Materials Traceability

Updated to place greater emphasis on end-to-end material traceability, helping facilities strengthen transparency and accountability across the supply chain. The updated guidance reinforces the need for robust traceability systems that enable materials to be tracked back to their source and supports a more effective response to non-conformities through the inclusion of root cause analysis (RCA) and corrective action plans (CAPs). The requirement wording has also been updated to align with StZ V2

July 2026

The previous two requirements were combined into one requirement. Requirement wording and numbers were updated to align with StZ V2 requirements

Previous requirements:

1. Implement a system of traceability of finished materials to input materials

2. Implement the practice of Root Cause Analysis (RCA)

Updated requirement:

1. The facility implements traceability for input materials and manages restricted substance risk in finished products

Guidance on “Maintain documented procedures describing material traceability” has been expanded with the addition of “root cause analysis and corrective action plan”

The guidance on maintaining documented procedures for material traceability has been expanded to include root cause analysis (RCA) and corrective action plans (CAP), strengthening the link between traceability and continuous improvement.

September 2025

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.