Pharmaceutical - Six Sigma

When benchmarked against other similar industries, such as the food industry, drug companies frequently come up far short in critical business benchmarks.

Typically, non GMP critical indicators such as stock turnover, manufacturing cycle times tool or machine changeover times and QC release times are well short of these benchmarks.

There is usually no GMP impediment to embrace the best from other industries. Tools and techniques successfully used in other industries, can be successfully applied to pharmaceutical facilities. The difficulty lies in doing this in conjunction with GMP and other Quality guidelines.

PharmOut offers a range of six sigma and other process improvement consulting services to assist pharmaceutical manufacturers in improving their processes and be GMP-compliant.

PharmOut will provide the Pharma-aware resources and skills to implement your cost reduction projects, whilst you concentrate on the core business.

What is Six Sigma

Six Sigma is a system of practices originally developed by Motorola to systematically improve processes by eliminating defects. Defects are defined as units that are not members of the intended population.

Since it was originally developed, Six Sigma has become an element of many Total Quality Management (TQM) initiatives.

The process was pioneered by Bill Smith at Motorola in 1986[2] and was originally defined as a metric for measuring defects and improving quality, and a methodology to reduce defect levels below 3.4 Defects Per (one) Million Opportunities (DPMO).

Six Sigma is a registered service mark and trademark of Motorola, Inc.

Motorola has reported over US$17 billion in savings[5] from Six Sigma as of 2006. In addition to Motorola, companies which also adopted Six Sigma methodologies early-on and continue to practice it today include Bank of America, Honeywell International (previously known as Allied Signal), Raytheon and General Electric (introduced by Jack Welch).

Key Concepts of Six Sigma At its core, Six Sigma revolves around a few key concepts. Critical to Quality:

Attributes most important to the customer Defect: Failing to deliver what the customer wants Process Capability:

What your process can deliver Variation:

What the customer sees and feels Stable Operations: Ensuring consistent, predictable processes to improve what the customer sees and feels Design for Six Sigma.

Example - Eli Lilly

9 December 2005 by Michael Marx, Six Sigma Contributing to Productivity at Lilly

A Press Release issued today by Eli Lilly and Company credits Six Sigma as a significant contributor to the 15% productivity increase they experienced in 2005:

"Lilly is utilizing several tools to increase productivity and lower its cost structure, including applying Six Sigma across its global operations, which is expected to free up resources, accelerate R&D output, enhance customer satisfaction, and improve earnings with a portion of the overall benefit; expanding the use of biomarkers to more than 90 percent of the company's clinical candidates to facilitate earlier development decisions.

Maintaining the July 2004 hiring limits that have already reduced headcount by 3,100 or nearly 7 percent, without using disruptive layoffs; and leveraging outsourcing when the work represents non-core business or can be done at a lower cost and similar quality.

Lilly’s initial efforts have resulted in productivity increasing about 15 percent in 2005 compared with 2004 as measured by adjusted operating income per Lilly employee.

"The presentation delivered during the web cast gives the outlook for Six Sigma at Lilly in 2006. They will have 200 additional Black Belts, 1,600 new projects, and approximately $250 million in benefits.

Other benefits Lilly expects to see from Six Sigma are faster R&D cycle times, enhanced customer interactions, improved earnings, and re-deployed resources in critical capabilities.