What this is
What is a complaint investigation record?
What is a complaint investigation record?
A complaint investigation record is the document that establishes the cause of a customer complaint by pulling the batch, line and shift records for the product concerned and comparing them against the complaint. It sits between the complaint being logged and any decision on recall, rework or corrective action.
Who carries out the investigation?
Quality, working with production. Quality owns the conclusion and the sign-off, but production holds the batch, line and shift context, and the crew who ran it can usually explain an anomaly in the record faster than it can be inferred from the data alone.
What does the investigation actually establish?
Three separate judgements: whether the complaint is substantiated by the evidence, whether the fault is attributable to the site rather than transport, storage or misuse after despatch, and whether other product from the same cause is still at risk. Each is a distinct question, and conflating them is the most common way an investigation goes wrong.
Scope
When is a complaint investigation record required?
The investigation is the diagnostic step in the complaints programme, sitting between the complaint being logged and any decision on rework, recall or corrective action. It answers what happened, not what to do about it.
Use this template when
- A customer complaint has been logged (Customer Complaint Record) and its cause needs establishing
- The batch, line, shift and production records for a specific complaint need to be pulled and reviewed
- A retained or returned sample needs to be tested and compared against the complaint sample
- The finding will decide whether other product is at risk or whether a recall must be considered
- A root cause analysis or corrective action needs a documented factual basis rather than the complaint description alone
Do not use it for
- Customer Complaint Record, which captures what the customer experienced and wants, not what caused it
- Complaint Response Record, which records what was said back to the customer once this investigation concludes
- Complaint Trend Review, which pulls investigations together over a period to show the pattern behind them
- Root Cause Analysis, which goes further than this record when the contributing causes need a structured method such as 5 Why
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Compliance mapping
Which ISO 9001 cl.10.2 requirements does this satisfy?
ISO 9001 treats a customer complaint as a nonconformity signal. The clauses that bear on this record are less about the complaint itself than about what the organisation is required to do with it once raised.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.8.5.2 | Identification and traceability of outputs throughout production, so the batch concerned can be located | Traceability |
| ISO 9001 cl.9.1.2 | Monitoring of customer perception of the degree to which requirements have been met, including complaints | Header |
| ISO 9001 cl.8.5.1 | Production carried out under controlled conditions, with monitoring and measurement records available for review | Production records reviewed |
| ISO 9001 cl.7.1.5.1 | Monitoring and measuring resources suitable for the verification activity, applied to the retained and complaint samples | Sample testing |
| ISO 9001 cl.8.7.1 | Identification and control of nonconforming outputs, to prevent unintended use or delivery | Conclusion |
| ISO 9001 cl.10.2.1 | React to the nonconformity, evaluate the need for action to eliminate the cause | Conclusion |
| ISO 9001 cl.10.2.2 | Retain documented information as evidence of the nature of the nonconformity and any subsequent action | Conclusion |
What it does not cover
- Customer Complaint Record, which captures what the customer said, experienced and asked for; this record starts once that exists.
- Root Cause Analysis, which is needed when the investigation establishes the point of failure but the contributing causes require a structured method such as 5 Why or a cross-functional RCA.
- Corrective and Preventive Action, which implements and tracks the fix; this record only raises the reference once action is required.
- The recall decision itself, which belongs in a dedicated recall plan once this record concludes that recall must be considered.
- Complaint Response Record, which is the communication sent back to the customer once this investigation reaches a conclusion, not the investigation itself.
Global
Complaint Investigation Record requirements by country
The duty to investigate a complaint is rarely stated as such; it is assembled from traceability, withdrawal and recordkeeping obligations that make an uninvestigated complaint indefensible if the product turns out to be unsafe.
FDA FSMA (21 CFR Part 117, Subpart F) and USDA FSIS recordkeeping requirements
Registered facilities must maintain a recall plan and the records needed to trace product; complaint-driven investigations draw directly on those records.
A complaint investigation that cannot locate the batch record is also a facility that cannot execute its own recall plan if one is needed.
General Food Law Regulation (EC) 178/2002, Articles 18 and 19, as retained in UK law; Food Safety Act 1990
One-step-back, one-step-forward traceability, and a duty to withdraw or recall unsafe food once identified.
The investigation is the mechanism that turns a complaint into the knowledge Article 19 requires you to act on.
ISO 9001:2015 cl.8.7 and cl.10.2
Nonconforming output must be controlled, and the organisation must react to nonconformity and evaluate whether action is needed to eliminate the cause.
Certification auditors look for a documented, evidenced conclusion, not a note that the customer was contacted.
How to complete it
How to complete a complaint investigation record, step by step
Most investigations are opened correctly and closed too quickly. The parts that determine whether the conclusion holds up later are the ones a template alone will not enforce.
The batch record, CCP records, pre-op sanitation, metal detection log and final inspection result for the batch, line and shift concerned already exist. Reading them first, before forming a view of what probably happened, is what separates an investigation from an educated guess.
A defect present in the complaint sample alone is consistent with damage after despatch; the same defect present in the retained sample from the same batch is consistent with a process cause. The comparison, not either sample in isolation, is what the finding rests on.
Whether the defect existed is one question. Whether the site caused it is a different one; transport, storage and handling after despatch can produce a genuine defect the site did not create. Answering both, and recording the reasoning, is what makes the conclusion defensible.
A foreign material or allergen complaint gets a fuller investigation than a labelling error even when the actual outcome was minor, because the level is set by the potential consequence, not the severity that happened to occur this time.
What auditors find
Most common complaint investigation record findings
Complaint investigation findings are rarely about a missing document; the record almost always exists. They concern whether it was built from the evidence or from a plausible account of it.
| Finding | Clause | What fixes it |
|---|---|---|
| Investigation closed from the complaint description alone, without pulling the batch, CCP, sanitation or inspection records. | ISO 9001 cl.8.5.2 | Require the underlying records to be attached or referenced before the investigation can be marked complete. |
| Retained sample not tested, or tested but never compared against the complaint sample. | ISO 9001 cl.7.1.5.1 | Make the comparison result, not just the individual test results, a required field. |
| Complaint substantiated and fault attributable to us recorded as a single judgement rather than two. | ISO 9001 cl.8.7.1 | Require both fields to be answered independently, with reasoning for each. |
| Other product at risk not properly assessed, so a wider review is never triggered. | ISO 9001 cl.8.7.1 | Treat other product at risk as its own decision, not a default no, and raise the extent-of-condition review whenever the cause could plausibly repeat. |
| Investigation level set by the outcome that occurred rather than the potential consequence of the hazard. | ISO 9001 cl.10.2.1 | Set the level from the hazard category at the point of logging, before the actual severity is known. |
| Action required marked yes with no CAPA or RCA reference raised, or a reference raised without an owner. | ISO 9001 cl.10.2.2 | Block sign-off until the referenced action record exists and carries an owner. |
Case in point
Case in point: the investigation that matched the wrong shift
A customer reported foreign material in a pack of sliced ham. The investigation pulled the batch record for the production date printed on the pack, reviewed that shift's CCP and metal detection records, found nothing untoward, and recorded the complaint as unsubstantiated with no cause identified.
A second look, prompted by a near-identical complaint on the same product two weeks later, found that the pack in question had come from a rework batch: product from an earlier run had been reprocessed and relabelled with a new production date under a different traceability record. The original investigation had matched the printed date to the primary batch record rather than the rework record, and so had reviewed the wrong shift's CCP and metal detection data entirely.
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.
5 sections
- Reference
- QUA-024
- Archetype
- Record
- Record ID
- CINV-2026-000
- Scoring
- Not scored
- Direction
- n/a
- Singleton
- No
- Basis
- ISO 9001 cl.10.2
- Links
- Links Case, Traceability
- Tags
- Quality, Customer
- Sections
- 5
- Fields
- 51
- Follow up fields
- 9
- Repeating sections
- 0
- Links out
- 8
Header
8 fieldsInvestigation ID*
Auto sequence. Format CINV-2026-000.
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
Case ID*
Thread key
Complaint Category*
- Foreign material0 pts
- Illness0 pts
- Allergen0 pts
- Off flavour or odour1 pt
- Appearance2 pts
- Texture2 pts
- Packaging2 pts
- Underweight1 pt
- Labelling1 pt
- Shelf life1 pt
- Delivery or service2 pts
Traceability
9 fieldsBatch Number*
Numeric key joining to your ERP batch record.
Links to External system reference
Product*
Production Date*
Line*
Shift*
Line Lead
Traceability Record ID
Links to QUA-073 Trace ID
Despatch Record ID
Links to QUA-075 Despatch ID
Quantity In That Batch
Production records reviewed
10 fieldsBatch Record Reviewed*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
CCP Records Within Limits*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Pre-Op Sanitation Passed*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Metal Detection Records Complete*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Final Inspection Passed*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Any Deviation Recorded That Day*
- No3 pts
- Yes0 pts
Deviation Case ID
Thread key
Maintenance Work That Day*
- No3 pts
- Yes0 pts
Work Order ID
Links to MNT-002 Work Order ID
New Or Unfamiliar Crew*
- No3 pts
- Yes0 pts
Sample testing
6 fieldsRetained Sample Available*
- Yes3 pts
- No0 pts
Retained Sample Tested*
- Yes3 pts
- Not required3 pts
- No0 pts
Retained Sample Result
- Conforming3 pts
- Same defect present0 pts
- Inconclusive1 pt
Complaint Sample Tested*
- Yes3 pts
- Not available1 pt
- No0 pts
Complaint Sample Result
Results Consistent
- Yes3 pts
- Partly1 pt
- No0 pts
Conclusion
18 fieldsComplaint Substantiated*
- No3 pts
- Partly1 pt
- Yes0 pts
Fault Attributable To Us*
- No3 pts
- Possibly1 pt
- Yes0 pts
Point Of Failure
Raw material, process, packaging, storage, transport or after despatch.
Other Product At Risk*
- No3 pts
- Yes0 pts
Extent Of Condition ID
Links to FDN-018 Review ID
Recall Consideration Required*
- No3 pts
- Yes0 pts
Recall Plan ID
Links to QUA-055 Plan ID
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
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
Investigator*
Signature*
Quality Manager*
Second Signature*
QUA-024 · record IDs look like CINV-2026-000 · Links Case, Traceability
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The investigation depends on records that were made by other processes, days or weeks earlier. What actually fails is the retrieval: the wrong batch matched, the retained sample never pulled, the RCA reference left blank.
Holds the investigation against the complaint, traceability and production registers, and flags when a referenced batch, CCP or sample record cannot be located.
Resolves the production date on a returned pack to the actual batch and traceability record, including rework and relabelled product, before the investigation is built on the wrong shift.
Watches investigations marked action required with no CAPA or RCA reference raised, and holds sign-off until the reference and its owner exist.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Complaint Investigation Record definitions and key terms
- Retained sample
- A sample of the batch kept back at production for exactly this purpose, tested against a returned or complaint sample to establish whether the defect existed at the point of manufacture.
- CCP
- Critical control point: a step in the process where control is essential to prevent or eliminate a food safety hazard, whose records are reviewed as part of the investigation.
- Point of failure
- The stage at which the defect most likely arose: raw material, process, packaging, storage, transport or after despatch, distinct from whether the site is at fault for it.
- Extent of condition
- The review of whether the same cause could be present in other batches, lines or products beyond the one complained about.
- Substantiated complaint
- A complaint the evidence supports, as distinct from one that is plausible but not confirmed by the batch, CCP or sample data.
FAQ
Frequently asked questions about complaint investigation record
What decides whether a complaint is substantiated?+
The evidence, not the complaint's plausibility. A complaint is substantiated when the batch, CCP or sample evidence supports it; a complaint can be entirely believable and still unsubstantiated if the retained sample and production records show no defect at the point of manufacture.
Should the retained sample or the complaint sample be tested first?+
Both are tested, and the comparison between them is the finding. Testing only the complaint sample tells you the state of one item that has been through transport, storage and possibly mishandling; the retained sample is the only evidence of the batch as it left the site.
What is the difference between substantiated and fault attributable to us?+
Substantiated asks whether the defect existed. Attributable asks whether the site caused it. A defect can be real and substantiated while having arisen in transport or storage after despatch, in which case the complaint is substantiated but the fault is not attributable to the site.
When must a recall be considered?+
Whenever the investigation finds that other product from the same cause could still be in circulation and could present a risk, regardless of whether the original complaint itself was serious. The trigger is the potential reach of the cause, not the severity of the single complaint that surfaced it.
Who carries out the investigation?+
Quality, working with production. Production supplies the context for the batch, line and shift; quality owns the conclusion, the sign-off, and the decision on whether further action is required.
What happens if the batch record shows a deviation that day?+
The deviation's case reference is pulled into the investigation directly, because a deviation on the same batch is the most likely explanation for a defect and should be checked before any other hypothesis is pursued.
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 Complaints
Customer Complaint Record
Records a complaint from a customer, with what they experienced and what they want
Complaint Response Record
Records what was said back to the customer, when, and by whom
Complaint Trend Review
Pulls together complaints over a period to show the patterns behind them
Customer Feedback Record
Captures feedback that is not a complaint, including praise, suggestions and survey results
Customer Visit Report
Records a customer visit or audit of your site, including what they looked at and what they raised
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 9001:2015 clauses 8.5.2, 8.7, 9.1.2 and 10.2
- FDA Food Safety Modernization Act, 21 CFR Part 117, Subpart F — recall plan requirements
- General Food Law Regulation (EC) No 178/2002, Articles 18 and 19 — traceability and withdrawal
- Food Safety Act 1990 (UK)
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.