subject: Lean Manufacturing Solutions in the Pharmaceutical Industry: A Continuing Journey [print this page] Lean manufacturing solutions do work, but their implementation has to be an ongoing and continuous affair. Obviously, there has to be a focus on quality, but that focus has to be on sustaining quality once attained by promoting a culture of continuous improvement. Toyota recently learned this lesson the hard way.
The Toyota Production System has been the touchstone for almost every lean manufacturing system attempted over the last few decades. But in late 2009 and early 2010, Toyota wound up recalling almost 9 million cars due to quality issues. Customer loyalty slid, and the ultimate cost to the company is projected to be in the neighborhood of $5 billion. And, further, people began to question lean manufacturing itselfwondering whether the inevitable result of all that waste reduction and emphasis on flow is compromised quality.
The consensus among analysts, however, is that Toyota's production became, in fact, less lean. Toyota, whose inventory turns fell dramatically from the 1990s to 2008, became too focused on growth, neglecting the necessary focus on quality and continuous improvement. Management, it seems, forgot that lean manufacturing implementation is a continuing journey and that culture is key. There is a lesson for the pharmaceutical industry here as well.
The pharmaceutical industry is currently in flux, and so must its pursuit and implementation of lean manufacturing solutions be. This industry has been attempting to embrace lean manufacturing since about the 1990s, often with less than resounding success. And now the industry situation calls for ongoing efforts to sustain quality while concurrently dealing with increasing complexity. Much of this complexity stems from cost-cutting measures such as the use of contract manufacturing organizations (CMOs), a practice that entails managing multiple complex external relationships. And this means that the implementation of lean manufacturing solutions must be ongoing to match the flux in the industrya journey, if you will.
On the journey toward a full and successful implementation of lean manufacturing solutions, here are a couple of the many steps pharmaceutical companies must take:
Implementing a holistic approach Most of the time, pharmaceutical companies have taken a cafeteria approach with respect to lean manufacturing implementation, just picking and choosing the parts that that suited them. This approach has led to minimal improvement, but usually nothing to shout about. In addition, most of the pharmaceutical industry is segmented and siloed, with each piece sticking to its own provincial purview. A holistic approach is needed, one which addresses the whole product flow and the entire process.
Managing knowledge Manufacturing must be viewed as an integral part of the entire value chain just as it is in other industries. Historically in the pharmaceutical industry, there has been an emphasis on the role of R&D and innovation, with manufacturing taking a back seat. Prior manufacturing knowledge needs to be integrated throughout the product life cycle so that manufacturing's participation can move upstream.
Here is the assessment of Bikash Chatterjee, President of PharmaTech Associates: "I think we are very, very early in our journey of Lean. . . . It's a journey. Toyota has been doing this for over 40 years, and even they stumbled." And that's precisely why lean manufacturing consultants can play such a vital role. Just as Dante needed his Virgil to reach the top, so do pharmaceutical companies need theirs.
Lean Manufacturing Solutions in the Pharmaceutical Industry: A Continuing Journey
