What this is
What is a foreign material report?
What is a foreign material report?
A record of anything found in product that should not be there: metal, glass, hard plastic, wood, rubber, bone, insect or personal item. It captures what was found, where and when, what the source investigation established, whether detection systems should have caught it, and what happened to the affected product.
Why does the object have to be retained?
Because identification drives everything downstream. Material type, dimensions, edge condition and wear pattern indicate the source, and the source determines how far back the affected product extends. An object described in words and discarded leaves the investigation with a category rather than a location.
Scope
When is a foreign material report required?
This report covers a discovery event. The prevention and detection systems it examines are separate records.
Use this template when
- Foreign material found in product, in-process or finished, at any stage
- Material found by a customer or consumer and reported back
- Detection system rejects where the object requires identification and source investigation
- Breakage of glass, brittle plastic or a blade in or near an open product area
- Material found during cleaning or maintenance that indicates product may have been exposed
Do not use it for
- The glass and brittle plastic register, which lists items and their inspection status
- Metal detection and x-ray verification records, which log routine test piece checks
- Blade and sharps accountability records, which reconcile issue against return
- The complaint record, where the finding came from a customer and both are needed
- Root cause analysis, which belongs in its own record for significant or repeating events
Compliance mapping
Which FDA FSMA requirements does this satisfy?
Foreign material control sits under a hazard analysis requirement and scheme detail that is considerably more prescriptive about detection and removal devices.
| Clause | Requirement | Where it lands |
|---|---|---|
| 21 CFR 117.130 | Hazard analysis identifying known or reasonably foreseeable physical hazards requiring preventive controls | Header |
| 21 CFR 117.150 | Corrective action procedures where a preventive control is not properly implemented | Product action |
| 9 CFR 417 | Where physical hazard is a CCP, monitoring, corrective action and verification requirements apply | Detection systems |
| BRCGS Issue 9 cl.4.9 | Chemical and physical product contamination control, including glass, brittle plastic and sharps | Source investigation |
| BRCGS Issue 9 cl.4.10 | Foreign body detection and removal equipment, sensitivity and failure procedures | Detection systems |
| SQF Edition 9 cl.11.2 | Foreign matter control including detection, removal devices and incident response | Header |
| FDA health hazard evaluation | Assessment of risk from hard or sharp objects by size and consumer group | Product action |
| ISO 22000 cl.8.9 | Control of nonconformity, corrections and corrective actions on product safety failure | Product action |
What it does not cover
- The glass and brittle plastic register, which lists items in production areas with their condition and inspection status.
- Detection system verification records, which log routine test piece checks and their outcomes.
- Blade and sharps reconciliation, which accounts for issue and return and is checked when a blade is missing.
- Root cause analysis, which is a separate record where the event is significant or recurring.
- The recall decision, which is a distinct process with named authority and its own criteria.
How to complete it
How to complete a foreign material report, step by step
Four things determine whether this report resolves an event or leaves an open question: the object, the location, the extent boundary and the detection review.
Time, location, product code, line and who found it, on the bag. Identification by material, dimensions, edge condition and wear is what points at a source, and photographs of the object next to a scale are the minimum where retention is impossible. Everything else in the investigation depends on this step and it takes thirty seconds.
Material found at packing may have entered at receipt, at mixing, during maintenance or from the building itself. Working backward through the process to the point of entry is what defines the affected population. Where the entry point cannot be established, the extent boundary has to be conservative, which is expensive and is the cost of not having the object.
The affected product runs back to the last point at which the source was demonstrably intact: the last sieve integrity check, the last blade reconciliation, the last equipment inspection. That is usually further back than teams expect, and getting it wrong is what turns a contained event into a recall discovered later.
If the object passed a metal detector or x-ray, that is a second finding. Was it detectable given its size, shape, orientation and the product effect? Was sensitivity set correctly and verified? Did the reject function work? A detection failure needs its own investigation, because it affects everything else that ran that day.
What auditors find
Most common foreign material report findings
Foreign material findings divide between the event handling and the systems that were meant to prevent it.
| Finding | Clause | What fixes it |
|---|---|---|
| Object discarded before identification. | BRCGS 4.9 | Retain and bag as the first instruction; identification drives the source and the extent. |
| Extent boundary set to the current batch without reference to the last known good check. | 21 CFR 117.150 | Run the boundary back to the last verified integrity check of the suspected source. |
| Detection system passed the object with no investigation of why. | BRCGS 4.10 | Treat a detection miss as a separate finding covering sensitivity, positioning and verification history. |
| Sieve, filter or magnet integrity not checked as part of the investigation. | SQF 11.2 | Inspect removal devices; they fail silently and continue to look installed. |
| Source recorded as unknown without an investigation trail. | 21 CFR 117.150 | Record what was examined and ruled out; unknown with no reasoning is not a conclusion. |
| Rising detection rate treated as evidence the detector is working. | BRCGS 4.10 | Trend detections by source; a rising rate points upstream at a deteriorating component. |
| Glass or brittle plastic breakage handled without a documented breakage procedure. | BRCGS 4.9 | Define the response in advance: isolate, clear, inspect, account for pieces, release. |
| Blade reconciliation not performed after a blade fragment was found. | SQF 11.2 | Reconcile immediately; a missing blade is a product hold decision, not a stores issue. |
| Customer-reported finding not linked to internal detection records for that run. | ISO 22000 cl.8.9 | Pull the detection history for the shift; the absence of a reject is itself information. |
| Health hazard evaluation not performed before disposition of affected product. | FDA guidance | Assess by object size, hardness and consumer group before deciding disposition. |
Case in point
Case in point: the wood in the corn dogs
Foreign material was the leading cause of USDA FSIS recalls in 2025, ahead of undeclared allergens. In one quarter alone it accounted for the largest recall volume by weight of any cause, driven substantially by a single recall of corn dog products containing wood running to more than fifty-eight million pounds.
Volume on that scale is rarely about the object. It is about the extent boundary. A wood fragment identified quickly and traced to a specific pallet, crate or utensil bounds the affected product tightly. The same fragment with no identified source forces a boundary drawn around everything produced since the last point anyone can vouch for.
The difference between a contained event and a recall measured in tens of millions of pounds is frequently the quality of the source investigation in the first hour.
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-009
- Archetype
- Record
- Record ID
- CASE-2026-000
- Scoring
- Risk band
- Direction
- High is bad
- Singleton
- No
- Basis
- FDA FSMA, SQF 11.2
- Links
- Feeds RCA, Extent of Condition
- Tags
- Quality, Food safety
- Sections
- 5
- Fields
- 54
- Follow up fields
- 10
- Repeating sections
- 0
- Links out
- 8
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*
Retain The Object
The physical object is the single most valuable piece of evidence. Bag it, label it with the batch and time, and photograph it against a scale before anyone handles it further.
What was found
8 fieldsMaterial Type*
Metal, glass, hard plastic, soft plastic, wood, bone, rubber, insect or other.
Approximate Size Millimetres*
Where It Was Found*
- In process3 pts
- At final inspection2 pts
- In warehouse1 pt
- By customer0 pts
- By consumer0 pts
Found By*
Description*
Photograph With Scale*
Object Retained*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Retention Location
Source investigation
10 fieldsLikely Source Identified*
- Yes3 pts
- Suspected2 pts
- No0 pts
Suspected Source
Equipment Inspected*
- Yes3 pts
- No0 pts
Asset
Asset ID
Format AST-0000.
Links to FDN-002 Asset ID
Missing Component Found On Equipment*
- No3 pts
- Yes0 pts
Glass Register Checked*
- Yes3 pts
- Not applicable3 pts
- No0 pts
Register ID
Links to QUA-052 Register ID
Tool Or Blade Accountability Checked*
- Yes3 pts
- No0 pts
Any Item Unaccounted For*
- No3 pts
- Yes0 pts
Detection systems
4 fieldsShould Detection Have Caught It*
- No, outside detection capability2 pts
- Yes0 pts
Detector Functioning At The Time
- Yes2 pts
- Unknown1 pt
- No0 pts
Detection Check ID
Links to QUA-020 Check ID
Detector Sensitivity Adequate For This Material
Stainless steel and non ferrous are harder to detect than ferrous, and glass is often invisible to both.
- Yes3 pts
- Marginal1 pt
- No0 pts
Product action
19 fieldsProduct Affected*
- 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.
Extent Of Condition ID
Where else could this same material have entered product.
Links to FDN-018 Review ID
Product Despatched*
- No3 pts
- Yes0 pts
Recall Consideration Required
- No3 pts
- Yes0 pts
Regulator Notification Considered
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
Quality Manager*
Signature*
Site Manager*
Second Signature*
QUA-009 · record IDs look like CASE-2026-000 · Feeds RCA, Extent of Condition
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The report is written by whoever found the object, usually with the line stopped. What fails is the object that was discarded and the boundary drawn from memory.
Holds the report against the batch and line, links to detection verification history for that shift, and blocks disposition until the extent boundary is reasoned.
Trends findings by material type, source and location, so a wearing component appears as a pattern rather than as eight separate events.
Connects the suspected source to its asset history and last inspection, which is what sets the last known good point.
Identifies where affected product has already shipped, so the boundary decision reflects what is recoverable.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Foreign Material Report definitions and key terms
- Foreign material
- Any object in product that should not be present: metal, glass, hard plastic, wood, rubber, bone, insect or personal item.
- Extent of condition
- The boundary of product potentially affected, running back to the last point at which the source was demonstrably intact.
- Removal device
- A sieve, filter, magnet or screen that physically removes material, distinct from a detector that identifies and rejects it.
- Detection sensitivity
- The smallest object reliably detected for a given product, established by validation and verified with certified test pieces.
- Product effect
- The influence of product composition on detector performance, which limits achievable sensitivity in wet, salty or metallised-pack products.
- Health hazard evaluation
- Assessment of the risk an object presents based on its size, hardness, shape and the consumer group.
- Blade accountability
- Reconciliation of blades issued against those returned, where a discrepancy triggers a product hold.
- Breakage procedure
- The predefined response to glass or brittle plastic breakage: isolate, clear, inspect, account for pieces, release.
FAQ
Frequently asked questions about foreign material report
Why must the object be kept?+
Because identification determines the source, and the source determines the extent boundary. Material type, dimensions, edge condition and wear pattern point at specific equipment. Without the object the investigation works from a description, the source often stays unknown, and the affected product boundary has to be drawn conservatively, which is where recall scope escalates.
Is foreign material still a major recall cause?+
Yes. It was the leading cause of USDA FSIS recalls in 2025, ahead of undeclared allergens, and in some quarters accounted for the largest recall volumes by weight. Under FDA jurisdiction allergens lead and foreign material remains prominent, so the picture differs by regulator while the exposure is real in both.
What if a detector should have caught it?+
That is a separate and equally serious finding. Investigate whether the object was detectable given its size, shape, orientation and the product effect, whether sensitivity was set and validated correctly, whether verification with test pieces was current, and whether the reject mechanism functioned. A detection miss affects confidence in everything that ran that day.
How far back should the affected product go?+
To the last point at which the suspected source was demonstrably intact: the last documented sieve integrity check, blade reconciliation or equipment inspection. Not to the start of the current batch, which is the intuitive boundary and frequently the wrong one. Where the source is unknown, the boundary has to be conservative by definition.
Does a rising detection rate mean the system is working?+
It means something upstream is producing more material. Detection catches a proportion of what passes, dependent on size, shape and orientation, so a rising rate indicates increasing input rather than improving capture. The correct response is upstream: which component is wearing, which device has lost integrity, which supplier has changed.
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:
- 21 CFR 117, hazard analysis and risk-based preventive controls, FDA
- USDA FSIS 2025 recall data, foreign material as leading recall cause
- BRCGS Food Safety Issue 9 clauses 4.9 and 4.10
- SQF Edition 9 clause 11.2, foreign matter control
- FDA health hazard evaluation guidance on hard or sharp foreign objects
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.