How to Evaluate Manufacturing Intelligence Costs/ROI

Understanding the features and benefits of MI software is one thing; making the business case for its implementation is quite another. The challenge for manufacturing and process development teams is to communicate to upper management how the efficiencies gained from MI or EMI software translate into a tangible return on investment.

A recent conference of EMI users made a series of recommendations on how teams can codify the benefits of Manufacturing Intelligence software to make the business case to decision-makers. Recommendations included:¹⁴

• Demonstrate that reducing the time and effort for data access frees up more time for analysis that can result in yield and quality improvements. If the cost of analysis is reduced, more hypotheses can be tested.
• Document the time saved for regulatory compliance issues and documentation.
• Use examples to demonstrate the value of data in context versus raw data.
• Don’t overestimate cost savings; inaccurate numbers are likely to distract from the bigger picture.
• Provide numbers for the capital cost of full-time equivalents (FTEs) versus the operational cost of changing their roles to make them more effective.
• Document and share best practices for obtaining and using data from disparate source systems.
• Research and publish the value of MI and EMI in other industries in addition to your own.

Consider the pharmaceutical industry as an example of how MI software can improve performance. Pharmaceutical companies are frequently tasked with tough decisions as to how best meet rising demand in the face of physical constraints on production. Increasing plant capacity and outsourcing are two obvious options, but they entail time, capital, and technology transfer risks. Many pharmaceutical companies are choosing to focus on process improvements, which have benefits that can readily be transferred across the extended enterprise.

Several pharmaceutical companies have used EMI software to support Design of Experiments (DOE) projects to identify cause/effect relationships between yield and input variables. A DOE team is charged with identifying the significant process variables that can have a positive impact on yield, as well as new valid operating ranges for these variables (which can drive yield increases). MI software is deployed to validate process repeatability and to provide assurance that the process maintains the new state of control.

In these instances, ROI can be powerful. With a 5% increase in production achieved through enhancing an existing process, many sites are able to realize tens of millions of dollars in savings. They also accrue additional benefits:

• Personnel have more time to work on other high-value activities.
• Self-service data access for manufacturing users means fewer demands on IT staff, freeing them to work on other projects.
• Reduced process variability enables lower inventory, typically stockpiled to avoid stock-outs.
• Supply chain predictability and reliability is improved.
• Understanding of process parameter relationships is improved, driving down the number of regulatory investigations. More time is available for regulatory response.
• Better technology transfer and faster scale to production speeds time to market for new products.
• Collaboration across the enterprise is improved.
• Better process understanding reduces the likelihood of batch failures.

To help management embrace the implementation of MI and EMI software, it is critical that they understand how this software creates efficiencies across manufacturing, process development, and IT, and that it works to add value to other enterprise systems.¹⁵