Lean, Six Sigma and the Clinical Laboratory
In the context of human error in health care, as described eloquently by Dr. Ashok Rattan, it is imperative to establish systems to dictate work processes rather than rely on objective human judgment. While accreditation programs and quality certifications such as ISO address rules and principles that govern the outcomes of a laboratory, it is important to review the work flow of a laboratory from a manufacturing industry perspective to address productivity, efficiency, costs and errors.
Six Sigma is a quality management program that measures and improves a company's operational performance by identifying and correcting defects in its processes and products. Originally, Six Sigma was defined as a process variation that would produce no more than 3.4 defects per million parts (or "opportunities"). Today, however, Six Sigma is applied to produce a product that satisfies the customer and minimizes supplier losses to the point at which it is not cost effective to pursue a higher quality.Six Sigma was pioneered at Motorola in the mid-1980s, followed by other large companies such as General Electric, which ultimately popularized the process. Although Six Sigma is usually applied to manufacturing companies, it can be applied wherever the control of variation is desired. In the lab industry, it has been taken to exceptional levels by Quest Diagnostics. The following link describes in concept at some length: http://www.questdiagnostics.com/brand/b_home_six_sigma.html .
Lean is all about reducing ‘wasteful processes’ and improving speed and efficiency. Waste is basically defined as anything that adds no value to the process (anything that a customer would not be willing to pay for). The results in Lean projects are often dramatic reductions in turnaround times and savings in staffing and work space. The aim is to usher an ‘assembly line’ mindset in drawing up work-flow protocols, much like the Toyota production lines where Lean techniques were first formulated.Six Sigma targets variation. Lean attempts to eliminate wasteful processes. Both aim to improve lab processes.