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Main Subject - Root Cause Analysis - Simple Techniques to Understand Why Performance is Doing What It's Doing
Measuring performance results is a great thing to do, but understanding the causes of those results is at least as worthwhile. Understanding causes means you have information about how to exercise more influence
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
(or control) over those results. If you want your results to improve, you've got to change the right things about the process or activity or function that produces those results.
Understanding the real causes of
Understanding the real causes of
; 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
performance results means taking a more rigorous approach than knee-jerk reacting to hearsay, opinion or gut feel. Here are some basic techniques to help you navigate through the stages of cause analysis:
* find
* find
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the likely causes, and measure the incidence of each
* assess the nature and size of the cause's impact
* check for interaction with other causal factors
Technique #1: flow charting
It's impossible to
* assess the nature and size of the cause's impact
* check for interaction with other causal factors
Technique #1: flow charting
It's impossible to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
do any kind of serious cause analysis unless you can actually trawl through all the factors that have some kind of potential impact on your performance result, and sift out those factors that have the most domina
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t impact. Flow charting the process or activity or function whose results you are measuring, is a great way to systematically trawl through all the potential causes of those results. There is software available f
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
r flow charting, but hand-drawn charts are quick and easy.
Technique #2: cause-effect diagrams
After flow charting your process and identifying what can sometimes be dozens of potential causes, you can have lon
Technique #2: cause-effect diagrams
After flow charting your process and identifying what can sometimes be dozens of potential causes, you can have lon
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
lists that contain duplicates and related causes. Cause-effect diagrams (or fishbone diagrams) are a great way to collate and organise potential causes as you identify them, clustering related causes together so
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
you can more clearly see the themes, and more easily discuss the most likely causes. There is software available for cause-effect diagrams, but again hand-drawn diagrams can do the job well enough.
Technique #3:
Technique #3:
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
Pareto charts
When you then go and count or measure how often or how much each likely cause is associated with your results, Pareto charts can then help you rank the causes and highlight those that have the bigg
When you then go and count or measure how often or how much each likely cause is associated with your results, Pareto charts can then help you rank the causes and highlight those that have the bigg
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
st impact. You're now getting the stage where you have between 2 and 5 (roughly) causal factors you may wish to learn even more about. In Microsoft Excel, just use a vertical bar chart on your data, after sorting
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
it from biggest to smallest.
Technique #4: scatter plots
When you arrived at the few causes that have the biggest impact on your performance result, it can be useful to know just how big that impact is. Scatte
Technique #4: scatter plots
When you arrived at the few causes that have the biggest impact on your performance result, it can be useful to know just how big that impact is. Scatte
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
plots are an easy and visual way to explore when the cause variable changes, how much and in which direction the performance result changes. Scatter plots are one of the charts available in Microsoft Excel.
Tec
Tec
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
nique #5: correlation coefficients
To get more a quantitative measure of the impact of a causal factor on your result, you can calculate a correlation coefficient which will give you a value between 0 and 1 indi
To get more a quantitative measure of the impact of a causal factor on your result, you can calculate a correlation coefficient which will give you a value between 0 and 1 indi
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
ating the strength of the relationship between your causal factor and the result. A postive value means that an increase in your causal factor will likely lead to an increase in your result, and a negative value
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
eans that an increase in your causal factor will likely lead to a decrease in your result. In Microsoft Excel, use the CORREL function to calculate your correlation coefficient.
Technique #6: regression analysis
Technique #6: regression analysis
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
Regression analysis goes a step further, and builds a mathematical model you could use to predict a result based on a change in your causal factor. Knowing this can help you set achievable targets for improvemen
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, and estimate realistically what resources you're really going to need to get that improvement. In Microsoft Excel, create your scatter plot between your causal factor and performance result, then add a trend li
.
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
e, with the options of showing the equation and R-squared value on the chart (the R-squared value is a measure the reliability of the equation).
There are certainly more statistical techniques that can help you
There are certainly more statistical techniques that can help you
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
ith cause analysis (such as multi-variate regression, experimental design and analysis of variance or ANOVA), but those provided above will still bring some valuable rigour to your performance improvement efforts
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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