Blending Process Analytical Technology and Six Sigma

	Bookmark This Page Email This Page Format for Printing Cite This Article Submit an Article Read More Articles
	Related Tools & Articles Lean Six Sigma Can Benefit Drug Discovery/Development FMEA: Preventing a Failure Before Any Harm Is Done The Importance of Statistical Thinking
	Discussion Forum "Anyone out there in the pharmaceutical industry where Six Sigma has been applied company wide or to a large extent?" Contribute to this Discussion

B

New from iSixSigma NEW VERSION! Process Management Training Slides Business Process Management E-book Six Sigma Leadership Series

y Terra Vanzant-Stern

Manufacturers face numerous challenges within their markets as the number of competitors grows and increasing material costs impact margins. Business methodologies such as Lean Six Sigma working in tandem with industry-specific approaches can increase the opportunity for success. An example of that is in the pharmaceutical industry, where an approach called Process Analytical Technology (PAT) is used for manufacturing.

Four Components of PAT

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency strongly encourage pharmaceutical companies to adhere to PAT Guidelines. PAT is a scientific program designed to reduce risk and is, essentially, about improving processes for effectiveness and efficiency in the pharmaceutical industry. PAT consists of four basic components:

1. Process understanding
2. Risk-reduction-based approach
3. Regulatory strategy to accommodate innovation
4. Real-time release

Because PAT is a system for measuring, analyzing and controlling manufacturing, it supports using any techniques that also lower risk. By implementing the tools and techniques used in Lean Six Sigma, many PAT principles are automatically satisfied.

Why Lean Six Sigma?

Continuous improvement systems are often used to boost operational performance. Areas that are commonly targeted include labor utilization, inventory levels, quality, asset utilization and cost of goods. In 2005, ARC Advisory Group, a research and advisory firm in manufacturing and supply chain solutions, reported that 80 percent of manufacturers are applying one or more continuous improvement methodologies to their plants. The most popular programs include Lean Six Sigma, Six Sigma, Total Quality Management and Theory of Constraints.

Of these methodologies, Lean Six Sigma is the strongest candidate to partner with PAT. Using a standard DMAIC model, Lean Six Sigma controls process and product variation by defining problems, and then measuring and analyzing the data. This optimizes quality control in the manufacturing process and improves production rates, enhances innovation and reduces cycle times.

In fact, tools used in Lean Six Sigma are often simpler than PAT for an employee to grasp. Examples of these tools include a SIPOC (suppliers, inputs, process, outputs, customers) diagram, and failure mode and effects analysis.

One of the reasons that Lean Six Sigma works well with PAT is the use of statistical process control and design of experiments (DOE). Statistical process control is an effective method of monitoring a process through the use of control charts. Its purpose is to isolate the natural variation in the process from other sources of variation that can be traced or whose causes may be identified. DOE includes the design of all information-gathering exercises where variation is present, whether under the full control of the experimenter or not. It is used to study processes and products. In a purely scientific procedure, DOE does not go after optimization, but rather simply the relationship between variables. In Lean Six Sigma, as well as PAT, the goal is to understand the complex relationships between several factors.

Achieving Common Goals

Both PAT and Lean Six Sigma promote reducing production cycle times, preventing rejects, increasing automation and facilitating continuous process improvement. Lean Six Sigma can play an important role in the application of PAT by providing a simplified template and a bevy of tools.

About the Author: Terra Vanzant-Stern, Ph.D., project management professional (PMP), is a Master Black Belt and lead facilitator at SSD Global Inc. She specializes in consulting and teaching for Lean thinking, Six Sigma and Lean Six Sigma. She is the chair-elect for the Denver Section of the American Society for Quality. Vanzant-Stern may be reached at Terra.Stern@ssdglobal.net.

"The Bottom Line" Links

BMG UNIVERSITY | Lean Six Sigma Online | . Reduce Travel Costs . Maximize Training Budget >> Get Certified Now..

VILLANOVA UNIVERSITY   Earn Your Lean, Green or Black Belt Six Sigma Master Certificate Online BOOST YOUR SALARY! *$38k more than uncertified counterparts. Learn From Industry Leaders!   START NOW

SIGMAPRO MBB, Lean Sigma, & DFSS   when experience matters most...

M O T O R O L A U N I V E R S I T Y Learn from the most experienced practitioners of Six Sigma in the world Public Training & Certification Click here to take a free Six Sigma Lesson

J URΛN   Lean Six Sigma Public Workshops Atlanta, GA - Sept 2008 Become one of your organization's 'vital few'. Get Juran Certified.

Finding that key person for your team is just a click away . . .     TheJobShop jobs.isixsigma.com

LodeStar Institute Affordable Lean Sigma, MBB  Public & On-site Certifications  Raleigh NC -  Green and Black Belt classes as low as $2,495 Sept 22!        >>Learn about LSI specials...

THE UNIVERSITY OF TEXAS AT AUSTIN 2 weeks + 1 project = Black Belt Certification

. Find us on LinkedIn Join the iSixSigma Network and Connect with Other Six Sigma Pros .

. iSixSigma Live! Summit & Awards Jan 13-16, 2009 • Miami, FL Save up to $700 • Click Here! Register by August 14 .

Download the iSixSigma Toolbar for 1-Click access. Search Your Way. Everyday. Without Delay.

BEST SELLING PRODUCTS (iSixSigma Publications) 2008 VERSION! Six Sigma DMAIC Training Slides The complete Lean Six Sigma DMAIC course prepares participants to perform the role of a LSS Black Belt; covering what’s ... Certified Lean Six Sigma Black Belt E-book In 670 pages learn everything within the Lean Six Sigma DMAIC body of knowledge to successfully achieve Black Belt certi... Certified Lean Six Sigma Green Belt Assessment Exam This assessment exam is useful for students interested in assessing their knowledge of Lean Six Sigma on the Green Belt ... Certified Lean Six Sigma Black Belt Assessment Exam Interested in assessing your knowledge of Lean Six Sigma? Preparing for certifications? Testing your students and traine... Certified Lean Six Sigma Green Belt E-book Learn everything within the Lean Six Sigma DMAIC body of knowledge required to successfully prepare for Green Belt certi... 5S Assessment Tool Download this Excel template to assess any work area on their 5S activity. Breaks down assessment into all 5 groups: So... Design of an Operational Risk Management System Project Example Great Lakes Finance Company (GLF), a small Michigan-based retail and commercial lender, experienced several severe opera... Sell Your Products