Putting Global Manufacturing Data at Your Fingertips

5. Capture “paper-based” data in a Part 11 compliant way. In spite of the fact that manufacturing execution systems (MES) have been around for a long time, as have electronic batch record (EBR) systems, we still deal with a lot of paper. You can’t do data analysis with paper unless the data values are captured in electronic form.

From a user’s perspective, the following tactical needs must be met to achieve the previously outlined objectives:

• Provide on-demand, interactive access directly by end-users to data in multiple databases and on paper records that are the sources of that data.
• Supply descriptive (what happened?) as well as investigational (why did it happen?) analysis capabilities in the environment in which users access their data. When the indicator on the dashboard signals an alert, you’re going to want to know why.
• Include all types of process development and manufacturing data in a combined form (i.e., discrete, continuous, replicate, event, keyword and free text data).
• Build systems for non-programmers and non-statisticians to collaborate across disciplines and geographies. Very few end users are comfortable with command lines!

If these objectives are met using the right on-demand data access technology platform, you can have investigational and descriptive analytics integrated into the same environment to better understand the sources of process variability and develop better models for process control.

Case Study: Integrating Data and Analytics

How do we leverage the systems we already have to provide the kind of data access and analytics environment we want for deriving information to improve process predictability? In summary, an on-demand data access platform, connected and mapped directly to the operational data stores of our existing manufacturing data infrastructure, allows users to understand the sources of process variability and achieve better process control.

What follows is an account of how one global manufacturer gained valuable experience about using an integrated on-demand data access and analytics platform for its manufacturing environment. Over several years, the company came to grips with the complex issues and real-world requirements of accessing data and delivering it to manufacturing practitioners in relevant time. After initiating the rollout of an enterprise-wide deployment of a commercial, off-the-shelf (COTS) on-demand data access and analytics platform, the company learned a great deal about the associated critical success factors.

The New IT Paradigm for Global Manufacturing Networks

Company leadership saw a new IT paradigm that required a shift in the role IT played within its manufacturing organization. Decision-makers made a strategic move to focus on its core competencies—it was not a software company, after all. It committed to acquiring COTS packages versus developing software solutions in-house. This meant that IT team members became project managers implementing COTS software instead of developers writing and testing code—or even customizing COTS packages. This was not necessarily an easy change for IT staff, who had to adopt new roles.

The company also needed to leverage its existing investments in large IT systems. It had made a strategic decision to use a large enterprise resource planning (ERP) system and needed to provide access to data from that system to its whole manufacturing environment. It also settled on a particular data historian standard for its manufacturing sites. With investments made in these underlying sources of data, the company needed to see a return on investment.

The company also wanted to employ standards-based interfaces to get data, and it needed to address current business and regulatory needs—a big stretch for the IT department, which traditionally had been focused on individual site IT requirements. The company asked its IT resources to better understand its manufacturing business, and not just its own technology expertise. Management needed IT to help lead its business units by showing them the possibilities of IT systems because the business units may not know what IT capabilities existed to satisfy their needs. At this global company, most IT folks knew the needs of their own sites, but they did not understand the manufacturing technology—or what goes on from a business perspective—on a global level. This was the new paradigm for IT.

To level the playing field, manufacturing needed to reduce the burden on the end users who needed to be looking at data with standardized tools. These users needed a single common system to access, analyze and report on what they learned from their data. To level geographic barriers, the company needed resources to help interdisciplinary global teams do shared problem solving to help multiple sites readily do comparisons. For example, the company produces one product in two separate plants, where benefits would be derived from drawing conclusions based on a shared understanding of all the process data.

Critical System Requirements

In terms of critical system requirements, the organization used the S95 standard as a data framework to level systems and allow data to flow throughout the world. This provided a common leveling tool for disparate source systems as well as a communication tool for IT professionals. The company wanted to provide access directly to the data in its source systems whenever possible—without putting in a data warehouse as in intermediate layer. The servers providing access to local historian data needed to be on site and also connected to external data sources in a way that would give users full access to data from all over the world without unacceptable network lag.

Making the Business Case