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- Creator:
- Pace, Teonta
- Description:
- 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 termination could cause significant risk of harm to patients. By implementing the Plan-Do-Study-Act framework to examine medical device recall data, this study utilized risk management tools to analyze risks and root causes associated with prolonged recall times for software related recalls. Through identification of root cause and risks, mitigation strategies are discussed to reduce time to recall. The results of the study indicate that recall events with prolonged recall durations are linked to organizations that struggle with recall management through regulatory compliance. Organizations can benefit from analyzing industry data to identify trending areas of risk within similar systems to mitigate impact of non-compliant policies that lead to prolonged time to recall.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Chase, Chrystal
- Description:
- 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 nonconformity. A gap analysis was generated that compiled ideal characteristics of positive organizational culture. Company XYZ was evaluated using the resulting gap analysis. Standard quality metrics as noted in existing literature were used to examine the relationship between a shift in organizational culture and product quality at Company XYZ. Results confirm a change in organizational culture correspond to significant changes within the business. Results also suggest a negative shift in
organizational culture has taken place. Quality metrics such as total defects and cost of nonconformity have increased post-change. This thesis adds to the collection of works supporting the necessity for managers to recognize and encourage positive organizational culture.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Espejel, Miguel
- Description:
- 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 ABC is challenged with wastes associated with over production, extra processing, non-value-added motion, excessive inventory, and bottlenecks in operations. The company needs cost effective solutions that are easily implemented with a minimal learning curve.
This thesis proposes a Lean manufacturing model using the five principles of Lean applied to a meat packing and distribution company. Lean process improvements facilitate on-time delivery, reduce defects, implement visual management, optimize workplace organization, and improve employee morale. The Lean processes business model is analyzed along with the challenges, obstacles, and lessons learned during its development and implementation. Lean tools and process metrics are used to monitor reduction of internal wastes, avoid bottlenecks, simplify processing steps, improve profitability, and customer satisfaction.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Akard, Michael E.
- Description:
- 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 interpretation of this musical form. To solve that problem, it is necessary to consider the instrument and the music for which it is used in historical context. Understanding how the Highland bagpipe has evolved and the social forces that have influenced both piobaireachd and ceol beag will result in more consistency
among scholars and better informed artistry among performers.
This study uses extensive video, pictorial, and print sources to identify changes in the Highland bagpipe and its music, as well as to reconstruct the social conditions in which they occurred. It also uses case studies to examine the resulting music, particularly piobaireachd, in order to analyze and describe changes in musical form, performance practice, and artistic interpretation.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Echols, Angela
- Description:
- 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 two children. This thesis expands standard organization-wide total quality management (TQM) principles into an industry-wide perspective. It looks at wheat flour supply chain segments as an interconnected system, working towards the shared aim of providing wheat flour products free from cross-contact with peanuts. Wheat and peanut supply chains are reviewed side-by-side, and TQM tools are used to identify risk and assess cross-contact areas. Regulations and industry best practices are examined for current preventive controls for allergen cross-contact. Recommendations are based on expanded TQM ideologies. This expansion of TQM into the wheat supply chain, while not without its limitations and challenges, can help keep consumer products safe from peanut crosscontact.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Winton, Meredith
- Description:
- 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 device may lead to discrepant, or no results, and will influence the diagnosis and likelihood of the patient to manage their illness. This thesis outlines a quantitative method to achieve a clinically relevant baseline of expected performance of an IVD medical device. The baseline data represents the probability associated with the clinical impact to the intended population after a failure in the system has occurred. The comparison of real-time data to the projected baseline can be used holistically throughout a company to influence three of the key elements of Total Quality Management (TQM): customer focus, continuous improvement, and teamwork.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Singh, Harvinder
- Description:
- 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 purchaser propensities, and expanded international competition. Due to these reasons the smallscale manufacturers have been compelled to implement Lean in order to optimize productivity while at the same time reduce waste. This thesis tries to expand on the difficulties and obstacles confronted while applying Lean concepts in job shop environment. The research relied on scientific literature to explain the main principles of Lean. On the basis of information collected, a number of challenges were recognized and recommendations on how to resolve them were presented. The outcomes of this study are expected to offer strategic and value addition to the small manufacturers on the use of Lean manufacturing with value stream mapping.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Nguyen, Khoi Ngoc
- Description:
- 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 the project, coupled with literature reviews, was to determine whether a 5S implementation project can impact eliminating wastes while improving efficiency. Qualitative measurements are observed and recorded from an empirical lens, via a 5S Assessment Checklist. The uniqueness of this project is that 5S Lean thinking has not been well documented or implemented in the cosmeceutical manufacturing environment. The completion and analysis of the 5S project data suggests that Seiri, Seiton, and Seiso are fairly easy to adopt, whereas Seiketsu and Shitsuke are the hardest—particularly Shitsuke. The data from this thesis suggest that 5S principles qualitatively contribute to minimizing wastes, thereby increasing productivity and improving quality for the organization in the cosmeceutical manufacturing environment
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Little, Musa
- Description:
- 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 of errors therein is impartial, as it is the only way through which the prevalence can be addressed making diagnosis more credible. This research involved the analysis of five laboratories, each of which participated for a period of one year, and recorded the incidences of pre-analytical errors. According to the data obtained, inadequate sample errors are the most prevalent at 61%, test order entry errors, followed at 37% with labeling and missing patient identities being reported as the least prevalent errors at 1%. Through this study, the reasons why the errors occurred have been identified and the resulting corrective measures discussed. Therefore, this study is monumental in the hematology/oncology laboratories as with remedies comes more perfection.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program
- Creator:
- Grosskopf, Lisa
- Description:
- 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 specific office process, product risk management, is explored in this paper. Most medical device regulatory agencies around the world require risk management. Compliance theoretically results in medical devices designed and manufactured in a manner resulting in safe and effective devices. Standards contain descriptions of tools used to analyze hazards and describe how to associate risk levels with these hazards. This paper presents the use of Lean tools and methodology to simplify the risk management process, making it understandable and compliance easy. Case studies of similar administrative projects are reviewed, and lessons learned are applied to this project. Additionally, risk management systems at three medical device manufacturers are evaluated, using Lean techniques.
- Resource Type:
- Masters Thesis
- Campus Tesim:
- Dominguez Hills
- Department:
- Quality Assurance Program