Advice You - Business

The concept of Six Sigma was first developed by Motorola Corporation as an approach to address the high defect rates within the company’s manufacturing processes. With the success of Six Sigma, Motorola has registered the Six Sigma brand name to the corporation.

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

The concept of Six Sigma advocates that data be collected from processes to measure performance and determine the extent of variation from target performance measurements.

This approach had been truly effective in ensuring quality in a manufacturing environmen

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t and was later adopted by the services industry during the 90s. However, as the Six Sigma framework relied heavily on the collection and analysis of data of individual processes, synchronizing processes between departments was ignored. This resulted in improvem

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

nt benefits being limited to specific functions only, without taking into consideration the integration with other processes. Another weakness of the Six Sigma methodology is the lack of control used to sustain improvements achieved. This stems from the fact Six

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Sigma utilizes manual processes to do this, an approach that lacks effectiveness.

In this sense, Business Process Management (BPM) initiatives address areas that Six Sigma falls short of, in line with the purpose of achieving excellence in organizations. These

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

two methodologies complement each other to compensate for areas of weaknesses. Although BPM addresses process enhancements and monitoring from a holistic viewpoint, it fails to address the analytical requirements required to solve complex issues.

Therefore, BP

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

approaches are used to define current processes and their role across multiple functions, identify areas within the process that affect critical success factors and develop process improvements for these areas of weaknesses. The identification of gaps between e

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

xisting processes and ideal processes are addressed with Six Sigma initiatives. Finally, process monitoring, evaluation and continuous improvement measures are implemented with BPM techniques. These are carried out for inter-related processes across the organiza

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

tion.

A step-by-step insight into how a BPM – Six Sigma initiative is implemented

Define

The first step for such an initiative is to define the current processes of a function, with outputs clearly determined. Data is collected to determine the health of the

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

erformance of the particular process as compared to predefined targets. If there is a deviation in the performance measured from the particular process, the effect of the deviation may be translated into monetary terms.

Measure

BPM process maps are developed w

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

hich incorporate various critical elements of the process. These would include business systems, people and resources that are involved in the entire process. The functions performed by each of these elements are defined and utilized in the analysis stage.

Anal

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

yze

With all data and information at hand, an analysis is conducted on the business process to determine areas of weaknesses. What are the key courses for the deviation? How does this deviation affect other processes? Which steps of the processes are too slow?

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

here is the backlog?

The key approach when analyzing existing processes is to identify parts of the processes which were irrelevant or which does not add value to the process. Most of the time, these areas of redundancy are the causes of delay within entire pro

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

cesses. Apart from that, dependency on a cross-functional process may also cause the current process to be inefficient.

Improve

Once weaknesses are discovered, areas for improvement to address these weaknesses will be identified. This would incorporate the use

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

of “what if” hypothetical solutions in order to shortlist several possible scenarios that would work to improve the current process.

Many times, process improvements will include the utilization of automated processes through the use of technology. Human inter

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

ention will still be required, but a form of integration between automated and human run processes will be developed.

At this juncture, the utilization of machines or applications for greater efficiency will be customized towards the particular business process

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

. Data flow between automated processes and human operated processes will need to be smooth. Therefore, all variables involved in a process will be taken into consideration during the design stage.

Control

A new process will have limited effectiveness to an or

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ganization if it is not constantly monitored for sustainability. This is why a monitoring and tracking system needs to be put in place, most probably in the form of a BPM monitoring system where performance indicators are constantly measured. This way, the manag

.

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

ment team will be able to react to deviations quickly, and make any amendments whenever necessary. Automated reports will be triggered to managers whenever a specific deviation and review meetings are held to address any process issues.

In conclusion, Six Sigma

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

Companies that provide selfless information through particip

and BPM when implemented together will produce outstanding results for the purpose of organizational excellence. This is possible through the synergy achieved from these two remarkable methodologies that help to improve organizational performance the world over

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/22922/adviceyou-Integrating-Six-Sigma-with-Business-Process-Management.html">Integrating Six Sigma with Business Process Management</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/22922/adviceyou-Integrating-Six-Sigma-with-Business-Process-Management.html]Integrating Six Sigma with Business Process Management[/url]

The article explains the characteristics of a good logo design and the factors to consider while deciding on your logo design. It also gives a guideline to select a proper logo designing firm and what should be their method of work.

Advertising is an excellent way to reach all of your clients. Free classified sites abound in the Internet, and you simply place your ad and watch them walk through the door.

68% of customers who stopped doing business with a company did so for one reason: they felt like that company didn’t care about them. If you show your customers that you care, your company will shine. You might even attract some of your competitors’ customers! It’s really not hard to show customers that you care, but it takes consistent commitment. Here are five ideas that will get you started building a customer-focused business.

Tags

Links

Advice You - Integrating Six Sigma with Business Process Management

Related Articles: