Building Traceability from the First Material
Finished-product information can only be interpreted in the context of the materials used to create it. A structured material program records origin, identity, status and relevant changes.
Supplier Review
Supplier assessment considers the information available about the organization, supplied material and supporting quality system.
Approval should be specific to the material and scope being reviewed rather than treated as a permanent or universal endorsement.
Incoming Material Status
Received materials should be identifiable and assigned a clear status while documentation and applicable checks are reviewed.
Material labels, lot references and receiving records help prevent different items or statuses from being confused.
Identity and Specification
Identity information establishes what a material is, while a specification defines the characteristics used to assess it.
No single document should automatically replace an appropriate review of the material, its source and its intended use.
Traceability and Change
Traceability links a finished lot to the material lots recorded in its production history.
Changes in supplier, specification or supporting documentation should be evaluated before the affected material is used within an established workflow.