In recent years, the number of medical device recalls for software defects has climbed steadily, with Class II recalls accounting for the majority of total voluntary recalls. Prolonging the time it takes between recall initiation and recall terminatio . . .

A review of literature highlights the importance of organizational culture and its relationship to organizational effectiveness. The success of an organization includes the ability to produce quality product without excessive rework or high costs for . . .

Most organizations question how to optimize performance to remain competitive and maintain customer loyalty. In today’s fierce competition, quality and process improvements are critical to reduce costs and maximize manufacturing performance. Company A . . .

Misconceptions abound regarding the Highland bagpipe. Despite the global presence of this instrument and its popularity for both solo and ensemble work, there is disagreement among scholars and performers regarding piobaireachd and appropriate interpr . . .

Compliance with the U.S. Department of Agriculture wheat flour milling standards and U.S. Food and Drug Administration regulations is not enough to prevent a major recall of wheat flour containing peanut residue that has caused adverse reactions in tw . . .

Many varieties of In-Vitro Diagnostic (IVD) Medical Devices exist to diagnose and monitor some of the world’s most prevalent diseases. The ability to diagnose and monitor illnesses is imperative to the survival of those affected by them. Faults in the . . .

In the last 20 years, wood items and the furniture industry in the United States have been influenced by the competitive business environment, unpredictable economic cycles, increased production levels and transportation expenditure, changing purchase . . .

The focus of this study is two-fold: (1) an exploratory literature review of Lean thinking implementation and (2) a directed Lean Thinking implementation project, specifically 5S, applied to a cosmeceutical manufacturing environment. The objective of . . .

Errors in laboratories are a common phenomenon. The hematology/oncology physicians primarily rely on results of samples taken to laboratories in order to make comprehensive inferences and diagnoses of the patients’ conditions. Therefore, the analysis . . .

Lean is a process that drives improvement in manufacturing facilities. With Lean’s focus on customer needs and continuous improvement, companies have used Lean tools and techniques to improve products and decrease manufacturing costs. Application to a . . .

Numerous deficiencies associated with the U.S. Navy’s supplier cost overruns, schedule delays, and reporting methods have been identified by the Government Accountability Office (GAO) during the last decade. This study adapted the Balanced Scorecard ( . . .

Improving the quality of healthcare has become a priority in order to make healthcare safer, more effective, and cost-controlling. The Center for Medicare and Medicaid Services (CMS) has been addressing the high hospital readmission rates with new reg . . .

Poor quality medical devices may lead to dire financial and reputational consequences for an organization. Food and Drug Administration (FDA) warning letters are indicators of the challenges the medical device industry has to overcome the deficiencies . . .

In today’s fiercely competitive society, the most valuable way of securing a competitive advantage and improving organizational performance is through quality improvement. XYZ is an organization which provides chemicals used to create nextgeneration c . . .

This study explores the problem of employee engagement as related to product quality in a manufacturing firm. The product quality characteristic is defined as the ability of a product to meet the specification limits of any design characteristic. To c . . .

Poor health costs the United States economy over half a trillion dollars a year, and a substantial percentage is from absenteeism due to illness or from employees coming to work but not performing their best. Health complaints in the workforce are ass . . .

Manufacturers face complex challenges in delivering quality products to successfully gain competitive market share. Organizations must learn how to collect and interpret data about process performance to discover best practices. Risk of food quality n . . .

The Food and Drug Administration (FDA) has issued increasing numbers of warning letters to medical device manufacturers, citing deficiencies in design control and risk management processes. Though FDA provides guidance through the Code of Federal Regu . . .

Emergency department overcrowding has exhibited an increasing trend, as described through the length of stay metric reported by hospital systems through the Centers for Medicare and Medicaid Services (CMS), a United States federal government program. . . .

The complexities surrounding emergency preparedness are evident for both employee and employer more than ever before: natural disasters, domestic terrorism, and a company’s own internal risks associated with manufacturing goods and providing services. . . .

Microsoft® Excel™ is default software used within the organization for drug development projects. Increased availability of statistical software packages in the pharmaceutical industry allows scientists and engineers to complete their analyses effortl . . .

Automotive manufacturers establish their quality management system (QMS) based on requirements from the International Automotive Task Force (IATF) 16949 and International Organization for Standardization (ISO) 9001:2105. The automotive industry is hig . . .

XYZ clinical laboratory is one of the leading healthcare providers in the country that is committed to the quality of the services provided to the customers. The dedication of the organization's leadership to continuous quality improvement is apparent . . .

A major problem in the field of continuous improvement is that approximately 60% of continuous improvement programs fail to deliver the desired results (McLean & Anthony, 2014). This problem exists in manufacturing industries around the world (Lodgaar . . .

This study demonstrates the Define-Measure-Analyze-Improve-Control (DMAIC) problem-solving tool to address increasing thousand kernel weight results seen in hybrid canola production. Production and quality data were analyzed together to determine if t . . .

The thesis study demonstrates the importance of incorporating Human Factors Engineering and Ergonomics (HFE/E) countermeasures, starting from the design phase of any process being developed. When not incorporated, risk of injury to the employee in the . . .

Supplier performance scorecards have been introduced and used throughout organizations for decades, but they often vary with different weight measurements and performance metrics. Suppliers play an important role within organizations, and the collabor . . .

The ever-increasing interconnection and sophistication of medical devices containing software presents a significant security risk management challenge for many manufacturers. While a number of methods have been established for addressing these risks . . .

The low adoption rate of product updates is a problem for companies in that valuable engineering resources are used to identify improvement areas and implement solutions that only a portion of customers are benefitting from. The value of these updates . . .

XYZ, a biopharmaceutical company, developed a patented drug to cure a skin disorder that impacts 3% of the world’s population. The addition of a second production line to the existing production line at a Contract Manufacturing Organization (CMO) cont . . .

Music programs in correctional institutions illuminate the paradoxical volley between inmate humanism and security apparatus ideology. This study examines the rehabilitative benefits of the arts and the security apparatus’s rationale for disallowing m . . .

At a critical stage when oral-systemic health studies link gum disease to other serious health problems, dental laser technology offers dentists and patients valuable benefits to help curtail growing health risks. However, adoption of this technology . . .

Continual improvement pioneer and visionary scholar in academia, Dr. W. Edwards Deming had been very vocal in saying that transformation is necessary in a prevailing style of management. The management transformation is needed in this age and time whe . . .

Today’s for-profit business supply chain is driven by the insular objective of maximizing profits and shareholder value. This financial slant is proving hazardous, as today’s supply chain construct is evermore linearized, frangible, and extended. The . . .

All industries can benefit from the improved productivity and success that result from attention to the costs of producing quality products, including the aerospace defense industry. Yet, this sector has struggled to accurately track costs of quality . . .

The present period has witnessed the emergence of many contemporary learning models because of the digital revolution. Due to the prevalence of learning models, a comprehensive understanding of these educational practices and an assessment framework a . . .

Traditionally, universities rely on Likert-scale or multiple-choice surveys to capture students’ Voice of the Customer (VOC) regarding educational program performance. Such surveys, convenient to collect and post-process, provide limited information f . . .

This thesis focuses on the voice of the customer by using focus groups of an organization’s internal customers, their employees. Using text analytics, the responses gathered during these focus groups have been analyzed. Internal customers are the eyes . . .

This research focused on whether all prisons are crucibles for criminal activity; specifically, the maximum security state prison in Graterford, Pennsylvania. The popular myths of people in prison have marred much of the works performed by organizatio . . .

Nuclear Energy relies on the design and manufacturing of precision components and advanced materials to meet the extremely high standards of quality and safety. ASME Section III Subsection NCA, “Rules for Construction of Nuclear Facility Components” s . . .

The management review cadence evaluates the efficacy of the quality system against key performance indicators or metrics established by leadership. Timeliness of activities such as customer feedback, training, and internal audits are reviewed robustly . . .

From 2011 to 2015, 4,880 reportable recalls were assigned to one of eight design defect root causes: Component Design/Selection, Device Design, Labeling Design, Package Design/Selection, Process Design, Software Design, Software Design Change, Softwar . . .

This study covers the application of human factors and ergonomics (HFE) through integration with the Lean Six Sigma DMAIC (define, measure, analyze, improve, and control) methodology within systems of pipettes and microscopes in a laboratory setting. . . .

The research that is the focus of this thesis spotlights an alternate method for measuring customer satisfaction by getting direct input from the customers themselves in a focus group setting and using text analytics to analyze the collected data. Cus . . .

Donation organizations, such as organ, eye, and tissue banks, receive a high degree of oversight by federal, state, regulatory, and accrediting entities, whose main purpose is to ensure patient safety. This thesis argues that organizations who have a . . .

Financial incentives exist to keep a healthy customer base. This study utilizes an individual interview format to develop ideas of what criteria create triggers or filters for problem importance for solutions via the Corrective and Preventive Action ( . . .

As the economy fluctuates, so does the success of many different industries such as the steel manufacturing industry in the United States. Several factors threaten the livelihood of the steel manufacturing industry, and each surviving company must fin . . .

Remedial training is a common corrective action when failure investigations identify human error as a causal factor. Over time, however, human error persists, and problems recur. Literature research supports the hypothesis that recurrence stems from t . . .

Continuous improvement is a principal objective sought in the world’s most advanced companies. One concept being implemented in quality management systems is Foreign Object Debris (FOD) elimination. This paper explores problems associated with stagnan . . .

It is difficult to comprehend the complexity of the public sector or their different customer types, but research shows that customers of the public sector, just as customers of the private sector, expect personalized and exceptional service delivery . . .