Manufacturing, Control, and Automation

This chapter identifies the common needs for process controls and automation that include methodologies to enable in-situ-level process controls, optimization at the plant or industry level, open-architecture software tools, adaptive control systems, methods and diagnostic tools for condition-based maintenance of process equipment in a manufacturing industry.

Abstract Versus Concrete: How Managers’ Construal Influences Organizational Control Systems and Problem Solving

This research considers how frontline managers’ construal affects their conceptualization of organizational problems, which in turn influences how they incentivize employees to search out appropriate solutions. Depending on whether they conceptualize problems in more abstract or more concrete ways, frontline managers will vary in organizational control mechanisms they use to incentivize their employees to engage in exploration and exploitation. Based on these relationships, we expect the solutions achieved by employees to vary in terms of efficiency and effectiveness. Using a database of 267 projects in a single firm, we find that, after holding project attributes constant, concrete-oriented managers tend to utilize more process controls that lead employees to solve organizational problems more efficiently, whereas abstract-oriented managers tend toward use of more outcome controls that lead to more effective problem solving. When employees engage in ambidextrous learning, both effectiveness and efficiency of outcomes are enhanced. This research sheds light on important microfoundational influences on organizational outcomes.

Understanding process controls on groundwater recharge variability across Africa through recharge landscapes

Groundwater is critical in supporting current and future reliable water supply throughout Africa. Although continental maps of groundwater storage and recharge have been developed, we currently lack a clear understanding on how the controls on groundwater recharge vary across the entire continent. Reviewing the existing literature, we synthesize information on reported groundwater recharge controls in Africa. We find that 15 out of 22 of these controls can be characterised using global datasets. We develop 11 descriptors of climatic, topographic, vegetation, soil and geologic properties using global datasets, to characterise groundwater recharge controls in Africa. These descriptors cluster Africa into 15 Recharge Landscape Units for which we expect recharge controls to be similar. Over 80% of the continents land area is organized by just nine of these units. We also find that aggregating the Units by similarity into four broader Recharge Landscapes (Desert, Dryland, Wet tropical and Wet tropical forest) provides a suitable level of landscape organisation to explain differences in ground-based long-term mean annual recharge and recharge ratio estimates. Furthermore, wetter Recharge Landscapes are more efficient in converting rainfall to recharge than drier Recharge Landscapes as well as having higher annual recharge rates. In Dryland Recharge Landscapes, we found that annual recharge rates largely varied according to mean annual precipitation, whereas recharge ratio estimates increase with increasing monthly variability in P-PET. However, we were unable to explain why ground-based estimates of recharge signatures vary across other Recharge Landscapes, in which there are fewer ground-based recharge estimates, using global datasets alone. Even in dryland regions, there is still considerable unexplained variability in the estimates of annual recharge and recharge ratio, stressing the limitations of global datasets for investigating ground-based information.

Characteristics and process controls of statistical flood moments in Europe – a data-based analysis

Many recent studies have sought to characterize variations of the annual maximum flood discharge series over time and across space in Europe, including some that have elucidated different process controls on different statistical properties of these series. To further support these studies, we conduct a pan-European assessment of process controls on key properties of this series, including the mean annual flood (MAF) and coefficients of variation (CV) and skewness (CS) of flood discharges. These annual maximum flood discharge series consist of instantaneous peaks and daily means observed in 2370 catchments in Europe without strong human modifications covering the period 1960–2010. We explore how the estimated moments MAF, CV and CS vary due to catchment size, climate and other controls across Europe, where their averages are 0.17 m3 s−1 km−2, 0.52 and 1.28, respectively. The results indicate that MAF is largest along the Atlantic coast, in the high-rainfall areas of the Mediterranean coast and in mountainous regions, while it is smallest in the sheltered parts of the East European Plain. The CV is largest in southern and eastern Europe, while it is smallest in the regions subject to strong Atlantic influence. The pattern of the CS is similar, albeit more erratic, in line with the greater sampling variability of CS. In the Mediterranean, MAF, CV and CS decrease strongly with catchment area, suggesting that floods in small catchments are relatively very large, while in eastern Europe this dependence is much weaker, mainly due to more synchronized timing of snowmelt over large areas. The process controls on the flood moments in five predetermined hydroclimatic regions are identified through correlation and multiple linear regression analyses with a range of covariates, and the interpretation is aided by a seasonality analysis. Precipitation-related covariates are found to be the main controls of the spatial patterns of MAF in most of Europe except for regions in which snowmelt contributes to MAF, where air temperature is more important. The Aridity Index is, by far, the most important control on the spatial pattern of CV in all of Europe. Overall, the findings suggest that, at the continental scale, climate variables dominate over land surface characteristics, such as land use and soil type, in controlling the spatial patterns of flood moments. Finally, to provide a performance baseline for more local studies, we assess the estimation accuracy of regional multiple linear regression models for estimating flood moments in ungauged basins.

Human Resources, Management Control, and Culture, an Exploratory Study of Indonesia's SME

This paper investigates the SME's management control, human resources, and cultural context in Indonesia. These perspectives come into 2 (two) themes; Professional Capacity and Company Strategy. Most SMEs show a struggle in developing human quality and in particular, Indonesia's SMEs, also lack process controls due to their beliefs and cultures. Nonetheless, despite the positive impacts for the business sustainability that previous researchers have found, the implementation of MCS still has not been adequately done by the SME due to their several limitations. Thus, this paper aims to analyze a company perspective regarding the MCS implementation, specifically in the new phenomenon related to the contingent factors that arise from company issues and challenges using a case study from a clothing manufacturing company. The research question proposes for this research study is "How does Indonesia's SME implement its management control within limited resources and local culture?" Keywords: management control system, SME, contingency-based research, SME Point of View, Business Issues, MCS strategy

RT-qPCR Detection of SARS-CoV-2 from Wastewater Using the AB 7500 v1

This method was developed at the FDA’s Center for Food Safety and Applied Nutrition for GenomeTrakr’s pandemic response project, monitoring SARS-CoV-2 variants in wastewater​​. Protocols developed for this project cover wastewater collection, concentration, RNA extraction, RT-qPCR detection, library prep, genome sequencing, quality control checks, and data submission to NCBI. This protocol describes triplex and duplex assays for the RT-qPCR detection of the nucleocapsid region of the SARS-CoV-2 genome. These assays, along with the murine norovirus (MNV; extraction control) and crAssphage (human indicator) RT-qPCR assay (RT-qPCR Detection of Process Controls (Murine noroviurs and crAssphage) from Wastewater (protocols.io)), were developed for use on the AB 7500 platform using software version 2.0 or 2.3. All assays incorporate an internal amplification control (IC) to prevent the reporting of false negatives due to inhibition or failure of the RT-qPCR. These multiplexed detection assays were developed for the qualitative determination SARS-CoV-2 nucleocapsid gene extracted from wastewater. Valid sample results are contingent upon the detection of the MNV extraction control from the sample being tested.

RT-qPCR Detection of Process Controls (Murine noroviurs and crAssphage) from Wastewater using AB 7500 v1

This method was developed at the FDA’s Center for Food Safety and Applied Nutrition for GenomeTrakr’s pandemic response project, monitoring SARS-CoV-2 variants in wastewater​​. Protocols developed for this project cover wastewater collection, concentration, RNA extraction, RT-qPCR detection, library prep, genome sequencing, quality control checks, and data submission to NCBI. This protocol describes the murine norovirus (MNV; extraction control) and crAssphage (human indicator) RT-qPCR assay developed for use on the AB 7500 platform using software version 2.0 or 2.3. The assay incorporates an internal amplification control (IC) to prevent the reporting of false negatives due to inhibition or failure of the RT-qPCR. This multiplexed detection assay was developed for the determination crAssphage extracted from wastewater, as an endogenous control, and MNV as an extraction control. The assay is designed to be used in conjunction with the SARS-CoV-2 RT-qPCR detection assay. Valid sample results for SARS-CoV-2 detection are contingent upon the detection of the MNV extraction control from the sample being tested.

Gene Therapy: Development, Design of Studies, and Approval Process

Genome editing can be applied to various areas of medical diagnosis and treatments. Gene therapy pre-market applications comprise of systematically assessing a product’s design controls, manufacturing process controls, and proposed protocols for post-marketing surveillance. Quality risk management principles have been described in various FDA regulatory guidances for several aspects of good manufacturing practices (GMPs) such as several stages of process validation and verification in the genome product’s life cycle including critical quality attributes (CQAs) and monitoring critical process parameters (CPPs). A CPP is defined as a process parameter whose variability has an impact on a CQA of genome product and, therefore, should be monitored or controlled to ensure that the manufacturing process produces an end product of the desired quality. FDA’s mission is to facilitate the premarket review and evaluation of new genomic products for clinical use. The FDA guidances emphasize a quality management approach to the design of studies by providing oversight and objective review based on risk-benefit analysis of new genomic products. FDA reviews, evaluates, verifies and validates the implementation of the regulatory design-control requirements which are applied to the control genomic product’s quality throughout the total product life cycle (TPLC) [1-5].

Enhanced Ball Shear Testing Configuration For Substrate LGA Sensor Devices

Semiconductor assembly mass production environment has means of testing and verifying bond consistency and reliability during wire bonding. Common bond integrity assessment is ball shear testing (BST). This test enables analysis of the strength between the bond pad and a ball bond. This paper presents significant procedure on how ball shear testing parameters should be treated during wirebond integrity check. Device complexity in terms of performing ball shear testing specifically on sensor dice has different output responses. Frequent shearing on die resulted as bond pads are elevated by 30 µm (microns). To address manufacturing in-process controls challenges, shearing tool position, dage settings, and optical scopes are taken into consideration. Also, a study was performed on the execution correctness in combination with proper dage parameters was explored to meet good ball shear test process capability and break modes.

Comparative Metabolite Profiling of Traditional and Commercial Vinegars in Korea

Vinegar, composed of various organic acids, amino acids, and volatile compounds, has been newly recognized as a functional food with health benefits. Vinegar is produced through alcoholic fermentation of various raw materials followed by acetic acid fermentation, and detailed processes greatly vary between different vinegar products. This study performed metabolite profiling of various vinegar products using gas chromatography–mass spectrometry to identify metabolites that are specific to vinegar production processes. In particular, seven traditional vinegars that underwent spontaneous and slow alcoholic and acetic acid fermentations were compared to four commercial vinegars that were produced through fast acetic acid fermentation using distilled ethanol. A total of 102 volatile and 78 nonvolatile compounds were detected, and the principal component analysis of metabolites clearly distinguished between the traditional and commercial vinegars. Ten metabolites were identified as specific or significantly different compounds depending on vinegar production processes, most of which had originated from complex microbial metabolism during traditional vinegar fermentation. These process-specific compounds of vinegars may serve as potential biomarkers for fermentation process controls as well as authenticity and quality evaluation.