Skepticism comes in many forms, says Lori Lesko, Associate Director of Continuous Improvement at pharmaceutical giant Pfizer. But it can be overcome. In this article Lesko looks at the lessons learned in tackling the challenges of fostering a culture of Continuous Improvement at Pfizer.
The old business model for the pharmaceutical industry is changing. Patents are expiring on many of our blockbuster drugs and the pressure to accelerate time to market at lower costs is eroding profit margins. Pharmaceutical companies have recently begun utilizing the tools and methodologies of continuous improvement to help respond to these issues. But changing a pharmaceutical business culture to one of continuous improvement is full of challenges.
I am a full-time Lean Six Sigma Black Belt tasked with developing a culture of continuous improvement to enable the business to more effectively meet these business challenges. I support the Safety & Regulatory Operations group which is responsible for Pharmacovigilance and regulatory submission activities.
The organization as it exists today was created following the Wyeth acquisition. The acquisition was announced in January 2009 and a lot of work was done to establish the operating structure and leadership that was effective upon the close of the acquisition in October 2009. The integrating of roughly 80,000 Pfizer and 49,000 Wyeth colleagues, still takes time to work out all the details.
"Haven’t we changed enough?"
Continual organizational changes, both as a result of the integration and also the global diversity of our organization, has resulted in evolving processes and a very dynamic culture. This evolving landscape presents a number of challenges for continuous improvement. It is difficult to measure and analyze the current state, as many processes may not be well defined or still changing.
I was asked to help a group improve the process for the management of our core product data sheets. I facilitated a workshop to get the subject matter experts in the process to define the current state and identify pain points. Midway through the session it became apparent that defining the current state was difficult because in practice there were two different processes.
Another challenge involves the multiple frames of reference that have to be considered when working with a group to improve their processes, in addition to tackling skepticism to the approach.
The example of the core product data sheet process illustrated to me that there are differences in how diverse groups believe their work should be done. It takes time to understand the perspective of each group and work out the best combined approach.
Skepticism itself comes in many forms. Often it is just a challenge to why we need to take a closer look and improve a particular process. I often hear "Haven’t we changed enough? Can’t we just see if what we have works or not before we change it again?" Other times it is a questioning of the approach and tools. Since many of the Lean Six Sigma tools came from Toyota and other non-Pharma companies there is a disbelief that they will work in the pharmaceutical industry; particularly in research and development.
1. Strong leadership is a key predictor of success
Actions drive culture change. Having a leader that understands the benefits of a structured approach to continuous improvement and not only talks about the importance but backs that up with actions; such as resourcing a continuous improvement group and modeling the behavior they want in the rest of the organization, goes a long way in breaking down cultural resistance.
2. Focus on establishing the processes and metrics to manage
In order to improve the process you need to be able to describe it and ensure there are measures in place to manage it effectively. These measures will then highlight opportunities for improvement which benefit from the methodology and tools of continuous improvement. This may mean taking a step back and focusing on establishing common processes first before you can apply continuous improvement methodology and tools.
3. Align building skills and competencies with the business need
Historically, a lot of effort was invested in providing training on continuous improvement in order to ensure colleagues understood and could use the methodology and tools. Unfortunately, many of those colleagues did not have an opportunity to apply the methodology and tools and have since forgotten how to use them. Learning from that, we are now utilizing a lean approach and offer training as projects are kicked off to focus more hands on application and less on the transfer of book knowledge.
4. Reap the low hanging fruit
Formal Lean Six Sigma projects following the DMAIC process often take a lot of time before you see results. There is a lot of opportunity to improve our processes and often involves getting people together to understand the current state and probe to root cause through a short Kaizen type event. Making these types of quick improvements helps build credibility to the approach, shows the business benefit and starts converting some of the skeptics.
5. Don’t be afraid to adapt the approach and language
Recognizing there is skepticism and resistance to some of the philosophies and tools of continuous improvement, it is important to adapt the approach and language to the business needs and culture. Changing the thought process is key to changing the culture; the tools and approach are just enablers. Opting for Kaizen events as opposed to running full green belt or black belt projects is one strategy.
In addition, be cognizant and adapt the language of Lean Six Sigma as necessary. Sometimes it is the use of acronyms such as DMAIC (Duh-May-ick) that continuous improvement practitioners forget not everyone understands. And sometimes it is the use of words such as customer that can have multiple meanings depending on the use. In the development organization, in particular, colleagues are often quite removed from the end customer - the patient taking our drugs - and instead look at the internal down stream recipient as their customer. Clarifying the definition into common words has been very effective in overcoming these barriers.
6. Ensure effective communication and knowledge sharing
As we are a large, global, diverse organization, it is difficult for everyone to be aware of improvement efforts that have taken place or overlaps with different initiatives. This has resulted in the same problems being solved over and over again in different areas of the business or a dilution of resources working on similar but competing improvement initiatives. This is one area we continue to brainstorm. We have communication vehicles such as websites, data repositories, newsletters and established communities of practice to network and share learning. But there is more work to be done to continually leverage the work and resources to further drive the business and build a sustaining continuous improvement culture at Pfizer.
Looking to the future – making it stick
We are fortunate in our group that we have strong leadership that is committed to improving the business and are advocates of the continuous improvement methodology. I along with a few other black belts from other parts of the company were recently brought in to re-launch the continuous improvement philosophy within the Safety & Regulatory Operations.
We have reflected on our collective lessons learned and have established our strategy and three year plan for changing the culture to one of continuous improvement thinking. It leverages our strong leadership, ensures we continue to demonstrate the value of the approach, and define the processes, measures for managing and control plans upon which continuous improvement opportunities can be quickly identified.
We will also be establishing a steering committee model, to aid in the selection, prioritization, and sharing of knowledge across the organization. Our hope is these efforts will enable the organization to maximize the return on investment in continuous improvement to effectively meet our business challenges.