# Lot and serial traceability > Lot versus serial tracking, forward and backward traces, the data to capture at receipt and shipment, a mock recall drill and the FDA food traceability rule. Source: https://docs.lumina-erp.com/distribution/lot-and-serial-traceability/ **In short.** Lot tracking ties a batch of product to where it came from and where it went. Serial tracking does the same for each individual unit. A trace is only as good as the data captured at every receipt, move and shipment, so test it with a timed mock recall before a real one tests it for you. Traceability is the ability to answer two questions quickly: where did this product come from, and where did it go? When a supplier recalls a batch, a customer reports a defect or a regulator asks for records, the answer decides whether you pull back 40 cases from three customers or everything you have sold for a month. :::caution[Not regulatory advice] We cover general concepts here and point to public FDA pages. Whether a rule applies to your business, and what it requires of you, depends on your products and role in the supply chain. Confirm with the regulator's own text and with qualified counsel. ::: ## At a glance | | Lot tracking | Serial tracking | |---|---|---| | Identifies | A batch of units made or packed together | One individual unit | | Typical items | Food, chemicals, adhesives, pharmaceuticals, fasteners with heat numbers | Equipment, tools, instruments, devices | | One number covers | Many units, often across many orders | Exactly one unit | | Common extra data | Expiration or manufacture date, supplier lot | Warranty dates, service history | | Transaction volume | Moderate | High, since every unit is scanned or keyed | ## Lot tracking and serial tracking ### Lot tracking A lot is a quantity of product made, packed or received under the same conditions, identified by one lot number. If something is wrong with the batch, it is wrong with every unit in it, so tracking the lot is enough to find them all. Lot tracking usually rides along with expiration dates, which lets the warehouse pick first-expiring stock first. A distributor often deals with two lot numbers for the same stock, the supplier's lot printed on the package and an internal lot assigned at receipt. Keep both. A recall notice will quote the supplier's lot, and your system will search on its own. ### Serial tracking A serial number identifies one unit. It lets you answer which customer has unit 4471, when it shipped and whether it came back for repair. Serial tracking costs more at the dock and the pack station because every unit must be captured, so it is normally kept for higher-value or regulated items. ### Choosing per item Tracking is set item by item, not company-wide. Track by lot or serial where a regulation, a supplier or a customer contract requires it, or where a recall would be costly enough to justify the effort. Tracking an item that does not need it adds scans and errors without adding safety. ## Forward and backward traces | Direction | Starts from | Answers | Typical trigger | |---|---|---|---| | Backward (trace back) | A lot or serial you shipped or hold | Which supplier, which receipt, which inbound lot? | A customer complaint or a defect found in stock | | Forward (trace forward) | A supplier lot you received | Which customers received it, where is the rest now? | A supplier recall | A full recall usually needs both. You trace back from the complaint to the supplier lot, then trace forward from that lot to every customer and every location still holding it. Traces cross transformations. If you break a drum into pails, kit items together or relabel product, the new lot must record which lots went into it. Without that link the trace stops at the transformation. ## What data must be captured A trace is a chain of records. One missing link, such as a receipt booked without a lot number or a shipment picked from the wrong lot, breaks it. ### At receipt - Item, quantity and unit of measure - Supplier, purchase order and receipt date - Supplier lot or serial numbers as printed - Internal lot number, if you assign one - Expiration or manufacture date where the item carries one - Storage location where the stock is put away ### While in your warehouse - Transfers between locations and branches, by lot or serial - Quantity adjustments, scrap and cycle count corrections, by lot - Transformations: breaking bulk, kitting, repacking, relabeling, with input lots linked to output lots - Holds and quarantines, with the reason ### At shipment - Customer and ship-to address - Order, shipment and invoice numbers - Lot or serial numbers actually shipped, with quantity per lot - Ship date and carrier ### On returns - Original invoice, lot or serial number returned, quantity and disposition (restock, scrap, return to supplier) :::tip Capture the lot at the moment of the physical transaction, by scan where possible. Lots assigned after the fact from memory or from a packing list are the most common cause of a trace that looks complete but is wrong. ::: ## Running a mock recall A mock recall is a timed drill: pick a lot, pretend it is recalled and see how fast and how completely you can account for it. Run one at least once a year per regulated product line, and after any system change that touches receiving, picking or shipping. 1. **Pick the lot.** Choose a real supplier lot that has been received, partly shipped and partly stocked, ideally one that passed through a transfer or transformation. Start a clock. 2. **Trace back.** From the lot, find the supplier, purchase order, receipt date and quantity received. Confirm the supplier's lot number matches the physical label. 3. **Trace forward.** List every shipment that included the lot: customer, ship-to, order, ship date and quantity. 4. **Find what is still on hand.** List every location, branch and in-transit transfer holding the lot. Physically count it. 5. **Reconcile the quantity.** Quantity received should equal quantity shipped plus on hand plus in transit plus scrapped or adjusted, minus returns restocked. Any gap is a finding. 6. **Place a hold.** Put the on-hand quantity on hold in the system so it cannot be picked, then release it once the drill is over. 7. **Build the contact list.** Produce the customer contacts you would notify, with the quantities each received, in a sortable electronic file. 8. **Stop the clock and record.** Note the elapsed time, the percentage of the lot accounted for and every place the trace needed a manual lookup or failed. Assign an owner to each gap. The two numbers to track from drill to drill are time to a complete trace and the percentage of the lot you could account for. A trace that accounts for 100% in four hours is better than one that accounts for 92% in 20 minutes. ## The FDA Food Traceability Rule (FSMA 204) The FDA's Food Traceability Rule implements section 204 of the Food Safety Modernization Act. It adds recordkeeping requirements for people who manufacture, process, pack or hold foods on the FDA's **Food Traceability List**. The FDA's rule page states the final rule was published on November 21, 2022. ### Which foods The Food Traceability List covers specific foods and categories, including certain soft cheeses, shell eggs, nut butters, fresh produce such as cucumbers, leafy greens, melons, peppers and tomatoes, several kinds of seafood and refrigerated ready-to-eat deli salads. Check the current list on fda.gov, since FDA can change it through a notice process. ### Critical Tracking Events and Key Data Elements The rule is built on two ideas: - Critical Tracking Events (CTEs) are the points in a food's journey where records are required. The FDA lists harvesting, cooling, initial packing, first land-based receiving (for seafood), shipping, receiving and transformation. - Key Data Elements (KDEs) are the specific pieces of information that must be kept for each event, and which differ by event. They are tied together by a traceability lot code, which identifies a lot in a firm's records. For most distributors the relevant events are receiving, shipping and, if you repack or relabel, transformation. The rule also calls for a written traceability plan describing how you keep these records and assign traceability lot codes. ### Producing records According to the FDA's rule page, firms must be able to give FDA the required records within 24 hours of a request, or a reasonable time FDA agrees to. In certain situations, such as an outbreak, firms must also provide an electronic sortable spreadsheet with the relevant traceability information. The mock recall steps above are a practical way to test that you can. ### The compliance date As stated on the FDA's rule page (page last updated 2026-07-24, retrieved 2026-09-28): - The original compliance date for everyone subject to the recordkeeping requirements was January 20, 2026. - FDA proposed extending the compliance date by 30 months, to **July 20, 2028**. - The Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 directed FDA not to enforce the rule before that same date, and FDA states it intends to comply with that directive. Dates like this change. Check the FDA page before you plan around it. ## Where traceability matters most | Industry | What drives it | Tracked by | |---|---|---| | Food | FDA Food Traceability Rule for listed foods, customer and retailer requirements, recalls | Lot, with dates | | Pharmaceuticals | The Drug Supply Chain Security Act (DSCSA) | Package-level product identifiers, including serial and lot | | Medical devices | FDA Unique Device Identification (UDI) system, customer and hospital requirements | Lot or serial, depending on the device | | Industrial and chemical | Shelf life, material certifications, customer quality requirements, supplier recalls | Lot, heat or batch number | ### Pharmaceuticals and DSCSA The FDA describes the Drug Supply Chain Security Act as setting out steps toward an interoperable, electronic way to identify and trace certain prescription drugs at the package level through the supply chain. Wholesale distributors have specific obligations under it, including licensure reporting. Start from the FDA's [DSCSA page](https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa) and its guidance documents. ### Medical devices and UDI The FDA's [UDI system page](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system) explains that labelers apply a unique device identifier to device labels and packages and submit device information to the GUDID database. Distributors of devices are often asked by hospital customers to capture lot or serial numbers at shipment so that the hospital can trace units to patients. ### Industrial and chemical Outside food and health care, lot tracking is usually driven by shelf life (adhesives, sealants, coatings), by material certifications (steel heat numbers, test reports that travel with a lot) and by customer quality programs that require you to name the lot on every shipment. The regulation is often the customer's, passed down to you in their purchase terms. ## Before you build 1. List the items that need lot or serial tracking and the reason for each: regulation, supplier, customer or risk. 2. Decide where lots are captured (receipt, pick, pack) and make it a scan wherever possible. 3. Make sure every transformation (break bulk, kit, repack, relabel) links input lots to output lots. 4. Run a mock recall on a real lot, time it and fix what it finds before the next one. 5. If you handle foods on the Food Traceability List, prescription drugs or medical devices, read the FDA pages linked above and confirm your obligations with qualified counsel. Getting units right matters as much as lots, since a trace quantity in the wrong unit is still a wrong trace. See [units of measure](/distribution/units-of-measure/). ## Sources - [FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (U.S. Food and Drug Administration)](https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods) - [Food Traceability List (U.S. Food and Drug Administration)](https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list) - [Drug Supply Chain Security Act (DSCSA) (U.S. Food and Drug Administration)](https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa) - [Unique Device Identification System (UDI System) (U.S. Food and Drug Administration)](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system) --- Epicor, Prophet 21, P21 and DynaChange are trademarks or registered trademarks of Epicor Software Corporation registered in the United States and other countries. 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