To meet strong market demand for its biopharmaceutical products, J&J established a corporate mandate to keep its plant running safely and efficiently at all times, in order to maximize safe, reliable production while meeting rigorous international regulatory requirements associated with pharmaceuticals production and cleanroom operation.
The plant’s existing CMMS provided only the most rudimentary capabilities and thus created significant compliance risk. And due in part to the limitations of the existing CMMS, the Malvern site did not meet the requirements of the J&J’s Manufacturing Equipment Excellence (ME2) program.
The objective was to implement a new CMMS that could streamline and optimize key maintenance-related activities, such as materials management, costing, capacity planning, maintenance scheduling, costing, purchasing and materials management). J&J’s goal was to improve overall plant reliability by enabling better maintenance practices. Ultimately, J&J is working to harmonize and standardize its reliability-related practices across other GBSC manufacturing sites.
J&J partnered with ABB to evaluate CMMS options, and once the SAP system was selected, ABB managed the implementation and adoption of the system.
The primary challenge of this initiative was two-fold:
- To customize and implement a validated, paperless CMMS that would manage maintenance-related activities at the Malvern site without violating strict regulatory requirements pertaining to biopharmaceutical manufacturing and cleanroom operation, and
- To re-engineer the underlying business processes and maintenance practices to optimize the capabilities of the new installation
To do this, ABB translated the business process requirements into the SAP configuration, incorporating feedback and suggestions from plant personnel along the way.
One of the most powerful tools that ABB configured into the SAP CMMS is a "calibration dashboard," which enables maintenance personnel to carry out all calibration transactions — with access to more than 5,000 underlying instrumentation calibration formats and protocols — on one user-friendly screen. The design of the dashboard template allows maintenance personnel to fill in the blanks and choose the most appropriate calibration standard. With the push of a button, the system carries out the calibrations.