How long should QC records be kept so a recall can be traced to a batch?

Main answer · Wecent Editorial Team

Short answer: Give every batch a code, link it to the components and inspection records and keep them for the whole sale life of the product plus a safe margin that covers warranty and liability. Write the period in your quality procedure after checking legal minimums. Keep retained samples from each lot for the same time if practical.

What traceability needs

When a problem appears, you need to answer: which units, made when, from which parts, and sold where? Without batch codes and linked records, a small defect can force a recall of everything.

What to record

• Lot or date code. On each unit or carton, linked to production dates.
• Bill of materials. The version used, and critical component lots.
• Inspection and test results. For each lot, with the inspector and date.
• Process records. Line, shift and settings, where relevant.
• Shipping records. Which lots went to which customers or warehouses.
• Retained samples. A few units from each lot, stored properly.

How long to keep them

The right period depends on legal rules and risk. Rules on records differ between product types and regimes, so ask a compliance adviser. A practical approach is to keep them through the sale life of the model and for several years after, to cover warranty claims and product-liability questions. Do not destroy records while a claim or investigation is open.

Make it usable

1. Use codes that people can read and that match across documents.
2. Store records in a system where you can search by lot.
3. Make a regular test of traceability: pick a lot and trace it forward and back in under a day.
4. Back up the records.

Supplier records

Ask your factory to keep its own records for the same period and give you access when needed.

Share with distributors

Distributors should record which lots went to which customers, so a recall can reach the right people.

Quick summary

Code each lot, link the records, keep them long enough and test your ability to trace regularly.

Traceability drill

Pick a lot at random and ask the team to list the dates, parts, inspections and shipments within one working day. Where the answer is slow or incomplete, fix the record system. Doing this drill every year is the best way to be ready for the day you need it.

Where this answer says to confirm with Wecent, the detail is not published on the product page and has to come from the datasheet or the factory. General facts come from the regulators, standards bodies or device makers named in the text.