Traceability
China Surgical Tools understands that Product Traceability (Lot Control) is an imperative requirement of our Medical Device, Aerospace and Defense customers. As such, China Surgical Tools maintains full traceability for all production processes in compliance with rigorous customer and regulatory specifications.
Quality control is embedded in each individual job through the utilization of printed travelers. These desk level work instructions not only serve to communicate risk and key process requirements, but are vital to maintaining a comprehensive and traceable audit record for each production operation.
With our continuous focus on technological advancement, China Surgical Tools’ integration of sophisticated JobBoss(R) ERP Data Collection Systems simultaneously creates an electronic record while providing real-time reporting for each action of every operation.
Our strict procedures for lot identification and segregation provide complete traceability to:
- Raw Stock – Source, Specifications, Inspection and Transaction Register Each job traveler identifies the product’s Material Specifications (alloy, size, print and regulatory requirements), the specific Material Lot Number used for production (traceable back to the original mill certification), and provides documentation of Receiving Inspection and a record of the Job Issue Inventory Transaction with full employee accountability.
- Production and In-Process Inspection Each operation on the job traveler, from the inspection of raw materials to the final shipment of completed product, is recorded as a transaction that is traceable to the machine, operator, date, quantity, in-process inspection approval and the disposition of scrap. First Article Inspection is performed for each job; critical dimension and key characteristic inspection results are recorded on the First Article Inspection Report and attached to each job traveler.
- Outside Process Verification A receiving inspection is performed and conformance documented for each process performed or component provided by our suppliers. Inspection reports and certification of product conformance are attached to the job router and included with all final inspection reports.
- Final Inspection and Certificate of Conformance A certificate of conformance is provided with each shipment. China Surgical Tools also provides more advanced and detailed final inspection reports in compliance with Medical, Aerospace and Defense industry regulatory requirements.
China Surgical Tools’ integrated traceability process is key to eliminating costly recalls, quickly isolating affected product lots, and minimizing the risk of future discrepancies. Additional benefits include:
- Provides real-time traceability to more accurately monitor each component as they advance through the manufacturing process.
- Provides real-time reporting on all components, machines, stations, shifts and operators.
- Identifies defects prior to customer delivery, reducing in-process and/or product recall costs.
- Allows for prompt and accurate root cause analysis on any product discrepancy traceable to each process and personnel involved in the defect.
Contact us today for more information on how China Surgical Tools can support your product traceability control requirements.