A very frustrated biotech client had two failed automation projects on their hands both causing significant production delays in producing Monoclonal Antibodies until they turned to Superior Controls for help… The client recognized Project Manager Terri Russell and Senior Validation Engineer Stephanie Simmons’s reputation for success and experience with other systems in the process area and hoped that Superior Controls could turn things around.
Project Manager/Senior Project Engineer Terri Russell and Senior Validation/Project Engineer Stephanie Simmons have worked together successfully on many projects for years. Terri takes responsibility for the overall project management, software design and programming, and Stephanie provides documentation review and test plan development.
While Terri and Stephanie and their Superior Controls teams have successfully completed
automation projects for this client, another project team struggled. In this case, the client had worked with the other system integrator for over two years to automate two systems. After the other system integrator failed to resolve a growing list of issues on one of the projects and showed little progress on the other, the client became frustrated to the point of needing to pull both projects from the other integrator, turning the projects over to Superior Controls. The client recognized Terri and Stephanie’s reputation for success and experience with other systems in the process area and hoped that Superior Controls could quickly turn things around. Due to production demands, however, the client was now in a rush to get both projects completed.
Issues with Schedule and COVID
It was difficult for the client to accept that two years of automation effort was wasted, and they initially asked that Superior Controls fix and validate the existing non-functioning PLC and data base code. The Superior Control’s team knew, however, that in order to have a successful result, there needed to be a thorough review of the design. Terri expressed that sometimes it is easier to start over and get it done the right way. “I knew if I [had] stayed with that code, the issue list would grow,” she said.
After a short while, the project stakeholders became confident as they witnessed Superior Controls’ proven project methodology and approach. Superior Control’s efforts to communicate with the client through the facilitated design reviews became critical, allowing us to make real time modifications to the design to meet the client’s needs, and get the documents reviewed and approved within the allowed schedule. Because the client committed the man power to quickly go through these review cycles, Terri was able to learn the client’s issues and requirements. The client was
thankful for the time taken to correct and complete the design.
There was only 6 months allowed in the schedule for the Superior Controls team to review and complete the design and programming and develop and execute the extensive Software Factory Acceptance Test (SFAT) and Site Acceptance Test (SAT) protocols. Stephanie mentioned that when the client talked about the schedule; it was extremely aggressive.
“The only way that these two projects were going to be successful was for me to completely focus on them,” she said. I had to rely on other Superior Validation/Project Engineers to take over some of my other projects so I could do that.”
Due to COVID-19, only one or two manufacturing representatives for each project were able to work with Superior in the Albany office to execute the SFATs, while the client’s engineering and validation groups supervised over a video call. In order to enter the customer’s facility to execute the SATs, the entire onsite team of Terri, Nate Sandmaier and Sean Callaghan were required to quarantine in New York after taking a COVID test. The rush and quarantine required that another co-worker, Christian Bossio, who lived in New York, drive to the Seabrook office to pick up the just-completed test plans from Stephanie and deliver them to New York.
During the SAT process, there were about 20 different manufacturing representatives that were brought in to assist with testing, allowing them to get a preview of the system and how it all worked. The continuous change of client personnel with each shift/day was challenging for the onsite team, but thankfully the client’s manufacturing representatives were very quick learners and provided essential support. The onsite team completed simultaneous execution of SATs for both projects during an incredibly short plant shutdown, where multiple other projects were also scheduled and there was limited access to the equipment and plant utilities. This was possible only through the amazing work ethic, focus and flexibility from Terri, Nate and Sean.
The team followed the Superior Controls’ documented work order execution procedure, a tried and tested method for project execution. Stephanie pointed out that, while other integrators may write their test plans according to the code, we write the test plans according to the design documentation. This way, any issues can be corrected, assuring that the design documentation and code match.
Stephanie was able to produce approximately 2000 pages of test procedures in an unbelievable short time, while Terri programmed and tested the system.
From Two Years to Six Months
The Superior Controls team was able to complete each project within 6 months while the other integrator had failed after 2 years of effort! The entire process with Stephanie and Terri was well organized and they demonstrated project management competence skilled automation experience in completing this difficult project. They followed the Superior Controls work order execution plan procedure and it worked, even with the tight schedule and challenging COVID-19 restrictions The client profusely thanked Terri and her Superior Controls automation team and is now shipping critically needed antibodies to patients throughout the country.