Manufacturers increasingly look to optimize their businesses by integrating their business processes with their manufacturing processes. ANSI/ISA-95 (S95) is an international standard for developing an automated interface between enterprise and control systems.
Over the last several years our Life Sciences Industry Center has been working with pharmaceutical and biotech manufacturers on this optimization process in pursuit of operational excellence. I caught up with integration consultant, Dick Seemann, who discussed some commonalities he sees in integration transactions between enterprise planning systems like SAP business software, manufacturing execution system (MES) software and control systems like the DeltaV system.
A key transaction is the process order download which comes from the planning and scheduling software to the manufacturing system in the form of a request for a campaign of process orders or a single process order. The transaction contains a process order number, material components, equipment requirements, and specific parameters that are exchanged through standard web services. The team typically uses Compliance Suite as the MES software between the SAP software and the DeltaV system.
The MES software combines this information from the production, material management, and quality management software and then manages the order execution, performs weigh and dispense, and executes the manual work instructions in conjunction with the automated control system tasks. A complete electronic batch record is maintained at MES level, since it combines recorded manual processes and procedures with electronic information at the control system and enterprise planning system levels. Alarms, events, operation actions, and batch history are passed as transactions from the control system to the MES.
The process orders as the campaigns are being executed provide status transactions back to the planning systems on status changes during execution and upon completion of the process order. Materials consumed during the production and recorded by the manufacturing execution system are passed back as transactions to the material management module to accurately reflect what is available for planning future production.
Start and end times for each of the steps in the batch are also passed back as transactions to the planning systems to provide and accurate picture of equipment utilization and how long production steps take compared to standard times.
Dick notes that all process manufacturers have different business processes and that there are many more transactions that can occur between the three levels. As these paper-based processes are moved into an integrated, transactional world, end-to-end cycle times are reduced resulting in greater manufacturing efficiency.
Transcription errors are also reduced when all communications is electronic-based versus the paper batch sheets. Also, troubleshooting problems becomes easier when a history of electronic batch records is available to review to analyze where inefficiencies have begun to occur.