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).
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)
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.
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.