Article Text
Abstract
Over the past year, Toyota has come under harsh scrutiny as a result of several recalls. These well publicized mishaps have not only done damage to Toyota's otherwise sterling reputation for quality but have also called into question the assertions from a phalanx of followers that Toyota's production system (generically referred to as TPS or Lean) is the best method by which to structure one's systems of operation. In this article, we discuss how Toyota, faced with the pressure to grow its business, did not appropriately cadence this growth with the continued development and maintenance of the process capabilities (vis a vis the development of human infrastructure) needed to adequately support that growth. We draw parallels between the pressure Toyota faced to grow its business and the pressure neurointerventional practices face to grow theirs, and offer a methodology to support that growth without sacrificing quality.
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Introduction
For decades, Toyota was regarded as the archetype of continuous improvement, boasting unparalleled quality and consistently increasing, record setting, sales. Over the past year, however, Toyota has come under harsh scrutiny as a result of recalls on several of the brand's models due to problems associated with accelerator pedals and braking systems. These well publicized mishaps have not only done damage to Toyota's otherwise sterling reputation for quality but have also called into question the assertions from a phalanx of followers that Toyota's production system (generically referred to as TPS or Lean) is the best method by which to structure one's systems of operation.
Some of the lingering questions borne from Toyota's recalls include: What did Toyota do wrong, and/or is the Toyota production system still a viable method to effect operational improvements? Having published an article on the Lean management system in this journal recently,1 we felt obligated to address these questions. Moreover, it is our thesis that the answers to these questions act to further strengthen the assertions we made in the aforementioned article and will further emphasize in this manuscript. It is our continued belief that the adoption of systems design to improve operational efficiency (using Lean as an example) will inure to the benefit of individual neurointerventional (NI) practices and the patients they serve.
Toyota's unmitigated growth
The early days of Toyota were marked by poor quality, inefficient production and limited variety in the vehicles they manufactured. To address these issues, Toyota focused on developing its workforce through a system of mentorship and rigorous learning. Toyota taught their employees to pay strict attention to each detail of the operation in an effort to identify potential flaws and to quickly structure mini experiments to address flaws in the production system once they were identified. As a natural byproduct of this learning and experimentation, Toyota developed a system of rapid and continuous process improvement, and it is this very system that allowed Toyota to emerge as the industry leader in quality and productivity.
However, in the late 1990s, Toyota's focus shifted from this system of mentorship and learning—what in this manuscript we refer to as developing human infrastructure—to one of business growth. As Toyota grew, so did the number of models Toyota produced, so did the number of suppliers Toyota contracted with and so did the complexity of the Toyota production environment. All this growth was built squarely on the capabilities of the Toyota workforce. Unfortunately, as recent events have demonstrated, the maintenance and development of those capabilities was not appropriately cadenced with the rate of growth. In fact, Toyota's president, Akio Toyoda, understood this fact when, shortly after assuming his position as president, on 23 June 2009, he indicated that the company would need to refocus on quality.2
Our healthcare reality
What we can glean from Toyota's stumble is that the capacity for developing one's workforce must control or at least be matched with the pace of growth. As difficult a proposition as this is in automotive manufacturing, it is likely more so in the healthcare industry, and more specifically in neurointerventional radiology (NIR). The Toyota workforce faced pressure to grow when its executive board, a relatively homogenous body, set the goal of raising its global market share from 11% to 15%3 without respect to any customer demand. This aggressive growth target “…meant that new products had to be introduced more quickly, new plants had to be opened more rapidly, and supply networks had to be expanded more aggressively”.4 The workforce became strained and crippled by a hubris borne of success5 and an overarching tendency for consensus; employees lost their ability to stop production when they become aware of errors and to think critically about their work.
NIR practice faces many and often analogous pressures, borne at times out of pragmatic necessity, as non-neuro based specialties begin to encroach on our practice and the potential for diminishing reimbursement rises, and out of our own desire to improve patient care. As technology used to treat patients improves, there is an anticipated, corresponding increase in the efficacy associated with treating higher acuity patients, which in turn increases the complexity of the treatment process. Finally, as the types of patients we are capable of treating expands, so to do our referral bases and exam volumes. This type of growth adds additional challenges to an already complex treatment environment. Our capacity to sustain this growth, and do so safety, effectively and in the best interests of the patient, is dependent on the capabilities of the staff operating in this treatment environment.
Develop the staff, before you treat the patient
The continual cultivation of staff capabilities, or development of human infrastructure, works best on a foundation of standard operating procedures and workplace organization. As we suggested in the first article in this series, the best and quickest way to improve practice, sustain growth and ensure safety for staff and patients is to begin with standardizing both the work processes and the environment in which these processes are conducted. We now advance that thesis to its next logical step; that considering the current and future state of our practice, it is essential to develop these skills in all staff role groups. This is a difficult proposition in any healthcare environment, not just NIR, for a number of reasons, including but not limited to: the longevity of the workforce, institutional history, intragroup social norms and, most importantly, the variability in treatment required by each individual patient. Due to these confounding factors many staff operating in such a treatment environment are reluctant to commit to any form of standardization for fear that it will hinder their ability to appropriately meet the needs of the patient. Their own previous experience with other efforts to standardize their work may have jaded them to this process.
Henry Ford put it best in his seminal work, Today and tomorrow where he stated that “Today's standardization…is the foundation upon which tomorrow's improvement will be based”. If you think of ‘standardization’ as the best way you know today, but which is to be improved tomorrow, you get somewhere. But if you think of standards as confining, then progress stops.6
Unfortunately, traditional efforts to standardize work processes in healthcare do not often follow the continuous improvement cycle that Mr Ford envisioned. Additionally, in a good number of cases, standardization efforts are motivated less by a desire to improve operations and staff performance but more so by the need to be compliant with outside regulatory bodies. These regulations impressed upon healthcare by outside agencies are often ambiguously defined, poorly understood and/or interpreted by management. As a result these may be simultaneously poorly implemented by management and enjoy little to no input from the staff who will need to comply with these regulations. As a result, there is often a general lack of understanding as to the need for and purpose of standardization. The result is such that education on the benefits of standardization is challenged from the start, leading to a workforce that is confused, potentially leading to suboptimal compliance. Essentially the staff is being asked to adjust their practice according to a standard they did not set, and whose rational they may not understand. Experience would suggest that, at best, this may not be ideal and in fact may not work.
We share a different approach to standardizing work processes and work environment that is aligned with the Lean philosophy. This method leverages the staff to both determine the standard and continually improve it.
Standardizing the continuous improvement of work processes
The concepts and principles of Lean management are being used more commonly in industries outside of automotive manufacturing.1 With that growing commonality is recognition of the difficulty associated with the sustainment of these Lean practices. Regardless of the industry or process improvement methodology leveraged, it is common to see an effort at improvement made and subsequently fall into disuse. Half implemented or abandoned process improvements have unintended consequences to long term quality, efficiency and, somewhat unique to our world, patient care. For those organizations that have successfully sustained long term and continuous improvements, the single most powerful component of ensuring those outcomes was the establishment of initial standards.7 Under the Lean philosophy, the most effective and sustainable method for developing and refining standards is to allow those doing the work to identify the best method.
Following the 3 day value stream mapping engagement described in our previous article,1 one of the first improvements implemented by the Massachusetts General Hospital NIR team was to develop the standards for work processes and the workplace environment. In order to accomplish this, clinical leadership delayed case start times on the days when these improvement activities would take place and backfilled staffing resources such that key frontline NIR team members would be able to participate in the establishment of the initial standards. For frontline staff, these acts demonstrated leadership sponsorship and commitment to standardization as both a benefit to patient care and as a mode to sustain their department's development. These values should pass to the workforce in an environment that supports mentoring and education of staff.
A multidisciplinary group of NIR staff representing various role groups were selected based on process knowledge, best practice workarounds and experience, and were offered the chance to volunteer for the standardization activities. Those staff members who volunteered to attend were provided education in the form of printed manuals and didactic presentation on the Lean standardization methodologies (5S and standard work) that they would be asked to employ. 5S and standard work are tools that foster leverage of human infrastructure.
5S
The concept of 5S was applied to the workplace environments and the tangible materials in it. This included procedural rooms, patient preparation areas and recovery areas. The latter was known for becoming increasingly chaotic as the work day progresses, a chaos often resulting from staff confusion with the time at which to expect patients returning from procedures, who on the care team was expected to do what for the patient and the frustration associated with not being able to locate supplies needed to recover the patients. 5S is a rational method for organization that seeks to bring order to the workplace environment. In its application, the steps in 5S are largely self-explanatory and sequential—sort, straighten, shine, standardize and sustain. Its application in our case went as follows.
Sort
Management and frontline staff sorted through over 600 pounds of excess inventory, paper clutter and irrelevant items, including boxes of syringes dating back to 1987 that were previously hidden from view (figure 1). During the sorting process items, deemed unnecessary were marked with red tags (figure 2). The red tags were used to indicate the reason why the item was unnecessary (not required, infrequent usage, aged/obsolete, too much stock/supply or other) and recommended action (replace, return to, discard, move to storage site). The name of the staff who flagged it, as well as the time it was red tagged were recorded. Red tagging is done first by each team member individually and then subsequently vetted with the entire group. All items that the group found to be unnecessary were temporarily stored in a location away from the immediate work site but within a reasonable distance such that if they were needed they could be easily acquired without compromising patient care. This temporary storage area was maintained for a period of 1 week before the ‘unnecessary items’ stored there were actually discarded. This temporary period allowed for further staff refinement of the materials they felt were needed at the work site.
Straighten
After sorting through the workplace materials to determine which were necessary, the second of the 5S's, straighten, was applied. In other words, items were given specific locations for storage between cases. These new ‘home’ locations were visually identified by labeling and shadow taping (ie, outline the physical shape of the items using tape on the location in/on which it is to be stored). Straightening the workplace is subsequently combined with a tertiary effort to shine the workplace (vide infra).
Shine
Shining ensures that all those in the areas can clearly see the visual management system created and identify ‘home’ locations for everything. To a large extent shining the workplace is already a common activity, but used in the context of Lean, 5S should afford cleaning staff a regular time and area to clean.
Standardize
Standardization is encouraged and requires the assignment of auditing responsibility to staff members. Each staff member is responsible for auditing the cleanliness and arrangement of the room based on the established standard. This creates a sense of workplace ownership and pride. To facilitate auditing responsibilities, a 5S audit sheet with photographs of the standard procedure room setup (see figure 3, 5S checklist) and dry erase communication boards were installed outside of both rooms to communicate status with compliance and suggestions for improvement. At the close of each week the tallied suggestions for improvement from the staff were reviewed with management and updated if appropriate.
Sustain
Instrumental to sustaining the 5S process is training and communication to all employees. 5S is collectively reviewed in a daily, 15 min ‘stand-up’ meeting and in addition to a weekly staff meeting. For us, daily ‘stand-up’ meetings are held in the hallway immediately outside of the procedural rooms and attended by not only the frontline staff but the Director of Operations, Director of Procedural Nursing and Medical Director for the NI service. At both daily and weekly staff meetings, 5S are discussed and reviewed as fundamental pillars of operational and individual improvement, all staff members are challenged and encouraged to get better by structuring mini experiments or ‘Kaizens’ around their workplace environment, the results of these improvement experiments are measured and decisions to keep the new work method are made at the group level. Examples include overhead storage bins, inventory par levels, supply room locations and cleanliness of equipment.
Standard work
The next step for the establishment of operational stability vis a vis the development of human infrastructure was to standardize the work process clusters within the NIR value stream. The entirety of NIR work processes included: scheduling, pre-procedure processing, pre-procedure patient prep, pre-procedure room prep, intra-procedural processing, post-procedural processing and post-procedural patient recovery.
Dedicated time was devoted (ie, a Kaizen was conducted) to identifying standard work for each process cluster. During these Kaizens, representatives from each role group (eg, physicians, technologists, nurses, etc) were brought together and given a short presentation on the importance of standard work, fundamentals of creating it and the work associated with sustaining it. The selected process cluster was then reviewed to ensure everyone had a full understanding of all the current process. After the current state was understood, the process was broken down into a series of important steps, or logical segments of the operation that advance the work. The important steps were then arranged into a sequence from the start of the process to its completion. Once each of the important steps had been sequenced, the team identified corresponding key points for and reasons why each step is executed. The key points associated with each step are an assemblage of specific domain knowledge or institutional knowledge that if the one doing the work is aware of, makes the completion of the identified important step easier. Management's job during these Kaizens was merely to ensure that the identified standards were compliant and did not sacrifice patient safety in the name of improved efficiency.
Associating reasons for performing each important step with each important step would seem superfluous to those without a full understanding of Lean. However, it is the essence of Lean that not only is it explicit how to perform the work but it is also clear why the work should be performed in this manner. The product of this effort was a work instruction sheet (WIS). This allowed the team to create a WIS, as seen in figure 4 below.
Creation of WIS allowed our team to reverse the typical industrial focus of process improvement to that of workforce development. Those individuals doing the daily work are the same individuals who identified operational problems and designed the solutions. To make these solutions stick, the NIR team used multiple approaches to ensure participation, feedback and continuous improvement of the standards. Not only did the frontline staff determine the best methods or standards, every frontline staff was also trained on the new methods. During this 10 day period, senior leadership conducted daily ‘leadership rounds’ to both ensure staff were using these practices but also to address any questions or concerns the staff may have. This allowed the staff adequate time to learn the new process and to make suggestions on how to further improve it. The staff was asked to document their recommendations on an electronic discussion forum that would be reviewed at biweekly staff meetings. As a multidisciplinary group, the frontline staff would then collectively agree on what areas of work steps, sequencing and roles were to be improved upon.
Conclusion
Toyota production system remains a viable method to effect operational improvements. Ironically, Toyota the car company fell victim to its success. They appeared to make the all too common mistake of organizations to commit to strategic growth targets, and not supporting those targets with correspondingly necessary infrastructure and tactical frontline feedback and suggestions. Toyota fell victim to this fate when its leadership set aggressive growth targets, which once achieved, outstripped the operational capabilities of its business, and perhaps more importantly, tactical ability. The characteristics that put Toyota ahead of its competition in the automotive manufacturing industry was a seemingly unrealistic discipline for and commitment to standardization and iterative refinement of those standards, all of which being the responsibility of their employees. This commitment to standardization and continuous improvement garnered Toyota numerous accolades for quality. To refocus on quality, a vow recently taken by Akio Toyoda, does not in and of itself preclude the setting or attainment of other strategic goals. In fact, it is our assertion that a focus on quality, vis a vis the development of human infrastructure to support continuous improvement, enables the attainment of other strategic objectives, including growth. Further, that the growth and maintenance of process capabilities must be appropriately cadenced with other strategic objectives. If organizations, for profit or otherwise, focus first on being effective, then efficiency will be a natural byproduct.
In NI, specifically of health care generally, quality of care must be the guiding principle. The doctor as a neurovascular artist is a wonderful vision in thinking about ourselves. Ultimately, optimization of management allows for those hard earned skills to be used more efficiently and hence in a greater number of patients. The thesis that we are advancing here is that one's ability to succeed, using Lean as a system, is leveraged to (in this case) the NI practice being able to develop the human infrastructure. The methods, and figures, depicted above reflect our attempt to better align our strategy to grow our practice with the simultaneous desire and need to provide the best possible care to the patients we treat.
Footnotes
Competing interests None.
Provenance and peer review Commissioned; not externally peer reviewed.