What does traceability mean in CBM T6, and what are typical examples?

• A. Ability to trace materials, data, and processes from end to start
• B. Ability to trace only batch numbers without data
• C. Traceability is optional in CBM T6
• D. Ability to trace materials, data, and processes from start to finish; examples include batch records, certificates of analysis, and test results

Answer: (D)

Traceability in CBM T6 means the ability to follow a material, the data generated, and the processes applied all the way from the starting point through to the finished product, so you can see the full history and provenance of an item. In practice, this means you can link what was used (materials), what was done (process steps), and what was observed or measured (test results and data) and have those links recorded and accessible for each batch. Typical examples include batch records that document the complete manufacturing or processing history for a specific batch, certificates of analysis that show the results of testing and whether the batch meets specifications, and the actual test results that provide the data used to confirm quality. This capability supports root-cause analysis, traceability for recalls, and compliance with quality systems. The idea is not just a batch number without data, and it's not about tracing from end to start or treating traceability as optional.