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Digg It - Continuous Improvement: The Lean Six Sigma Left-Right Punch
1. Why Lean Six Sigma?
I guess before we talk of the “why” of Lean Six Sigma, we should briefly address the “what”.
Lean operations consist as much as possible of only value added activities: “Lean” aims to eliminate all waste in the work place. The outcome is that your operations become high-speed and low-cost.
“Si
I guess before we talk of the “why” of Lean Six Sigma, we should briefly address the “what”.
Lean operations consist as much as possible of only value added activities: “Lean” aims to eliminate all waste in the work place. The outcome is that your operations become high-speed and low-cost.
“Si
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
x-sigma” focuses on achieving consistent product and service quality by eliminating sources of variation.
“Lean Six-sigma” is the fusion of these approaches to achieve high speed, low cost and defect free operations, with products and services that delight the customer and guarantee profitability for the business. It is nece
“Lean Six-sigma” is the fusion of these approaches to achieve high speed, low cost and defect free operations, with products and services that delight the customer and guarantee profitability for the business. It is nece
; 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
ssary because each by itself is deficient. For instance Lean does not recognise the impact of variation nor does it explicitly seek customer input. Six-sigma incorporates customer viewpoints via the Voice of the Customer tools but fails to specifically identify waste.
2. Lean Concepts: Pull, WIP and Value-Added
The b
2. Lean Concepts: Pull, WIP and Value-Added
The 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.
asis of the lean approach is that we produce only what is required just when it is needed (leading to the term “Just-In-Time”).Lean accelerates the velocity of a process by reducing all forms of waste.
Pull:
The idea is that the work done in a process should be driven entirely by customer demand. Each step in the pro
Pull:
The idea is that the work done in a process should be driven entirely by customer demand. Each step in the pro
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cess commences only when there is a signal from downstream indicating that an item has exited the process. Implementing a pull system eliminates overproduction and reduces the need for inventory.
WIP:
Work in process represents the number of things waiting to be worked on. The speed of the process is inversely propor
WIP:
Work in process represents the number of things waiting to be worked on. The speed of the process is inversely propor
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tional to the amount of work in process.
Lead time = Work in process/Completion rate
Given a desired lead time and a known completion rate (obtained from observation), the allowable work in process can be calculated.
Value Added:
This concept has been discussed in our previous articles. Only work which adds
Lead time = Work in process/Completion rate
Given a desired lead time and a known completion rate (obtained from observation), the allowable work in process can be calculated.
Value Added:
This concept has been discussed in our previous articles. Only work which adds
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
features for which the external customer is ready to pay is value added. A second category of work necessary to satisfy an internal customer or regulatory requirements is known as organisational value added. All others (rework, multiple approvals, unnecessary movement etc) are non-value added.
A measure of the degree of valu
A measure of the degree of valu
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
addition is process cycle efficiency.
PCE = Value added time/Total lead time
In many instances, PCE especially in service situations is below 10% and represents huge opportunities for improvement.
3. Six Sigma Concepts: Variation and Process Capability
Six-sigma eliminates variation by removing the special
PCE = Value added time/Total lead time
In many instances, PCE especially in service situations is below 10% and represents huge opportunities for improvement.
3. Six Sigma Concepts: Variation and Process Capability
Six-sigma eliminates variation by removing the special
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
and common causes, thus improving the capability of the process.
A fundamental expression of the relationship between a process output Y and the process variables Xi is:
Y = f(X1 X2 X3 X4 … Xn)
In attempting to improve the process, we seek to identify those process variables with the highest impact on process perfor
A fundamental expression of the relationship between a process output Y and the process variables Xi is:
Y = f(X1 X2 X3 X4 … Xn)
In attempting to improve the process, we seek to identify those process variables with the highest impact on process perfor
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
mance and work to optimise those. The six-sigma methodology follows a specific sequence with the acronym DMAIC (define, measure, analyse, improve and control) and tools exist for carrying out each step of the sequence.
Variation:
An important tenet of statistical process control is that every measurable phenomenon i
Variation:
An important tenet of statistical process control is that every measurable phenomenon i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s a statistical distribution. This means that the output of a process will generally vary around its typical values.
Two types of variation exist. Variation from special causes or assignable variations are caused by conditions that can be identified and where necessary, eliminated. Common cause variations are random and cann
Two types of variation exist. Variation from special causes or assignable variations are caused by conditions that can be identified and where necessary, eliminated. Common cause variations are random and cann
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
ot be traced to a specific cause. A process which only has common cause variations is said to be under control.
The standard deviation of the parameter of interest, sigma (symbol σ), is a measure of this variation.
Process capability:
This parameter measures the degree to which a business process, with its cur
The standard deviation of the parameter of interest, sigma (symbol σ), is a measure of this variation.
Process capability:
This parameter measures the degree to which a business process, with its cur
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
rent level of variation, is able to satisfy the requirements of the customer. It is defined as the smaller difference between the upper or lower customer-tolerable limit (CL or CU) and the process average (X), divided by the process standard deviation.
Cpk = min[|X-CL|,|CU-X|]/σ
Acceptable values for this ratio
Cpk = min[|X-CL|,|CU-X|]/σ
Acceptable values for this ratio
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
are in the range 3 and over. A low value indicates that the process is incapable of meeting customer requirements at a Six-sigma level. The process outputs will contain defects in excess of 3.4 per million opportunities.
4. Implementing Lean Six Sigma
Many organisations have transformed themselves significantly throu
4. Implementing Lean Six Sigma
Many organisations have transformed themselves significantly throu
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
h the implementation of Lean Six-sigma. Yet others have faltered in their attempts at deployment. This is because it is as much about people and organisational culture, as it is about specific tools and techniques. To emphasise tools and techniques to the exclusion of cultural factors is to guarantee failure.
Preparation:
Preparation:
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
Michael George advises the following sequence to prepare for a successful Lean Six-sigma implementation.
- Select a Lean Six-sigma champion with leadership and communication skills
- Establish a baseline snapshot of the organisation with respect to the business status, existing knowledge and attitudes towa
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
rds the Lean Six-sigma initiative
Interview top management to identify critical elements of success for the business and for Lean Six-sigma
Engage key influencers (formal and informal) through focus groups and interviews, to apply tipping point effects in rallying support
Assess the impact of what you learn
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Deployment:
In summary, deployment should be carried out as follows using the DMAIC model:
- Stretch the process by applying lean techniques
- Solve the problem of deviation from standards
- Ensure maintenance of the improved processes using six-sigma
Define: Agree on the problem and st
.
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
akeholders, ascertain linkage to corporate strategy and impact on ROIC, agree process boundaries and metrics
Measure: Establish process baselines, observe the process and collect data
Analyse: Apply tools like value stream mapping, time trap analysis, failure modes and effects analysis, ANOVA etc
Improve: Use lean tools li
Measure: Establish process baselines, observe the process and collect data
Analyse: Apply tools like value stream mapping, time trap analysis, failure modes and effects analysis, ANOVA etc
Improve: Use lean tools li
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
ke 5S, TPM, Kanban, Kaizen, Poka yoke, flow improvement, and six sigma tools like hypothesis testing etc to improve the process
Control: Implement visual management, control charts, process control plans and the Plan-Do-Check-Act cycle
Our next article considers the application of Lean Six Sigma to services and transactions
Control: Implement visual management, control charts, process control plans and the Plan-Do-Check-Act cycle
Our next article considers the application of Lean Six Sigma to services and transactions
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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