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Six Sigma and Lean For the Pharmaceutical Industry


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This is because Six Sigma aims at minimizing variation in products and processes, and Lean Manufacturing aims at eliminating manufacturing waste.

Possible Areas for Implementation:

  • Research and Development

    The Research and Development process is the most important process in pharmaceutical companies and forms a major part of costs. The Lean concept is desirable in this scenario to understand the critical processes to new drug development, and to research and streamline existing ones.

    It is important to have these objectives to reduce drug failures, effect maximum utilization of resources, and increase productivity and optimum utilization of staff and other resources.

  • Cycle Times

    Increased cycle times are major factors affecting the timely manufacture, supply and launch new drugs. The earlier companies can take advantage of this market situation ultimately means the difference between success and failure of the product.

    Value stream mapping and process modeling concepts of Lean Manufacturing and Six Sigma can help in reducing cycle times and operational costs, in addition to increasing the efficiency of processes as well as staff.

  • Defects

    Any defects with respect to drugs would be a big blow to any pharmaceutical company. Lean concepts such as DFSS can help, as they utilize tested scientific tools and statistical tools that help reduce the cost of human errors.

    Companies can use advanced tools to conduct quality analysis, yield analysis, cost comparison of jobs, risk assessment and comparison of manufacturing processes at different sites.

    Rewards of Six Sigma

    The Lean transformation has to happen at the operations and management levels, as well as in the behaviors towards customer focus and consistent mission statement and values. Six Sigma teams should endeavor to change momentum in their organizations.

    Six Sigma training cannot be ignored; a comprehensive strategy towards training needs at multiple points in the transformation to Lean means achieving stronger organizational skills throughout top management and other staff members.

    In the transition to Lean Six Sigma, IT plays a very important role towards continual improvement. The complex pharmaceutical manufacturing structure requires flexible and interoperable IT systems. Systems should be in place that enable data mining and analysis quickly, accurately and efficiently. The data will then be more reliable.

    With unduplicated data, the information recovered becomes the driving force in decision-making, as well as in lowering administrative costs. For example, if a batch of drugs released is defective, a reliable IT system can provide data towards the locations to which it has been dispatched, as well to find out where the defect may have originated. With more dependence on automated checks built into the system, quality results are achievable.

    This enables rapid analysis and design changes for the improvement of operating efficiency and compliance. Last but not least is the utilization of real-time demand driven sales, which helps reduce inventory and its carrying costs before product expiration.

    The Six Sigma and Lean approach to the pharmaceutical industry has possibilities for implementation. Though not the easiest, its implementation can definitely reduce costs, process errors and product defects.

    Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solutions - Six Sigma Online ( ) offers online six sigma training and certification classes for six sigma professionals including, lean six sigma, black belts, green belts, and yellow belts.

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