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Digg It - Some Lean Six Sigma Tools - Analyse, Improve and Control
The cost, speed and quality leaps of Lean Six Sigma are obtained through the application of appropriate tools. We conclude by reviewing some tools from the Analyse, Improve and Control phases of DMAIC.
The Analyse Phase
Purpose of Analyse:
In implementing Lean Six Sigma this phase identifies and
The Analyse Phase
Purpose of Analyse:
In implementing Lean Six Sigma this phase identifies and
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
verifies the relationships between causes and their effects. It helps in the discovery of factors that affect key process inputs and outputs. The analyse phase seeks to find patterns in the data obtained during the measure phase in order to make sense of it all.
Tools for Analyse:
Scatter Plots:
Two variables are
Tools for Analyse:
Scatter Plots:
Two variables are
; 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
plotted against each other on a graph. The resulting picture gives a visual indication of how well correlated the variables are.
Regression Analysis:
This can be regarded as a mathematical equivalent of the scatter plot. Here an equation is derived to express the dependence of one of the variables on one or more others. The equat
Regression Analysis:
This can be regarded as a mathematical equivalent of the scatter plot. Here an equation is derived to express the dependence of one of the variables on one or more others. The equat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ion can then be used to predict values of the dependent variable for given values of the independent variables.
Fish bone diagram:
A large arrow is drawn with the effect whose causes are being analysed show on the right at the end of the arrow. Main categories of probable causes are shown on branches emanating from the main line.
Fish bone diagram:
A large arrow is drawn with the effect whose causes are being analysed show on the right at the end of the arrow. Main categories of probable causes are shown on branches emanating from the main line.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
For each category, detailed causes are brainstormed and indicated against the corresponding branch.
x-process
Time Trap Analysis and Capacity Constraint Identification: A time trap is a process activity that inserts delays into the process and may be due to capacity constraints or other operational inefficiencies. Whatever the so
Time Trap Analysis and Capacity Constraint Identification: A time trap is a process activity that inserts delays into the process and may be due to capacity constraints or other operational inefficiencies. Whatever the so
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
urce of the delays, it finally shows up as long lead times. A capacity constraint is a sub-process or activity whose output per unit time is less than that of the preceding and/or subsequent sub-process or activity.
Non Value-Added Analysis:
From the as is value stream map, each process activity is examined to determine its contri
Non Value-Added Analysis:
From the as is value stream map, each process activity is examined to determine its contri
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
bution to customer requirements. Those which do not contribute to customer valued outcomes and are not necessary for other business reasons (e.g. regulatory requirements) are eliminated.
The Improve Phase
Purpose of Improve:
In the previous phases, defects (variability outside the customer's spec
The Improve Phase
Purpose of Improve:
In the previous phases, defects (variability outside the customer's spec
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
ifications) and wastes (non-value added activities and costs) have been identified, measured and their causes found through analysis. The purpose of the improve phase is to eliminate the defects and wastes.
Tools for Improve:
To Be Process Maps: A map of the desired process is created, in which identified non-valu
Tools for Improve:
To Be Process Maps: A map of the desired process is created, in which identified non-valu
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e added activities have been eliminated
Setup reduction:
From the capacity constraint and time trap analysis carried out in the Analyse phase, we can determine whether the major source of delay was due to long setup times. In that case, the following steps are applied.
* Document and classify setup procedures
* Improve organisat
Setup reduction:
From the capacity constraint and time trap analysis carried out in the Analyse phase, we can determine whether the major source of delay was due to long setup times. In that case, the following steps are applied.
* Document and classify setup procedures
* Improve organisat
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
ion-Study work area layout and analyse required movements. Use 5S if necessary to remove inefficiencies. Brainstorm improvement opportunities in the setup steps.
* Where possible convert internal (setup activities that are done with the machine down) to external (setup activities that do not affect the running of the machine) proce
* Where possible convert internal (setup activities that are done with the machine down) to external (setup activities that do not affect the running of the machine) proce
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ures. In transactional situations, this means converting serial procedures to parallel.
* Improve the remaining internal setup procedures.
* Eliminate need for adjustments.
5S: This lean tool results in a clean and organised work area, with a place for everything and everything in its place. The steps of the methodology are:
*
* Improve the remaining internal setup procedures.
* Eliminate need for adjustments.
5S: This lean tool results in a clean and organised work area, with a place for everything and everything in its place. The steps of the methodology are:
*
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
Sort
* Straighten
* Shine
* Standardise
* Sustain
Applying 5S eliminates inefficiencies resulting from lack of organisation by reducing the amount of unnecessary motion and transportation.
Total Productive Maintenance
Where downtime is a major cause of low process cycle efficiency, total productive maintenance, which aims to
* Straighten
* Shine
* Standardise
* Sustain
Applying 5S eliminates inefficiencies resulting from lack of organisation by reducing the amount of unnecessary motion and transportation.
Total Productive Maintenance
Where downtime is a major cause of low process cycle efficiency, total productive maintenance, which aims to
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
reduce the percentage of downtime, should be applied.
Mistake Proofing:
By proper design of the processes and equipment, the possibility of errors (and with them the need for inspections) is eliminated. Examples are designing online forms that cannot be submitted if data is incompletely entered, or if the wrong type of data is ent
Mistake Proofing:
By proper design of the processes and equipment, the possibility of errors (and with them the need for inspections) is eliminated. Examples are designing online forms that cannot be submitted if data is incompletely entered, or if the wrong type of data is ent
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
ered. Similar to this are parts that can only be assembled in one way.
Design Of Experiments:
This is the statistical design of experiments to enable you determine the impact of two or more variables on another variable of interest. This tool also accounts for interaction effects between variables.
Hypothesis Testing:
This is a
Design Of Experiments:
This is the statistical design of experiments to enable you determine the impact of two or more variables on another variable of interest. This tool also accounts for interaction effects between variables.
Hypothesis Testing:
This is a
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
statistical tool for testing the validity of assumptions. In this case the assumptions might relate to the impact of causes on effects. For example, if performance is suspected to be operator dependent, tests might be carried out to verify whether observed differences in performance between two operators are statistically significan
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
t.
Solution Selection Matrix:
Generally there will be more than one possible solution identified to the problems under consideration. The selection matrix compares them using a set of weighted criteria to determine the most appropriate.
Project Management:
Actual implementation of agreed solutions will be in the form of a projec
Solution Selection Matrix:
Generally there will be more than one possible solution identified to the problems under consideration. The selection matrix compares them using a set of weighted criteria to determine the most appropriate.
Project Management:
Actual implementation of agreed solutions will be in the form of a projec
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
t, and will require use of the usual project management tools for planning, communication, risk assessment, and monitoring.
The Control Phase
Purpose of Control:
The purpose of the control phase is to ensure that the gains from the improve phase become embedded in the organisation.
Tools
The Control Phase
Purpose of Control:
The purpose of the control phase is to ensure that the gains from the improve phase become embedded in the organisation.
Tools
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
for Control:
Standard Operating Procedures:
The improved process design will certainly include new operating practices. These must be codified in an operating manual to which operators can refer. Having a standard operating manual helps prevent slippage into old inefficient practices.
Statistical Process Control:
Contr
Standard Operating Procedures:
The improved process design will certainly include new operating practices. These must be codified in an operating manual to which operators can refer. Having a standard operating manual helps prevent slippage into old inefficient practices.
Statistical Process Control:
Contr
.
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
ol charts, reflecting the improved capabilities of the process must be constructed and used to monitor process performance over time.
Visual Management:
The essence of visual management is captured in the idea that an employee should be able to walk through the work area and come away with 90% of the information. This is achieved
Visual Management:
The essence of visual management is captured in the idea that an employee should be able to walk through the work area and come away with 90% of the information. This is achieved
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
through 5S organisation, illustrations of process steps placed close to the process, SIPOC diagrams and value stream maps, the use of shadow boards etc.
Conclusion
The list of tools considered in this article and the last are only a few of the several available. On any one project, only a few are likely to be used
Conclusion
The list of tools considered in this article and the last are only a few of the several available. On any one project, only a few are likely to be used
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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