It had to. Six Sigma strives to reduce variation in products and processes, while Lean manufacturing goes for ending manufacturing waste.  It is clear that there are several areas within the pharmaceutical industry where these two could be implemented, and are strongly advised by expert pharmaceutical consultants:

-Research and Development (R&D).  This is the principal process where the business starts for all pharmaceutical companies, and it is also the most expensive one.  Lean manufacturing comes into the picture to understand and define the critical procedures for developing new drugs, as well as to analyze and guide the current ones.  In this way, pharmaceutical companies are trying to reduce drug failures, learn to utilize resources to the maximum, increase productivity, and apply effective criteria to use personnel and other resources efficiently.

-Cycle times.  Cycle times for pharmaceutical procedures are extensive, and these are affecting on-time manufacture, supply, and launch of new products.  Timing is critical for the success of a new drug, thus, companies must reduce production timings to take full advantage of the market.  Lean manufacturing and Six Sigma offer value stream mapping and process modeling concepts capable of reducing these cycles and costs, making the processes and staff, more efficient.

-Defects.  These are a huge risk for pharmaceutical companies.  No one wants to risk making people ill or to cause a death.  Lean’s DFSS uses scientific and statistical tools which reduce the cost of human mistakes and inefficiencies.

Six Sigma creates many opportunities for pharmaceutical companies using it. While Lean happens at the operations and management levels, applies to the behaviors towards customer focus and coherent mission statements and values, Six Sigma’s goal is to change the organization’s momentum.

A broad strategy towards Six Sigma training is required during several stages of the change to Lean manufacturing, in order to gain stronger organizational skills at the management and general staff levels.

IT is vital in the transitioning process to ensure constant improvement.  The complexity of the manufacturing processes makes it necessary to acquire flexible and practical IT systems.  Data gathering and analysis must occur fast, effectively, and accurately; improving reliability.

The reliability aspect makes this information the basis for guiding, decision-making, and cost lowering.  Over time, an automatic system will make quality results possible, speeding analysis and design changes to improve the operation’s efficiency and compliance.

By being able to meet the demands in real time, inventories and costs are reduced efficiently before the drugs’ expiration dates.

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