| Audit Item | Yes | No | Comments |
|---|---|---|---|
| Is there a documented procedure for lot traceability? | |||
| Is every lot uniquely identified and labeled throughout the process? | |||
| Is lot information accurately recorded in all relevant records? | |||
| Are records readily available to trace product history? | |||
| Is the traceability system tested regularly? | |||
| Is the process for managing non-conformances traceable to lot number? | |||
| Is rework/reprocessing clearly traceable to the original lot? |