EPCAM: A Strategy to Enable Manufacturing-Process Control Transformation - Pharmaceutical Technology

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EPCAM: A Strategy to Enable Manufacturing-Process Control Transformation
Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.


Pharmaceutical Technology



Figure 2: The deployment of process analytical technology helps manufacturers achieve adaptive control and automatic fault correction. MES is manufacturing execution system, WIP is wash in place, and PAT is process analytical technology. (AUTHORS)
FDC brings process control to higher than CpK 2.5, a level at which operators can adjust or shut down processes well before problems or nonconformances occur. If a problem is likely, FDC directs the operator to the cause to correct it. The effect of this achievement on a life-sciences or healthcare company is great. The cost of compliance plummets. Technical resources are directed to continuing process improvements, which no longer require revalidation if a QbD strategy is followed with the FDA, or product-development activities instead of addressing nonconformances. FDA audits can be forestalled by providing regulators access to process systems and results. Additional benefits include a more frequent on-time product launches (see Figure 2).

The business-process model and closed-loop systems architecture for EPCAM combine the process orientation of Six Sigma and advanced manufacturing technologies. EPCAM was developed by a joint task force comprising IBM's Research and Development, Software Development, Integrated Supply Chain, Engineering and Technical Services, and Global Business Services experts. The conceptual architecture shown in Figure 2 delivers 8.0-sigma process capability at IBM's semiconductor fabrication facility in East Fishkill, New York.

Commercially available ERP and MES software systems are foundational layers of EPCAM needed to move from 2-sigma performance up the process-control hierarchy. Middleware moves data between the processing centers and the APC and FDC systems.

EPCAM can be built incrementally, focusing on the most critical areas of the operation, based on the individual business's priority. The end state should be envisioned before the process begins to ensure that the integration will be achieved and the business value will be realized.

Organization

The transformation required to implement EPCAM is a cultural change enabled by advanced tools that reduce risk and shorten the process. The process includes organizational challenges such as:

  • Skills development
  • Changes in job roles and organizational structures
  • Changes in mindset and culture
  • Modification of policies and procedures
  • Data sharing
  • Establishing the primacy of science.

The EPCAM architecture may integrate existing stand-alone tools, or employ new technologies that require extensive training and support. Advanced technologies often are already in place, and the organizational comfort and technology maturity are sometimes high. Even when an organization is technologically advanced, individuals learn at different rates. Supervisers must consider this variable when they design and execute the learning and knowledge-transfer process.

New tools, increased levels of automation and integration, and process changes, will lead to changes in job roles. A process orientation, focused on the outcome of an integrated series of activities, is one of the most significant benefits and one of the largest role-based changes of the EPCAM strategy. Tasks, measurements, and reinforcements should be realigned to maintain a sustained focus on the entire process.


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