Six Sigma and Lean Manufacturing Library

The Six Sigma and Lean Manufacturing Library

Six Sigma and Lean Manufacturing LibraryThe Six Sigma and Lean Manufacturing Library offers a focused, easy-to-search source of case histories and best practices that pharma and biopharma companies are using to improve their manufacturing operations and supply chain agility. It also features benchmarking studies from other industries that can be adapted and applied to pharmaceutical manufacturing.



Cracks in the Armor by Bikash Chatterjee


  • Securing the Global Supply Chain
    Processes and systems must be well understood before technologies can be implemented. Recent events surrounding the contamination of heparin supplied by a Chinese API manufacturer bring home the risks and realities of our expanding global economy.

Black Belt Not Required by Penelope Przekop


  • Six Sigma from the Bottom Up: Don’t Wait for Top Management
    Don't wait for top management support — improve quality from the inside out by applying Six Sigma in your everyday work. The first step in achieving this goal is to begin thinking about managing quality from a more personal perspective.

  • Don’t Wait for Six Sigma to Come to You
    If it's going to work, Six Sigma must be the way you do business, not just a tool or technique. Have you got religion? Johnson & Johnson Pharmaceuticals Group's Penelope Przekop helps you find your way.

  • Do You Know What They Really Want?
    In the words of Dale Carnegie, “You can close more business in two months by becoming interested in other people than you can in two years by trying to get other people interested in you.” Penelope Przekop discusses how to discern and respond to the needs of your internal customers — no matter how difficult they may be.

  • Where Did You Learn to Drive?
    Data-driven management yields valuable business metrics to support your team's accomplishments. The key is to identify the types of data needed, using practicality as a watchword.

  • What’s Your Strategy?
    Moving beyond routine management and firefighting requires a strategy for business excellence — a strategy based on Six Sigma.

Ten Steps to Process Improvement by Ron Snee

More Articles


Process Control

Case Histories


Johnson & Johnson




White Papers

  • Improving Time to Market: Pharma’s Lean Imperative
    Lean business practices, better IT integration and "servant leadership" are becoming essential to survival in pharmaceutical manufacturing. This white paper from Oracle Corp. discusses how some drug makers are implementing those solutions.

  • Pitfalls of Back-of-the-Envelope OEE
    Many manufacturers do not have a handle on their plants' true efficiency. By taking a strict approach to calculating Overall Equipment Effectiveness (OEE), companies can identify all sources of lost time and lost production. In this paper, engineers from Parsec Automation Corp. illuminate how to calculate OEE accurately.

  • Using a Real Options Approach to Maximize Manufacturing Flexibility
    Good pharmaceutical investment decisions often translate into tremendous profits and market opportunities. Sanofi-Pasteur’s Dr. Guillaume Pfefer and Uriel Kusiatin, principal and co-founder of 2Value Consulting Group, outline new methods for decision-makers to get the most bang for their bucks.

  • Creating a Six Sigma Culture by Tracy Thurkow of CLG
    Many Six Sigma efforts confront "cultural inertia" — the gravitational pull for people to do things “the way we’ve always done them.” How do you help people embrace Six Sigma? The key is to treat your efforts as a culture change.

  • Pharmaceutical Six Sigma Quality by Design
    Dr. Hussain's recent presentation at the 28th Annual Midwest Biopharmaceutical Statistical Workshop at Ball State University provides a detailed overview of how Six Sigma principles can best be applied to improve quality in pharmaceutical manufacturing.

  • Customer First...and Last
    All the skills that are key to Six Sigma Leadership are put to their ultimate test in this challenge of balancing customer needs and your organization’s self-interest today while being always ready to change with the customer, or to begin serving new customers.This chapter from Peter Pande's "The Six Sigma Leader" will review ideas and approaches to building a more solid and practical approach to increasing customer focus balanced by the need for flexibility and long-term success. These approaches will increase your odds of staying connected to a group of satisfied — and profitable — customers.

  • More Whitepapers...


Videos and Podcasts





Ask the Experts




Submit Information on Six Sigma and Lean Manufacturing

Have you developed expertise in Lean, Six Sigma or any facet of operational excellence as it pertains to pharmaceutical scaleup and manufacturing?  Would you like to share best practices and lessons learned with your colleagues around the world?  If so, please let us know and send us a draft of the article, or a 250-word abstract summarizing what you'd like to write about.  We'll use that to develop the article for publication and/or add it to this online library.  Please send your abstracts or articles to