Six Sigma In IVD Business
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Written by Mangesh Chorge   


1) Define, Measure, Analyze, Improve and Control steps.

2) Reduce a level of defect to 3.4 defects per million opportunities.

METHOD: Following are the ways to achieve above objectives.

Customer Oriented Approach:

To be most effective, companies should aim to gather customer feedback from at least 25% to 30% of their target customer base (critical mass). The power of method is in what customers say about manufacturing defects, service levels products, etc. to achieve a high confidence factor that you clearly understand their needs. Define stage exists to ensure that the most important issues are being worked on. One of the biggest company killers is rework. Production function should be close to shipping and receiving, where the inventory is stored. For example in one company after closing the area by 25 to 30 feet saved 75 miles walk a year which increased throughput by 3% to 5%.

When you're sitting with the customer and going through the process- defining project parameters, identifying project parameters, identifying critical to quality requirements and determining how to most efficiently apply resources- it leads to most efficient time lines and an increased ability to deliver great quality at competitive price. You get payback before the project even begins just by spending that time with them.

Keep growing:

One of the best ways to advance is to do more projects and interact with more people in different areas. Expertise is about more than knowing how to use the tools. It is the perspectives and experience practitioner will pick up from others over time

Cultivate collaboration:

The difference between four sigma, in which parts are 99.379% error free, and Six Sigma, in which parts are 99.99966% error free, may not seem significant, but simply moving from four sigma to Five sigma requires a 27 fold improvement in performance. Motorola has learned that it is impossible to provide their customers with products and services developed at a Sigma Level Six if they are receiving products and services from their suppliers at a four sigma. The proper use of Lean six sigma reduces the factory floor size , allowing for very complex system integration in a very compact efficient area.


It is not that necessary to recruit a Black belt to achieve six sigma. Above steps if followed properly in their correct meaning, six sigma will not be a dream but reality for any organization which strive to be best.

Mangesh is R&D executive in Transasia Biomedical Ltd Mumbai. He has a M.Sc. By research in Applied Biology from Haffkine Institute, Mumbai and has 9 years experience in IVD with great passion to improve the quality of community health.

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