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The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two,

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

it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodo

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

Examples of combination products may in

ogies in tackling the issues.

Six Sigma – A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In

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

oing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption

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

f processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understandin

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

Combination pro

. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided intern

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

ally. This enables the “belts” to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation

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

make the picture clearer and help the “belts” to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond sta

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

dardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful ev

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

nts and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activitie

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

with the vision of the leader of the company. The approach is “how to” rather than “what to” deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates

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

Following aspects would a

on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is

dd to the challenges in developing combination products:

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

on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and qual

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

ty systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, b

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

sed on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and docume

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

t control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given

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

Professional from academic institutions, pharmaceutical industries, health care indust

emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several

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

industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within y

.

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

ur company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business

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

Companies that provide selfless information through particip

ctivity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify

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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