Lean 6 Sigma

Lean 6 Sigma quality and lean 6 six Sigma methodology online

Lean Six Sigma Certification to fast track your career

What is six sigma?

Six sigma is a highly disciplined approach used to reduce the process variations to the extent that the level of defects are drastically reduced to less than 3.4 per million process, product or service opportunities (DPMO). Six sigma is a powerful approach to achieve breakthrough improvements in manufacturing, engineering and business processes. The approach relies heavily on advanced statistical methods that complement the process and product knowledge to reduce variation in processes. It is new way of doing business that would eliminate the existing defects efficiently and would prevent defects from occurring.;

What is sigma?

Sigma is a Greek letter that is used to describe variability. In statistical quality control, this means “standard deviation”.

Who is using six sigma approach?

The six sigma approach was first introduced and developed at Motorola in late 1980s. Later in the mid-nineties, it was adopted by General Electric and Allied Signal. According to Jack Welch CEO of GE “Six sigma is the most challenging and potentially rewarding strategy GE have ever undertaken” GE listed tremendous benefits of the approach in their annual report in 1997. Six Sigma is now adopted by many other reputed companies.

Why should we implement six sigma?

GE listed tremendous benefits of the approach in their annual report in 1997. These benefits included:

* 10 fold increase in the life of CT scanner x-ray tubes at Medical Devices

* Improved yield resulting in increased capacity without additional investments at Superabrasives- their industrial diamond business

* 62% reduction in turnaround time at the repair shops of the railcar leasing business

* Addition of 300 million pounds of new capacity This was equivalent to adding new plant!

Your company can also get similar benefits by implementing six sigma.

Who is a six sigma black belt?

Black belts are full time six sigma project leaders who are selected to execute the project. Selection of candidates is critical for the success. The project leaders go through in-depth training of six sigma approach and tools and work full time on the project. They are usually future leaders of the organization. Black belt projects can be from any function in the company Financial benefits of a black belt project may be about 100000 US $. However, this may vary considerably depending on the stage of six sigma implementation.

What are green belts?

Green belts also lead six sigma projects. But the complexity of the projects and the benefits are somewhat less than that of black belt projects. Green belts work part time on projects and the projects usually belong to their own function. The training could be less intensive as compared to black belts. Financial benefits of a green belt project may be about 20000 US $. How are six sigma projects selected? Six sigma projects are identified considering the:

* Strategic direction of the company

* Impact on the bottom-line

* Impact on customer satisfaction

The projects having large impact requires project leaders with high degree of competence. Full time project leaders, called black belts, are selected to execute the project. Selection of candidates is critical for the success. The project leaders go through in-depth training of six sigma approach and tools and work full time on the project. Projects are expected to be completed by the belts in about six months time. Black belts may work on more than one projects at a time.

What are project sponsors?

Each project has a sponsor who is adequately senior in the organization. Sponsor ensures that

* The belt gets appropriate support from functions

* Resources are available

* The progress is as per schedule

* Organizational blocks are removed

In general, the sponsor owns the project and is accountable for the success of the project. Six sigma projects are identified considering the What is the difference between statistical quality control (SQC) and six sigma? There are many tools that were known to statisticians including design of experiments. However, the usage of tools was very limited. Also, few quality professions used these. In six sigma approach, the tools are learned by black and green belts who belong to different functions and apply the tools to make improvements in business processes. Thus six sigma is a company-wide initiative while as SQC was primarily deployed for quality control.

What is the role of senior management?

Top management must be committed to six sigma implementation. This must be demonstrated through:

* Making high performers available as black and green belts for six sigma projects.

* Making resources available for training and implementation.

* Project successes are celebrated and belts and team members are recognized and rewarded appropriately. Their presence during recognition is a strong indicator. GE made six sigma implementation as a condition from promotion of their managers.

Some of the senior managers should take up and implement six sigma projects Can we implement Six sigma along with other improvement initiative such as TPM? There is no rule of thumb. However, many of the resources, such as members of steering committee, are common to these initiatives. More than one initiatives becomes highly taxing for senior and middle management. In the days of lean organizations, both initiatives may suffer due to inadequate resource availability. In terms of principles, usually there are no contradictions between various improvement initiatives such as TPM, Six Sigma or TQM.

What is duration of six sigma black belt training?

Black belt training duration is usually three to four weeks. However, belts go through one week training and apply the learnings for the project. Thus, there is one week training every month for three months. In addition to this, there is a short two days introductory training for belts as well as sponsors in the beginning.

Is there any training required for senior management?

Yes. This is executive overview if six sigma approach, benefits and roles of belts, sponsors and top management. Duration could be one to two days

Is there any black or green belt certification?

There could be internal or external certification. This is based on successful completion of training and project. One of the widely recognized external certifications is by American Society for Quality (ASQ). ASQ conducts examination of multiple choice questions periodically. Link to ASQ six sigma black belt certification: http://www.asq.org/cert/types/sixsigma/requirements.html

How many years it will take to reach six sigma level?

Six sigma is an approach and achieving six sigma level in all measures of a company is still only a dream. It is possible to reach this level in some of the processes. Many companies that are considered good by us may be at 4 sigma level. Moving to five sigma level may take 3 to 5 years and will have a complete paradigm shift in the operations. Following table shows relation between sigma level and defects per million parts:

 

Sigma Level

PPM

2

308,537

3

66,807

4

6,210

5

233

6

3.4

 

 

We can see that improvement from 4 to 5 sigma level is more than 26 times! One sigma change in the operational measures mean a complete overhaul of the processes and may take a fairly long time. What level a company should target depends on the likely competition.

How many black belts should we have?

There is no standard for this. However, a rule of thumb is one black belt per 100 employees. It is essential that the technology of the organization is considered to arrive at a critical mass of black belts. Where the industry is labor intensive, number of black belts can be less

What is a master black belt (MBB)?

A master black belt is very highly proficient in the six sigma tools and can train others in the methodology. Number of master black belts may be very few.

Do we need consultants to help implementation?

Usually yes. Implementation of six sigma relies heavily on extensive training to belts and sponsors. Consultants can also help implementation during the initial one or two cycles of projects

Can six sigma be useful for improvements in service industry?

Six sigma was initially applied to improving manufacturing industry. However, in later years, companies have successfully applied six sigma to make improvements in service sectors such as Healthcare, Banking, Software, Education etc. Some of the powerful Six Sigma Tools were first used in Agriculture to improve yield. Thus Six Sigma Approach and Tools can be applied to virtually any industry.


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Lean Six Sigma Certification and Training Tips

Developed originally by the famous company Motorola, today Six Sigma Certification and Training has become a part of every industry. A famous strategy for business management as well as quality, Six Sigma is a process of identifying the myriad causes of low quality and thereby improving performance. This strategy is also used to reduce the variability in terms of performance and rise in the cost of production.

Six Sigma Certification and Training has gained new levels by promoting itself. There are different levels which a person can achieve and play an important role in the implementation of Six Sigma projects. These roles are:

>> Executive Leadership

>> Champions

>> Master Black Belts

>> Black Belts

>> Green Belts

>> Yellow Belts

Each of these roles has a diverse yet significant part to play in the implementation of Six Sigma thought process.This gives an ample opportunity to understand how and where the errors are being committed and eliminate them thereby, improving the quality of the process being worked upon.These roles are hierarchical and one has to attain every level of expertise, starting from being a yellow belt before going on to the next level.

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Many countries especially in Asia have adopted the principle of Six Sigma in a big way.We enumerate them to understand how the application has practical uses. Here are a few benefits of Lean Six Sigma Training in Asia.

>> Customers tend to be more loyal towards the products of your company because of its quality and value for money.

>> Increase in production of quality products thereby lowering their chances of rejection.

>> Providing Lean Six Sigma Training in Asia is highly beneficial. Productions of goods which are of better quality and getting acclaim for it is a huge motivational factor for an employee.

>> Application of the Six Sigma principle in practical situation not only benefits us but also the other key members in the entire supply chain.

A big question that comes our way is which few Six Sigma Certification and Training tips are to be kept in mind before taking the training session.

>> One cannot choose between quality and efficiency. They go hand in hand.

>> Choose simple yet effective tools to deliver quality. Do not use tools just because others are using them.

>> Last but definitely not the least; choose a Lean Six Sigma Training in Asia as well as in other places, where the emphasis is on application of the methodology rather than classroom talks.
Six Sigma Center of Excellence (SSCX) enables people and organizations to achieve bolder results through business process improvement. For more details on Lean Six Sigma Training in Asia and Six Sigma Certification and Training than please visit our website www.sscxinternational.com
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Why a Six Sigma Based Quality System May be the Answer for Pharmaceutical Companies

Life science companies experience no lack of quality system ideas, quality system conversation, quality system arguments, quality system implementation methods, etc.

After all, even the required systems of quality management such as the FDA’s GMP, GCP and GLP regulations and guidelines are specified to a certain extent but still don’t determine all of the whens, hows, whys and whats of in-house quality system management. As a result, life science companies are left with a few decisions to make:

1) On what system(s) should a quality system be based?

2) How will the quality system’s data be managed?

3) How will the quality system’s documentation be managed?

4) What will be the KPIs (key performance indicators) of the quality system?

5) How will a need for improvement be justified?

Note: The first of these questions will be the focus of this article although questions #2 and #3 will also be discussed as auxiliaries to discussion regarding #1.

What Quality System is the Right Quality System?

First of all, it is essential for life science companies to realize that every quality system is nothing more than stated limits of discipline and a successful quality system is made of stated limits of discipline that are followed. Those stated limits of discipline however must originate from a specific mentality or template for a “starter quality system.” The quality system that a life science company selects will of course continue to evolve but upon the initiation of a new or revised quality system it is important to choose the “quality system mentality” best suited to any given company.

This can be difficult.

After all, some say lean manufacturing must be adhered to; others vouch for PAT and still others Six Sigma. Some say a combination of these systems work best and all of them are probably (at best) only partially right. So, how will pharmaceutical companies make the best decision for the unique needs of their own company?

Could Six Sigma be the right starter quality system?

This article posits the idea that as a starter quality system, Six Sigma is ideal for the pharmaceutical industry. This position does not exclude lean manufacturing or PAT systems of management, but instead recommends Six Sigma as the initial system of practice. Why? For starters, Six Sigma ideals are based on intense statistical analysis and serious data collection, and the pharmaceutical industry just happens to have colossal amounts of data and documentation. This data and documentation, with the appropriate amount of time, could be analyzed according to Six Sigma methods and then used to adjust less-than-stellar aspects of the quality system. The Six Sigma system also focuses on the near obliteration of deviation or nonconformance events which for pharmaceutical companies falls exactly into line with regulatory standards and quality management goals.

Easier Said Than Done

Any reader may easily volley this article’s position by stating that Six Sigma is difficult to implement and that most pharmaceutical companies don’t want to change anyways. According to an online source1 however the benefits of making the right changes within the very wealthy pharmaceutical industry are staggering. The online article states that “the potential worldwide cost savings from efficiency improvement could be as high as $90 billion.” This article still acknowledges however that the reader is correct in saying that Six Sigma is difficult to implement; Six Sigma implementation requires know-how and the appropriate instrumentation. That know-how and instrumentation will vary greatly since it is likely that a very small percentage of Six Sigma black belts would be even remotely qualified to cross the pharmaceutical threshold (an intelligent in-house manager might do well simply studying up on Six Sigma principles).

Six Sigma tools may vary as well. After all, the “Six Sigma mentality” doesn’t specify tools (the Six Sigma calculator wouldn’t necessarily even be a required purchase) but does specify the principles of data collection, analysis and a decrease in deviation.

What tools can be used for the implementation of Six Sigma?

A vast variety of software solutions might be able to help provide the needed Six Sigma success but should be chosen carefully. For most pharmaceutical companies it seems likely that management tools/software for data collection (data and document management software) and tools for any type of deviations or nonconformance management could be valuable. Since small amounts of deviation usually depend on the speed of information distribution within a company (although even that assumption could be subjected to Six Sigma analysis), an automated training solution triggered by changes in SOPs, work instructions, etc. might also be of great value.

Conclusion

Essentially the keys of Six Sigma are rigorous data collection, analysis and a decrease in deviation, principles which would seem to attract the naturally rigorous pharmaceutical industry.

1 http://www.contractpharma.com/articles/2007/10/lean-practices-in-a-life-sciences-organization

Marci Crane is a copywriter for MasterControl in Salt Lake City, UT. For more information in regards to quality system solutions, please feel free to contact a MasterControl representative.
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