Six Sigma is a well established process improvement technique. The goal is to drive down defects in manufactured products, and thus to enhance customer satisfaction and contribute to the financial results of the business. Key to Six Sigma is that it provides a quantitative approach to the improvements; to support this approach a variety of mainly statistical tools are used.
A production facility running at a Six Sigma level is close to perfection, meaning that only 3.4 defects per million opportunities or units will be recorded. Many processes act on lower sigma levels; a 5 sigma level would result in approx 230 defects per million opportunities. This doesn’t sound great, but it is still a relatively low number in regards to defect ratios. Thinking of it as on-time deliveries for your daily newspaper, 5 sigma translates to the newspaper being late only once every twelve years!
The Six Sigma improvement process involves five steps, identified by the acronym DMAIC. DMAIC stands for Define, Measure, Analyze, Improve and Control. It takes a project management approach where each of these steps or phases finalizes before you can continue with the next. Define creates the business case on which the project will concentrate. In the Measure step, the data needed to make choices for the improvement are defined and gathered. In the Analyze step, the data are studied and improvements are defined which are implemented in the Improve phase. The Control phase will measure the consistency of the improvements over time.
LIMS and Six Sigma
Now how can your LIMS implementation leverage Six Sigma, and which of the Six Sigma steps can be helpful?
A clear first choice is the Measure step since you use the LIMS system to store all the relevant data from your measurements inside this system. Now the LIMS system does not only store the data, it also helps you make informed decisions based on the facts and records you have entered into it. Factors affecting the decision are units, specifications and any calculations you apply to the data. As with any item in the measurement system, this requires calibration. You will need to verify that the data you feed into the system will deliver the desired output. Storing data is only one of the process steps, other steps could be sampling, preparation or chemical measurements. Each of these will contribute to the variation of the final result.
“Variation is the enemy” as stated by Edward Deming, one of the pioneers of Six Sigma. This is the foundation for the analyze step. During the analyze step we should identify, quantify and reduce the variation to more accurately obtain a reproducible result.
Your LIMS system becomes the single source of truth for the data that will drive your Six Sigma process. Without data there is no quantifiable improvement possible; “if you cannot measure it, you cannot manage it” is known management mantra.
In the future, I will expand on more examples of the use of the LIMS system in the measurement step as well as in the analyze phase, applying the different statistical tools available with this methodology. And if you think that six sigma is only for manufacturing, you will be pleasantly surprised when we take a look at examples where your laboratory workflow, and the services that your laboratory offers can benefit from using Six Sigma tools and techniques.