In the past few years, as the pharmaceutical industry has come to grips with patent expiries, declining revenue, increasing global competition, aging infrastructure, and widely publicized quality problems, more serious Lean efforts have taken root at companies across the industry.
In our work helping pharma organizations translate Lean principles into specific practices, we’ve seen the results add up in site-wide and global rollouts of Lean and TPM, in production and packaging areas, and in laboratories. We’ve also identified particular challenges that reinforce key lessons for companies in any industry.
Consequences of a compliance focus
In heavily regulated industries, change comes hand-in-hand with a burdensome companion—the need to ensure compliance. Productivity’s Catherine Converset noted in a recent interview with Pharmaceutical Manufacturing, that there are “difficulties for pharmaceutical companies” when they try “to really change their processes, because they have to go through the recertification process.”
In turn, that focus on compliance fosters a “test and inspect” style quality system. As Christine Moore, Acting Director at the FDA’s Office of New Drug Quality Assessment, pointed out in her presentation at the International Conference on Drug Development earlier this year, a fundamental barrier to quality in the industry is a lack of a “quality culture.” When manufacturing objectives are targeted to meet compliance requirements rather than patient expectations, you get short-sighted decision making.
Industry applications of the corrective and preventive action process (CAPA) required by the FDA have been critiqued for years. CAPA has a history of being set in motion only after a failure occurs rather than in a truly preventive way, and it’s been applied inconsistently across companies. Moore says pharma quality systems that have been dominated by a reactive-style CAPA approach need to morph to ones in which product performance and quality monitoring as well as change management carry the most weight.
Converset points out that pharmaceutical companies “are doing a lot of work today on quality and on how to better monitor their CAPA process to be more efficient when handling a CAPA event.” Moreover, she says the industry “understands that it has to make a lot of changes, and it is now really challenged to make continuous improvement efforts.” When the objective is preventing and correcting errors systemically, the process needs to be continuous and to involve everyone as they do their daily work.
Lean in the lab
We’ve seen Lean principles work extremely well in laboratories as well as in pharma manufacturing operations. Lean lab transformations we’ve been involved with have yielded results that include:
- 40-50% reductions in changeover time;
- Lead time reductions ranging from 50% to 90% depending on the type of analysis and service;
- Productivity improvements from 30-50%, allowing for cross-training and redeployment of staff; and
- Significant reduction in the costs of supplies such as reagents, as a result of visual inventory management and kanban supply systems.
(Also see “Lean in the Lab: Build It Right and It Will Come” for a good overview case study of Lean as applied by Pfizer in quality control labs.)
But particular challenges arise when attempting to apply Lean in lab environments:
- Staff must learn to see and fully understand all aspects of waste—not just non-compliance issues. Rather than following GMP compliance tasks in a rote manner (even when they are unnecessary) it’s important for lab staff to develop an understanding of the why’s behind tasks, and to distinguish when activities are necessary, what they are exactly, and who should perform them.
- The parameters and limitations of the CAPA process must be rethought. CAPA has caused confusion about what is a truly “preventive” action— one that gets out in front of a potential problem—versus one that prevents the recurrence of a known problem (which is really part of corrective action). It has also made staff accustomed to long improvement lead times. Defining stretch targets with managers helps spur more rapid and consistent action.
- Customer-supplier relationships can be difficult for lab teams to grasp. When teams map the entire value stream, it helps them see the relationships and interactions among steps in their processes.
- An ingrained “batch” culture prevails. Batch analysis is seen as the most efficient way to work, and the value of shorter operational lead times is not well recognized. Demonstrating the principles and value of flow in terms of evening out workloads and optimizing lead times is critical.
- Skillsets are lab-specific, limiting flexibility. The value of cross-training in multiple skill sets should be addressed and demonstrated to managers who may think it’s too difficult.
- There is a heavy reliance on computer systems for managing operations. While IT systems have their place, the value of visual management should be taught.
- Employees need consistent encouragement to call out problems. As in other industries including clinical healthcare, there is a tendency to “kill the messenger.” Cultures in which problems are covered up or “worked around” take time to change, as staff members learn to trust new ways of working and problem solving.
Especially helpful tools for Lean labs are those that make problems visible, including 5S and visual standards, as well as problem-solving methodologies. Solid team processes, with regular meetings and reviews, combined with consistent leadership support all help drive systemic change
A few key factors can strengthen the foundation for lean and make changes sustainable:
- Develop in leaders and managers a shared vision of what Lean means —covering the why’s, what’s and how’s, including their specific roles in leading efforts. Leaders must develop the facility to manage the process, measure progress, help develop countermeasures, and pull people through to subsequent stages of evolution.
- Ground all laboratory associates in the basic tools of 5S, visual standards, and problem solving. Without a common shared knowledge, it is impossible to move ahead and institute changes in behavior lab-wide, which in turn is the only way that culture begins to shift.
- In addition to training, set up a system for actively coaching staff leaders in the live workplace. Only when leaders have a chance to practice their skills over time with mentoring and feedback will changes truly take hold. And the operational leaders play a pivotal role in Lean transformations; they form the critical bridge between the strategic upper management teams and the teams who implement value-added changes in daily work.
Ask the Consultants
Q. How can we develop a culture of daily improvement, and move away from the use of kaizen events?
A. We do indeed find that many companies focus almost exclusively on kaizen events to drive improvement, and neglect the daily improvements and behavioral changes that are the force behind a lean culture. But a complete improvement strategy encompasses three interacting elements—daily improvement; broad training in lean skills; and the appropriate use of kaizen events. (In fact, Productivity introduced the kaizen event format to the U.S. back in the 1980s.) For more on how to foster daily improvement along with the other two strategic elements, read Mike Kuta’s most recent blog post, “The Improvement Strategy Trinity.”