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Six Sigma is a relatively new concept as compared to Total Quality Management (TQM). However, when it was conceptualized, it was not intended to be a replacement for TQM. Both Six Sigma and TQM h

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

ave many similarities and are compatible in varied business environments, including manufacturing and service industries. While TQM has helped many companies in improving the quality of manufactu

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

Examples of combination products may in

red goods or services rendered, Six Sigma has the potential of delivering even sharper results.

Total Quality Management

Total Quality Management is often associated with the development, deplo

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

yment, and maintenance of organizational systems that are required for various business processes. It is based on a strategic approach that focuses on maintaining existing quality standards as we

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

ll as making incremental quality improvements. It can also be described as a cultural initiative as the focus is on establishing a culture of collaboration among various functional departments wi

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

Combination pro

thin an organization for improving overall quality.

Comparison To Six Sigma

In comparison, Six Sigma is more than just a process improvement program as it is based on concepts that focus on con

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

tinuous quality improvements for achieving near perfection by restricting the number of possible defects to less than 3.4 defects per million. It is complementary to Statistical Process Control (

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

SPC), which uses statistical methods for monitoring and controlling business processes. Although both SPC and TQM help in improving quality, they often reach a stage after which no further qualit

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

y improvements can be made. Six Sigma, on the other hand, is different as it focuses on taking quality improvement processes to the next level.

The basic difference between Six Sigma and TQM is

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

the approach. While TQM views quality as conformance to internal requirements, Six Sigma focuses on improving quality by reducing the number of defects. The end result may be the same in both the

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

concepts (i.e. producing better quality products). Six Sigma helps organizations in reducing operational costs by focusing on defect reduction, cycle time reduction, and cost savings. It is diff

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

Following aspects would a

erent from conventional cost cutting measures that may reduce value and quality. It focuses on identifying and eliminating costs that provide no value to customers such as costs incurred due to w

dd to the challenges in developing combination products:

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

aste.

TQM initiatives focus on improving individual operations within unrelated business processes whereas Six Sigma programs focus on improving all the operations within a single business proce

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

ss. Six Sigma projects require the skills of professionals that are certified as ‘black belts’ whereas TQM initiatives are usually a part-time activity that can be managed by non-dedicated manage

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

rs.

Applications Where Six Sigma Is Better

Six Sigma initiatives are based on a preplanned project charter that outlines the scale of a project, financial targets, anticipated benefits and mile

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

stones. In comparison, organizations that have implemented TQM, work without fully knowing what the financial gains might be. Six Sigma is based on DMAIC (Define-Measure-Analyze-Improve-Control)

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

Professional from academic institutions, pharmaceutical industries, health care indust

that helps in making precise measurements, identifying exact problems, and providing solutions that can be measured.

Conclusion

Six sigma is also different from TQM in that it is fact based and

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

data driven, result oriented, providing quantifiable and measurable bottom-line results, linked to strategy and related to customer requirements. It is applicable to all common business processe

.

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

s such as administration, sales, marketing and R & D. Although many tools and techniques used in Six Sigma may appear similar to TQM, they are often distinct as in Six Sigma, the focus is on the

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

Companies that provide selfless information through particip

strategic and systematic application of the tools on targeted projects at the appropriate time. It is predicted that Six Sigma will outlast TQM as it has the potential of achieving more than TQM

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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