This article describes how Lean can not only provide the basis for an overall business system, cutting the time taken from creation to profit, but also how it can drive the creation of an improvement culture within pharmaceutical companies.
What is Lean?Lean can best be defined as a 'long-term philosophy of growth by generating value for the customer, society, and the economy with the objectives of reducing costs, improving delivery times and improving quality through the total elimination of waste.'1 It is derived from the Toyota Production System which was introduced by Toyota's Taiichi Ohno, a Toyota executive and father of the Lean concept, in the 1950s as a successful response to competition from larger car manufacturers.2
It is important to note that Lean is heavily based on the principle that continuous improvement can be found through the power of respect for people. 'The culture of the company is crucial in designing the business system that motivates people to want to improve, teaching them the tools of improvement and motivates them to apply those tools every day.'3 Lean therefore, must go beyond just the manufacturing process and business strategy; it needs to involve all employees, at all levels and not just the decision-makers, in order to be successful. While the concept is simple and inexpensive, it needs commitment and determination to work. It is estimated that 50% of change programmes like Lean fail to deliver or be sustained.4
Lean in pharma
Since several large pharmaceutical organisations had shown a willingness to simplify operations and processes, and reduce costs via Lean, such as AstraZeneca, Johnson and Johnson, and Pfizer, which had implemented Lean Six Sigma,5 more organisations within the industry have pricked their ears to the benefits Lean can provide.
One major concern for many pharmaceutical companies looking to implement a Lean methodology is how to integrate it into its current good manufacturing practice (cGMP) approach, where the main aim is to deliver a safe and effective medicinal product and the need to control the manufacturing environment.6 In fact, contrary to this concern, Lean and cGMP go hand-in-hand, as quality is sustained at a higher level with lower costs due to the Lean principles that are applied.