Human enhancement with IoT to meet quality standards in medical devices manufacturing(BLX -01 + ATS)

Updated: Mar 22




Case background

Despite the great advances in industrial automation, a large portion of the world's specialized manufacturing still requires the intervention of manufacturing operators for processes in which manual work is still more effective and efficient than machines.


Monitoring and control of production and quality in these manual processes require, in turn, human vigilance by production supervisors and operators themselves. Therefore, is common practice to use handwritten document controls that are susceptible to errors and costly reprocessing time dedicated to digitizing the information and generating reports of units produced by the production line or the number of parts rejected due to quality.


The problem: Medical devices manufacturing quality assurance

A medical products manufacturing company has many manual production lines with substations and assigned personnel. To comply with quality regulations, its process requires the operator to carry out an operation in specialized equipment and to keep the product in this equipment for a standard minimum of seconds. If by mistake or haste the operator removes the product from the equipment in advance, the product must be considered non-conforming according to the specifications and should be withdrawn and never sent to the market.


To carry out a more efficient and precise control of this operation, the company needed to implement a system that would measure the minimum execution time of the process at each step of the substation. Besides they had the requirement for the system to adjust to the ergonomics of a human being in a way that would not affect its performance and that would allow the operator to effortlessly document the information related to its production job.


Lantern solution

The Lantern team designed a production timer, counting, and reporting system based on a pedal-type instrument with an IoT controller, and a small monitor screen located on the line. The system allows the operator to activate the special tooling with the pedal and the system counts the execution time of the process. In this way, line personnel can detect if the minimum standard waiting time is not met at any station while counting the number of units and the quality throughput in real-time.


Finally, the system sends the information wirelessly to an IoT Gateway which forwards the information from all the lines to a Lantern’s ATS platform for storage and reporting in the cloud. It is available on the web to be accessed by production managers and supervisors.





Conclusion

Thanks to this system, production supervisors can view the production of each line in real-time. There is also an automatic quality report based on the number of rejected units, which allows warning and action in real-time if the quality KPIs are deteriorating at any point. Previously, improvement decisions were made at the end of the shift or when the lots were closed, while thanks to this system, immediate corrective actions can be taken throughout the shift. The system also helps them prevent non-compliant products from reaching the market and management reports are generated without human intervention by shift, day, week, person, or product, which avoids devoting valuable engineering time to the administrative work of reports generation.

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