Enabling Improved Data Capture During Manufacturing for FDA-required Batch Traceability
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- Solution: An automated solution was created to sample the product multiple times each second during production. The superior tracking of temperature curing from the simultaneous statistical sampling system resulted in improved quality validation and more accurate batch traceability. The new eight station quality control system substantially improved testing speed. Automated reports generated from the comprehensive data captured saved time preparing mandatory FDA reporting.
- Benefits:
- An improved automated sampling process maintained the medical-grade standard needed for the product while increasing production consistency and traceability
- The increased number of stations in the quality control system allowed for improved throughput, and could be scaled up based on future production needs
- The new sampling system saved time and effort by enabling more comprehensive data capture and automating FDA compliance reporting
The Challenge
The Company manufactures a medical product that is used directly on patients. Production requires close monitoring of quality and documentation of compliance for FDA traceability, batch by batch. The process of monitoring and recording results was a time-consuming manual process. The process the Company used gathered the necessary data, but the capture of that data was limited to the speed of a human operator utilizing a single quality control station.
Since medical products are subject to strict government regulatory requirements, the data gathering requirements during manufacturing are extensive, and can limit the speed of production throughput. |
Creating an automated testing and data-gathering solution to provide detailed, traceable records for medical manufacturing |
There was a need for greater data resolution, requiring higher speed data acquisition, which wasn’t possible to do manually. For better statistical representation of a batch, measurement of multiple samples was desired, but the Company knew it would be too time-consuming if done through a manual process.
The Solution
S5 Solutions worked in partnership with the Company to design and implement an automated test station capable of gathering all the desired data to meet regulatory requirements for batch traceability. The high-speed system has multiple test cells which are monitored simultaneously. This system makes it possible to get a more statistically significant sample of the batch without a lengthy manual test process.
One of the factors monitored occurs at a high rate of speed difficult for a human technician to measure accurately. The system’s high-speed acquisition collects much more information than is possible manually. That data is then run through an algorithm that finds the desired temperature inflection point with great accuracy and repeatability, removing the dependence on a judgment call by a technician.
Data from the testing and quality control system is recorded electronically and transmitted to a controlled documentation system for permanent storage. This process provides better security and integrity for the data, critical for regulatory recordkeeping. The electronic data management system is a major improvement over the previous pen and paper process, ensuring higher levels of accuracy. |
The Results
The new testing and quality control system enables data collection that is more accurate, more detailed, and more repeatable than previously possible. Batch data for the medical product is now electronically stored in a highly secure recordkeeping system, ensuring improved management and tracking of historic production batch data. The electronic data management system, which exceeds the regulatory recordkeeping requirements of the FDA, provides unprecedented visibility for the company into the performance and quality of their product.
The new automated testing and quality control system exceeded performance expectations. The Company was so pleased with the outcome it added additional units to speed up the production batch validation and data tracking process even further.
The new automated testing and quality control system exceeded performance expectations. The Company was so pleased with the outcome it added additional units to speed up the production batch validation and data tracking process even further.