the physical disposition of the affected batch once this investigation has concluded, not the investigation itself.
- Root Cause Analysis, the structured investigation this report should route into once a process cause is suspected, rather than a substitute for one.
- Corrective and Preventive Action, which tracks the action arising from the conclusion, not the investigation that produced it.
- Calibration records, which are checked against here but are maintained and closed as their own system, not inside this report.
Global
Out of Specification Report requirements by country
Laboratory competence and OOS investigation practice are set by ISO 17025 and FDA guidance rather than by a single statute, so the practical variation is in how strictly a regulator expects the phased sequence to be evidenced.
FDA OOS guidance; 21 CFR 211.192
Investigation of any unexplained failure to meet specification is a cGMP expectation, and the OOS guidance sets the phased method regulators expect.
FDA inspectors read a retest run ahead of a completed laboratory investigation as testing into compliance, one of the most cited laboratory findings in warning letters.
UKAS accreditation to ISO 17025; MHRA GMP inspection
Accredited laboratories must demonstrate the nonconforming work procedure was followed, and MHRA-regulated sites face the same phased-investigation expectation as FDA.
An accredited laboratory unable to show its OOS procedure was followed on a result risks a finding against its accreditation, independent of any product decision.
ISO 17025:2017
Clause 7.10 requires nonconforming work to be evaluated for significance before further action, the principle FDA OOS guidance applies specifically to pharmaceutical and food testing.
Any accredited laboratory is assessed on whether it evaluates before it acts, not on whether it uses this specific report format.
How to complete it
How to complete an out of specification report, step by step
The fields prompt for the checks. What determines whether the report survives an audit is the reasoning that connects those checks to the conclusion reached.
Method, calibration, reagents, controls and calculation each need a specific answer, not a blanket pass. A laboratory error recorded without a corresponding entry in the error detail field reads as a conclusion chosen before the investigation was done.
A retest justified by a laboratory error still needs its protocol, sample and acceptance criteria defined before the result is known. A protocol written after the second result confirms whichever answer was preferred is not a retest.
Whether other batches were affected has to be answered against what the same cause could plausibly have touched, not against what has actually been tested so far. Closing before this is settled is how a genuine failure reaches a second batch.
A quick debrief closes a clear laboratory error; a genuine out of specification result with product still in the field needs a full or cross-functional root cause analysis. The lighter option chosen because the result is inconvenient defeats the report's purpose.
What auditors find
Most common out of specification report findings
OOS reports are unusual among quality records because the underlying event is unambiguous. What audits find wrong is the reasoning between the result and the conclusion.
| Finding | Clause | What fixes it |
|---|---|---|
| Retest run before the laboratory investigation was completed. | FDA OOS guidance, phase I | Complete method, calibration, reagent, control and calculation checks and reach a phase one conclusion first. |
| Laboratory error concluded with no supporting detail in the error field. | ISO 17025 cl.7.10 | Require a specific, evidenced entry whenever laboratory error is identified; a checkbox alone is not a finding. |
| Retest protocol was not defined until after the retest result was seen. | FDA OOS guidance, phase I | Record the protocol, sample plan and acceptance criteria at the point the retest is justified, before it runs. |
| Other batches from the same cause not identified or not placed on hold. | ISO 17025 cl.7.10 | Assess scope against what the suspected cause could plausibly affect, and raise the hold before closing. |
| Process investigation skipped despite an inconclusive laboratory phase. | FDA OOS guidance, phase II | Treat an inconclusive phase one result as a trigger for phase two, not a route to closing the report. |
| Conclusion reached without a rationale a reviewer could independently follow. | ISO 17025 cl.7.11 | Require the rationale field to state the evidence for the conclusion, not restate the conclusion. |
Case in point
Case in point: the retest that closed the wrong question
A dairy plant's finished yoghurt failed a microbiological release test. The analyst re-ran the sample the same afternoon on a fresh aliquot, the second result passed, and the batch was released with the report noting analyst error as the cause without further detail. Three weeks later a customer complaint led to testing of a retained sample from the same batch, which also failed.
The retrospective review found the laboratory investigation had never checked whether the incubator used for the first test was within its calibrated temperature range, and it was not; the second test happened to run in a different, correctly calibrated unit. The retest had not investigated anything, it had simply repeated the test under different conditions and taken the pass as vindication. The corrective action was requiring the phase one checklist, including equipment status, to be completed and evidenced before any retest could be authorised at all.
The template
The template, field by field
The form exactly as it installs. Every field, option, score and conditional rule is editable, and the links to other templates come with it.
6 sections
- Reference
- QUA-010
- Archetype
- Record
- Record ID
- CASE-2026-000
- Scoring
- Not scored
- Direction
- n/a
- Singleton
- No
- Basis
- ISO 17025, FDA OOS guidance
- Links
- Feeds RCA, Hold
- Tags
- Quality, Laboratory
- Sections
- 6
- Fields
- 54
- Follow up fields
- 10
- Repeating sections
- 0
- Links out
- 5
Header
13 fieldsCase ID*
Auto sequence. Format CASE-2026-00000.
The record's own ID. Other templates point at this value.
Status*
Drives who this goes to next.
- Planned2 pts
- In progress2 pts
- Complete3 pts
- Deferred0 pts
- Open0 pts
- Closed3 pts
- Overdue0 pts
Date and Time*
Raised By*
Site*
Site ID*
Format SITE-000.
Links to FDN-001 Site ID
Line*
Shift*
Line Lead
Batch Number*
Numeric key joining to your ERP batch record.
Links to External system reference
Product*
Production Date*
Investigate Before Retesting
A result outside specification is treated as real until proven otherwise. Investigate the laboratory first, then the process. Retesting until you get a pass is not investigation.
The result
8 fieldsTest Performed*
Specification*
Result Obtained*
Laboratory*
Analyst
Date Tested*
Sample Reference*
Sample Retained*
- Yes3 pts
- No0 pts
Phase one, laboratory investigation
9 fieldsMethod Followed Correctly*
- Yes3 pts
- Deviation found0 pts
Equipment Calibrated*
- Yes3 pts
- No0 pts
Calibration Record ID
Links to QUA-065 Calibration ID
Reagents In Date*
- Yes3 pts
- No0 pts
Controls And Standards Passed*
- Yes3 pts
- No0 pts
Calculation Checked*
- Yes3 pts
- No0 pts
Sample Handling Correct*
- Yes3 pts
- Deviation found0 pts
Laboratory Error Identified*
- No3 pts
- Yes0 pts
Error Detail
Retest decision
5 fieldsRetest Justified*
Only where a laboratory error is identified. Not because the first result was inconvenient.
- Yes, laboratory error identified3 pts
- No0 pts
Retest Protocol Defined Before Testing
- Yes3 pts
- No0 pts
Number Of Retests
Retest Results
Retest Conclusion
Phase two, process investigation
9 fieldsProcess Investigation Required*
Other Batches Affected*
- No3 pts
- Yes0 pts
Other Batches Placed On Hold*
- No3 pts
- Yes0 pts
Quantity Affected
Hold ID
Raise the hold record, then enter its reference.
Links to QUA-003 Hold ID
Product Location
Where the affected product physically is right now.
Investigation Required*
Set by potential outcome, not by what actually happened.
- No3 pts
- Yes0 pts
Investigation Level
RCA ID
Format RCA-2026-00000.
Links to FDN-013 RCA ID
Conclusion
10 fieldsFinal Conclusion*
- Laboratory error, result invalid2 pts
- Genuine out of specification result0 pts
- Inconclusive1 pt
Rationale*
Action Required*
Raise the action record, then enter its reference here.
- No2 pts
- Yes0 pts
Priority
- High0 pts
- Medium1 pt
- Low3 pts
CAPA ID
Format CAPA-2026-00000.
Links to FDN-014 CAPA ID
Action Owner
Laboratory Manager*
Signature*
Quality Manager*
Second Signature*
QUA-010 · record IDs look like CASE-2026-000 · Feeds RCA, Hold
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The report captures a single result. What fails afterwards is whether the scope decision, the retest protocol and the downstream hold actually happen in the order the investigation requires.
Holds the OOS register against open holds and RCAs, and flags any retest recorded before phase one shows a completed conclusion.
Tracks where the affected batch physically sits once a hold is raised, so scope decisions match what can actually be recovered.
Watches for a retest entered against an open phase one investigation and holds the record for review before it can close.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Out of Specification Report definitions and key terms
- Out of specification
- A test result that falls outside the specification limits set for that parameter, confirmed by the analyst rather than a raw or transcription error.
- Phase one investigation
- The laboratory investigation into method, equipment, reagents, controls and calculation, carried out before any retest is considered.
- Phase two investigation
- The process or manufacturing investigation triggered when phase one does not identify a laboratory cause for the result.
- Retest
- A further test run on the original sample or a fresh one, justified only by an identified laboratory error and governed by a protocol fixed in advance.
- Retained sample
- A portion of the original sample kept back specifically so it can support a retest or an independent check of the result.
FAQ
Frequently asked questions about out of specification report
Can we retest before finishing the laboratory investigation?+
No. FDA OOS guidance treats an early retest as testing into compliance, one of the most consistently cited laboratory findings. A specific laboratory cause must be identified before a retest is justified.
What if the laboratory investigation is inconclusive?+
It routes into a process investigation. Inconclusive is not licence to average the original and retest results, or to close on the more favourable figure; it is the trigger for phase two.
Does averaging the original and retest results solve the problem?+
No, and FDA guidance specifically warns against it. Averaging conceals which result was correct and treats two different measurements as though they were one.
Who decides whether other batches are affected?+
Quality, working from what the identified or suspected cause could plausibly touch, not from what has already been tested. A cause traced to a reagent lot or equipment scopes to everything that used it.
What closes an OOS report?+
A conclusion of laboratory error, genuine out of specification result, or inconclusive, each with a stated rationale, plus a decision on further action and signature from both the laboratory and quality managers.
Does an inconclusive result count as passing?+
No. Inconclusive means the investigation could not establish a laboratory cause, which under FDA OOS guidance defaults the batch toward the genuine failure side, not toward release.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in Nonconformance and Complaints
Root Cause Analysis
Finds out why something happened rather than who was involved
Corrective and Preventive Action
The single action record used everywhere
Product Nonconformance Report
Records product that does not meet specification
Process Deviation Report
Records a process that ran outside its set limits, even where the product still passed
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
Rework Authorization
Authorises rework on nonconforming product and sets out exactly what will be done
More in Nonconformance
Product Nonconformance Report
Records product that does not meet specification
Process Deviation Report
Records a process that ran outside its set limits, even where the product still passed
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
Rework Authorization
Authorises rework on nonconforming product and sets out exactly what will be done
Scrap Record
Records product written off, with quantity, reason and cost
Concession Request
Requests permission to use or ship product that does not fully meet specification
Written and reviewed by
Siddarth Singh
Founder & Chief Executive Officer, Knowella
Certified Safety Professional and industrial and systems engineer with more than a decade inside food supply chain, freight and manufacturing operations. This page was written against the current text of the standards it cites, not against secondary summaries of them.
- Certified Safety Professional (CSP), Board of Certified Safety Professionals
- MBA, University of Chicago Booth School of Business
- MS and BS, The Ohio State University, Industrial and Systems Engineering
- Six Sigma Black Belt
Sources and last review. Reviewed 16 August 2026 against:
- ISO 17025:2017 clauses 6.4, 7.2, 7.9, 7.10 and 7.11
- FDA guidance for industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- 21 CFR 211.192 — Production record review
- MHRA GMP inspection guidance on laboratory investigations
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.