The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and workflows.At the base, level 1 involves the instrumentation and final control elements that drive the process. Level 2 includes monitoring, supervisory and automated control of the production process for batch, continuous and discrete control operations. Level 3 is where manufacturing operations management occurs and involves production dispatching, scheduling, reliability assurance, etc. Emerson’s Michalle Adkins notes the importance of prototyping for projects in the level 3 space of the hierarchy. Like Enterprise IT projects that span business groups and organizations, so do manufacturing operations management projects.
Manufacturing Execution Systems (MES), such as Syncade Suite software, require the involvement of many groups and impact many business processes. These business processes must be adjusted to include an electronic, MES solution.
For example, approval of master batch records will look a little different in the integrated electronic world and equipment log books and associated processes will be managed via the integrated solution versus paper logs and standard operating procedures (SOPs).
Prototyping is used to identify and understand the capability and limitations in meeting the business objectives sought. One has in their head what they think the tasks the MES should help accomplish and often even how it should do it. Regardless of the solution that is used, these ideas needs to be vetted with all the stakeholders and compared to the capabilities of the MES solution.
There are often several different ways to accomplish the same task and one may make more sense for one stakeholder while another may make more sense for another stakeholder. Michalle stressed the importance of ensuring that the project team understands the drivers of the project so that when they review the prototype, they can evaluate particular solutions against the project drivers.A prototype is one way to review the future state process with all of the stakeholders in order to gain alignment on how the business will be run in the future. Often companies want to minimize customization and use off-the-shelf product to accomplish as much as possible. In so doing, the company will need to evaluate how some of its business processes may need to change in order to stay aligned with this vision for the project.
In some cases business processes cannot be changed and some level of customization for any MES solution may be needed; however, the stakeholders need to be involved in those decisions based on the criticality to their business and not based on personal preference. The LSISG consulting team has used matrix analysis in conjunction with prototyping to help guide customers through these decision processes.
By involving stakeholders in this process, risks can be mitigated earlier and the scope can be defined more clearly when defining the project. Certainly, risks and scope changes are much easier to mitigate and less costly to address when you engage the right people in the organization in the goal setting and prototyping phase of the project.
Michalle shared with me an eight-step rapid prototype plan:
- Understand the business drivers, issues and current processes
- Establish a prototype plan with guiding principles and scope
- Define a prototype map, including scenarios to be considered
- Develop prototype and options analysis including benefits, costs, risk and change implications
- Review and analyze the prototype performing options analysis
- Document agreed upon items and begin pilot documentation
- Update prototype for any additional “must see” capabilities and review
- Document final decisions for the pilot
Some example capabilities to define in the prototype plan include the approval process for the master batch record (MBR), methods for managing and receiving materials, allocating and dispensing materials, when to require second person verifications in electronic batch records, managing deviations, and how to approve the executed batch including an example review by exception report among other topics. These specific use cases help to identify the stakeholders that need to be part of the pilot planning and execution process.
You can connect and interact with Michalle and Life Sciences consultants and other experts in the Life Sciences group in the Emerson Exchange 365 community. Or, if you prefer to discuss the specifics of your project, feel free to ask the team a question to connect directly with them.