The ISA-95 (IEC 62264) Enterprise-Control System Integration (part 1, part 2, part 3, part 4, part 5) international standard provides a model to help define the boundaries between the enterprise systems and process control systems.

As manufacturing operations seek to gain competitive efficiencies, this integration also involves a great number of people and their associated work processes within the organization.

Emerson’s Michalle Adkins, a Life Sciences Consulting Manager on the Global Industry Solutions team, shared her experiences on the stakeholders typically involved in an operations management / manufacturing execution project. A typical Life Sciences Syncade project involves many different business processes in a plant. In addition to the actual production process management, the plant processes include materials, equipment, people, documentation, batch record review, and batch release to name a few.

When the project team analyzes and dissects the materials management process, it likely will include receiving materials, taking samples, storing materials, releasing materials for use, dispensing appropriate quantities, adjusting inventories, charging the right materials to the batch production process, consuming materials/intermediates, and issuing the intermediates/products to inventory.

These processes are also highly interdependent and integrated. The right quantity of the correct, released materials must be added to the right equipment. This equipment must be in the right state at the right point in the process. The people who are performing steps in the process must have been trained and approved to work on that production process.

To meet the project objectives and desired future state, all of the stakeholders impacted by a change in the workflows transitioning from a manual, paper-based process to an electronic batch record-based process, should be included in requirements gathering and business process analysis. It is also critical to gain alignment on the objectives and the vision of success.

Once these objectives, requirements, and a vision have been collected, distilled, and reviewed with the stakeholders, the potential solution is defined. During the definition of the solution architecture, potential implementation strategies and regulatory impact assessment are defined again providing opportunities to ask questions that keep stakeholders aligned.

And, as we highlighted in an earlier post, You Already Asked Me That!, it’s critical that the project consultants make sure that they are using a consistent vocabulary—the same acronyms or words with the same definitions as they speak with people in various departments across the organization. This helps avoid misunderstanding, uncover misperceptions of what other departments do, and keep the project vision in focus.

Michalle mentioned that during the course of these interview sessions, she has heard several interesting comments from her customers. Comments such as “I had no idea you did that!”, “This week was like drinking from a fire hose!”, and “Wow, is that what our process really looks like? We have a lot of non-value added activities.” These types of comments really highlight the value in stakeholder alignment and business process analysis for integration projects.