Medical device manufacturer uses Camstar Medical Device Suite to enable agile business processes and continuous growth.
Lot Traceability
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 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), device history records (eDHR), batch records (eBR) and travelers is 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.
The correlation of elements points to the need for more frequent maintenance, and is only possible with complete and accessible lot traceability.
Forward or where-used correlation using lot traceability
If a defective component lot is identified, forward traceability tells us “where-used”, or every sub-assembly or final product in which it is found. Likewise, if a piece of equipment or a process revision caused a nonconformance during a specific time period, where-used analysis tells us every lot, device, batch or unit that was processed on it during that time. Instant access to where-used details enables fast bracketing, and precisely identifies the affected products that need to be contained.
Forward and backward lot traceability of products, components, equipment, processes, operators and test results – across multiple sites – is necessary for comprehensive where-used analysis.
Backward or correlation using lot traceability
Backward lot traceability complements forward traceability and where-used analysis in that it details every component, sub-assembly, equipment, process and operator that contributed to a given lot or unit.
If certain units of a product are found defective, it may not be readily apparent what manufacturing conditions they have in common. Fast computer correlation analysis might reveal that all 15 (and no others) were processed on Machine 2 on Tuesdays, just before weekly preventive maintenance was due. The correlation of these elements points to the need for more frequent maintenance, and is only possible with complete and accessible lot traceability.
Correlation of forward and backward product, components, equipment, process, operator and test result traceability – across multiple sites – is necessary for true root-cause analysis and effective resolution. These traceability data can be correlated to reveal the combination of conditions that cause a product issue.