Adopted from the Toyota production system, Lean, also known as synchronous manufacturing, is a philosophy that seeks to enhance efficiencies by eliminating waste (1). Both value and an orientation towards the customer are central to its philosophy. Waste refers to that which “consume resources but from a customer’s perspective create no value”. These Mudas increase the costs for a company (2). Lean methodology is aimed at reducing waste to improve customer value, while Six Sigma helps organizations by improving processes and fixing inefficiencies. Clinical laboratories are under increasing pressure to reduce costs while performing at their best.

Lean and Six Sigma methodology have recently been adopted in healthcare specifically into the clinical laboratory as a tool for continuous quality improvement (3). Clinical Biochemistry Laboratories within Eastern Health Authority (EH) are ISO 15189 plus accredited. These cater to the population of province of Newfoundland and Labrador, Canada. EH spends approximately CAD $400,000 annually in procurement of quality control material. To reduce such expenditure, a project on cost analysis of current quality control practices was initiated.

Work was organized according to the Six Sigma DMAIC process (Divided into 5 phases; Define, Measure, Analyze, Improvement and Control) and is organized accordingly in the following. During the Define phase: The Work Breakdown Structure was developed to organize the work plan. SWOT analysis(To assess Strength, Weakness, Opportunity, Threats related to the project), a SIPOC (Supplier, Input, Process, Output, Customer) Diagram to detail processes, and a Critical to Quality (CTQ) tree to relate improvement actions to requirements, were developed to understand the workflow of the laboratories. Biweekly regular Starburst Brainstorming sessions were organized to discuss the process map of the work. During the Measure phase: There was review of existing quality control strategies and determination of defects related to these processes. Several defects were identified, which included a sub-optimized test menu on analyzers involving programming of several low volume tests placed on multiple analyzers within the same site and several low workload routine tests were performed at multiple laboratory sites. The quality control frequency was not based on number of tests received. Furthermore, there was excessive repeating of quality control samples and a higher than required number of calibrations for these chemistries. Analyze Phase: Data on these defects was collected, compiled, and analyzed. Changes in processes were suggested and risk assessment was done for the suggested changes by Failure Modes and Effects Analysis (FMEA). During the Improvement Phase: An Individualized Quality Control Plan (IQCP) was developed involving redesigning of quality control processes (4), redrafting of standard operating procedures, developing new quality control algorithm, organizing quality control huddles for all technologists and collection of data on preventable wastage and cost savings. In Control Phase: Monitoring of the effectiveness of new modified procedures and assessment of cost savings on procurement processes was completed. We observed, 25 -50 % annual reduction in usage and procurement costs for quality control material depending upon type of material used and up to 40 % reduction in usage of calibrators. Estimated savings on procurement of calibrators was up to 60 %. This shows that Lean Six Sigma methods can be used to investigate wastes and variability within processes that can be minimized for improving clinical laboratory efficiency and reducing expenditures.

The results from this pilot study were significant and we further propose to implement the optimized quality control plan at other sites in our network as future projects.


  1. Meredith JR, Shafer SM. Operations Management for MBAs. 5th ed. Hoboken, NJ: John Wiley & Sons, Inc; 2013. pages 171-181,197,198.
  2. Inal T C et al. Lean six sigma methodologies improve clinical laboratory efficiency and reduce TAT.J Clin Lab Anal. 2018;32: e22180.
  3. White S K. What is Lean Six Sigma? Blending methodologies to reduce waste and improve efficiency. Https://
  4. Westgard, J. O., & Westgard, S. A. (2019). Establishing evidence-based statistical quality control practices. American journal of clinical pathology, 151(4), 364-370.