<p> Active Pharmaceutical Ingredient (API) repackagers play a niche, yet critical role in the expansive pharmaceuticals industry. Many repackagers have sub-optimally implemented quality management systems (QMS) leading to sub-optimal performance and elevated risks. This study sets out to demonstrate a strategy to strengthen the case for quality for this industry sector. Dr. Deming's Plan-Do-Study-Act cycle serves as the study's framework, while Phil Crosby's <i>Quality Is Free</i> philosophy forms the theoretical basis. An archival measure of FDA Warning Letters concerning APIs has been performed to bring a considerable failure cost factor to the forefront. A statistical analysis has been performed on data available from the study's pilot firm to demonstrate relationships between quality-related and revenue performance indicators in order to present a bottom-line approach preferred by management. Results from the study indicate a linkage between QMS factors and business outcomes and call for improved understanding, increased support, and a push towards QMS maturation.</p>

<p> Agile methodology has been widely adopted by both commercial and government software development projects since 2001. Agile methodology promotes product delivery by executing multiple small iterations that are also known as sprints. Each sprint is a small software development project with own planning, development, testing, demonstration, with possible deployment for production. Agile software development projects commonly use Yesterday&rsquo;s Weather Model to estimate sprint effort capacity. However, the accuracy of Yesterday&rsquo;s Weather Model is unreliable. Over 60% of Agile software development projects experience schedule delays, cost overruns, or cancellations and inaccurate effort estimation is one of the leading causes of these issues. As such, Agile software development projects may benefit from a sprint effort capacity estimation model with improved accuracy. In this research, we compute the error rate of Yesterday&rsquo;s Weather Model using a large-scale real data from the U.S. Customs and Border Protection&ndash;Cargo Systems Program Directorate and identify a list of essential predictors that can be used to estimate sprint effort capacity. Using machine learning algorithms, we develop, test, and validate a sprint effort capacity estimation model on the same historical data. The model demonstrated better performance when compared to other models including Yesterday&rsquo;s Weather Model.</p><p>

<p> The last thirty years have seen multiple DoD acquisition programs with significant cost and schedule overruns. This paper posits that the primary driver of schedule overruns is the difficulty of &ldquo;inventing on a schedule&rdquo; by undertaking risky technology development efforts within a Major Defense Acquisition Program (MDAP), what the paper terms &ldquo;innovation-based acquisition&rdquo; and proposes an alternate approach relying on shorter term &ldquo;integration-based acquisition&rdquo; coupled with directed science and technology development external to the MDAP that is periodically harvested for incremental or spiral upgrades of systems or development of follow on systems. </p><p> This paper uses a hybrid of several models to examine the system development process as a system, in and of itself. It treats the likelihood of developing and integrating subsystem technologies as a component in a system to examine the impact on schedule. The paper uses simulations of two well documented programs, the F-15 and F-22, to develop calibration values for Monte Carlo simulations of the F-16 and F-35. Those results are then evaluated against actual program performance. The results show good agreement between the predicted schedule distribution and actual program performance. Further, the research suggests an alternate process based on the low likelihood of meeting schedule goals when technology development activities are carried into Engineering and Manufacturing Development</p><p>

<p> The current American workforce is at a crossroads due to the number of Baby Boomers either retiring or on the cusp of retirement. For many organizations, this cohort possesses knowledge and experiences that can be lost if this knowledge is not transferred before their departure from the organization. This ability to share knowledge is increasingly recognized both as a valuable asset for organizations and as a modern-day challenge for leaders. The purpose of this research was to explore the process of organizational knowledge sharing resulting from the Baby Boomers&rsquo; retirement. Using case study methodology and a single-stage sampling procedure, twelve participants were recruited to participate, and research questions were designed, to address how two generations of aerospace engineers describe their experiences with knowledge transfer and the strategies used to support such a transfer. Sources of information for this study were face-to-face, semi-structured interviews, organizational documents, and artifacts. Data were analyzed, generating codes and conceptual categories that eventually led to the emergence of the three themes of organizational knowledge transfer, promote knowledge sharing, and tacit and explicit knowledge. An analysis of these three themes resulted in three specific recommendations for action which were: (a) turning tacit knowledge into explicit knowledge, (b) creating knowledge sharing activities, and (c) developing purposeful leadership. Future researchers could explore management views of knowledge sharing and the impact on the organization.</p><p>

<p> Early stage research and development (R&amp;D) projects, programs, or efforts are characterized by a high degree of uncertainty. In the public sector, these efforts are defined as those with technology readiness levels up to 4. Both project management and systems engineering cultures proliferate throughout the public sector. Project management traditionally uses earned value management system to track the progress of its projects. Systems engineers apply Technical Performance Measurement methodology (TPM) to R&amp;D efforts to monitor progress of quality factors with respect to those efforts. Both of these methods have numerous alternative implementations, and both strive to provide risk management indicators and insight into future performance. This paper discusses a conceptual framework for monitoring early stage R&amp;D by altering a TPM method. By quantifying and monitoring the &ldquo;learning&rdquo; or technical uncertainty toward the project goal, early stage R&amp;D is given a measurement for technical progress. Learning values are determined using pairwise comparisons of R&amp;D activities that contribute to learning. How the effort increases learning, or degrades uncertainty, over time serves as the baseline for performance management. In order to predict future performance, the learning baseline is regressed in linear segments. Using simulated project status, those predictions are shown to have acceptable uncertainty by validating against prediction intervals.</p><p>

<p>Faced with increasing domestic competition from non-U.S. firms and a growing global marketplace, U.S.-based engineering firms have turned their focus to globalizing their services. Understanding the multifaceted cultural aspects of marketing and penetrating the global engineering market requires heightened cross-cultural leadership competencies in tandem with a strategic market orienting activities. The purpose of this quantitative correlational study was to determine any relationship that may exist between the variables of cultural intelligence and market orientation of decision makers at U.S.-based engineering firms to the dependent variable of entering the global marketplace. Participants were composed of senior-level global engineering and marketing decision makers from U.S.-based engineering firms listed on ENR?s Top Global and International Design Firms listings. The study included an online survey consisting of the Cultural Intelligence Scale and the individual market orientation scale, the I-MARKOR instrument. Statistical correlational analysis of the collected data indicated some positive relationships between factors of cultural intelligence and global market orientation. The analysis indicated a significant relationship exists between the aggregates of cultural intelligence and global market orientation. The study conclusions should assist globally-focused engineering firms to better penetrate the worldwide marketplace and to recognize the benefits of cultural intelligence and global market orientation leadership skillsets. Since there was a significant relationship between cultural intelligence and individual market orientation, global-looking domestic engineering firms are encouraged to invest deeper in enhancing the factors that comprise cultural intelligent leadership decisions in the organization. The recommendations presented in the research study outline suggestions for future research and practice.

<p> The United States Department of Defense (DoD) loses billions of dollars annually on cancelled or failed acquisition programs. Several DoD acquisition studies, Office of Management and Budget Studies, Government Accountability Office Reports, as well as other studies highlight the disturbing fact, of a plethora of programs that fail to meet full operational requirement capabilities, and therefore, are eventually cancelled. In these cases, the DoD loses billions of investment dollars without any return. Scholars, program managers, and systems engineers posit that there are a host of factors that influence whether a program is cancelled or allowed to continue. They include, but are not limited to political pressures, cost overruns, schedule overruns, and performance shortfalls. </p><p> The research here aims to add to the body of knowledge of systems engineering, program management, and the factors that influence acquisition program terminations within the United States Department of Defense (DoD). Specifically, this research surveyed the United States DoD acquisition program managers, defense industry program managers, and defense industry consultants, to evaluate and analyze the key program factors that influence DoD acquisition program terminations. The research also conducted a comparison of different attributes that would lead to project failure amongst various groups. This research used relatively important weight calculations and a chi-squared distribution analysis in order to compare the differences between DoD acquisition program managers, defense industry program managers, and defense industry consultants, with regards to the factors that lead to DoD acquisition program terminations. This research aims to further answer several interrelated research questions, in order to identify the factors that have the greatest influence on program and project cancellation from the expert&rsquo;s perspective, and capture any significant differences between DoD program managers, DoD industry personnel, and DoD consultants. The research questions include the following: </p><p> 1) Are there any statistically significant differences between what DoD program managers, DoD industry personnel, and DoD consultants personnel think influence program cancellation? 2) Are there statistically significant differences of the various DoD acquisition program factors between what DoD program managers, DoD industry personnel, and DoD consultants personnel think influence program cancellation? </p><p> An exhaustive literature review identified 11 critical factors that were associated with program management for examination. For this study, the examination and methodology used were the Relative Importance Weight technique, to analyze the attributes and factors. RIW methodology consisted of conducting a survey to identify and evaluate the relative importance of the signi?cant factors influencing program termination. Respondents of this survey included the following groups: 1) DoD program and project managers, 2) DoD Industry personnel, and 3) DoD consultants. The outcomes of this research serve three primary purposes: 1) identify the Relative Importance Weight of DoD acquisition program factors that influence program termination, 2) fulfill a system&rsquo;s engineering and program management&rsquo;s knowledge gap, by understanding and identifying the most critical factors within the unique DoD acquisition program management system, and 3) serve as a spring board for future research for DoD program management. The results of this research indicate that a statistically significant difference does not exist between the three groups with relative importance of 11 program management factors.</p>

<p> Pre-design Methodology for Establishing Scope-Budget and Scope-Duration Alignment for Capital Projects It is well established that projects do not meet their cost, schedule and scope objectives and often fail to deliver the benefits that were hoped for. Part of the challenge is that at the conceptual/pre-design stage, the level of scope definition is often only 1-2% and the resulting pre-design cost estimates typically have an accuracy range of -50% to +100%. Project teams may not feel confident providing this information to the designers as design-to-cost targets and overall project cost management suffers as a result. The proposed methodology was developed to assist with pre-design estimating on a new student health center at a college in the mid-Atlantic region of the United States. Development of a preliminary work breakdown structure allowed development of a cost model targeted at the major cost elements of a capital project by removing cost elements such as sitework and general conditions that have greater variability that is often concealed in cost/SF historical data used for modeling. The regression equation developed, based on five data points of comparable projects ranging in size from 20,000SF to 72,714 SF , with a zero intercept, has an <i>R</i>² of 0.9925, a P Value &lt;0.0001 and a F test score of 661.63. 63. Using the model to validate the cost of the comparable projects resulted in a cost forecast range of -10.3% to + 39.4% as compared to industry standard expected cost range in the pre-design period of -50% to+100%. Using the forecast cost and Bromilow equations to forecast project duration resulted in duration forecasts within approximately +/-18% of the contracted durations. The need for vigorous cost management over the life of a project remains, but this methodology offers an approach to (1) develop design-to-cost targets and (2) for the project team to have greater confidence they have scope-budget and scope-duration matches as the project enters design.</p>

<p> Systems engineering leaders have a huge impact on the success of acquisition programs in the defense industry. Many systems engineers are promoted to leadership positions based on technical merit without receiving the adequate leadership tools to succeed. This study explored the competencies that influence successful systems engineering leaders in the defense industry as well as the professional experiences that shape these leaders. The findings from this study are the result of a qualitative design utilizing 25 interviews from systems engineering leaders in the defense industry who have: (1) served as a systems engineering leader in a successful acquisition program; and (2) greater than 20 years of experience in systems engineering. This study resulted in five key findings of successful systems engineering leaders in the defense industry: (a) over 80% use the emotional and social intelligence competencies of adaptability, conflict management, influence, organizational awareness, self awareness, and teamwork; (b) over 80% use the systems thinking cognitive competencies of open minded, understands the big picture, understands systems from multiple perspectives, and understands interconnections; (c) over 80% use the leadership competencies of builds trusting relationships, communicates, empowers others, learns from successes and failures, makes timely decisions, promotes collaboration, and solves problems and analyzes issues; (d) over 80% have been enabled by professional experiences that include opportunities to broaden perspective, opportunities to collaborate and bring teams together, a culture that is tolerant of failure, and a culture that empowers others; and (e) over 80% have been developed to cultivate their acumen by learning by doing, using mentors, and using program management skills. The contributions and implications for practice are also discussed, as well as opportunities for future research.</p>

<p> In the past two decades, retailers have witnessed rapid changes in markets due to an increase in competition, the rise of e-commerce, and ever-changing consumer behavior. As a result, retailers have become increasingly aware of the need to better coordinate inventory control with pricing in order to maximize their profitability. This dissertation was motivated by two of such problems facing retailers at the interface between pricing and inventory control. One considers inventory control decisions for settings in which planned prices fluctuate over time, and the other considers pricing of multiple substitutable products for settings in which customers hold inventory as a consequence of stockpiling when promotional prices are offered. </p><p> In Chapter 1, we provide a brief motivation for each problem. In Chapter 2, we consider optimization of procurement and inventory allocation decisions by a retailer that sells a product with a long production lead time and a short selling season. The retailer orders most products months before the selling season, and places only one order for each product due to short product life cycles and long delivery lead times. Goods are initially stored at the warehouse and then sent to stores over the course of the season. The stores are in high-rent locations, necessitating efficient use of space, so there is no backroom space and it is uneconomical to send goods back to the warehouse; thus, all inventory at each store is available for sale. Due to marketing and logistics considerations, the planned trajectory of prices is determined in advance and may be non-monotonic. Demand is stochastic and price-dependent, and independent across time periods. We begin our analysis with the case of a single store. We first formulate the inventory allocation problem given a fixed initial order quantity with the objective of maximizing expected profit as a dynamic program and explain both technical and computational challenges in identifying the optimal policy. We then present two variants of a heuristic based on the notion of equalizing the marginal value of inventory across the time periods. Results from a numerical study indicate that the more sophisticated variant of the heuristic performs well when compared with both an upper bound and an industry benchmark, and even the simpler variant performs fairly well for realistic settings. We then generalize our approaches to the case of multiple stores, where we allow the stores to have different price trajectories. Our numerical results suggest that the performance of both heuristics is still robust in the multiple store setting, and does not suffer from the same performance deterioration observed for the industry benchmark as the number of stores increases or as price differences increase across stores and time periods. For the pre-season procurement problem, we develop a heuristic based on a generalization of the newsvendor problem that accounts for the two-tiered salvage values in our setting, specifically, a low price during end-of-season markdown periods and a very low or zero salvage value after the season has concluded. Results for numerical examples indicate that our modified newsvendor heuristic provides solutions that are as good as those obtained via grid search. </p><p> In Chapter 3, we address a retailer's problem of setting prices, including promotional prices, over a multi-period horizon for multiple substitutable products in the same product category. We consider the problem in a setting in which customers anticipate the retailer's pricing strategy and the retailer anticipates the customers' purchasing decisions. We formulate the problem as a two-stage game in which the profit maximizing retailer chooses prices and the utility maximizing customers respond by making explicit decisions regarding purchasing and consumption, and thus also implicit decisions regarding stockpiling. We incorporate a fairly general reference price formation process that allows for cross-product effects of prices on reference prices. We initially focus on a single customer segment. The representative customer's utility function accounts for the value of consumption of the products, psychological benefit (for deal-seekers) from purchasing at a price below his/her reference price but with diminishing marginal returns, costs of purchases, penalties for both shortages and holding inventory, and disutility for deviating from a consumption target in each period (where applicable). We are the first to develop a model that simultaneously accounts for this combination of realistic factors for the customer, and we also separate the customer's purchasing and consumption decisions. We develop a methodology for solving the customer's problem for arbitrary price trajectories based on a linear quadratic control formulation of an approximation of the customer's utility maximization problem. We derive analytical representations for the customer's optimal decisions as simple linear functions of prices, reference prices, inventory levels (as state variables), and the cumulative aggregate consumption level (as a state variable). (Abstract shortened by ProQuest.) </p><p>