Bringing Real-time Operational Intelligence to the Genentech DNA
Global Business Process Owner
At Genentech Inc. (a member of the Roche Group), we state our purpose as “Doing now what patients need next”. We believe it is urgent to reliably deliver medical solutions right now – even as we develop innovations for the future. Our manufacturing attests to this mission with its industry leading processes and achievements:
· We became the first biotechnology company to scale up protein manufacturing successfully from the small quantities used for research to the much larger quantities needed for clinical trials and marketing.
· To ensure the safety and purity of our products, we rigorously control all aspects of manufacturing.
· Today we are a world leader in biologics manufacturing, with more FDA-approved manufacturing capacity for the production of biotech medicines than any other company.
In the life sciences industry, it is common to have specialized business systems to ensure that processes are in compliance with health authority requirements and also support a reliable and agile supply chain. As a consequence, users must interact with numerous systems to make day to day decisions. Manufacturing operations users are concerned about the number of different systems, screens and fields that must be entered to organize and complete routine operations. This complexity adds risk, and adversely impacts productivity. Until now there have been no cost effective and robust solutions to deal with this complexity.
As a company known for its research and innovation, there is a high value placed on continuous improvement and evaluation of new solutions – especially ones that support our value chain processes, including manufacturing operations. When OpsVeda demonstrated their capabilities with the process agnostic data store using rule based processing, and the ability to generate metrics and dashboards, we were very excited about the prospect of applying this to a “Manufacturing Cockpit”. The fact that that their platform could integrate different systems that we had identified, and analyze the information from all of them in real-time, presented an opportunity to coordinate our complex daily work activities in a brand new way.
The systems in question are SAP ERP (process orders, inspection lots, batch characteristics, material/batch movements, usage decisions), Trackwise, a discrepancy management workflow system where we maintain batch related discrepancies, and Excel Spreadsheets used for assigning and monitoring various shop floor support operations. Previous attempts to integrate these activities were not highly successful, primarily due to three reasons:
- The relationships between the processes executed across various systems is complicated. It was not possible to map them together into a single tool.
- Given the data volumes, there was no solution that would ensure acceptable performance of the system.
- The cost of implementing systems with the required balance of robustness and sufficient flexibility was prohibitive.
OpsVeda demonstrated that these issues could be addressed through their Process Agnostic Data Store and the high performance of SAP HANA. While the architecture and performance sounded ideal, we needed to see the actual performance in our unique setting before deploying broadly. We designed a Proof of Concept to ensure all business requirements could be satisfied. Though the application was available on the cloud, given the sensitivity of our data as well as system access constraints, we decided on an on premise deployment.
About 6 weeks later, we were live with the Proof of Concept. We were extremely impressed that all core requirements were met, and additional benefits delivered as well. The integration across systems was seamless, relevant data from each of the connected systems was mapped and streaming into OpsVeda; and a very pleasant surprise – the system appeared to handle the load well. The OpsVeda architecture and in-memory lineage of SAP HANA were clearly going to have a positive impact.
But the impact of an Operational Intelligence Platform like OpsVeda cannot be determined on IT parameters. The value has to be realized by operational users that plan the activities in Manufacturing and Quality Control. Let me paraphrase some of the feedback we got from them:
Health Authorities require us to document the entire manufacturing batch execution process. The process spans MES, SAP ERP, Trackwise and other support systems. Production schedules are impacted because discrepancies associated with batches are tracked by comparing data in between SAP and Trackwise DMS…
With OpsVeda, the entire tactical batch genealogy is displayed in the form of a tree, including related information about upstream batches. Inputs to batch release are tracked in the system. The batches with discrepancies are highlighted in a different color. One screen tells the user about issues with raw material batches and all the downstream products that have been affected.
EFFICIENT BATCH REVIEW:
Before an inspection lot can be certified, multiple inputs must be reviewed by Quality. Ensuring that all entries are being provided in time to support the schedule is a critical task, but requires multiple manual queries in the source systems. This process consumes valuable time from critical Quality personnel…
Real time process order confirmation data and status tracking of critical inputs to Quality are available in OpsVeda enabling timely follow up and prevention of surprise delays.
EFFICIENT PRODUCTION PLANNING:
Manufacturing, Quality and Maintenance have their own workflows. The tasks performed by these groups are very dynamic, and conflicts between them can go unnoticed till the last minute, when it can result in inefficiencies and delays…
With OpsVeda, a single Gantt chart provides visibility to schedules of each department (including tasks that are not in a system other than spreadsheets), and it is updated in real-time when the departments make changes to their schedule. The color-coded real-time visibility ensures efficient planning and usage of resources. The application proactively shows when workflows performed in different systems will result in aligned or misaligned completion dates.
TIMELY IMPACT ANALYSIS:
Production & Quality operations must be predictable and stable. However, the reality is that there are minor changes every production shift, every day. The impact of such changes is usually assessed using spreadsheet based tools. The process is both wasteful and error-prone, and often challenges effective shift change handover…
Today we can see the impact on the production schedule of changes on process steps, including the detailed set up and tear down tasks that are not in SAP, and specific areas that need attention as production shifts change. Real time visibility into overdue operations, pending notifications and exceptions is enabled.
TRACKING PROCESS HEALTH:
Adherence to Schedule (ATS), is a leading indicator of our ability to satisfy the Production Plan, and a critical process health indicator to ensure we are planning and scheduling within our capacity. To date this has been measured using rigid and costly BW solutions…
With OpsVeda, we have a single window for all departments to monitor their PHIs (Process Health Indicators) including ATS in real-time. In addition we are able to monitor schedule changes, standard lead time attainment, yield, and yield variance. The solution also allows us to drill-down from the PHIs to the underlying process order, notification or batch details.
The examples outlined above require a good amount of data-analysis and simulation to find the right solution. Simple reports fall short, and spreadsheet based analysis and simulations have their human, time and scale limitations. This is especially true as the complex manufacturing process needs effective planning, handover, and collaboration among stakeholders.
With OpsVeda, powered by SAP HANA, we are confident of putting our decision making rules into the system and harnessing its speed. The OpsVeda Manufacturing Cockpit enables the Plants to plan workload and inter departmental collaboration in a pro-active and prescriptive manner, executed under a ‘manage by exception’ paradigm.