Wednesday's Words of Quality,
Lesson #11: Deviation Management
Richard Zarbo, MD © 2022 Wednesday’s Words of Quality
Lesson #11 of 13
In our Lean business system, we have created numerous quality management subsystems and structures to support managers and supervisors in understanding the outcomes of their work and driving continuous improvements from the level of the work with their engaged and empowered team members. Lean parlance the word Gemba refers to the actual workplace where value is created. Our approach to Gemba level PDCA-based problem solving and continuous improvement at the level of the work with reliance on management subsystems that support that goal is illustrated below (1).
In 2013, our adaptation of a structured Daily Management system allowed us to focus on deviations or nonconformances that were assessed by management to represent the critical few processes required for daily success at each work place (2). However, we recognized that there existed, yet many deviations experienced by our workforce and our customers that we failed to consistently identify and target for improvement. The apt analogy of flying a plane blind without instruments in zero visibility comes to mind. It was broader and deeper knowledge of these undocumented opportunities that we sought next.
Our continuous improvement culture took a leap forward when we pursued and achieved ISO 15189 accreditation in 2013 as the largest integrated system of medical laboratories in the United States. The primary driver for us to create a standardized health system-wide deviation management system was the ISO 15189 requirement for a robust system to track nonconformances or deviations in the work and the customer experience.
Our next intent in developing a Deviation Management system was to provide structure to empower all employees to own the responsibility of more comprehensively recording workplace defects that they encountered, contributing to real-time corrective action and root cause analysis and to subsequently working through our accountable Lean culture to eliminate prioritized deviations with PDCA problem solving and process change.
The fuel that now drives our engine of risk reduction and continuous improvement is derived from Deviation Management- knowledge of what we receive from “suppliers” and what we deliver to “customers” that does not conform to expectations. This manager-owned system with participation of all employees is designed to move beyond sporadically used whiteboards to capture in real-time a standardized taxonomy of defects and variations from expected work practices as experienced by all involved.
Our Deviation Management system is described in detail here (3).
Most work systems are fraught with process inefficiencies and wastes that dominate the total time of human effort compared to the actual fraction of time involved in creating value. The fact that even well intentioned business systems are not “Lean” was well articulated 92 years ago by Henry Ford who recognized in his own operations renowned for efficiency that: “We still waste more than we use. We waste men, we waste materials, we waste everything, and consequently we have to work too hard and too long to accomplish what in the end amounts to very little. But at least we are learning that we can not get anywhere without the kind of management which extends from the smallest detail to the whole purpose of what you are about.” (4).
This is especially true in the business of healthcare where process defects may readily escalate to medical errors that currently account for the number 3 cause of death in the United States (5). The Joint Commission recognizes the culture of Lean as a component of “robust process improvement” that should be pursued for healthcare to be effective in achieving high reliability exhibited by consistent excellence in quality and safety (6). It is our sincere desire that our shared experiences here will serve others to drive continuous improvement through culture change, Deming-style philosophy of management, workforce education and new business management systems that support this transformation. In our view, these elements are essential to pursue a new condition where healthcare is highly reliable.
In our pursuit of high reliability, we have focused on creating a Lean laboratory enterprise whose consistency of execution is guided by quality management systems and structures. These management systems are designed to deepen the effectiveness of our continuous improvement culture by promoting managers’ understanding of the variation in the work they are charged with overseeing and fostering effective engagement of their employees in process improvement. This has resulted in gains in standardization of processes, work flow efficieincy and mitigation of risk for our employees and customers. This new focus on managers having good knowledge of the quality of their work product in turn promotes consistent execution and higher levels of performance.
In any work system of management that requires continuous improvement, how does one know what to tackle next and specifically how to make effective change to eliminate problems?
Early in a Lean transformation many implement workplace whiteboards to capture knowledge of deviations. Our experience with this approach was less than optimal over the years. Although whiteboards were an opportunity for the workforce to document variation and waste, the unstructured format commonly led to inconsistency of defect capture and spotty employee participation. Whiteboards often degraded to “whining” boards. Our intent in creating the Deviation Management subsystem was to provide our employees with a tool to foster real-time defect capture with structured deeper knowledge related to the deviation (case, source, type, and person). We integrated into this process the opportunity to begin the root cause analysis and documentation of the corrective action taken. Ultimately, we have promoted local ownership for documentation and follow-through, pushing solutions down in our organization to the Gemba level where expertise lies.
A Deviation Management subsystem that provides managers with enhanced surveillance of the many nonconformances, as they are detected daily, becomes a much more powerful system to continually fill the diagnostic funnel of knowledge. We have been influenced by Dr. Deming’s cautions that “It is not enough to do your best; you must know what to do, and then do your best” and that “Information is not knowledge. Let’s not confuse the two.” By employing Deviation Management as a standardized and integrated subsystem across the Laboratory Product Line, we have fostered actionable knowledge from structured examination of workplace defects. That structure provides for commonality of cause and resolution in all hospitals, core laboratories and clinic laboratories as well as outreach sites. In contrast to the free-form whiteboard approach, the power of this subsystem design structures behaviors to identify quality defects at the source with root causes and interventions accomplished temporally closer to the actual event. By operating in this fashion, we have set the daily expectation of work improvement by empowering all managers and employees in efforts to reduce defects, inefficiencies and variation in processes as an additional requirement of their work. The expectation is that the workforce does the work and improves the work, continually. In essence, we have created the foundation of knowledge to enable continuous improvement. Our experience with Deviation Management has become our cultural foundation to establish Deming’s call for profound knowledge for leaders to impact change and improvement.
Much of the variation represented in the nonconformances that we have identified using the Deviation Management subsystem can be traced back to a human action or lack of action. This calls for innovative approaches to make human behaviors and actions more reliable, often in a highly visual and accountable work environment. This knowledge and opportunities for work improvement from analysis of nonconformities identified in Deviation Management becomes the standard work of the manager in order to effect consistency and reliability in the work that they are charged with overseeing. In this new culture, armed with knowledge of work quality, or lack thereof, the managers’ defining raison detre and success becomes prominently apparent and often visual to the entire work team. We have derived 3 modes of functionality from Deviation Management that assist managers- surveillance for defect detection, monitoring for assessment of control of nonconformities and effectiveness in their elimination, and employee engagement in detection and process improvement.
Another key quality management subsystem focused on correcting the few prioritized deviations within the day is Daily Management, that we have described in detail (2). This is another aspect of the managers’ standard work that provides a structured system to prioritize the critical few defects that require repair now and should not be repeated. Daily Management allows for deeper dives with employees to focus on a few important defect types on a 24-hour basis. This focus results in further understanding of the problem beyond implementation of daily countermeasures to root cause determination and visual tracking and trending as the problem is solved and eliminated through process change interventions. Deviation Management and Daily Management are 2 key quality management subsystems that engage all employees in structured Lean PDCA problem solving at the level of the work (Gemba), as illustrated here.
Using our focus on the Laboratories as a product line or system, we can identify nonconformances of common root cause for system-wide solution testing. We do this by instituting the discipline of quarterly managerial review and presentation of summarized nonconformities identified in each of our hospitals to the higher management level of the monthly Quality Management System meeting. The lesson for managers of the Laboratory Product line is that they are not alone, and it is not unreasonable that if a vexing nonconformance occurs in one hospital, then it likely occurs in others. In this manner, we achieve global thinking and systemic process improvements.
As we see it, the quality management systems that we have developed provide a framework of processes and procedures structured to ensure that people do the right and expected thing in performing tasks consistently and in continually seeking improvement. This pertains not only to our own laboratory personnel but to our clinicians, nurses, medical assistants, phlebotomists and other clinical “customers”. Because nearly 3/4 of the more than 70,000 annual documented deviations handed to the laboratory by these individuals as specimen ordering and process defects, they are rightfully considered the main “suppliers” to the laboratory. Shown below are the total number and percent distribution of documented deviations by lab testing phase we encountered from 2013 to 2016. In 2016, only 10 deviation types accounted for 78% of the total 71,641 deviations documented. Deviation management provided managers with knowledge enabling them to prioritize improvement activities for maximal impact.
Total Deviations | Pre- Analytic | Analytic | Post- Analytic | |
2013 | 11,872 | 84.0% | 8.0% | 8.0% |
2014 | 27,343 | 93.0% | 3.4% | 3.6% |
2015 | 52,971 | 91.0% | 5.0% | 4.0% |
2016 | 71,641 | 74.8% | 23.6% | 1.6% |
Just as in manufacturing where a poor-quality part supplied for assembly can have a costly downstream impact, our version of supplied defects must be addressed at the source. Therefore, we seek to change human behavior to consistently achieve superior results by continually seeking improvement both in the work we do and the work that our clinical colleagues do in the form of requests for testing and collected human specimens provided to the laboratory. These are the 2 largest categories of pre-analytic defects, test ordering and specimen collection, and therefore present the greatest opportunities for improvement. Knowledge from Deviation Management is helpful in providing data when change in the form of supplier standardization is required to improve quality at the source as well.
In this digital age it is tempting to push “electronic solutions” for data capture. In fact, as we matured in use of the Deviation Management system, we integrated electronic data related to specimen adequacy from automated analyzers. However, there remain advantages to paper-based data collection. This includes a cost avoidance associated with providing many computer terminals for individual employees across a large system of laboratories and the avoidance of continual developmental costs to improve and upgrade software and changes in taxonomies. We have been able to achieve these changes and improvements using paper and Excel spreadsheets over the years. Our approach also avoids the need for bench employees to get up to access a computer terminal to enter data thereby promoting participation at the level of work, anywhere a defect is encountered, to avoid increased documentation time and human motion. One of the simplest yet effective aspects of the paper-based system that promotes employee participation with easier input and speeds the selection of defect type is the empowerment of local teams to customize their paper input form. Many work cells have now created a custom layout with a simplified taxonomy list to include only commonly encountered issues. This has fostered local ownership for work quality and improvement.
The aphorism ‘systems don’t produce quality, people do” is very applicable to the success of a Deviation Management subsystem like this designed for comprehensive capture of workplace wastes and inefficiencies. If employees do not participate in defect identification and documentation, then the human “sensors” at the level of the work are effectively silent. This is the equivalent to unplugging the fuel level gauge in an automobile yet expecting to know when to intervene and refill the tank before becoming stranded. Our intensive 51 face to face 1-hour sessions in 2016 of employee training in use of subsystems and tools of improvement which included Deviation Management, promoted engagement of our human “sensors”. The success of simplified education focused on key elements of expected human engagement and accountability in improving the work itself is demonstrated in the 35% increase in deviations documented in 2016 after this intensive annual education. This can be seen in the table above.
At its core, Lean and the management subsystems that support the expected outcome of continuous improvement and employee engagement require continuous education and human development. Systems are not enough. In the words of Dr. Deming from his last 2 management principles #13 and #14, “Institute a vigorous program of education and self-improvement. Put everybody in the company to work to accomplish the transformation. The transformation is everybody’s job.” (7)
In summary, we have shown Deviation Management to be a key business system providing managerial understanding of the process variation and quality of the work they are charged with overseeing. This is now managers’ standard work whereby knowledge of nonconformities assists in directing corrective actions, improvements and process changes with engaged employees by sharpening their focus on continuous improvements that promote consistent execution and higher levels of performance.
We strongly believe that for healthcare to become highly reliable, a culture change is required. One key aspect of success in this transformation is to drive consistency in the managers’ standard work with structure that functions like this Deviation Management system.
Using this approach in conjunction with a Deming-style philosophy of management, will foster continuous improvement toward the goal of consistently high quality.
The Deviation Management structure provides for managerial consistency through real-time understanding of the process variation, identification of opportunities and tests for meaningful process change with participation of their engaged employees that ultimately results in ever higher levels of performance.
(1) Zarbo RJ. Management systems to structure continuous quality improvement. Am J Clin Pathol 2022;157:159-170. DOI: 10.1093/AJCP/AQAB109
(2) Zarbo RJ, Varney RC, Copeland JR, D’Angelo R, Sharma G: Daily management system of the Henry Ford Production System: QTIPS to focus continuous improvements at the level of the work. Am J Clin Pathol 144:1-15, 2015.
(3) Zarbo RJ, Copeland JR, Varney RC: Deviation Management: Key management subsystem driver of knowledge-based continuous improvement in the Henry Ford Production System. Am J Clin Pathol 2017;148:354-367, DOI: 10.1093/ajcp/aqx084
(4) Ford H. How Henry Ford Manages. The Literary Digest, January 16, 1926, pp. 21-22.
(5) Makary, MA, Daniel M: Medical error—the third leading cause of death in the US. BMJ 2016;353:i2139.
(6) Chassin MR and Loeb JM. High-Reliability Health Care: Getting There From Here. The Milbank Quarterly 2013;Vol. 91, No. 3, pp. 459–490.
(7) Deming WE. Out of the Crisis. Cambridge, MA: Massachusetts Institute of Technology Press. 1986, pg 24.
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