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Digg It - Pros and Cons of Six Sigma
Pros and Cons of Six Sigma
Six Sigma is a business strategy that seeks to identify and eliminate causes of errors, defects or failures in business processes by focusing on outputs that are critical to customers. It is a measure of quality that strives for the near elimination of defects by
Six Sigma is a business strategy that seeks to identify and eliminate causes of errors, defects or failures in business processes by focusing on outputs that are critical to customers. It is a measure of quality that strives for the near elimination of defects by
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
using the application of statistical methods. A defect is defined as anything which could lead to customer dissatisfaction. The fundamental objective of the Six Sigma methodology is the implementation of a measurement-based strategy that focuses on process improvement and variation reducti
; 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
on.
When the Six Sigma approach was introduced to many organizations, the initial reactions included a lot of skepticism, such as:
• It is another quality improvement initiative or flavor of the month
• There is nothing really new in Six Sigma compared to other past quality initiatives
When the Six Sigma approach was introduced to many organizations, the initial reactions included a lot of skepticism, such as:
• It is another quality improvement initiative or flavor of the month
• There is nothing really new in Six Sigma compared to other past quality initiatives
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
• This too shall pass like others
• It is an ‘old wine in a new bottle’
• This won’t work in our business
• We are doing Six Sigma already
• It is nothing more than a hype
• It is not for us as Six Sigma requires complicated statistical methods However, the following aspects of the Si
• It is an ‘old wine in a new bottle’
• This won’t work in our business
• We are doing Six Sigma already
• It is nothing more than a hype
• It is not for us as Six Sigma requires complicated statistical methods However, the following aspects of the Si
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
x Sigma approach were not accentuated in previous quality improvement initiatives:
• Six Sigma strategy places a clear focus on achieving measurable and quantifiable financial returns to the bottom-line of an organization. No Six Sigma project is approved unless the bottom-line impact has
• Six Sigma strategy places a clear focus on achieving measurable and quantifiable financial returns to the bottom-line of an organization. No Six Sigma project is approved unless the bottom-line impact has
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
been clearly identified and defined.
• Six Sigma strategy places an unprecedented importance on strong, passionate leadership and the support required .for its successful deployment
• Six Sigma methodology of problem solving integrates the human elements (culture change, customer focus, b
• Six Sigma strategy places an unprecedented importance on strong, passionate leadership and the support required .for its successful deployment
• Six Sigma methodology of problem solving integrates the human elements (culture change, customer focus, b
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
elt system infrastructure, etc.) and process elements (process management, statistical analysis of process data, measurement system analysis, etc.) of improvement.
• The Six Sigma methodology utilizes the tools and techniques for fixing problems in business processes in a sequential and di
• The Six Sigma methodology utilizes the tools and techniques for fixing problems in business processes in a sequential and di
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
ciplined fashion. Each tool and technique within the Six Sigma methodology has a role to play and when, where, why and how these tools or techniques should be applied is the difference between success and failure of a Six Sigma project.
• Six Sigma emphasizes the importance of data and dec
• Six Sigma emphasizes the importance of data and dec
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ision making based on facts, rather than assumptions and hunches! Six Sigma forces people to put measurements in place. Measurement is considered as a part of the culture change…What gets measured, gets done!!
Just like any other quality improvement initiative we have seen in the past, Six
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
Sigma has its own limitations. The following are some of the limitations of the Six Sigma approach, creating future opportunities for research:
• The challenge of having access to quality data, especially in processes where no data is available to begin with (sometimes this task could ta
• The challenge of having access to quality data, especially in processes where no data is available to begin with (sometimes this task could ta
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ke the largest proportion of the project time)
• The right selection and prioritization of projects is one of the critical success factors of a Six Sigma program. The prioritization of projects in many organizations is still purely subjective. Very few tools exist for prioritizing projects
• The right selection and prioritization of projects is one of the critical success factors of a Six Sigma program. The prioritization of projects in many organizations is still purely subjective. Very few tools exist for prioritizing projects
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
and this should be the major thrust for future research.
• The statistical definition of Six Sigma is 3.4 defects or failures per million opportunities. In service processes, a defect may be defined as anything which does not meet customer needs or expectations. However, it would be illo
• The statistical definition of Six Sigma is 3.4 defects or failures per million opportunities. In service processes, a defect may be defined as anything which does not meet customer needs or expectations. However, it would be illo
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
gical to assume that all defects are equally bad. For instance, a defect in a hospital could be a wrong admission procedure, misdiagnosis, misbehavior of staff members, unwillingness to help patients when they have specific queries, etc. Assumption of 1.5 sigma shift (standard improvement)
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
for all business processes does not make much sense. This particular issue should be dealt with extra caution as a small shift in sigma could lead to erroneous defect calculations.
• Six Sigma can easily digress into a bureaucratic exercise, if the focus is on such things as the number of
• Six Sigma can easily digress into a bureaucratic exercise, if the focus is on such things as the number of
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
trained Black Belts and Green Belts, number of projects completed, etc. instead of bottom line savings.
• There is an overselling of Six Sigma by too many consulting firms. Many of them claim expertise in Six Sigma when they barely understand the tools, techniques and the Six Sigma roadma
• There is an overselling of Six Sigma by too many consulting firms. Many of them claim expertise in Six Sigma when they barely understand the tools, techniques and the Six Sigma roadma
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
p.
• The relationship between Cost of Poor Quality (COPQ) and Process Sigma Quality Level requires more justification.
What does the future hold for Six Sigma?
In my opinion, Six Sigma will be around as long as the projects yield measurable or quantifiable bottom-line results in monetary
• The relationship between Cost of Poor Quality (COPQ) and Process Sigma Quality Level requires more justification.
What does the future hold for Six Sigma?
In my opinion, Six Sigma will be around as long as the projects yield measurable or quantifiable bottom-line results in monetary
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
or financial terms…when Six Sigma projects stop yielding bottom-line results, it might disappear.
One of the real dangers of Six Sigma is to do with the capability of Black Belts (the so called technical experts) who tackle challenging projects in organizations. We cannot simply assume th
One of the real dangers of Six Sigma is to do with the capability of Black Belts (the so called technical experts) who tackle challenging projects in organizations. We cannot simply assume th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
at all Black Belts are equally good. Another danger is the attitude of many senior managers in organizations that Six Sigma is “an instant pudding’, solving all their ever-lasting problems.
I would like to accentuate the point that Six Sigma does provide an effective means for deploying
.
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
and implementing measurement based thinking based on the following three rudimentary principles:
• All work occurs in a system of interconnected processes
• Variation exists in all processes, and
• The Variation in processes can be measured and controlled
The above principles of statist
• All work occurs in a system of interconnected processes
• Variation exists in all processes, and
• The Variation in processes can be measured and controlled
The above principles of statist
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
ical thinking within Six Sigma are robust and it is fair to assume that Six Sigma will continue to grow in the next few years. However the total package may change in the evolutionary process and Six Sigma will probably be supplanted by a new business management approach in the near future
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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