Identification and Traceability

ISO 9001 section 7.5.3 addresses identification and traceability of product.  Identification is normally performed by assigning a part number.  Purchased components normally contain a part number from the supplier.  When this is not the case, one should be assigned to the parts or to them upon receipt.

During production, a product that goes through multiple process steps must be identified as to which process steps it has gone through.  This is often accomplished by attaching a traveler document.  A traveler will indicate which process steps have been accomplished.  This is critical when the process step does not change the appearance of the product like passivation, cleaning, inspection and annealing.   Another way to do this is by changing the part number as the product goes through different process steps.

Position can be used as an indicator of production or inspection status.  For example, purchased product is not moved to inventory until inspection has occurred.  Any product not in inventory is considered uninspected.  All products in inventory are considered inspected.  Once removed from inventory, the product cannot be returned to inventory until it has been inspected.

If a product is removed from inventory, processed and returned to inventory, its part number should change when it is returned to inventory.  For example, an item that is plated and returned to inventory awaiting additional processing should have a different part number after plating.

Some parts cannot be marked with a part number.  In this case, the outer packaging should identify the part number of the item, and the item should be left in this packaging until consumed.  In cases where this is not possible, such as items that go into a clean room, the product should be placed in some acceptable tote container, and the container should be marked with the part number.

Test status must also be maintained in all stages of production.  Again, a traveler can indicate inspection status, or an inspection report can be attached to the product.  Also inspection steps that release only inspected product to the next process can be an indicator of inspection status, but is a less secure method.

While identification relates to part number or status, traceability relates to specific parts or production batches.  Traceability is required in some industries.  Lot control is easy to implement and should be considered by most organizations.  Lots can be controlled by marking them by production date.  In many cases, traceability is lost when the packaging is discarded.  In these cases, shipping paperwork should record which production batch (es) were shipped in each shipment.

Some see traceability as unnecessary extra work, but an ounce of prevention is worth a pound of cure.  Consider a product defect that gets into the field.  Knowing the production date where the defect started provides a method of creating a containment plan.  Knowing where that product was shipped, permits a positive recall that assures that only the potentially defective product is recalled.

In one company, we maintained serial number control of finished product and recorded lot numbers of each component on our inventory pick tickets as components went into assembly.  We had received a substandard batch of 14 bearings that started failing in the field.  We were able to recall a select group of 20 serial numbers (there were two lots of bearings in the production batch) for re-inspection and bearing replacement where needed.  Only a few customers needed notification, minimizing our exposure.  We were also able to identify the supplier and charge back the supplier for the defects.

Traceability is important when multiple suppliers supply the same product.  It can be a powerful tool for defect reduction and quality improvement.  Use it wherever possible.

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