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SIX SIGMA AND LEAN CONCEPT IN LABORATORY
MEDICINE
Abdurrahman COŞKUN, MDDüzce University, School of Medicine, Department of Clinical Biochemistry
Düzce-TURKEY
Six Sigma The Six Sigma was developed in the
early 1980s by Motorola Corp. to improve the products reliability
The methodology represents an evolution in quality management that is being widely implemented in business and industry in the new millennium
The Six Sigma strategy
The Six Sigma strategy measures the degree to which any process deviates from its goal
The sigma value indicates how often errors are likely to occur; the higher the higher the sigma value, the less likely it the sigma value, the less likely it is that the process will produce is that the process will produce errors.errors.
Sigma metrics
Sigma metrics are being adopted as a universal measure of quality and the performance of all processes can be characterized on the "Sigma scale."
Any process can be evaluated in terms of the number of sigma metrics that fit acceptable limits.
The process Sigma level can be calculated by dividing the allowable tolerance for the process by twice the process SD:
Sigma = Total process tolerance /
(2×process SD).
However in clinical laboratory measurements, it is straightforward to measure the sigma performance of analytical methods as formulated below:
Sigma = (TEa-bias)/CV
where TEa is the total error allowable and CV is the coefficient of variation.
Ideally, Six Sigma, or six SD, should fit within the acceptable limits of a process
-6s -5s -4s -3s -2s -1s 0s 1s 2s 3s 4s 5s 6s
-6s -5s -4s -3s -2s -1s 0s 1s 2s 3s 4s 5s 6s
T
Tests Sigma
Triglyceride 10.8
ALT 16.1
CK 26.0
TSH 10.4
The best or ‘‘world class’’ processes have a level of 6 sigma, which means that in this process fewer than 3.4 errors occur per million products or tests (with 1.5 standard deviation (SD) shift)
Sigma metric EPM without shift
EPM with shift
1.00 317400 697700
2.00 45400 308637
2.50 12419 158686
3.00 2700 66807
3.50 465 22750
4.00 63 6210
4.50 6.8 1350
5.00 0.57 233
5.50 0.038 32
6.00 0.002 3.4
6.8
3.4
In clinical laboratories, Sigma is usually calculated for the analytical phase of testing process
However the entire medical loop of the total testing process, i.e. from the clinician to the laboratory and back to the clinician consist 5 phases: Pre-pre-analytical, Pre-analytical, Analytical, Post-analytical and Post-post-analytical phases.
Phase Error Rate (%)
Pre-pre-analytical phase
12.0
Pre-analytical-phase 2.0
Analytical Phase 0.2
Post-analytical Phase 3.2
Post-post-analytical phase
5.0
Total ErrorSigma
202.4
Strooban et al 2003
Lean Concept
In patient focused quality management high level of quality itself is not adequate, the result of patients’ the result of patients’ tests should be reported within tests should be reported within the given timethe given time and in communication with the physicians.
For that reason we should combine the Lean
concept with Six Sigma to make the work faster (using Lean principles) and better (using Six Sigma principles)
Traditionally the ‘Six Sigma’ focused more on quality than the speed and the ‘Lean’ focused on the flow speed than quality improvement
The ‘four keys’ of Lean Six Sigma could be defined as: Delight patients with speed and
quality, Improve methods and processes, Work together for maximum gain, and Base decision on data and facts
Clinical laboratories, which have been used Lean Six Sigma in total quality management, decreased errors and contributed patients’ safety more than most other healthcare sectors