This year, 139 professionals working in the pharmaceutical industry took our survey on Operational Excellence, with between 92 and 99 individuals responding to every question. Results indicate broad trends and signal some changes from previous survey results.
What united respondents this year were three overarching goals (Figure 1), in order of priority:
- Improving internal quality systems
- Increasing manufacturing agility
- Boosting capacity utilization
They were also unanimous in viewing management as the leading obstacle to continuous improvement, with 36% citing senior management and 34%, middle management (Figure 2). “Middle management wants to reap the benefits of what Lean and Six Sigma can do,” writes one respondent from a Big Pharma company, “but they do not want to take the time to educate the line operators on why we are doing what we are doing. So, with the operators, you have to get and keep them involved.” When asked about Quality by Design, less than 20% said the concept had full support from top management, where 52% said it had “some degree of support.”
Roughly 11% said top management paid lip service to QbD but didn’t actively support it, where 14% said it wasn’t even on management’s radar screen. (Figure 3) For Lean and Six Sigma, a quarter of respondents said these programs were fully supported, 36% said theyhad some support, but another 36% said they were either not really supported or not supported at all. (Figure 4) In verbatim comments, some respondents described changeresistant cultures within their organizations. “There’s a reluctance to investigate new areas and incorporate them into practice, even after they’ve been proven to be safe and effective,” writes one. Strained resources have only increased the level of fire-fighting at some facilities, where continuous improvement has fallen to the bottom of the priority list. “There’s not enough time, given the constant press of production,” explains one respondent. Others describe a situation in which Lean Six Sigma efforts are piecemeal and results fail to coalesce or last.
Complains one, who works at a mid-sized facility owned by a top pharmaceutical company “We are trying to implement Lean Six Sigma, but we only seem to ‘get started’ and never fully integrate the methodologies,” hewrites. “For example, we do 5-S but we don’t follow through to make sure we are keeping it up after each exercise. We talk about DMAIC but only during a Six Sigma project.”
In addition, for most respondents, concepts of Lean Six Sigma are only being applied to manufacturing, rather than throughout the organization. 41% of respondents said their organizations were applying the concepts to quality, R&D, and other operations. Experts on Lean and continuous improvement agree that regulatory pressures have made the adoption of Lean a bit slower in pharma than it has been in other industries. “The drug industry is not lean,” says Avi Edelstein, partner with the consulting firm, Tefen, Ltd. (New York City), “It’s not even close.”
Perhaps readers can take heart from the fact that peers from many industries, including some that have been at this for a long time, report suffering from the effects of “Lean as Mistakenly Executed,” the symptoms of which are:
- Lack of management support
- Failure to solicit suggestions from those actually performing the work. This is usually followed by failure to act on those suggestions, and then to offer tangible rewards to individuals for those ideas.
- Ongoing confusion of Lean programs with cost-cutting
- Isolated results.
Experts note that Lean and continuous quality take time to become established within any corporate, or industrial culture. Joseph Juran, whose Quality by Design book and concept helped transform Japanese and U.S. manufacturing, used to describe the situation with this homespun simile, relates Joseph De Feo, CEO of the Juran Institute (Southbury, Conn.). Quality, Juran said, is like an egg. If you try to rush its hatching by applying heat, the egg not only won’t hatch, it will become hard-boiled.
Avoiding the Tool Trap
“Many people fall into the tool trap, says Fred Greulich, director with Maxiom Group (Waltham, Mass.). “They learn and implement a few tools, post a few short term results and call it Lean or Six Sigma,” he says, noting that there are really three separate, yet integrated dimensions to a successful Lean implementation: an operating system, a management system, and a set of tenets and beliefs that underlies them. “You also need to implement a new set of metrics to support Lean or Six Sigma,” he says. “Success also requires that you have enlightened leadership that is asking the hard questions and rewarding the right behaviors.”
What is essential, Greulich says, is connecting Lean and Six Sigma to business objectives directly. A lot of pharmaceutical companies may understand that “process is king” as far as the actual steps involved in making a product — the SOPs, batch records — but the same mindset must be carried forward when it comes to managing and improving other parts of the business, including engineering and back office functions. Management support is critical, he says.
“You can’t call it Lean or Six Sigma when someone at a low level in the organization gets interested in 5S, Failure Mode and Effects Analysis (FMEA) and other tools and applies them in a few places. They can try some things in good faith and score some early wins, but without leadership, they can’t migrate or sustain these initiatives,” he says. At the heart of the problem is failure to manage for quality and reward individuals for their contributions.