QUALITY CONTROL

At the end of this course, students are expected to: Understand the Quality Control technical terms commonly used in induatries. Know the quality control methods for some materials like cosmetics, soap etc. Understand the meaning of Industrial Safety and Control measures Explain the quality control of pharmaceutics and brewery industries Have a good understanding of Threshold Limit Value (TLV) Understand the meaning of ranges and charts in statistical quality contro

FAST : a fault detection and identification software tool

The aim of this work is to improve the reliability and safety of complex critical control systems by contributing to the systematic application of fault diagnosis. In order to ease the utilization of fault detection and isolation (FDI) tools in the industry, a systematic approach is required to allow the process engineers to analyze a system from this perspective. In this way, it should be possible to analyze this system to find if it provides the required fault diagnosis and redundancy according to the process criticality. In addition, it should be possible to evaluate what-if scenarios by slightly modifying the process (f.i. adding sensors or changing their placement) and evaluating the impact in terms of the fault diagnosis and redundancy possibilities. Hence, this work proposes an approach to analyze a process from the FDI perspective and for this purpose provides the tool FAST which covers from the analysis and design phase until the final FDI supervisor implementation in a real process. To synthesize the process information, a very simple format has been defined based on XML. This format provides the needed information to systematically perform the Structural Analysis of that process. Any process can be analyzed, the only restriction is that the models of the process components need to be available in the FAST tool. The processes are described in FAST in terms of process variables, components and relations and the tool performs the structural analysis of the process obtaining: (i) the structural matrix, (ii) the perfect matching, (iii) the analytical redundancy relations (if any) and (iv) the fault signature matrix. To aid in the analysis process, FAST can operate stand alone in simulation mode allowing the process engineer to evaluate the faults, its detectability and implement changes in the process components and topology to improve the diagnosis and redundancy capabilities. On the other hand, FAST can operate on-line connected to the process plant through an OPC interface. The OPC interface enables the possibility to connect to almost any process which features a SCADA system for supervisory control. When running in on-line mode, the process is monitored by a software agent known as the Supervisor Agent. FAST has also the capability of implementing distributed FDI using its multi-agent architecture. The tool is able to partition complex industrial processes into subsystems, identify which process variables need to be shared by each subsystem and instantiate a Supervision Agent for each of the partitioned subsystems. The Supervision Agents once instantiated will start diagnosing their local components and handle the requests to provide the variable values which FAST has identified as shared with other agents to support the distributed FDI process.Per tal de facilitar la utilització d'eines per la detecció i identificació de fallades (FDI) en la indústria, es requereix un enfocament sistemàtic per permetre als enginyers de processos analitzar un sistema des d'aquesta perspectiva. D'aquesta forma, hauria de ser possible analitzar aquest sistema per determinar si proporciona el diagnosi de fallades i la redundància d'acord amb la seva criticitat. A més, hauria de ser possible avaluar escenaris de casos modificant lleugerament el procés (per exemple afegint sensors o canviant la seva localització) i avaluant l'impacte en quant a les possibilitats de diagnosi de fallades i redundància. Per tant, aquest projecte proposa un enfocament per analitzar un procés des de la perspectiva FDI i per tal d'implementar-ho proporciona l'eina FAST la qual cobreix des de la fase d'anàlisi i disseny fins a la implementació final d'un supervisor FDI en un procés real. Per sintetitzar la informació del procés s'ha definit un format simple basat en XML. Aquest format proporciona la informació necessària per realitzar de forma sistemàtica l'Anàlisi Estructural del procés. Qualsevol procés pot ser analitzat, només hi ha la restricció de que els models dels components han d'estar disponibles en l'eina FAST. Els processos es descriuen en termes de variables de procés, components i relacions i l'eina realitza l'anàlisi estructural obtenint: (i) la matriu estructural, (ii) el Perfect Matching, (iii) les relacions de redundància analítica, si n'hi ha, i (iv) la matriu signatura de fallades. Per ajudar durant el procés d'anàlisi, FAST pot operar aïlladament en mode de simulació permetent a l'enginyer de procés avaluar fallades, la seva detectabilitat i implementar canvis en els components del procés i la topologia per tal de millorar les capacitats de diagnosi i redundància. Per altra banda, FAST pot operar en línia connectat al procés de la planta per mitjà d'una interfície OPC. La interfície OPC permet la possibilitat de connectar gairebé a qualsevol procés que inclogui un sistema SCADA per la seva supervisió. Quan funciona en mode en línia, el procés està monitoritzat per un agent software anomenat l'Agent Supervisor. Addicionalment, FAST té la capacitat d'implementar FDI de forma distribuïda utilitzant la seva arquitectura multi-agent. L'eina permet dividir sistemes industrials complexes en subsistemes, identificar quines variables de procés han de ser compartides per cada subsistema i generar una instància d'Agent Supervisor per cadascun dels subsistemes identificats. Els Agents Supervisor un cop activats, començaran diagnosticant els components locals i despatxant les peticions de valors per les variables que FAST ha identificat com compartides amb altres agents, per tal d'implementar el procés FDI de forma distribuïda.Postprint (published version

Development of aquatic animal genetic improvement and dissemination programs : current status and action plans

Aquatic animals, Breeding, Genetics, Fish

Exploring Heterogeneity in Consumers’ Meat Store Choices in an Emerging Market

Chinese consumers’ choices among meat stores are examined through a model that can capture consumer heterogeneities both in their opinion of various store attributes and in how much weight they attach to each attribute. This approach not only informs store managers as to what attributes should receive focus for improving their store images, but also provides insight about which specific attribute could be improved to achieve the most effective result. Based on the individual-level parameters obtained through an empirical Bayes analysis, managers or competitors are able to strategically target their store promotions to specific individual consumers based on their demographic characteristics.heterogeneity, individual-level parameters, logit models, meat store, Livestock Production/Industries, Research and Development/Tech Change/Emerging Technologies,

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines

Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges. Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative qualitative review was performed. Results: The review revealed that Health Canada uses mAb specific guidelines from EMA or USFDA when necessary. The BRICS agencies (except Russia) have incorporated some or most of the WHO SBP TRS and related annexes in similar national biotechnological/biological guidelines; however, gaps or insufficient information have been identified. The Russian Federation has issued general product registration guideline/s with very brief information about mAbs. The TMMDA (Turkey) has published an updated biosimilar guideline which parallels those of the EMA and the ones from WHO; however, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a biotechnological/biological product registration guideline with no information about mAb. The SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical and clinical aspects. The comparative evaluation of BRICS-TM agencies indicates a gap pertaining to clarification for physico-chemical characterization, manufacturing process, overages and compatibility requirements between biological substances and excipients specifically on mAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo studies mostly have disparity in terms of necessity, type of studies as well as design and criteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies, however detailed information pertaining to design, size of populations, requirements for primary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICS-TM agencies allow extrapolation of indications provided that pre-defined conditions are met. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability nor substitution. Pediatric research remains questionable across BRICS-TM. Conclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition, they also contain specific requirements pertaining to their own region. BRICS-TM has considerably less defined mAb specific biosimilar development and comparability parameters in their published guidelines.Peer reviewedFinal Published versio

Architecture and Information Requirements to Assess and Predict Flight Safety Risks During Highly Autonomous Urban Flight Operations

As aviation adopts new and increasingly complex operational paradigms, vehicle types, and technologies to broaden airspace capability and efficiency, maintaining a safe system will require recognition and timely mitigation of new safety issues as they emerge and before significant consequences occur. A shift toward a more predictive risk mitigation capability becomes critical to meet this challenge. In-time safety assurance comprises monitoring, assessment, and mitigation functions that proactively reduce risk in complex operational environments where the interplay of hazards may not be known (and therefore not accounted for) during design. These functions can also help to understand and predict emergent effects caused by the increased use of automation or autonomous functions that may exhibit unexpected non-deterministic behaviors. The envisioned monitoring and assessment functions can look for precursors, anomalies, and trends (PATs) by applying model-based and data-driven methods. Outputs would then drive downstream mitigation(s) if needed to reduce risk. These mitigations may be accomplished using traditional design revision processes or via operational (and sometimes automated) mechanisms. The latter refers to the in-time aspect of the system concept. This report comprises architecture and information requirements and considerations toward enabling such a capability within the domain of low altitude highly autonomous urban flight operations. This domain may span, for example, public-use surveillance missions flown by small unmanned aircraft (e.g., infrastructure inspection, facility management, emergency response, law enforcement, and/or security) to transportation missions flown by larger aircraft that may carry passengers or deliver products. Caveat: Any stated requirements in this report should be considered initial requirements that are intended to drive research and development (R&D). These initial requirements are likely to evolve based on R&D findings, refinement of operational concepts, industry advances, and new industry or regulatory policies or standards related to safety assurance

A constructive review of the State Forest Inventory in the Russian Federation

The State Forest Inventory (SFI) in the Russian Federation is a relatively new project that is little known in the English-language scientific literature. Following the stipulations of the Forest Act of 2006, the first SFI sample plots in this vast territory were established in 2007. The 34 Russian forest regions were the basic geographical units for all statistical estimates and served as a first-level stratification, while a second level was based on old inventory data and remotely sensed data. The sampling design was to consist of a simple random sample of 84,700 circular 500m(2) sample plots over forest land. Each sample plot consists of three nested concentric circular subplots with radii of 12.62, 5.64 and 2.82m and additional subplots for assessing and describing undergrowth, regeneration and ground vegetation. In total, 117 variables were to be measured or assessed on each plot.Although field work has begun, the methodology has elicited some criticism. The simple random sampling design is less efficient than a systematic design featuring sample plot clusters and a mix of temporary and permanent plots. The second-level stratification is mostly ineffective for increasing precision. Qualitative variables, which are not always essential, are dominant, while important quantitative variables are under-represented. Because of very slow progress, in 2018 the original plan was adjusted by reducing the number of permanent sample plots from 84,700 to 68,287 so that the first SFI cycle could be completed by 2020.Peer reviewe

A family of group chain acceptance sampling plans based on truncated life test

Acceptance sampling is a statistical quality control procedure used to accept or reject a lot, based on the inspection result of its sample. For high quality products, zero acceptance number is considered and the life test is often terminated on a specific time, hence called truncated life test. A plan having zero acceptance number is deemed unfair to producers as the probability of lot acceptance drops drastically at a very small proportion defective. To overcome this problem, chain sampling which uses preceding and succeeding lots information was introduced. In ordinary chain sampling plans, only one product is inspected at a time, although in practice, testers can accommodate multiple products simultaneously. In this situation, group chain sampling plan with small sample size is preferred because it saves inspection time and cost. Thus, it is worthwhile to develop the various types of chain sampling plans in the context of group testing. This research aims to develop new group chain (GChSP), modified group chain (MGChSP), two-sided group chain (TS-GChSP) and modified two-sided group chain (TS-MGChSP) sampling plans using the Pareto distribution of the 2nd kind. These four plans are also generalized based on several pre-specified values of proportion defective. This study involves four phases: identifying several combinations of design parameters; developing the procedures; obtaining operating characteristic functions; and measuring performances using both simulated and real lifetime data. The constructed plans are evaluated using various design parameters and compared with the established plan based on the number of minimum groups, and probability of lot acceptance,. The findings show that all the proposed plans provide smaller and lower compared to the established plan. All the plans are able to reduce inspection time and cost, and better at protecting customers from receiving defective products. This would be very beneficial to practitioners especially those involved with destructive testing of high quality products

DESIGNING FOOD SAFETY REGULATIONS: THE EFFECT OF INSPECTION POLICY AND PENALTIES FOR NONCOMPLIANCE ON FOOD PROCESSOR BEHAVIOR

In the United States, federal, state, and local governments are involved with the regulation of the safety of the food supply. Food safety regulations that set standards for food processors usually include inspection policies for monitoring performance and penalties for processors who do not comply with regulatory standards. In this analysis, we examine how penalties and inspection policies interact to influence processor behavior. We distinguish between internal penalties (imposed by the regulator) and external penalties (imposed by the market or by the court). Using a model of the processor's expected annual cost, we find that under a given inspection policy internal penalties are only relevant under specific conditions. For cases in which internal and external penalties can be influenced, we use comparative statics to discover that internal penalties are more economically efficient for motivating processors than external penalties. These results imply that regulators should utilize internal penalties for noncompliance rather that rely on market or court-imposed penalties.Food Consumption/Nutrition/Food Safety,