17 - Product Traceability

A company that is aware of their product being defective but is unable to trace the product is exposed to significant product liability risk (i.e. consumer injuries, property damage, financial loss, etc) and in most cases has no option but to recall all units of the product regardless of them being defective or not. Product traceability provides the ability to identify and track a product or a component to its point of origin. The point of origin may be a particular lot or batch, production line and timeframe, field or supplier.  Product traceability is very important to reliability.  If a particular lot of a critical component is found to be defective after being used in product that is already sold, traceability provides a means of identifying the units for recall.

What do we look for?

Exposures

  • High volumes of durable goods sold
  • Products are end of line
  • Strict industry or regulatory requirements for upstream and downstream traceability
  • Products have very long life and is likely to be sold and resold
  • Complex distribution chains.

Controls

  • Strict batch / lot size limitation
  • Adequate batch control labeling and identification of the products sold
  • Suitable records and archiving for raw materials and goods supplied (upstream) or sold (downstream).
  • Company records can accurately identify product and their history (by model, serial number, batch or date codes).
  • Comprehensive records that can trace customers.

Risk improvement ideas

  • Adopting a product traceability system to identify products uniquely in terms of product identification, manufacturing order number, process order number, lot number, and inspection order number in all stages of manufacturing.
  • Ensuring the product traceability system also links each component element, whether material, process, measuring gauge or personnel to any related activities related to the final product.

Risk topics

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