Dr Lee is a maternal-fetal medicine specialist at Northwest Perinatal Center, Women’s Healthcare Associates, LLC, Portland, Oregon.

Thomas Lee, MD, MBA

	Clinicians' efforts to help our patients are increasingly being hampered by the global systems in which we practice. Metrics addressing quality, cost, and patient satisfaction often conflict with our desires for work-life balance, appropriate financial remuneration, and job satisfaction. Add to this the never-ending changes in healthcare reimbursement, billing and documentation requirements, and regulatory considerations, and it is not surprising that a majority of clinicians in the United States report flagging morale.

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	Significant changes in how we practice medicine are urgently needed if we are to continue to provide compassionate, high-value care to our patients and their families within our current healthcare environment. While global healthcare reform may be beyond the scope of most clinicians, changing how one's practice operates and addresses the aforementioned issues is something that is more realistic and achievable.

	How do we as front-line care providers bring about significant change within our practices without formal training? The unfortunate reality is that healthcare operations are not typically taught during medical training, yet have increasingly become a part of our professional lives. This article is a high-level, non-MBA primer on the concepts of Lean and Six Sigma process improvement techniques-concepts that may be increasingly referenced in your day-to-day administrative discussions. The concepts of Lean and Six Sigma can be used by clinicians on the front lines to begin to change how their practices operate. Improving the efficiency of our office practices by working smarter and not necessarily harder can enhance the experiences of our patients, provide them with high-value care, and improve the financial performance of our organizations.

	Lean and Six Sigma do not stand alone. Rather, they are essential components of a global approach to workflow and efficiency improvement. Table 1 is an example of a systematic approach to process improvement. Within this approach, Lean and Six Sigma reside within the "process improvement" phase.

	Standardization is the foundation for any process improvement initiative. Significant clinical variation is the enemy of efficiency. This is not to say that clinicians should not individualize care for select patients; however, the starting point for most patients should align with consensus-driven, evidence-based protocols. How to accomplish that is beyond the scope of this article, but progress on this issue needs to occur prior to addressing process efficiency.

	Lean production was initially developed by Taiichi Ohno at Toyota after World War II and originated from the company's just-in-time production practices as part of the Toyota production system. The conceptual origins of Lean can be traced back through history, from the standardized manufacture of crossbows seen under the Chinese emperor Qin Shi Huangdi in 221 BC to the automobile production lines developed by Henry Ford.

 Lean is fundamentally based upon the philosophy of 

, Japanese for "improvement." Kaizen involves employees at all levels working collectively toward incremental improvements. Since its introduction, the Lean production approach has been widely adopted in many commercial fields and it has also spread to healthcare.

	Lean's kaizen objective is to create a seamless flow to the production process by reducing wasteful steps that contribute to inefficiency. Within the Lean system, waste (known as 

) can take numerous forms (Table 2). When Lean process improvement is applied to healthcare, the steps involved in care delivery are individually examined as to whether they either 1) add value to the end goal, or 2) are wasteful and do not add value to the process. The ultimate goal of Lean process optimization is to eliminate those steps that do not add value to the delivery of care in your clinic-leading to a more streamlined, efficient workflow.

	Many concepts and tools within the Lean lexicon of process optimization can assist in identifying and eliminating waste. The following are a few basic tools to consider using as you start to minimize inefficiency.

	Value-stream mapping is a powerful Lean tool that combines process mapping and time data into a single view (Figure 1). Value-stream mapping lists the individual steps within a process in order to identify value-added steps and non-value-added steps that contribute to the process cycle times (the time it takes your staff to complete a task) and their associated wait times (the time your patients wait in between).

	Value-stream mapping formally documents the tasks your staff members are performing as part of the chain of care. When these tasks and actions (ie, processes) are then viewed in conjunction with their associated cycle times and wait times in this format, it should initiate discussion and raise questions such as 1) What actually is the process in our office? 2) Why are there variations among our staff members? 3) Are all these steps necessary? and 4) How do these processes contribute to the cycle times and wait times? Once you start asking these questions, the targets for process efficiency frequently become readily apparent.

	One of the key benefits of value-stream mapping is that it helps to identify actual problems in the workflow, rather than relying on perceived anecdotal notions that you or your staff may have about clinic inefficiency. Furthermore, it allows you to understand what your staff is doing, what your patients are experiencing, and where improvements can be made.

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	Unnecessary movement is a significant type of 

. A spaghetti diagram is a visual depiction of the movement of staff, patients, and supplies within an office. The benefit of a spaghetti diagram is to first identify and then minimize wasted or redundant movement within the office workflow. Insights from a spaghetti diagram may lead you to change where supplies are placed, where staff workspaces are located, or even the design of the office layout.

	Following a value-stream mapping exercise, a structured process called root-cause analysis is used to identify the factors that contribute to the non-value-added steps identified by the value-stream mapping. One type of root-cause analysis is the 5 Whys technique, which simply boils down to repeatedly asking the question “Why?” It is a way to peel away the layers of symptoms to uncover the root cause of a problem, since frequently the ostensible reason for a problem will lead you to another question.

 Usually about 5 rounds is a good rule of thumb. An advantage of the 5 Whys technique is that it is a simple tool that can be used without statistical analysis.

	Six Sigma was developed in the 1980s at Motorola as their in-house quality improvement initiative. The approach has since been adopted by many other organizations such as GE and IBM as part of their strategies to improve product and service quality. Six Sigma has also found a niche within many healthcare organizations as part of their quality improvement programs.

	The goal of Six Sigma is to eliminate defects by removing variance within manufacturing and business systems. In contrast to Lean, Six Sigma’s techniques for quality improvement place a much greater emphasis on data, statistical analysis, and mathematical modeling. In fact, the term 

 comes from the mathematical concept that maintaining 6 standard deviations of variation within the confines of the process tolerance limits will nearly eliminate products that fail to meet required specifications (with the goal of no more than 3.4 defects per million opportunities). Formal Six Sigma methodology incorporates the use of a martial-arts-like hierarchical organizational infrastructure (Figure 4) along with specialized training and certification to define the roles that each person plays within the Six Sigma process.

	While formal Six Sigma certification and its statistical methodology may be beyond the scope of most practicing clinicians, several tools may be useful in your approach to process improvement.

	A commonly used Six Sigma tool is the Define-Measure-Analyze-Improve-Control (DMAIC) cycle (Figure 5). The DMAIC cycle is composed of the following phases:

efine: understand the problem to be solved or the process to be improved.

easure: understand how the current state is meeting the clinic’s requirements.

nalyze: examine collected data to determine the influential variables.

mprove: identify solutions and implement.

ontrol: hardwire the changes to maintain the gains achieved.

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	Using this series of steps as a roadmap allows your team to systematically gain an understanding of the process that you are trying to improve and work toward a sustainable solution.

	Six Sigma employs 7 basic quality control tools to help maintain consistency of products and services. These tools were first popularized by Kauro Ishikawa, who believed that up to 95% of quality-related problems could be addressed with these fundamental tools.

	• Fishbone diagram: a cause-and-effect tool useful in root-cause analysis (Figure 6, online)

	• Check sheet: a custom data collection form to track quantitative and qualitative data on problems and defects in real time

	• Histogram: a graph to illustrate probability or frequency distributions

	• Pareto chart: a sorted histogram that focuses on the most influential factors; based upon the Pareto principle that 80% of costs, issues, or defects can be attributed to 20% of the items being measured

	• Scatter plot: a graph of the relationship between 2 factors, suggesting either causation or correlation

	• Run chart: a chronologic plot of a process metric, useful in examining trends

	Much of how all this business theory applies to healthcare may be overwhelming to a clinician or practice manager who does not have formal training in Lean or Six Sigma. The 2 approaches overlap substantially, and many organizations have advocated the use of Lean and Six Sigma philosophies and tools in tandem as what is known as 

. In this author’s opinion, the combined Lean Six Sigma approach is better for use within healthcare because it brings together the goals of Lean’s reduction of waste and Six Sigma’s reduction of process variability.

	Figure 8 is a conceptual illustration of how these 2 systems can be used together in the clinical realm. Imagine that points A and B represent the beginning and end of a clinical process such as seeing a patient for a LEEP. The steps involved in completing the procedure are represented by each oval (eg, check-in, notifying the MA, reviewing the chart and indications, setting up the procedure room, retrieving the patient, notifying the MD, etc.). Each step in the process is characterized by an “amplitude” that represents the variability for that specific step, since each staff member is likely to have a slightly different way of completing that task. In order to improve efficiency, Lean techniques can be used to eliminate wasteful (or non-value-added) steps and thereby reduce the overall length of the process. Six Sigma techniques can also be brought to bear on the process to reduce the workflow variation among staff members (through work standardization), which is represented by a reduction in the amplitude of the step. The end result is a more streamlined, less wasteful workflow for performing the LEEP, which is the ultimate goal of your efficiency improvement efforts.

	Lean and Six Sigma systems contain a wealth of tools and techniques that can be used to improve the quality and efficiency of your practice. Having a general understanding of the differences between Lean and Six Sigma along with how they can also work in synergy is the first step in getting started. Remember though that these tools do not stand alone and should be incorporated into a sequential approach that starts with development of an organizational strategic plan and a multidisciplinary process improvement team. Folding a DMAIC structure, value-stream mapping, and root-cause analyses into the efficiency improvement process comes later. However, knowledge of the tools you will have available when that time comes should give you confidence in taking that first step.

	With a good roadmap and the right tools, the goals of providing higher-value healthcare, increased patient and provider satisfaction, and improved financial performance are attainable for providers and offices on the front lines of care delivery. Resources are available for those who are inspired to rise to the challenge. ï¼

	1. Ray W, Norbeck T. Survey of 20,000 physicians reports morale still low, but slightly improving. 

 (2014 Oct 3). Retrieved February 14, 2016 from 

http://www.forbes.com/sites/physiciansfoundation/2014/10/03/survey-of-20000-physicians-reports-morale-stilllow-but-slightly-improving/#3304cd2724d5

	2. Hunt B. The history and simplicity of Lean process improvement. 

 (2009 July 7). Retrieved February 14, 2016 from 

http://www.processexcellencenetwork.com/lean-six-sigma-business-transformation/articles/the-history-and-simplicity-of-lean-process-improve/

. Chicago, IL: Health Administration Press; 2012.

	4. iSixSigma. (2015). Determine the Root Cause: 5 Whys. Retrieved July 2, 2015, from 

http://www.isixsigma.com/tools-templates/cause-effect/determine-root-cause-5-whys/

	5. Bandyopadhyay JK, Coppens K. Six Sigma approach to healthcare quality and productivity management. 

Int J Productivity and Quality Management

Articles

A look at how Lean and Six Sigma can help streamline medical practice.