NC State of Business

Organizations often seek opportunities to improve their competitive advantage within their respective industries. Many organizations struggle to accomplish this goal without the use of a systematic approach to improve their organizational performance as it relates to quality products or services. Lean and Six Sigma are proven quality techniques that can help improve organizational performance. Although most organizations want to improve quality and cut costs, the deployment and implementation of continuous improvement methodologies is commonly viewed as a daunting undertaking.

For various reasons, some organizations focus their efforts on implementing Lean concepts, while others focus their efforts towards the implementation of Six Sigma methodologies. Lean is considered to be a systematic approach of eliminating waste in all processes of an organization and is based on the Toyota Production System (TPS). The term Six Sigma was coined by engineers at Motorola in the 1980’s which focuses primarily on reducing variation within a manufacturing or business process. Six Sigma improvements are based on a structured problem-solving methodology which requires project management skills.

Many organizations seem to find the appropriate balance of integrating both Lean and Six Sigma within their organizations to achieve optimal improvement performance. The term Lean Six Sigma represents this collaborative approach. By incorporating the tools and concepts of Lean into the structured DMAIC (Define, Measure, Analyze, Improve and Control) framework of Six Sigma, organizations are reaping the benefits of two very powerful and effective quality improvement methodologies.

In this blog, Marianne Jackson, a physician that has recently emerged herself into the Toyota Production System (TPS) or ‘lean’ philosophy for continuous improvement, explores a very important subject of engaging physicians into lean transformation. Specifically, she focuses her thoughts around the subject of standardization and its meaning to physicians. Not only this subject is relevant and important, but it challenges us to search for common ground to exchange and share knowledge with physicians in one industry in serious operational crisis – healthcare.

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Immersed as I am now in Lean literature and methodology, it is sometimes hard to recall my first reactions as a physician to the words Standardization and Compliance. I am reminded, however, of my negative reflexes when I see the responses of physicians who attend Lean educational sessions. Those who are following along contentedly through Value Stream Mapping and A3s suddenly throw up walls of defensiveness when they hear Standardization and Compliance.

The response of Quality Assurance staff and facilitators often is to become frustrated and critical of us physicians for being too conservative and wedded to our autonomy. They may proceed with improvement efforts without physician participation. I’d like to explore the physician context and in so doing, suggest means for introducing Standardization and Compliance in ways that physicians can accept because physician engagement is critical to the success of the majority of Lean Healthcare transformations.

Lean has only been aggressively adapted to the healthcare market for about a decade. We promoters understand it to be an integrated approach to improving processes and systems using the innovations of all of the workers who touch the process, top to bottom and bottom to top. Prior to Lean, quality initiatives came strictly from the top and often from outside the hospital walls. Regulatory agencies developed and imposed “standards” and only negative indicators of poor outcomes such as infection rates, low APGAR scores and returns to OR without the input of those who provided the care.

Enforcement of “standards” or compliance was given to the Quality Control Officer (intimidating language) whose job it was to comb through charts finding the omissions, failures and faults in order to display them for the Medical Staff for review and report to the Board. Such statistical methods applied to very small sample sizes and minimally meaningful indicators created anger and rejection of the process among medical staff. For example, a physician who had saved a life by diagnosing a post-operative bleed, who took the patient back to the OR was “dinged” and judged as culpable by the indicators. Many of these practices continue today. If an error is caught in a non-Lean regulatory environment, what are the incentives to identify and disclose it if you are going to be penalized?

Physicians work with many sharply competing incentives. Reduce costs, see more patients, make no errors, document to satisfy even the harshest malpractice lawyer, be compassionate, spend more time with all patients, screen for seatbelt or tobacco use, complete required authorizations for HMO’s, coordinate care with all providers, and be prepared to respond to any emergencies. We will resist Standards if they feel like another burdensome injunction to “remember to do” one more thing that is going to be measured.

On being introduced to Lean, physicians are likely to think of it is a means of meeting current reporting requirements while we know it can have much greater impact. I saw a recent example at Scotland Memorial Hospital in Laurinburg. Surgeons began using Lean to investigate why they had deficiencies in meeting SCIPS DVT prophylaxis indicators and why orders for heparin were omitted. When they went on a Gemba walk they discovered the many wastes in their whole pre-operative admission process. They discovered how Lean methodology could be used to simplify, not burden their practices. They discovered how standardization is about having resources, routines and safeguards in place that protect their practice of medicine. Simple examples of standards and routines include having laboratory results reported in an accurate and timely manner, for having outside records available prior to consults, for medication refills ready for signing after checking for allergies, for check lists for pre surgical authorizations and registrations. These examples and others can demonstrate how standardized work can avoid errors, redundancy, waiting, and rework while simplifying medical practice but not constraining it.

To engage physicians, emphasize that Lean Methodology is devoted to establishing processes throughout an organization that reliably support the physician’s efforts. Demonstrate how standardization links the physicians’ work to those who come before and after in the sequence. Compliance with standard work is a means of confidently controlling the mundane work and focusing the physician’s efforts on the exceptional and unusual cases. Physicians will see that the processes associated with standard work assist them to provide individualized care and responsiveness to unpredictable need.

For assurance, we should emphasize what Lean is not – it is not a means of controlling, policing or punishing. It is not a set of Do’s to remember. It is not a denial of individual patient or physician needs. It is not strictly an efficiency tool. And it is not the enemy of innovation. Atul Gawande, MD, in his outstanding book “Better” examines several stories of clinics and practitioners whose outstanding outcomes are many percentage points above the expected. He challenges us to look at that variability for the sources of true excellence. Compliance with standards by everyone in the workflow is not going to eliminate all variability or stifle innovation but it will provide an unprecedented level of support and stability to highly competent physicians who will be able to focus on excellence.

We physicians are not necessarily resistant or obstructionist when it comes to Lean or quality improvement efforts. The Lean transformations of Virginia Mason and Theda Care were led by physicians. Engaging physicians is critical for success in Lean Healthcare. As a facilitator, sensei or change agent, success will be when you find the ways to align the Lean principles with the physicians’ goals – they are not incompatible. The true transformation in the medical culture will be achieved when this alignment results in trust and cooperation among all providers of patients’ care.

Written by Marianne Jackson, MD, MPH
Forwarded by Lukasz Mazur, Ph.D.

Recently I was asked whether formal Quality Management Systems like ISO 9001, and programs like Lean and Six Sigma can work together effectively. Many people think that there are conflicts between the goals of ISO 9001 and the goals of Lean and Six Sigma. In reality, the goals of the three programs are generally the same – to continually improve processes, remove waste and non-value added activities, reduce process variation and enhance customer satisfaction.

We know that a quality management system like ISO 9001 (or AS9100, TS16949, etc.) provides the basic framework for managing a company’s processes as an integrated system with the goal of enhancing customer satisfaction. The standard requires that the processes must be defined and “criteria and methods” must be determined to “ensure that the operation and control of the processes are effective.” The standard also requires that the quality management system be continuously improved and suggests potential sources of improvement will come from the corrective and preventive action (CAPA) programs. This is where Six Sigma and Lean programs can add value and be integrated into the ISO 9001 program.

Six Sigma emphasizes the Define, Measure, Analyze, Improve, and Control (DMAIC) process for continual improvement. The focus of DMAIC is to define potential process problems, measure the processes to determine the critical factors which affect process performance, analyze the data and look for root causes, improve the process by implementing actions to fix the root cause problems and implement controls to “sustain the gains”. It is not much of a stretch to see that a well managed Six Sigma process would provide potential preventive actions for the CAPA program and could be a method to solve some of the recurring Corrective Actions.

Actually, in analyzing the language of the ISO 9001 standard, you will find that it has some terms in commom with the DMAIC process. There is a section in the standard titled “Measurement, analysis and improvement” which is the middle three steps of the DMAIC process. Control is required throughout the standard, specifically addressing monitoring and measurement activities and the use of monitoring and measurement equipment to provide the “controlled conditions” necessary for the effective operation of the processes. A Define focus is implied throughout the standard in determining the processes and their interactions, defining the root causes of problems and potential problems, and in reviewing the data collected for potential process problems.

So how does lean fit in? We know that Lean is focused on eliminating waste and non-value added steps in processes. Exploring the language of the standard again, we can find where the company is required to determine the processes needed for the quality management system and their application, sequence and interaction throughout the organization. Lean tools like Value Stream Mapping could be a robust way to address this requirement. We can look at the control of non-conforming materials requirements to see the importance of eliminating the waste of rejected parts. The Corrective/Preventive action program requirements seek to further eliminate waste by identifying and correcting product or process problems. Overall ISO 9001 requirements for Customer Focus and Continual Improvement align with the Lean enterprise focus on satisfying the customer and continuous improvement.

Integrating your ISO 9001, Lean and Six Sigma programs will align all your process improvement initiatives and increase the success of your business management system. This should lead to common goals instead of conflicting goals and, in the long run, increase the effectiveness and efficiency of your organization.

This week I happened to be working as a Lean Six Sigma facilitator. It was the second week of a client’s on-site Green Belt training series. One of my favorite activities is when we hear team presentations from our training lab as well as presentations from the new and in-process company projects.

After several days of introducing powerful data analysis and optimization tools such as hypothesis testing and design of experiments, we ask the program participants to display and explain how they defined, measured, analyzed, improved, and controlled the problem process presented to them at the start of the training.

Since the tools are new, we always see interesting ways teams attempt to apply them and interpret results. I can never remember this exactly, but there is a good story our Lean Six Sigma team manager often tells about how a large statistical analysis software firm executive describes two key aspects of a project.

When you are collecting and analyzing the problem processes, reading graphs, making discovery and judgments, and developing solutions; he relates that to the work of a crime scene investigator. It is really all about knowing what you are doing technically, ruling out possibilities, getting to a root cause, and identifying solutions.

On the other hand, when it is time to present your results to management, he says you must be similar to a prosecuting attorney often putting on a case for investing thousands of dollars now to save millions over time. Weak and confusing presentations can often discredit months of great Lean Six Sigma work. Executives often care little about multiple presentation slides of complex graphs from statistical packages even though the Black Belt or Green Belt practitioner will carry great pride in his or her proper use of a critical analysis tool.

Lean Six Sigma presentations are not unlike any other displays of information for discussion. We must work very hard to consider practical concerns of the audience. Although the “devil may be in the details”, it is okay to leave him there and put more effort into your interpretation as to what must now be done to realize those bottom-line savings. You did promise them at the beginning of your project...

Okay, the New Year's parties have been over for a week and we're back to ... what, exactly? This time last year, we knew the election was coming; now, the new administration is coming. This time last year the stock market was riding high; now, many of us are poorer than we were a year ago because of how far the market has fallen.

We're starting off 2009 with a lot of questions we didn't have when 2008 started.

• - How hard will this year be?
• - How long will this recession last, and how quickly will our economy recover?
• - What can we do, individually and together, to protect our families, our businesses and our investments?

With all the uncertainties around us, it seems the standard New Year's resolutions may not apply. Often we resolve to improve ourselves in some way, possibly by exercising more or eating better, only to find that our resolve isn't as strong as we'd like it to be. Sometimes we resolve to improve the world around us, maybe by supporting a charity or volunteering for a worthy cause. Those are still worthy things, but from the tone of recent news reports I get the impression that some people may be resolving only to survive the year.

I think that's the wrong attitude. This year will test our resolve, yes, but that's no reason to lower our expectations all the way to bare survival. We should be resolving to thrive -- not to follow the crowd, but to lead it, not to hope for the markets to improve but to dig in and do what we can to push them upward.

As the IES Executive Director, I've been thinking about what we at IES can do to go beyond "business as usual" to help our clients bull their way through this stagnant economy. We don't have a magic wand to wave to get funding or reduce healthcare costs or anything dramatic like that, and almost every client we touch reports significant savings or job retention -- so I think it comes down to how can we do better at what we already do well, and still remain good stewards of our clients' and the taxpayers' resources.

So I've decided on three resolutions for IES:

1. We will reduce our operating costs as much as we can and still provide excellent service to our clients. We'll reduce our travel, postpone buying new computers or equipment, and that sort of thing before we impact our people. In fact, if things get too hard I'll ask for volunteers to take short furloughs before I think about downsizing.
2. We will develop at least one small-scale, fast, super-low-cost on-site service based on lean or Six Sigma principles to offer clients quick results at minimal cost. (Thanks to Steve Swain, our automobile industry expert, for that idea.)
3. We will look for new opportunities to serve more North Carolina industries -- and IES will become a meaningful presence in at least one underserved industry sector this year.

I know I can't do these things alone, and I'm glad I don't have to: I have a great team of dedicated people at IES and I'm proud of every one of them. And together, we're going to make it a good year.

And I hope you will, too.