With a typical useful lifetime measured in decades, facilities represent one of the largest investments an organization can make. Facilities require significant capital investment well in advance of proof of clinical efficacy, and yet they typically end up being the gating activity to moving your product to market. In terms of strategic impact, applying Lean manufacturing principles to facility design elevates this investment to its correct place in an organization’s strategic plan, because it maximizes value and efficiency.
Lean manufacturing focuses upon creating value in a process value stream while eliminating waste. Applying Lean concepts to facility planning and design exercise is the perfect opportunity for anorganization to add value to the overall productdevelopment process.
LEAN MANUFACTURING
Originated by Taiichi Ohno to analyze processes within the Toyota Production System, Lean principles have evolved into a development philosophy that strives to identify and eliminate waste by concentrating on what is valuable to the customer. Lean also evaluates wasted effort and lost time between operations, here characterized by the letters of the word “downtime.”Identifying the potential for waste and translatingit into facility design considerations is the essence ofLean facility design. If properly designed, a Lean facilityis flexible, low cost, and efficient.
The Lean facility design roadmap mirrors the standard approach to facility design but takes it to a new level. Lean facilities marry the classical design criteria (material, personnel, equipment, and finished product flow) with operational considerations including information flow and value stream performance measurement. This distinction is the essence of the competitive advantage created by Lean facilities.
While the temptation may be great to launch into the layout phase of a facility, it is important to establish a well defined user requirements document before designing the facilities operations. For facilities this is termed the Basis of Design (BOD). The BOD is a critical document that defines quality, operational, and performance metrics. Once you establish a BOD, the facility development will flow logically in all phases, from site selection to detailed workstation design.
Let’s focus on those elements which are unique to a Lean facility.
Table 1 shows a phased structure for addressing a lean facility design project. We’ll examine these phases through the lens of their role in Lean facility design.
SITE SELECTION
An existing development or manufacturing site that is considering expanding its capabilities in a designated location does not need to broaden its search to a global level. However, if the purpose is to look at the most suitable location for building this capability there are many factors to consider in the site selection phase.
Historically, cheap labor and tax breaks were the primary business drivers for site selection in combination with the technical requirements for supporting the operation (e.g. adequate water, power, etc.) Gradually this has evolved to include factors such as availability of trained personnel and access to universities to feed a growing operation. Lean principles extend this thinking to the strategic level. Issues such as geographic relationshipto key suppliers, availability of local warehousing,and access to major transportation routesbecome central to ensuring the facility will achieve thelevel of efficiency necessary to meet evolving needs.With the globalization of our marketplace, regionalrequirements can have a tremendous impact in termsof final operating efficiency.
SITE PLANNING
A solid site plan will allow a growing company to expand in an orderly fashion. Lean considerations at this point include developing macro value stream maps tailored to meet the business requirements of the organization. For example, if the facility is intended to house all packaging operations within a therapeutic portfolio, the value stream map will reflect the impact on operating efficiency as more lines are added to the organization. This includes information flow, operating layout, and performance metrics for the support functions outside the facility that feed operations within the facility. Ultimately, these metrics relate to organizationalperformance, therefore establishing them atthe outset will help avoid the disruption associated withrelocation or worse—the realization that the plant is not capable ofaccommodating the business’ needs.
BUILDING LAYOUT
This constitutes the first step in translating strategic elements of the business plan into facility attributes. Layout is a function of the space plan and consists of key components called planning modules (PM), the available space for placement, any process, organizational attributes, or affinities required for function and predefined constraints. It is these last two components which incorporate the Lean thinking element as their basis. For example, utilities constrained by zoning laws and operability requirements (power, drainage etc.), would be fixed and used as datum for laying out the PMs. Lean differs from classical building layouts in that we look at the relationships between operations as a continuous flow. This means the affinities between PMs will change and reflect the process and informational flow requirements of the operation rather than just thefunctional requirements.
A comparison between traditional and lean building layout is depicted in Figures 1 and 2.
DEPARTMENT OR CELL LAYOUT
Next, we optimize the layout of operations based upon the steps required to function within the department or work cell. Lean considerations include identifying the number of operations and optimizing the time required to execute each task within the process value stream. For example, if a development area is working with small scale fermentation, a Lean design may locate and orient the operations to a work cell with access to the autoclave, fermenter, and centrifuge purification in a workstation format instead of requiring operators to move from room to room to execute purification and fill/finish.
WORKSTATION DESIGN
The final step is to apply the principles of Lean operations to the function of each individual workstation. Methods such as Poke-Yoke (mistake proofing) and 5S (sort, straighten, shine, standardize, and sustain) help establish an orderly workplace and institute measurement metrics to maintain these improvements and allow the facility to operate as it was intended.
CONCLUSION
The application of Lean principles easily integrates into the traditional approach to designing a pharmaceutical or biotech facility. Lean will help you set clear performance metrics at the outset of the exercise to ensure that the facility is capable of meeting the needs of your organization as it grows and evolves. Moreover, in so doing you can avoid the challenges associated with culture change—you’ll be prepared to move best practice to standard practice.
Bikash Chatterjee is the president of Pharmatech Associates, Inc. He has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 20 years. His expertise includes site selection, project management, design, and validation of facilities for both U.S. and European regulatory requirements.
