Materials Traceability

Materials Traceability Chapter added. Linking products to their input materials, enabling root cause analysis and corrective action when non-conformities occur.

Materials traceability focuses on linking finished materials back to the specific lots of input materials and their suppliers, ensuring transparency and accountability across the supply chain.

It requires suppliers to establish systems that record and track batches of materials — ideally using digital tools or identifiers such as barcodes or QR codes connected to ERP systems — so that any non-conformities can be quickly traced to their source.

When issues like restricted substance failures occur, suppliers are expected to perform a Root Cause Analysis (RCA) to identify the affected batches, determine the origin of the problem, review documentation, and implement corrective and preventive measures.

This approach strengthens supply chain integrity, supports compliance, and enables rapid, data-driven responses to potential risks.