Life sciences consulting is beginning to catch on in the technologically complicated and highly regulated location of biopharmaceutical manufacturing. The reason is that numerous previous attempts at implementing lean manufacturing methods in this business have normally been “superficial” and have, consequently, produced “only restricted benefits.” With qualified consultants, nevertheless, the story can have a diverse ending.
In an October 2009 write-up, “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 a lot of manufacturing industries, where it has triggered significant transformations. However, LEAN has usually brought only limited rewards. The initial reason is that LEAN typically has been implemented in a superficial manner, with a focus on ‘just-in-time’ objectives only, without becoming understood as an entire program that ought to permeate an organization’s culture.” And there’s the key: an organization-wide purchase-in and subsequent cultural shift.
Pharmaceutical consultants have the job, then, of fostering a “process-oriented organization . . . to make sure optimal support of LEAN and the development of a culture of continuous improvement.” Stoll and Guilland propose a exclusive 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 entails is finding 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 basically 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 establish the situation-certain Lean objectives and precise actions to be taken.
Stoll and Guilland preserve that this approach typically outcomes in far more “ambitious” Lean target objectives and a far more robust implementation, frequently with “dramatic improvements.” “This approach,” according to Stoll and Guilland, “has two major advantages over a conventional stepwise optimization method, where incremental improvements are created sequentially in various areas (e.g., technical, operational, organizational) or activities (e.g., manufacturing steps).” The 1st benefit is that improvements typically come about sooner and are far more marked since every person is operating from a “clear vision of the end-stage.” Second, this approach usually offers a way about the resistance of team members. They are involved from the quite beginning and have already made “the mental journey of going initial to the perfect and theoretical scenario.”
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 identical consulting approach can be applied to, for example, the supply chain and technical development as nicely. They explain that Lean’s “philosophy and principles can, and ought to, be applied to other company areas, to increase processes and teamwork by eliminating bureaucracy and silo thinking.” Still, they caution that a successful Lean implementation “should not be a 1-time project” and ought to be “executed in a number of 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, particularly in biopharmaceutical manufacturing.
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