	Process efficiency programs at pharmaceutical companies-whether called operational excellence, lean manufacturing, six sigma, total quality management, or some other name -are key for reducing cost and maintaining or improving quality at the same time.  A primary goal of these programs is to identify and eliminate or reduce process variation to create a reliable, repeatable, and predictable process, explains Jerry Rosenthal, senior consultant at Lean Six Sigma Experts. Once the process is predictable, manufacturers can identify and reduce waste. "All of the big players (and small ones) are using these programs in some capacity," says Rosenthal. "There are organizations all across the maturity spectrum. Some are just using basic tools, and some have structured operational excellence programs with positions such as master black belt, black belt, green belt, project champion, and sponsor.  The bottom line is that success is obtained by the effective use of the tools, including using the right tool for the right situation and keeping it simple whenever possible."

	One such tool, which is an ideal place to start for any process, is value stream mapping. "A value-stream map is more than just a process map with a duration for each step," explains Rosenthal. "It identifies exchanges of materials and information from point A to B and person or system A to B to create a visual flow diagram that everyone affected by the process can clearly see. This diagram is an effective starting point for any process, prior to selecting where to focus and what tools to use."  It is important, however, for companies to be certain the map is made properly. "Companies pull process maps out of the drawer and exclaim that they have value stream maps," says Rosenthal. "What they don’t realize is that if the wrong people have created the map, it isn’t truly representative of what is happening in the production environment.  The key is getting those closest to the actual process involved. It would be ideal to keep managers, directors, and the like away from value-stream creating exercises."

	After value-stream mapping, companies should identify gaps between the current state and the future state (i.e., vision), prioritize those gaps, and create action plans based on a critical few that will get them to the future state, explains Rosenthal. Having a good measurement system in place is also important for confirming whether real improvement to the process was made. "If a current process takes 50 days and, through process improvement activities, you have reduced it to 48.5 days, you need to be sure that you really have saved 1.5 days and that the difference isn’t just ‘statistical noise'," says Rosenthal. "You also need to question if you are working on the right things, if you are targeting a 20% improvement and only achieve 3% gains."

	Lean manufacturing is applicable to many aspects of process management, including manufacturing execution systems (MES). At CBI's MES conference in Philadelphia on Aug. 14, 2014, Rosenthal gave a presentation on "Data and Operational Definitions: What does better look like?".

	One recent example of a pharmaceutical company that has used a lean-management strategy is Pfizer. The company used lean strategies, including value-stream mapping, in its design process for a new vaccine suite and a drug-substance bioprocess suite in its Ireland Pharmaceutical’s Grange Castle manufacturing plant. The capacity-expansion project won a 2014 ISPE Facility of the Year Award for Operational Excellence. Pfizer's project team used value-stream mapping of all production processes, and developed over 200 maps. The team also used 5S in the design process, and developed a six-sigma toolkit that was given to all project personnel. 

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