Electronic Device History Records
A medical device manufacturer contracted ACC to provide a solution to help them manage workflow, control data and improve the manufacturing process. The result of this effort was a paperless system which collects data for process analysis and produces an Electronic Device History Record (eDHR).  Paper is no longer used on the manufacturing floor.

The production workflow is kicked off by scanning in work orders from the ERP system.  From this point forward, operators are guided through the manufacturing process by interfacing with electronic forms via PCs located in various departments, including staging, production and QC (where results of inspection and tests are entered into the system).
The forms and workflow are built and presented via ACC’s processRecords® workflow management software.  At the end of each work order, processRecords generates an exception report – allowing for quicker review and approval of each lot.

Process information is collected through a combination of manual (operator-entered) steps and automation.  The automation front-end utilizes Rockwell’s View SE and FactoryTalk Historian platform for process monitoring and alarms.
Eight large screen LCDs are strategically located throughout the facility (mounted from the ceiling) providing highly-visible real-time insight into the process.

In addition to the eDHRs and the exception based reports, the system collects key parameters throughout the manufacturing process.  This data is used to analyze and improve the operation.