The 'History', 'Why' and 'How' of Continuous Quality Improvement

To all of our LEAN Leaders-

The approaches to quality in healthcare have been derived largely from those in the manufacturing industry. Our quality journey in pathology and laboratory medicine can be traced from early quality control of clinical laboratory testing in the 1940s to proficiency testing in the 1970s, quality assurance and total quality management in the 1980s, and the 1990s parallels to industrial benchmarking, dashboard indicators, and more recently problem solving methods of six sigma and PDCA-based Lean. Some of this quality activity has been mandated by federal accreditation requirements through their dominant authorized lab accrediting bodies- the Joint Commission and the College of American Pathologists (CAP).

New to the United States hospital accreditation scene is the Norwegian Det Norske Veritas (DNV), that applies the International Standards Organization (ISO) based criteria for accreditation. It appears that ISO will play a major role in next phase of quality thinking in US hospitals and laboratories. To this end, voluntary ISO-based certification (ISO 15189 for lab) is now offered through the CAP.

After 20 years of driving quality as a lab leader, what follows is my perspective on why all leaders must create a foundation not only for the tools of quality but more importantly for sustaining cultures of quality by reinforcing quality-driven work practices and processes of the business that you oversee and those associated with your 'suppliers'. I write from the perspective of the laboratory business for our own leaders, but the principles are the same for any healthcare 'business' endeavor.

Current Methods of Problem Solving- Using the Scientific Method


The philosophy of continuous improvement is founded in Deming and was fairly ineffective 20 years ago in this country when introduced as 'total quality management'. Today what we know
by the term 'Lean' are professors' descriptions of Toyota's production system. The success of Toyota derives from a management culture of continuous improvement that over many decades perfected the principles of Deming and innovated aspects of efficient production design.

The challenge then, for other businesses of any type, and especially healthcare, is how to adopt that Deming-style of management rather than merely how to apply the principles and use the tools of Toyota's efficient production system. The key lesson from the TQM past is that what is really required for success is a change in culture- that is, the behavioral incentives that derive from the norms, values, belief systems, decision making processes, and political power bases that make an organization function. Anything less comes up short when the goal is to effect continuous process improvement. Why is that?

Toyota's success goes well beyond continuous flow processing and just-in-time production. Quite simply their organizational structure and cultural expectations empower organized teams of employees to drive a daily examination of continuous improvement opportunities, thereby allowing employees to be accountable, in charge of their own jobs and allowed to design their own standardized work. As described by Spear and Bowen, there are defined work rules that focus on standardization of work activities, standardized connections between customers and suppliers and standardized pathways for each service or product. With this discipline then, workers at the level where the work is done, are engaged in improving their own work, under the guidance of a teacher or team leader, using the data-driven Deming cycle (Plan, Do, Check, Act), aiming to continuously improve their product or service by constantly redesigning processes to eliminate sources of waste. The Toyota approach is designed to highlight problems in real time, where the work is performed, by getting to the root cause and by the person doing the job at the time the problem occurs.

That's it. Sounds simple but it is very difficult to create and sustain this 'Japanese' culture within a 'Western' management culture. Our friend Dr. Jeffrey Liker, author of The Toyota Way, tells us that 90% of organizations who try to adopt Lean management fail. Those leaders with more span of control will have more opportunity for significant change but that doesn't mean that you should not try to establish the culture of continual quality improvement in your domain. It does mean that as a leader you must invest your time and efforts differently to change the status quo. As we have observed before in our paper, Transforming to a Quality Culture: the Henry Ford Production System - "Toyota's success is the result of leadership and employee involvement. To be functional leaders, senior staff at Toyota must believe, drive, understand, and live the same training philosophy and employee empowerment that in turn reinforces the culture established by the original company founders."

Toyota's culture values respect for people equally with continuous improvement and therefore more closely melds with the culture of healthcare. According to Liker and Hoseus in Toyota Culture. The Heart and Soul of the Toyota Way, "Lean systems and structure is buried 2 levels down in Toyota's model and not the focus."

ToyotaCul 1

Steven Spears observes that- "The real challenge is to expand beyond understanding lean as a set of
tools, and more aggressively pursuing an understanding of the comprehensive approach to managing organizations so they are capable of self-diagnosis, learning, and relentless internally generated improvement and innovation."

Or as James Womack notes, "Observers confuse the tools and practices they see on their plant visits with the system itself. While various process-improvement tools and techniques are important, the underlying condition for a successful transition from conventional to lean manufacturing is the ability of an organization to create a unique culture that supports and stimulates continuous growth and improvement."

That culture is founded in Deming's ideas for management, summarized in his 14 points, that emphasizes creating a business culture that moves away from thinking about quality as a desirable outcome, to thinking about quality as a competitive strategy. This strategy of continual quality improvement as a driver of customer satisfaction, market share, productivity, and profits while reducing prices and costs is summarized in the so-called Deming Quality Chain Reaction.

DemingsQuality 2

Six Sigma

Six sigma is another popular manufacturing business-based quality improvement method developed at Allied Signal, perfected by Motorola, and effectively used by General Electric to satisfy customer requirements while enhancing profitability. Sigma is a performance metric referring to the variability defined by statistical deviations from the performance goal at the opportunity level. For example, six sigma (99.99966%yield) reflects 3.4 defects per million opportunities and is commonly accepted as a manufacturing goal. The problem solving approach of six sigma, inspired by the Deming cycle, is also based on measurement and data analysis and known by the acronym DMAIC -Define the problem, Measure the problem, Analyze the data, Improve, Control the process change. Six sigma is leader/management driven, focused on hard savings, measurement systems, statistical modeling and process control to reduce variation and defects and improve output. Unlike a Lean culture, an empowered workforce is not a part of a six sigma team. These teams are typically composed of an executive leader, the champion, the deployment champion, the project champion, and the black belt who is trained in the science of statistical process control. Also unlike Lean, that results in hundreds of small process focused incremental improvements, six sigma achieves results with large projects focused on financial return on investment. Six sigma tends to be a top driven process of
prioritizing and solving problems. As such, it's a less uncomfortable fit with the culture of healthcare where complex processes are best solved and sustained at the front-line by multi-disciplinary teams.

Lean-Six Sigma

The amalgamation of the disciplines of Lean and six sigma aims to reduce cost and meet customer requirements and stakeholder expectations by optimizing processes, reducing waste and improving quality by measuring and eliminating defects. The focus and approaches are different, as summarized in the 2 methodologies above.

My sense as a leader charged with creating and sustaining a culture is that this appears to be a consultant's convenience that combines 2 management philosophies and has no basis in practical organizational reality. So what's it gonna be? If you intend to establish and lead a culture of continual quality improvement, then choose! Worker empowered or leader driven change?