Lean Six Sigma as a Performance Multiplier

by Jay Armstrong

Internal and external issues are significantly escalating pressure on the pharmaceutical industry to improve their output of drugs, while managing costs.  This is a difficult balancing act, as there are shrinking drug pipelines, an imminent patent cliff and the emergence of generics as an alternative to the traditional drug manufacturers.  Additionally, R&D productivity and spending have declined, even as new global markets are emerging with substantial, unmet therapeutic needs.

You can’t improve a process if you do not understand the variables and factors that impact it. The industry must now try to find ways of improvement while meeting product, customer, regulatory and efficiency demands. Lean Six Sigma has been used by some of the world’s most successful companies leading to savings of billions of dollars, striking increases in speed and capacity and achieving better customer relationships.

Lean Six Sigma focuses on a smaller number of critical projects to ensure higher profitability and faster solutions. Organizations traditionally face two potential scenarios – First, there is an already existing process that is working reasonably well – this requires the application of “DMAIC” – Define, Measure, Analyze, Improve and Control.  Motorola and GE were early adopters and powerful champions of DMAIC.  Indeed, their dramatic cost savings and improvements can be directly traced to the adoption and embedding of these principles.  In the second instance, an organization may have no process at all.  This situation requires a distinctly different path – DFSS – Design for Six Sigma.  This process utilizes the IDOV strategy – Identify, Design, Optimize and Validate.  This thinking is a radical departure from traditional lean Six Sigma solutions in that quality is essentially designed into the process during its creation. DFSS has attracted the interest of the FDA, because it closely mimics “Quality by Design” (QbD)

One way that a pharmaceutical company is able to do this is referred to as an “Open Innovation Strategy.”  Open innovation distances itself from traditional R&D, wherein the company itself owns and manages the entire R&D process chain, rather than leveraging outside help to stimulate innovation. R&D in an open system assumes that even the most capable organization needs to identify and work alongside external companies as a means to enhance innovation.  Thus, pharmaceutical companies have been seeking to work with universities, hospitals government, private research institutions, and biotech companies to enhance their innovation processes.

To be able to optimize the benefits of Lean Six Sigma, it is important that the work in all areas of the organization utilize the same mind-set. There is data indicating that significant benefits can be realized by including non-manufacturing activities, since these are only about 70% efficient.    As General Electric continued to develop the Six Sigma system originally created at Motorola, they realized that the potential of Lean Six Sigma was far greater than the current applications on their manufacturing processes. This ensures that the root causes for variation or bottle necks are truly eliminated and not just moved along in the system. Sadly, even though the pharmaceutical industry is highly regulated to ensure that the companies meet all the requirements from regulatory agencies, many core processes are not meeting the requirements of today’s market.  The arduous process of drug development as a prime example. One potential solution to the business issue and challenge of high costs and long time lines for product development is the use of Six Sigma. Companies implement Six Sigma for a number of reasons and some of the main targets when implementing Six Sigma in the R&D organization include decreased costs, decreased time to market and improving the process and product quality.

When starting implementation of Six Sigma the entire organization needs to be evaluated to see where to start the implementation work. During this process it is important to be open-minded and think out of the box to ensure that an area with great potential is chosen to start with. The initial successful implementation work will send out a message (to all the company staff) and facilitate future work.

Lean Six Sigma thinking has evolved far beyond its traditional manufacturing roots and is now recognized as  a cogent driver for operational excellence and competitive advantage.  We believe that substantial and sustainable cost and time savings, as well as quality improvements can be realized through a broad and deep application of Lean Six Sigma principles and tools.


Jay Armstrong holds certification as an ASQ Six Sigma Black Belt and advanced degrees from Stanford, University of Pennsylvania, Johns Hopkins in fields such as Biotechnology, Management, Biomedical Technology. He holds certificates in Project Management, and Decision/Risk Management. He has led workshops in employee coaching, designing and fundamentals with led to eight Kaizen events, and five discovery events. He was the leader in launching of the process workshops for clinical trials, and developed and led a clinical trials E-2-E work-stream which identified 10 clinical process area improvements. He is responsible for leading of five R&D process-improvement teams in delivering major cycle time, cost, and resource reductions of up to 80%, leading to $11M savings.

Why Get an ASQ Certification?

We hear the term “certification” used in many contexts: certificates, certifications, associate certifications, and professional certifications to name a few. But, there are distinguishing differences. ASQ offers professional certifications. What’s the difference? 

“Professional Certification…requires an organization whose sole focus and goal is to ensure that the people to whom it issues certification designations have demonstrated a defined minimum level of competency and experience in a given field of practice. It also requires adherence to ethical codes of conduct. It should not be ‘easy’ to achieve professional certification through organizations that establish strong, credible professional certification systems” (Budnick).

We all have an opportunity to work towards earning an ASQ Certification. If you think you’d like a little help, ASQ Philly offers certification preparation courses that meet in a classroom or stream online with recorded classes. Not sure if our courses are meant for you? Contact us and file9421269543382we’d be happy to answer questions. We make a go/no-go decision on courses based on a minimum number of students, so to ensure your class happens be sure to register soon! Has the course started already? It may not be too late to join; contact us.

We’re here to serve our members and to help you succeed with Quality.

Budnick, Peter. “Professional Certification: Why It’s Important, Why You Should Embrace It.” The Ergonomics Report. 12 Feb 2012. cited in Web blog post. Ergonomics Today. Ergoweb, 8 May 2013. Web. 15 Mar 2016.

Cost of Quality

“Cost of quality is a methodology that allows an organization to determine the extent to which its resources are used for activities that prevent poor quality, that appraise the quality of the organization’s products or services, and that result from internal and external failures. Having such information allows an organization to determine the potential savings to be gained by implementing process improvements.”

Excerpted from The ASQ Quality Improvement Pocket Guide: Basic History, Concepts, Tools, and Relationships, Grace L. Duffy, ASQ Quality Press, 2013, pages 62–65.

Learn more about the Cost of Quality, including videos, training, books, and case studies by visiting the ASQ website. Or for an instructor-led workshop or training, contact ASQ Philly or the Education Chair for potential training opportunities for both individuals or on-site at your place of business for your group.

ASQ and Your Career

The ASQ Philadelphia is a resource that can help you to develop your career. Listed are 6 of the many ways we can help:
  1. The ASQ Philadelphia website includes tools to help connect local jobs and applicants. See our Jobs/Opportunities menu and check back often for updated information. If you’re a freelance consultant and a member, see the menu for how to get added to our consultant list.
  2. The ASQ Philadelphia offers courses for learning new tools and techniques, expanding your portfolio of knowledge. schoolVisit our Upcoming Events and Courses list frequently for updated information. If a Course you’re interested in is not offered, yet, contact our Education Chair to find out if it will be offered soon and to express your interest.
  3. The ASQ Certification can help you prepare for a change in careers or to enhance the career you’re enjoying. Learn more by visiting our Certification menu.
  4. The ASQ Philadelphia has a varied membership with a lot of experienAgreementce. Are you looking to change to a particular quality career but not sure if it’s the right choice for you? Our Jobs Chair may be able to connect you with another member who would be willing to share their experiences.
  5. For members, the ASQ has a Career for Quality section that not only lists job opportunities but also has career tips, services, and tools. Watch this video about quality careers.
  6. The ASQ Philadelphia hosts career events. George Ericsson spoke at a past event and had a suggestion of a way to approach your career selection.  Watch the short video:

American Society for Quality