What this is
What is a batch traceability record?
What is a batch traceability record?
A batch traceability record links the raw material lots and quantities that went into a production batch to the finished product lots that came out, and on to the customers those lots were shipped to. It is the document that turns a recall from a search into a lookup.
How is a batch traceability record different from a despatch record?
The despatch record captures what left the site, on which vehicle and to which customer. The batch traceability record captures the manufacturing linkage that makes that despatch traceable back to specific input lots. One without the other tells you where the product went but not what it was made from, or the reverse.
Why does mass balance matter on a traceability record?
Reconciling total input against total output, with rework and carryover accounted for, is the check that the trace is actually complete rather than merely plausible. A record that never reconciles quantities can look finished while quietly excluding a portion of the batch from the trace.
Scope
When is a batch traceability record required?
This record is the manufacturing link in the trace chain, not the whole chain. Using it to cover coding, despatch or the recall decision itself produces gaps that only surface when a real recall needs all three at once.
Use this template when
- A production batch has run and the input lots, quantities and output lots need to be linked
- Rework or carryover has occurred and the source batches need to be captured before the memory of which lot went where fades
- A new record is needed; each one gets its own ID in the form TRACE-2026-000
- You are running the Traceability and Recall programme and this batch is one of its steps
- A mock recall or real recall needs the manufacturing linkage for a specific batch
Do not use it for
- Lot Coding Verification, which confirms the code physically printed on the pack is correct and readable, not what the system says the batch contains
- Despatch Record, which records what left the site, when, on which vehicle and to which customer
- Trace Exercise Record, which records a practice trace on a selected batch, forward and backward, outside of a live mock recall
- Recall Plan and Mock Recall Record, which govern the decision to withdraw product and the exercise that tests it, using this record as an input rather than duplicating it
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Compliance mapping
Which FSMA requirements does this satisfy?
Food traceability regulation increasingly names the events that must produce a record and the data each event must capture, rather than leaving the method open the way general risk regulation does.
| Clause | Requirement | Where it lands |
|---|---|---|
| FSMA Sec. 204(d); 21 CFR 1.1305 | Traceability plan describing how critical tracking events are identified and how traceability lot codes are assigned | Header |
| 21 CFR 1.1335 | Records for the receiving critical tracking event: supplier, supplier's lot reference, quantity and date received | Inputs |
| ISO 22005:2007 cl.5 | Traceability system design must define how inputs and outputs are identified and linked at each stage, including blending and rework | Rework and carryover |
| 21 CFR 1.1340 | Records for the transformation critical tracking event: traceability lot code assigned to the new lot, and the lot codes of the ingredients combined into it | Outputs |
| 21 CFR 1.1350 | Records for the shipping critical tracking event: quantity shipped, date, and the entity the product was shipped to | Outputs |
| ISO 22005:2007 cl.5 | Traceability records must permit reconciliation of quantities through the process, not identification alone | Mass balance |
| FSMA Sec. 204(d) | Traceability plan and its records reviewed and modified when the process they describe changes | Header |
What it does not cover
- Lot Coding Verification, which needs the physical code on the pack checked against the specification, not the system's record of what was assigned.
- Despatch Record, which needs the vehicle, driver, seal and delivery detail this record does not capture.
- Trace Exercise Record, which needs a timed practice run against a target, not the underlying data the practice run tests.
- Mock Recall Record, which needs the withdrawal decision and communication trail, using this record as one of its inputs rather than replacing it.
- Label or artwork approval, which confirms the traceability lot code format was approved before the run, not that a specific batch's record was completed correctly.
Global
Batch Traceability Record requirements by country
Food traceability has moved from a general duty to a named, dated rule in the largest market this template serves, which changes what a defensible record now looks like.
FSMA Section 204(d); 21 CFR Part 1, Subpart S (Food Traceability Rule)
Entities handling foods on the Food Traceability List must maintain records for each critical tracking event, with a compliance date extended to 2028.
For covered foods the record must capture the specific data elements the rule names for each event, in a form producible within 24 hours of a request.
Regulation (EC) 178/2002 Art.18 as retained in UK law; FSA traceability guidance
One-step-back-one-step-forward is the legal minimum: know your immediate supplier and immediate customer for every batch.
Less prescriptive than FSMA 204 on data elements, but retailer and certification scheme audits routinely set a higher practical bar than the legal minimum.
ISO 22005:2007
A management-system standard for traceability design, specifying identification, linkage of inputs and outputs, and retention rather than a food-safety duty in itself.
Used as a certification or design reference where a customer requires a documented traceability system beyond the regulatory floor.
How to complete it
How to complete a batch traceability record, step by step
The template captures the data. Whether the record proves a trace holds together depends on decisions the fields alone do not force.
Input data gets recorded while production is watching the line. Despatch reference, customer and pallet references get recorded later, if at all, once attention has moved to the next batch. Treat the output section as due at despatch, not at convenience, because it is the half of the trace a recall needs first.
Recording carryover as a yes or no answers the wrong question. Continuous processes carry material forward by an amount, and that amount determines how far back a contamination event reaches. An unquantified answer turns a defined problem into an undefined one at the exact point a recall needs precision.
Total input, total output and the accounted-for percentage exist to be checked against each other, not filled in independently. A discrepancy left unexplained, or explained as 'partly', means part of the batch has left the trace without anyone deciding where it went, a condition a recall discovers at the worst time.
Marking trace complete as yes should mean the record can answer, right now, what went in and where the output went, not that every field happens to be filled. A record scored complete with the despatch reference pointing nowhere has certified the wrong thing.
What auditors find
Most common batch traceability record findings
Findings on batch traceability records concentrate on the output half of the form and on carryover, because both depend on someone returning to the record after the pressure of the run has passed.
| Finding | Clause | What fixes it |
|---|---|---|
| Despatch record ID or customer left blank on a batch marked complete. | 21 CFR 1.1350 | Hold the record open until despatch closes it, rather than closing it at end of production. |
| Carryover recorded as occurring but not quantified. | ISO 22005:2007 cl.5 | Require a quantity whenever carryover is answered yes, and reject the record without it. |
| Mass balance discrepancy present with no explanation, or explanation recorded as partly. | ISO 22005:2007 cl.5 | Investigate and record the cause before closing the record; do not accept partly as final. |
| Rework used without a source batch reference or authorisation ID. | 21 CFR 1.1340 | Make the source batch and authorisation reference mandatory at the point rework is used, not afterwards. |
| Trace marked complete while input or output data was reconstructed from stock movements rather than recorded at the time. | FSMA Sec. 204(d) | Distinguish real-time entries from reconstructed ones, and treat reconstructed entries as a finding in themselves. |
| Action raised against a discrepancy with no owner, date or linked CAPA. | 21 CFR 1.1305 | Assign an owner and raise the CAPA reference when the action is identified, not at review. |
Case in point
Case in point: the batch that traced backward and nowhere else
A dairy processor received a supplier notification about a raw milk contamination event affecting a specific collection date. Quality pulled the batch traceability records for every batch produced from that intake and found the input side complete, matching the affected collection, but only three of eleven affected batches had a despatch record ID and customer recorded. The other eight had been marked complete with the output fields blank, because the shift ended before despatch closed out the day's records. All eleven scored above ninety percent complete, because the score weighted filled fields rather than the ones that mattered here.
The site could tell the supplier exactly which batches were affected. It could not tell the recall team where eight of them had gone without a manual search through despatch paperwork that took most of a day. The fix was not a better scoring formula; it was making the despatch link mandatory to close a batch record, so a batch with no destination cannot be marked complete regardless of what else it has.
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-073
- Archetype
- Record
- Record ID
- TRACE-2026-000
- Scoring
- Completeness percent
- Direction
- High is good
- Singleton
- No
- Basis
- FSMA, ISO 22005
- Links
- Links Batch, Vendor, Customer
- Tags
- Traceability
- Sections
- 5
- Fields
- 45
- Follow up fields
- 6
- Repeating sections
- 2
- Links out
- 5
Header
13 fieldsTrace ID*
Auto sequence. Format TRACE-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
Line*
Shift*
Line Lead
Batch Number*
Numeric key joining to your ERP batch record.
Links to External system reference
Product*
Production Date*
One Step Back, One Step Forward
The legal minimum is knowing your immediate supplier and your immediate customer. Being able to do it in under four hours is what turns a recall from a catastrophe into an inconvenience.
Inputs
Repeats7 fieldsMaterial*
Supplier*
Vendor ID*
Links to FDN-005 Vendor ID
Supplier Batch*
Quantity Used*
Goods In Reference
Recorded At Point Of Use*
Recorded when the bag was opened, not reconstructed afterwards from stock movements.
- Yes3 pts
- Reconstructed later0 pts
Rework and carryover
5 fieldsRework Used*
Rework Source Batches
Rework Authorization ID
Links to QUA-004 Authorization ID
Carryover From Previous Batch*
Continuous processes carry material forward. Define how much and record it.
- No3 pts
- Yes, quantified2 pts
- Yes, not quantified0 pts
Carryover Quantity
Outputs
Repeats6 fieldsFinished Product*
- Pass2 pts
- Partial1 pt
- Fail0 pts
- N/Aexcluded from denominator
Quantity Produced*
Date Code Applied*
Pallet References
Despatch Record ID
Links to QUA-075 Despatch ID
Customer
Mass balance
14 fieldsTotal Input*
Total Output*
Accounted For Percent*
Discrepancy
Discrepancy Explained
- Yes3 pts
- Partly1 pt
- No0 pts
Trace Complete*
- Yes3 pts
- Partly1 pt
- No0 pts
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
Production*
Signature*
Quality*
Second Signature*
QUA-073 · record IDs look like TRACE-2026-000 · Links Batch, Vendor, Customer
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The record links data that lives in several places at once. What fails is the connective tissue: the despatch reference nobody chased and the discrepancy nobody explained before the record was filed.
Holds the batch traceability library against the batch register, flags records closed without a despatch link, and routes mass balance discrepancies to an owner.
Supplies the despatch record and customer reference the output side depends on, so the forward trace does not wait on a manual search.
Watches for batches marked complete with a blank despatch field or an unexplained mass balance gap, and raises the review rather than trusting the completeness score.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Batch Traceability Record definitions and key terms
- Critical tracking event
- A point in the supply chain, such as receiving, transformation or shipping, at which a specific set of traceability data must be created and kept.
- Traceability lot code
- The identifier assigned to a batch or lot at a critical tracking event, used to link records across the chain without relying on a shared internal system.
- One-step-back-one-step-forward
- The general traceability minimum: knowing the immediate supplier of an input and the immediate customer of an output, for every batch.
- Mass balance
- Reconciliation of total quantity input against total quantity output, including rework and carryover, used to test whether a trace is complete rather than merely plausible.
- Carryover
- Material from a previous batch remaining in a continuous process and entering a subsequent batch, which extends how far back a contamination event can reach.
FAQ
Frequently asked questions about batch traceability record
Do we need a batch traceability record for every batch, or only ones flagged as a risk?+
Every batch. The record's value is that it exists before you know a batch will matter, because you never know in advance which one a supplier notification will implicate. Retrofitting it afterwards is the reconstruction problem this template exists to avoid.
How much detail does the mass balance section need?+
Enough to reconcile input against output within a stated tolerance and explain any gap beyond it. It does not need laboratory precision; it needs a discrepancy that cannot be explained to be treated as a finding rather than filed as a number.
Is carryover the same as rework?+
No. Rework is a deliberate decision to reintroduce material from an identified earlier batch, carrying an authorisation. Carryover is material a continuous process leaves behind and forwards automatically, and still needs to be quantified even though nobody chose to add it.
What does 'recorded at point of use' actually protect against?+
It protects against the input record being reconstructed from stock movements after the fact, which tends to average out substitutions and last-minute supplier swaps that happened on the day. A record built from what was opened, when, is harder to get quietly wrong than one built from what the system says should have been used.
Who should close the output side of the record?+
Whoever owns despatch, working from the despatch record, not production working from memory once the shift has ended. The output fields exist to survive the gap between when a batch is made and when someone asks where it went.
How is a batch traceability record scored?+
Completeness percent, where high is good. Treat the score as a prompt to check the fields that matter for recall readiness, particularly the despatch link, rather than as proof the trace itself holds together.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in Traceability and Recall
Recall Plan
Sets out how product would be traced, held and recovered if it had to be recalled
Mock Recall Record
Tests the recall plan by tracing a real batch forward and back without actually recalling it
Lot Coding Verification
Confirms the lot or date code printed on product is correct and readable
Despatch Record
Records what product left, when, on which vehicle and to which customer
Trace Exercise Record
Records a practice trace on a selected batch, forward and backward, outside of a mock recall
Date Coding Verification
Verifies date and batch coding is present, legible, correct and in the right position
More in Traceability
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:
- FSMA Section 204(d) and 21 CFR Part 1, Subpart S — Requirements for Additional Traceability Records for Certain Foods
- ISO 22005:2007 — Traceability in the feed and food chain, general principles and requirements
- Regulation (EC) No 178/2002, Article 18 — traceability (as retained in UK law)
- FDA Food Traceability List and associated compliance guidance
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.