What this is
What is a batch record?
What is a batch record?
A batch record is the consolidated record of everything that happened during the production of one batch: materials used and their supplier batches, any rework added, process events and checks performed, and the output and release decision. It is completed through the run and reviewed by quality before release.
How is a batch record different from a setup approval record?
The setup approval record is the gate before the run starts, confirming the line is correctly configured. The batch record documents the run itself once underway and complete. This template's process record section carries a Setup Approval ID field so it can show which setup approval covered it, rather than repeating the setup checks.
Why does a regulator or customer ask for a batch record by batch number?
Because the batch number is the join key between what the customer received and everything that happened to produce it. A recall, complaint investigation or certification audit all start from a batch number and work backward through this record.
Scope
When is a batch record required?
The batch record documents a single run from materials to release. Treating it as a substitute for the checks feeding into it, rather than where those checks are referenced from, produces a record that looks complete and is not.
Use this template when
- A production run is underway or has just completed and needs its materials, process events and output documented
- A new batch record is needed; each one gets its own ID in the form BATCH-2026-000
- The batch needs releasing, holding, or linking to a hold record depending on its completeness and release answers
- A linked record needs this one to exist: links job, asset, traceability, and the setup approval that preceded the run
Do not use it for
- Setup Approval Record, which confirms the line is correctly configured before the run starts, rather than documenting the run itself
- Control Plan, which sets out what is measured on a process on an ongoing basis and what to do when a measurement goes out of limits
- Statistical Process Control Log, which records measurements across many runs so variation can be tracked, not one run's history
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Compliance mapping
Which ISO 9001 cl.8.5.1 requirements does this satisfy?
ISO 9001 clause 8.5.1 and GMP both require controlled, documented production conditions, but neither prescribes the batch record's layout, so its defensibility rests on which conditions each section actually evidences.
| Clause | Requirement | Where it lands |
|---|---|---|
| ISO 9001 cl.8.5.2 | Identification and traceability of outputs, including materials and their status, throughout production | Materials used |
| ISO 9001 cl.8.5.1(b) | Availability and use of monitoring and measuring resources to verify materials before use | Materials used |
| ISO 9001 cl.8.7 | Control of nonconforming outputs, including reprocessing, applied to rework as a controlled input | Rework used |
| ISO 9001 cl.7.5.3 | Availability of documented information at the point of use, satisfied by linking checks rather than re-recording them | Process record |
| ISO 9001 cl.10.2 | Reaction to nonconformity, including recording and evaluating a deviation raised during production | Process record |
| ISO 9001 cl.8.6 | Release of products and services only when planned arrangements have been satisfactorily completed | Output and release |
| ISO 9001 cl.8.5.1(e) | Appointment of competent persons responsible for production and for release | Header |
What it does not cover
- Setup Approval Record, which needs its own settings verification and dual sign-off before the run this record documents is allowed to start.
- Control Plan, which specifies ongoing measurement frequency and reaction plans, not a single run's history.
- Traceability Record in full, where a recall requires forward and backward trace beyond this batch's own materials and output.
- Hold and Release Record, which manages a batch or material on hold, referenced here by Hold ID but not replaced by it.
- CCP Monitoring Log, which needs its own continuous readings against critical limits, referenced by CCP Log ID rather than repeated.
Global
Batch Record requirements by country
No jurisdiction names a batch record by that title in statute, but the expectation that a run be traceable back to its materials, checks and release decision runs through food safety and quality regimes generally.
FDA 21 CFR Part 117, current good manufacturing practice and preventive controls
Requires monitoring and corrective action records demonstrating control, without prescribing a single consolidated batch document.
In a recall investigation, the batch record is the practical answer to what the regulation asks for in principle: evidence of what happened to a specific lot.
BRCGS Food Safety Standard, traceability and process control requirements
Retailer-driven certification expects a batch traceable from raw material through to finished product within a defined time.
Auditors trace a batch number forward and backward through the record and treat any gap, such as a missing supplier batch, as a traceability failure.
Codex Alimentarius General Principles of Food Hygiene; ISO 9001:2015 clause 8.5.1
Both expect production under controlled, documented conditions and outputs traceable to their inputs.
Certification and customer audits under either framework use the batch record as primary evidence that control held through a specific run.
How to complete it
How to complete a batch record, step by step
The batch record is filled in mostly by reference to other checks, which is what makes it fast to complete and easy to complete with quiet gaps.
Supplier Batch and Quantity Used need entering for every material in the recipe, not only the primary ingredient. A record with the main ingredient's batch recorded and a minor one left blank has a traceability gap invisible until that minor ingredient is the one under recall.
Rework Added, Rework Source Batch and Rework Allergen Compatible exist as a set because rework carries the allergen and quality status of whatever batch it came from. Rework recorded without its source and authorization has added an untraceable ingredient to a traceable batch.
Pre-Op Sanitation ID, CCP Log ID, Metal Detection Check ID and In Process Inspection ID are references, not summaries. The record is complete when every check performed has its ID captured here, found or not.
All Records Complete and Batch Released are separate questions for a reason: a batch can be otherwise ready with one linked record, such as a CCP log or deviation case, still open. Batch Released should not be Yes while All Records Complete is anything other than Yes.
What auditors find
Most common batch record findings
The batch record is long enough that gaps concentrate in a few places: the repeating materials section, rework, and the point where release is signed against records not actually all closed.
| Finding | Clause | What fixes it |
|---|---|---|
| Supplier Batch or Quantity Used left blank for one or more materials in the recipe. | ISO 9001 cl.8.5.2 | Require every repeated material row to carry a supplier batch and quantity before the section can be marked complete. |
| Rework Added answered Yes without a Rework Source Batch, Rework Authorization ID or allergen compatibility check recorded. | ISO 9001 cl.8.7 | Make rework sub-fields mandatory the moment Rework Added is Yes, and route to the authorization referenced. |
| Any Deviation Raised answered Yes with no Deviation Case ID captured, or a case ID that does not resolve to an open record. | ISO 9001 cl.10.2 | Block release while a deviation case is unresolved, and require the case ID when raised, not at review. |
| Batch Released answered Yes while All Records Complete is Minor gaps or No. | ISO 9001 cl.8.6 | Enforce the dependency: release cannot be Yes unless completeness is confirmed Yes. |
| Retained Samples Taken answered Yes with no Number Of Retained Samples or Retention Location recorded. | GMP | Require quantity and location with the taken confirmation; a sample nobody can locate is not retained. |
| Second Person Verified left blank or No on an allergen-bearing or low-inclusion material, with no note of why. | ISO 9001 cl.8.5.1(b) | Treat second-person verification as required, not optional, for allergen-bearing or low-inclusion materials. |
Case in point
Case in point: the recall that could not find its own answer
A dairy processor received a supplier notice that a minor stabiliser lot might carry foreign material. Quality pulled batch records for the affected window to find which batches used it. Most records showed the primary ingredients' supplier batches clearly, but the stabiliser, added from a pre-weighed bag, had its Supplier Batch field left blank on eleven of forty records, with only Quantity Used filled in.
Without the supplier batch, the team could not confirm from the record alone whether the flagged lot was involved, and had to reconstruct the answer from goods-received logs instead, over two days rather than the few hours a complete record would have taken. Every one of those eleven records had scored above ninety percent complete; the missing field was never the one a completeness score would have surfaced.
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-061
- Archetype
- Record
- Record ID
- BATCH-2026-000
- Scoring
- Completeness percent
- Direction
- High is good
- Singleton
- No
- Basis
- ISO 9001 cl.8.5.1, GMP
- Links
- Links Job, Asset, Traceability
- Tags
- Process, Record
- Sections
- 5
- Fields
- 55
- Follow up fields
- 7
- Repeating sections
- 1
- Links out
- 11
Header
16 fieldsBatch Record ID*
Auto sequence. Format BATCH-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*
The Document A Regulator Asks For
Everything that happened to this batch, in one place, signed. It is the primary evidence in a recall, a complaint investigation and a certification audit.
Recipe Or Formulation Reference*
Planned Quantity*
Actual Quantity*
Materials used
Repeats6 fieldsMaterial*
Supplier Batch*
Quantity Used*
Within Shelf Life*
- Yes3 pts
- Expired0 pts
Weighed And Checked*
- Yes3 pts
- No0 pts
Second Person Verified
Critical for allergen containing and low inclusion ingredients.
- Yes3 pts
- Not required3 pts
- No0 pts
Rework used
5 fieldsRework Added*
Rework Source Batch
Rework Quantity
Rework Allergen Compatible
- Yes, like into like3 pts
- Checked and acceptable2 pts
- Not verified0 pts
Rework Authorization ID
Links to QUA-004 Authorization ID
Process record
13 fieldsStart Time*
End Time*
Crew
Pre-Op Sanitation ID
Links to QUA-030 Inspection ID
Startup Check ID
Links to QUA-022 Check ID
Setup Approval ID
Links to QUA-060 Setup ID
CCP Log ID
Links to QUA-048 Log ID
Metal Detection Check ID
Links to QUA-020 Check ID
In Process Inspection ID
Links to QUA-013 Inspection ID
Any Stoppages*
- No3 pts
- Yes1 pt
Stoppage Detail
Any Deviation Raised*
- No3 pts
- Yes0 pts
Deviation Case ID
Thread key
Output and release
15 fieldsQuantity Produced*
Quantity Scrapped
Yield Percent*
Retained Samples Taken*
- Yes3 pts
- No0 pts
Number Of Retained Samples
Retention Location
Final Inspection ID
Links to QUA-014 Inspection ID
All Records Complete*
- Yes3 pts
- Minor gaps1 pt
- No0 pts
Batch Released*
- Yes3 pts
- Yes with conditions2 pts
- No0 pts
Hold ID
Links to QUA-003 Hold ID
Traceability Record ID
Links to QUA-073 Trace ID
Production*
Signature*
Quality Release*
Second Signature*
QUA-061 · record IDs look like BATCH-2026-000 · Links Job, Asset, Traceability
Open in KnowellaRun it with agents
From a document you fill in to a programme that runs itself
The batch record is assembled from many smaller checks. What fails is the assembly: a reference left blank, a rework added without its source, a release signed while a linked record is still open.
Holds the batch record against the checks it references, flags any linked ID that does not resolve to a closed record, and blocks release while one remains open.
Matches supplier batch numbers on materials used against goods-received and recall notices, tracing a flagged lot to affected batches directly.
Confirms production and quality signatories hold current competency for the product and process before their signature is accepted.
Rolls completeness and open linked records into one view across the shift, and surfaces any batch nearing release with a gap a percentage score would not flag.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Meet KnowQuality→Glossary
Batch Record definitions and key terms
- Batch record
- The consolidated record of materials, process events, checks and release decision for one batch, referenced by batch number in a recall, complaint or audit.
- Rework
- Previously produced material reintroduced into a new batch, carrying the quality and allergen status of the batch it came from and needing its own authorization and traceability.
- Retained sample
- A physical sample of the finished batch kept for a defined period so it can be tested against a later complaint.
- Deviation
- A departure from the planned process or specification, recorded against a case so its investigation is tracked separately from the batch record.
- GMP
- Good Manufacturing Practice: the baseline hygiene, process and documentation disciplines a HACCP system is built on top of.
FAQ
Frequently asked questions about batch record
What is a batch record?+
It is a record used in KnowQuality documenting everything that happened during the production of one batch, including materials, settings, checks and people. It is built against ISO 9001 clause 8.5.1 and GMP, completed through the run, and signed by quality before release.
How does the batch record relate to the setup approval record?+
It follows it. The process record section carries a Setup Approval ID field linking back to the setup approval for the same run, so the batch record only references those checks, not repeats them.
What does completeness percent measure on this template?+
How much of the record is filled in, but a high percentage can still hide a single missing field, such as a supplier batch on a minor ingredient, that matters more to a traceability question than every other field combined.
What happens if rework is added to a batch?+
The template asks for the rework's source batch, quantity, allergen compatibility and an authorization ID, because rework carries the status of the batch it came from. Recording it added without those details breaks the traceability the record depends on.
Can a batch be released with a deviation still open?+
The template allows Any Deviation Raised to be Yes with a Deviation Case ID captured, but Batch Released and All Records Complete are separate fields precisely so an open deviation case can withhold release rather than pass through quietly.
Who signs off a batch record?+
Production signs first, then Quality Release provides the second signature before the batch is treated as released, keeping the two acts distinct.
Keep going
Related templates and programmes
Industries this is written for
Programmes this belongs to
Used together in HACCP and Food Safety
Unannounced Audit Readiness Check
Checks whether the site would pass an audit arriving today, covering records, standards and area condition
Product Nonconformance Report
Records product that does not meet specification
Hold and Release Record
Places suspect product on hold and records the decision to release, rework or scrap it
HACCP Plan
The hazard analysis and critical control point plan for a product or process
HACCP Verification Record
Confirms the HACCP plan is being followed and still works
CCP Monitoring Log
Records readings at a critical control point, such as cook temperature, chill time or metal detection
More in Process Control
Control Plan
Sets out what is measured on a process, how often, by what method and what to do when it goes out of limits
Statistical Process Control Log
Records measurements over time so process variation can be seen and acted on before product fails
Process Capability Study
Measures whether a process can reliably hold its specification, using data from a stable run
Setup Approval Record
Confirms a new setup is correct and approved before the run continues past the first pieces
Yield Analysis Record
Compares material in against product out and accounts for the difference
Shift Handover Record
Passes on what the incoming shift needs to know, including running issues, holds and changes
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 clause 8.5.1, Control of production and service provision
- ISO 9001:2015 clause 8.5.2, Identification and traceability
- Codex Alimentarius Code of Practice, General Principles of Food Hygiene (CXC 1-1969)
- US FDA 21 CFR Part 117, CGMP, Hazard Analysis and Risk-Based Preventive Controls
This page is general guidance, not legal advice. Confirm requirements with your jurisdiction’s regulator.