Digg It - Business

Lean Six Sigma combines the quality improvements that come from using Six Sigma with the speed improvements that come from using Lean manufacturing principles . Six Sigma is a disciplined, data-driven approach and methodology f

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

or eliminating defects in any process -- from manufacturing to transactional and from product to service. Lean manufacturing focuses on improving the speed of a process and the elimination of waste primarily by eliminating non-

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

alue added steps. Lean Flow and Six Sigma are strongly compatible. Combining these two powerful process improvement methods are combining the contents of two toolboxes that can help your organization improve quality and efficie

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

cy.

Lean Six Sigma and Lean Flow initiatives go by many names, including Lean Enterprise, Lean Manufacturing, Lean Sigma, and Lean Service. These concepts are a natural complement to Six Sigma and can be applied to every type

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of business and process. Both Lean and Six Sigma have points of commonality in their strategies and methods. Both are built around the idea that businesses are composed of processes that serve customer needs. They share the go

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

l to identify and eliminate sources of waste and activities that do not add value, in order to create flow with maximum productivity, capacity, and throughput. Both place great emphasis on training to bring members of an organi

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ation to a high level of understanding and expertise on the tools and processes of the methodology. Also, both lean and Six Sigma require and encourage the engagement of management and key mentors within the organization to ass

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

re that the prioritized projects are executed as part of a way of doing business.

Lean methods and data are used to reduce costs, shorten cycle times, expand capacity, and improve productivity. Lean concepts and the Lean Flow

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ystem quickly identify improvement opportunities through the use of value stream mapping. Lean emphasizes all-encompassing principles together with targeted recommendations to achieve improvements. However, Lean principles are

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ftentimes inadequate to solve some of the more complicated problems that require advanced analysis.

Because Six Sigma requires in-depth statistical metrics to analyze quality at all levels of the supply chain, eliminating defe

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ts it can improve all Lean methods. Six Sigma – when combined with Lean – allows for easier identification and quicker resolution of quality issues or problems, and reaps quick results while opening people's eyes to new and bet

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ter possibilities on plant floors. Six Sigma's core implementation strategy of establishing dedicated Six Sigma champions and black belts who oversee and mentor process improvement projects provides crucial structure and guidan

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e, thus greatly enhancing Lean initiatives. Therefore, Six Sigma is very valuable when introduced during the deployment of Lean principles to ensure that the improvement roadmap includes a generic problem-solving approach.

Lea

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Six Sigma creates greater understanding of the value of your work by defining it as something that your customers want to pay for. Lean Six Sigma helps build customer loyalty by driving improvement in areas most important to y

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ur customers. Its metrics generate clear targeting of customer needs, and drives real, tangible value creation.

Lean Six Sigma is a highly sustainable approach that becomes woven into the fabric of the organization and involvi

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

g people at all levels - from the executive suite to the front line. Full deployment of Lean Six Sigma will f oster an environment of continuous improvement where the cultural norm of your organization becomes striving for the

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

otal elimination of waste through a succession of small, action-oriented ( kaizen ) events within the production process.

Lean Six Sigma fulfills your overall strategy and future success by significantly improving quality and

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

educing waste. It empowers every employee with new ways of thinking about your processes and helps make drastic improvements to the organization's performance. Lean Six Sigma creates a powerful linkage from your strategic prior

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ties to operational improvements and facilitates the transformation of a business.

Peter Peterka is President of Six Sigma us. For additional information on

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

f="http://www.6sigma.us/dmaic-step-zero-leadership.php">DMAIC or other Lean Six Sigma project programs contact Peter Peterka http://www.6sigma.us

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/23563/diggit-What-is-Lean-Six-Sigma.html">What is Lean Six Sigma</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23563/diggit-What-is-Lean-Six-Sigma.html]What is Lean Six Sigma[/url]

To accentuate your business brochures you need to think professionalism. Believe it or not if you are too professional and a small business and you have spent too much on your brochures making them look corporate and slick some customers are afraid to do business with you because they think the prices are too high.

If you're a top sales or marketing professional working in the business to business technology, manufacturing, healthcare or business services industries, I've got some advice for you on how to best go about optimizing your career search. I'm also going to talk about the job market now and the new way of looking for great positions which or often times not advertised. I'll also give you a number of other tips and tricks regarding interviewing, resume building techniques, and other useful ideas that I hope you will put to work in order to improve your ability to find that next great position that you’re thinking and dreaming about.

Even something seemingly as basic as making sure my customer service phone line gets answered used to be a logistical nightmare for me -- until I started using a live answering service.

Tags

Links

Digg It - What is Lean Six Sigma

Related Articles: