# Lot Traceability for Medical Turned Components > Source: https://netray.co/resources/lot-traceability-medical-turned-components > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Knowledge Base ## Short answer Lot traceability for medical turned components: heat numbers, ISO 13485 records, device history, recall readiness and how Swiss shops tie bar lots to shipments. ## Category erp-general ## Content **Intro:** Lot traceability for medical turned components means being able to trace every shipped part back to the bar heat number, the machine and operator records, the inspection data and the outside processors that touched it, and forward from a suspect bar to every affected customer. Device manufacturers flow ISO 13485 expectations down to their component suppliers, and a Swiss shop making bone screws, implant components or surgical instrument parts is expected to prove it. This guide covers the records involved, common traceability gaps in turned-parts shops, and how to test your system with a mock recall. **Sections:** #### What Customers Expect From a Component Supplier **Body:** Medical device makers operate under ISO 13485 and, in the United States, FDA requirements that now align Part 820 with ISO 13485 through the Quality Management System Regulation. Those obligations reach suppliers through purchasing controls and quality agreements. For a turned-parts shop, the practical expectations are lot identification on every shipment, material certification linked to the lot, controlled processes with validated special processes, calibrated measuring equipment, documented nonconformance and corrective action, and change control that requires notification before material or process changes. Read the quality agreement closely, since it defines the records and retention period you owe. **Bullets:** - Heat or lot number of bar stock linked to each production lot - Material certs such as EN 10204 type 3.1 or equivalent, including chemistry and mechanical properties - Records of special processes: passivation, electropolish, anodize, heat treat, with processor certs - Inspection records tied to the lot, including first article and in-process checks - Defined retention periods, often many years, for device records #### Where Traceability Breaks in Turned-Parts Shops **Body:** Breaks typically occur at transitions. A bar is split across two jobs and the heat number is recorded on only one traveler. Parts from two machines are combined into one container. Parts go out for plating, return mixed with another job, and the lot identity is lost. Rework is done off the routing. Remnants are returned to stock without the heat number. ERPs can track lots, but only if the shop floor enters the lot at issue and at every transfer. The weak link is almost always procedure and discipline, then the software. #### Material Certs and Heat Numbers in the ERP **Body:** Store the mill cert against the heat number at receiving, and make the receiving step reject a bar without a cert. When a bar is issued to a job, capture the heat, so the job record shows which heat went into which lot. For shops with a requirement of one heat per lot, the system should warn when a second heat is added. Titanium and implant-grade stainless, such as ASTM F136 and F138 materials, often come with additional certification and traceability expectations on top of the basic mill cert. Check that the ERP can print a certificate of conformance that references the heat and the processor certs. #### Test It With a Mock Recall **Body:** The practical test is a mock recall. Pick a heat number from a year ago and, without help from the person who set up the system, produce every job, lot, customer and shipment that used it, within an hour. Then reverse the test: pick a shipped lot and produce the bar heat, machines, operators, inspection data and processor certificates. Time the exercise and list every place you had to open a binder or ask a person. Those places are your gaps, and fixing them before a customer or auditor asks is far cheaper than doing it during a real event. #### Where AI Helps, and Limits **Body:** AI can assemble the trace faster once the underlying records exist: reading scanned certs and travelers, linking them to ERP lots, and answering a question like which shipments used heat number X, with the source documents cited. It can also flag lots where cert data is missing or the heat on the traveler does not match the ERP. It cannot create traceability that was never recorded, and it does not replace validated procedures. If your records are already clean and your ERP answers the mock recall in minutes, you do not need AI for this. **Cta:** Netray can index your ERP lots, mill certs and travelers privately and answer heat-to-shipment trace questions with sources, so a mock recall takes minutes. **Faq:** #### What traceability do medical device customers require from machine shops? **Answer:** Typically lot identification, material certs linked to heat numbers, records for special processes and inspections, calibrated equipment, nonconformance control and change notification, as defined in the quality agreement. Retention periods are often long, so confirm them in writing. #### Do I need ISO 13485 certification to supply medical components? **Answer:** Not always, but many device manufacturers require or strongly prefer it, and flow down equivalent controls through quality agreements. Check each customer's supplier requirements, since some accept ISO 9001 plus specific controls while others require ISO 13485. #### How do I trace a bar heat number to finished parts? **Answer:** Record the heat at receiving, capture it when the bar is issued to each job, and carry the lot identity through every transfer and outside process. Then test by running a mock recall from the heat number forward to shipments. ## Related Slugs - healthcare-medical-device-erp - lot-traceability-electronics-manufacturing - infor-m3-lot-traceability-configuration - syteline-iso-9001-erp-compliance-guide ## Search terms lot traceability medical device components, ISO 13485 machine shop traceability, heat number traceability ERP, medical turned parts supplier requirements, mock recall exercise manufacturing, mill cert tracking software --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json