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As indicated in my previous TQM article titled: TQM Implementation Project published on May 13, 2006 02:48:20 pm, In my last article Part 3a, I have shared issues pertaining to Data Collection, Trend Chartin

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

g and Pareto Analysis. In this article, I will deal with Fish-bone Diagram and Why-Why Analysis in the D.A.I.C. Methodology.

Just to recap, tools used in the ANALYZE Phase are:

Data Collection | Trend

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

Examples of combination products may in

Charting | Pareto Analysis | Fish-Bone Diagram | Why-Why Analysis

Case Study in Fish-bone Diagram

Once the Pareto Analysis is completed, team have an idea what are the main contributors to the m

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

terial lost based on the 80/20 rule of Pareto Analysis. However, this only provide information that is limited to contributing factors to material loss but it does not give a clue what causes it.

A Fish-Bond d

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

iagram would be used to collate possible causes to the contributing factors to material loss. This is done using brainstorming of the common 4M namely; Man, Machine, Method and M

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

Combination pro

/b>aterial as a guide. Once it is completed, team needs to verify all those contributing factors are indeed truly happened. This is done using a verification table which has to identify verification method, its f

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

inding. Members took time to verify with the findings whether the possible cause is true or false

How to overcome Fish-Bone Diagram Issue

Nromally, there is no major issue with the Fish-bone Diagram. Most

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

f the problem faced with team are the accuracy of the verification because findings from verification is not conclusive and at time do not support whether it is true or false.

To overcome some of this verification

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

problem, team need to consider using data to support the verifications. It can be taken from Pareto Analysis, run a control lot, take a sample etc instead of using Brainstorming. The reason is that these methods

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

re drawn from data, hence it must be true. Then further verification is not needed.

Case Study in Why-Why Analysis Issues

Once the contributing factor in the fish-Bone is confirmed true, Why-Why Analysi

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

s is performed to find out the root cause to the contributing factors. There are several issues arisen from this step. Some of them are :- 1) Member does not know when to stop asking why?

2) Members find it

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

Following aspects would a

difficult to link each level of why question

3) Member quote the consequence rather than the cause

4) Members tend to quote recent incident encountered as the root cause

5) Most commonly, member quote corrective

dd to the challenges in developing combination products:

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

action as the root cause

How to overcome Why-Why Analysis Issues

This is the most difficult tool to master. Not only member must know the logical sequence of asking why, to structure the question itself i

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

s challenging. One of the guide to use this tool is to asked the immediate cause. Example: Why is he late to work? Answer is : His car broke down half way on the road. Instead of answer as He woke up late in th

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

morning.

In summary, this ANALYZE Phase is the most crucial phase which team members need to analyze the right root cause of the possible cause hence lead to the root cause of the problem. With this root cause i

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

dentified, then corrective action to be taken. In my next article, I will continue to share the problem faced with the IMPROVE Phase of the D.A.I.C. Improvement Methodology. I welcome readers feedback how el

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

Professional from academic institutions, pharmaceutical industries, health care indust

e I could present these articles.

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Disclaimer

All rights reserved. This article is written by the author based on his practical application

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

experience. All definitions and interpretation of terminology are his point of view and has it has no intention to conflict with experts in similar topic. The author holds no responsibility for the use of this arti

.

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

le in any way.

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Free to reprint or re-publish

All rights reserved. You are free to reprint or re-publish this article as long as you includ

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

Companies that provide selfless information through particip

e my resource box at the end of this article. Please ensure that the URL in the resource box remain intact and it is linked to the author's website.

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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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Digg It - TQM Implementation Project Part 3b - The Analyze Phase, How To Overcome Issues

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