Once the mindset change from an individual operation focus to an end-to-end orientation is accomplished, other elements of
the operating culture must be addressed. Fear commonly accompanies the deployment of technologies. Individuals experience
anxiety when they are asked to maintain their performance while learning new methods and tools. Personnel may become uncertain
when asked for the first time to focus on the science and chemistry of the operation rather than on managing the equipment.
Reducing reliance on intuition (often perceived as skill developed over time) and increasing scientific understanding may
be difficult for some employees. Abandoning established approaches is challenging, particularly for employees who have maintained
high performance using those methods.
Perhaps the most critical cultural change is trusting the data, process, policies, and procedures to produce the batch, and
trusting the technologies to integrate and capture the information. Without this trust, the benefits of EPCAM are quickly
lost. One of IBM's clients referred to the skills-development process as "upskilling," and employed a rigorous change-management
program to create adequate awareness, obtain acceptance, and provide training and support.
Figure 3 shows a transformation "road map" featuring one progression from the current state to the EPCAM capability in a logical
and feasible timeframe. The figure depicts when the effort should begin and when EPCAM capability should be achieved to meet
the future needs of the supply chain.
Figure 3: A road map for progressing from the current state to enterprise process control and management capability. APC is
adaptive process controls, ERP is enterprise resource planning, FDC is fault detection and classification, LIMS is laboratory
information management system, MES is manufacturing execution system, PAT is process analytical technology, PLM is product
life cycle management, RFID is radio-frequency identification, SC is supply chain, and TTS is target treatment solutions.
The process for implementing EPCAM
Organizational capabilities must be built along with tools and technology. Technology is great enabler of process understanding
but it requires a management team with vision and a commitment to success. The management team must include dedicated people
with process skill to use tools and improve process capability. Many people employed today in the life-science industry have
math and science backgrounds. Many of these employees can be trained to focus on process improvement.
The first step in establishing EPCAM is a foundational layer of process-management training that includes lean and Six Sigma,
implements ERP, and sets the stage for a strategic change.
The second step is attaining point-to-point process control, deploying radio-frequency identification internally to track
products, and implementing electronic batch records. Experience with process control accumulates at this stage. The organization
should undergo training to foster the right skills and behaviors.
The third step is the integration of the existing ERP, LIMS, MES, PLM, PLCs, sensors, and actuators to the APC system. Integration
puts the foundational data in place and facilitates the change from point-to-point control to end-to-end process management.
The company should set a target for the percent of end-to-end processes to be within APC control. A good initial goal is 30–50%.
The new process-improvement organization should regularly perform advanced analysis using the data and APC capabilities to
continually improve process capability. All new products in development should use the APC capabilities.
The next step is implementing FDC and continuing to expand the end-to-end process coverage within APC. FDC captures the environmental
features that affect the product and brings stability and standardization at the highest level of process control. Expanding
control to trading partners such as raw-material suppliers and subcontractors should be part of this step. Product development
should be fully integrated with the manufacturing systems at this step as well.
An incremental progression is possible. The project is a large undertaking that will take more than five years, but each step
creates great business value. The quality of the product and the process is enhanced at each step. Risk is lowered for the
manufacturer, and safety is increased for the patient.