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Lean Six Sigma, innovation, and the change acceleration process can work together.

On the surface, the thought of "standardization" with Lean Six Sigma and the use of open or disruptive innovation to inject new and different methods of doing business seem contrary and almost mutually exclusive.

But in reality, the two methods go hand-in-hand, are complementary, and should become part of any health care strategic plan. The change acceleration process is a model that can be used to rapidly integrate the changes brought about by the use of innovation or Lean Six Sigma tools, and may help to make productive change a part of the strategic plan as well.

Lean Six Sigma

Lean Six Sigma is the blending of two distinct processes, Lean and Six Sigma, into a systematic effort to reduce waste and cost while simultaneously standardizing in order to achieve both quality and economic gains.

As a result of an increasing demand for transparency and reimbursements now being tied to quality, as well as the overall health care consumer quality movement, even the smallest hospitals are beginning to look at incorporating Lean Six Sigma practices into their operational and strategic plans.

Six Sigma was developed in large part by the Motorola Corporation in an effort to reduce its errors in performance, principally in manufacturing, to less than 3.4 errors per million. Although initially sought for standardization in manufacturing, it was quickly recognized that the standardization had utility for quality and potential cost savings throughout all the processes of Motorola's business, not just manufacturing.

It took nearly 20 years for this engineering and manufacturing process to be applied to health care, and one could argue that, based on the current medical error rates, it currently has not caught on broadly enough to realize its potential for improving patient safety.

In essence, Six Sigma is reducing the amount of variation around a mean. If your goal is zero hospital acquired infections in the ICU, then every infection begins to take you further from the desired mean of zero.

Engaging in Six Sigma usually requires that you know what question and desired result you intend to have up front. Deming approached quality with his plan, do, check, act cycle. General Electric took Deming's PDCA cycle even further by implementing a define, measure, analyze, design, and verify cycle (See Figure 1).


This process essentially outlines what Six Sigma will be applied to and consists of:

* Define--Defining service, product, process, or outcome that needs to be improved. What defines successful improvement? Is this from the customer's perspective, clinician's perspective, or administration's perspective?

* Measure--Evaluate the object to calculate or measure the item's performance.

* Analyze--Examine possible causes or weaknesses and develop benchmarks, best practices, and enablers as comparisons.

* Design--Develop a process of corrective action that enables the future state.

* Verify--Measure the new item with quantifiable metrics to ensure it meets the intended goal.

The other half of Lean Six Sigma is the Lean process. The development of the Lean process as we know it today is generally credited to the Toyota Corporation, but the term itself is credited to James Womack.

Lean has at its functional heart the elimination of waste. Waste can create increased costs, but top-heavy processes can also create variation and in turn reduce quality. Lean techniques are used to streamline those processes based on these simple principles:

* Value--Create value by examining what is important to the end-user or customer.

* Value Stream--Understand and determine which steps in the process add value and which do not.

* Flow--Keep a forward momentum throughout the process and eliminate waste or delays.

* Pull--Avoid making a surplus or storehouse of product and allow customer demand to pull the product and determine the supply.

* Strive for Perfection--The optimum level of performance is determined by the level of perfected product, which may require continuous pursuit of improvements or refinements of the process to achieve.

Putting the two concepts together, Lean and Six Sigma allow the removal of waste, streamlining of processes, and standardization of those processes to allow both decreased cost and increase in quality. These are certainly valuable goals in delivery of health care.

But succeeding in business, including the business of health care, involves more than just being the best at what you do today, but also what you will do tomorrow, It involves anticipation of key inflection points in the industry, changing your business and product lines to meet changing consumer demand, and bringing new and innovative processes into the business model in order to constantly pursue value.

This is why the pursuit of such concepts as disruptive and open innovation has come to the forefront of many Fortune 500 business models. In essence, you don't want to be the last guy still selling floppy disks when the industry has changed to CD-ROMs and USBs.


Harvard Business School professor and reknowned author Clayton Christensen popularized the term "innovation" in his book The Innovator's Dilemma, which has become an almost biblical canon in the business world, especially in the technology and Internet sectors where change happens quickly.

The essence of Christensen's book is that you have to serve your core business while simultaneously keeping an eye on new entrants into the market that are typically in your blind spot. Service lines have to accommodate to changes in the market, and those that find a niche can grow rapidly, and ignoring them comes with great peril to tomorrow's business.

One danger is the assumption that disruptive innovation has to be in the form of expensive "new" technologies or "out-of-the-box" thinking that creates a totally new business line. Although new technologies and new discoveries undoubtedly do create opportunities for new business and new growth, the majority of disruptive innovation occurs on a smaller scale, and changes the business model or service lines due to a change in market thinking or "inflection point."

A good example in medicine is the ankle X-ray. Two decades ago every patient that presented with ankle sprain got an X-ray. This was driven partly by the need to diagnose fracture, partly by fear of litigation for missed fractures, and partly by consumer expectations.

Today, only a moderate percentage of patients that present with an ankle sprain get an X-ray. This isn't because a new technology usurped the X-ray machine, but rather that evidence-based medicine and clinical protocols in the form of the Ottawa Ankle Rules showed that an X-ray was not necessary in many cases.

The Ottawa Ankle Rules were a "disruptive innovation" for how we treat ankle sprains. The application of the Ottawa Ankle Rules in the emergency department by each clinician in the same fashion via clinical practice guidelines are a form of Six Sigma standardization in clinical practice.

The ability for the nurse to triage the patient who walked into the department with a complaint of ankle pain either to X-ray or away from X-ray is a form of Lean process.

Marriage of Lean Six Sigma and innovation

It's clear that Lean Six Sigma and innovation can co-exist and are not mutually exclusive, and in fact are vital components to the bottom line equation of quality, cost, and value.

Marrying the two concepts is not difficult, but takes a commitment by those in management to incorporate the changes that they bring about into the operational strategy, and ensure that the implementers understand and accept the main purpose and goal.

Middle management and department heads typically don't respond to change for the sake of change, but change to stay ahead of the competition or to increase patient safety are tangible goals they can understand and commit themselves to enacting. In the health care setting, this combined model is especially important.

Let's look at a current issue: the radiation exposure and potential carcinogenic effects of multiple CT scans. Recent evidence has warned about the routine overuse of CT to make a diagnosis, especially in the pediatric and young adult population, due to the radiation exposure and the potential for cancers to occur as a result of that exposure.

This represents a key inflection point. The consumer (patient) will demand a decrease in this risk of radiation exposure due to overuse of the CT technology. The medical industry will respond with either new technologies, procedures, clinical protocols, or some other method to address this consumer and market demand.

Once validated by evidence-based medicine and agreement that this new low-radiation technology or improved protocol meets acceptable standards, the demand from the consumer will be high. The astute hospital or clinic would have a method to incorporate this new innovation into its business model or service line.

In order to ensure uniform application and high-quality service, protocols would be established to standardize how this innovation would be used, either in the form of checklists or clinical practice guidelines.

The entire process from patient referral to execution of the new innovation would be streamlined to eliminate waste or unrecouped costs so as to maximize the profit margin for the hospital without pricing themselves out of the competitive market. This would be an example of a successful application of innovation and Lean Six Sigma.

But throwing words like innovation around in the staff or strategic planning meeting does not give your team clear guidance for how these systematic processes will be used, so it is absolutely necessary that the leadership be trained in these processes to at least the "champion" level and that the strategic plan outline how these will be used in the business model (See Figure 2).


Change is difficult for any organization, but accelerated change in response to the market changes requires the leadership to employ a purposeful method to gain acceptance and guarantee effective results. The change acceleration process model is one such method that is used for this purpose.

Change acceleration process

GE uses the change acceleration process (CAP) to transform how people accept, operate, and employ new business strategies. This CAP model allows GE to manage how change in its business model is implemented, allowing it to respond and adapt to new innovations more quickly, and incorporate those innovations into its quality and Lean Six Sigma processes. It is essentially a culture change process, but one that relies heavily on champions and communication to get buy-in from the end users quickly.

Resistance to change can be high, particularly among physicians. The implementation of a new electronic medical record (EMR) is probably the best example in the health care industry. With so many positives, both in terms of patient safety and business structure, it would seem that implementing a new EMR would have little or no resistance by the staff.

But anyone who has strapped on this task knows that it is anything but easy. Is it innovative? Absolutely. Does it incorporate the standardization of Lean Six Sigma? You bet. But very often it lacks acceptance by the end user, and GE recognized that the success or failure of a new business project had as much to do with acceptance as it did with the quality of the technical work.

This is represented by GE by the equation Q x A = E, where "Q" represents the quality of the technical work, "A" represents the acceptance of the change, and "E" is the effective results.

General Electric uses the methodical structure of the CAP model to shepherd "change" in order to overcome resistance and gain acceptance of the changed processes for faster implementation into its business practices (See Figure 3).


In the end, the pursuit of patient safety, higher quality, and effective business models necessitate the use of many different techniques that are available in the industrial, health care, and business industries.

These techniques are not mutually exclusive, and they can be combined into an effective strategy to increase quality, lower waste, and accelerate innovative changes into clinical practice and effective business models.

The key to the successful use of any tool is the support of the leadership structure behind it and the acceptance by those who have to implement it. The effective physician executive must become familiar with all of these tools and business techniques, and know how best to deploy them in their particular institution.

Changes on the horizon in the health care industry will cause key inflection points in both clinical and business practice, and this will necessitate that the physician executive embrace and become a champion of change.


1. Trusko BE, Pexton C, Harrington J and Gupta P. Improving Healthcare Quality and Cost with Six Sigma. FT Pres, April, 2007.

2. Womack JP and Jones DT. Lean Thinking: Banish Waste and Create Wealth in Your Corporation. Free Press, 2nd Ed, June, 2003.


J.D. Polk, DO, MS, MMM, CPE, FACOEP, is chief of space medicine for NASA.


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Title Annotation:Quality
Author:Polk, J.D.
Publication:Physician Executive
Geographic Code:1USA
Date:Jan 1, 2011
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