Featured Case Study
Reduce Process Variability
A leading Pharmaceutical company was struggling with process variability in a complex step in their manufacturing process of a product that generated $3B of revenue annually. This variability led regulatory inspectors to question the company’s specification limits and their ability to manufacture the product reliably.
Streamline Annual Product Reviews
An international company with a broad line of Consumer Packaged Goods, Pharmaceutical and Biotechnology products wanted to improve their ability to access and analyze manufacturing process data on-demand but first needed to build a compelling business case.
A cross-functional, multi-site team was formed to brainstorm potential areas of cost savings and process improvement that were closely linked to the company's key business goals. The group identified over 20 areas that could be positively impacted by the right on-demand data access and analysis solution and prioritized the list to determine the areas that had the largest impact.
In addition to improving cycle times, root cause investigations, process yields and stabilizing product quality, the group determined that Annual Product Reviews (APRs) could be prepared more efficiently.
APRs were singled out for closer examination
A smaller team was assigned to quantify the opportunities for improvemen (especially the financial savings). The team identified the major data sources and components of the APR process including Release data, Stability data, Equipment and Calibration data, Adverse Events, Investigations and other data from key electronic and paper data sources. Their research showed that it required in excess of 300 hours over 30 days by a team of individuals to complete a single APR.
Savings were estimated at 25,000 hours/site
Using conservative assumptions about which data sources would be integrated and which APR sections could be automated in the initial implementation, the team determined for a site that produced in excess of 100 APRs per year the savings were in excess of 25,000 hours/year, or the equivalent of 12 FTEs. The savings could enable the elimination of headcount, or reallocation of valuable resources to other high-value projects.
Routine process visibility could also be significantly improved
Aegis' Discoverant enables sites to produce "Daily Product Reviews" for internal use, providing senior management support groups with the ability to review much more frequently the efficacy of their manufacturing processes, product related investigations and complaints, and other complex indicators of the overall manufacturing process.