Tools
Quality Improvement, Management, and Assurance
Summary / Explanation
Quality management (QM), quality improvement (QI), and quality assurance (QA) are 3 independent yet interconnected methodologies within a systematic framework. These methods collectively enhance the quality of an organization's products, services, and processes. Integral to healthcare, each model plays a critical role in QM systems, influencing institutional culture and health outcomes.
Quality encompasses various dimensions, as viewed by the global leader, the American Society for Quality, which defines it as the "totality of features and characteristics of care or service that bears on its ability to satisfy given needs."[1] Engineer and management advocate Joseph Juran further defined quality as "conformance to requirements," echoing philosopher John Ruskin's proclamation that "Quality is never an accident; it is always the result of intelligent effort."[1][2]
QM in healthcare involves proactive management aimed at mitigating risks inherent in complex processes to achieve quality within constraints.[3][4][5] Often referred to as the father of QM, American statistician William Edwards Deming supposed that "The right quality and uniformity are foundations of commerce, prosperity, and peace."[6] QM systems in healthcare encompass the coordination of activities within an organization, including establishing policies, setting objectives, and executing strategic planning to ensure patient care meets standards and regulatory requirements. Total QM (TQM) and continuous QI (CQI) are examples of QM models and approaches.[5] QM is the overarching concept that encompasses QA and other quality initiatives.[7]
In healthcare, QI is often focused on transforming medical delivery, using experimental learning to raise the level of performance in medicine.[8] The focus is to systematically apply current knowledge of healthcare, data, and innovation to improve the patient care experience through change.[9] In contrast, QA prioritizes the ongoing commitment to adhering to best practices while proactively preventing system-based errors. Quality concerns within healthcare delivery processes are often surveyed while defining benchmark standards influenced by regulatory or accreditation organizations.[7][10][11]
A significant milestone in healthcare improvement emerged from the efforts of Hungarian obstetrician Ignaz Semmelweis, who, in 1847, observed high mortality rates and introduced chlorine hand disinfection, resulting in a 3- to 10-fold decrease in mortality rates.[12][13] In the following century, Boston surgeon Ernest Codman pursued surgical perfection through a methodology he termed the "end-result system," during which he examined, tracked, and documented data in pursuit of perfection through improvement.[14][15] "The end-result idea implies that the hospital should be conscious of its shortcomings and constantly on the watch to improve its equipment and method," he asserted.[15] The American College of Surgeons later adopted the end result system.[15] Around the same time as Codman, statistician Walter Shewhart developed methods for QI, pioneering the first control chart.[16] This chart enabled organizations to systematically analyze and display data, evaluating change and effectiveness over time.[17]
Clinical Significance
In December 2018, The Joint Commission (TJC), a healthcare quality accreditation body, issued a sentinel event warning emphasizing the importance of reporting culture. This initiative was one of many calls to action aimed at enhancing the quality of patient care, as "improved quality benefits all, reduces costs, and identifies problems before they cause harm."[1][18] Examples of vital QM, QA, or QI tools or approaches include the Plan-Do-Study-Act (PDSA) cycle, Root Cause Analysis (RCA), and Failure Modes and Effects Analysis (FMEA).[19][20] The descriptions of some of these tools and approaches are listed below.
The PDSA cycle is an iterative, 4-step methodology designed to improve a particular process. The PDSA cycle begins with identifying a plan, often an opportunity for improvement, followed by developing, implementing, analyzing, and then either proceeding with, modifying, or halting the plan.[21] PDSA is a frequently used tool alongside various continuous improvement approaches, including Lean Six Sigma (LSS).[22][23]
Six Sigma is a structured methodology developed in 1986 by Motorola to improve process quality.[24][25][26] The etiology is rooted in the lower-case Greek letter sigma, representing standard deviation, with the ultimate goal of decreasing failures to statistical significance (ie, 6 standard deviations from the mean).[25] Lean, derived from the Toyota Production System, concentrates on waste elimination.[27][26][27] Combined with Six Sigma to form LSS, it aims to streamline operations and eliminate waste to optimize quality by recognizing that every process comprises both value-added and non-value-added components.[24][28]
An approach of Six Sigma is the 5-step quality process "DMAIC"—an acronym representing Define, Measure, Analyze, Improve, and Control.[29] DMAIC provides a structured approach to achieving possible goals of LSS, often in conjunction with 2 analytical tools that can be applied during data analysis, as represented by the Pareto Chart and Ishikawa diagram.[30] The Pareto chart, developed by economist Vilfredo Pareto, is a QI tool that identifies weighted factors to enhance efficiency, adhering to the Pareto principle, which suggests that approximately 80% of effects stem from 20% of causes.[31] An Ishikawa diagram, also known as a fishbone diagram, is a tool leaders can use during an RCA to identify innovative causes of factors leading to events. The diagram is particularly beneficial due to its visual representation and capacity to involve team members.[32][33] The Ishikawa diagram considers inputs to evaluate process variation outputs, named after its creator, author, and chemical engineer Kaoru Ishikawa. Ishikawa emphasized the importance of group dialogue and shared communication, believing that "In management, the first concern of the company is the happiness of the people connected with it. If people do not feel happy and cannot be made happy, that company does not deserve to exist."[34]
RCA is a term used to describe an overarching methodology to retrospectively identify the underlying causes of quality problems. While different institutions may implement RCAs in various ways, the process typically commences with identifying a problem, often through an error reporting system, followed by forming a team. Subsequent steps involve event mapping and flow diagrams, with the ultimate objective of achieving measured outcomes through corrective actions and subsequent review to promote QI.[35] The TJC, expecting physicians to foster RCAs and similar patient safety initiatives, has a significant role in promoting and advocating for these practices. TJC mandates not only the execution of an RCA within 45 days following specific events but also thorough documentation and monitoring of action plans.[35][36][37]
FMEA, first introduced by the United States Military in 1940, is similar to a RCA.[38] Both tools can be used for QI, although RCA is retrospective, whereas FMEA is prospective. The steps of FMEA mirror those of RCA, starting with the identification of improvement opportunities. Subsequent steps involve creating a process diagram and engaging in creative discussions to pinpoint potential error opportunities, with failure modes assigned numerical values based on severity to prioritize more severe issues.[18]
History has shown QM, QI, and QA are indispensable components of management and innovation, guiding healthcare toward achieving excellence in patient outcomes and organizational effectiveness. Successful improvement initiatives necessitate robust leadership, infrastructure support, and a culture that prioritizes healthcare quality.[13]
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