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Business management kaizen and six sigma essay

The publisher's final edited version of this article is available at J Investig Med See other articles in PMC that cite the published article. Abstract Background Lean and Six Sigma are business management strategies commonly used in production industries to improve process efficiency and quality.

During the past decade, these process improvement techniques increasingly have been applied outside of the manufacturing sector, for example, in health care and in software development. This article concerns the potential use of Lean and Six Sigma to improve the processes involved in clinical and translational research. Methods This article presents a description of the main principles, practices, and methodologies used in Lean and Six Sigma.

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Available literature involving applications of Lean and Six Sigma to health care, laboratory science, and clinical and translational research is reviewed. Specific issues concerning the use of these techniques in different phases of translational research are identified. Results Examples are provided of Lean and Six Sigma applications that are being planned at a current CTSA site, which could potentially be replicated elsewhere.

We describe how different process improvement approaches are best adapted for particularly translational research phases. Lean, Six Sigma, process improvement, translational research, quality, TQM, CQI Introduction Various business management strategies have been developed to improve the performance of organizations by improving the processes by which they carry out their work.

These strategies, which include Lean and Six Sigma, aim to implement process improvements through a coordinated set of principles and practices that promote greater efficiency and effectiveness, with fewer wasteful practices or errors. Evolving from their original application in manufacturing industries, these process improvement strategies have been extended to other settings including construction, software development, financial services, health care delivery, and laboratory sciences.

The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research

While the definition of clinical and translational research is still being debated, there is broad consensus that formal and sustained processes are needed to improve the timeliness and efficiency of research along the biomedical continuum.

Reducing the time between biomedical research discoveries and their adoption into clinical practice requires increased coordination, systematic planning, and new types of connections within biomedical research organizations. This article suggests that better coordination, timeliness, efficiency and value of clinical and translational research can be achieved by applying the set of principles, practices and methods represented by Lean business management kaizen and six sigma essay Six Sigma.

Examples include mistakes which need rectification, unneeded process steps, movement of materials or people without a purpose, unnecessary waiting because upstream activity was not delivered on time, and the creation of goods or services that are not really needed by end users.

Implementation of Lean involves systematic process assessment and analysis. The value stream map is a key tool for identifying opportunities to reduce waste and more tightly integrate process steps, thus improving process efficiency. Improvement approaches such as Lean and Six Sigma grow out of a long tradition of quality and process improvement efforts in manufacturing.

Current thinking about process improvement draws heavily on the ideas of W. Six Sigma, like Lean, is a business management strategy used to improve the quality and efficiency of operational processes. While Lean focuses on identifying ways to streamline processes and reduce waste, Six Sigma aims predominantly to make processes more uniform and precise through the application of statistical methods.

The name Six Sigma refers to a quality level defined as the near-perfect defect rate of 3.

  1. Some changes have already been made as the result of preliminary investigation, such as revising patient scheduling procedures. This will result in time simulations for optimal process flow.
  2. Nonetheless, Lean and Six Sigma approaches are potentially applicable in both clinical and non-clinical laboratory settings. It should come as no surprise that even the slightest changes to the particular metric that importance is placed upon would certainly lead to decisively divergent outcomes and results.
  3. It is primarily focused on improving the quality of the result or outcome of the process.

A variety of systematic methodologies for identifying, assessing and improving processes have been developed as part of the Six Sigma approach.

Other distinctive Six Sigma features include the expectation that process quality improvements be translated into financial metrics to assess value and the active involvement of top management in all Six Sigma initiatives. Various combinations of Lean and Six Sigma techniques have been developed, which frequently are described as Lean Six Sigma approaches.

  • If results are positive, adopt the solution throughout the organization;
  • It has proven quite successful in improving or removing all the inefficient steps of a process that waste time, energy, finance or raw materials.

Proponents of a combined approach assert that organizations can benefit from utilizing both the customer-orientation and focus on eliminating waste inherent in Lean along with the statistical tools and systematic defect reduction strategies featured in Six Sigma. The selection of a particular process improvement approach will depend upon the specific circumstances and needs existing in a working environment, including the type of processes, the improvement objectives, and the skills, knowledge, and resources available in that setting.

For example, some approaches may b better suited to statistical analysis of defects e. We chose to focus primarily on Lean and Six Sigma in this article because of literature suggesting their applicability to biomedical and research settings reviewed below.

For example, selected service functions such as basic laboratory, pharmacy, admitting and discharge, medical records, housekeeping, and material support services were relocated to patient care areas to improve organizational efficiency. In one TQM application, the turnaround of radiology reports was improved by revising work flow to feature electronic signature by radiologists, elimination of a trainee signature requirement, accelerated transcription, structured reports, faster film delivery to reading desks, and training about the importance of radiology reports for clinical decision making.

Several critics characterized TQM as a vague and indistinct fad, with little tangible content. Since 2000, there have been a variety of projects applying Lean and Six Sigma strategies to health care quality improvement.

For example, pilot programs utilizing Lean approaches at Intermountain Healthcare resulted in substantially reduced turnaround time for pathologist reports from an anatomical pathology lab. Most laboratory applications of Lean and Six Sigma have occurred in clinical environments. A recent review article by Gras and Phillippe 2007 describes many of these applications.

What is the difference between Kaizen, Lean and Six Sigma

This difference may reflect the greater access to process improvement expertise available to clinical laboratories, as these facilities are generally part of larger health care delivery systems. Nonetheless, Lean and Six Sigma approaches are potentially applicable in both clinical and non-clinical laboratory settings.

For example, Six Sigma techniques have been recommended as a means to avoid cross contamination of cell lines. The NIH envisions a clinical research process that becomes more efficient and effective by improving linkages between system components and better integrating the continuum spanning basic science, clinical studies, and the uptake of new practices by medical practitioners and their patients.

The NIH has identified a variety of impediments plaguing the current research environment, particularly the lengthy timeframe needed for conducting research, testing approaches in patient populations, and getting effective approaches accepted into clinical practice. The NIH hopes that establishment of the CTSA sites will address important problems, such as poor coordination between existing research networks and lack of data sharing among researchers.

The CTSA awards contain funds for training of new researchers who will be expected to work collaboratively in a transdisciplinary environment that fosters new ideas and creates more efficient processes for moving novel practices and technologies into the health care delivery setting. What is Clinical and Translational Research? The NIH has defined clinical and translational science as follows: Translational research includes two areas of translation.

One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans.

The second area of translation concerns research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.

The T2 sphere extends the results of clinical studies into everyday clinical practice and health decision making. Several theorists have developed translational research models with three or more stages. T1, in which preclinical and animal testing is shifted to human subjects; T2, in which the results of initial testing in human subjects migrates to patients, and T3, involving implementation and dissemination of research discoveries into accepted clinical practice.

The end goal of clinical and translational science initiatives sponsored by NIH is to make this process more rationale, coordinated, efficient, cost-effective, and timely, with fewer impediments and less wasted effort. These management strategies, imported from the industrial environment, can be applied to help systemically analyze and improve the array of process steps involved in most clinical and translational research projects. The CTSA structure that NIH has adopted facilitates the selection and introduction of process management techniques that can be applied to clinical and translation research programs.

This is an opportunity that is waiting to be tested. A few applications of Lean and Six Sigma techniques at other clinical business management kaizen and six sigma essay translational research sites have been reported.

Kaizen (continuous improvement)

In that analysis, the investigators developed and utilized a Translational Research Performance Index to quantify performance measures of translational research, such as the number of researchers in various cross-functional teams and the number of existing research partnerships.

Marti 2005 reported on an application of Lean Six Sigma in which the time needed to complete a phase 1 clinical trial was improved by redesigning standardized case record forms, setting up a dashboard system for monitoring key performance indicators, and acquiring new hardware and software systems for reducing cycle time for data analysis.

For example, Lean techniques were used by a contract research organization to improve assay turnaround times and reduce assay result variance. Some of the projects that are now being designed and initiated include: This process is often prolonged and burdensome owing to the need to develop appropriate disclosure agreements, arrange and conduct sponsor qualification visits, and develop the language and attain legal review for the clinical research contract.

A Lean analysis is being considered to examine these issues. A related process study is being designed to expand a charge-back process for the clinical trials unit by which costs for different services will be compared e.

Six Sigma and Lean methods are being used to investigate the process steps and issues involved in establishing reciprocal IRB agreements between affiliated academic and non-academic research institutions. The review process for soliciting, evaluating, and awarding of pilot project awards, clinical research traineeships, and test-bed projects for novel technologies will be examined using Six Sigma and Lean techniques, with the goal of making the process quicker, more efficient, and fair.

This will result in time simulations for optimal process flow. Some changes have already been made as the result of preliminary investigation, such as revising patient scheduling procedures. Because the nature of clinical and translational research activities varies considerably between the different research phases described previously T1, T2, T3, T4the application of process improvement strategies utilizing Lean and Six Sigma can be expected to also differ among the research phases.

Adopting a business management kaizen and six sigma essay model of translational research based loosely on Khoury et al. Table 1 details some of the specific practices associated with Lean and Six Sigma, and illustrates how applications of these two approaches could be relevant to each translational research phase.