PEOPLE + INFORMATION
Clearly, when looking across the complexities of a contemporary drug maker’s operational continuum, two elements emerge as critical priorities in pursuit of Lean Six-Sigma-optimized operations: people and information.
It’s generally agreed, especially among pharma’s Lean pioneers, that any programmatic approach to effectively institutionalizing Lean Six-Sigma values into an organization requires that considerable attention be paid to the human element; the role individuals and teams play in supporting and sustaining Lean Six-Sigma operational excellence initiatives. Michael Curran-Hays, a practice leader for Kepner-Tregoe, a management consulting and training company, offered that process excellence in manufacturing is an acceptable vehicle for organizational transformation. “It brings a bias for disciplined action, clarifies the intuitive knowledge gained from experience and puts an organization on the path to accelerated business results. In the quest to attain ‘flow’ with ‘zero’ waste, organizations are falling short on the people management aspect of process excellence implementation.”
Kepner-Tregoe explains that in their experience, the people who are actually responsible for sustaining lean programs can be pushed to the background by cadres of lean gurus. The rank & file’s importance to successful lean journey’s success is often ignored and misunderstood. This, says Kepner-Tregoe, leads to variable and unpredictable process improvements and business results that can’t be sustained. Curran-Hays maintains that when it comes to lean initiatives, focusing on the people piece helps organizations solve the lean puzzle and that the results are translatable consistently across other parts of the organization.
To achieve process excellence, notes Curran-Hays, “We must first understand the landscape, management practices and the performance system that drives project team behavior. To understand the landscape, observe the manufacturing landscape — not as a process excellence expert, but through the eyes of the people who experience waste mitigation first hand as it gets implemented across their organization.” The view, says the consultancy, can be frustrating and confusing. “It is not uncommon to find that the strategic business objectives of an organization are at odds with when and where Lean and waste mitigation are implemented.”
A Kepner-Tregoe white paper offered an example: “A consumer products plant of a large pharmaceutical company decided to transform itself into a ‘Lean Enterprise’ with 37 distinct projects that focused on improving manufacturing flows and fill rates and reducing cycle times. While the projects were implemented, the company was being strategically benchmarked against labor costs in offshore countries.” In this case, says Kepner-Tregoe, a Lean job well done was at cross purposes with the company’s strategic objective to lower labor costs. Results from Lean projects coincided with the closure of the production facility. For people affected by the plant closure, going Lean did not help, it only created disbelief in Lean principles.
According to TayganPoint Consulting Group CEO, Joy Taylor, pharmaceutical companies have recently become more focused on cost reduction and productivity metrics. “For as many clients as we serve, we have seen as many organizational models created to drive operational efficiencies. However, Lean Sigma practices and principles are certainly the most common and are creating unique operational models to fit their culture and infrastructure.” Some, says Taylor, use the centralized model where Lean Sigma is driven by a global Lean Sigma or Productivity group (largely made up of master black belts and black belts) which works mainly on the key cross functional improvement initiatives and provide lean sigma training and support to key initiatives. “The other model is decentralized whereby each function develops its own capabilities to drive Lean Sigma in their functions through functional green belts and black belts. Both models have value, but regardless of the structure, efforts must be strategically aligned to the organizational mission and vision.
In Taylor’s experience, many of her big-brand clients have centralized process excellence groups that provide process improvement and Lean Sigma principles throughout key functions such as the supply chain, support functions, clinical development and aspects of sales and marketing. “But what organizations now require in order to sustain these improvements is a robust enterprise analytics capability; they must be able to track each unit. As such, we see many clients setting up global process owners and governance entities to drive enterprise-wide process management.”
Taylor says her consultancy’s clients have had mixed results from the institutionalization of Lean Sigma and process excellence. “To be exceptional,” says Taylor “requires an all-in philosophy particularly in the supply chain/manufacturing space, which also means you must have access to data. And for some, that is the limitation, hence why ‘big data’ is such a hot button right now. But those who are successful set clear improvement targets and have measurement mechanisms to ensure realization of benefits. For example, having the ability to understand metrics such as OTIF (On Time In Full) or discard metrics can help an organization generate millions in revenue and also save it millions in waste.”
OPEX REQUIRES OPDATA
John P. Helfrich, Sr director, Analytical, Development, Quality and Manufacturing Solutions for Accelrys, finds the mantra in the C-suite for life science companies lately is “operational excellence” from all segments of the supply chain, both internal and external. A key strategic element says Helfrich, to a successful operational excellence effort is capturing and cataloging the experimental and operational data streams as the product transitions from early phase development through pilot and into commercial operations. These data constitute the foundation for true data management transformation to operational wisdom. “As companies initiate Lean Six-Sigma programs and begin the now-popular externalization of processes that previously were performed in-house — from R&D through pilot operations and now into full CMO-based API production and packaging — executive managers are becoming increasingly aware that their information/data management infrastructure requires updating.”