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Assessing Six Sigma is not end-of-the-process post implementation, although an analysis of a failed Six Sigma project points out the lack of commitment by upper m

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

anagement and lack of attention to the cultural and business investment required for accomplishing and sustaining new tiers of performance. It is in this context

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

Examples of combination products may in

that assessment of Six Sigma becomes necessary, especially when new attempts by companies on improvement projects, reveal that the journey will be long and hard.

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

Assessing The Different Implementation Stages of Six Sigma

The key to the success of Six Sigma implementation lies in assessing the status quo at various stages

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

. Assessments reveal the deviations the implementation efforts have taken from the intended line of progress. As the deployment of Six Sigma is signified by empha

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

Combination pro

sis on accomplishing benchmarks in process optimization and control to render progressively higher degrees of quality, performance efficiency and timeliness, a sy

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

stem of assessment needs to be inbuilt which puts in place an appropriate set of checks and balances.

Six Sigma Assessment Procedures

There has not been a singl

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

e assessment procedure either devised or used by any one company which applies to all processes and industries. Companies successful at their Six Sigma implementa

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

tion have developed and adopted their own assessment procedures. Some of them have used their own internal audit teams with their own criteria to assess the progr

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

ess of Six Sigma implementation. Even using the audit procedures developed by Malcolm Baldrige Quality Awards is not new and unique. Many Six Sigma companies have

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

actually gone ahead with evolving a custom developed audit system based on ISO 9000.

The Assessment Categories in Six Sigma

The fundamental premise of assessme

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

Following aspects would a

nt in Six Sigma is identifying and reading the gaps between ‘as is’ and ‘should be’ conditions of the process stages. The ‘should be’ list of conditions is what i

dd to the challenges in developing combination products:

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

s established at the beginning of the deployment described in great length for each category. The categories for assessment are listed below:

1. Leadership

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

2. Communication and Implementation in Everyday Activities
3. Project Effectiveness and Efficiency
4. Organizational Transformation
5. Customer Imp

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

act

The requirements of these top level categories are the customized topics needed for achieving overall objectives. The method of assessment contains written t

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

ests and interviews starting with top level managers down to line employees, in addition to meetings and seminars.

The overall results are shown as applicable to

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

Professional from academic institutions, pharmaceutical industries, health care indust

the core business process. The results of leadership assessments that show possible areas for improvements are essentially helpful in chalking out a course corre

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

ction plan. The results also show weaknesses that are to be assessed as the first step toward fine tuning the exercise for needed changes.

The need for assessmen

.

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

t may be fulfilled whenever it is warranted. In the normal course, where the results take 4-6 months to show, the assessment can be scheduled as an annual exercis

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

Companies that provide selfless information through particip

e. Experience from successful implementation of Six Sigma has shown that major roadblocks in changing an organizational mind set lies in sustaining the gains made

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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