MGT456 – W7D – Banner Pharmacaps Six Sigma

For this week’s discussion, read about Banner Pharmacaps Six Sigma in chapter 8 of the textbook, and address the following questions: 

  • What role did training of employees and champions in lean Six Sigma concepts play in meeting their quality improvement, cycle time, and employee development objectives for their operations? 
  • How did Banner’s R&D scientist use the DMADV approach and DOE tools to reduce the time required for development and registration of products with the FDA? 
  • What savings was Banner able to realize from their projects? 
  • Discussion (with examples) how DFMEA might be used in a service application rather than in a pure product design application.
Textbook – An Introduction to Six Sigma & Process Improvement 2e
By James R. Evans and William M. Lindsay

Banner Pharmacaps specializes in the research, development, manufacturing, and distribution  of  innovative  soft-gelatin  dosage  forms  of  health  care  products.  In  1992, Banner developed and patented a gelatin coating for tablets and caplets or cores, as they refer to themfor ease of swallowing. Fish oil soft gels, which are made  using  Banners  proprietary  enteric  technology,  EnteriCare,  are  the  star  product  in  its  line  of  direct-to-market  nutritional  supplements.  The  company  employs 499 people at its facility in High Point, North Carolina.

Because the active pharmaceutical ingredient (API) in some products is very expensive,  multiple  attempts  to  produce  the  right  blend  of  ingredients  for  the  same  batch  can  be  extremely  costly.  Banner  sought  a  tool  that  would  aid  earlier  submissions of product to the Food and Drug Administration (FDA). Shorter cycle times were needed to make the company more competitive. Banner was also inter-ested in continuing to build a workforce of problem-solvers.

The company trained employees and champions in Lean Six Sigma concepts to  help  minimize  variability,  decrease  cycle  times,  and  help  build  a  work  force  empowered  to  focus  on  root  cause  methodology.  By  incorporating  the  LSS philosophy, one team was able to increase the Soflet gelcap yield for one of their products  from  94.15  percent  to  98.3  percent.  Even  more  importantly,  employees  are  now  challenged  to  improve.  They  look  at  the  data,  make  recommendations,  and lead initiatives.

Six Sigma principles are not used only in Banners manufacturing processes. A senior scientist in research and development who earned a Green Belt applied a design of experiment (DOE) approach to an Rx product in the development pipe-line. Even when developing a generic pharmaceutical product, development and registration  of  the  product  with  the  FDA  is  a  time-consuming  and  arduous  pro-cess. Producing a registration batch that meets all the criteria necessary for a physi-cally and chemically stable product in comparison to the branded product could take 18 months or more. The project mission was to reduce the product formula-tion time from 18 months to 15 months. The DMADV approach was used to deter-mine optimal settings for the registration batch, while simultaneously ensuring a robust  process  and  quality  product.  The  result  was  that  the  design  project  sur-passed its goal significantly and allows earlier submissions to the FDA. Depending on the timing of FDA approval and commercial launch, this project has the poten-tial to increase this products earnings by more than twice the initial forecast. The company  realized  $650,000  in  cost  savings,  increased  yield  from  94.15  percent  to  98.3 percent, and reduced formulation time from 18 months to 15 months.