Lean Six Sigma and Process Analytical Technology (PAT)

According to the iSixSigma article:

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

Read more…

From the definition alone, it’s quite obvious that it is a perfect fit with Lean Six Sigma. Because like PAT, Lean Six Sigma:

1. breaks down processes to make them more manageable
2. works toward streamlining processes to reduce waste or risk
3. encourages and supports innovation
4. improves processes to achieve efficiency

Care to add to the list of reasons?

Filed under: Lean Six Sigma, Processes, Pharmaceuticals, Innovation, Six Sigma, Productivity, PAT

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Strategies in Developing a Comprehensive Lean Six Sigma Culture

Would you like to learn strategies in developing a comprehensive Lean Six Sigma culture?

Then you shouldn’t miss the 6th Lean Six Sigma Pharmaceutical, Biotech, and Medical Device Excellence. You will hear practical and real-life accounts from big reputable companies.

Pfizer, Amgen, Johnson & Johnson, Abbott, Bristol-Myers Squibb Company, and others will explain their strategies in developing a comprehensive Lean Six Sigma culture.

Industry-leading companies including Baxter, Gen-Probe, Wyeth, Medtronic and Pharmatech Associates will share their insights on Lean Six Sigma at the LSS 2008 conference.

This year’s event features best methods in: Adapting approaches for deploying Lean Six Sigma into the organizational culture and environment, streamlining account payable processes with lean tools and techniques, and developing effective metrics to measure and improve the Lean Six Sigma culture within the organization.

Read more…

Filed under: Lean Six Sigma, Six Sigma Organizations, Pharmaceuticals, Johnson & Johnson, Six Sigma

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Six Sigma at McKesson Corp.

McKesson Corp., the largest pharmaceutical distributor in the U.S., is using the latest technology and Six Sigma to be ahead of the pack.

McKesson’s EVP and CIO, Randall N. Spratt shares with WSJ how his company is using technology to make its operations more efficient, to improve health care and to create a better environment for the company’s workers, dispelling the impression that many healtcare companies lag in terms of technology use.

This is how the interview started.

WSJ: McKesson makes 1.5 cents for every dollar it takes in on its distribution business, so efficiency is critical. Not surprisingly, the company relies on technology to make its warehouse operations more efficient. What is the process you go through to determine what technology might help?
Mr. Spratt: We have a large investment in a process-improvement methodology called Six Sigma. We employ somewhere north of 100 Six Sigma professionals, whose job is to take apart business processes. It could be as small as taking something off a truck and putting it on a shelf, or it could be as broad as what happens from the time we take an order to the time we ship an invoice. What they are trained to do is take a given business process, analyze it and take it apart to find where the highest variability is.

WSJ: One technology that McKesson developed is a small computer that warehouse workers wear on their wrists and that is attached to a scanner on the worker’s finger. How did you come up with this system and what has it accomplished?
Mr. Spratt: It came from a Six Sigma analysis. Most errors in the warehouse came at the point of picking, which is taking something off a warehouse shelf, associating it with an order, and putting it in the right bin for shipping. The second-highest error rate came from stocking errors. If you stock a drug in the wrong place, the pickers have to search for it and they waste a lot of time. So they sat down and said how can we solve these problems.
Continue reading…

It’s pretty obvious that McKesson is trying to combine modern technology and Six Sigma. If they are able to do this successfully, then they’ll be a force to reckon with in the pharma/healthcare industry.

Source:
SmartBrief News

Filed under: Six Sigma Organizations, Deployment, Healthcare, Interview, Pharmaceuticals, Technology, Six Sigma

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Lean Six Sigma in the Pharma and Biotech Industries

Lean is all about speed and streamlined processes and Six Sigma has the statistically sound methods and tools. From these merits alone it is not surprising that Lean Six Sigma will find its way to the pharma and biotech laboratories.

True enough, Lean Six Sigma can put the quality into the process of drug discovery and development. As Narendra Soman said,

With steadily increasing R&D costs, lagging productivity, and the continuing need to adopt, implement, and integrate novel processes and technologies, the pharma and biotech sectors are well-positioned to benefit from the advantages that Lean Six Sigma has to offer. Its robust, statistically sound methods and tools will help these industries conserve resources, optimize protocols and processes, and streamline operations. This structured approach complements the U.S. Food and Drug Administration’s process analytical technology initiative published in 2003 to design quality into drug products, rather than test quality into final dosage forms. Over time, Lean Six Sigma will become a seamless and critical operational strategy that will enable lasting change and significant improvements in efficiency and productivity.

Read more…

If anything else, this makes me feel a lot better. If only we could also apply Lean and Six Sigma to the practice of medicine. We can surely avoid, if not eliminate, what we call medical malpractice.

*Photo from Stock.Xchng

Filed under: Lean Six Sigma, Deployment, Healthcare, Inventory, Pharmaceuticals, iSixSigma, Lean Manufacturing

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DFSS for Recruiting Process Design

Let me share with you today case study that illustrates how a pharmaceutical company applied selected DFSS (Design for Six Sigma) tools to develop a new recruiting process for sales representatives.

Tools and activities are described along the IDOV (Identify, Design, Optimize, Verify) phases, which served as a guiding roadmap through this process design project.

Read the case study here.

More: DFSS - IDOV Methodology

Source: iSixSigma Europe Channel

Filed under: Tools/Toolkits, Manufacturing, Deployment, Six Sigma References, Processes, Pharmaceuticals, iSixSigma, DFSS

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Lean and Six Sigma Conferences @ GoingToMeet.com

GoingToMeet.com has featured relevant Six Sigma conferences for you. Below are the ongoing and upcoming events on Lean and Six Sigma. Hope you can join in one of them.

Filed under: Lean Six Sigma, Healthcare, Events/Announcements, Pharmaceuticals, Mining, Defense

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Six Sigma Reference: Sanofi-Aventis Pharma, A Case Study

Western pharmaceuticals companies are now being challenged by Asian—particularly, India and China—pharmaceuticals that are making significant headway in the field. The Asian companies have an edge in terms of low labor cost and minimal environmental requirements. Thus, the Western companies have to rethink their strategies. Many of them are now using Six Sigma to accomplish their new corporate strategies and face head on among other things, the Asian challenge.

Sanofi-Aventis, one of the world’s leading pharmaceuticals, is one of the Western companies that have embraced the Six Sigma methodology and have run their processes using DMAIC. Through Six Sigma, Sanofi-Aventis sped up run times and increased cost savings.

Dr. Ingolf Stückrath, who joined Sanofi_Aventis in 2000 as assistant plant manager, became Six Sigma Black Belt in 2002, headed the Six Sigma deployment at the Frankfurt Biotechnology site, and went on to become Six Sigma Master Black Belt.

Dr. Stückrath shares their Six Sigma deployment in a case study. In a nutshell, this is how the Six Sigma implementation goes:

1. Training, facilitated by Motorola, of employees to be Six Sigma Black Belts.
2. Broadening of Six Sigma activities by incorporating Lean Six Sigma Tools.
3. Boost of the morale of employees when they saw Six Sigma as part of their job to continuously improve processes. Six Sigma has pervaded the whole organization as employees took ownership of the initiative and got rewarded by their efforts.
4. The result: Sanofi-Aventis’ Frankfurt Biotechnology site is always ready to conquer all future business challenges.

Update:

Over at PharmaManufacturing.com, there’s a good discussion on the pathway to continuous improvement. It tells about how continuous improvement initiatives, such as Six Sigma, are increasing efficiency and productivity, and reducing cycle and setup times in manufacturing at pharmaceuticals.

Filed under: Manufacturing, Lean Six Sigma, Training, Team Dynamics, Deployment, Healthcare, Pharmaceuticals, DMAIC, Sanofi-Aventis

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Six Sigma News Round-up

For today’s Six Sigma news round-up, we’ll see some movements.

Alton D. Johnson has been appointedGeneral Manager of Dallas Airmotive’s Premier Turbines division in Neosho, Missouri. He will be responsible for the day-to-day operations and P&L for the engine repair and overhaul facility. A licensed A&P mechanic, a Six Sigma Green Belt and certified in Kaizen and Lean flow process manufacturing, Johnson has an extensive experience in operations and personnel management, having worked for GE and US Army Aviation.

Cindy Cullen is now Chief Technology Officer of SAFE-BioPharma Association. She will oversee and administer all aspects of technology for SAFE-BioPharma and will be the Chief Systems Architect for SAFE. Cullen is a CISSP (Certified Information Systems Security Professional), CISM (Certified Information Security Manager) and SSBB (Six Sigma Black Belt).

Ingersoll Rand has chosen PowerSteering for enterprise-wide Project Portfolio Management comprising multiple strategic initiatives. Once implemented PowerSteering will deliver business benefits such as corporate information technology, shared services PMO, enterprise innovation, and Lean Six Sigma.

Source: iSixSigma.com

Filed under: Lean Six Sigma, Human Resource, Events/Announcements, Pharmaceuticals, iSixSigma, US Army Aviation

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Six Sigma and TAGSYS

TAGSYS, the global leader in item-level RFID systems and tags, has announced that they are launching a Six Sigma Performance Program initially for pharmaceuticals. The program guarantees no more than four failures per million reads for high frequency (13.56 MHz) passive RFID tags used for item-level pharmaceutical product tracking.

With this new program, TAGSYS is hopeful it will bring in new confidence in RFID quality-of-service (QoS) that pharmaceutical companies need for large-scale deployments.

The service is initially for the pharmaceutical industry to facilitate track-and-trace applications, but it could be expanded to other industries. Jordon cited the results Cardinal Health released last year from its UHF Gen2 item-level tagging pilot as an example of how low performance expectations are a barrier to adoption (see Pharmaceutical RFID Pilot Finds Promise, Problems). Cardinal said it learned a lot from its pilot and considered the program a success, but attained a top item-level read rate of 99.5 percent for one operation and a low of 7.8 percent for another. Case-level read rates ranged from 76.3 to 100 percent.

Read more about TAGSYS RFID Six Sigma Performance System…

Source:
RFID Update, “TAGSYS Guarantees Six Sigma RFID Performance” with the link provided by Six Sigma Zone

*Photo credit: RFID Journal

Filed under: Manufacturing, Software/Technology, Pharmaceuticals, RFID

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Six Sigma News Round-up

With Six Sigma, much has happened in the last couple of days. For this round-up, we visit two of the top news sources for Six Sigma.

First is iSixSigma. Blackstone’s private equity group has a new executive director. Ravi Ramanan will help work on improving productivity through continuous improvement. Ravi has worked for Solectron Corporation and General Electric, and being a certified Black Belt and Master Black Belt in Six Sigma, he will definitely be an added value to Blackstone.

Michael Marx, research manager of iSixSigma magazine, released the fourth annual iSixSigma Global Salary Survey. The results reflect salary and bonus data from more than 2,500 Six Sigma professionals around the globe currently employed in a full-time Six Sigma role. Check it out here and find out if you’re receiving what you should be receiving.

Next is news from Six Sigma Zone. Washington Hospital Center Labs goes lean. Washington Hospital Center, part of MedStar Health, has begun a systemwide Lean initiative, including the WHC Department of Pathology & Laboratory Medicine (Washington, DC). In 2002, they began Six Sigma and in 2005 started Lean.

The last in this round-up is about Angiotech Pharmaceuticals, Inc. appointing Victor Diaz as Senior Vice President for Global Manufacturing & Supply Chain Management. With his experience and skills, Victor will bring in his solid background in global manufacturing, Six Sigma, procurement, distribution, supply chain, lean manufacturing, inventory management, ISO and FDA regulations and compliance.

Filed under: Benefits and Savings, Lean Six Sigma, Six Sigma Organizations, Healthcare, Events/Announcements, Processes, Pharmaceuticals

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