Lot Traceability Software: What Real Lot Genealogy Looks Like
Every system can trace a clean lot. Ask it to trace a reworked, partly used one, both ways, with quantities. That is the test.
In Short
- Trace backward for complaints, forward for supplier recalls.
- Record lots by scan where they are used, not at the end of the week.
- Test splits, blends, rework and relabels specifically.
Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
- Follow a lot both ways.
- Reconcile a trace before acting on it.
- Run a timed trace exercise.
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
Inventory & Traceability: the Practical Operations Guide
From goods-in to dispatch: practical controls for locations, usable stock, movements, counting, picking and traceability. Use it with or without V5.
Most ERP systems claim lot traceability, but many can only show which finished lot used which raw lot at the end of a period. Useful lot traceability works in both directions, is recorded when material is received, used, split, reworked and shipped, and survives mixing and partial lots. This guide covers forward and backward tracing, where the requirements come from, where lots are created and changed, mock recalls and how to test a system before you buy.
Forward and Backward Tracing
Backward tracing starts from a finished lot or a complaint and finds every input lot, supplier and process record behind it. Forward tracing starts from an input lot, such as a supplier recall, and finds every intermediate and finished lot it went into, and every customer that received them.
More on forward and Backward Tracing
Both matter: a supplier recall needs forward tracing; a customer complaint needs backward tracing and then forward tracing from any suspect input.
Where requirements come from
Food: one step back and one step forward under EU Regulation 178/2002 Article 18; records under the US Bioterrorism Act (21 CFR Part 1 Subpart J); and the Food Traceability Rule (21 CFR Part 1 Subpart S) for foods on the Food Traceability List. Drugs: batch production records under 21 CFR 211.188.
More on where requirements come from
Devices: traceability under ISO 13485:2016 clause 7.5.9 through the QMSR. Supplements: batch records under 21 CFR 111 Subpart I. Your customers may require more than the law.
Where lots are created and changed
Lots are received, created when product is made, split when stock is divided, combined when material is blended or reworked, relabelled when packed, and shipped. Each of these events should record the input lot, the output lot, the quantity, the date and the location.
Where lots are born and change
| Event | Record | Watch for |
|---|---|---|
| Receive | Supplier lot, quantity, date | Supplier lot captured, not just item |
| Make | Input lots, output lot, quantity | Actual lots, not planned BOM |
| Split | Parent lot, child lots | Quantities add up |
| Blend / rework | Every input lot | Rework keeps its history |
| Repack / relabel | Old and new lot | Link not lost |
| Ship | Lot, quantity, customer | Lot on every shipment line |
- Receive
- Record
- Supplier lot, quantity, date
- Watch for
- Supplier lot captured, not just item
- Make
- Record
- Input lots, output lot, quantity
- Watch for
- Actual lots, not planned BOM
- Split
- Record
- Parent lot, child lots
- Watch for
- Quantities add up
- Blend / rework
- Record
- Every input lot
- Watch for
- Rework keeps its history
- Repack / relabel
- Record
- Old and new lot
- Watch for
- Link not lost
- Ship
- Record
- Lot, quantity, customer
- Watch for
- Lot on every shipment line
More on where lots are created and changed
The hardest cases are rework, partial use of a lot across several jobs and lots that are repacked or relabelled; test these specifically.
Mock Recalls
A mock recall picks a lot and traces it forward and backward, accounting for quantity: produced, in stock, shipped and to whom. Record the time taken, the gaps found and the actions.
Worked Example: Mock Recall from Supplier Lot RM-551
- 0:00Start: supplier reports a problem with RM-551QA
- 0:10Forward trace: RM-551 used in FG-2207 and rework lot RW-14, then in FG-2215QA
- 0:20Quantities: 1,200 made; 300 in stock; 900 shipped to 4 customersQA
- 0:25Stock on hand placed on holdWarehouse
- 0:40Gaps recorded: one shipment line missing lot; action raisedQA
More on mock Recalls
Rotate the starting point: a raw material, a finished lot and a reworked lot. Customers and certification schemes often set expectations for how often and how fast; use their requirement where one applies.
Where ERP-only traceability breaks
Consumption posted from the planned bill of materials rather than actual lots used. Lots recorded at the end of a shift or week.
More on where ERP-only traceability breaks
Rework and blends that lose the link to their inputs. Partial lots that cannot be split in the system. Shipping that records product but not lot. These gaps are invisible until you trace a real lot.
Choosing Lot Traceability Software
Ask the vendor to trace one of your own reworked lots forward and backward, live, with quantities. Check that lots are recorded by scan at the step where they are used, not reconciled later.
More on choosing Lot Traceability Software
Check how splits, blends, rework and relabels are handled. Check what the trace report shows and whether you can export it. Check how holds are placed on the affected stock once the trace is done.
Questions
Is lot traceability the same as serialisation?
No. Lot traceability tracks batches. Serialisation gives each unit a unique identifier, as required for some products such as prescription drugs under DSCSA.
Does an ERP module count as lot traceability software?
It can, if it records actual lots at each event, including splits, blends and rework, and traces both ways with quantities. Test it with a real lot.
How quickly should a mock recall complete?
There is no single legal time for all products. Use your customers' and certification schemes' requirements where they apply, and your own recall plan's target.
Can a spreadsheet work for a small manufacturer?
For very few products and lots, possibly. It becomes risky as volumes, rework and customers grow, because each link depends on manual entry.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
- Batch Traceability Software: How Batch Genealogy Works
Chemical Traceability Software: Batch, Lot and SDS Records
Ingredient Traceability: Records, Lot Links and Bakery Examples
Meat Traceability Software: 9 CFR 320 and Mock Recalls
Traceability Software Buyer's Guide: Capabilities to Test
Cannabis Traceability and Recall Readiness: Lots, Labs and State Systems