With focus on agile project execution and GMP compliance, NNE supported Novo Nordisk with a fast-tracked shutdown. The engineering company prepared seven months in advance to execute the critical shutdown, which prepared the multiline facility for process justification of two different products.
Facility shutdowns require extensive planning, agile execution and speedy review. Novo Nordisk’s shutdown for its multiline production facility was no exception. Novo Nordisk turned to pharmaceutical engineering company NNE for support in preparing the line for a post-shutdown process justification.
The shutdown result would ensure that all functionalities were in place on the same platform with no further restorations necessary. All the while, NNE applied a high level of GMP compliance throughout the implementation of the multiline production.
Though the fast-tracked shutdown ran in weeks 29-32, NNE began shutdown planning long before its execution in week 3 of 2016, quickly performing a conceptual brief and beginning the conceptual and basic design simultaneously. In fact, certain scope IDs allowed NNE to design flexibly, focusing on the basic design and enabling them to skip portions of the conceptual design, saving the customer time and money.
“There was a close collaboration between the user organization and the NNE team, which ensured timely and effective project execution.”
Knowing that alignment was key, NNE made decision points with the project’s steering group and kept everyone from top management down informed of the project’s status with a detailed road map.
The entire project team – Novo Nordisk, NNE and suppliers – met twice daily to plan and review the day’s activities. In addition, the engineering company practiced ongoing review. NNE project portfolio manager Flemming Jensen explains:
“Instead of saving all reviews for the last day, which can cause critical delays, we conducted quality assurance reviews as the tasks were completed. This required a very close and candid relationship with the customer, which we succeeded in developing, in part, because our quality engineers sit with Novo Nordisk’s quality team for maximum efficiency.”
This close relationship opened other opportunities of efficiency. Two weeks before the actual shutdown, the NNE team was able to enter the facility, thus eliminating the need to be on-site 24-hours a day during the shutdown.
“We would not have had this sudden opportunity were it not for the close collaboration between engineering provider and customer,” Jensen says. “When you develop close relationships, you actively search for ways to make the project smoother and mutually beneficial.”
USD 5 million
7 months (with shutdown lasting 4 weeks)
Conceptual brief, conceptual design, basic design, detail design to handover