Toyota is generally credited with developing the basic principles of lean manufacturing and formulating the strategies for this implementation. But these production techniques actually go back even further-to Henry Ford and beyond. In developing his assembly-line flow, Ford pursued continuous quality improvement and the elimination of waste. Lean manufacturing is, therefore, associated in many minds mainly with the automotive industry.
That entrenched association has sometimes been at the root of the pharmaceutical industry’s slow adoption and halting, incomplete application of lean manufacturing solutions. The overall lack of success in this implementation in this industry can also be attributed to the fact that in automotive manufacturing all the pieces of the production process are contiguous and proceed in an obvious end-to-end flow. There is an integrated system in which activities flow. But that’s manifestly not the case in pharmaceutical manufacturing.
Our industry tends to be divided up into discrete silos of operation. For example, R&D has its peculiar function, engineering has its own purview, and so does QA-with each generally doing a good job within the given area of operation, but usually not overly concerned with how it affects other departments. This runs counter to the idea of product flow and fails to consider customer needs.
Also, when lean manufacturing consultants come in using alien Japanese words and lean jargon, framing everything in terms of a different industry, there’s often a reluctance to fully embrace the new system. So, an unaltered application of an automotive version of lean manufacturing seldom has the desired results.
Further, the failure, primarily on the part of consultants, to fully understand and adjust for industry-specific issues has also been an impediment to a thoroughgoing and successful implementation. The pharmaceutical industry is vastly different from the auto industry, especially with respect to the many unit operations and the complicated requirements of regulatory compliance. FDA regulations have typically-until fairly recent developments like PAT initiatives intended to support innovation and efficiency-contravened the goals of lean manufacturing.
Lean manufacturing implementation is built on action-reducing waste, improving efficiency, and delivering value to the customer. But in the drug industry, any change slows down the process much more than in other industries. Regulatory compliance burdens and mandates imposed by the FDA require extensive validation and proof that the system changes won’t compromise quality. This means that when a pharmaceutical company determines exactly how to effect lean improvements, it may actually take months for a full implementation.
In a 2006 interview, Phil Emard, President of OpEx, Inc., had this to say about the situation: “Basically, they [pharmaceutical companies] have to stay focused a lot longer than companies in other industries.” He also outlined several important points for a successful implementation in the pharmaceutical industry:
– Keep an eye on what is of value to the customer.
– Begin with a value stream/product flow analysis, and strive for product flow.
– Work toward eliminating errors and reducing lead time.
– Get rid of non-value-added activities.
– Create a sense of urgency.
– Involve everyone.
According to Emard, “Lean principles are very easy to understand, but they’re very hard to implement.” But lean manufacturing consultants with the requisite knowledge and industry experience can ease the transition from an automotive to a pharmaceutical implementation.