Lean and Six Sigma Principles
In an effort to do more with less, CMOs are using several analytical approaches to create a more efficient operating environment. The industry is turning to lean design methods to identify manufacturing inefficiencies and improve supply chain management.
Manufacturing bottlenecks can be identified through operational simulations and multivariate analysis, using inline sensors to generate process data in real time. To ensure success, the lean manufacturing concept not only needs commitment from the top management, but it is essential that the concept be part of the culture and ingrained in everyone’s daily activity.
Boehringer Ingelheim has been using Six Sigma and lean manufacturing tools to improve business and manufacturing processes for its biopharmaceutical operations since 2003. In order to gain maximal results and a continuous improvement culture, BI has a top-down and a bottom-up systematic methodology.
BI’s business process excellence (BPE) policy has the commitment of top management as well as every employee. “We defined clear functions and responsibilities, made a process analysis, mapped the most value-added processes, and fixed them in a process landscape,” Esch added.
According to Esch, “efficiency gained from Six Sigma and lean manufacturing tools included minimizing redundant process steps and reduction of wait and throughput times by more than 15 percent.”
Meridian is another company where the lean manufacturing concept is ingrained in its culture. All Meridian management is expected to lead a process improvement project. Project progress is reviewed with the division president on a quarterly basis. Process improvement is also expected of each employee even if they have not gone through formal lean or Six Sigma training.
“By improving and streamlining our manufacturing processes we have seen dramatic improvements to the top line and bottom line, less complaints, improved customer audits, less variability, time savings, and less scrap,” reported Lourdes Weltzien, GM.
Merck sites recently implemented the Merck Production System (MPS), which is based on Toyota’s production system and incorporates key principles of Six Sigma across the manufacturing sites. “Process development is closely integrated with manufacturing activities so we are carefully planning how to deliver the benefits of MPS in process development so that it strengthens rather than compromises the strong innovative culture we have in place,” Taylor commented.
In 2009, RecipharmCobra focused specifically on reducing lead times by applying visual planning as a tool to improve throughput, which led to a significant reduction in lead times for deviation close-out. “Clearly, for a CMO, standardization of business processes is an area where benefits can be generated, and this continues to be important to us in an environment where customer projects are unique,” said Dr. Fenge.
Besides the hard quantifiable savings from lean manufacturing tools, there are intangible benefits that translate to high success rates in process transfers, improved flexibility in manufacturing scheduling, and increased manufacturing robustness as reported by Boehringer Ingelheim. Dr. Esch also touted “soft factor” benefits including team spirit and improved communication between departments that can lead to better identification and elimination of process risks.