Short answer: A capable PCB assembly partner should trace, for every board: which component lots and date codes went into it (per reel), the solder paste lot, the reflow profile and machine programme used, the moisture-sensitivity (MSL) handling record, the AOI, X-ray and electrical or functional test results, the operator and date of any rework, and the batch or serial number under which it shipped, with a certificate of conformance. Lot-level traceability should be standard; serial-level traceability is expected for medical, marine safety, energy and any IPC class 3 product.
What is recorded, and where
| Level | What is traced | Why you need it |
|---|---|---|
| Component lot | Manufacturer, part number, lot/date code per reel, distributor, incoming inspection | Recall containment, counterfeit exclusion, EOL analysis |
| Materials and process | Solder paste lot, stencil ID, reflow profile, MSL bake and floor-life records | Root cause of joint defects, class 3 evidence |
| Board / batch | Work order, board revision, panel, operator, date, AOI and X-ray results | Field failure investigation, yield analysis |
| Serial number | Per-unit test results, firmware version, calibration data, rework history | Medical device history record, warranty, remote diagnostics |
| Shipment | Certificate of conformance, packing list, RoHS/REACH declaration | Customer audit, customs, regulatory file |
Which level do you need?
- Industrial and IoT products: batch-level traceability with component lots; serial numbers when the product has firmware or calibration.
- Medical devices (IEC 60601, ISO 13485 environment): serial-level traceability, device history records, controlled rework.
- Marine safety, rail, energy: serial-level, with process records retained for the product's service life.
- Consumer and general: batch-level is normally sufficient.
How Comtec Labs records it
Every reel is registered at incoming inspection with manufacturer, part number and lot; feeders are verified against the BOM before the run starts; AOI and test results are stored per board; MSL-sensitive parts carry a floor-life record; rework is logged per board with the operator and the IPC-7711/7721 procedure used; and each shipment carries a certificate of conformance. Serial-number traceability and per-unit test reports are configured per product.
Key facts
- Lot-level traceability should be standard from any EMS; ask to see a real record, not a description.
- MSL records matter: a moisture-sensitive part reflowed after its floor life can crack invisibly and fail months later.
- Serial-level records are what a medical device history record and a marine safety file require.
- Comtec Labs retains production records for the agreed product life and provides them within one working day on request.
How to specify traceability in your order
State on the assembly drawing or in the purchase agreement: the traceability level (batch or serial), the records to be retained and for how long, the format of test reports, whether rework must be approved by you, and the certificate of conformance requirement per shipment. Comtec Labs confirms the traceability plan with the quote.
Frequently asked questions
What is the difference between batch and serial traceability?
Batch traceability tells you which lots and process records apply to a production batch of boards; serial traceability links every record, including test results and rework, to one individual board.
Do I need traceability if my product is not regulated?
Batch-level traceability is inexpensive and protects you against component recalls and counterfeit parts, regulated or not.
Can I get test results for each board?
Yes. Per-board or per-serial-number test reports are provided when serial traceability is configured for the product.
How long are records kept?
For the agreed product life; typically 5–10 years for industrial products and per the regulatory requirement for medical devices.
Ready to reduce PCB surprises?
Comtec Labs offers a full suite of services to streamline your workflow:
PCB design service
PCB prototyping service
PCB component sourcing
PCB component assembly
PCB testing service
PCB repair and modifications
Printed circuit board production
PCB mass production