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Although Six Sigma has its roots in manufacturing, it works just as effectively in service industries. It's no secret that service environments, such as financial organiza

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

tions, healthcare providers, retail companies, and hospitality organizations have a harder time applying Six Sigma principles. However, the core principles of Six Sigma al

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

Examples of combination products may in

ow it to cost-effectively translate manufacturing-oriented Six Sigma tools into the service delivery process.

Service organizations have different root causes of problems

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

and a unique set of processes and metrics. Thus, the tools and methodology required to achieve the improvements of Six Sigma are significantly different. While problems in

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

the manufacturing setting may lie within a process, the issue in a service environment often is the process itself. Service industries are full of waste--and ripe for the

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

Combination pro

enefits of Six Sigma. It is easy to apply relatively simple statistical and lean tools that will reduce costs and achieve greater speed with less waste in service processe

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

. There are numerous case studies that demonstrate how Six Sigma can be used in service organizations just as effectively as in manufacturing-and with even faster results.

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

In a service organization, the critical factors in quality and efficiency are flow of information and interaction between people, especially interactions with customers.

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

ransforming the process of these flows will yield quality results. At the heart of every service business are the opinions, behaviors and decisions made by people. Analyzi

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

g and modifying human performance in service environments is as complex as any manufacturing situation. Six Sigma achieves documented bottom-line strategic business result

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

by initiating an organization-wide culture shift. Until a process focus–rather than a task focus–is developed, the scope and endurance of improvements will be limited. An

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

Following aspects would a

alyzing and modifying human performance in these environments is complex, but Six Sigma provides the tools and methodology required to achieve significant long-term improv

dd to the challenges in developing combination products:

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

ments.

Service managers trained in Six Sigma become skilled at advanced process analysis and problem solving techniques relevant to the “real world” of service environmen

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

s. They learn to identify and eliminate poor decision-making processes, standardize practices, reduce cycle times and manage the risk of the extensive changes required for

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

breakthrough process improvement in people-oriented transactional processes. Successful Six Sigma services projects will lead to improved customer satisfaction, increased

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

rofit margins, reduced costs, and lower turnover. Six Sigma tools can be used in many service environments, even service areas within a non-service industry. Areas such as

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

Professional from academic institutions, pharmaceutical industries, health care indust

procurement, call centers, surgical suites, government offices, R&D, and many more will all receive benefits from implementing Six Sigma process improvement.

Six Sigma wi

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

l help a service environment become a customer-centered organization, gain control over process complexity, and improve response time on signature services.

Peter Peterka

.

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

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

elt.php">Six Sigma Green Belt or other Six Sigma Certification programs contact Peter Peterka

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

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Having a hard time getting balanced performance measures? Let me give you some tips about what having balanced measures really means. And no, it's NOT about adopting the Balanced Scorecard - in fact, it's virtually the opposite!

This paper will examine different management styles and ideas that have come about over the last few decades and examine their effectiveness and relevance to managing a 21st century organisation. It is hoped that the views held and purported by recent business thinkers will be of assistance in understanding the pressures faced by contemporary companies due to the increased competition through the globalisation of modern markets.

This article deal with How to interpret the Eight Quality Management Principles in the ISO9001:2000 revision Quality Management System (QMS). The author will share his encounters how these principles are interpreted and applied in companies he worked with.

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