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The cost, speed and quality leaps of Lean Six Sigma are obtained through the application of appropriate tools. Following the DMAIC improvement model of Lean Six Sigma, we will look at a number of tools from each phase.

The Define Phase

Purpose of Define:
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
ong> This phase of the Lean Six Sigma implementation identifies the improvement opportunities and customer deliverables and defines a scope. At the end of the define phase, we should have a project charter, clearly identified stakeholders, a project team, estimation of business impli
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
ations, an evaluation of customer requirements, a high level process map and project management and communication plans.

Tools for Define:

Stakeholder Analysis:
The various stakeholders (customers, shareholders, employees) are listed and the potential impact of
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

he improvement project on each assessed as substantial, average, low or nil.

SIPOC diagram:
Of the tools applied in this stage of the improvement project, perhaps the most commonly used is the SIPOC diagram. SIPOC stands for Suppliers, Inputs, Process, Outputs and Customers. The d
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
iagram provides a visual answer to the questions required to understand the process: who are the primary stakeholders of this process? What value does it create? Who is the owner of the process? What are the inputs and who provides them? What resources are consumed by the process? Wh
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
t process steps create the value?

The steps involved in creating the SIPOC diagram and the involvement of team members in brain storming and idea generating sessions are as important as the resulting diagram.

VOC - Voice of the Customer:
Critical to a proper definition of the imp
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
ovement project is the availability of data representing customer viewpoints and requirements. These are collected using VOC tools like interviews, surveys, focus groups, comment cards, suggestion/complaint boxes etc. The definition of customer here includes internal and external cus
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
tomers.

Using Kano analysis coverts raw quantitative and qualitative data obtained from the above into clearer expressions of the value customers place on various product and service features you offer.

Development of critical-to-quality requirements converts customer statements, whi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
h may be imprecise, to precise requirements (valued from the customer's perspective) for your product or service.

The Measure Phase
Purpose of Measure:
This phase quantifies the current state of the process with respect to cost, speed and quality and provides
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
an idea of the gaps to be filled. At the end of this phase, we have a detailed map of the process, data on key input and output variables, an analysis of the capability of the process, refined project charter and plans where warranted by new information, and recommended actions to pic
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
low hanging fruits.

Tools for Measure:
Operational definition - various measures are defined so that all team members apply the same definitions when gathering data for the improvement project.

Process map, value stream map, complexity value stream map: This p
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
roduces a more detailed representation of the process than the SIPOC diagram and includes such information as wait times, processing times, resource consumptions, process operator etc.

Cause Effect Matrix:
This tabulates causes against effects and calculates scores which are use
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
to rank the causes. As a measure tool, this matrix is used to select which inputs to focus on because of their significant impact on the process outputs.

Preliminary FMEA (failure modes and effects analysis): This tool has a similar function to the cause and effect matrix. All poss
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ble failures in the inputs are considered, and then weighted according to probability of occurrence, severity of impact on outputs and difficulty of detection. This assessment also helps to determine what inputs the project team should focus on.

Data collection plan:
This includ
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
es decisions as to what data (balanced between input and output) to collect, identification of stratification factors (these help determine patterns in the data), determination of sample size, identification of data sources, development of data collection sheets and assignment of data
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
collection duties among team members.

Pareto charts:
This is one more tool for focusing the team's efforts on the most important problems. A Pareto chart is a bar chart where the horizontal axis represents categories. On the vertical axis we can plot in descending order, the fre
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
uency of occurrence, or cost, speed or quality impact of each category. Where a clear Pareto effect exists, only a few of the categories (typically 20% or less) are responsible for majority of the effects (80% or more).

Measurement systems analysis:
The process of obtaining meas
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
urements is subjected to standard analyses to ensure reliability, repeatability and reproducibility. Other attributes of the measurement system are stability, bias and discrimination.

Control charts:
A control chart is a run chart sequence of quantitative data with three horizonta
.

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
lines showing a centred mean and upper and lower control limits. Control charts help to assess the nature of variation of the process. In-control processes are expected to yield data points randomly distributed around the mean but within the calculated control limits.

Process capabi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ity assessment:
This tool measures of process capability assess the ability of a process to meet functional requirements. Several measures of capability exist. All of them are compare the process standard deviation to the allowable range of variation as specified by the customer

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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Digg It - Some Lean Six Sigma Tools - Define and Measure

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