4.8. Product Identification and Traceability

You must maintain procedures for the proper identification and the documentation of materials as they move through the production, installation, and delivery processes to ensure that the customer’s requirements are satisfied.

Depending on your customer’s requirements, you also may need to address production lot identification or component traceability. The standard says this is to be done “where appropriate”, meaning as required by your customer. Your customer may request that your product have varying degrees of traceability. You must ensure there are formal and documented methods and records in place to satisfy this request.

To maintain product identification and traceability:

• You must have a documented system for ensuring the materials are uniquely identified from the moment they arrive to the point of customer receipt.
• If contracted by your customers or required by regulatory bodies or you have determined that material traceability is desired, you must have a documented system that records the appropriate information to achieve this objective.