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Digg It - 5 Laws Of Lean Six Sigma
Thinking about how Six Sigma and Lean Manufacturing work well together despite being distinct, independent and complete tools? The combined princ
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
iples gel so well that they compliment each other and progress parallels to each other on a well-defined path. The paths are defined by the 5 Law
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
s of Lean Six Sigma as we know today.
5 Laws of Lean Six Sigma
The 5 laws have been formulated in order that efforts on improving quality and b
5 Laws of Lean Six Sigma
The 5 laws have been formulated in order that efforts on improving quality and b
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
siness process aimed at improving customer satisfaction and ROI as primary concerns. The 5 laws have evolved over time and are a collection of ke
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
y ideas derived both from Lean Manufacturing and Six Sigma.
1. The Zeroth Law: The first law is called so because all other principles are built
1. The Zeroth Law: The first law is called so because all other principles are built
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
upon this fundamental one. It States that the Law of the Market - Customer Critical to Quality defines quality and is the highest priority for im
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
provement, followed by ROI (Return on Investment) and Net Present value.
2. The First Law: This is called as The Law of Flexibility. It states t
2. The First Law: This is called as The Law of Flexibility. It states t
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
at the velocity of any process is proportional to the flexibility of the process. Interpretation: the more the process is receptive and flexible
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to adopt changes, the better the progress of the project implementation is.
3. The Second Law: The second law is known as The Law of Focus - it
3. The Second Law: The second law is known as The Law of Focus - it
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
s defined as 20% of the activities in a process cause 80% of the delay. This can be interpreted as main causes of delay of activities originating
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
from just 20% of activities thus enables a faster refocus during the reorientation phase.
4. The Third Law: The Law of Velocity as the third la
4. The Third Law: The Law of Velocity as the third la
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
w is known is stated as the velocity of any process is inversely proportional to the amount of WIP. This is also called "Little's Law". This expl
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ins how the inertia of WIP, Work in Progress, bears heavily on the velocity of project implementation. Higher the number of works in progress (re
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ad unfinished tasks) the lower is the speed of progress due to various ground level handicaps
5. The Fourth Law: The Fourth Law, which is the la
5. The Fourth Law: The Fourth Law, which is the la
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
t of the 5 laws of lean Six Sigma, is defined as The complexity of the service or product offering adds more non-value, costs and WIP than either
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
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
poor quality (low Sigma) or slow speed (un-Lean) process problems. The bulky nature of products is against the foundation of Lean Manufacturing
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rinciples. The bulk, complex manufacturing process and product and service specifications contributes to render the offerings redundant. As an il
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lustration to this 4th Law of lean Six Sigma, you can try and reason out why passenger cars are more and more becoming driver friendly despite th
.
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
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
ir complex engineering features and functions.
You can revisit the definitions of Six Sigma and Lean Manufacturing principles which emphasize el
You can revisit the definitions of Six Sigma and Lean Manufacturing principles which emphasize el
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
iminating process errors and variations. It also concentrates on efforts to invest less human labor, inventory, and time for product development
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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