Advice Pool - Self Improvement

In this TQM article, I shall share with you what role can a Team Leader play in order to lead a TQM Team to success. Data Verification is a success factor to TQM Improvement project. This TQM article is a case study of a TQM i

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

mplementation project for Reduction in variable cost. It provides an insights of the importance of Data Verification and the role of the Team Leader to ensure it is done effectively.

Which phase in the D.A.I.C. Improvement Me

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

Examples of combination products may in

thodology call for Data Verification? It is stated in the ANALYZE Phase as in my previous article titled : TQM Implementation Project published on May 13, 2006 02:48:20 pm.

Just to recap, Data Verification is a sub set to

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

l in the Fish-Bone diagram and Why-Why Analysis tools. As both of these tools brainstorm possible causes of a problem, it needed to be verified before any action is taken. This is to ensure the team does not work on something

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

which is not real. Hence Data Verification is carried out to ascertain the possible causes are quantifiable with fact.

I have several discoveries during my hand-holding project. In several occasions, team members confirmed th

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

Combination pro

possible causes based on their memories or past experience. They assumed things would not changed hence confirmed the possible causes as true. Due to this assumption, the team leader, in most cases, consented to the judgment

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

made by the members. Consequently, the team spent unnecessary time on these so called true causes. By the end of the project, the team do not see any improvement result after implemented solution to these true causes.

During

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

a project progress meeting on 18 May 2007, the following conversation were captured. Below are some of the conversion between Team Leader (TL) and the team members(TM) :-

TL: We ought to verify several possible causes as brou

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

ht up during the brainstorming of Fish-Bone diagram one month ago. Team member please report the progress.

TM1: The usage of mild steel nut has been high over the last 6 months. I have checked the usage and it was meant to re

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

place worn out nut.

TL : Did you verify why the replacement quantity was high?

TM1: Yes, the worn out was caused by dirty nut during the work process.

TL: Besides dirty nut, did you investigate what else could cause the nut

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

to worn out?

TM1: Oo... the impact wrench pressure setting was the same for all sizes of nut. Hence, it is over tightened for smaller size nut.

TL: Why is it so?

TM: Because the worker set to the highest pressure.

TL: What

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

Following aspects would a

is the reason for worker to set to the highest pressure?

TM: Worker are not trained.

TL: Naturally, the solution is to provide training for these workers, right?

TM1: Agreed

The Team Leader could have accepted the progres

dd to the challenges in developing combination products:

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

s report and move on. However, after some deliberation, the team leader has decided to witness the situation herself with the team members.

Below are their new discovery:-

1) The usage of nuts was high over the last 6 months

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

2) Most quantity consumed belongs to 3/4 inch size nut

3) 2 out of 6 new nut tested for fitness failed.

4) Impact wrench was set to maximum because the air hose to the wrench leaks which caused weak air pressure.

From the

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

findings, the solutions generated are as follows:-

a) set up quality check on purchased nut;

b) repair air hose;

c) Training worker on pressure setting. This round of decision differs from the initial decision to train the

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

worker.

Summary: When conducting data verification, team cannot rely on past record alone as thing could have changed over time. Team leader has to play a bigger role to ensure the integrity of data verification. If need be,

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

Professional from academic institutions, pharmaceutical industries, health care indust

personally involved to understand the situation based on current state of affair.

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Disclaimer: This article is written by the author based on

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

his practical application 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 us

.

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

of this article 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 a

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

Companies that provide selfless information through particip

s you include 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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