The healthcare industry argues that process-improvement efforts are hampered by regulations and that they must spend as much as 50% of each improvement program on validation. These claims are true, but new regulations allow manufacturing processes to be validated according to a science-based mechanistic understanding of process control. Once this validation is accomplished, the requirement for ongoing validation efforts is greatly reduced. Ongoing process-improvement efforts can proceed with minimal revalidation.
The US Food and Drug Administration is actively encouraging manufacturers to adopt process analytical technology (PAT) and quality by design (QbD). Both strategies require a process-control management method and a technical infrastructure for ongoing operations.Enterprise process control and management (EPCAM) is a strategy for achieving this increase in process understanding. EPCAM is a macromanagement process executed through an integrated information solution and supported by associated systems and data, including machine-process controls through programmable logic controls (PLCs), supervisory control and data-acquisition systems (SCADA), manufacturing execution systems (MES), middleware, statistical process control (SPC), laboratory information management systems (LIMS), adaptive process control (APC), and fault detection and classification (FDC). EPCAM uses Six Sigma as the fundamental macro management process to supervise manufacturing-process control across the entire value chain for any given element, including raw materials, suppliers, and subcontractors.
EPCAM has largely been overlooked for three major reasons. First, process control is typically executed manually and is primarily focused on stand-alone unit operations. Second, data integration across operations is lacking. Third, the software to draw the relationships between process parameters and product attributes is not widely known or commercially available. Some examples of these issues include the following:
The requirements of manufacturing in the regulated life-sciences and healthcare environments often necessitate that manufacturing-process improvement take second priority to validation and responding to nonconformances. As a result, process control in many manufacturing operations is not well understood.
Many companies turn to Six Sigma as the preferred method for process improvement, then apply it problem by problem. Six Sigma is well suited for improving business processes following the methodology of define, measure, analyze, improve, and control (DMAIC). The problem with most DMAIC efforts is the amount of time and resources needed to collect the relevant process data and analyze them with the corresponding product data.
For example, a plant site of about 350 people adopted the Six Sigma process hierarchy with the intention of continually improving the Sigma of the critical processes and the overall process. The idea was sound, but significant practical problems derailed the implementation. The first problem was that the effort required about 30 full-time employees to track and maintain the data. The second problem was uncertainty about what to do with 10,000 SPC charts after they had been gathered.
EPCAM solves this process-execution and data-management problem by: