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Engineering documentation control/configuration management standards manual : policies, procedures, flow diagrams, forms and form instructions for product manufacturing companies
\" Describes the best of the best management practices for the configuration management processes\" -- Provided by publisher.
Book
Combining business process management and lean manufacturing to improve information and documentation flows: a case study
PurposeThe objective of this work is to demonstrate how the use of a business process management (BPM) methodology reinforced with the use of lean manufacturing (LM) tools and practices enhances information and documentation flows.Design/methodology/approachFor this purpose, a case study on a large wind blade manufacturing company is described, in which BPM and LM were combined to improve information and documentation flows associated to the process of quality inspections and quality controls.FindingsThe joint use of BPM and LM strongly contributed to the improvement of information and documentation flows. The BPM lifecycle can be used to guide the entire improvement process, while LM tools can be used to act at specific points with an emphasis in the process analysis and implementation phases. Thus, LM complements a BPM approach leading to significant process improvements.Practical implicationsThe results show that LM can be used to support some phases of the BPM lifecycle. Furthermore, LM can contribute to identify lean waste in information and documentation flows associated to quality management processes and help in the selection of methods and tools to support process improvements.Originality/valueThis study is one of the first reporting the use of LM tools and practices as complementary to the BPM methodology to support the improvement of information and documentation flows associated to quality management in a large manufacturing company. This research enriches the literature by presenting empirical evidence that these two continuous improvement approaches are not incompatible in their objectives and visions and can complement each other.
Journal Article
Lean Six Sigma: yesterday, today and tomorrow
Purpose
The purpose of this paper is to share the experiences and perspectives of three practitioners from two continents on the subject of Lean Six Sigma (LSS) from both academic and industrial viewpoints. The authors of the paper have each been working on the topic of LSS over the past 15 years and have contributed over 150 journal and conference papers to the topics of lean and Six Sigma.
Design/methodology/approach
The approach is to synthesize the practical experiences and research conducted by three authorities on the topic of LSS. In addition, relevant secondary data have also been used in the sections where and when appropriate.
Findings
The authors initially present the history of LSS emphasizing the importance of integration of the two most effective process excellence methodologies over the past 30 years. The authors also report the current trends of LSS in organizations as well as the emerging future trends. They argue that LSS will continue to grow and evolve across the globe for several years.
Practical implications
The paper is intended to be equally useful to both academics and practitioners who are interested on the topic of LSS. From a pure practical standpoint, the paper provides an overview of the past, present and future trends of LSS as a powerful business strategy and problem-solving methodology for all industrial sectors, irrespective of their size and nature. The documentation of the history and recent developments in LSS should be useful to researchers in academia.
Originality/value
In authors’ best knowledge, there are no recent journal articles which cover all the three of these aspects; the past, the present and the future of LSS. This paper presents the above three aspects in a unique manner and addresses the gap between the current state and future directions of LSS.
Journal Article
Why Does China Allow Freer Social Media? Protests versus Surveillance and Propaganda
In this paper, we document basic facts regarding public debates about controversial political issues on Chinese social media. Our documentation is based on a dataset of 13.2 billion blog posts published on Sina Weibo—the most prominent Chinese microblogging platform—during the 2009–2013 period. Our primary finding is that a shockingly large number of posts on highly sensitive topics were published and circulated on social media. For instance, we find millions of posts discussing protests, and these posts are informative in predicting the occurrence of specific events. We find an even larger number of posts with explicit corruption allegations, and that these posts predict future corruption charges of specific individuals. Our findings challenge a popular view that an authoritarian regime would relentlessly censor or even ban social media. Instead, the interaction of an authoritarian government with social media seems more complex.
Journal Article
Monitoring process-related impurities in biologics–host cell protein analysis
During biologics development, manufacturers must demonstrate clearance of host cell impurities and contaminants to ensure drug purity, manufacturing process consistency, and patient safety. Host cell proteins (HCPs) are a major class of process-related impurities and require monitoring and documentation of their presence through development and manufacturing. Even in residual amounts, they are known to affect product quality and efficacy as well as patient safety. HCP analysis using enzyme-linked immunosorbent assay (HCP-ELISA) is the standard technique, due to its simple handling, short analysis time, and high sensitivity for protein impurities. Liquid chromatography mass spectrometry (LC–MS) is an orthogonal method for HCP analysis and is increasingly included in regulatory documentation. LC–MS offers advantages where HCP-ELISA has drawbacks, e.g., the ability to identify and quantify individual HCPs. This article summarizes the available knowledge about monitoring HCPs in biologics and presents the newest trends in HCP analysis with current state-of-the-art HCP measurement tools. Through case studies, we present examples of HCP control strategies that have been used in regulatory license applications, using an MS-based coverage analysis and HCP-ELISA and LC–MS for HCP quantification. This provides novel insight into the rapid evolving strategy of HCP analysis. Improvements in technologies to evaluate HCP-ELISA suitability and the implementation of orthogonal LC–MS methods for HCP analysis are important to rationally manipulate, engineer, and select suitable cell lines and downstream processing steps to limit problematic HCPs.
Journal Article
Towards an integrated lightweight 3D interactive approach to guidance in assembly process
Assembly is an essential part of the product life cycle. Inefficient assembly has a direct impact on the effectiveness and quality of the product. One of the main problems of current on-site assembly operations is clear and efficient guidance, which consists of two aspects: the lack of efficient reuse of existing data and confusion in the form of presentation. In order to reduce errors and the time required to perform assembly tasks, we aim to propose an integrated lightweight 3D interactive method to guidance in assembly process. It enables the reuse of previous process design and simulation stages, which can reduce the duplication of content and enhance the content preparation efficiency. At the same time, the method is platform-independent, does not rely on high-performance workstations, and can be presented on mobile, cross-platform. One case of disassembling the graphic card in the computer is presented to verify the method.
Journal Article
Moving analytical ultracentrifugation software to a good manufacturing practices (GMP) environment
Recent advances in instrumentation have moved analytical ultracentrifugation (AUC) closer to a possible validation in a Good Manufacturing Practices (GMP) environment. In order for AUC to be validated for a GMP environment, stringent requirements need to be satisfied; analysis procedures must be evaluated for consistency and reproducibility, and GMP capable data acquisition software needs to be developed and validated. These requirements extend to multiple regulatory aspects, covering documentation of instrument hardware functionality, data handling and software for data acquisition and data analysis, process control, audit trails and automation. Here we review the requirements for GMP validation of data acquisition software and illustrate software solutions based on UltraScan that address these requirements as far as they relate to the operation and data handling in conjunction with the latest analytical ultracentrifuge, the Optima AUC by Beckman Coulter. The software targets the needs of regulatory agencies, where AUC plays a critical role in the solution-based characterization of biopolymers and macromolecular assemblies. Biopharmaceutical and regulatory agencies rely heavily on this technique for characterizations of pharmaceutical formulations, biosimilars, injectables, nanoparticles, and other soluble therapeutics. Because of its resolving power, AUC is a favorite application, despite the current lack of GMP validation. We believe that recent advances in standards, hardware, and software presented in this work manage to bridge this gap and allow AUC to be routinely used in a GMP environment. AUC has great potential to provide more detailed information, at higher resolution, and with greater confidence than other analytical techniques, and our software satisfies an urgent need for AUC operation in the GMP environment. The software, including documentation, are publicly available for free download from Github. The multi-platform software is licensed by the LGPL v.3 open source license and supports Windows, Mac and Linux platforms. Installation instructions and a mailing list are available from ultrascan.aucsolutions.com.
Journal Article
Carbon Footprint Data Flow Process Improvement for Strawberry Jam Tube Product by Lean Techniques
Environmental transparency in food manufacturing requires efficient carbon footprint data collection, yet multi-departmental coordination often creates time-consuming, fragmented processes that impede adoption. This study applies lean office methodologies to optimize carbon footprint assessment processes in food manufacturing. Using a case study approach at a Thai food processing facility, we implemented flow process charts, value stream mapping, eight waste analysis, and ECRS methodology to evaluate the data collection process for strawberry jam production. The baseline assessment documented 142 activities across 12 departments, requiring 17,540 min. The lean interventions included establishing a centralized cross-functional team, developing standardized data collection templates, implementing a unified digital repository system, and consolidating redundant verification procedures. The improved process reduced activities from 142 to 63, decreased the required time from 17,540 to 11,190 min (36.2% reduction), and eliminated 95.8% of non-value-added activities while maintaining regulatory compliance. These efficiency gains enable more frequent environmental assessments and facilitate the broader adoption of carbon footprint measurement within resource-constrained manufacturing contexts. The study demonstrates that lean principles effectively optimize environmental assessment processes themselves, providing a replicable framework adaptable across diverse food manufacturing facilities and product lines while addressing critical adoption barriers including resource constraints and administrative complexity.
Journal Article
AI-Enabled Process Improvement in Information-Intensive Administrative Work: Real-Case Applications of LLMs in a Lean Six Sigma Context
Lean Six Sigma (LSS) improvement work increasingly depends on information-intensive activities such as document handling, data interpretation, reporting, and communication, yet current discussions of Artificial Intelligence in LSS remain largely technology-centric. This paper proposes a task-first, process-centric framework to support the governed application of Large Language Model (LLM)-enabled tools in such environments. The study makes three contributions: (i) a set of cross-functional organizational process types relevant to LSS practice, (ii) a functional classification of recurring tasks and LLM-enabled tool categories, and (iii) a dual-encoded task–tool matching matrix that separates alignment strength from interaction mode, distinguishing capability fit from governance logic. The framework is empirically anchored through two real-world industrial applications: customs document processing and shop-floor data digitalization and reporting. The results show that (i) stronger outcomes emerge when LLM-enabled support is matched to bounded, repetitive, and structured work, or when analytical support is built on stable and traceable data layers; (ii) operational value depends not only on technical capability, but on workflow embeddedness, data readiness, and human validation checkpoints. The framework also clarifies where support, augmentation, and partial automation are appropriate for different task classes and under explicit accountability constraints in information-intensive administrative work connected to improvement practice and governance.
Journal Article