Given the complexities of the global pharmaceutical supply chain in 2013 and the recently clouded performance of the industry in relation to quality excursions, it has become obvious to many that the need to cut operational costs, boost output and increase quality has never been as acute as it is now. But for many in pharma, the journey to Lean is only just now gaining momentum. Smart characterizes it this way: “There is still not uniform acceptance at all levels within organizations across the industry that this is a set of principles that will truly make a difference.”
Smart offers that in many cases, quality management actually benefits from Lean implementation because Lean assures that the appropriate level of resources is applied to each individual process task and that, in many cases, the exercise frees up redundant resources to be used beneficially in other areas. He notes, however, this staccato type of implementation can be exacerbated by emphasizing the award of belt-level projects on specific, often one-time programs instead of adopting a more integrated approach that would truly streamline a company’s operational functionality as well as enhancing its competitive edge.
In some organizations, Smart says, Lean is being employed simply as a resource cutting mechanism and/or an efficiency building tool. “Neither of these address the real value of incorporating Lean into a company’s operating philosophy and culture; frequently viewed by the workforce as another ‘flavor-of-the month’ gimmick that will probably fizzle out within a year as it gives way to the next idea.” So has progress be made? “Absolutely,” says Smart, “but the fault lies in the fact that as an industry we are not universally applying the principles and tools in an integrated holistic fashion that will allow us to fully realize its full potential.”
Considering that the rest of the manufacturing industry took at least a decade or more of trial, error and cultural alignment before it started to get more right than wrong from implementing Lean and Six-Sigma initiatives, pharma’s adaptation cycle is proceeding at about the same pace. In late 2011, PEX Network conducted its “Global Benchmarking Study of Trends and Success Factors in Business Process Excellence.” Among the study’s 676 managerial and executive respondents, approximately 6.3% were from the health care sector and another 6.7% from pharmaceutical. According to PEX Network’s findings, slightly more than 40% had operational excellence programs running for the past four to five years (Figure 1). For the most part, the snapshot of data suggests that for pharma, the industry is really just starting to hit its mid-life stride honing the cost-cutting katana of Lean and aligning its methodologies with pharma’s particular culture and operational infrastructure.
So, for pharma, the journey to Lean is beginning to gain momentum and maturity, overcoming, however awkwardly, the status-quo inertia and sacred-cow confrontations that can derail less-than-robust implementations. What’s ironic is the fact that Lean Six-Sigma (even the philosophy has consolidated in terminology to embrace the methodologies of current operational/process excellence programming) is so seemingly right in guiding the pharmaceutical industry as it responds to the regulatory environment and the FDA’s cGMP/Quality by Design (QbD)-based compliance regimes. Lean Six-Sigma methodologies, based on statistical process data and the identifying, understanding and elimination of deviation in process are well-suited to manage quality and provide continuous improvement to myriad pharmaceutical operations. “Quality within all industries is important,” says commentary on Six Sigma Online, Aveta Business Institute’s online Six Sigma certification portal, “but within the pharmaceutical industry it’s essential. Because lives are at stake, quality, when it comes to creating and manufacturing medicines for individuals, is necessary. Because the Six Sigma quality improvement theory boasts less than 3.4 defects per million opportunities, it is worth exploring in any industry, especially this one!”
TEVA’s LEAN QBD APPROACH
In the industry’s generic drug sector, process efficiency is seen to have a higher priority because so much of a given company’s business success is driven by effectively managing product costs.
Earlier this year, Uri Hillel, Head of R&D Quality and Corporate Quality & Compliance outlined Teva’s approach to QbD for Pharmaceutical Manufacturing: “Teva has worked on implementing the FDA guidelines defining QbD guidance and has adopted the QbD philosophy in its development of generic products. For Teva, this means understanding the products, formulations and processes in depth, and submitting appropriate applications to the authorities using a more systematic development approach.”
Hillel’s description of its institutionalization of QbD in support of operational excellence has the unmistakable characteristics of a Lean Six-Sigma-guided system.
“Internal Teva QbD Guidelines,” says Hillel, “were developed. Design of experiments methodology and statistical tools have been successfully implemented at global R&D sites. Research and development is interactively working with Operations, Regulatory and QA on the manufacturing process prior to production of the registration batches, identifying and proposing mitigation to risks at scale up, reviewing together the proposed control strategy, operation ranges and product specifications.”
Friedli’s 2008 study affirmed Teva’s approach noting: “As long as PAT and QbD are managed in isolation, as single pilot projects, we will not see a big impact on the average sigma levels of the manufacturing processes. PAT and QbD have to be integrated into the total plant quality improvement program.”