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Why a Six Sigma Based Quality System May be the Answer for Pharmaceutical Companies


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Life science companies experience no lack of quality system ideas, conversation, arguments, 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 management. As a result, life science companies are left with a few decisions to make:

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

2) How will the system's data be managed?

3) How will the 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.


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.


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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