A pharmaceutical manufacturer requested a project manager with experience delivering qualified process automation system projects on schedule. They had a short shutdown to install new process control and manufacturing execution systems, complete relevant testing, and engineering runs to verify the new system operates the existing equipment as specified.
Coordinated schedule activities between the automation implementation team and the overall shutdown execution.
Managed the resource allocation across 24x7 shiftwork to support manufacturing testing while taking care of team health to keep everyone engaged and functioning at peak performance..
Worked with stakeholders from manufacturing, maintenance, and contractors to coordinate equipment events, allowing the critical path activities of automation testing and implementation to be completed on schedule and restart the facility on schedule.
Many activities were planned for the same equipment during the shutdown; however, activities in the master shutdown schedule were not planned, sequenced, and resourced appropriately to optimize equipment availability.
Understanding the timing of maintenance activities, getting advance notice of upcoming equipment booking requests, and unexpected test results required schedule changes for critical system repairs.
There were significant mechanical and non-automation controls issues that complicated testing and troubleshooting of the new process control and manufacturing execution systems.
Proactive communication and high availability were key to the success of this engagement. With so many stakeholders and no direct authority, conflict could only be resolved by someone who was experienced in operations, was accessible to everyone every day, and was viewed as a neutral party. Shenberger Technology was able to fill this role and negotiate between parties to accomplish key maintenance and repair activities while not interfering with the critical path automation implementation and testing that needed to occur on a specific day.
The project team determined that the overall project schedule was lacking the proper Level 4 Work Breakdown Structure and resourcing for the control system activities. The Shenberger Technology team built out the new work breakdown structure and resourcing, which was then integrated into the overall project schedule, allowing for increased visibility into the critical path activities. The automation engineering team then had sufficient planning detail to drive critical tasks to completion and inform stakeholders of upcoming testing tasks 2-3 days in advance, allowing for greater coordination across all the shutdown workstreams.
Scheduling and planning are critical to the success of time-limited, multiple-workstream shutdowns. Enough time must be invested in identifying all the expected maintenance activities, capital improvements, automation testing, along with all necessary qualification steps to complete change control execution successfully in the allotted time. In addition, these schedules must be resourced appropriately for the work to be accomplished.
One specific issue typified the lack of detail in the planning. A tank inspection was scheduled toward the end of an outage period in the middle of the overall shutdown. It identified remediation that was required to be completed during the shutdown, but that had not been accounted for. If the inspection had been scheduled early in the shutdown, then the remediation could have been scheduled off the critical path; however, since it wasn’t, the remediation moved onto the critical path and could have prevented manufacturing startup if other items hadn’t finished early.
Despite all the challenges, the initial manufacturing batches using the new (MES) software started on schedule. Due to continued mechanical challenges, the projected yield ramp-up was delayed; however, this allowed for the implementation of additional changes to the software that enabled the eventual ramp-up to full capacity manufacturing once the mechanical issues were resolved.