June 21, 2024

GHBellaVista

Imagination at work

Life Sciences Consulting to Create a Lean Culture in Biopharmaceutical Manufacturing

Life sciences consulting is beginning to catch on in the technologically complex and highly regulated area of biopharmaceutical manufacturing. The reason is that many previous attempts at implementing lean manufacturing techniques in this industry have generally been “superficial” and have, consequently, produced “only limited benefits.” With qualified consultants, however, the story can have a different ending.

In an October 2009 article, “Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing” (BioPharm International 22.10), Thibaud S. Stoll and Jean-Francois Guilland explain: “LEAN has… been implemented in many manufacturing industries, where it has triggered major transformations. However, LEAN has often brought only limited benefits. The first reason is that LEAN often has been implemented in a superficial manner, with a focus on ‘just-in-time’ objectives only, without being understood as an entire system that must permeate an organization’s culture.” And there’s the key: an organization-wide buy-in and subsequent cultural shift.

Pharmaceutical consultants have the job, then, of fostering a “process-oriented organization… to ensure optimal support of LEAN and the development of a culture of continuous improvement.” Stoll and Guilland propose a unique way for consultants to go about this during the preliminary assessment and analysis stages of a Lean implementation.

They propose, after the quantitative objectives have been set, the use of what they call a “blue sky vision.” What this involves is getting the team to envision the how the process would look freed of any limitations or constraints, that is, “the ideal efficiency level.” To arrive at this blue-sky vision, all “regulatory, technological, organizational, economic,” and “safety-related” constraints are simply set aside. And, then, “only the constraints which cannot be realistically eliminated within the timeframe of the project are carefully added back.” The result is what Stoll and Guilland call the “practical vision”-the vision that consultants and management together use to determine the situation-specific Lean objectives and precise steps to be taken.

Stoll and Guilland maintain that this approach usually results in more “ambitious” Lean target objectives and a more robust implementation, often with “dramatic improvements.” “This approach,” according to Stoll and Guilland, “has two main advantages over a traditional stepwise optimization process, where incremental improvements are made sequentially in different areas (e.g., technical, operational, organizational) or activities (e.g., manufacturing steps).” The first advantage is that improvements generally come about sooner and are more marked because everyone is operating from a “clear vision of the end-stage.” Second, this approach often provides a way around the resistance of team members. They are involved from the very beginning and have already made “the mental journey of going first to the ideal and theoretical situation.”

Further, with respect to life sciences consulting in Lean implementation efforts, Stoll and Guilland are firm in insisting that it is “not just about manufacturing,” that the same consulting approach can be applied to, for example, the supply chain and technical development as well. They explain that Lean’s “philosophy and principles can, and should, be applied to other business areas, to improve processes and teamwork by eliminating bureaucracy and silo thinking.” Still, they caution that a successful Lean implementation “should not be a one-time project” and should be “executed in several steps” in order to develop a sustainable “culture of continuous improvement.”

Engendering and sustaining that “culture of continuous improvement” is where qualified pharmaceutical consultants, steeped in all aspects life sciences consulting, can prove to be a great boon, especially in biopharmaceutical manufacturing.