While basic Lean concepts are simple and can be extremely effective, many companies – in pharmaceuticals and other industries – have struggled to gain the same kind of benefits in a laboratory environment as achieved in manufacturing. Pfizer has taken the traditional concept of Lean manufacturing and, with some innovation and collaboration, reinvented it as a replicable process easily adapted across Quality Control (QC) laboratories in its global supply network of more than 70 sites.
Pfizer has been applying Lean techniques in QC laboratories for a number of years, yet the concept created some early skeptics. How could a Lean approach apply uniformly across such a complex and highly regulated business? At each site, there could be hundreds of analytical methods, many configurations serving different countries and high product volume variability. The end result product could take various dosing forms, including tablets, caplets, capsules, liquid-gels, ointments, creams, gels, liquids and injectables. Was it even possible to apply Lean tools, such as leveling of incoming workload and standardization of work tasks, to gain the desired improvements in productivity, speed and quality?
Building the House of Lean Laboratory
What won over the skeptics and allowed the process to work throughout the Pfizer Global Supply organization was applying traditional Lean concepts in an untraditional way. The creation of the House of Lean Laboratory was established as a business objective in 2009; in 2010 it became a reality.
Like Lean itself, the basic concept was simple:
1) Begin with input from a broad cross-section of functions and locations
2) Create a standard approach with enough flexibility to be adapted to the specific needs of individual sites and lab types
3) Make it easy for each site to implement Lean initiatives by packaging the elements in an accessible way and offering a one-stop shop for information and applications
4) Address cultural and behavioral aspects, which can be a make-or-break success factor
5) Include components to ensure sustainability and foster continuous improvement
Designed with the Toyota House of Quality in mind, the Pfizer House of Lean Laboratory began taking shape in January 2010. A workshop, held in Puerto Rico, was attended by Pfizer representatives from 19 sites, spanning all seven business units (primary care/oncology, established products, specialty/biotechnology, emerging markets, consumer healthcare, nutrition and animal health), along with relevant center functions.
This was not simply a sharing of best practices. The work at hand was to develop a process at the corporate level that could be rolled out across all products, all divisions, and all locations. The approach would be open and flexible, with the benefits to adoption being so clear as to create an internal “pull” from the sites.
The goals of Lean Labs were established as follows:
- Improve productivity within the QC laboratory, with reduced costs of operations, reduced lead times in delivering results to the customer and greater consistency of result delivery to the customer
- Improve first-time quality, thereby reducing laboratory investigations and rework
- Build a culture of continuous improvement to sustain business benefits from the customer down to the analyst level, drawing on new and innovative ideas, and sustaining its impact with mindset and behavior transformations across the laboratory
- Develop a standard but flexible, holistic Lean Laboratory design that could be easily replicated and rapidly deployed across the entire global supply network
Lean Labs was to be something everyone would want to undertake because it would make their work more efficient, more effective and more profitable.
The structure of Lean Labs took the form of a typical house. (See Fig. 1.) It sits on a solid foundation of customer focus (both internal and external), where designs are based on customer expectations for speed and quality, and a continuous-improvement culture that promotes long-term sustainability of the design.
Lean Labs is supported by pillars of Quality Systems that align with the improvements undertaken and a Lean Lab Forum for site-to-site support and sharing of information and best practices.
Fig. 1: The Pfizer House of Lean Laboratory contains concepts for improving quality, driving down cost, and creating a continuous improvement culture that can be rapidly implemented and replicated across the broad network of Pfizer business units.
The three tiers correspond to the levels of a house, with each level containing a number of concepts, or “rooms.” Each room is set up the same way so people know what to expect and how to navigate to the information they need. Rooms contain an overview that defines and sets the scope for implementation, noting resource requirements and constraints. There is step-by-step implementation guidance, site-specific examples as models to show what others have done, and links to tools and templates.
Level I begins with the basics: simpler approaches requiring less investment that can be implemented right away. The expected benefits at this level are a 15% to 45% improvement in productivity and effectiveness.
These benefits come from:
- The leveling of incoming workload and standardization of work tasks
- Optimization of the workplace in labs with 5S and organization strategies, work cells and visual management tools
- Lab performance management through metrics, Key Performance Indicators, “gemba” walks through laboratories to identify best practices, and shift huddles
- Method improvements to reduce repeated and unnecessary testing
- A flexible cross-trained workforce
- Error reduction through the use of human performance models
Level II may require longer implementation timelines because these activities may require capital investment or regulatory filings. They can contribute 10% to 25% productivity and efficiency gains, largely through: