In manufacturing, lot traceability is readily available access to the complete history of all manufactured lots, batches and serialized units, spanning production in multiple plants. It includes materials consumed, processes and equipment utilized, parametric and quality data collected, exceptions, rework, dates and times and electronic signatures.
A complete as-manufactured audit trail that spans all activities across the entire supply chain provides lot traceability intelligence that enables correlating test results and field data with components, equipment, processes and operators – dramatically improving root-cause analysis and leading to proper, containment and resolution.
The traceability of manufactured lots and batches of serialized units includes the “5 Ms”, that is, material, (hu)man, machine, method and measurement. These correspond to time-stamped records of materials consumed, operator electronic signatures, equipment and tools utilized, processes and exceptions, and parametric and quality data collected.
Lot traceability in the form of electronic as-manufactured lot history records (eLHR), electronic device history records (eDHR), electronic batch records (eBR) and travelers are completely searchable – forward and backward–enabling “where-used” and “correlation” analyses. By configuring these searches, the user can:
- See the data needed to quickly determine the correlation among materials, processes, people and time
- Isolate the affected – and only the affected – lots and material for containment, rework, investigation or other actions
- Improve true root cause analysis and take effective corrective and preventive actions
Optimal, detailed lot traceability incorporates multi-level track and trace for maximum visibility, for example by batch, lot, serial number, etc., as well as in combinations of these.
An easily searchable database of lot traceability provides fast analysis for correlation and replaces the burden of manual engineering trial and error. Two types of lot traceability can be employed, forward or where-used traceability and backward or correlation traceability.
Related products: Opcenter Execution | Opcenter Quality
