Advice You - Business

Six Sigma is powered by principles which are governed by continuous improvement. In pure terms, Six Sigma helps manufacturing organizations reduce the number of errors or reduce the number of defective products manufactured by them.

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

This is achieved by a regular sharpening of the process and constant monitoring on processes and how they can be improved.

However, Six Sigma today has moved on from the manufacturing realm of business and is also very much a part

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

Examples of combination products may in

of the services industries where the spirit of the process is lauded. Constant improvements are sought in almost all industries today. A reason for the phenomenal success of this business process and quality management and practice

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

as been the short term and long term impact it has on bottom line of the business.

Six Sigma is not a process which begins to show results only over a long period of time or results which can only be measured by abstract measuremen

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

s. In fact its results can be measured right away by the reduction in the number of faulty products, reduction in returns from customer and reduction of useless inventory. A before and after the Six Sigma implementation can easily h

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

Combination pro

ghlight the benefits to the organization. If you are new to this concept and have only heard about it on the passing, here are some vital answers to frequently asked queries:

What does it take to implement Six Sigma in an organizat

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

on?

It takes phenomenal operational efficiency and discipline as well as organizational leadership to implement Six Sigma. Since the concentration of the manufacturing process has to be reducing the number of defects or defective p

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

roducts, each process has to be scrutinized closely and amended to work towards this goal. In-house champions make this quality conscience-ness possible as it is not possible for all processes and involved managers to be highly qual

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

ty conscience. Technology is also a great enabler in the implementation of Six Sigma as it helps reduce faults to a large extent.

A number of professionals are required to be employed to be able to implement this business process i

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

provement method in an organization. There are individuals who have in-depth knowledge about the principles of Six Sigma as well as manufacturing processes (some even have specialized working knowledge pertaining to some specific in

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

ustries such as automobiles, aircrafts, etc).

Achieving Six Sigma certification in your organization requires you to execute one project completely in the recommended process. Documenting the process and training existing business

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

Following aspects would a

nd manufacturing heads forms a large part of the implementation of Six Sigma processes. An organization also requires investments within the company by way of people, man hours, machine hours, technology etc to implement Six Sigma.

dd to the challenges in developing combination products:

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

Getting familiar with the nomenclatures of Six Sigma:
The Total Quality Management process of Six Sigma has gained popularity over the past few years specially as businesses have become more quality conscience and as manufacturin

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

processes become more complicated. The key industries implementing Six Sigma are Healthcare, Banking, Insurance and Construction. The two prominent methodologies are DMAIC (Define Measure Analyze, Improve and Control ) and DMADV (

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

Define, Measure, Analyze, Design and Verify). There is also operational hierarchy when it comes to Six Sigma. Apart from the senior Management, there are Champions, Master black belts, Black Belts and Green Belts who have a predefin

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

d role in the implementation of Six Sigma in the organization.

If the benefits are so prominent, why are more companies not implementing Six Sigma?
Six Sigma has not changed much from the time it was put together way back in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

1980s. The success factor has been the absolute number of achieving 3.4 defects per million products which is phenomenal. Even with this measurement, Six Sigma has largely remained a territory for the large companies and very few sm

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

ll to medium enterprises have ventured in this direction. The primary reason has been the cost of implementing this process is very prohibitive. The man power resources required to manage the process is equally difficult.

Some orga

.

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

izations which are very convinced about this quality management procedure adapt something called the Lean Six Sigma. The Lean Six Sigma has the same spirit but lesser number of defines processes and steps and is quite suited for sma

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

Companies that provide selfless information through particip

ler organizations.

Six Sigma which started at Motorola can be found as an initiative in most large quality conscience organizations which have a commitment ot quality and a vision for better products and services to their customers

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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