Friday, September 30, 2011

Defining Work Stations and Teams

The role of leaders is to talk with those who actually do the work and diagram just what these 'work stations' are and what they do. Our definition of 'work stations' in healthcare are semi-autonomous and multi-skilled work teams along the path of workflow that contribute to a task, service or product that is used by or serves another group in the workplace. You are now creating a Work Process Flow Map, understanding what is done so you can create reporting structure for change. The next steps will allow you to understand what is done that adds value, doesn’t add value but is required or what is done that is of no value and can be changed. With more detail about each process in that work station, you are creating a Value Stream Map. The level of detail required to understand wasteful and inefficient processes may include cycle time, set up time, the number people/staff/shifts, the volume/batch size, the defect rate, measures of reliability, and identifiable defects and bottlenecks.




The structure should define work as it is done or contributed to or passed to numerous contributors. How do you get to this point?  Here's a suggestion. Tape a long piece of butcher paper to the wall and begin diagramming the flow of your product or service to follow the patient, or the specimen or the invoice, etc, sequentially, until you are finished with all you can do. That is your workstation. Align and connect these workstations horizontally and identify team leaders and members for each workstation. You may identify inefficiencies of work looping back to the same workstation or forking to two different workstations for no good reason. These are opportunities for workflow redesign.

The identification of a Team Leader, if none already exists, may be accomplished in a number of ways. This includes appointment by ability, by passion or by vote of the work station members. The option to bypass a non-effective Lean team leader with the appointment of a co-leader should be noted as a dysfunctional team is a significant barrier and the role of the team leader is often key to success. For areas with multiple shifts, it is important to have a team leader for the workstation on each shift so that the input and voice of all workers can be channeled for continuous improvements.

Tuesday, September 27, 2011

Defining Reporting Relationships for Accountability

In the Henry Ford Production System, we have adapted to our healthcare environment the best of several structures (see figure below): 1) Toyota's line-level organizational structure for quality improvement using Group Leaders, Team Leaders and their respective Team Members aligned with 'work stations'; 2) Team Members empowered to represent their team in Customer-Supplier meetings in the interface as work is passed across work stations, units, departments and hospitals; and 3) Process improvements lead not by the Team Leader as in Toyota but by the empowered healthcare Team Members themselves. This requires leaders to adopt the Deming-style of management rather than merely applying the principles and using the tools of Toyota's efficient production system in focused projects. 



That organizational structure is depicted in the cartoon below for continuous improvement linking numerous multidisciplinary workstations and teams at the level of the worker. It is expanded for the work designated "Initial Patient Evaluation" into further sequential Teams along that path of workflow contributing to "Initial Evaluation." If there is no designated Team Leaders, for these 'work stations,' make sure that there are. The designation of a Team Leader for process improvement is an HR-free one, that is, it requires no Human Resources Department permission. I view this role as an expansion of the job description duty usually listed as - "other duties as assigned". In an effective Lean culture that "other" box can and should become very large. This person is key and is tasked with driving and facilitating the team-based approach to process improvements at the level of the actual work. 


Sunday, September 25, 2011

The Transformation Process

The process of transforming to a structured culture of continuous quality improvement is a defined one in Toyota. It begins with training of top management, agreement and definition of the quality mission and goals, team leader training in process improvement, identification of quality targets, then learning by doing at the 'shop floor' level in a model line area. In this scheme it is the Team Leader who is responsible for immediate patch fixes on the shop floor and more sustained process redesign through data-based PDCA change. The team member, who is on the automated line, is responsible for calling attention to the defects encountered or stopping the line so they can be fixed.


In healthcare, we don’t have a shop floor or an automated model line producing cars. But we do have analogous opportunities for highly educated and trained workers themselves, not just Team Leaders, to become engaged in the process of improvement at the level of the work, wherever that may be-- at the bedside, the clinic, the laboratory bench, the radiology suite, the emergency room, the ICU, the OR, the kitchen, etc.

The figure below depicts our Henry Ford Production System (HFPS) model for cultural transformation in healthcare. First the leaders train as a cohesive group, then the team members are trained and are empowered to work together in a defined structure before 'learning by doing.'  We find it is far more effective to train the team rather than the individual. We also include the requirement for workplace metrics of performance expectation and variability that Team Leaders and Team Members own.  This serves to frame the ongoing identification of quality target goals for teams to achieve. A defined structure with Team Leaders and Customer-Supplier meetings fosters the ability of teams to improve processes horizontally as the work flows, across existing silos of control. Structure also enables us to more effectively succeed with key Deming management principles #6-#9 that foster managers and team members to behave differently when encountering problems that they can now resolve in a blameless manner.


6. Institute modern methods of training on the job
7. Institute modern methods of supervision & leadership
8. Drive out fear
9. Break down barriers between departments



Thursday, September 22, 2011

Structure and Teams That Promote a Culture of Continuous Improvement


"Start as soon as possible to construct with deliberate speed 
an organization to guide continual improvement of quality."            
- W. Edwards Deming

Lean success is sustained only when leaders and managers develop the environment, structures and aligned incentives to foster an educated and trained workforce that is empowered to work horizontally along the path of workflow. This is the key to obtaining the hundreds of small, granular process improvements done at the level of the work that the employees truly own.  A Lean culture is successful when workers are informed by metrics of work variation and empowered to make change, in concert with their leader, using the scientific method, e.g., data-driven PDCA.  Transformation to this culture of work and the structures designed to foster this manner of continuous process improvement by the workers are the responsibility of the leader. To begin a Lean journey without thinking through this structural element is toying with failure. Don’t do it.

In a true Lean management culture you don't have to have all the answers anymore. Your people do. The answers you provide are the organizational structure, reporting relationships, accountability, pace, recognition and reward and incentive to work in the new order. This approach to work allows you to tap the creativity from the workforce, continuously.

Without a structure though there will be potential chaos with so many anxious to use their newfound empowerment. Its one thing to tell someone they are empowered but quite something else to provide structure to ensure they behave in an empowered manner, respecting the existing order. This empowerment may range from serving as a leader of a defined work team, representing team members of customer-supplier meeting, or serving as a team member who consistently signals defective work and its causes through workplace whiteboards.

Toyota's production management system, the basis of Lean, is structured to thoroughly eliminate waste in pursuit of maximum cost reductions. That structure is defined by leadership and underscores the behavioral expectations that result in Toyota's culture. However, there is no direct translation from manufacturing and the structure and principles successful for Toyota's culture must be adapted from manufacturing to our own healthcare environments. Therefore, initial structural work is required of healthcare leaders in order to obtain success with the Lean management system. 

Saturday, September 17, 2011

Changing the Way People Work

Further Practical Tips in Producing Change in the Way People Work

The structures we create and the support we provide to sustain worker-involved change is critical to its success. Dr. Jeffrey Liker has nicely framed the key issues for leaders intent on truly changing culture that will result in "a business transformation that puts customers first and does this through developing people. People who do the work have to improve the work."

"As we are progressing on the 'Lean journey', companies are maturing from process-improvement toolkits to lean value-stream management, to employee engagement in problem solving, to aligned culture focused by self-aware leadership on the right business problems. The companies I teach are begging for guidance on leadership. They have had enough discussion of tools. They understand that path is a dead end. It is the right time for this discussion, but how do you have the discussion?

...There are tools, but they are not tools for 'improving the process.' They are tools for making problems visible and for helping people think about how to solve those problems. Whether it is a kanban or standardized work or 5S, these are tools to set a standard and make the deviation from the standard visible to the work group. Then the work group must develop problem-solving skills to identify the root cause and solve the real problem.

...Any solution is an experiment that is 'right half the time.' If the tools do not change the way people who do the work think about their own processes, the tools are a failure. If leaders do not understand how to use the tools to unleash the creativity and motivation of people, they are not leaders-they are just administering a bureaucratic process."

The Bottom Line

"You get what you accept and what you accept sets the standard."  -Joseph Bujak, MD

It is common to for leaders to speak of change in the same sentence with changing culture. But our own experience with culture change these past 6 years in the Henry Ford Production System across all laboratories of nearly 800 workers in Henry Ford Health System has taught us repeatedly that culture is a desirable but secondary outcome to changing structure and process that enables and expects employees to work differently.


It is the investment of time in training our people to work collaboratively in the structures that we create that enables a continuous push for incremental improvement. This is how leaders incentivize people to behave and ultimately defines our culture. 


Dr. Liker has shared with us that
"People development takes 10 times longer than process improvement."

So don't expect miracles from a Lean culture overnight. It takes time to train and form functional problem-solving teams. It's one small step after another that takes you toward the goal. Just never stop striving. 




References

Jeffrey K. Liker: Personal communication and book review at Lean Enterprise Institute of The Lean Manager: A Novel of Lean Transformation (2009, Balle and Balle)

Wednesday, September 14, 2011

Leader's Role in Leading Change

You Must Lead the Change

What is your role in leading change and assuring successful transformation to a Lean working culture? What is expected of you? What is the difference between leadership and management?

John Kotter, a voice of the Western management style, would say,
"Leadership is the development of vision and strategies, the alignment of relevant people behind those strategies, and the empowerment of individuals to make the vision happen, despite obstacles. This stands in contrast with management, which involves keeping the current system operating through planning, budgeting, organizing, staffing, controlling, and problem solving."

Both roles are very important to business success and we often wear both hats.

But Deming would call us to a different understanding for business success in the LEAN culture, notably his Principle #7- Adopt and Institute Leadership.  By leadership he means, 

"The job of management is not supervision, but leadership.  Management must work on sources of improvement, the intent of quality of product and of service, and on the translation of the intent into design and actual product."

In other words, your primary focus is overseeing the continuous development of a better system of work in which employees can be more effective in achieving the goals that you have assigned them. Otherwise, you're not doing the job. And they can’t be expected to do their jobs to your level of expectation in a flawed system of work.

To quote Deming again,  "The required transformation of Western style of management requires that managers be leaders."

Kotter's 8 Steps of Change

Change, especially significant change of the status quo is not easy. Everyone loves the idea of change for the better, until it’s his or her time to change. Kotter describes a number of managerial behaviors that are critical to succeed in producing change. When managers produce successful change of any significance in organizations, the effort is usually a time-consuming and highly complex 8-step process, never a 1-2-3, hit-and-run affair.  According to Kotter, managers who opportunistically skip steps or proceed in the wrong order rarely achieve their aspirations.

In the most successful change efforts, leaders must move through 8 complicated stages in which they (1) create a sense of urgency, (2) put together a strong enough team to direct the process, (3) create an appropriate vision, (4) communicate that new vision broadly, (5) empower employees to act on the vision, (6) produce sufficient short-term results to give their efforts credibility and to disempower the cynics, (7) build momentum and use that momentum to tackle the tougher change problems, and (8) anchor the new behavior in organizational culture.




References

W. Edwards Deming: Out of the Crisis. MIT Press 2000.
John P. Kotter: On What Leaders Really Do. Harvard Business School Press, 1999.

Monday, September 12, 2011

Constancy of Purpose

The Leader's Focus on Constancy of Purpose

Creating constancy of purpose towards improving work product and service levels is the basis of continual improvement.  This enables us to be competitive and to grow in a very tough healthcare market where patients and reimbursements are declining. Ultimately, this allows us to stay in business and to provide jobs.

This constancy of purpose is focused on the customer. Who are your customers?  Internal as well as external?  Who are your passing your work product to? What do they want?  What specifically are their needs and expectations?   How well are you serving them?  Are you just meeting minimum expectations and someone else's benchmarks or are you thrilling them? How do you know?

Constancy of purpose requires leaders to address:
  • philosophy and policy
  • core values
  • long term strategic course

    In the previous blog entry, I discussed the philosophy at the core of people development, supported by an appropriate management system that empowers the workforce to effectively employ technical tools of work efficiency and process improvement.  It is our role as leaders to reinforce this cultural transformation in the workers perception of their work roles, to create structures for empowered workers to be accountable and successful, to communicate, support, reward and model this culture of engaged workers, helping to identify and resolve defects and eliminate waste. Leaders must be engaged and lead from "the shop floor" to use the manufacturing analogy. It is from this perspective that opportunities for improvement become evident daily, at a very granular level. This leader engagement is more than just taking a walk-around to ask how things are going. 

    What To Do

    "Doing your best is not good enough. You have to know what to doThen do your best."
    -W. Edwards Deming

    As a leader, knowing what to do is the part each of you and your workers own in your area of expertise. That requires constant attention to refining what you do to be better, continually. For that you need a structure that provides accountability by defined teams for continual identification and correction of defective work and work processes in the workplace and at individual workstations where this occurs with on-going measures of how well you are performing. I will address the specifics of these topics with "how to" examples subsequently in this Lean Leaders Guerrilla Handbook series.



    References

    W. Edwards Deming: Out of the Crisis. MIT Press 2000.

    Saturday, September 10, 2011

    The Business Case for Change

    "If you don't like change, you will like irrelevance even less."
    - General Eric Shinseki

    Deming's Quality Chain Reaction

    Our business case for change lies in the sensitivity that "Learning is not compulsory, neither is survival" as Dr. Deming was fond of saying. Key to our survival strategy is Deming’s Quality Chain Reaction (figure below) where pursuit of quality by designing systems capable of people doing things right the first time increases productivity, decreases costs, and in turn lowers prices and increases profits and customer satisfaction.  This is the basis for creating a culture of continuous improvement and change that sees quality as more than a desirable outcome but as the foundation of a business strategy to remain competitive.


    The term Continuous Improvement connotes the ongoing nature of the strategy. According to Deming, Quality is not a state to be achieved but rather an ongoing company-wide effort at continual improvement.  This is THE PROCESS- the way everyone thinks, talks, works and acts every day. This is the definition of culture- the way we all behave.

    But don’t just listen to Deming's rationale for continual change. Henry Ford got it right almost 100 years ago:

    "Our own attitude is that we are charged with discovering the best way of doing everything, and that we must regard every process employed in manufacturing as purely experimental. If we reach a stage in production which seems remarkable as compared with what has gone before, then that is just a stage of production and nothing more."

    The success of this strategy is obvious in comparing organizations in which Continuous Improvement is at the core of their DNA. The Lean 20 is a list of Lean companies suggested by readers of Evolving Excellence and Superfactory. The Lean 20 Average of 12.71% is a simple average of the year to date performance of each company, which can be compared to the S&P 500. The 10 top performers returned 16- 32% more than the S&P 500 so far in 2010.



    References

    W. Edwards Deming: Out of the Crisis. MIT Press 2000.

    Thursday, September 8, 2011

    Begin With Philosophy That Promotes People

    A culture of Continuous Improvement is founded in philosophy, supported by a management system and operationalized by people working in structures that produce a daily focus by empowered workers on improving the work according to defined rules and principles. At the core of the Henry Ford Production System is the philosophy and management principles of Deming that foster respect for people and human development. This allows for a culture of respected, empowered and accountable employees who are recognized for their expertise and knowledge of the work that they do. The pillars of respect for people and continuous improvement underlie Toyota's Way. In the Henry Ford Production System, this is our way as well.

    The figure below illustrates these two core values of respect for people and continuous improvement that meld our development of people with a supportive management system and effective technical tools. This enables our empowered employees to achieve and maintain a stable and ever improving work state.

    The underlying cornerstones of behavior reiterate our tenets:

    1) Our promise to prioritize our patients' needs

    2) To be sensitive to each other as mutual customers and suppliers in our daily work, often being aware that functional work takes place horizontally not in vertical silos

    3) To be motivated and trusted to solve our own problems as empowered teams, based on data (PDCA)

    4) That the identification and resolution of problems is at the level of the work and that the worker is the expert in this domain

    5) That we will assume nothing but rather 'go and see' to understand the condition for ourselves before leaping to conclusions that may result ineffective solutions 

    6) That we take ownership for the quality of our work so that we never accept, make or pass a defect. Defect correction is rework, a time delay, a patient and customer dissatisfier and not a compensated task.


    Sunday, September 4, 2011

    Creating, Structuring and Sustaining a Culture of Continuous Improvement in Healthcare

    These words are meant for those who are tired of the status quo and intend to create, lead and manage a Lean enterprise based on a Deming-style management system.  I am not talking about accomplishing leader-prioritized Lean projects with selected tools but rather creating a culture of a healthcare workforce engaged, structured and incentivized to participate in the work of improvement at all levels. That is to say, a Lean enterprise, defined as a culture of continuous improvements made by empowered workers. 

    As of this writing, we have had the pleasure these past 6 years to lecture, train and share the story of our journey of continuous improvement all over the world. Most audiences see the results we describe, the standardization, and the visual artifacts of our way of working throughout the laboratories as the success. Initially, we described in the peer reviewed literature our plan to transform to a functional culture that allowed for continuous improvement (Transforming to a Quality Culture: The Henry Ford Production System, AJCP 2006;126(Suppl 1):S21-S29). We have learned much since that early plan. But it is that culture change and what we have learned in that quest that is the true success.

    As a product of the culture that we created, we have been transformed, leaders and workers alike. We have learned many lessons by doing, succeeding, failing, adjusting, reinventing, innovating and doing again. In reflection, we have performed continual and successive PDCA cycles in that transformation to a quality culture.  In this next series of blog entries, I will review our lessons in the implementation 'how to' create, structure and sustain a culture of continuous improvement in healthcare with parallels borrowed from Henry Ford, W. Edwards Deming, and the successful Toyota Motor manufacturing management system.

    We don't make cars in healthcare. We make people well and we work differently in a very complex environment of hand-offs with much variability. We don't have a 'shop floor' but we do have work as seen by those closest to it at the level of the 'bench' and at the level of the 'bed pan.'  Lessons from Lean must therefore be extrapolated to very different work conditions and professional relationships. This is hard work and requires understanding the best from others' work systems and innovating and adapting approaches that mine those successes to achieve our goal of transforming our healthcare culture.

    What will follow in subsequent blog entries are our lessons learned from first hand experience in creating an effective PDCA-based culture of continuous process improvement that aren't typically taught in Lean training courses. This is from the 'school of hard knocks.' I was intent on writing a book but I feel this is the most efficient way of sharing these lessons so others may adapt and implement successfully in their own environments as well. We don't have time to waste in American healthcare.

    I call this series that follows THE LEAN LEADERS GUERRILLA HANDBOOK.

    I hope it helps you.

    Let me hear from you so we can all learn something.

    Thursday, September 1, 2011

    On Leadership

    This editorial is reproduced from the  American Journal of Clinical Pathology (September 2010; 134:361-365) and outlines a call to arms, a manifesto, as in “a public declaration of principles, policies, or intentions, especially of a political nature." We who are trusted with the higher calling of healthcare must see that the people who are passionate in selflessly dedicating their lives to the well being of others can work in effective and safe systems. After all, "it's not systems that produce quality, its people who do." But systems are designed and lead by leaders and that is where one must start if anything will change from the status quo. Here are my observations and call for leaders to lead change in this most important human endeavor. After all, what will be said of our generation, what did we do with our time here? Maintain the status quo?  Not!


    Leaders Wanted: A Call to Change the Status Quo in Approaching Health Care, Once Again
    Richard J. Zarbo, MD, DMD
    (editorial from the American Journal of Clinical Pathology, September 2010)

    It has been more than 20 years since Don Berwick, MD, newly appointed administrator of the Centers for Medicare & Medicaid Services and well known as the CEO of the Institute for Healthcare Improvement, called for a change in American health care to a systems-based culture of continuous quality improvement (CQI). His seminal 1989 article, “Continuous Improvement as an Ideal in Health Care,” highlighted the then “new” (to us) Japanese concept of total quality control or total quality management (TQM) that has been idealized as a model of culture, management, and efficiency since the early 1990s.(1)

    The world’s most successful implementation of CQI is the Toyota Production System, now popularly referred to as LEAN or LEAN management. What we know of LEAN are professors’ descriptions during the past 20 years of Toyota’s culture, production system principles, work rules, and process improvement tools.(2-5) The LEAN philosophy at its heart is a culture underlying a core business strategy founded in the ideal of continuous improvement (kaizen) that is based on the knowledge of process variation. It is founded in the management system proposed by W. Edwards Deming, a management guru to the Japanese since the early 1950s, who was discovered late by Western businesses.(6) Looking at the recent decline of American automotive manufacturing, some would say too late.

    LEAN is a scientifically based approach to quality improvement predicated on the data-driven Plan-Do-Check- Act (PDCA) analytic, also known as the Shewhart or Deming Cycle, that was fairly ineffective 20 years ago in this country when practiced as TQM (Figure 1)

    Application of PDCA problem solving seems to be in resurgence, but successful application for change is highly variable, especially in health care. Toyota’s success during the past 50 years, rarely reproduced, derives from a leadership-driven management culture of continuous improvement that over many decades perfected the principles of Deming and innovated aspects of efficient production design with worker empowerment to produce thousands of process improvements, many at the level of the worker, year in and year out.(7) Toyota’s organizational structure and cultural expectations empower organized teams of employees to drive a daily examination of continuous improvement opportunities and learnings, thereby allowing them to be accountable, in charge of their own jobs, and allowed to design their standardized work. The result is CQI bread into the DNA of Toyota’s culture. This cultural transformation of work is what will be required in health care for the true power of LEAN to be leveraged. We failed to change our culture when attempting TQM 20 years ago, and the fate of LEAN will be no different. Transforming the culture of work or, more correctly, the employees’ incentives to relate to each other and work differently is a requirement to obtain success in a LEAN enterprise that is continuously learning and improving. This requires leadership, as only leaders can make this kind of significant change and support realignment of incentives so that workers in connected workstations are encouraged to work collaboratively and horizontally along the path of workflow. This is the only way to obtain the strengths of Toyota’s culture, namely: (1) employees in charge of their own jobs; (2) employees designing standardized work; and (3) employees working to continually improve the work at their own level, with changes made and effectiveness assessed by the customer-focused PDCA cycle.

    (Figure 1)
    The never-ending cycle of continuous improvement. The Shewhart or Deming cycle.

    At the core of continuous process improvement is a leader’s understanding of the consistency and reliability of the work product or service produced and the extension of that knowledge to empowered work teams. In other words, the leader’s focus should be on having real-time insight or metrics about in-process variation of work product or service that direct continuous process improvements. As the saying goes, If you can’t measure it, you can’t fix it! This is our challenge in medicine, how to understand what is occurring “in the shop” in real-time, at the level of each piece of work. Ironically, managers of the produce we purchase at the local grocery store are supported by more computerized information to make informed decisions in real time at the level of the individual head of cabbage than we have in most hospitals and laboratories. More often than not, because of paper-based or crude information systems that cannot communicate with each other, this requires manual collection of data, at the level of the worker, where the defects are encountered, to gain a deeper understanding of indicators that are “critical to quality.”

    Defects and waste in process are measures of variation. These are the twin enemies of quality. They are also the enemies of productivity and profit, for no one pays for second time rework and we are often not well paid for first-time work. Often not much is known about in-process variation leading to waste and poor quality. In the laboratory environment, we define a defect as a deviation from a predetermined outcome of a process, which is a flaw, an imperfection, or a deficiency in specimen processing requiring delaying or stopping work or returning work to the sender. These defects are noninterpretive defects critical to quality and trigger a series of reworks to satisfy set standards.

    Waste can be defined as an amount of time, resources, and human skills that were consumed but did not contribute to value addition in a product or service as it moved across a value-addition process. Waste can take the form of idle time between steps, duplication and rework for each step of a process, and nonutilization of human, organizational, and physical resources. In pursuit of a “zero-defects” performance goal in our quality culture, the Henry Ford Production System, we have designed novel and simple data collection tools to assess current conditions and sources of defects in the workplace to get a handle on these forms of waste and variation.(8,9) This method is applicable to any work environment where automated data are not available or sufficiently granular to lend insight into the detailed root causes of defective work.

    In their 1999 Harvard Business Review article, Decoding the DNA of the Toyota Production System, Spear and Bowen(3) described 4 work rules of LEAN. The first 3 rules deal with the extremely important reduction of variation through standardization of work activities, connections, and pathways. Measurement is the basis of the fourth rule dealing with how improvements are to be made. In this approach to work, problem solving is done by the workers to improve their own work, at the level where the work is done, guided by a teacher, using data, to move incrementally toward an ideal condition through continuous cycles of improvement. This is the scientific approach to problem solving and change based on the Deming Cycle, or PDCA (Plan, Do, Check, Act). Therefore, the fourth rule of LEAN work is founded in measurement that reveals to the manager and worker what is not going right or, in other words, insight into work variation. Notably, the fourth rule also calls for employee engagement, the basis of the team approach to quality improvement.

    So, how do the manager and the worker gain insight into the workplace variation that they own and they can change?

    For a manager to ensure a system’s consistency and reliability, it is vital to understand the level of variation (defects) in operations on a daily basis in order to focus efforts to bring work quality within predictable limits. This requires continually “feeling the pulse of the machine” so to speak, from assessment of daily metrics. This is the manager’s role in LEAN.

    There are essentially 3 types of metrics of value that indicate variation in an operation and that should be used as a basis of PDCA-based “scientifically” designed process improvements. The specific metrics, per se, are best determined by the need for leaders and empowered work teams to understand in real time the quality of work, namely the sources of defects and types of waste associated with the work for which they are accountable.

    What are these metrics?
    1. Defects that are handed to you by your “supplier”
    2. In-process defects that you make
    3. Defects that you hand off to your “customer.”

    The definition of the terms customer and supplier used here, although borrowed from manufacturing, are translatable to our own complex processes along the path of workflow in health care. Who passes work to you? (Your supplier.) You rely on your supplier for information, data, parts, tools, tasks, patients, etc. Who requests or gets work from you? (Your customer.) Are customers inside your section, division, or department (internal customers) or outside your sphere (external customers)?

    The use of daily metrics in feedback loops to guide quality initiatives that improve processes is illustrated in Figure2. For laboratories, these are the opportunities to understand preanalytic, intra-analytic, and postanalytic variation along the path of workflow.

    (Figure 2) 
    Customer feedback informing improvements.


    This systematic approach to work improvement is not new. In 1926, Henry Ford,(10) reflecting on the extremely efficient auto manufacturing business he created and that was an inspiration for Toyota, reflected that: “Our system of management is not a system at all; it consists of planning the methods of doing the work as well as the work.” The old way of doing business is to manage outcomes such as labeling defects and misidentifications by detecting defects after the fact. Inspection is a countermeasure when you cannot trust what you just produced, ordered, or received to be defect-free. Inspection itself is rework. It is far better to eliminate the need for inspection on a mass basis by building quality into the product (or service) in the first place. How do we do this? By constantly monitoring in-process feedback and customer feedback to understand variation. It is this “scientific” understanding of the workplace that allows work to be redesigned by educated managers and trained, empowered work teams who use LEAN work rules focused on standard work, workflow principles, and process improvement tools.

    Successful change of the status quo is highly dependent on effective leadership and follows from Deming’s call for managers and leaders to adopt the new philosophy of management. That philosophy is nicely summarized by Gabor(11) in The Man Who Discovered Quality: How W. Edwards Deming Brought the Quality Revolution to America.

    “In companies that have embraced Deming’s vision, management’s job is to ‘work on the system’ to achieve continual product and process improvement. The Deming-style manager must: 
    • Ensure a system’s consistency and reliability, by bringing
    • Level of variation in its operations within predictable limits, then by
    • Identifying opportunities for improvement, by
    • Enlisting the participation of every employee, and by
    • Giving subordinates the practical benefit of his experience and the help they need to chart improvement strategies.”

    By leveraging our investment in the creation of a LEAN managed culture and empowered employees, we have had much success in the large, integrated laboratory operations of the Henry Ford Health System, Detroit, MI. For example, in the surgical pathology division, within 1 year of roughly 100 process improvements, the number of cases with defects was reduced by 55% (including specimen receipt, specimen accessioning, grossing, histology slides, and slide recuts).(12) This number was further reduced by 91% after 2 years of LEAN management in the Henry Ford Production System. Patient safety also wins when there is a focus on waste and defect reduction and work simplification. Through the implementation of process redesign and bar code–specified work processes, laboratory misidentification defects were reduced by approximately 62% overall (95% reduction in slide misidentification defects while increasing technical throughput at the microtome stations by 125%).(13) 

    And we are never done, and we should never be satisfied with the status quo. In this quality culture, we have become our own benchmark for what is possible. All quality is local. What we do well today we can do better tomorrow. We need only ask: “What would you, as the patient (or customer), expect?” to guide our continuous improvement efforts.

    This brings us back to why TQM failed 20 years ago and why LEAN should not fail today. In fact, in personal conversations with Jeffrey Liker, MD, author of The Toyota Way(4) and Toyota Culture,(5) I am informed that 90% of organizations that try to adopt LEAN management fail. Why?

    Quite simply, it is very difficult to create and sustain a “Japanese-style” management culture within a “Western” management culture. People with more span of control will have more opportunity for significant change, but that does not mean that you should not try. It does mean that as a leader you must invest your time and efforts differently to change the status quo. As observed in the description of our own quality initiative, “Transforming to a Quality Culture: the Henry Ford Production System”(8): “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.”

    It is no stretch to look to the most successful business of manufacturing for health care solutions. Toyota’s culture that foremost values respect for people equally with continuous improvement most closely melds with the culture of health care that is invested heavily in well-trained but often uncoordinated care teams. According to Liker and Hoseus(5) 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.” Without the creation by leadership of an organizational structure and value system to encourage and support a bottom-up, worker-empowered culture of continual improvement, significant and sustained change à la the Toyota Production System with hundreds of process improvements is not possible; only sporadic leader directed projects, often prompted by crisis, and application of disconnected quality tools or focused but limited kaizen events will be seen.

    From my personal learnings during 5 years in promoting a LEAN culture in the laboratories of the Henry Ford Health System, this is how I see the required steps for leaders to transform to an effective PDCA-based culture of continuous process improvement in an existing non-LEAN culture, with my apologies to Deming and his 14 principles of management. Upper leadership and midlevel management must agree on and drive the following elements:

    1. There must  be one culture, one incentivized way of doing things. If there are too many models, silos are perpetuated and workers doubt sincerity of the change. Confusion results, and workers, unsure of what is expected, continually seek clarity about the direction. This lack of cultural coherence results in the conclusion that they are being subjected to another management fad of the month that can be dodged or outlasted. This is leadership failure. Welcome to Liker’s 90% of places that tried LEAN and failed!
    2. Leaders and managers must adopt the basic principles of management that allow the process- improvement model to work effectively across work units and business units in a horizontal manner as the work flows. A spirit of selfless collaboration enables the breakdown of the silos to achieve true horizontal management. Again, incentives must be realigned for the new behavior to become reality, and this must come from top management.
    3. Leaders must adopt their new role to continually work on the “system of work,” push the change with their “direct reports” and workers, and, by doing this, live by the new culture. Absent elements 1, 2, and 3, the remaining points are not sustainable. Stop now. You’re into lip service.
    4. Structure must be established to teach and adopt standard work rules that promote standardization of activities, connections, and pathways and allow empowered workers to implement PDCA-based process improvements with their established teams.
    5. Structure must be established to teach and adopt process improvement tools aimed at the chief enemies of quality, namely, variation, defects, and waste. Eventually, sufficient efficiencies will be achieved in workflow smoothing, work simplification, and just-in-time approaches to work, resulting in increased productivity, throughput, timeliness, and customer satisfaction with decreased rework and cost.
    6. Organizational structures must be created to sustain the preceding and recognize the value of engaged workers, their effective, collaborative teams, and their leaders.



    LEAN success does not result from merely training in the process-improvement tools; it is founded in culture and the empowered worker! We need more than a handful of foot soldiers trained in “boot camps.” Success will require effective battalions and brigades supported by impassioned generals. Success starts and ends with leadership. The current challenge for businesses of any type, and especially health care, is how to adopt the Deming style of management rather than merely how to apply the principles and use the tools of Toyota’s efficient production system. I have related my approach above.

    The key lesson from the TQM history in health care 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. Are you ready to lead?

    From the Department of Pathology and Laboratory Medicine, Henry Ford Health System, Detroit, MI.

    References
    1. Berwick DM. Continuous improvement as an ideal in health careN Engl J Med. 1989;320:53-56.
    2. Womack JP, Jones DT, Roos D. The Machine That Changed the World: The Story of Lean Production: How Japan’s Secret Weapon in the Global Auto Wars Will Revolutionize Western IndustryNew York, NY: Rawson Associates; 1990.
    3. Spear SJ, Bowen HK. Decoding the DNA of the Toyota Production SystemHarvard Bus Rev. September 1, 1999:96-106.
    4. Liker JK. The Toyota Way: 14 Management Principles From the World’s Greatest Manufacturer.New York, NY: McGraw-Hill; 2004.
    5. Liker JK, Hoseus M. Toyota Culture. The Heart and Soul of the Toyota Way. New York, NY: McGraw Hill; 2008.
    6. Deming WE. Out of the Crisis. Cambridge, MA: Massachusetts Institute of Technology; 1986.
    7. Ohno T. Toyota Production System: Beyond Large-Scale ProductionPortland, OR: Productivity Press; 1988.
    8. Zarbo RJ, D’Angelo R. Transforming to a quality culture: the Henry Ford Production SystemAm J Clin Pathol. 2006;126(suppl 1):S21-S29.
    9. D’Angelo R, Zarbo RJ. The Henry Ford Production System: measures of process defects and waste in surgical pathology as a basis for quality improvement initiativesAm J Clin Pathol 2007;128:423-429.
    10. Ford H. Today and TomorrowNew York, NY: Doubleday; 1926.
    11. Gabor A. The Man Who Discovered Quality: How W. Edwards Deming Brought the Quality Revolution to America: The Stories of FORD, XEROX, and GMNew York, NY: Times Books; 1990.
    12. Zarbo RJ, D’Angelo R. The Henry Ford Production System: effective reduction of process defects and waste in surgical pathology. Am J Clin Pathol. 2007;128:1015-1022.
    13. Zarbo RJ, Tuthill JM, D’Angelo R, et al. The Henry Ford Production System: reduction of surgical pathology in-process misidentification defects by bar code–specified work process standardization. Am J Clin Pathol. 2009;131:468-477.




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