46 CFR 160.115-15 - Production inspections, tests, quality control, and conformance of winches.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Winches § 160.115-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

46 CFR 160.132-15 - Production inspections, tests, quality control, and conformance of davits.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Launching Appliances-Davits § 160.132-15 Production inspections, tests, quality control, and conformance of... necessary to maintain quality control and to monitor compliance with the requirements of this subpart. (b...

7 CFR 58.149 - Alternate quality control programs for dairy products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Alternate quality control programs for dairy products... and Grading Service 1 Operations and Operating Procedures § 58.149 Alternate quality control programs for dairy products. (a) When a plant has in operation an acceptable quality control program which is...

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

46 CFR 160.133-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and..., tests, quality control, and conformance of release mechanisms. (a) Unless the Commandant directs.... The Commandant may prescribe additional production tests and inspections necessary to maintain quality...

46 CFR 160.133-15 - Production inspections, tests, quality control, and conformance of release mechanisms.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and..., tests, quality control, and conformance of release mechanisms. (a) Unless the Commandant directs.... The Commandant may prescribe additional production tests and inspections necessary to maintain quality...

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

[Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

PubMed

Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

2017-03-01

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels.

PubMed

Zupke, Craig; Brady, Lowell J; Slade, Peter G; Clark, Philip; Caspary, R Guy; Livingston, Brittney; Taylor, Lisa; Bigham, Kyle; Morris, Arvia E; Bailey, Robert W

2015-01-01

Pressures for cost-effective new therapies and an increased emphasis on emerging markets require technological advancements and a flexible future manufacturing network for the production of biologic medicines. The safety and efficacy of a product is crucial, and consistent product quality is an essential feature of any therapeutic manufacturing process. The active control of product quality in a typical biologic process is challenging because of measurement lags and nonlinearities present in the system. The current study uses nonlinear model predictive control to maintain a critical product quality attribute at a predetermined value during pilot scale manufacturing operations. This approach to product quality control ensures a more consistent product for patients, enables greater manufacturing efficiency, and eliminates the need for extensive process characterization by providing direct measures of critical product quality attributes for real time release of drug product. © 2015 American Institute of Chemical Engineers.

21 CFR 111.135 - What quality control operations are required for product complaints?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.135 What quality control operations are required for...

[A strategy of constructing the technological system for quality control of Chinese medicine based on process control and management].

PubMed

Cheng, Yi-Yu; Qian, Zhong-Zhi; Zhang, Bo-Li

2017-01-01

The current situation, bottleneck problems and severe challenges in quality control technology of Chinese Medicine (CM) are briefly described. It is presented to change the phenomenon related to the post-test as the main means and contempt for process control in drug regulation, reverse the situation of neglecting the development of process control and management technology for pharmaceutical manufacture and reconstruct the technological system for quality control of CM products. The regulation and technology system based on process control and management for controlling CM quality should be established to solve weighty realistic problems of CM industry from the root causes, including backwardness of quality control technology, weakness of quality risk control measures, poor reputation of product quality and so on. By this way, the obstacles from poor controllability of CM product quality could be broken. Concentrating on those difficult problems and weak links in the technical field of CM quality control, it is proposed to build CMC (Chemistry, Manufacturing and Controls) regulation for CM products with Chinese characteristics and promote the regulation international recognition as soon as possible. The CMC technical framework, which is clinical efficacy-oriented, manufacturing manner-centered and process control-focused, was designed. To address the clinical characteristics of traditional Chinese medicine (TCM) and the production feature of CM manufacture, it is suggested to establish quality control engineering for CM manufacturing by integrating pharmaceutical analysis, TCM chemistry, TCM pharmacology, pharmaceutical engineering, control engineering, management engineering and other disciplines. Further, a theoretical model of quality control engineering for CM manufacturing and the methodology of digital pharmaceutical engineering are proposed. A technology pathway for promoting CM standard and realizing the strategic goal of CM internationalization is elaborated. Copyright© by the Chinese Pharmaceutical Association.

Expert database system for quality control

NASA Astrophysics Data System (ADS)

Wang, Anne J.; Li, Zhi-Cheng

1993-09-01

There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

Terms of Productivity, Including the Relationship Between Productivity, Effectiveness and Efficiency.

DTIC Science & Technology

1989-04-01

for Awareness Juran on Planning for Quality, 1988, J.M. Juran What is Total Quality Control? The Japanese Way, 1985, Kaoru Ishikawa Guide to Quality...Control, 1982, Kaoru Ishikawa Andrews, M. (1985). Statistical Process Control: Mandatory Management Tool. Production April 1985. Bushe, G. (1988

Network-based production quality control

NASA Astrophysics Data System (ADS)

Kwon, Yongjin; Tseng, Bill; Chiou, Richard

2007-09-01

This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2013 CFR

2013-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2013-01-01 2013-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2012 CFR

2012-01-01

... quality test shall be made to determine product stability. ... 7 Agriculture 3 2012-01-01 2012-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

A case study: application of statistical process control tool for determining process capability and sigma level.

PubMed

Chopra, Vikram; Bairagi, Mukesh; Trivedi, P; Nagar, Mona

2012-01-01

Statistical process control is the application of statistical methods to the measurement and analysis of variation process. Various regulatory authorities such as Validation Guidance for Industry (2011), International Conference on Harmonisation ICH Q10 (2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance for Product Quality Review (2008), and International Organization for Standardization ISO-9000:2005 provide regulatory support for the application of statistical process control for better process control and understanding. In this study risk assessments, normal probability distributions, control charts, and capability charts are employed for selection of critical quality attributes, determination of normal probability distribution, statistical stability, and capability of production processes, respectively. The objective of this study is to determine tablet production process quality in the form of sigma process capability. By interpreting data and graph trends, forecasting of critical quality attributes, sigma process capability, and stability of process were studied. The overall study contributes to an assessment of process at the sigma level with respect to out-of-specification attributes produced. Finally, the study will point to an area where the application of quality improvement and quality risk assessment principles for achievement of six sigma-capable processes is possible. Statistical process control is the most advantageous tool for determination of the quality of any production process. This tool is new for the pharmaceutical tablet production process. In the case of pharmaceutical tablet production processes, the quality control parameters act as quality assessment parameters. Application of risk assessment provides selection of critical quality attributes among quality control parameters. Sequential application of normality distributions, control charts, and capability analyses provides a valid statistical process control study on process. Interpretation of such a study provides information about stability, process variability, changing of trends, and quantification of process ability against defective production. Comparative evaluation of critical quality attributes by Pareto charts provides the least capable and most variable process that is liable for improvement. Statistical process control thus proves to be an important tool for six sigma-capable process development and continuous quality improvement.

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

Code of Federal Regulations, 2013 CFR

2013-10-01

... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... Lifeboats (SOLAS) § 160.135-15 Production inspections, tests, quality control, and conformance of lifeboats...

46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

Code of Federal Regulations, 2012 CFR

2012-10-01

... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... Lifeboats (SOLAS) § 160.135-15 Production inspections, tests, quality control, and conformance of lifeboats...

A real time quality control application for animal production by image processing.

PubMed

Sungur, Cemil; Özkan, Halil

2015-11-01

Standards of hygiene and health are of major importance in food production, and quality control has become obligatory in this field. Thanks to rapidly developing technologies, it is now possible for automatic and safe quality control of food production. For this purpose, image-processing-based quality control systems used in industrial applications are being employed to analyze the quality of food products. In this study, quality control of chicken (Gallus domesticus) eggs was achieved using a real time image-processing technique. In order to execute the quality control processes, a conveying mechanism was used. Eggs passing on a conveyor belt were continuously photographed in real time by cameras located above the belt. The images obtained were processed by various methods and techniques. Using digital instrumentation, the volume of the eggs was measured, broken/cracked eggs were separated and dirty eggs were determined. In accordance with international standards for classifying the quality of eggs, the class of separated eggs was determined through a fuzzy implication model. According to tests carried out on thousands of eggs, a quality control process with an accuracy of 98% was possible. © 2014 Society of Chemical Industry.

[Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine].

PubMed

Xu, Bing; Shi, Xin-Yuan; Wu, Zhi-Sheng; Zhang, Yan-Ling; Wang, Yun; Qiao, Yan-Jiang

2017-03-01

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness. Copyright© by the Chinese Pharmaceutical Association.

A Quality Assurance Initiative for Commercial-Scale Production in High-Throughput Cryopreservation of Blue Catfish Sperm

PubMed Central

Hu, E; Liao, T. W.; Tiersch, T. R.

2013-01-01

Cryopreservation of fish sperm has been studied for decades at a laboratory (research) scale. However, high-throughput cryopreservation of fish sperm has recently been developed to enable industrial-scale production. This study treated blue catfish (Ictalurus furcatus) sperm high-throughput cryopreservation as a manufacturing production line and initiated quality assurance plan development. The main objectives were to identify: 1) the main production quality characteristics; 2) the process features for quality assurance; 3) the internal quality characteristics and their specification designs; 4) the quality control and process capability evaluation methods, and 5) the directions for further improvements and applications. The essential product quality characteristics were identified as fertility-related characteristics. Specification design which established the tolerance levels according to demand and process constraints was performed based on these quality characteristics. Meanwhile, to ensure integrity throughout the process, internal quality characteristics (characteristics at each quality control point within process) that could affect fertility-related quality characteristics were defined with specifications. Due to the process feature of 100% inspection (quality inspection of every fish), a specific calculation method, use of cumulative sum (CUSUM) control charts, was applied to monitor each quality characteristic. An index of overall process evaluation, process capacity, was analyzed based on in-control process and the designed specifications, which further integrates the quality assurance plan. With the established quality assurance plan, the process could operate stably and quality of products would be reliable. PMID:23872356

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES Quality Control Procedures for... maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate... the biological quality of the protein. A protein biological quality analysis is not necessary for a...

Control by quality: proposition of a typology.

PubMed

Pujo, P; Pillet, M

The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control operators. Strategic control by quality is then detailed, and the two main approaches, the continuous improvement approach and the proactive improvement approach, are introduced. Finally, the authors observe that at each of the three levels, the continuous process improvement, which is a component of Total Quality, becomes an essential preoccupation for the control. Ultimately, the recursive utilization of the Deming cycle remains the best practice for the control by quality.

Evaluation of thin-layer chromatography methods for quality control of commercial products containing Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis.

PubMed

Ramírez-Durón, Rosalba; Ceniceros-Almaguer, Lucía; Salazar-Aranda, Ricardo; Salazar-Cavazos, Ma de la Luz; Waksman de Torres, Noemi

2007-01-01

In Mexico, plant-derived products with health claims are sold as herbal dietary supplements, and there are no rules for their legal quality control. Aesculus hippocastanum, Turnera diffusa, Matricaria recutita, Passiflora incarnata, and Tilia occidentalis are some of the major commercial products obtained from plants used in this region. In this paper, we describe the effectiveness of thin-layer chromatography methods to provide for the quality control of several commercial products containing these plants. Standardized extracts were used. Of the 49 commercial products analyzed, only 32.65% matched the chromatographic characteristic of standardized extracts. A significant number of commercial products did not match their label, indicating a problem resulting from the lack of regulation for these products. The proposed methods are simple, sensitive, and specific and can be used for routine quality control of raw herbals and formulations of the tested plants. The results obtained show the need to develop simple and reliable analytical methods that can be performed in any laboratory for the purpose of quality control of dietary supplements or commercial herbal products sold in Mexico.

21 CFR 106.30 - Finished product evaluation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR HUMAN CONSUMPTION INFANT FORMULA QUALITY CONTROL PROCEDURES (Eff. until 7-10-14) Quality Control... the maintenance of nutrient content throughout the shelf life of the product. (c) The manufacturer... nutrients, and the biological quality of the protein. A protein biological quality analysis is not necessary...

7 CFR 1728.202 - RUS Bulletin 1728H-702, RUS Specification for Quality Control and Inspection of Timber Products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... calendar year. (2) Ultimate quality control is the responsibility of the producer's management; however, a... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS Bulletin 1728H-702, RUS Specification for Quality... for Quality Control and Inspection of Timber Products. (a) Scope. This specification describes in more...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2012 CFR

2012-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2013 CFR

2013-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2011 CFR

2011-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

Code of Federal Regulations, 2014 CFR

2014-04-01

... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... for Quality Control § 111.123 What quality control operations are required for the master... for the master manufacturing record, the batch production record, and manufacturing operations must...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality control kit for blood banking reagents... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Products Used In Establishments That Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a...

Measuring Software Product Quality: The ISO 25000 Series and CMMI

DTIC Science & Technology

2004-06-14

performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

Total quality assurance

NASA Astrophysics Data System (ADS)

Louzon, E.

1989-12-01

Quality, cost, and schedule are three factors affecting the competitiveness of a company; they require balancing so that products of acceptable quality are delivered, on time and at a competitive cost. Quality costs comprise investment in quality maintenance and failure costs which arise from failure to maintain standards. The basic principle for achieving the required quality at minimum cost is that of prevention of failures, etc., through production control, attention to manufacturing practices, and appropriate management and training. Total quality control involves attention to the product throughout its life cycle, including in-service performance evaluation, servicing, and maintenance.

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

PubMed

Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

2017-07-01

The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

PubMed Central

2015-01-01

Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

Advancement in modern approaches to mineral production quality control

NASA Astrophysics Data System (ADS)

Freidina, EV; Botvinnik, AA; Dvornikova, AN

2017-02-01

The natural resource potential of mineral deposits is represented by three categories: upside, attainable and investment. A modern methodology is proposed in this paper for production quality control, and its tools aimed at ensuring agreement between the product quality and the market requirements are described. The definitions of the costs of the product quality compliance and incompliance with the consumer requirements are introduced; the latter is suggested to use in evaluating resource potential of mineral deposits at a certain degree of probability.

10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

10 CFR 32.25 - Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Conditions of licenses issued under § 32.22: Quality... Concentrations and Items § 32.25 Conditions of licenses issued under § 32.22: Quality control, labeling, and... in the manufacture of the product to assure that each production lot meets the quality control...

A system framework of inter-enterprise machining quality control based on fractal theory

NASA Astrophysics Data System (ADS)

Zhao, Liping; Qin, Yongtao; Yao, Yiyong; Yan, Peng

2014-03-01

In order to meet the quality control requirement of dynamic and complicated product machining processes among enterprises, a system framework of inter-enterprise machining quality control based on fractal was proposed. In this system framework, the fractal-specific characteristic of inter-enterprise machining quality control function was analysed, and the model of inter-enterprise machining quality control was constructed by the nature of fractal structures. Furthermore, the goal-driven strategy of inter-enterprise quality control and the dynamic organisation strategy of inter-enterprise quality improvement were constructed by the characteristic analysis on this model. In addition, the architecture of inter-enterprise machining quality control based on fractal was established by means of Web service. Finally, a case study for application was presented. The result showed that the proposed method was available, and could provide guidance for quality control and support for product reliability in inter-enterprise machining processes.

Statistical Methods in Assembly Quality Management of Multi-Element Products on Automatic Rotor Lines

NASA Astrophysics Data System (ADS)

Pries, V. V.; Proskuriakov, N. E.

2018-04-01

To control the assembly quality of multi-element mass-produced products on automatic rotor lines, control methods with operational feedback are required. However, due to possible failures in the operation of the devices and systems of automatic rotor line, there is always a real probability of getting defective (incomplete) products into the output process stream. Therefore, a continuous sampling control of the products completeness, based on the use of statistical methods, remains an important element in managing the quality of assembly of multi-element mass products on automatic rotor lines. The feature of continuous sampling control of the multi-element products completeness in the assembly process is its breaking sort, which excludes the possibility of returning component parts after sampling control to the process stream and leads to a decrease in the actual productivity of the assembly equipment. Therefore, the use of statistical procedures for continuous sampling control of the multi-element products completeness when assembled on automatic rotor lines requires the use of such sampling plans that ensure a minimum size of control samples. Comparison of the values of the limit of the average output defect level for the continuous sampling plan (CSP) and for the automated continuous sampling plan (ACSP) shows the possibility of providing lower limit values for the average output defects level using the ACSP-1. Also, the average sample size when using the ACSP-1 plan is less than when using the CSP-1 plan. Thus, the application of statistical methods in the assembly quality management of multi-element products on automatic rotor lines, involving the use of proposed plans and methods for continuous selective control, will allow to automating sampling control procedures and the required level of quality of assembled products while minimizing sample size.

21 CFR 111.105 - What must quality control personnel do?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must quality control personnel do? 111.105..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must...

Flexible optical metrology strategies for the control and quality assurance of small series production

NASA Astrophysics Data System (ADS)

Schmitt, R.; Pavim, A.

2009-06-01

The demand for achieving smaller and more flexible production series with a considerable diversity of products complicates the control of the manufacturing tasks, leading to big challenges for the quality assurance systems. The quality assurance strategy that is nowadays used for mass production is unable to cope with the inspection flexibility needed among automated small series production, because the measuring strategy is totally dependent on the fixed features of the few manufactured object variants and on process parameters that can be controlled/compensated during production time. The major challenge faced by a quality assurance system applied to small series production facilities is to guarantee the needed quality level already at the first run, and therefore, the quality assurance system has to adapt itself constantly to the new manufacturing conditions. The small series production culture requires a change of paradigms, because its strategies are totally different from mass production. This work discusses the tight inspection requirements of small series production and presents flexible metrology strategies based on optical sensor data fusion techniques, agent-based systems as well as cognitive and self-optimised systems for assuring the needed quality level of flexible small series. Examples of application scenarios are provided among the automated assembly of solid state lasers and the flexible inspection of automotive headlights.

Improved GMP-compliant multi-dose production and quality control of 6-[18F]fluoro-L-DOPA.

PubMed

Luurtsema, G; Boersma, H H; Schepers, M; de Vries, A M T; Maas, B; Zijlma, R; de Vries, E F J; Elsinga, P H

2017-01-01

6-[ 18 F]Fluoro-L-3,4-dihydroxyphenylalanine (FDOPA) is a frequently used radiopharmaceutical for detecting neuroendocrine and brain tumors and for the differential diagnosis of Parkinson's disease. To meet the demand for FDOPA, a high-yield GMP-compliant production method is required. Therefore, this study aimed to improve the FDOPA production and quality control procedures to enable distribution of the radiopharmaceutical over distances.FDOPA was prepared by electrophilic fluorination of the trimethylstannyl precursor with [ 18 F]F 2 , produced from [ 18 O] 2 via the double-shoot approach, leading to FDOPA with higher specific activity as compared to FDOPA which was synthesized, using [ 18 F]F 2 produced from 20 Ne, leading to FDOPA with a lower specific activity. The quality control of the product was performed using a validated UPLC system and compared with quality control with a conventional HPLC system. Impurities were identified using UPLC-MS. The [ 18 O] 2 double-shoot radionuclide production method yielded significantly more [ 18 F]F 2 with less carrier F 2 than the conventional method starting from 20 Ne. After adjustment of radiolabeling parameters substantially higher amounts of FDOPA with higher specific activity could be obtained. Quality control by UPLC was much faster and detected more side-products than HPLC. UPLC-MS showed that the most important side-product was FDOPA-quinone, rather than 6-hydroxydopa as suggested by the European Pharmacopoeia. The production and quality control of FDOPA were significantly improved by introducing the [ 18 O] 2 double-shoot radionuclide production method, and product analysis by UPLC, respectively. As a result, FDOPA is now routinely available for clinical practice and for distribution over distances.

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

PubMed

Içten, Elçin; Giridhar, Arun; Nagy, Zoltan K; Reklaitis, Gintaras V

2016-04-01

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Information quality-control model

NASA Technical Reports Server (NTRS)

Vincent, D. A.

1971-01-01

Model serves as graphic tool for estimating complete product objectives from limited input information, and is applied to cost estimations, product-quality evaluations, and effectiveness measurements for manpower resources allocation. Six product quality levels are defined.

Theoretical approach to society-wide environmental quality control

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ayano, K.

1982-01-01

The study outlines the basis for a theory of societal control of environmental quality in the US based on the concepts and philosophy of company-wide quality control which has developed in Japan as a cross-disciplinary approach to problem-solving in the industrial realm. The basic concepts are: 1) every member of society, as a producer of environmental products and services for future generations, in principle has the responsibility to control the quality of his output; 2) environment quality is the quality of life, or the fitness of use of environment for humans; and 3) societal control is any activity necessary formore » quality production of environmental products and services continuously or in the long run. A motivator-hygiene theory of environmental quality is identified, and a proposal is made that the policy provision must be formulated differently between those aimed at hygiene factors of environmental quality and those aimed at motivators, the former in a collectivistic manner, the latter as an individual problem. The concept of societal cost of environmental quality is introduced. Based on the motivator-hygiene theory of environmental quality, the collectivistic and individual approaches are differentiated and discussed.« less

Quality control education in the community college

NASA Technical Reports Server (NTRS)

Greene, J. Griffen; Wilson, Steve

1966-01-01

This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

Greenhouse production of Impatiens wallerana using a controlled-release fertiliser produces quality finished plants with enhanced garden performance

USDA-ARS?s Scientific Manuscript database

Nutrient management during production can greatly influence post-production quality of plants. The objective of this research was to evaluate the effect of controlled release fertilizer (CRF) applied at the time of plug planting on the garden performance (post-production) of impatiens (Impatiens wal...

46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

Code of Federal Regulations, 2012 CFR

2012-10-01

... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2012-10-01 2012-10-01 false Production inspections, tests, quality control, and... inspections, tests, quality control, and conformance of rescue boats and fast rescue boats. (a) Unless the...

46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

Code of Federal Regulations, 2013 CFR

2013-10-01

... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... 46 Shipping 6 2013-10-01 2013-10-01 false Production inspections, tests, quality control, and... inspections, tests, quality control, and conformance of rescue boats and fast rescue boats. (a) Unless the...

ProSens: integrated production control by automated inspection planning and efficient multisensor metrology

NASA Astrophysics Data System (ADS)

Glaser, Ulf; Li, Zhichao; Bichmann, Stephan, II; Pfeifer, Tilo

2003-05-01

By China's entry into the WTO, Chinese as well as German companies are facing the question, how to minimize the risk of unfamiliar cooperation partners when developing products. The rise of customer demands concerning quality, product diversity and the reduction of expenses require flexibility and efficiency with reliable component suppliers. In order to build and strengthen sino-german cooperations, a manufacturing control using homogenized and efficient measures to assure high quality is of vital importance. Lack of unifications may cause identical measurements conducted at subcontractors or customers to be carried out with different measurement processes which leads to incomparable results. Rapidly growing company cooperations and simultaneously decreasing of manufacturing scope cause substantial difficulties when coordinating joint quality control activities. "ProSens," a sino-german project consortium consisting of industrial users, technology producers and research institutes, aims at improving selected production processes by: Creation of a homogeneous quality awareness in sino-german cooperations. Sensitization for process accompanying metrology at an early stage of product development. Increase of the process performance by the use of integrated metrology. Reduction of production time and cost. Unification of quality control of complex products by means of efficient measurement strategies and CAD-based inspection planning.

7 CFR 58.928 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

7 CFR 58.335 - Quality control tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

Water Quality in the Production of Containerized Longleaf Pine Seedlings

Treesearch

David J. Moorhead; John M. Ruter

2002-01-01

The consistent production of quality container grown seedlings requires that key production variables be identified and controlled; otherwise, quality and the percentage of marketable plants will be erratic (Garber and Ruter 1993a). Additionally, production times and costs may increase unless production variables are monitored and managed throughout the production...

Quality control process improvement of flexible printed circuit board by FMEA

NASA Astrophysics Data System (ADS)

Krasaephol, Siwaporn; Chutima, Parames

2018-02-01

This research focuses on the quality control process improvement of Flexible Printed Circuit Board (FPCB), centred around model 7-Flex, by using Failure Mode and Effect Analysis (FMEA) method to decrease proportion of defective finished goods that are found at the final inspection process. Due to a number of defective units that were found at the final inspection process, high scraps may be escaped to customers. The problem comes from poor quality control process which is not efficient enough to filter defective products from in-process because there is no In-Process Quality Control (IPQC) or sampling inspection in the process. Therefore, the quality control process has to be improved by setting inspection gates and IPCQs at critical processes in order to filter the defective products. The critical processes are analysed by the FMEA method. IPQC is used for detecting defective products and reducing chances of defective finished goods escaped to the customers. Reducing proportion of defective finished goods also decreases scrap cost because finished goods incur higher scrap cost than work in-process. Moreover, defective products that are found during process can reflect the abnormal processes; therefore, engineers and operators should timely solve the problems. Improved quality control was implemented for 7-Flex production lines from July 2017 to September 2017. The result shows decreasing of the average proportion of defective finished goods and the average of Customer Manufacturers Lot Reject Rate (%LRR of CMs) equal to 4.5% and 4.1% respectively. Furthermore, cost saving of this quality control process equals to 100K Baht.

Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design-A Worked-through Case Study.

PubMed

Paolantonacci, Philippe; Appourchaux, Philippe; Claudel, Béatrice; Ollivier, Monique; Dennett, Richard; Siret, Laurent

2018-01-01

Polyvalent human normal immunoglobulins for intravenous use (IVIg), indicated for rare and often severe diseases, are complex plasma-derived protein preparations. A quality by design approach has been used to develop the Laboratoire Français du Fractionnement et des Biotechnologies new-generation IVIg, targeting a high level of purity to generate an enhanced safety profile while maintaining a high level of efficacy. A modular approach of quality by design was implemented consisting of five consecutive steps to cover all the stages from the product design to the final product control strategy.A well-defined target product profile was translated into 27 product quality attributes that formed the basis of the process design. In parallel, a product risk analysis was conducted and identified 19 critical quality attributes among the product quality attributes. Process risk analysis was carried out to establish the links between process parameters and critical quality attributes. Twelve critical steps were identified, and for each of these steps a risk mitigation plan was established.Among the different process risk mitigation exercises, five process robustness studies were conducted at qualified small scale with a design of experiment approach. For each process step, critical process parameters were identified and, for each critical process parameter, proven acceptable ranges were established. The quality risk management and risk mitigation outputs, including verification of proven acceptable ranges, were used to design the process verification exercise at industrial scale.Finally, the control strategy was established using a mix, or hybrid, of the traditional approach plus elements of the quality by design enhanced approach, as illustrated, to more robustly assign material and process controls and in order to securely meet product specifications.The advantages of this quality by design approach were improved process knowledge for industrial design and process validation and a clear justification of the process and product specifications as a basis for control strategy and future comparability exercises. © PDA, Inc. 2018.

Stability evaluation of quality parameters for palm oil products at low temperature storage.

PubMed

Ramli, Nur Aainaa Syahirah; Mohd Noor, Mohd Azmil; Musa, Hajar; Ghazali, Razmah

2018-07-01

Palm oil is one of the major oils and fats produced and traded worldwide. The value of palm oil products is mainly influenced by their quality. According to ISO 17025:2005, accredited laboratories require a quality control procedure with respect to monitoring the validity of tests for determination of quality parameters. This includes the regular use of internal quality control using secondary reference materials. Unfortunately, palm oil reference materials are not currently available. To establish internal quality control samples, the stability of quality parameters needs to be evaluated. In the present study, the stability of quality parameters for palm oil products was examined over 10 months at low temperature storage (6 ± 2 °C). The palm oil products tested included crude palm oil (CPO); refined, bleached and deodorized (RBD) palm oil (RBDPO); RBD palm olein (RBDPOo); and RBD palm stearin (RBDPS). The quality parameters of the oils [i.e. moisture content, free fatty acid content (FFA), iodine value (IV), fatty acids composition (FAC) and slip melting point (SMP)] were determined prior to and throughout the storage period. The moisture, FFA, IV, FAC and SMP for palm oil products changed significantly (P < 0.05), whereas the moisture content for CPO, IV for RBDPO and RBDPOo, stearic acid composition for CPO and linolenic acid composition for CPO, RBDPO, RBDPOo and RBDPS did not (P > 0.05). The stability study indicated that the quality of the palm oil products was stable within the specified limits throughout the storage period at low temperature. The storage conditions preserved the quality of palm oil products throughout the storage period. These findings qualify the use of the palm oil products CPO, RBDPO, RBDPOo and RBDPS as control samples in the validation of test results. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

21 CFR 211.100 - Written procedures; deviations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Process Controls § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality... approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b...

Image processing system performance prediction and product quality evaluation

NASA Technical Reports Server (NTRS)

Stein, E. K.; Hammill, H. B. (Principal Investigator)

1976-01-01

The author has identified the following significant results. A new technique for image processing system performance prediction and product quality evaluation was developed. It was entirely objective, quantitative, and general, and should prove useful in system design and quality control. The technique and its application to determination of quality control procedures for the Earth Resources Technology Satellite NASA Data Processing Facility are described.

Multicapillary SDS-gel electrophoresis for the analysis of fluorescently labeled mAb preparations: a high throughput quality control process for the production of QuantiPlasma and PlasmaScan mAb libraries.

PubMed

Székely, Andrea; Szekrényes, Akos; Kerékgyártó, Márta; Balogh, Attila; Kádas, János; Lázár, József; Guttman, András; Kurucz, István; Takács, László

2014-08-01

Molecular heterogeneity of mAb preparations is the result of various co- and post-translational modifications and to contaminants related to the production process. Changes in molecular composition results in alterations of functional performance, therefore quality control and validation of therapeutic or diagnostic protein products is essential. A special case is the consistent production of mAb libraries (QuantiPlasma™ and PlasmaScan™) for proteome profiling, quality control of which represents a challenge because of high number of mAbs (>1000). Here, we devise a generally applicable multicapillary SDS-gel electrophoresis process for the analysis of fluorescently labeled mAb preparations for the high throughput quality control of mAbs of the QuantiPlasma™ and PlasmaScan™ libraries. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Development and Application of the Key Technologies for the Quality Control and Inspection of National Geographical Conditions Survey Products

NASA Astrophysics Data System (ADS)

Zhao, Y.; Zhang, L.; Ma, W.; Zhang, P.; Zhao, T.

2018-04-01

The First National Geographical Condition Survey is a predecessor task to dynamically master basic situations of the nature, ecology and human activities on the earth's surface and it is the brand-new mapping geographic information engineering. In order to ensure comprehensive, real and accurate survey results and achieve the quality management target which the qualified rate is 100 % and the yield is more than 80 %, it is necessary to carry out the quality control and result inspection for national geographical conditions survey on a national scale. To ensure that achievement quality meets quality target requirements, this paper develops the key technology method of "five-in-one" quality control that is constituted by "quality control system of national geographical condition survey, quality inspection technology system, quality evaluation system, quality inspection information management system and national linked quality control institutions" by aiming at large scale, wide coverage range, more undertaking units, more management levels, technical updating, more production process and obvious regional differences in the national geographical condition survey and combining with novel achievement manifestation, complicated dependency, more special reference data, and large data size. This project fully considering the domestic and foreign related research results and production practice experience, combined with the technology development and the needs of the production, it stipulates the inspection methods and technical requirements of each stage in the quality inspection of the geographical condition survey results, and extends the traditional inspection and acceptance technology, and solves the key technologies that are badly needed in the first national geographic survey.

14 CFR 21.147 - Changes in quality control system.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

14 CFR 21.147 - Changes in quality control system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 3 2013-07-01 2013-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

33 CFR 385.21 - Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

Quality Control through Design and Process: Gambrel Roof Truss Challenge

ERIC Educational Resources Information Center

Ward, Dell; Jones, James

2011-01-01

Customers determine whether a product fulfills their needs or satisfies them. "Quality control", then, is the process of finding out what the customer wants, along with designing, producing, delivering, and servicing the product--and ultimately satisfying the customer's expectations. For many years, people considered a product to be of good…

Quality control troubleshooting tools for the mill floor

Treesearch

John Dramm

2000-01-01

Statistical Process Control (SPC) provides effective tools for improving process quality in the forest products industry resulting in reduced costs and improved productivity. Implementing SPC helps identify and locate problems that occur in wood products manufacturing. SPC tools achieve their real value when applied on the mill floor for monitoring and troubleshooting...

A quality system for PET: An industry perspective

NASA Astrophysics Data System (ADS)

Zigler, Steven S.; Breslow, Kenneth; Nazerias, Michael

2005-12-01

Quality systems have been employed in a variety of industries to develop and supply products that meet customer expectations and regulatory requirements. Most quality systems address organizational structure, design controls, production, complaints, audits, corrective actions and preventive actions. This paper describes PETNET's efforts to develop a quality system for use in the production of PET tracers. Our goal is to ensure quality products and to facilitate compliance with impending PET good manufacturing practice (GMP) regulations.

[Comparison and review on specifications of fermented Cordyceps sinensis products].

PubMed

Yang, Ping; Zhao, Xiao-Xia; Zhang, Yong-Wen

2018-02-01

There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensis， they have similar names， chemical components and even clinical applications. However， because of the different strain species and fermentation processes， there was significant difference in quality. As a result， they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990s， so there was difference in quality standards for different products， and their quality control levels of some products were not perfect. At present， some of the products are approved as Chinese medicine， others are approved as chemical drugs， with a confusion in products name， management and clinical application. In this paper， the approval numbers， quality standards and clinical applications， and current problems of these products were summarized and compared; some suggestions were put forward， such as standardizing the product name， unifying the management of approval number category， and increasing the specific quality control attributes， in order to provide reference for standard implementation， quality control and drug regulation for fermented Cordyceps crude drugs and their preparations. Copyright© by the Chinese Pharmaceutical Association.

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 864.9650 - Quality control kit for blood banking reagents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Quality control kit for blood banking reagents... Manufacture Blood and Blood Products § 864.9650 Quality control kit for blood banking reagents. (a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells...

21 CFR 640.56 - Quality control test for potency.

Code of Federal Regulations, 2010 CFR

2010-04-01

... quality control test for potency may be performed by a clinical laboratory which meets the standards of... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Quality control test for potency. 640.56 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.56 Quality control...

Epidemiology and quality assurance: applications at farm level.

PubMed

Noordhuizen, J P; Frankena, K

1999-03-29

Animal production is relevant with respect to farm income and the position of the sector in the market, but also with respect to the quality and safety of products of animal origin, related to public health. Animal production is part of a chain of food production. Therefore, producers have to take consumer expectations and demands in the domains of animal health, welfare and environment into account. A different attitude for production has to be adopted; this attitude can be visualized in good farming practice, GFP, codes. Farmers who focused on quality in its broadest sense need a system supporting them in their management and control of quality risks. Generally speaking, there are three systems for that purpose: GFP, ISO and HACCP. When the hypothesis followed relates to animal health being a feature of quality, or else welfare and environmental issues, then animal health care can be executed following quality control principles. The HACCP concept is well suited for quality control at farm level, involving risk identification and risk management. The on-farm monitoring and surveillance system of critical control points in the animal production process is the most important tool in this procedure. Principles for HACCP application as well as certification fitness of HACCP are elaborated upon. They are illustrated by using salmonellosis in meat-pig farms as objective for an HACCP approach. It is further discussed that, in addition to animal health and quality, animal welfare and environmental issues could also be covered by an HACCP-like system in an integrated manner. Ultimately, the HACCP modules could end up in an overall ISO certification.

Field Methods and Quality-Assurance Plan for Quality-of-Water Activities, U.S. Geological Survey, Idaho National Laboratory, Idaho

USGS Publications Warehouse

Knobel, LeRoy L.; Tucker, Betty J.; Rousseau, Joseph P.

2008-01-01

Water-quality activities conducted by the staff of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation's water resources. The activities are conducted in cooperation with the U.S. Department of Energy's (DOE) Idaho Operations Office. Results of the water-quality investigations are presented in various USGS publications or in refereed scientific journals. The results of the studies are highly regarded, and they are used with confidence by researchers, regulatory and managerial agencies, and interested civic groups. In its broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the 'state-of-the-art' technology, and quality assurance ensures that quality control is maintained within specified limits.

Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

PubMed

Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

2013-12-01

Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

Quality assurance in forensic odontology

PubMed

Solheim, T

2018-05-30

Quality assurance or quality control is a term and concept coming from the industry. Here it is most important. All products must have a minimum quality and variation in size, for example, must be kept within certain strict limits. There must be a system to control this. May be not every single product is controlled, but spot tests must be taken. Measures must be taken to improve the quality if it is not good enough. This concept has been transferred to medicine, odontology, and consequently also to forensic odontology. These areas have in common with industry the production of that certain products. However, they are usually handmade and not produced in an industrial process. In addition, dentistry is a great deal of art and judgement and quality control of these factors may be difficult. In this paper, I will focus on forensic odontology. What are the problems? What can we do and cannot do? In addition, how can we assure the quality of the work, the assessment and conclusion, and the report? I have some personal opinions on that and I will give some suggestions. Quality assurance on an international level is difficult. Conditions and juridical systems are different in different countries. Especially forensic odontologists are different and have different opinions. This presentation will be relevant to the ongoing discussion and attempts at revising the IOFOS' guidelines for quality assurance.

[Which one is more important, raw materials or productive technology?--a case study for quality consistency control of Gegen Qinlian decoction].

PubMed

Zhong, Wen; Chen, Sha; Zhang, Jun; Wang, Yu-Sheng; Liu, An

2016-03-01

To investigate the effect of Chinese medicine raw materials and production technology on quality consistency of Chinese patent medicines with Gegen Qinlian decoction as an example, and establish a suitable method for the quality consistency control of Chinese patent medicines. The results showed that the effect of production technology on the quality consistency was generally not more than 5%, while the effect of raw materials was even more than 30%, indicating that the effect of raw materials was much greater than that of the production technology. In this study, blend technology was used to improve the quality consistency of raw materials. As a result, the difference between the product produced by raw materials and reference groups was less than 5%, thus increasing the quality consistence of finished products. The results showed that under the current circumstances, the main factor affecting the quality consistency of Chinese patent medicines was raw materials, so we shall pay more attention to the quality of Chinese medicine's raw materials. Finally, a blend technology can improve the quality consistency of Chinese patent medicines. Copyright© by the Chinese Pharmaceutical Association.

[Establishment of industry promotion technology system in Chinese medicine secondary exploitation based on "component structure theory"].

PubMed

Cheng, Xu-Dong; Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Jia, Xiao-Bin

2014-10-01

The purpose of the secondary exploitation of Chinese medicine is to improve the quality of Chinese medicine products, enhance core competitiveness, for better use in clinical practice, and more effectively solve the patient suffering. Herbs, extraction, separation, refreshing, preparation and quality control are all involved in the industry promotion of Chinese medicine secondary exploitation of industrial production. The Chinese medicine quality improvement and industry promotion could be realized with the whole process of process optimization, quality control, overall processes improvement. Based on the "component structure theory", "multi-dimensional structure & process dynamic quality control system" and systematic and holistic character of Chinese medicine, impacts of whole process were discussed. Technology systems of Chinese medicine industry promotion was built to provide theoretical basis for improving the quality and efficacy of the secondary development of traditional Chinese medicine products.

Quality Control Circles: A Vehicle for Just-in-Time Implementation.

ERIC Educational Resources Information Center

Sepehri, Mehran

1985-01-01

Explains just-in-time (JIT) material flow and production, a method of production designed to eliminate waste. Discusses why quality control circles work so well with a JIT system, and describes how several companies have made JIT work for them. (CT)

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

[Testing of medicinal products produced from pooled plasma].

PubMed

Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

2014-10-01

Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

Off-Line Quality Control In Integrated Circuit Fabrication Using Experimental Design

NASA Astrophysics Data System (ADS)

Phadke, M. S.; Kackar, R. N.; Speeney, D. V.; Grieco, M. J.

1987-04-01

Off-line quality control is a systematic method of optimizing production processes and product designs. It is widely used in Japan to produce high quality products at low cost. The method was introduced to us by Professor Genichi Taguchi who is a Deming-award winner and a former Director of the Japanese Academy of Quality. In this paper we will i) describe the off-line quality control method, and ii) document our efforts to optimize the process for forming contact windows in 3.5 Aim CMOS circuits fabricated in the Murray Hill Integrated Circuit Design Capability Laboratory. In the fabrication of integrated circuits it is critically important to produce contact windows of size very near the target dimension. Windows which are too small or too large lead to loss of yield. The off-line quality control method has improved both the process quality and productivity. The variance of the window size has been reduced by a factor of four. Also, processing time for window photolithography has been substantially reduced. The key steps of off-line quality control are: i) Identify important manipulatable process factors and their potential working levels. ii) Perform fractional factorial experiments on the process using orthogonal array designs. iii) Analyze the resulting data to determine the optimum operating levels of the factors. Both the process mean and the process variance are considered in this analysis. iv) Conduct an additional experiment to verify that the new factor levels indeed give an improvement.

Sustainable improvement of animal health care by systematic quality risk management according to the HACCP concept.

PubMed

Noordhuizen, J P; Welpelo, H J

1996-12-01

This paper addresses the principles of the Hazard Analysis Critical Control Point (HACCP) concept as applied to animal health management strategy. Characteristics of the concept were analysed and compared with those of current animal health care strategies for disease risk identification and herd health management, insurance, and certification. HACCP is a hybrid strategy of quality control at both production process and product level. Animal health is considered a particular quality feature. We show that process control (expressed in terms of controlling both general and specific disease risk factors) and product control (expressed in terms of testing animals or animal products for specific disease agents) could form the basis for improving animal health. We conclude that HACCP provides ample opportunity for preventive health action and risk management at a relatively low cost in terms of labour, finance and documentation expenditure, at both the farm and sector level. Epidemiological field studies are currently needed to identify critical control points and to design HACCP procedures for livestock producers. In the long run, HACCP based animal health care can be further developed into a quality control systems approach to cover all aspects that are related, either directly or indirectly, to animal health.

Computer applications in scientific balloon quality control

NASA Astrophysics Data System (ADS)

Seely, Loren G.; Smith, Michael S.

Seal defects and seal tensile strength are primary determinants of product quality in scientific balloon manufacturing; they therefore require a unit of quality measure. The availability of inexpensive and powerful data-processing tools can serve as the basis of a quality-trends-discerning analysis of products. The results of one such analysis are presently given in graphic form for use on the production floor. Software descriptions and their sample outputs are presented, together with a summary of overall and long-term effects of these methods on product quality.

On-Site Construction Productivity Improvement Through Total Quality Management

DTIC Science & Technology

1991-12-01

morale of the work force. i Kaoru Ishikawa , Guide to Ouality Control, (2d ed; New York: Asian Productivity Organization, 1982), p. 45. ’"Ibid. 34...Curve Kaoru Ishikawa , Guide to Quality Control, (2d ed; New York: Asian Productivity Organization, 1982), p. 62. 54 For any normal distribution, 99.73...KAIZEN The Key to Japan’s Comoetitive Success. New York: Random House Business Division, 1986. Ishikawa , Kaoru , Guide to Ouality Control. 2d ed; New

[Discussion on research and development of new traditional Chinese medicine preparation process based on idea of QbD].

PubMed

Feng, Yi; Hong, Yan-Long; Xian, Jie-Chen; Du, Ruo-Fei; Zhao, Li-Jie; Shen, Lan

2014-09-01

Traditional processes are mostly adopted in traditional Chinese medicine (TCM) preparation production and the quality of products is mostly controlled by terminal. Potential problems of the production in the process are unpredictable and is relied on experience in most cases. Therefore, it is hard to find the key points affecting the preparation process and quality control. A pattern of research and development of traditional Chinese medicine preparation process based on the idea of Quality by Design (QbD) was proposed after introducing the latest research achievement. Basic theories of micromeritics and rheology were used to characterize the physical property of TCM raw material. TCM preparation process was designed in a more scientific and rational way by studying the correlation among enhancing physical property of raw material, preparation process and product quality of preparation. So factors affecting the quality of TCM production would be found out and problems that might occur in the pilot process could be predicted. It would be a foundation for the R&D and production of TCM preparation as well as support for the "process control" of TCMIs gradually realized in the future.

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

7 CFR 58.929 - Frequency of sampling for quality control.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false Frequency of sampling for quality control. 58.929... Service 1 Operations and Operating Procedures § 58.929 Frequency of sampling for quality control. (a... to control composition. On continuous production runs, enough samples shall be taken throughout the...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

30 CFR 74.6 - Quality control.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

A Methodology for Performing Effects-Based Assessments

DTIC Science & Technology

2006-03-01

can then be used to make assessments (Smith, 2002:384). 2.8 Cause-and-Effect Diagrams Developed by Dr. Kaoru Ishikawa in the field of Quality Control...John Wiley & Sons, Inc., 2004. Ishikawa , Kaoru . Guide to Quality Control. White Plains NY: Asian Productivity Organization, 1989...various causes affecting product quality by sorting out and relating the causes. Cause-and-effect diagrams are sometimes called Ishikawa diagrams, or

[Aquaculture in Italy. An integrated model of product quality control].

PubMed

De Giusti, Maria; Cocchieri, Renata Amodio; De Vito, Elisabetta; Grasso, Guido Maria; Ortaggi, Giancarlo; Reali, Daniela; Ricciardi, Gualtiero; Romano-Spica, Vincenzo; Boccia, Antonio

2007-01-01

Aquaculture is becoming increasingly diffuse even in Italy. The increased production introduces new problems such as product quality control and process safety. This article presents the results of a research project, funded by the Ministry of the Environment, whose aim was to evaluate and promote aquaculture product quality and safety in an environmentally responsible way. Four intensive land-based and offshore aquaculture sites were monitored to evaluate microbiological, biological and chemical (i.e. polychlorinated biphenyls and endocrine disruptors) quality of water, products and fish feed. In total 154 samples were analysed, of which 66 were water samples, 55 product samples and 33 feed samples. Salmonella and other enteric pathogens were absent in products and the aquatic environment, while other environmental pathogens of the Vibrio species were detected. Bacterial load and fecal indicators were found to be higher in off-shore products and in mussels from all aquaculture sites. PCBs were detected in all products in concentrations below 2 microg/g fresh product (Food and Drug Administration), but on average, higher concentrations were detected in off-shore products. No estrogen mimetic activity was detected in fish feed, in contrast it was detected in offshore products and water. Product quality was found to be strictly correlated with the quality of the environment. Genetically modified organisms were detected in fish feed but no integration of genetic material in products occurred.

The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

NASA Astrophysics Data System (ADS)

Zhan, Jinliang; Lu, Pei

2006-11-01

Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

30 CFR 28.32 - Proposed quality control plans; approval by MSHA.

Code of Federal Regulations, 2010 CFR

2010-07-01

... subpart shall be reviewed by MSHA to determine its effectiveness in insuring the quality of short-circuit... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FUSES FOR USE WITH DIRECT CURRENT IN PROVIDING SHORT-CIRCUIT PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.32 Proposed quality control...

Field methods and quality-assurance plan for water-quality activities and water-level measurements, U.S. Geological Survey, Idaho National Laboratory, Idaho

USGS Publications Warehouse

Bartholomay, Roy C.; Maimer, Neil V.; Wehnke, Amy J.

2014-01-01

Water-quality activities and water-level measurements by the personnel of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation’s water resources. The activities are carried out in cooperation with the U.S. Department of Energy (DOE) Idaho Operations Office. Results of the water-quality and hydraulic head investigations are presented in various USGS publications or in refereed scientific journals and the data are stored in the National Water Information System (NWIS) database. The results of the studies are used by researchers, regulatory and managerial agencies, and interested civic groups. In the broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the “state-of-the-art” technology, and quality assurance ensures that quality control is maintained within specified limits.

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process.

PubMed

Singh, Ravendra; Román-Ospino, Andrés D; Romañach, Rodolfo J; Ierapetritou, Marianthi; Ramachandran, Rohit

2015-11-10

The pharmaceutical industry is strictly regulated, where precise and accurate control of the end product quality is necessary to ensure the effectiveness of the drug products. For such control, the process and raw materials variability ideally need to be fed-forward in real time into an automatic control system so that a proactive action can be taken before it can affect the end product quality. Variations in raw material properties (e.g., particle size), feeder hopper level, amount of lubrication, milling and blending action, applied shear in different processing stages can affect the blend density significantly and thereby tablet weight, hardness and dissolution. Therefore, real time monitoring of powder bulk density variability and its incorporation into the automatic control system so that its effect can be mitigated proactively and efficiently is highly desired. However, real time monitoring of powder bulk density is still a challenging task because of different level of complexities. In this work, powder bulk density which has a significant effect on the critical quality attributes (CQA's) has been monitored in real time in a pilot-plant facility, using a NIR sensor. The sensitivity of the powder bulk density on critical process parameters (CPP's) and CQA's has been analyzed and thereby feed-forward controller has been designed. The measured signal can be used for feed-forward control so that the corrective actions on the density variations can be taken before they can influence the product quality. The coupled feed-forward/feed-back control system demonstrates improved control performance and improvements in the final product quality in the presence of process and raw material variations. Copyright © 2015 Elsevier B.V. All rights reserved.

Harmonisation Initiatives of Copernicus Data Quality Control

NASA Astrophysics Data System (ADS)

Vescovi, F. D.; Lankester, T.; Coleman, E.; Ottavianelli, G.

2015-04-01

The Copernicus Space Component Data Access system (CSCDA) incorporates data contributions from a wide range of satellite missions. Through EO data handling and distribution, CSCDA serves a set of Copernicus Services related to Land, Marine and Atmosphere Monitoring, Emergency Management and Security and Climate Change. The quality of the delivered EO products is the responsibility of each contributing mission, and the Copernicus data Quality Control (CQC) service supports and complements such data quality control activities. The mission of the CQC is to provide a service of quality assessment on the provided imagery, to support the investigation related to product quality anomalies, and to guarantee harmonisation and traceability of the quality information. In terms of product quality control, the CQC carries out analysis of representative sample products for each contributing mission as well as coordinating data quality investigation related to issues found or raised by Copernicus users. Results from the product analysis are systematically collected and the derived quality reports stored in a searchable database. The CQC service can be seen as a privileged focal point with unique comparison capacities over the data providers. The comparison among products from different missions suggests the need for a strong, common effort of harmonisation. Technical terms, definitions, metadata, file formats, processing levels, algorithms, cal/val procedures etc. are far from being homogeneous, and this may generate inconsistencies and confusion among users of EO data. The CSCDA CQC team plays a significant role in promoting harmonisation initiatives across the numerous contributing missions, so that a common effort can achieve optimal complementarity and compatibility among the EO data from multiple data providers. This effort is done in coordination with important initiatives already working towards these goals (e.g. INSPIRE directive, CEOS initiatives, OGC standards, QA4EO etc.). This paper describes the main actions being undertaken by CQC to encourage harmonisation among space-based EO systems currently in service.

Effective Process Design for the Production of HIC-Resistant Linepipe Steels

NASA Astrophysics Data System (ADS)

Nieto, J.; Elías, T.; López, G.; Campos, G.; López, F.; Garcia, R.; De, Amar K.

2013-09-01

Production of slabs for sour service applications requires stringent control in slab internal quality and secondary processing so as to guarantee resistance against hydrogen-induced cracking (HIC). ArcelorMittal Steelmaking facility at Lazaro Cardenas, Mexico had recently implemented key steelmaking and casting processing technologies for production of sound, centerline free slabs for catering to the growing API Linepipe and off-shore market for sour service applications. State-of-the-art steelmaking with use of residual-free Direct-reduced Iron and continuous casting facilities with dynamic soft reduction were introduced for the production of slabs with ultra clean centerline. Introduction of controlled cooling of slabs for atomic hydrogen control well below 2 ppm has enabled production of slabs suitable for excellent HIC-resistant plate processing. Substantial tonnages of slabs were produced for production of API X52-X65 grade plates and pipes for sour service. Stringent quality control at each stage of steelmaking, casting, and slab inspection ensured slabs with excellent internal quality suitable for HIC resistance to be guaranteed in final product (Plates & Pipes). Details of production steps which resulted in successful HIC-resistant slab production have been described in this article.

Toward Higher QA: From Parametric Release of Sterile Parenteral Products to PAT for Other Pharmaceutical Dosage Forms.

PubMed

Hock, Sia Chong; Constance, Neo Xue Rui; Wah, Chan Lai

2012-01-01

Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach for determining the pharmaceutical quality of the finished dosage form. In the case of terminally sterilized parenteral products, the limitations of conventional batch testing have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms, beyond terminally sterilized parenteral products. For parametric release to be possible, manufacturers must be capable of designing quality into the product, monitoring the manufacturing processes, and controlling the quality of intermediates and finished products in real-time. Process analytical technology (PAT) has been thought to be capable of contributing to these prerequisites. It is believed that the appropriate use of PAT tools can eventually lead to the possibility of real-time release of other pharmaceutical dosage forms, by-passing the need for end-product batch testing. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. Last but not least, current regulations governing the use of PAT and the manufacturing challenges associated with PAT implementation are also discussed. Pharmaceutical products are generally subjected to end-product batch testing as a means of quality control. Due to the inherent limitations of conventional batch testing, this is not the most ideal approach. In the case of terminally sterilized parenteral products, these limitations have been successfully addressed with the application of parametric release (the release of a product based on control of process parameters instead of batch sterility testing at the end of the manufacturing process). Consequently, there has been an increasing interest in applying parametric release to other pharmaceutical dosage forms. With the advancement of process analytical technology (PAT), it is possible to monitor the manufacturing processes closely. This will eventually enable quality control of the intermediates and finished products, and thus their release in real-time. Hence, this literature review attempts to present the basic principles of PAT, introduce the various PAT tools that are currently available, present their recent applications to pharmaceutical processing, and explain the potential benefits that PAT can bring to conventional ways of processing and quality assurance of pharmaceutical products. It will also discuss the current regulations governing the use of PAT and the manufacturing challenges associated with the implementation of PAT.

Pulse-Flow Microencapsulation System

NASA Technical Reports Server (NTRS)

Morrison, Dennis R.

2006-01-01

The pulse-flow microencapsulation system (PFMS) is an automated system that continuously produces a stream of liquid-filled microcapsules for delivery of therapeutic agents to target tissues. Prior microencapsulation systems have relied on batch processes that involve transfer of batches between different apparatuses for different stages of production followed by sampling for acquisition of quality-control data, including measurements of size. In contrast, the PFMS is a single, microprocessor-controlled system that performs all processing steps, including acquisition of quality-control data. The quality-control data can be used as real-time feedback to ensure the production of large quantities of uniform microcapsules.

A Guide for Implementing Total Quality Management in the U.S. Coast Guard Reserve

DTIC Science & Technology

1991-12-01

quality field were reviewed. The main ones studied were: Total Quality (Deming 1988); Single-Minute Exchange of Die (SMED) (Shingo 1985); Poka - yoke (mistake...Productivity Press, 1985. Shingo, Shigeo. Zero Quality Control: Source Inspection and the Poka - Yoke System. Cambridge, MA: Productivity Press, 1986. Snead

The influence of farmland pollution on the quality and safety of agricultural products

NASA Astrophysics Data System (ADS)

Ma, Z. L.; Li, L. Y.; Ye, C.; Lin, X. Y.; B, C.; Wei

2018-02-01

The quality and safety of agricultural products is not only a major livelihood issues for people’s health, but also the main barriers to international trade of agricultural products nowadays. The soil is the foundation to the production of agricultural products and the guarantee of agricultural development. The farmland soil quality is directly related to the quality and safety of agricultural products. Our country’s soil has been polluted by a series of pollution, Such as the excessive discharge of industrial wastes, the encroachment of household waste, and the unreasonable use of pesticides and fertilizers. Soil degradation is a serious threat to the quality and safety of agricultural products, so eliminating soil degradation is the fundamental way out for quality and safety of agricultural products. By analyzing problems of the quality and safety of agricultural products in our country, and exploring the farmland soil influence on the quality and safety of agricultural products. This article provides a reference for improving the control level of quality and safety of agricultural products and the farmland soil quality.

Defect Analysis Of Quality Palm Kernel Meal Using Statistical Quality Control In Kernels Factory

NASA Astrophysics Data System (ADS)

Sembiring, M. T.; Marbun, N. J.

2018-04-01

The production quality has an important impact retain the totality of characteristics of a product or service to pay attention to its capabilities to meet the needs that have been established. Quality criteria Palm Kernel Meal (PKM) set Factory kernel is as follows: oil content: max 8.50%, water content: max 12,00% and impurity content: max 4.00% While the average quality of the oil content of 8.94%, the water content of 5.51%, and 8.45% impurity content. To identify the defective product quality PKM produced, then used a method of analysis using Statistical Quality Control (SQC). PKM Plant Quality Kernel shows the oil content was 0.44% excess of a predetermined maximum value, and 4.50% impurity content. With excessive PKM content of oil and dirt cause disability content of production for oil, amounted to 854.6078 kg PKM and 8643.193 kg impurity content of PKM. Analysis of the results of cause and effect diagram and SQC, the factors that lead to poor quality of PKM is Ampere second press oil expeller and hours second press oil expeller.

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

Chinese vaccine products go global: vaccine development and quality control.

PubMed

Xu, Miao; Liang, Zhenglun; Xu, Yinghua; Wang, Junzhi

2015-05-01

Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

9 CFR 108.11 - Water quality requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Water quality requirements. 108.11... LICENSED ESTABLISHMENTS § 108.11 Water quality requirements. A certification from the appropriate water pollution control agency, that the establishment is in compliance with applicable water quality control...

Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities.

PubMed

Lynch, Rob; Barabani, David; Bellorado, Kathy; Canisius, Peter; Heathcote, Doug; Johnson, Alan; Wyman, Ned; Parry, Derek Willison

2018-01-01

In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management (1), the use of risk-based approaches may be applied to assess and continuously improve established changeover processes. All processes, including changeover, can be improved with investment (money/resources), parallel activities, equipment design improvements, and standardization. However, processes can also be improved by eliminating waste. For product changeover, waste is any activity not needed for the new process or that does not provide added assurance of the quality of the subsequent product. The application of a risk-based approach to changeover aligns with the principles of Quality Risk Management. Through the use of risk assessments, the appropriate changeover controls can be identified and controlled to assure product quality is maintained. Likewise, the use of risk assessments and risk-based approaches may be used to improve operational efficiency, reduce waste, and permit concurrent manufacturing of products. © PDA, Inc. 2018.

A multiple objective optimization approach to quality control

NASA Technical Reports Server (NTRS)

Seaman, Christopher Michael

1991-01-01

The use of product quality as the performance criteria for manufacturing system control is explored. The goal in manufacturing, for economic reasons, is to optimize product quality. The problem is that since quality is a rather nebulous product characteristic, there is seldom an analytic function that can be used as a measure. Therefore standard control approaches, such as optimal control, cannot readily be applied. A second problem with optimizing product quality is that it is typically measured along many dimensions: there are many apsects of quality which must be optimized simultaneously. Very often these different aspects are incommensurate and competing. The concept of optimality must now include accepting tradeoffs among the different quality characteristics. These problems are addressed using multiple objective optimization. It is shown that the quality control problem can be defined as a multiple objective optimization problem. A controller structure is defined using this as the basis. Then, an algorithm is presented which can be used by an operator to interactively find the best operating point. Essentially, the algorithm uses process data to provide the operator with two pieces of information: (1) if it is possible to simultaneously improve all quality criteria, then determine what changes to the process input or controller parameters should be made to do this; and (2) if it is not possible to improve all criteria, and the current operating point is not a desirable one, select a criteria in which a tradeoff should be made, and make input changes to improve all other criteria. The process is not operating at an optimal point in any sense if no tradeoff has to be made to move to a new operating point. This algorithm ensures that operating points are optimal in some sense and provides the operator with information about tradeoffs when seeking the best operating point. The multiobjective algorithm was implemented in two different injection molding scenarios: tuning of process controllers to meet specified performance objectives and tuning of process inputs to meet specified quality objectives. Five case studies are presented.

Production system with process quality control: modelling and application

NASA Astrophysics Data System (ADS)

Tsou, Jia-Chi

2010-07-01

Over the past decade, there has been a great deal of research dedicated to the study of quality and the economics of production. In this article, we develop a dynamic model which is based on the hypothesis of a traditional economic production quantity model. Taguchi's cost of poor quality is used to evaluate the cost of poor quality in the dynamic production system. A practical case from the automotive industry, which uses the Six-sigma DMAIC methodology, is discussed to verify the proposed model. This study shows that there is an optimal value of quality investment to make the production system reach a reasonable quality level and minimise the production cost. Based on our model, the management can adjust its investment in quality improvement to generate considerable financial return.

New strategy to improve quality control of Montenegro skin test at the production level.

PubMed

Guedes, Deborah Carbonera; Minozzo, João Carlos; Pasquali, Aline Kuhn Sbruzzi; Faulds, Craig; Soccol, Carlos Ricardo; Thomaz-Soccol, Vanete

2017-01-01

The production of the Montenegro antigen for skin test poses difficulties regarding quality control. Here, we propose that certain animal models reproducing a similar immune response to humans may be used in the quality control of Montenegro antigen production. Fifteen Cavia porcellus (guinea pigs) were immunized with Leishmania amazonensis or Leishmania braziliensis , and, after 30 days, they were skin tested with standard Montenegro antigen. To validate C. porcellus as an animal model for skin tests, eighteen Mesocricetus auratus (hamsters) were infected with L. amazonensis or L. braziliensis , and, after 45 days, they were skin tested with standard Montenegro antigen. Cavia porcellus immunized with L. amazonensis or L. braziliensis , and hamsters infected with the same species presented induration reactions when skin tested with standard Montenegro antigen 48-72h after the test. The comparison between immunization methods and immune response from the two animal species validated C. porcellus as a good model for Montenegro skin test, and the model showed strong potential as an in vivo model in the quality control of the production of Montenegro antigen.

Quality Assurance/Quality Control Jobs

NASA Astrophysics Data System (ADS)

Fanslau, Melody; Young, Janelle

The production of a quality and safe food product is essential to the success of any food manufacturing facility. Because of this great importance, a career in quality can be extremely rewarding. Without happy customers willing to buy a product, a company would not be able to survive. Quality issues such as foreign objects, spoiled or mislabeled product, failure to meet net weight requirements, or a recall can all turn customers away from buying a product. The food industry is a customer-driven market in which some consumers are brand loyal based on a history of high quality or in which a single bad experience with a product will turn them away for a lifetime. With this said, the main role of a quality department is to help ensure that quality issues such as these are eliminated or kept to a minimum to maintain or increase the number of customers purchasing their product.

[Quality process control system of Chinese medicine preparation based on "holistic view"].

PubMed

Wang, Ya-Qi; Jiao, Jiao-Jiao; Wu, Zhen-Feng; Zheng, Qin; Yang, Ming

2018-01-01

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development. Copyright© by the Chinese Pharmaceutical Association.

A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.

PubMed

Santos, Ana M C; Doria, Mara S; Meirinhos-Soares, Luís; Almeida, António J; Menezes, José C

2018-01-01

Microbial quality control of non-sterile drug products has been a concern to regulatory agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted if such events occur. To better manage risk and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in non-sterile drug products manufacturing, be able to evaluate their potential impact on final product quality, and apply mitigation actions. Herein we discuss the most likely root causes involved in microbial contaminations referenced in warning letters issued by US health authorities and non-compliance reports issued by European health authorities over a period of several years. The quality risk management tools proposed were applied to the data gathered from those databases, and a generic risk ranking was provided based on a panel of non-sterile drug product manufacturers that was assembled and given the opportunity to perform the risk assessments. That panel identified gaps and defined potential mitigation actions, based on their own experience of potential risks expected for their processes. Major findings clearly indicate that the manufacturers affected by the warning letters should focus their attention on process improvements and microbial control strategies, especially those related to microbial analysis and raw material quality control. Additionally, the WLs considered frequently referred to failures in quality-related issues, which indicates that the quality commitment should be reinforced at most companies to avoid microbiological contaminations. LAY ABSTRACT: Microbial contamination of drug products affects the quality of non-sterile drug products produced by numerous manufacturers, representing a major risk to patients. It is necessary to understand the microbial hazards involved in the manufacturing process and evaluate their impact on final product quality so that effective prevention strategies can be implemented. A risk-based classification of most likely root causes for microbial contamination found in the warning letters issued by the US Food and Drug Administration and the European Medicines Agency is proposed. To validate the likely root causes extracted from the warning letters, a subject matter expert panel made of several manufacturers was formed and consulted. A quality risk management approach to assess microbiological contamination of non-sterile drug products is proposed for the identification of microbial hazards involved in the manufacturing process. To enable ranking of microbial contamination risks, quality risk management metrics related to criticality and overall risk were applied. The results showed that manufacturers of non-sterile drug products should improve their microbial control strategy, with special attention to quality controls of raw materials, primary containers, and closures. Besides that, they should invest in a more robust quality system and culture. As a start, manufacturers may consider investigating their specific microbiological risks, adressing their sites' own microbial ecology, type of manufacturing processes, and dosage form characteristics, as these may lead to increased contamination risks. Authorities should allow and enforce innovative, more comprehensive, and more effective approaches to in-process contamination monitoring and controls. © PDA, Inc. 2018.

If You Don't Know, Ask! Using Expert Knowledge to Determine What Content Is Needed in an Undergraduate Food Quality Management and Control Course

ERIC Educational Resources Information Center

Joyner, Helen S.; Stevenson, Clinton D.

2017-01-01

Quality management and quality control of food products are critical to producing food that is safe to consume and has consistent quality and sensory attributes. The extent to which undergraduate students are equipped with competencies in quality management/control, in theory, has a direct connection with their career potential to ensure food…

[Construction of NIRS-based total quality control system for compound Ejiao oral liquid and relative thinking].

PubMed

Zhang, Yan; Zhang, Lu; Tian, Shou-Sheng; Zhou, Xiang-Shan; Li, Wen-Long; Qu, Hai-Bin

2016-10-01

In this paper, near infrared spectroscopy (NIRS)-based total quality control system of compound Ejiao oral liquid is introduced briefly, including the quality control of raw traditional Chinese medicine (TCM) materials, monitoring and control of the extract and the alkaline precipitation technics, and also the inspection of finished products in both open bottle and non-opening modes. By analyzing and summing up the significance and difficulties, several important problems in the practical applications of NIRS technology are proposed, which will provide references for the similar studies of other TCM products. Copyright© by the Chinese Pharmaceutical Association.

Quality Control System using Simple Implementation of Seven Tools for Batik Textile Manufacturing

NASA Astrophysics Data System (ADS)

Ragil Suryoputro, Muhammad; Sugarindra, Muchamad; Erfaisalsyah, Hendy

2017-06-01

In order to produce better products and mitigate defect in products, every company must implement a quality control system. Company will find means to implement a quality control system that is capable and reliable. One of the methods is using the simple implementation of the seven tools in quality control defects. The case studied in this research was the level of disability xyz grey fabric on a shuttle loom 2 on the Batik manufacturing company. The seven tools that include: flowchart, check sheet, histogram, scatter diagram combined with control charts, Pareto diagrams and fishbone diagrams (causal diagram). Check sheet results obtained types of defects in the grey fabric was woven xyz is warp, double warp, the warp break, double warp, empty warp, warp tenuous, ugly edges, thick warp, and rust. Based on the analysis of control chart indicates that the process is out of control. This can be seen in the graph control where there is still a lot of outlier data. Based on a scatter diagram shows a positive correlation between the percentage of disability and the number of production. Based on Pareto diagram, repair needs priority is for the dominant type of defect is warp (44%) and based on double warp value histogram is also the highest with a value of 23635.11 m. In addition, based on the analysis of the factors causing defect by fishbone diagram double warp or other types of defects originating from the materials, methods, machines, measurements, man and environment. Thus the company can take to minimize the prevention and repair of defects and improve product quality.

Application of the suggestion system in the improvement of the production process and product quality control

NASA Astrophysics Data System (ADS)

Gołaś, H.; Mazur, A.; Gruszka, J.; Szafer, P.

2016-08-01

The elaboration is a case study and the research was carried out in the company Alco-Mot Ltd., which employs 120 people. The company specializes in the production of lead poles for industrial and traction batteries using gravity casting. The elements embedded in the cast are manufactured on a machining centre, which provides the stability of the process and of the dimensions of the product as well as a very short production time. As a result of observation and analysis the authors have developed a concept for the implementation of a dynamic suggestion system in ALCO-MOT, including, among others, a standard for actions in the implementation of the suggestion system, as well as clear guidelines for the processing and presentation of the activities undertaken in the time between the establishment of the concept (suggestions) and the benefits analysis after the proposed solutions have been implemented. The authors also present how suggestions proposed by ALCO-MOT staff contributed to the improvement of the processes of production and quality control. Employees offered more than 30 suggestions, of which more than a half are being implemented now and further actions are being prepared for implementation. The authors will present the results of improvements in, for example, tool replacement time, scrap reduction. The authors will present how kaizen can improve the production and quality control processes. They will present how the production and quality control processes looked before and after the implementation of employee suggestions.

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

40 CFR 1051.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM RECREATIONAL ENGINES AND VEHICLES Testing Production-Line Vehicles and Engines § 1051.345 What production-line testing records must I send to EPA? (a.... We have not changed production processes or quality-control procedures for test engines (or vehicles...

Intercropping of oat and field pea in Alaska: an alternative approach to quality forage production and weed control

USDA-ARS?s Scientific Manuscript database

Intercropping of legumes with non-legumes is an ancient crop production method used to improve quality and dry matter (DM) yields of forage and grain, and to control weeds. However, there is little information regarding intercropping at high latitudes. The objectives of this field study were to eval...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2010 CFR

2010-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2013 CFR

2013-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2012 CFR

2012-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2014 CFR

2014-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

27 CFR 27.75 - Samples of distilled spirits, wine, and beer for quality control purposes.

Code of Federal Regulations, 2011 CFR

2011-04-01

... spirits, wine, and beer for quality control purposes. 27.75 Section 27.75 Alcohol, Tobacco Products and... DISTILLED SPIRITS, WINES, AND BEER General Requirements Exemptions § 27.75 Samples of distilled spirits, wine, and beer for quality control purposes. Samples of distilled spirits, wine, and beer in containers...

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis.

PubMed

Rathore, Anurag S; Kumar Singh, Sumit; Pathak, Mili; Read, Erik K; Brorson, Kurt A; Agarabi, Cyrus D; Khan, Mansoor

2015-01-01

Fermentanomics is an emerging field of research and involves understanding the underlying controlled process variables and their effect on process yield and product quality. Although major advancements have occurred in process analytics over the past two decades, accurate real-time measurement of significant quality attributes for a biotech product during production culture is still not feasible. Researchers have used an amalgam of process models and analytical measurements for monitoring and process control during production. This article focuses on using multivariate data analysis as a tool for monitoring the internal bioreactor dynamics, the metabolic state of the cell, and interactions among them during culture. Quality attributes of the monoclonal antibody product that were monitored include glycosylation profile of the final product along with process attributes, such as viable cell density and level of antibody expression. These were related to process variables, raw materials components of the chemically defined hybridoma media, concentration of metabolites formed during the course of the culture, aeration-related parameters, and supplemented raw materials such as glucose, methionine, threonine, tryptophan, and tyrosine. This article demonstrates the utility of multivariate data analysis for correlating the product quality attributes (especially glycosylation) to process variables and raw materials (especially amino acid supplements in cell culture media). The proposed approach can be applied for process optimization to increase product expression, improve consistency of product quality, and target the desired quality attribute profile. © 2015 American Institute of Chemical Engineers.

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

Microbial contamination of autologous peripheral blood stem cell products: incidence, clinical outcome, quality control and management strategies.

PubMed

Cheah, Poh Lin; Ong, Chong Wei; Crispin, Philip

2011-06-01

Microbial screening is part of quality control for autologous peripheral blood stem cell (PBSC) manipulation. The incidence of culture positive products varies widely. The clinical significance of infusing culture positive products is uncertain, with no consensus on the interventions required. Microbial cultures of 606 consecutive autologous PBSC products from 278 patients between 1995 and 2005 were retrospectively analysed to determine the incidence of culture positivity and classified according to likely clinical significance. Clinical outcomes of patients who received culture positive products were reviewed. Using the baseline probability of contamination, a quality control method to detect a systematic source of contamination during product manipulation was developed. Eleven (1.8%) of 606 products were culture positive in eight (2.9%) patients. Ten products yielded coagulase negative Staphylococcus species and one Corynebacterium accolens. One patient had catheter sepsis during collection. Five patients received culture positive products, with prophylactic antibiotics when there was known coagulase negative Staphylococcus species. None had clinical evidence of infection following product infusion. The incidence of culture positive products was comparable to published series. Only skin commensals were isolated. Infusion of skin commensal positive products appears safe with antibiotic prophylaxis. Using local and published experience, clinical and laboratory policies were developed for culture positive products.

The development of a contract quality assurance program within the Virginia Department of Highways.

DOT National Transportation Integrated Search

1989-01-01

In order to assure the quality of construction products and processes, the Virginia Department of Transportation has established three levels of construction control. First, contractors themselves provide oversight and quality control as set out in t...

Mathematical modeling for resource and energy saving control of extruders in multi-assortment productions of polymeric films

NASA Astrophysics Data System (ADS)

Polosin, A. N.; Chistyakova, T. B.

2018-05-01

In this article, the authors describe mathematical modeling of polymer processing in extruders of various types used in extrusion and calender productions of film materials. The method consists of the synthesis of a static model for calculating throughput, energy consumption of the extruder, extrudate quality indices, as well as a dynamic model for evaluating polymer residence time in the extruder, on which the quality indices depend. Models are adjusted according to the extruder type (single-screw, reciprocating, twin-screw), its screw and head configuration, extruder’s work temperature conditions, and the processed polymer type. Models enable creating extruder screw configurations and determining extruder controlling action values that provide the extrudate of required quality while satisfying extruder throughput and energy consumption requirements. Model adequacy has been verified using polyolefins’ and polyvinylchloride processing data in different extruders. The program complex, based on mathematical models, has been developed in order to control extruders of various types in order to ensure resource and energy saving in multi-assortment productions of polymeric films. Using the program complex in the control system for the extrusion stage of the polymeric film productions enables improving film quality, reducing spoilage, lessening the time required for production line change-over to other throughput and film type assignment.

Use of artificial intelligence in the production of high quality minced meat

NASA Astrophysics Data System (ADS)

Kapovsky, B. R.; Pchelkina, V. A.; Plyasheshnik, P. I.; Dydykin, A. S.; Lazarev, A. A.

2017-09-01

A design for an automatic line for minced meat production according to new production technology based on an innovative meat milling method is proposed. This method allows the necessary degree of raw material comminution at the stage of raw material preparation to be obtained, which leads to production intensification due to the traditional meat mass comminution equipment being unnecessary. To ensure consistent quality of the product obtained, the use of on-line automatic control of the technological process for minced meat production is envisaged. This system has been developed using artificial intelligence methods and technologies. The system is trainable during the operation process, adapts to changes in processed raw material characteristics and to external impacts that affect the system operation, and manufactures meat shavings with minimal dispersion of the typical particle size. The control system includes equipment for express analysis of the chemical composition of the minced meat and its temperature after comminution. In this case, the minced meat production process can be controlled strictly as a function of time, which excludes subjective factors for assessing the degree of finished product readiness. This will allow finished meat products with consistent, targeted high quality to be produced.

Achieving Quality in the Navy Field Contracting System

DTIC Science & Technology

1986-12-01

they place on suppliers increase. Unless the supplier can satisfy the consumer , the consumer will go elsewhere for his/her needs. This reality caught...Quality products sell. Today’s consumers are willing to pay for quality so a company with a quality product is likely to control the market. Finally...the quality doctrine, but will provide a central point within the KFCS to address problems founc in improving quality. Training is another important

Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

PubMed

Boiret, Mathieu; Chauchard, Fabien

2017-01-01

Near-infrared (NIR) spectroscopy is a non-destructive analytical technique that enables better-understanding and optimization of pharmaceutical processes and final drug products. The use in line is often limited by acquisition speed and sampling area. This work focuses on performing a multipoint measurement at high acquisition speed at the end of the manufacturing process on a conveyor belt system to control both the distribution and the content of active pharmaceutical ingredient within final drug products, i.e., tablets. A specially designed probe with several collection fibers was developed for this study. By measuring spectral and spatial information, it provides physical and chemical knowledge on the final drug product. The NIR probe was installed on a conveyor belt system that enables the analysis of a lot of tablets. The use of these NIR multipoint measurement probes on a conveyor belt system provided an innovative method that has the potential to be used as a new paradigm to ensure the drug product quality at the end of the manufacturing process and as a new analytical method for the real-time release control strategy. Graphical abstract Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.

46 CFR 160.135-15 - Production inspections, tests, quality control, and conformance of lifeboats.

Code of Federal Regulations, 2014 CFR

2014-10-01

... materials are as per the plans approved under § 160.135-13(h) of this subpart. (2) Post assembly tests and... each design must pass each of the tests described in the IMO Revised recommendation on testing, part 2... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and...

Iridium-192 Production for Cancer Treatment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rostelato, M.E.C.M.; Silva, C.P.G.; Rela, P.R.

2004-10-05

The purpose of this work is to settle a laboratory for Iridium -192 sources production, that is, to determine a wire activation method and to build a hot cell for the wires manipulation, quality control and packaging. The paper relates, mainly, the wire activation method and its quality control. The wire activation is carried out in our nuclear reactor, IEA- R1m.

Manufacturing Squares: An Integrative Statistical Process Control Exercise

ERIC Educational Resources Information Center

Coy, Steven P.

2016-01-01

In the exercise, students in a junior-level operations management class are asked to manufacture a simple product. Given product specifications, they must design a production process, create roles and design jobs for each team member, and develop a statistical process control plan that efficiently and effectively controls quality during…

21 CFR 226.40 - Production and control procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Production and control procedures. 226.40 Section 226.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control...

Quality assurance and control in the production and static tests of the solid rocket boosters for the Space Shuttle

NASA Technical Reports Server (NTRS)

Cerny, O. F.

1979-01-01

The paper surveys the various aspects of design and overhaul of the solid rocket boosters. It is noted that quality control is an integral part of the design specifications. Attention is given to the production process which is optimized towards highest quality. Also discussed is the role of the DCA (Defense Contract Administration) in inspecting the products of subcontractors, noting that the USAF performs this role for prime contractors. Fabrication and construction of the booster is detailed with attention given to the lining of the booster cylinder and the mixing of the propellant and the subsequent X-ray inspection.

Total Quality Management Guide. Volume 2. A Guide to Implementation

DTIC Science & Technology

1990-02-15

Kaoru . Guide to Quality Control. Asian Productivity Organization. 1984. Ishikawa , Kaoru . What is Total Quality Control? The Japanese Way. Englewood...of the new Systems Age. The theories of Deming, Juran, Ishikawa , and other management methods that still predominate are pioneers of Systems Age...Feigenbaum, Armand V. Total Quality Control. New York: McGraw-Hill Book Company. 1983. bnai, Masaaki. Kaizen. New York: Random House. 1986. Ishikawa

Quality engineering as a profession.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kolb, Rachel R.; Hoover, Marcey L.

Over the course of time, the profession of quality engineering has witnessed significant change, from its original emphasis on quality control and inspection to a more contemporary focus on upholding quality processes throughout the organization and its product realization activities. This paper describes the profession of quality engineering, exploring how todays quality engineers and quality professionals are certified individuals committed to upholding quality processes and principles while working with different dimensions of product development. It also discusses the future of the quality engineering profession and the future of the quality movement as a whole.

Benefits and Limitations of DNA Barcoding and Metabarcoding in Herbal Product Authentication

PubMed Central

Raclariu, Ancuta Cristina; Heinrich, Michael; Ichim, Mihael Cristin

2017-01-01

Abstract Introduction Herbal medicines play an important role globally in the health care sector and in industrialised countries they are often considered as an alternative to mono‐substance medicines. Current quality and authentication assessment methods rely mainly on morphology and analytical phytochemistry‐based methods detailed in pharmacopoeias. Herbal products however are often highly processed with numerous ingredients, and even if these analytical methods are accurate for quality control of specific lead or marker compounds, they are of limited suitability for the authentication of biological ingredients. Objective To review the benefits and limitations of DNA barcoding and metabarcoding in complementing current herbal product authentication. Method Recent literature relating to DNA based authentication of medicinal plants, herbal medicines and products are summarised to provide a basic understanding of how DNA barcoding and metabarcoding can be applied to this field. Results Different methods of quality control and authentication have varying resolution and usefulness along the value chain of these products. DNA barcoding can be used for authenticating products based on single herbal ingredients and DNA metabarcoding for assessment of species diversity in processed products, and both methods should be used in combination with appropriate hyphenated chemical methods for quality control. Conclusions DNA barcoding and metabarcoding have potential in the context of quality control of both well and poorly regulated supply systems. Standardisation of protocols for DNA barcoding and DNA sequence‐based identification are necessary before DNA‐based biological methods can be implemented as routine analytical approaches and approved by the competent authorities for use in regulated procedures. © 2017 The Authors. Phytochemical Analysis Published by John Wiley & Sons Ltd. PMID:28906059

Benefits and Limitations of DNA Barcoding and Metabarcoding in Herbal Product Authentication.

PubMed

Raclariu, Ancuta Cristina; Heinrich, Michael; Ichim, Mihael Cristin; de Boer, Hugo

2018-03-01

Herbal medicines play an important role globally in the health care sector and in industrialised countries they are often considered as an alternative to mono-substance medicines. Current quality and authentication assessment methods rely mainly on morphology and analytical phytochemistry-based methods detailed in pharmacopoeias. Herbal products however are often highly processed with numerous ingredients, and even if these analytical methods are accurate for quality control of specific lead or marker compounds, they are of limited suitability for the authentication of biological ingredients. To review the benefits and limitations of DNA barcoding and metabarcoding in complementing current herbal product authentication. Recent literature relating to DNA based authentication of medicinal plants, herbal medicines and products are summarised to provide a basic understanding of how DNA barcoding and metabarcoding can be applied to this field. Different methods of quality control and authentication have varying resolution and usefulness along the value chain of these products. DNA barcoding can be used for authenticating products based on single herbal ingredients and DNA metabarcoding for assessment of species diversity in processed products, and both methods should be used in combination with appropriate hyphenated chemical methods for quality control. DNA barcoding and metabarcoding have potential in the context of quality control of both well and poorly regulated supply systems. Standardisation of protocols for DNA barcoding and DNA sequence-based identification are necessary before DNA-based biological methods can be implemented as routine analytical approaches and approved by the competent authorities for use in regulated procedures. © 2017 The Authors. Phytochemical Analysis Published by John Wiley & Sons Ltd. © 2017 The Authors. Phytochemical Analysis Published by John Wiley & Sons Ltd.

Operational CryoSat Product Quality Assessment

NASA Astrophysics Data System (ADS)

Mannan, Rubinder; Webb, Erica; Hall, Amanda; Bouzinac, Catherine

2013-12-01

The performance and quality of the CryoSat data products are routinely assessed by the Instrument Data quality Evaluation and Analysis Service (IDEAS). This information is then conveyed to the scientific and user community in order to allow them to utilise CryoSat data with confidence. This paper presents details of the Quality Control (QC) activities performed for CryoSat products under the IDEAS contract. Details of the different QC procedures and tools deployed by IDEAS to assess the quality of operational data are presented. The latest updates to the Instrument Processing Facility (IPF) for the Fast Delivery Marine (FDM) products and the future update to Baseline-C are discussed.

[The technological innovation strategy for quality control of Chinese medicine based on Big Data].

PubMed

Li, Zhen-hao; Qian, Zhong-zhi; Cheng, Yi-yu

2015-09-01

The evolution of the quality control concepts of medical products within the global context and the development of the quality control technology of Chinese medicine are briefly described. Aimed at the bottlenecks in the regulation and quality control of Chinese medicine, using Big Data technology to address the significant challenges in Chinese medicine industry is proposed. For quality standard refinements and internationalization of Chinese medicine, a technological innovation strategy encompassing its methodology, and the R&D direction of the subsequent core technology are also presented.

The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs.

PubMed

De Mattia, Fabrizio; Chapsal, Jean-Michel; Descamps, Johan; Halder, Marlies; Jarrett, Nicholas; Kross, Imke; Mortiaux, Frederic; Ponsar, Cecile; Redhead, Keith; McKelvie, Jo; Hendriksen, Coenraad

2011-01-01

Current batch release testing of established vaccines emphasizes quality control of the final product and is often characterized by extensive use of animals. This report summarises the discussions of a joint ECVAM/EPAA workshop on the applicability of the consistency approach for routine release of human and veterinary vaccines and its potential to reduce animal use. The consistency approach is based upon thorough characterization of the vaccine during development and the principle that the quality of subsequent batches is the consequence of the strict application of a quality system and of a consistent production of batches. The concept of consistency of production is state-of-the-art for new-generation vaccines, where batch release is mainly based on non-animal methods. There is now the opportunity to introduce the approach into established vaccine production, where it has the potential to replace in vivo tests with non-animal tests designed to demonstrate batch quality while maintaining the highest quality standards. The report indicates how this approach may be further developed for application to established human and veterinary vaccines and emphasizes the continuing need for co-ordination and harmonization. It also gives recommendations for work to be undertaken in order to encourage acceptance and implementation of the consistency approach. Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

PubMed

Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

Contribution au developpement d'une methode de controle des procedes dans une usine de bouletage

NASA Astrophysics Data System (ADS)

Gosselin, Claude

This thesis, a collaborative effort between Ecole de technologie superieure and ArcelorMittal Company, presents the development of a methodology for monitoring and quality control of multivariable industrial production processes. This innovation research mandate was developed at ArcelorMittal Exploitation Miniere (AMEM) pellet plant in Port-Cartier (Quebec, Canada). With this undertaking, ArcelorMittal is striving to maintain its world class level of excellence and continues to pursue initiatives that can augment its competitive advantage worldwide. The plant's gravimetric classification process was retained as a prototype and development laboratory due to its effect on the company's competitiveness and its impact on subsequent steps leading to final production of iron oxide pellets. Concretely, the development of this expertise in process control and in situ monitoring will establish a firm basic knowledge in the fields of complex system physical modeling, data reconciliation, statistical observers, multivariate command and quality control using real-time monitoring of the desirability function. The hydraulic classifier is mathematically modeled. Using planned disturbances on the production line, an identification procedure was established to provide empirical estimations of the model's structural parameters. A new sampling campaign and a previously unpublished data collection and consolidation policy were implemented plant-wide. Access to these invaluable data sources has enabled the establishment of new thresholds that govern the production process and its control. Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this Finally, as a substitute for the traditional quality control process, we have implemented a new strategy based on the use of the desirability function. Our innovation is not in using this function as an indicator of overall (economic) satisfaction in the production process, but rather in proposing it as an "observer" of the system's state. The first implementation steps have already demonstrated the method's feasibility as well as other numerous industrial impacts on production processes within the company. Namely, the emergence of the economical aspect as a strategic variable that assures better governance of production processes where quality variables present strategic issues.

A Machine Vision Quality Control System for Industrial Acrylic Fibre Production

NASA Astrophysics Data System (ADS)

Heleno, Paulo; Davies, Roger; Correia, Bento A. Brázio; Dinis, João

2002-12-01

This paper describes the implementation of INFIBRA, a machine vision system used in the quality control of acrylic fibre production. The system was developed by INETI under a contract with a leading industrial manufacturer of acrylic fibres. It monitors several parameters of the acrylic production process. This paper presents, after a brief overview of the system, a detailed description of the machine vision algorithms developed to perform the inspection tasks unique to this system. Some of the results of online operation are also presented.

Some Inspection Methods for Quality Control and In-service Inspection of GLARE

NASA Astrophysics Data System (ADS)

Sinke, J.

2003-07-01

Quality control of materials and structures is an important issue, also for GLARE. During the manufacturing stage the processes and materials should be monitored and checked frequently in order to obtain a qualified product. During the operation of the aircraft, frequent monitoring and inspections are performed to maintain the quality at a prescribed level. Therefore, in-service inspection methods are applied, and when necessary repair activities are conducted. For the quality control of the GLARE panels and components during manufacturing, the C-scan method proves to be an effective tool. For in-service inspection the Eddy Current Method is one of the suitable options. In this paper a brief overview is presented of both methods and their application on GLARE products.

Effect of superdosing phytase on productive performance and egg quality in laying hens.

PubMed

Kim, Jong Hyuk; Pitargue, Franco Martinez; Jung, Hyunjung; Han, Gi Ppeum; Choi, Hyeon Seok; Kil, Dong Yong

2017-07-01

An experiment was conducted to determine the effect of superdosing phytase on productive performance and egg quality in laying hens. A total of 200 42-wk-old Hy-Line Brown laying hens were allotted into 1 of 5 dietary treatments with 5 replicates consisting of 8 hens per replicate. The positive control (PC) and negative control diets (NC) were prepared based on the recommended P levels in layer diets. Supplemental phytase was added to the negative control diet at 10,000 (SD10), 20,000 (SD20), or 30,000 (SD30) fytase units (FTU)/kg. Productive performance was summarized for 6 weeks from 42 weeks to 47 weeks of age. Egg quality was assessed from 4 eggs per replicate randomly collected at the conclusion of the experiment. The SD20 treatment had greater (p<0.05) hen-day egg production than PC, NC, and SD10 treatment groups. There was no difference in hen-day egg production between SD20 and SD30 treatment groups. However, SD30 treatment had greater (p<0.05) hen-day egg production than PC treatment, but showed no difference in hen-day egg production as compared to NC and SD10 treatment groups. However, egg weight, egg mass, feed intake, and feed conversion ratio were not affected by dietary treatments. Egg quality including eggshell strength, eggshell color, egg yolk color, and haugh unit was not influenced by dietary treatments. Superdosing level of 20,000 FTU/kg phytase in diets has a positive effect on egg production rate, but no beneficial effect on egg quality in laying hens.

Identification of milling and baking quality QTL in multiple soft wheat mapping populations

USDA-ARS?s Scientific Manuscript database

Wheat derived food products require a range of characteristics. Identification and understanding of the genetic components controlling end-use quality of wheat is important for crop improvement. We assessed the underlying genetics controlling specific milling and baking quality parameters of soft wh...

[Update on microbiological quality assurance meat and meat products in Morocco].

PubMed

Rachidi, H; Latrache, H

2018-03-01

Food safety has become an absolute necessity in all countries. As a result, Morocco has taken several measures and actions to develop food safety and food-borne disease control. This study aimed to highlight the level of improvement in the quality assurance of meat and meat products in Morocco. It is based on a non-exhaustive review of the regulatory texts governing food safety in the country, as well as a statistical study on establishments of meat and meat products adopting a self-checking system and approved by the National Office of Sanitary Safety of Food. Morocco has introduced several laws and regulations requiring sanitary control of food products. Also, the number of establishments of meat and meat products adopting a system of self-control and approved by the National Office of Sanitary Safety of Food has improved significantly. It has increased from 58 in 2007 to 273 in 2016. The adoption of self-monitoring systems allows better access to international markets, improved quality of food products and a considerable reduction in microbial contamination. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Microbial ecology and quality assurance in food fermentation systems. The case of kefir grains application.

PubMed

Plessas, S; Alexopoulos, A; Voidarou, C; Stavropoulou, E; Bezirtzoglou, E

2011-12-01

Fermentation technology has become a modern method for food production the last decades as a process for enhancing product stability, safety and sensory standards. The main reason for this development is the increasing consumers' demand for safe and high quality food products. The above has led the scientific community to the thorough study for the appropriate selection of specific microorganisms with desirable properties such as bacteriocin production, and probiotic properties. The main food products produced through fermentation activity are bread, wine, beer cheese and other dairy products. The microorganisms conducting the above processes are mainly yeasts and lactic acid bacteria. The end products of carbohydrate catabolism by these microorganisms contribute not only to preservation as it was believed years ago, but also to the flavour, aroma and texture and to the increase of the nutritional quality by thereby helping determine unique product characteristics. Thus, controlling the function of specific microorganisms or the succession of microorganisms that dominate the microflora is therefore advantageous, because it can increase product quality, functionality and value. Throughout the process of the discovery of microbiological diversity in various fermented food systems, the development of starter culture technology has gained more scientific attention, and it could be used for the control of the manufacturing operation, and management of product quality. In the frame of this review the presentation of the quality enhancement of most consumed fermented food products around the world is attempted and the new trends in production of fermented food products, such as bread is discussed. The review is focused in kefir grains application in bread production. Copyright © 2011 Elsevier Ltd. All rights reserved.

High-performance thin layer chromatography to assess pharmaceutical product quality.

PubMed

Kaale, Eliangiringa; Manyanga, Vicky; Makori, Narsis; Jenkins, David; Michael Hope, Samuel; Layloff, Thomas

2014-06-01

To assess the sustainability, robustness and economic advantages of high-performance thin layer chromatography (HPTLC) for quality control of pharmaceutical products. We compared three laboratories where three lots of cotrimoxazole tablets were assessed using different techniques for quantifying the active ingredient. The average assay relative standard deviation for the three lots was 1.2 with a range of 0.65-2.0. High-performance thin layer chromatography assessments are yielding valid results suitable for assessing product quality. The local pharmaceutical manufacturer had evolved the capacity to produce very high quality products. © 2014 John Wiley & Sons Ltd.

Soil management shapes ecosystem service provision and trade-offs in agricultural landscapes.

PubMed

Tamburini, Giovanni; De Simone, Serena; Sigura, Maurizia; Boscutti, Francesco; Marini, Lorenzo

2016-08-31

Agroecosystems are principally managed to maximize food provisioning even if they receive a large array of supporting and regulating ecosystem services (ESs). Hence, comprehensive studies investigating the effects of local management and landscape composition on the provision of and trade-offs between multiple ESs are urgently needed. We explored the effects of conservation tillage, nitrogen fertilization and landscape composition on six ESs (crop production, disease control, soil fertility, water quality regulation, weed and pest control) in winter cereals. Conservation tillage enhanced soil fertility and pest control, decreased water quality regulation and weed control, without affecting crop production and disease control. Fertilization only influenced crop production by increasing grain yield. Landscape intensification reduced the provision of disease and pest control. We also found tillage and landscape composition to interactively affect water quality regulation and weed control. Under N fertilization, conventional tillage resulted in more trade-offs between ESs than conservation tillage. Our results demonstrate that soil management and landscape composition affect the provision of several ESs and that soil management potentially shapes the trade-offs between them. © 2016 The Author(s).

46 CFR 160.156-15 - Production inspections, tests, quality control, and conformance of rescue boats and fast rescue...

Code of Federal Regulations, 2014 CFR

2014-10-01

... materials are as per the plans approved under § 160.156-13(h) of this subpart. (2) Post assembly tests and... of each design must pass each of the tests described in the IMO Revised recommendation on testing... 46 Shipping 6 2014-10-01 2014-10-01 false Production inspections, tests, quality control, and...

Using the scanning electron microscope on the production line to assure quality semiconductors

NASA Technical Reports Server (NTRS)

Adolphsen, J. W.; Anstead, R. J.

1972-01-01

The use of the scanning electron microscope to detect metallization defects introduced during batch processing of semiconductor devices is discussed. A method of determining metallization integrity was developed which culminates in a procurement specification using the scanning microscope on the production line as a quality control tool. Batch process control of the metallization operation is monitored early in the manufacturing cycle.

ATAD control goals through the analysis of process variables and evaluation of quality, production and cost.

PubMed

Nájera, S; Gil-Martínez, M; Zambrano, J A

2015-01-01

The aim of this paper is to establish and quantify different operational goals and control strategies in autothermal thermophilic aerobic digestion (ATAD). This technology appears as an alternative to conventional sludge digestion systems. During the batch-mode reaction, high temperatures promote sludge stabilization and pasteurization. The digester temperature is usually the only online, robust, measurable variable. The average temperature can be regulated by manipulating both the air injection and the sludge retention time. An improved performance of diverse biochemical variables can be achieved through proper manipulation of these inputs. However, a better quality of treated sludge usually implies major operating costs or a lower production rate. Thus, quality, production and cost indices are defined to quantify the outcomes of the treatment. Based on these, tradeoff control strategies are proposed and illustrated through some examples. This paper's results are relevant to guide plant operators, to design automatic control systems and to compare or evaluate the control performance on ATAD systems.

Acquisition Strategies for Purchasing Bulk Petroleum in DoD.

DTIC Science & Technology

1980-12-01

Oligopoly . . . . . . . . 41 2. Pricing Policy . . . . . . . . . . . . . . 42 a. Crude Oil Price Controls . . . . . . 43 b...Petroleum Product Price Controls 4. . . c. OPEC Price Controls . . .. . 4 6l 3. Product Policy ...... ....... 45 4. Policy Toward Rivals...Market conduct in the petroleum industry will be divided into three areas: pricing policies , product quality policies , and policies toward

Economic production quantity model for items with continuous quality characteristic, rework and reject

NASA Astrophysics Data System (ADS)

Tsou, Jia-Chi; Hejazi, Seyed Reza; Rasti Barzoki, Morteza

2012-12-01

The economic production quantity (EPQ) model is a well-known and commonly used inventory control technique. However, the model is built on an unrealistic assumption that all the produced items need to be of perfect quality. Having relaxed this assumption, some researchers have studied the effects of the imperfect products on the inventory control techniques. This article, thus, attempts to develop an EPQ model with continuous quality characteristic and rework. To this end, this study assumes that a produced item follows a general distribution pattern, with its quality being perfect, imperfect or defective. The analysis of the model developed indicates that there is an optimal lot size, which generates minimum total cost. Moreover, the results show that the optimal lot size of the model equals that of the classical EPQ model in case imperfect quality percentage is zero or even close to zero.

9 CFR 318.309 - Finished product inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... microbiological contamination; (2) An FSIS-approved total quality control system; (3) Alternative documented... associated with microbial contamination, where there is no approved total quality control system, or where... Office of Management and Budget under control number 0583-0015) [51 FR 45619, Dec. 19, 1986, as amended...

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Application of a tablet film coating model to define a process-imposed transition boundary for robust film coating.

PubMed

van den Ban, Sander; Pitt, Kendal G; Whiteman, Marshall

2018-02-01

A scientific understanding of interaction of product, film coat, film coating process, and equipment is important to enable design and operation of industrial scale pharmaceutical film coating processes that are robust and provide the level of control required to consistently deliver quality film coated product. Thermodynamic film coating conditions provided in the tablet film coating process impact film coat formation and subsequent product quality. A thermodynamic film coating model was used to evaluate film coating process performance over a wide range of film coating equipment from pilot to industrial scale (2.5-400 kg). An approximate process-imposed transition boundary, from operating in a dry to a wet environment, was derived, for relative humidity and exhaust temperature, and used to understand the impact of the film coating process on product formulation and process control requirements. This approximate transition boundary may aid in an enhanced understanding of risk to product quality, application of modern Quality by Design (QbD) based product development, technology transfer and scale-up, and support the science-based justification of critical process parameters (CPPs).

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.

PubMed

Jordan, A; Chen, D; Yi, Q-L; Kanias, T; Gladwin, M T; Acker, J P

2016-07-01

Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs). We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit. Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma. Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products. © 2016 International Society of Blood Transfusion.

Model of refrigerated display-space allocation for multi agro-perishable products considering markdown policy

NASA Astrophysics Data System (ADS)

Satiti, D.; Rusdiansyah, A.

2018-04-01

Problems that need more attention in the agri-food supply chain are loss and waste as consequences from improper quality control and excessive inventories. The use of cold storage is still being one of favourite technologies in controlling product quality by majority of retailers. We considerate the temperature of cold storage in determining the inventory and pricing strategies based on identified product quality. This study aims to minimize the agri-food waste, utility of cold storage facilities and maximize retailer’s profit through determining the refrigerated display-space allocation and markdown policy based on identified food shelf life. The proposed model evaluated with several different scenarios to find out the right strategy.

Near infrared spectroscopy based monitoring of extraction processes of raw material with the help of dynamic predictive modeling

NASA Astrophysics Data System (ADS)

Wang, Haixia; Suo, Tongchuan; Wu, Xiaolin; Zhang, Yue; Wang, Chunhua; Yu, Heshui; Li, Zheng

2018-03-01

The control of batch-to-batch quality variations remains a challenging task for pharmaceutical industries, e.g., traditional Chinese medicine (TCM) manufacturing. One difficult problem is to produce pharmaceutical products with consistent quality from raw material of large quality variations. In this paper, an integrated methodology combining the near infrared spectroscopy (NIRS) and dynamic predictive modeling is developed for the monitoring and control of the batch extraction process of licorice. With the spectra data in hand, the initial state of the process is firstly estimated with a state-space model to construct a process monitoring strategy for the early detection of variations induced by the initial process inputs such as raw materials. Secondly, the quality property of the end product is predicted at the mid-course during the extraction process with a partial least squares (PLS) model. The batch-end-time (BET) is then adjusted accordingly to minimize the quality variations. In conclusion, our study shows that with the help of the dynamic predictive modeling, NIRS can offer the past and future information of the process, which enables more accurate monitoring and control of process performance and product quality.

9 CFR 381.309 - Finished product inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FSIS-approved total quality control system; or (3) Alternative documented procedures that will ensure... contamination, where there is no approved total quality control system, or where the establishment has no... Office of Management and Budget under control number 0583-0015) [51 FR 45634, Dec. 19, 1986, as amended...

Layoffs and tradeoffs: production, quality, and safety demands under the threat of job loss.

PubMed

Probst, Tahira M

2002-07-01

Employees often face a conflict between production targets, quality assurance, and adherence to safety policies. In a time when layoffs are on the rise, it is important to understand the effects of employee job insecurity on these potentially competing demands. A laboratory experiment manipulated the threat of layoffs in a simulated organization and assessed its effect on employee productivity, product quality, and adherence to safety policies. Results suggest that student participants faced with the threat of layoffs were more productive, yet violated more safety rules and produced lower quality outputs, than participants in the control condition. Implications for organizations contemplating layoffs and directions for future research are discussed.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

40 CFR 1054.345 - What production-line testing records must I send to EPA?

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM NEW, SMALL NONROAD SPARK-IGNITION ENGINES AND... 1054. We have not changed production processes or quality-control procedures for test engines in a way...) Describe any facility used to test production-line engines and state its location. (2) State the total U.S...

The design of control system of livestock feeding processing

NASA Astrophysics Data System (ADS)

Sihombing, Juna; Napitupulu, Humala L.; Hidayati, Juliza

2018-03-01

PT. XYZ is a company that produces animal feed. One type of animal feed produced is 105 ISA P. In carrying out its production process, PT. XYZ faces the problem of rejected feed amounts during 2014 to June 2015 due to the amount of animal feed that exceeds the standard feed quality of 13% of moisture content and 3% for ash content. Therefore, the researchers analyzed the relationship between factors affecting the quality and extent of damage by using regression and correlation and determine the optimum value of each processing process. Analysis results found that variables affecting product quality are mixing time, steam conditioning temperature and cooling time. The most dominant variable affecting the product moisture content is mixing time with the correlation coefficient of (0.7959) and the most dominant variable affecting the ash content of the product during the processing is mixing time with the correlation coefficient of (0.8541). The design of the proposed product processing control is to run the product processing process with mixing time 235 seconds, steam conditioning temperature 87 0C and cooling time 192 seconds. Product quality 105 ISA P obtained by using this design is with 12.16% moisture content and ash content of 2.59%.

[Quality control in herbal supplements].

PubMed

Oelker, Luisa

2005-01-01

Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products.

PubMed

Almaya, Ahmad; De Belder, Lawrence; Meyer, Robert; Nagapudi, Karthik; Lin, Hung-Ren Homer; Leavesley, Ian; Jayanth, Jayanthy; Bajwa, Gurjit; DiNunzio, James; Tantuccio, Anthony; Blackwood, Dan; Abebe, Admassu

2017-04-01

Continuous manufacturing (CM) has emerged in the pharmaceutical industry as a paradigm shift with significant advantages related to cost, efficiency, flexibility, and higher assurance of quality. The inherent differences from batch processes justify examining the CM control strategy more holistically. This article describes the current thinking for the control and implementation of CM, using the example of a direct compression process and taking into consideration the ICH Q10 definition of "state of control" and process validation requirements. Statistical process control using control charts, sources of variation, process capability, and process performance is explained as a useful concept that can help assess the impact of variation within a batch and indicates if a process is in state of control. The potential for time-variant nature of startup and shutdown with CM is discussed to assure product quality while minimizing waste as well as different options for detection and isolation of non-conforming materials due to process upsets. While different levels of control are possible with CM, an appropriate balance between process control and end product testing is needed depending on the level of process understanding at the different stages of development from the production of clinical supplies through commercialization. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Feasibility of UV-VIS-Fluorescence spectroscopy combined with pattern recognition techniques to authenticate a new category of plant food supplements.

PubMed

Boggia, Raffaella; Turrini, Federica; Anselmo, Marco; Zunin, Paola; Donno, Dario; Beccaro, Gabriele L

2017-07-01

Bud extracts, named also "gemmoderivatives", are a new category of natural products, obtained macerating meristematic fresh tissues of trees and plants. In the European Community these botanical remedies are classified as plant food supplements. Nowadays these products are still poorly studied, even if they are widely used and commercialized. Several analytical tools for the quality control of these very expensive supplements are urgently needed in order to avoid mislabelling and frauds. In fact, besides the usual quality controls common to the other botanical dietary supplements, these extracts should be checked in order to quickly detect if the cheaper adult parts of the plants are deceptively used in place of the corresponding buds whose harvest-period and production are extremely limited. This study aims to provide a screening analytical method based on UV-VIS-Fluorescence spectroscopy coupled to multivariate analysis for a rapid, inexpensive and non-destructive quality control of these products.

Tumorigenicity assessment of human cell-processed therapeutic products.

PubMed

Yasuda, Satoshi; Sato, Yoji

2015-09-01

Human pluripotent stem cells (hPSCs) are expected to be sources of various cell types used for cell therapy, although hPSCs are intrinsically tumorigenic and form teratomas in immunodeficient animals after transplant. Despite the urgent need, no detailed guideline for the assessment of tumorigenicity of human cell-processed therapeutic products (hCTPs) has been issued. Here we describe our consideration on tumorigenicity and related tests of hCTPs. The purposes of those tests for hPSC-based products are classified into three categories: 1) quality control of raw materials; 2) quality control of intermediate/final products; and 3) safety assessment of final products. Appropriate types of tests need to be selected, taking the purpose(s) into consideration. In contrast, human somatic (and somatic stem) cells are believed to have little tumorigenicity. Therefore, GMP-compliant quality control is essential to avoid contamination of somatic cell-derived products with tumorigenic cells. Compared with in vivo tumorigenicity tests, in vitro cell proliferation assays may be more useful and reasonable for detecting immortalized cells that have a growth advantage in somatic cell-based products. The results obtained from tumorigenicity and related tests for hCTPs should meet the criteria for decisions on product development, manufacturing processes, and clinical applications. Copyright © 2015.

Recycling of inorganic nutrients for hydroponic crop production following incineration of inedible biomass.

PubMed

Bubenheim, D L; Wignarajah, K

1997-01-01

The goal of resource recovery in a regenerative life support system is maintenance of product quality to sure support of reliable and predictable levels of life support function performance by the crop plant component. Further, these systems must be maintained over extended periods of time, requiring maintenance of nutrient solutions to avoid toxicity and deficiencies. The focus of this study was to determine the suitability of the ash product following incineration of inedible biomass as a source of inorganic nutrients for hydroponic crop production. Inedible wheat biomass was incinerated and ash quality characterized. The incinerator ash was dissolved in adequate nitric acid to establish a consistent nitrogen concentration is all nutrient solution treatments. Four experimental nutrient treatments were included: control, ash only, ash supplemented to match the control treatment, and ash only quality formulated with reagent grade chemicals. When nutrient solutions were formulated using only ash following incineration of inedible biomass, a balance in solution is established representing elemental retention following incineration and nutrient proportions present in the original biomass. The resulting solution is not identical to the control. This imbalance resulted in a suppression of crop growth. When the ash is supplemented with reagent grade chemicals to establish the same balance as in the control--growth is identical to the control. The ash appears to carry no phytotoxic materials. Growth in solution formulated with reagent grade chemicals but matching the quality of the ash only treatment resulted in similar growth to that of the ash only treatment. The ash product resulting from incineration of inedible biomass appears to be a suitable form for recycle of inorganic nutrients to crop production.

An approach to quality and security of supply for single-use bioreactors.

PubMed

Barbaroux, Magali; Gerighausen, Susanne; Hackel, Heiko

2014-01-01

Single-use systems (also referred to as disposables) have become a huge part of the bioprocessing industry, which raised concern in the industry regarding quality and security of supply. Processes must be in place to assure the supply and control of outsourced activities and quality of purchased materials along the product life cycle. Quality and security of supply for single-use bioreactors (SUBs) are based on a multidisciplinary approach. Developing a state-of-the-art SUB-system based on quality by design (QbD) principles requires broad expertise and know-how including the cell culture application, polymer chemistry, regulatory requirements, and a deep understanding of the biopharmaceutical industry. Using standardized products reduces the complexity and strengthens the robustness of the supply chain. Well-established supplier relations including risk mitigation strategies are the basis for achieving long-term security of supply. Well-developed quality systems including change control approaches aligned with the requirements of the biopharmaceutical industry are a key factor in supporting long-term product availability. This chapter outlines the approach to security of supply for key materials used in single-use production processes for biopharmaceuticals from a supplier perspective.

Quality data collection and management technology of aerospace complex product assembly process

NASA Astrophysics Data System (ADS)

Weng, Gang; Liu, Jianhua; He, Yongxi; Zhuang, Cunbo

2017-04-01

Aiming at solving problems of difficult management and poor traceability for discrete assembly process quality data, a data collection and management method is proposed which take the assembly process and BOM as the core. Data collection method base on workflow technology, data model base on BOM and quality traceability of assembly process is included in the method. Finally, assembly process quality data management system is developed and effective control and management of quality information for complex product assembly process is realized.

Dropwise additive manufacturing of pharmaceutical products for melt-based dosage forms.

PubMed

Içten, Elçin; Giridhar, Arun; Taylor, Lynne S; Nagy, Zoltan K; Reklaitis, Gintaras V

2015-05-01

The US Food and Drug Administration introduced the quality by design approach and process analytical technology guidance to encourage innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. As part of this renewed emphasis on the improvement of manufacturing, the pharmaceutical industry has begun to develop more efficient production processes with more intensive use of online measurement and sensing, real-time quality control, and process control tools. Here, we present dropwise additive manufacturing of pharmaceutical products (DAMPP) as an alternative to conventional pharmaceutical manufacturing methods. This mini-manufacturing process for the production of pharmaceuticals utilizes drop on demand printing technology for automated and controlled deposition of melt-based formulations onto edible substrates. The advantages of drop-on-demand technology, including reproducible production of small droplets, adjustable drop sizing, high placement accuracy, and flexible use of different formulations, enable production of individualized dosing even for low-dose and high-potency drugs. In this work, DAMPP is used to produce solid oral dosage forms from hot melts of an active pharmaceutical ingredient and a polymer. The dosage forms are analyzed to show the reproducibility of dosing and the dissolution behavior of different formulations. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Partnership for Continuous Improvement

NASA Technical Reports Server (NTRS)

1990-01-01

The proceedings are presented of the sixth annual conference on quality control between NASA and its contractors. The emphasis is placed on a commitment to quality and excellence that guarantees mission success. A forum is provided for representatives from government, industry, and academia to exchange ideas and experiences, encouraging total quality performance that results in high quality products and services. Key points are highlighted from the presentations and activities are described that have resulted in a broad range of improvements in products and services from government, industry, and academia. Long term commitment to quality is an essential requirement that ensures future success. That commitment reinterates the dedication to excellence in space exploration and to national quality and productivity improvement.

Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

PubMed

Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

2017-11-01

Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

Design and implementation of a control structure for quality products in a crude oil atmospheric distillation column.

PubMed

Sotelo, David; Favela-Contreras, Antonio; Sotelo, Carlos; Jiménez, Guillermo; Gallegos-Canales, Luis

2017-11-01

In recent years, interest for petrochemical processes has been increasing, especially in refinement area. However, the high variability in the dynamic characteristics present in the atmospheric distillation column poses a challenge to obtain quality products. To improve distillates quality in spite of the changes in the input crude oil composition, this paper details a new design of a control strategy in a conventional crude oil distillation plant defined using formal interaction analysis tools. The process dynamic and its control are simulated on Aspen HYSYS ® dynamic environment under real operating conditions. The simulation results are compared against a typical control strategy commonly used in crude oil atmospheric distillation columns. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

Un modelo para el control de calidad academica de los textos de instruccion a distancia (A Model for Controlling the Academic Quality of Distance Education Texts).

ERIC Educational Resources Information Center

Bolanos-Mora, Guiselle; And Others

1992-01-01

In response to the need for a system of control over the academic quality of distance education texts, this article proposes a methodological model based on criteria that evaluate written materials based on their instructional quality, design, and production. A discussion and figures evaluate educational aspects of content, communication,…

Chemical investigation of commercial grape seed derived products to assess quality and detect adulteration.

PubMed

Villani, Tom S; Reichert, William; Ferruzzi, Mario G; Pasinetti, Giulio M; Simon, James E; Wu, Qingli

2015-03-01

Fundamental concerns in quality control arise due to increasing use of grape seed extract (GSE) and the complex chemical composition of GSE. Proanthocyanidin monomers and oligomers are the major bioactive compounds in GSE. Given no standardized criteria for quality, large variation exists in the composition of commercial GSE supplements. Using HPLC/UV/MS, 21 commercial GSE containing products were purchased and chemically profiled, major compounds quantitated, and compared against authenticated grape seed extract, peanut skin extract, and pine bark extract. The antioxidant capacity and total polyphenol content for each sample was also determined and compared using standard techniques. Nine products were adulterated, found to contain peanut skin extract. A wide degree of variability in chemical composition was detected in commercial products, demonstrating the need for development of quality control standards for GSE. A TLC method was developed to allow for rapid and inexpensive detection of adulteration in GSE by peanut skin. Copyright © 2014 Elsevier Ltd. All rights reserved.

Use of Psychrotolerant Lactic Acid Bacteria (Lactobacillus spp. and Leuconostoc spp.) Isolated from Chinese Traditional Paocai for the Quality Improvement of Paocai Products.

PubMed

Liu, Aiping; Li, Xiaoyan; Pu, Biao; Ao, Xiaolin; Zhou, Kang; He, Li; Chen, Shujuan; Liu, Shuliang

2017-03-29

To improve the quality of Chinese traditional Paocai, two psychrotolerant lactic acid bacteria (LAB) strains were isolated from Paocai, and the quality of Chinese Paocai product using these two strains as starter cultures was compared to a control sample fermented with aged brine at 10 °C. The results suggested that the physicochemical and sensory features of Paocai fermented with psychrotolerant LAB were more suitable for industrial applications. The nitrite content of Paocai fermented with psychrotolerant LAB was 1 mg/kg, which was significantly lower than that of the control Paocai (P < 0.05). Low-temperature fermentation with the starter cultures of psychrotolerant LAB could effectively prevent overacidity and over-ripening of the Paocai products. Additionally, Paocai fermented with psychrotolerant LAB harbored relatively simple microbial flora as revealed by polymerase chain reaction-denaturing gradient gel electrophoresis. This study provides a basis for improving the quality of Chinese traditional Paocai and the large-scale production of low-temperature Chinese traditional Paocai products.

Review of nuclear pharmacy practice in hospitals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kawada, T.K.; Tubis, M.; Ebenkamp, T.

1982-02-01

An operational profile for nuclear pharmacy practice is presented, and the technical and professional role of nuclear pharmacists is reviewed. Key aspects of nuclear pharmacy practice in hospitals discussed are the basic facilities and equipment for the preparation, quality control, and distribution of radioactive drug products. Standards for receiving, storing, and processing radioactive material are described. The elements of a radiopharmaceutical quality assurance program, including the working procedures, documentation systems, data analysis, and specific control tests, are presented. Details of dose preparation and administration and systems of inventory control for radioactive products are outlined.

A novel approach to rapidly explore analytical markers for quality control of Radix Salviae Miltiorrhizae extract granules by robust principal component analysis with ultra-high performance liquid chromatography-ultraviolet-quadrupole time-of-flight mass spectrometry.

PubMed

Song, Jing-Zheng; Li, Song-Lin; Zhou, Yan; Qiao, Chun-Feng; Chen, Shi-Lin; Xu, Hong-Xi

2010-11-02

In a well-controlled experiment, outliers discriminated by robust principal component analysis (RPCA) represent contents in samples which are of particular quality distinguishable from the rest of the others, therefore chemical constituents in a natural product causing discrimination between outliers and the majority of samples could be considered as analytical markers for quality control. Based on this strategy, a novel approach for rapidly exploring characteristic analytical markers was proposed for the quality control of extract granules of Radix Salviae Miltiorrhizae (EGRSM). In this study, large sizes of samples were analyzed via high-throughput ultra-high performance liquid chromatography-ultraviolet-quadrupole time-of-flight mass spectrometry (UHPLC-UV-Q-Tof MS). RPCA was first performed on the three groups of samples: RSM (the raw material), the in-house prepared aqueous extract of Radix Salviae Miltiorrhizae (AERSM) and commercial product of EGRSM, to determine the variation of specific constituents between raw material and the final products as well as the effect of manufacturing process on the overall quality. Then RPCA was performed on the commercial products of EGRSM to explore the applicability of identified characteristic markers for the quality control of EGRSM. Candidate markers were extracted by RPCA, and their molecular formulae were determined by high resolution electrospray ionization-mass spectrometric (ESI-MS) analysis. The suitability of identified markers was then evaluated by determining the relationship between quantities of the identified markers with their antioxidant activities biologically, and further confirmed in a variety of samples. In conclusion, the combination of RPCA with UHPLC-UV-Q-Tof MS is a reliable means to identify chemical markers for evaluating quality of herbal medicines. Copyright (c) 2010 Elsevier B.V. All rights reserved.

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2010 CFR

2010-04-01

... products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels. (e) The accuracy, sensitivity, specificity, and...

Comparison of laboratory and field bioassays of lab-reared Cydia pomonella (Lepidoptera: Tortricidae) quality and field performance.

USDA-ARS?s Scientific Manuscript database

Maximum production and fitness of insect species that are mass-reared for biological control programs such as the sterile insect technique (SIT) have benefitted from the employment of quality control and quality management. With a growing interest in the use of SIT as a tactic for the suppression/e...

Comparison of Grand Median and Cumulative Sum Control Charts on Shuttlecock Weight Variable in CV Marjoko Kompas dan Domas

NASA Astrophysics Data System (ADS)

Musdalifah, N.; Handajani, S. S.; Zukhronah, E.

2017-06-01

Competition between the homoneous companies cause the company have to keep production quality. To cover this problem, the company controls the production with statistical quality control using control chart. Shewhart control chart is used to normal distributed data. The production data is often non-normal distribution and occured small process shift. Grand median control chart is a control chart for non-normal distributed data, while cumulative sum (cusum) control chart is a sensitive control chart to detect small process shift. The purpose of this research is to compare grand median and cusum control charts on shuttlecock weight variable in CV Marjoko Kompas dan Domas by generating data as the actual distribution. The generated data is used to simulate multiplier of standard deviation on grand median and cusum control charts. Simulation is done to get average run lenght (ARL) 370. Grand median control chart detects ten points that out of control, while cusum control chart detects a point out of control. It can be concluded that grand median control chart is better than cusum control chart.

A Controlled Agitation Process for Improving Quality of Canned Green Beans during Agitation Thermal Processing.

PubMed

Singh, Anika; Pratap Singh, Anubhav; Ramaswamy, Hosahalli S

2016-06-01

This work introduces the concept of a controlled agitation thermal process to reduce quality damage in liquid-particulate products during agitation thermal processing. Reciprocating agitation thermal processing (RA-TP) was used as the agitation thermal process. In order to reduce the impact of agitation, a new concept of "stopping agitations after sufficient development of cold-spot temperature" was proposed. Green beans were processed in No. 2 (307×409) cans filled with liquids of various consistency (0% to 2% CMC) at various frequencies (1 to 3 Hz) of RA-TP using a full-factorial design and heat penetration results were collected. Corresponding operator's process time to impart a 10-min process lethality (Fo ) and agitation time (AT) were calculated using heat penetration results. Accordingly, products were processed again by stopping agitations as per 3 agitation regimes, namely; full time agitation, equilibration time agitation, and partial time agitation. Processed products were photographed and tested for visual quality, color, texture, breakage of green beans, turbidity, and percentage of insoluble solids in can liquid. Results showed that stopping agitations after sufficient development of cold-spot temperatures is an effective way of reducing product damages caused by agitation (for example, breakage of beans and its leaching into liquid). Agitations till one-log temperature difference gave best color, texture and visual product quality for low-viscosity liquid-particulate mixture and extended agitations till equilibration time was best for high-viscosity products. Thus, it was shown that a controlled agitation thermal process is more effective in obtaining high product quality as compared to a regular agitation thermal process. © 2016 Institute of Food Technologists®

Reconnaissance Report on Papillion Creek Reservoirs.

DTIC Science & Technology

1981-03-01

The appearance of the reservoir and production of malodors are nonaesthetic. The general charateristics of the flood control reservoirs near Lincoln...characteristic of extremely unproductive soft transparent waters to extremely productive hard waters turbid with plankton. A more current trend in lake...quality and biological productivity . The process of nutrient enrichment does not always result in the degradation of water quality. Whether or not the

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2012 CFR

2012-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2011 CFR

2011-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923

PubMed Central

Treangen, Todd J.; Maybank, Rosslyn A.; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F.; Karaolis, David K. R.; Koren, Sergey; Ondov, Brian; Phillippy, Adam M.; Bergman, Nicholas H.

2014-01-01

Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. PMID:25377701

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

Quality assurance: Importance of systems and standard operating procedures

PubMed Central

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. PMID:21584180

Quality assurance: Importance of systems and standard operating procedures.

PubMed

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

Data Quality Screening Service

NASA Technical Reports Server (NTRS)

Strub, Richard; Lynnes, Christopher; Hearty, Thomas; Won, Young-In; Fox, Peter; Zednik, Stephan

2013-01-01

A report describes the Data Quality Screening Service (DQSS), which is designed to help automate the filtering of remote sensing data on behalf of science users. Whereas this process often involves much research through quality documents followed by laborious coding, the DQSS is a Web Service that provides data users with data pre-filtered to their particular criteria, while at the same time guiding the user with filtering recommendations of the cognizant data experts. The DQSS design is based on a formal semantic Web ontology that describes data fields and the quality fields for applying quality control within a data product. The accompanying code base handles several remote sensing datasets and quality control schemes for data products stored in Hierarchical Data Format (HDF), a common format for NASA remote sensing data. Together, the ontology and code support a variety of quality control schemes through the implementation of the Boolean expression with simple, reusable conditional expressions as operands. Additional datasets are added to the DQSS simply by registering instances in the ontology if they follow a quality scheme that is already modeled in the ontology. New quality schemes are added by extending the ontology and adding code for each new scheme.

Evaluation of Safety, Quality and Productivity in Construction

NASA Astrophysics Data System (ADS)

Usmen, M. A.; Vilnitis, M.

2015-11-01

This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

[Application of THz technology to nondestructive detection of agricultural product quality].

PubMed

Jiang, Yu-ying; Ge, Hong-yi; Lian, Fei-yu; Zhang, Yuan; Xia, Shan-hong

2014-08-01

With recent development of THz sources and detector, applications of THz radiation to nondestructive testing and quality control have expanded in many fields, such as agriculture, safety inspection and quality control, medicine, biochemistry, communication etc. Compared with other detection technique, being a new kind of technique, THz radiation has low energy, good perspectivity, and high signal-to-noise ratio, and thus can obtain physical, chemical and biological information. This paper first introduces the basic concept of THz radiation and the major properties, then gives an extensive review of recent research progress in detection of the quality of agricultural products via THz technique, analyzes the existing shortcomings of THz detection and discusses the outlook of potential application, finally proposes the new application of THz technique to detection of quality of stored grain.

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2010 CFR

2010-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2013 CFR

2013-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2014 CFR

2014-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2012 CFR

2012-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

10 CFR 830.122 - Quality assurance criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

... control design interfaces. (4) Verify or validate the adequacy of design products using individuals or... quality problems. (2) Identify, control, and correct items, services, and processes that do not meet..., specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e...

The Modern Measurement Technology And Checking Of Shafs Parameters

NASA Astrophysics Data System (ADS)

Tichá, Šárka; Botek, Jan

2015-12-01

This paper is focused on rationalization checking parameters of shaft in companies engaged in the production of components of electric motors, wind turbines and vacuum systems. Customers increasing constantly their requirements to ensure the overall quality of the product, i.e. the quality of machining, dimensional and shape accuracy and overall purity of the subscribed products. The aim of this paper is to introduce using modern measurement technology in controlling these components and compare the results with existing control methodology. The main objective of this rationalization is to eliminate mistakes and shortcomings of current inspection methods.

The process of managerial control in quality improvement initiatives.

PubMed

Slovensky, D J; Fottler, M D

1994-11-01

The fundamental intent of strategic management is to position an organization with in its market to exploit organizational competencies and strengths to gain competitive advantage. Competitive advantage may be achieved through such strategies as low cost, high quality, or unique services or products. For health care organizations accredited by the Joint Commission on Accreditation of Healthcare Organizations, continually improving both processes and outcomes of organizational performance--quality improvement--in all operational areas of the organization is a mandated strategy. Defining and measuring quality and controlling the quality improvement strategy remain problematic. The article discusses the nature and processes of managerial control, some potential measures of quality, and related information needs.

WHO Expert Committee on Biological Standardization.

PubMed

2002-01-01

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

GEOSPATIAL QUALITY COUNCIL

EPA Science Inventory

Geospatial Science is increasingly becoming an important tool in making Agency decisions. QualIty Control and Quality Assurance are required to be integrated during the planning, implementation and assessment of geospatial databases, processes and products. In order to ensure Age...

Patients with Gout Treated with Conventional Urate-lowering Therapy: Association with Disease Control, Health-related Quality of Life, and Work Productivity.

PubMed

Wood, Robert; Fermer, Steve; Ramachandran, Sulabha; Baumgartner, Scott; Morlock, Robert

2016-10-01

Implications of inadequate gout control were assessed through health-related quality of life (HRQOL) and work productivity of patients with gout adequately controlled while taking conventional urate-lowering therapy (ULT) for ≥ 3 months vs those whose gout was inadequately controlled. Retrospective data were drawn from the Adelphi Disease Specific Programme (DSP), a cross-sectional survey of patients with gout in France, Germany, the United Kingdom, and the United States. Patients completed these questionnaires: EQ-5D (3L), Patient Reported Outcomes Measurement Information System (PROMIS) Health Assessment Questionnaire (HAQ), and Work Productivity and Activity Impairment. Inadequate control was defined as the most recent serum uric acid (SUA) level > 6 mg/dl (> 360 µmol/l) or ≥ 2 flares in the last 12 months; adequate control as SUA level ≤ 6 mg/dl (≤ 360 µmol/l) and 0 flares. Appropriate statistical tests were used to assess differences between groups. There were 836 (69%) inadequately and 368 (31%) adequately controlled gout cases. Mean age was 61 and 63 years and duration of current ULT was 32 and 57 months, respectively. Patients experiencing inadequate control reported significantly worse functioning and HRQOL, as measured by the EQ-5D (0.790 vs 0.877; difference: -0.087; p < 0.001) and PROMIS HAQ (13.21 vs 6.91; difference: 6.30; p < 0.001) scales. Productivity was also more impaired (work time missed: 4.5% vs 1.3%; impairment while working: 19.1% vs 5.2%; overall work impairment: 20.4% vs 5.6%; activity impairment: 20.3% vs 5.3%; all p < 0.001). Less than one-third of patients had gout that was adequately controlled. Those experiencing inadequately controlled gout reported significantly worse functioning, quality of life, and work productivity. Gout treatment strategies to improve disease control may lead to improvements in HRQOL and productivity.

Effects of climatic control on tomato yield and nutritional quality in Mediterranean screenhouse.

PubMed

Leyva, Rocío; Constán-Aguilar, Christian; Blasco, Begoña; Sánchez-Rodríguez, Eva; Romero, Luis; Soriano, Teresa; Ruíz, Juan M

2014-01-15

The quality of vegetables for fresh consumption is a complex issue. In this study the yield and quality of cherry tomato fruits were assessed under different environmental control conditions, namely in a screenhouse (S), in a screenhouse equipped with a fogging system (SF) and in a screenhouse with complements such as plastic sheeting to maintain the microclimate created by the fogging system (SFS), as well as under open field (OF) cultivation. Levels of vitamin C, carotenoids (lycopene, β-carotene and lutein), phenolic compounds (flavonoids and phenolic acids), sugars (fructose, glucose and sucrose), organic acids (citric acid and malic acid) and flavour indices were measured. The aim of the study was to determine how different environmental control technologies could influence production and quality traits in tomato cherry fruits cultivated in a Mediterranean area. The results showed that the fogging system treatment's decline in maximum vapour pressure deficit (by 0.7 kPa compared with OF cultivation), increase in mean fruit weight (by about 4 g per fruit) and low radiation and temperature values may exert a positive effect on lycopene accumulation. For the production and nutritional parameters measured, it is postulated that the fogging system treatment offers a better balance between production and nutritional quality. This treatment proved to be best in terms of productivity, vitamin C and lycopene contents and antioxidant capacity. © 2013 Society of Chemical Industry.

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

46 CFR 160.049-5 - Inspections and tests. 1

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Specification for a Buoyant Cushion Plastic Foam § 160.049-5... maintain quality control of the materials used, manufacturing methods and the finished product so as to... samples and components produced to maintain the quality of the finished product. Records of tests...

Effect of production variables on microbiological removal in locally-produced ceramic filters for household water treatment.

PubMed

Lantagne, Daniele; Klarman, Molly; Mayer, Ally; Preston, Kelsey; Napotnik, Julie; Jellison, Kristen

2010-06-01

Diarrhoeal diseases cause an estimated 1.87 million child deaths per year. Point-of-use filtration using locally made ceramic filters improves microbiological quality of stored drinking water and prevents diarrhoeal disease. Scaling-up ceramic filtration is inhibited by lack of universal quality control standards. We investigated filter production variables to determine their affect on microbiological removal during 5-6 weeks of simulated normal use. Decreases in the clay:sawdust ratio and changes in the burnable decreased effectiveness of the filter. Method of silver application and shape of filter did not impact filter effectiveness. A maximum flow rate of 1.7 l(-hr) was established as a potential quality control measure for one particular filter to ensure 99% (2- log(10)) removal of total coliforms. Further research is indicated to determine additional production variables associated with filter effectiveness and develop standardized filter production procedures prior to scaling-up.

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

Chapter 6: Tree-compatible ground covers for reforestation and erosion control

Treesearch

J. Burger; V. Davis; C. Zipper; J. Skousen; C. Barton; P. Angel

2017-01-01

Productive native forests create economic value for landowners, produce raw materials for wood-based products, and provide benefits such as watershed control, water quality protection, carbon storage, wildlife habitat, and native plant diversity. Owners of lands mined for coal in the Appalachian region are increasingly interested in assuring that productive forests are...

Application of visible/near infrared spectroscopy to quality control of fresh fruits and vegetables in large-scale mass distribution channels: a preliminary test on carrots and tomatoes.

PubMed

Beghi, Roberto; Giovenzana, Valentina; Tugnolo, Alessio; Guidetti, Riccardo

2018-05-01

The market for fruits and vegetables is mainly controlled by the mass distribution channel (MDC). MDC buyers do not have useful instruments to rapidly evaluate the quality of the products. Decisions by the buyers are driven primarily by pricing strategies rather than product quality. Simple, rapid and easy-to-use methods for objectively evaluating the quality of postharvest products are needed. The present study aimed to use visible and near-infrared (vis/NIR) spectroscopy to estimate some qualitative parameters of two low-price products (carrots and tomatoes) of various brands, as well as evaluate the applicability of this technique for use in stores. A non-destructive optical system (vis/NIR spectrophotometer with a reflection probe, spectral range 450-1650 nm) was tested. The differences in quality among carrots and tomatoes purchased from 13 stores on various dates were examined. The reference quality parameters (firmness, water content, soluble solids content, pH and colour) were correlated with the spectral readings. The models derived from the optical data gave positive results, in particular for the prediction of the soluble solids content and the colour, with better results for tomatoes than for carrots. The application of optical techniques may help MDC buyers to monitor the quality of postharvest products, leading to an effective optimization of the entire supply chain. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Commercialization of veterinary viral vaccines.

PubMed

Flore, P H

2004-12-01

If vaccines are to reliably prevent disease, they must be developed, produced and quality-controlled according to very strict regulations and procedures. Veterinary viral vaccine registrations are governed by different rules in different countries, but these rules all emphasize that the quality of the raw materials--the cells, eggs, animals or plants that are used in production--need to be carefully controlled. The veterinary vaccine business is also very cost-conscious. Emphasis over the last 5-10 years has therefore been to develop culture systems that minimize labor and sterility problems and thus provide for reliable and cost-effective production. Implementing these often more complex systems in a production environment takes considerable effort, first in scale-up trials and further down the line in convincing production personnel to change their familiar system for something new and possibly untried. To complete scale-up trials successfully, it is absolutely necessary to understand the biochemistry of the cells and the influence of the virus on the cells under scale-up and later production conditions. Once a viral product can be produced on a large scale, it is imperative that the quality of the end-product is controlled in an intelligent way. One needs to know whether the end-product performs in the animal as was intended during its conception in the research and development department. The development of the appropriate tests to demonstrate this plays an important role in the successful development of a vaccine.

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2014 CFR

2014-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2013 CFR

2013-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2011 CFR

2011-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2012 CFR

2012-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

Code of Federal Regulations, 2010 CFR

2010-04-01

... returned dietary supplements? 111.130 Section 111.130 Food and Drugs FOOD AND DRUG ADMINISTRATION... PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production... are required for returned dietary supplements? Quality control operations for returned dietary...

Parameter Trending, Geolocation Quality Control and the Procedures to Support Preparation of Next Versions of the TRMM Reprocessing Algorithm

NASA Technical Reports Server (NTRS)

Stocker, Erich Franz

2004-01-01

TRMM has been an imminently successful mission from an engineering standpoint but even more from a science standpoint. An important part of this science success has been the careful quality control of the TRMM standard products. This paper will present the quality monitoring efforts that the TRMM Science Data and Information System (TSDIS) conducts on a routine basis. The paper will detail parameter trending, geolocation quality control and the procedures to support the preparation of next versions of the algorithm used for reprocessing.

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

HPTLC Fingerprint Analysis: A Quality Control for Authentication of Herbal Phytochemicals

NASA Astrophysics Data System (ADS)

Ram, Mauji; Abdin, M. Z.; Khan, M. A.; Jha, Prabhakar

Authentication and consistent quality are the basic requirement for Indian traditional medicine (TIM), Chinese traditional herbal medicine (TCHM), and their commercial products, regardless of the kind of research conducted to modernize the TIM and TCHM. The complexities of TIM and TCHM challenge the current official quality control mode, for which only a few biochemical markers were selected for identification and quantitative assay. Referring too many unknown factors existed in TIM and TCHM, it is impossible and unnecessary to pinpoint qualitatively and quantitatively every single component contained in the herbal drug. Chromatographic fingerprint is a rational option to meet the need for more effective and powerful quality assessment to TIM and TCHM. The optimized chromatographic fingerprint is not only an alternative analytical tool for authentication, but also an approach to express the various pattern of chemical ingredients distribution in the herbal drugs and preserve such "database" for further multifaced sustainable studies. Analytical separation techniques, for example, high-performance liquid chromatography (HPLC), gas chromatography (GC) and mass spectrometry (MS) were among the most popular methods of choice used for quality control of raw material and finished herbal product. Fingerprint analysis approach using high-performance thin-layer chromatography (HPTLC) has become the most potent tool for quality control of herbal medicines because of its simplicity and reliability. It can serve as a tool for identification, authentication, and quality control of herbal drugs. In this chapter, attempts are being made to expand the use of HPTLC and at the same time create interest among prospective researcher in herbal analysis. The developed method can be used as a quality control tool for rapid authentication from a wide variety of herbal samples. Some examples demonstrated the role of fingerprinting in quality control and assessment.

Characterization of a whole, inactivated influenza (H5N1) vaccine.

PubMed

Tada, Yoshikazu

2008-11-01

Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine formulations. Improving vaccine productivity, shortening the production period and improving antigen yield of the avirulent vaccine strains were also considered important vaccine development criteria.

Complete Genome Sequence of the Quality Control Strain Staphylococcus aureus subsp. aureus ATCC 25923.

PubMed

Treangen, Todd J; Maybank, Rosslyn A; Enke, Sana; Friss, Mary Beth; Diviak, Lynn F; Karaolis, David K R; Koren, Sergey; Ondov, Brian; Phillippy, Adam M; Bergman, Nicholas H; Rosovitz, M J

2014-11-06

Staphylococcus aureus subsp. aureus ATCC 25923 is commonly used as a control strain for susceptibility testing to antibiotics and as a quality control strain for commercial products. We present the completed genome sequence for the strain, consisting of the chromosome and a 27.5-kb plasmid. Copyright © 2014 Treangen et al.

New methods to monitor emerging chemicals in the drinking water production chain.

PubMed

van Wezel, Annemarie; Mons, Margreet; van Delft, Wouter

2010-01-01

New techniques enable a shift in monitoring chemicals that affect water quality from mainly at the end product, tap water, towards monitoring during the whole process along the production chain. This is congruent with the 'HACCP' system (hazard analysis of critical control points) that is fairly well integrated into food production but less well in drinking water production. This shift brings about more information about source quality, the efficiency of treatment and distribution, and understanding of processes within the production chain, and therefore can lead to a more pro-active management of drinking water production. At present, monitoring is focused neither on emerging chemicals, nor on detection of compounds with chronic toxicity. We discuss techniques to be used, detection limits compared to quality criteria, data interpretation and possible interventions in production.

Total Quality Management: A Recipe for Success

DTIC Science & Technology

1990-04-02

Total Quality Management (TQM) is a high level Department of Defense (DOD) initiative that is being touted as the primary management tool to force...to create a DOD wide organizational climate that will stimulate and perpetuate individual productivity enhancing contributions. Keywords: Quality control; Quality management ; TQM.

Assessment of microbiological quality of retail fresh sushi from selected sources in Norway.

PubMed

Hoel, Sunniva; Mehli, Lisbeth; Bruheim, Torkjel; Vadstein, Olav; Jakobsen, Anita Nordeng

2015-05-01

Retail fresh sushi is gaining popularity in Europe. This study was conducted to investigate the microbiological quality of selected samples of fresh sushi with a shelf life of 2 to 3 days offered as complete meals in Norwegian supermarkets. Analysis of aerobic plate counts in 58 sushi samples from three producers revealed large variations in microbiological quality, and 48% of the analyzed sushi boxes were rated as unsatisfactory (> 6.0 log CFU/g). Mesophilic Aeromonas spp. was detected in 71% of the samples. In a follow-up study, we collected products and raw materials directly from the production facility of one producer and observed a significant decrease (P < 0.01) in aerobic plate counts compared with the initial sampling. The observed difference between products purchased in stores compared with those collected directly from the factory suggests that poor temperature control during distribution and display in stores leads to reduced microbiological quality. Microbiological analysis of the sushi ingredients revealed that potentially pathogenic bacteria such as mesophilic Aeromonas spp. or bacteria belonging to the Enterobacteriaceae can be introduced into sushi through both raw vegetables and fish. The results highlight the importance of high quality ingredients and proper temperature control to ensure stable quality and safety of these food products.

Optimizing anaerobic soil disinfestation for fresh market tomato production: Nematode and weed control, yield, and fruit quality

USDA-ARS?s Scientific Manuscript database

Anaerobic soil disinfestation (ASD) has potential as an alternative to chemical-fumigation for controlling soilborne pathogens and pests. Previously, control of nutsedge was sub-optimal and the quantity of inputs for commercial production was an impediment to adoption. Field studies were conducted i...

Japanese Quality Control Circles.

ERIC Educational Resources Information Center

Nishiyama, Kazuo

In recent years, United States scholars with an interest in international business and organizational communication have begun to notice the success of Japanese "quality control circles." These are small groups, usually composed of seven to ten workers, who are organized at the production levels within most large Japanese factories. A…

Containing the Damage: Quality Control of Local Data Production.

ERIC Educational Resources Information Center

Blair, Norman A.

1983-01-01

The ability of operating departments of an institution to mechanically gather, summarize, and report "local" data is discussed. Problems are outlined that arise when departments have the ability to produce data and do so with rigorous quality control by the institution's central information management organization. (MLW)

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

PubMed

Challa, Shruthi; Potumarthi, Ravichandra

2013-01-01

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples.

PubMed

Ooi, Shing Ming; Sarkar, Srimanta; van Varenbergh, Griet; Schoeters, Kris; Heng, Paul Wan Sia

2013-04-01

Continuous processing and production in pharmaceutical manufacturing has received increased attention in recent years mainly due to the industries' pressing needs for more efficient, cost-effective processes and production, as well as regulatory facilitation. To achieve optimum product quality, the traditional trial-and-error method for the optimization of different process and formulation parameters is expensive and time consuming. Real-time evaluation and the control of product quality using an online process analyzer in continuous processing can provide high-quality production with very high-throughput at low unit cost. This review focuses on continuous processing and the application of different real-time monitoring tools used in the pharmaceutical industry for continuous processing from powder to tablets.

PEF and UV combined system for pathogen microorganisms inactivation in liquid food products

NASA Astrophysics Data System (ADS)

Cramariuc, R.; Popa, M.; Tudorache, A.; Brînduşe, E.; Kontek, A.; Mitelut, A.; Fotescu, L.; Cramariuc, B.; Geicu, M.; Nisiparu, L.

2011-06-01

Pulsed electrical field (PEF) treatment is a non-thermal food preservation technology based on the use of the electrical field in impulses applied in order to inactivate and control pathogen microorganisms in foods. This technology is highly appreciated for its ability to prolong the shelf life of the treated product without the use of heat and also for its ability to preserve the product's sensory qualities and nutritional value as well as for the microbiological control of the treated products. This paper presents the PEF and UV treatment methods, or a combination between the two, for microbe inactivation in liquid products. The experiments were carried out using yeasts, lactic bacteria and acetic bacteria in the following systems: stand-alone treatments (PEF or UV) or in combination (UV+PEF or PEF+UV). The results of these experiments showed that one can obtain total inactivation of microorganisms using the combined UV+PEF system, thus leading to the possibility of increasing liquid food products quality as compared to the quality obtained using thermal pasteurization.

Quality management of manufacturing process based on manufacturing execution system

NASA Astrophysics Data System (ADS)

Zhang, Jian; Jiang, Yang; Jiang, Weizhuo

2017-04-01

Quality control elements in manufacturing process are elaborated. And the approach of quality management of manufacturing process based on manufacturing execution system (MES) is discussed. The functions of MES for a microcircuit production line are introduced conclusively.

Total Quality Management (TQM) Awareness Seminar. Revision 8

DTIC Science & Technology

1990-04-18

in the United States and abroad, including Dr. W. Edwards Deming, Dr. Joseph Juran, Philip Crosby, Genichi Taguchi, Kaoru Ishikawa , and Armand...Hall, Inc., Englewood Cliffs, NJ 07022. 1985 Ishikawa , Kaoru , Guide to Quality Control, Tokyo; Asian Productivity Organization, 1976 (Available from...Random House Business Division, 201 East 50th Street, New York, NY 10022. � Ishikawa , Karou, What is Total Quality Control?: The Japanese Way, Prentice

Process performance and product quality in an integrated continuous antibody production process.

PubMed

Karst, Daniel J; Steinebach, Fabian; Soos, Miroslav; Morbidelli, Massimo

2017-02-01

Continuous manufacturing is currently being seriously considered in the biopharmaceutical industry as the possible new paradigm for producing therapeutic proteins, due to production cost and product quality related benefits. In this study, a monoclonal antibody producing CHO cell line was cultured in perfusion mode and connected to a continuous affinity capture step. The reliable and stable integration of the two systems was enabled by suitable control loops, regulating the continuous volumetric flow and adapting the operating conditions of the capture process. For the latter, an at-line HPLC measurement of the harvest concentration subsequent to the bioreactor was combined with a mechanistic model of the capture chromatographic unit. Thereby, optimal buffer consumption and productivity throughout the process was realized while always maintaining a yield above the target value of 99%. Stable operation was achieved at three consecutive viable cell density set points (20, 60, and 40 × 10 6 cells/mL), together with consistent product quality in terms of aggregates, fragments, charge isoforms, and N-linked glycosylation. In addition, different values for these product quality attributes such as N-linked glycosylation, charge variants, and aggregate content were measured at the different steady states. As expected, the amount of released DNA and HCP was significantly reduced by the capture step for all considered upstream operating conditions. This study is exemplary for the potential of enhancing product quality control and modulation by integrated continuous manufacturing. Biotechnol. Bioeng. 2017;114: 298-307. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Minimization of Defective Products in The Department of Press Bridge & Rib Through Six Sigma DMAIC Phases

NASA Astrophysics Data System (ADS)

Rochman, YA; Agustin, A.

2017-06-01

This study proposes the DMAIC Six Sigma approach of Define, Measure, Analyze, Improve/Implement and Control (DMAIC) to minimizing the number of defective products in the bridge & rib department. There are 5 types of defects were the most dominant are broken rib, broken sound board, strained rib, rib sliding and sound board minori. The imperative objective is to improve the quality through the DMAIC phases. In the define phase, the critical to quality (CTQ) parameters was identified minimization of product defects through the pareto chart and FMEA. In this phase, to identify waste based on the current value stream mapping. In the measure phase, the specified control limits product used to maintain the variations of the product, the calculation of the value of DPMO (Defect Per Million Opportunities) and the calculation of the value of sigma level. In analyze phase, determine the type of defect of the most dominant and identify the causes of defective products. In the improve phase, the existing design was modified through various alternative solutions by conducting brainstorming sessions. In this phase, the solution was identified based on the results of FMEA. Improvements were made to the seven priority causes of disability based on the highest RPN value. In the control phase, focusing on improvements to be made. Proposed improvements include making and define standard operating procedures, improving the quality and eliminate waste defective products.

MALDI-TOF MS for quality control of high protein content sport supplements.

PubMed

De Ceglie, Cristina; Calvano, Cosima D; Zambonin, Carlo G

2015-06-01

High protein content sport nutritional supplements are found as powder products containing, as ingredients, amino acids and proteins with important nutritional values as milk, soy and egg proteins. An EU Food Supplements Directive (2002) requires that supplements should be safe, both in dosages and in purity. It is important, then, to develop rapid and sensitive methods to be employed for the quality control of these substances. In this work, we apply, for the first time, matrix-assisted laser desorption ionization-mass spectrometry as a fast, reproducible and sensitive method for the quality control of sport nutritional supplements based on proteins. To this aim, several commercial egg- and/or milk-based powder products have been processed by in gel or in solution digestion and analyzed in comparison to pure standard products. This strategy allowed to assess the reliability of the indications on proteins (as caseins, whey proteins and ovalbumin) declared in the label of several sport nutritional supplements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Protein Aggregation and Its Impact on Product Quality

PubMed Central

Roberts, Christopher J.

2014-01-01

Protein pharmaceutical products are typically active as folded monomers that are composed of one or more protein chains, such as the heavy and light chains in monoclonal antibodies that are a mainstay of current drug pipelines. There are numerous possible aggregated states for a given protein, some of which are potentially useful, while most of which are considered deleterious from the perspective of pharmaceutical product quality and performance. This review provides an overview of how and why different aggregated states of proteins occur, how this potentially impacts product quality and performance, fundamental approaches to control aggregate formation, and the practical approaches that are currently used in the pharmaceutical industry. PMID:25173826

The National Shipbuilding Research Program. Design for Production Manual 2nd Edition

DTIC Science & Technology

1999-07-01

New York, 1979 Montgomery, Douglas C., Introduction to Statistical Quality Control, 3rd Edition, John Wiley & Sons, New York, 1997 Ishikawa , Kaoru ...references: Feigenbaum, A.V., Total Quality Control: Engineering and Management, 3rd edition, New York McGraw Hill, 1983. Ishikawa , Kaouro., Guide to

Sequence verification as quality-control step for production of cDNA microarrays.

PubMed

Taylor, E; Cogdell, D; Coombes, K; Hu, L; Ramdas, L; Tabor, A; Hamilton, S; Zhang, W

2001-07-01

To generate cDNA arrays in our core laboratory, we amplified about 2300 PCR products from a human, sequence-verified cDNA clone library. As a quality-control step, we sequenced the PCR products immediately before printing. The sequence information was used to search the GenBank database to confirm the identities. Although these clones were previously sequence verified by the company, we found that only 79% of the clones matched the original database after handling. Our experience strongly indicates the necessity to sequence verify the clones at the final stage before printing on microarray slides and to modify the gene list accordingly.

Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

PubMed

Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

2013-02-01

Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

ENVIRONMENTAL ACCOUNTING: BALANCING ECONOMIC GROWTH AND ENVIRONMENTAL QUALITY

EPA Science Inventory

Modern industrial economies depend on the environment to support economic production and a high standard of living. Economic production, in turn, impacts the productivity of ecosystems through waste production and resource use or diversion. Human activities control many energy an...

Automatic Quality Inspection of Percussion Cap Mass Production by Means of 3D Machine Vision and Machine Learning Techniques

NASA Astrophysics Data System (ADS)

Tellaeche, A.; Arana, R.; Ibarguren, A.; Martínez-Otzeta, J. M.

The exhaustive quality control is becoming very important in the world's globalized market. One of these examples where quality control becomes critical is the percussion cap mass production. These elements must achieve a minimum tolerance deviation in their fabrication. This paper outlines a machine vision development using a 3D camera for the inspection of the whole production of percussion caps. This system presents multiple problems, such as metallic reflections in the percussion caps, high speed movement of the system and mechanical errors and irregularities in percussion cap placement. Due to these problems, it is impossible to solve the problem by traditional image processing methods, and hence, machine learning algorithms have been tested to provide a feasible classification of the possible errors present in the percussion caps.

A longitudinal study to identify the influence of quality of chronic care delivery on productive interactions between patients and (teams of) healthcare professionals within disease management programmes

PubMed Central

Cramm, Jane Murray; Nieboer, Anna Petra

2014-01-01

Objective The chronic care model is an increasingly used approach to improve the quality of care through system changes in care delivery. While theoretically these system changes are expected to increase productive patient–professional interaction empirical evidence is lacking. This study aims to identify the influence of quality of care on productive patient–professional interaction. Setting Longitudinal study in 18 Dutch regions. Participants Questionnaires were sent to all 5076 patients participating in 18 Disease Management Programmes (DMPs) in 2010 (2676 (53%) respondents). One year later (T1), 4693 patients still participating in the DMPs received a questionnaire (2191 (47%) respondents) and 2 years later (in 2012; T2) 1722 patients responded (out of 4350; 40% response). Interventions DMPs Primary outcome measure Patients’ perceptions of the productivity of interactions (measured as relational coordination/coproduction of care) with professionals. Patients were asked about communication dimensions (frequent, accurate, and problem-solving communication) and relationship dimensions (shared goals and mutual respect). Findings After controlling for background characteristics these results clearly show that quality of chronic care (T0), first-year changes in quality of chronic care (T1—T0) and second-year changes in quality of chronic care (T2—T1) predicted productive interactions between patients and professionals at T2 (all at p≤0.001). Furthermore, we found a negative relationship between lower educational level and productive interactions between patients and professionals 2 years later. Conclusions We can conclude that successfully dealing with the consequences of chronic illnesses requires proactive patients who are able to make productive decisions together with their healthcare providers. Since patients and professionals share responsibility for management of the chronic illness, they must also share control of interactions and decisions. The importance of patient-centeredness is growing and this study reports a first example of how quality of chronic care stimulates productive interactions between patients and professionals. PMID:25239294

Make no mistake—errors can be controlled*

PubMed Central

Hinckley, C

2003-01-01



 Traditional quality control methods identify "variation" as the enemy. However, the control of variation by itself can never achieve the remarkably low non-conformance rates of world class quality leaders. Because the control of variation does not achieve the highest levels of quality, an inordinate focus on these techniques obscures key quality improvement opportunities and results in unnecessary pain and suffering for patients, and embarrassment, litigation, and loss of revenue for healthcare providers. Recent experience has shown that mistakes are the most common cause of problems in health care as well as in other industrial environments. Excessive product and process complexity contributes to both excessive variation and unnecessary mistakes. The best methods for controlling variation, mistakes, and complexity are each a form of mistake proofing. Using these mistake proofing techniques, virtually every mistake and non-conformance can be controlled at a fraction of the cost of traditional quality control methods. PMID:14532368

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

Near-infrared Spectroscopy in the Brewing Industry.

PubMed

Sileoni, Valeria; Marconi, Ombretta; Perretti, Giuseppe

2015-01-01

This article offers an exhaustive description of the use of Near-Infrared (NIR) Spectroscopy in the brewing industry. This technique is widely used for quality control testing of raw materials, intermediates, and finished products, as well as process monitoring during malting and brewing. In particular, most of the reviewed works focus on the assessment of barley properties, aimed at quickly selecting the best barley varieties in order to produce a high-quality malt leading to high-quality beer. Various works concerning the use of NIR in the evaluation of raw materials, such as barley, malt, hop, and yeast, are also summarized here. The implementation of NIR sensors for the control of malting and brewing processes is also highlighted, as well as the use of NIR for quality assessment of the final product.

Higher body mass index and lower intake of dairy products predict poor glycaemic control among Type 2 Diabetes patients in Malaysia

PubMed Central

Shu, Ping Soon; Chan, Yoke Mun; Huang, Soo Lee

2017-01-01

This cross-sectional study was designed to determine factors contributing to glyceamic control in order to provide better understanding of diabetes management among Type 2 Diabetes patients. A pre-tested structured questionnaire was used to obtain information on socio-demographic and medical history. As a proxy measure for glycaemic control, glycosylated haemoglobin (HbA1c) was obtained as secondary data from the medical reports. Perceived self-care barrier on diabetes management, diet knowledge and skills, and diet quality were assessed using pretested instruments. With a response rate of 80.3%, 155 subjects were recruited for the study. Mean HbA1c level of the subjects was 9.02 ± 2.25% with more than 70% not able to achieve acceptable level in accordance to WHO recommendation. Diet quality of the subjects was unsatisfactory especially for vegetables, fruits, fish and legumes as well as from the milk and dairy products group. Higher body mass index (BMI), poorer medication compliance, lower diet knowledge and skill scores and lower intake of milk and dairy products contributed significantly on poor glycaemic control. In conclusion, while perceived self-care barriers and diet quality failed to predict HbA1c, good knowledge and skill ability, together with appropriate BMI and adequate intake of dairy products should be emphasized to optimize glycaemic control among type 2 diabetes patients. PMID:28234927

Higher body mass index and lower intake of dairy products predict poor glycaemic control among Type 2 Diabetes patients in Malaysia.

PubMed

Shu, Ping Soon; Chan, Yoke Mun; Huang, Soo Lee

2017-01-01

This cross-sectional study was designed to determine factors contributing to glyceamic control in order to provide better understanding of diabetes management among Type 2 Diabetes patients. A pre-tested structured questionnaire was used to obtain information on socio-demographic and medical history. As a proxy measure for glycaemic control, glycosylated haemoglobin (HbA1c) was obtained as secondary data from the medical reports. Perceived self-care barrier on diabetes management, diet knowledge and skills, and diet quality were assessed using pretested instruments. With a response rate of 80.3%, 155 subjects were recruited for the study. Mean HbA1c level of the subjects was 9.02 ± 2.25% with more than 70% not able to achieve acceptable level in accordance to WHO recommendation. Diet quality of the subjects was unsatisfactory especially for vegetables, fruits, fish and legumes as well as from the milk and dairy products group. Higher body mass index (BMI), poorer medication compliance, lower diet knowledge and skill scores and lower intake of milk and dairy products contributed significantly on poor glycaemic control. In conclusion, while perceived self-care barriers and diet quality failed to predict HbA1c, good knowledge and skill ability, together with appropriate BMI and adequate intake of dairy products should be emphasized to optimize glycaemic control among type 2 diabetes patients.

Statistical quality control through overall vibration analysis

NASA Astrophysics Data System (ADS)

Carnero, M. ^a. Carmen; González-Palma, Rafael; Almorza, David; Mayorga, Pedro; López-Escobar, Carlos

2010-05-01

The present study introduces the concept of statistical quality control in automotive wheel bearings manufacturing processes. Defects on products under analysis can have a direct influence on passengers' safety and comfort. At present, the use of vibration analysis on machine tools for quality control purposes is not very extensive in manufacturing facilities. Noise and vibration are common quality problems in bearings. These failure modes likely occur under certain operating conditions and do not require high vibration amplitudes but relate to certain vibration frequencies. The vibration frequencies are affected by the type of surface problems (chattering) of ball races that are generated through grinding processes. The purpose of this paper is to identify grinding process variables that affect the quality of bearings by using statistical principles in the field of machine tools. In addition, an evaluation of the quality results of the finished parts under different combinations of process variables is assessed. This paper intends to establish the foundations to predict the quality of the products through the analysis of self-induced vibrations during the contact between the grinding wheel and the parts. To achieve this goal, the overall self-induced vibration readings under different combinations of process variables are analysed using statistical tools. The analysis of data and design of experiments follows a classical approach, considering all potential interactions between variables. The analysis of data is conducted through analysis of variance (ANOVA) for data sets that meet normality and homoscedasticity criteria. This paper utilizes different statistical tools to support the conclusions such as chi squared, Shapiro-Wilks, symmetry, Kurtosis, Cochran, Hartlett, and Hartley and Krushal-Wallis. The analysis presented is the starting point to extend the use of predictive techniques (vibration analysis) for quality control. This paper demonstrates the existence of predictive variables (high-frequency vibration displacements) that are sensible to the processes setup and the quality of the products obtained. Based on the result of this overall vibration analysis, a second paper will analyse self-induced vibration spectrums in order to define limit vibration bands, controllable every cycle or connected to permanent vibration-monitoring systems able to adjust sensible process variables identified by ANOVA, once the vibration readings exceed established quality limits.

The NCC project: A quality management perspective

NASA Technical Reports Server (NTRS)

Lee, Raymond H.

1993-01-01

The Network Control Center (NCC) Project introduced the concept of total quality management (TQM) in mid-1990. The CSC project team established a program which focused on continuous process improvement in software development methodology and consistent deliveries of high quality software products for the NCC. The vision of the TQM program was to produce error free software. Specific goals were established to allow continuing assessment of the progress toward meeting the overall quality objectives. The total quality environment, now a part of the NCC Project culture, has become the foundation for continuous process improvement and has resulted in the consistent delivery of quality software products over the last three years.

TQM - Total Quality Management (Bibliography)

DTIC Science & Technology

1990-05-01

ISBN: 0-941893-00-6 Price: $27.00 NAVSWC Library Call No: TS156 S358 GUIDE TO OUALITY CONTROL Author: Ishikawa , Kaoru Publisher: Asian Productivity...teachings of Juran, Deming, Feigenbaum, Crosby, Taguchi, Shewhart, Ishikawa , and others. 19 OUT OF BEDLAM: MANAGEMENT BY QUALITY LEADERSHIP Author...Price: $60.00 WHAT IS TOTAL QUALITY CONTROL? THE JAPANESE WAY Author. Ishikawa , K oru Publisher: Prentice Hall Date: 1985 Pagination: 215pp ISBN: 0-13

Criteria for Assessing Quality in Academic Research: The Views of Biomedical Scientists, Clinical Scientists and Social Scientists

ERIC Educational Resources Information Center

Albert, Mathieu; Laberge, Suzanne; McGuire, Wendy

2012-01-01

This study empirically addresses the claim made by Gibbons et al ("The new production of knowledge: The dynamics of science and research in contemporary societies." Sage, Thousand Oaks, 1994) that a novel form of quality control (associated with Mode 2 knowledge production) is supplementing the "traditional" peer-review process…

76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

... chemical production and polytetrafluoroethylene operations; from paint, resin, and adhesive manufacturing... miscellaneous industrial adhesives control techniques guideline (CTG) category in accordance with the... to COMAR 26.11.19.30 ``Control of VOC from Chemical Production and Polytetrafluoroethylene Operations...

Understanding Emissions from Control-Related Equipment used in Oil and Gas Production Operations to Support EPA’s Air Quality Modeling of Ozone Non-attainment Areas

EPA Science Inventory

Oil and gas production has increased significantly in the United States over the past ten years. Improperly maintained and controlled oil and gas extraction and production (E&P) processes have the potential to emit significant amounts of pollutants that can impact human health an...

Commercial Probiotic Products: A Call for Improved Quality Control. A Position Paper by the ESPGHAN Working Group for Probiotics and Prebiotics.

PubMed

Kolaček, Sanja; Hojsak, Iva; Berni Canani, Roberto; Guarino, Alfredo; Indrio, Flavia; Orel, Rok; Pot, Bruno; Shamir, Raanan; Szajewska, Hania; Vandenplas, Yvan; van Goudoever, Johannes; Weizman, Zvi

2017-07-01

Probiotics have been proposed for a number of indications ranging from the hypothetical long-term immunomodulatory effects to proven benefits in the management of different clinical conditions.An increasing number of commercial products containing probiotics are available. In those products, irrespective if it is food, food supplement, medical food, or drug, the probiotic microorganisms have to be present in a sufficient number by the end of the shelf-life, to pass through the gastrointestinal tract resisting acid and bile, to colonize the gut, and to retain functional properties required to obtain the suggested beneficial effect. Finally, it should be contamination-free.Studies organized worldwide and summarized in this article have shown that inconsistencies and deviations from the information provided on the product label are surprisingly common. Frequently strains are misidentified and misclassified, products are occasionally contaminated, sometimes with even facultative or obligatory pathogens, strains are not viable, the labeled number of colonies cannot be verified, or the functional properties are diminished to the extent that preclude the proposed health benefit. As the probiotic preparations are commonly used for a wide range of conditions, the aim of the Working Group was to summarize results of the studies looking into the quality of the probiotic products and to raise the awareness of the important issue of their quality control.Based on the results obtained, we strongly suggest a more stringent quality control process. This process should ensure that the probiotic content as mentioned on the label meets the actual content throughout the shelf life of the product, while no contamination is present.

The Papers Printing Quality Complex Assessment Algorithm Development Taking into Account the Composition and Production Technological Features

NASA Astrophysics Data System (ADS)

Babakhanova, Kh A.; Varepo, L. G.; Nagornova, I. V.; Babluyk, E. B.; Kondratov, A. P.

2018-04-01

Paper is one of the printing system key components causing the high-quality printed products output. Providing the printing companies with the specified printing properties paper, while simultaneously increasing the paper products range and volume by means of the forecasting methods application and evaluation during the production process, is certainly a relevant problem. The paper presents the printing quality control algorithm taking into consideration the paper printing properties quality assessment depending on the manufacture technological features and composition variation. The information system including raw material and paper properties data and making possible pulp and paper enterprises to select paper composition optimal formulation is proposed taking into account the printing process procedure peculiarities of the paper manufacturing with specified printing properties.

CIDR

Science.gov Websites

quality, cutting-edge genomic services and technologies in order to expand our understanding of disease high quality next generation sequencing and genotyping services to investigators working to discover issues as they relate to study design, data production and quality control. Completed studies encompass

Information system of quality assessment for liquid and gaseous medium production

NASA Astrophysics Data System (ADS)

Bobrov, V. N.; Us, N. A.; Davidov, I. S.

2018-05-01

A method and a technical solution for controlling the quality of production of liquid and gaseous media is proposed. It is also proposed to monitor harmful factors in production while ensuring safe working conditions. Initially, using the mathematical model of an ideal atmosphere, the projection to the horizontal surface of the observation trajectory is calculated. At the second stage, the horizontal projection of the observation trajectory in real conditions is measured. The quality of the medium is judged by the difference between the projections of observation trajectories. The technical result is presented in the form of a device allowing obtaining information about the quality of the medium under investigation.

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... or other nationally recognized standards and use instruments accurate to at least one significant figure beyond the desired accuracy. (c) Control production documentation so that the product is...

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... or other nationally recognized standards and use instruments accurate to at least one significant figure beyond the desired accuracy. (c) Control production documentation so that the product is...

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... or other nationally recognized standards and use instruments accurate to at least one significant figure beyond the desired accuracy. (c) Control production documentation so that the product is...

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... or other nationally recognized standards and use instruments accurate to at least one significant figure beyond the desired accuracy. (c) Control production documentation so that the product is...

Long-term quality assurance of [(18)F]-fluorodeoxyglucose (FDG) manufacturing.

PubMed

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of (18)F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade "A" isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade "A" isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [(18)F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems.

Long-term quality assurance of [18F]-fluorodeoxyglucose (FDG) manufacturing

PubMed Central

Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

2016-01-01

Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of 18F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade “A” isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade “A” isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [18F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems. PMID:27508102

Synthesis and quality control of fluorodeoxyglucose and performance assessment of Siemens MicroFocus 220 small animal PET scanner

NASA Astrophysics Data System (ADS)

Phaterpekar, Siddhesh Nitin

The scope of this article is to cover the synthesis and quality control procedures involved in production of Fludeoxyglucose (18F--FDG). The article also describes the cyclotron production of 18F radioisotope and gives a brief overview on operations and working of a fixed energy medical cyclotron. The quality control procedures for FDG involve radiochemical and radionuclidic purity tests, pH tests, chemical purity tests, sterility tests, endotoxin tests. Each of these procedures were carried out for multiple batches of FDG with a passing rate of 95% among 20 batches. The article also covers the quality assurance steps for the Siemens MicroPET Focus 220 Scanner using a Jaszczak phantom. We have carried out spatial resolution tests on the scanner, with an average transaxial resolution of 1.775mm with 2-3mm offset. Tests involved detector efficiency, blank scan sinograms and transmission sinograms. A series of radioactivity distribution tests are also carried out on a uniform phantom, denoting the variations in radioactivity and uniformity by using cylindrical ROIs in the transverse region of the final image. The purpose of these quality control tests is to make sure the manufactured FDG is biocompatible with the human body. Quality assurance tests are carried on PET scanners for efficient performance, and to make sure the quality of images acquired is according to the radioactivity distribution in the subject of interest.

Using quality control to limit bismuth in copper cathodes

NASA Astrophysics Data System (ADS)

Serrano, John R.; Berger, Dennis; Bridges, Bill

1994-10-01

This article describes quality-control work at Phelps Dodge, undertaken as part of ISO 9003 certification, to better identify and prevent the contamination of copper cathodes by bismuth. It also overviews the implementation of a production control system as well as associated training designed to minimize the possibility of bismuth-contaminated copper progressing beyond the cathode stage to other areas of manufacturing or distribution.

Multipurpose electroslag remelting furnace for modern energy and heavy engineering industry

NASA Astrophysics Data System (ADS)

Dub, A. V.; Dub, V. S.; Kriger, Yu. N.; Levkov, L. Ya.; Shurygin, D. A.; Kissel'man, M. A.; Nekhamin, C. M.; Chernyak, A. I.; Bessonov, A. V.; Kamantsev, S. V.; Sokolov, S. O.

2012-12-01

In 2011, a unique complex based on a multipurpose unit-type electroslag remelting (ESR) furnace is created to meet the demand for large high-quality solid and hollow billets for the products of power, atomic, petrochemical, and heavy machine engineering. This complex has modern low-frequency power supplies with a new control level that ensure a high homogeneity and quality of the billets and an increase in the engineering-and-economical performance of the production. A unique pilot ESR furnace is erected to adjust technological conditions and the main control system elements.

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2013 CFR

2013-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2014 CFR

2014-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

40 CFR 85.1412 - Maintenance and submittal of records for equipment certifiers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... original equipment being replaced; (4) A description of the quality control plan used to monitor production... taken in implementing the quality control plan, and any subsequent analyses of that data; and (6) All in... the equipment certifier has offered to sell its certified equipment for less than the life cycle cost...

40 CFR 85.1412 - Maintenance and submittal of records for equipment certifiers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... original equipment being replaced; (4) A description of the quality control plan used to monitor production... taken in implementing the quality control plan, and any subsequent analyses of that data; and (6) All in... the equipment certifier has offered to sell its certified equipment for less than the life cycle cost...

21 CFR 111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve...

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR DIETARY SUPPLEMENTS Returned Dietary Supplements § 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing? (a) You must ensure that any returned dietary supplements that are reprocessed meet all product specifications established in accordance...

Citrus Quality Control: An NMR/MRI Problem-Based Experiment

ERIC Educational Resources Information Center

Erhart, Sarah E.; McCarrick, Robert M.; Lorigan, Gary A.; Yezierski, Ellen J.

2016-01-01

An experiment seated in an industrial context can provide an engaging framework and unique learning opportunity for an upper-division physical chemistry laboratory. An experiment that teaches NMR/MRI through a problem-based quality control of citrus products was developed. In this experiment, using a problem-based learning (PBL) approach, students…

Tools for Schools: Filtration for Improved Air Quality. Technical Services Bulletin.

ERIC Educational Resources Information Center

2001

This product bulletin addresses air pollution control in educational facilities to enhance educational performance, provides air quality recommendations for schools, and examines the filtration needs of various school areas. The types of air particles typically present are highlighted, and the use of proper filtration to control gases and vapors…

The impact of onsite workplace health-enhancing physical activity interventions on worker productivity: a systematic review.

PubMed

Pereira, Michelle Jessica; Coombes, Brooke Kaye; Comans, Tracy Anne; Johnston, Venerina

2015-06-01

The aim of this study is to investigate the effects of onsite workplace health-enhancing physical activity (HEPA) programmes on worker productivity. The PROSPERO registration number is CRD42014008750. A search for controlled trials or randomised controlled trials (RCTs) that investigated the effects of onsite workplace HEPA programmes on productivity levels of working adults was performed. Risk of bias of included studies was assessed, and the inter-rater reliability of the quality assessment was analysed. Qualitative synthesis of available evidence is presented. Eight studies were included in the review. There is consistent evidence that onsite workplace HEPA programmes do not reduce levels of sick leave. There appears to be inconsistent evidence of the impact of onsite workplace HEPA programmes on worker productivity. A high-quality study of an onsite combination (aerobic, strengthening and flexibility) HEPA regime and a moderate-quality study of a Tai Chi programme improved worker productivity measured with questionnaires in female laundry workers and older female nurses, respectively. Two high-quality studies and four moderate-quality studies did not show benefit. Studies that showed benefit were mainly those designed with productivity measures as primary outcomes, delivered to occupations involved with higher physical loads, and had higher compliance and programme intensity. The small number of studies and the lack of consistency among studies limited further analyses. There is inconsistent evidence that onsite workplace HEPA programmes improve self-reported worker productivity. Future high-quality RCTs of onsite workplace HEPA programmes should be designed around productivity outcomes, target at-risk groups and investigate interventions of sufficient intensity. High attendance with improved recording is needed to achieve significant results in augmenting worker productivity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Automated quality control in a file-based broadcasting workflow

NASA Astrophysics Data System (ADS)

Zhang, Lina

2014-04-01

Benefit from the development of information and internet technologies, television broadcasting is transforming from inefficient tape-based production and distribution to integrated file-based workflows. However, no matter how many changes have took place, successful broadcasting still depends on the ability to deliver a consistent high quality signal to the audiences. After the transition from tape to file, traditional methods of manual quality control (QC) become inadequate, subjective, and inefficient. Based on China Central Television's full file-based workflow in the new site, this paper introduces an automated quality control test system for accurate detection of hidden troubles in media contents. It discusses the system framework and workflow control when the automated QC is added. It puts forward a QC criterion and brings forth a QC software followed this criterion. It also does some experiments on QC speed by adopting parallel processing and distributed computing. The performance of the test system shows that the adoption of automated QC can make the production effective and efficient, and help the station to achieve a competitive advantage in the media market.

Automated Quality Control of in Situ Soil Moisture from the North American Soil Moisture Database Using NLDAS-2 Products

NASA Astrophysics Data System (ADS)

Ek, M. B.; Xia, Y.; Ford, T.; Wu, Y.; Quiring, S. M.

2015-12-01

The North American Soil Moisture Database (NASMD) was initiated in 2011 to provide support for developing climate forecasting tools, calibrating land surface models and validating satellite-derived soil moisture algorithms. The NASMD has collected data from over 30 soil moisture observation networks providing millions of in situ soil moisture observations in all 50 states as well as Canada and Mexico. It is recognized that the quality of measured soil moisture in NASMD is highly variable due to the diversity of climatological conditions, land cover, soil texture, and topographies of the stations and differences in measurement devices (e.g., sensors) and installation. It is also recognized that error, inaccuracy and imprecision in the data set can have significant impacts on practical operations and scientific studies. Therefore, developing an appropriate quality control procedure is essential to ensure the data is of the best quality. In this study, an automated quality control approach is developed using the North American Land Data Assimilation System phase 2 (NLDAS-2) Noah soil porosity, soil temperature, and fraction of liquid and total soil moisture to flag erroneous and/or spurious measurements. Overall results show that this approach is able to flag unreasonable values when the soil is partially frozen. A validation example using NLDAS-2 multiple model soil moisture products at the 20 cm soil layer showed that the quality control procedure had a significant positive impact in Alabama, North Carolina, and West Texas. It had a greater impact in colder regions, particularly during spring and autumn. Over 433 NASMD stations have been quality controlled using the methodology proposed in this study, and the algorithm will be implemented to control data quality from the other ~1,200 NASMD stations in the near future.

Chemistry and quality of Hibiscus (Hibiscus sabdariffa) for developing the natural-product industry in Senegal.

PubMed

Juliani, H R; Welch, C R; Wu, Q; Diouf, B; Malainy, D; Simon, J E

2009-03-01

The objectives of this study were to assess and improve the quality of the hibiscus calyces from Senegal over 2 production seasons (2004 to 2005), to develop and adapt new procedures for the determination of hibiscus anthocyanins and analysis of the 2 major ones, delphinidin-3-sambubioside and cyanidin-3-sambubioside. The foreign matter, total ashes, and acid insoluble ashes showed that the calyces harvested in 2005 were produced following hygienic practices, while the color assessment of the calyces and analysis of hibiscus active principles also showed higher amounts of anthocyanins in 2005. A protocol to measure anthocyanins by pH-differential UV-Vis spectrophotometry was adapted to measure the hibiscus anthocyanins from a water extract. The spectrophotometric method for quantitation of total anthocyanins showed a close correlation (r(2)= 0.82) when compared with the HPLC method, suggesting the use of the colorimetric method in quality control programs as an affordable alternative method to assess anthocyanin content in hibiscus. New and raised standards for the cleanliness and active principle content in hibiscus are also proposed. This study demonstrated that the implementation of a quality control program and the application of agricultural good practices in the production and processing of hibiscus calyces can lead to higher quality natural plant products.

Implementation of quality by design toward processing of food products.

PubMed

Rathore, Anurag S; Kapoor, Gautam

2017-05-28

Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

Lessons Learned on Quality (of) Standards

NASA Astrophysics Data System (ADS)

Gerlich, Rainer; Gerlich, Ralf

2011-08-01

Standards are used to describe and ensure the quality of products, services and processes throughout almost all branches of industry, including the field of software engineering. Contractors and suppliers are obligated by their customers and certification authorities to follow a certain set of standards during development. For example, a customer can easier actively participate in and control the contractor's process when enforcing a standard process..However, as with any requirement, a standard may also impede the contractor or supplier in assuring actual quality of the product in the sense of fitness for the purpose intended by the customer.This is the case when a standard defines specific quality assurance activities requiring a considerable amount of effort while other more efficient but equivalent or even superior approaches are blocked. Then improvement of the ratio between cost and quality exceeding miniscule advances is heavily impeded.While in some parts being too specific in defining the mechanisms of the enforced process, standards are sometimes too weak in defining the principles or goals on control of product quality.Therefore this paper addresses the following issues: (1) Which conclusions can be drawn on the quality and efficiency of a standard? (2) If and how is it possible to improve or evolve a standard? (3) How well does a standard guide a user towards high quality of the end product?One conclusion is that the analyzed standards do interfere with technological innovation, though the standards leave a lot of freedom for concretization and are understood as technology-independent.Another conclusion is that standards are not only a matter of quality but also a matter of competitiveness of the industry depending on resulting costs and time-to- market. When the costs induced by a standard are not adequate to the achievable quality, industry encounters a significant disadvantage.

Effects of NaCl Replacement with Gamma-Aminobutyric acid (GABA) on the Quality Characteristics and Sensorial Properties of Model Meat Products

PubMed Central

Chun, Ji-Yeon; Cho, Hyung-Yong; Min, Sang-Gi

2014-01-01

This study investigated the effects of γ-aminobutylic acid (GABA) on the quality and sensorial properties of both the GABA/NaCl complex and model meat products. GABA/NaCl complex was prepared by spray-drying, and the surface dimensions, morphology, rheology, and saltiness were characterized. For model meat products, pork patties were prepared by replacing NaCl with GABA. For characteristics of the complex, increasing GABA concentration increased the surface dimensions of the complex. However, GABA did not affect the rheological properties of solutions containing the complex. The addition of 2% GABA exhibited significantly higher saltiness than the control (no GABA treatment). In the case of pork patties, sensory testing indicated that the addition of GABA decreased the saltiness intensity. Both the intensity of juiciness and tenderness of patties containing GABA also scored lower than the control, based on the NaCl reduction. These results were consistent with the quality characteristics (cooking loss and texture profile analysis). Nevertheless, overall acceptability of the pork patties showed that up to 1.5%, patties containing GABA did not significantly differ from the control. Consequently, the results indicated that GABA has a potential application in meat products, but also manifested a deterioration of quality by the NaCl reduction, which warrants further exploration. PMID:26761294

Influence of Wheat-Milled Products and Their Additive Blends on Pasta Dough Rheological, Microstructure, and Product Quality Characteristics

PubMed Central

Dhiraj, B.; Prabhasankar, P.

2013-01-01

This study is aimed to assess the suitability of T. aestivum wheat milled products and its combinations with T. durum semolina with additives such as ascorbic acid, vital gluten and HPMC (Hydroxypropyl methyl cellulose) for pasta processing quality characteristics such as pasta dough rheology, microstructure, cooking quality, and sensory evaluation. Rheological studies showed maximum dough stability in Comb1 (T. aestivum wheat flour and semolina). Colour and cooking quality of Comb2 (T. durum semolina and T. aestivum wheat flour) and Comb3 (T. aestivum wheat semolina and T. durum semolina) were comparable with control. Pasting results indicated that T. aestivum semolina gave the lowest onset gelatinization temperature (66.9°C) but the highest peak viscosity (1.053 BU). Starch release was maximum in Comb1 (53.45%) when compared with control (44.9%) as also proved by microstructure studies. Firmness was seen to be slightly high in Comb3 (2.430 N) when compared with control (2.304 N), and sensory evaluations were also in the acceptable range for the same. The present study concludes that Comb3 comprising 50% T. durum semolina and 50% T. aestivum refined wheat flour with additives would be optimal alternate for 100% T. durum semolina for production of financially viable pasta. PMID:26904601

Sleep, health-related quality of life, and functional outcomes in adults with diabetes.

PubMed

Chasens, Eileen R; Sereika, Susan M; Burke, Lora E; Strollo, Patrick J; Korytkowski, Mary

2014-11-01

This study explored the association of sleep quality with physical and mental health-related quality of life (HRQoL) and functional outcomes in 116 participants with type 2 diabetes. The study is a secondary analysis of baseline data from a clinical trial that examined treatment of obstructive sleep apnea on physical activity and glucose control. Instruments included the Pittsburgh Sleep Quality Index, Medical Outcomes Short-Form Physical Component and Mental Component Scores, and Functional Outcomes of Sleep Questionnaire. Higher physical HRQoL was significantly associated with better sleep quality and improved functional outcomes of increased activity and productivity. Higher mental HRQoL was associated with improved sleep quality and improved functional outcomes of increased activity, social interactions, vigilance, and productivity. Poor sleep quality was a predictor of decreased functional outcomes while controlling for age, race, education, BMI, marital status and physical and mental HRQoL. Poor sleep quality is associated with negative physical, mental, and functional outcomes in adults with type 2 diabetes. Copyright © 2014 Elsevier Inc. All rights reserved.

Automation of testing modules of controller ELSY-ТМК

NASA Astrophysics Data System (ADS)

Dolotov, A. E.; Dolotova, R. G.; Petuhov, D. V.; Potapova, A. P.

2017-01-01

In modern life, there are means for automation of various processes which allow one to provide high quality standards of released products and to raise labour efficiency. In the given paper, the data on the automation of the test process of the ELSY-TMK controller [1] is presented. The ELSY-TMK programmed logic controller is an effective modular platform for construction of automation systems for small and average branches of industrial production. The modern and functional standard of communication and open environment of the logic controller give a powerful tool of wide spectrum applications for industrial automation. The algorithm allows one to test controller modules by operating the switching system and external devices faster and at a higher level of quality than a human without such means does.

Honeywell Technical Order Transfer Tests.

DTIC Science & Technology

1987-06-12

of simple corrections, a reasonable reproduction of the original could be generated. The quality was not good enough for a production environment. Lack of automated quality control (AQC) tools could account for the errors.

Assessment of the iodine concentration in table salt at the production stage in South Africa.

PubMed Central

Jooste, Pieter L.

2003-01-01

OBJECTIVE: To determine the iodine content of iodized salt at the production stage, to assess the perceptions and knowledge of salt producers about the prevention and control of iodine deficiency, and to examine the internal quality control procedures used during iodization in South Africa. METHOD: Salt samples were collected for iodine analysis by titration from the 12 producers iodizing salt in South Africa. Information on the producers' knowledge of iodine deficiency disorders and on internal quality control was obtained by means of questionnaires. FINDINGS: The legal requirement of 40-60 ppm iodine was met in 30.9% of salt samples; 57.9% contained more than 30 ppm iodine; 34.8% contained under 20 ppm iodine. There were shortcomings in perceptions and knowledge about iodine deficiency disorders and in the internal quality control procedures of a substantial proportion of the producers. CONCLUSION: In order to encourage and support salt producers to achieve optimal iodization there should be an information, education and communication strategy aimed at improving knowledge of iodine deficiency disorders and at raising the standard of internal quality control procedures. External monitoring should continue. PMID:12973644

The National Shipbuilding Research Program, Analytical Quality Circles

DTIC Science & Technology

1986-09-01

standard tools for quality control, in English, see “Guide to Quality Control” by Dr. Kaoru Ishikawa , Asian Productivity Organization, Aoyama Dai-ichi...factors affect work evaluation is shown schemati- cally by Characteristic-Factor Diagrams (also called Fishbone or Ishikawa Diagrams), see Figure 2-5

Prospective change control analysis of transfer of platelet concentrate production from a specialized stem cell transplantation unit to a blood transfusion center.

PubMed

Sigle, Joerg-Peter; Medinger, Michael; Stern, Martin; Infanti, Laura; Heim, Dominik; Halter, Joerg; Gratwohl, Alois; Buser, Andreas

2012-01-01

Specialized centers claim a need for blood component production independent from the general blood transfusion services. We performed a prospective change control analysis of the transfer of platelet (PLT) production for hematological patients at the University Hospital Basel from the Department of Hematology to the Blood Transfusion Centre, Swiss Red Cross, Basel in February 2006. We wanted to demonstrate that neither quality nor transfusion outcome was affected. Production quantity and efficiency, product quality and transfusion outcome were systematically recorded. A 2-year pretransfer period was compared to a 2 year post-transfer period. After transfer production quantity at the Blood Transfusion Centre increased from 4,483 to 6,190 PLT concentrates. Production efficiency increased with a significant decrease in the rate of expired products (18% vs. 8%; P < 0.001). Product quality showed a slight decrease in median PLT count per unit (2.84 vs. 2.75 × 10(11); P < 0.001) and a slight increase in mean storage time prior to transfusion (3.18 vs. 3.30 days; P < 0.001). Transfusion outcome measured as median corrected count increment one hour post-transfusion (10.5 vs. 10.7; P = 0.3) and the rate of patients with inadequate post-transfusion increment (31.5% vs. 32.1%; P = 0.6) did not differ. Supply and quality of PLT products was maintained after the transfer of PLT production to the Blood Transfusion Centre. An optimization of the supply chain process with markedly decreased expiration rates was achieved. These results argue against the need of specialized PLT production sites for selected patient groups. Copyright © 2012 Wiley Periodicals, Inc.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

PubMed

Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

2016-11-01

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

MapReduce Based Parallel Bayesian Network for Manufacturing Quality Control

NASA Astrophysics Data System (ADS)

Zheng, Mao-Kuan; Ming, Xin-Guo; Zhang, Xian-Yu; Li, Guo-Ming

2017-09-01

Increasing complexity of industrial products and manufacturing processes have challenged conventional statistics based quality management approaches in the circumstances of dynamic production. A Bayesian network and big data analytics integrated approach for manufacturing process quality analysis and control is proposed. Based on Hadoop distributed architecture and MapReduce parallel computing model, big volume and variety quality related data generated during the manufacturing process could be dealt with. Artificial intelligent algorithms, including Bayesian network learning, classification and reasoning, are embedded into the Reduce process. Relying on the ability of the Bayesian network in dealing with dynamic and uncertain problem and the parallel computing power of MapReduce, Bayesian network of impact factors on quality are built based on prior probability distribution and modified with posterior probability distribution. A case study on hull segment manufacturing precision management for ship and offshore platform building shows that computing speed accelerates almost directly proportionally to the increase of computing nodes. It is also proved that the proposed model is feasible for locating and reasoning of root causes, forecasting of manufacturing outcome, and intelligent decision for precision problem solving. The integration of bigdata analytics and BN method offers a whole new perspective in manufacturing quality control.

Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody.

PubMed

Agarabi, Cyrus D; Schiel, John E; Lute, Scott C; Chavez, Brittany K; Boyne, Michael T; Brorson, Kurt A; Khan, Mansoora; Read, Erik K

2015-06-01

Consistent high-quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex and not optimized, small changes in composition and control may yield a finished product of less desirable quality. Therefore, changes proposed to currently validated processes usually require justification and are reported to the US FDA for approval. Recently, design-of-experiments-based approaches have been explored to rapidly and efficiently achieve this goal of optimized yield with a better understanding of product and process variables that affect a product's critical quality attributes. Here, we present a laboratory-scale model culture where we apply a Plackett-Burman screening design to parallel cultures to study the main effects of 11 process variables. This exercise allowed us to determine the relative importance of these variables and identify the most important factors to be further optimized in order to control both desirable and undesirable glycan profiles. We found engineering changes relating to culture temperature and nonessential amino acid supplementation significantly impacted glycan profiles associated with fucosylation, β-galactosylation, and sialylation. All of these are important for monoclonal antibody product quality. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Engineering Quality Software: 10 Recommendations for Improved Software Quality Management

DTIC Science & Technology

2010-04-27

lack of user involvement • Inadequate Software Process Management & Control By Contractors • No “Team” of Vendors and users; little SME participation...1990 Quality Perspectives • Process Quality ( CMMI ) • Product Quality (ISO/IEC 2500x) – Internal Quality Attributes – External Quality Attributes... CMMI /ISO 9000 Assessments – Capture organizational knowledge • Identify best practices, lessons learned Know where you are, and where you need to be

[Introduction of hazard analysis and critical control points (HACCP) principles at the flight catering food production plant].

PubMed

Popova, A Yu; Trukhina, G M; Mikailova, O M

In the article there is considered the quality control and safety system implemented in the one of the largest flight catering food production plant for airline passengers and flying squad. The system for the control was based on the Hazard Analysis And Critical Control Points (HACCP) principles and developed hygienic and antiepidemic measures. There is considered the identification of hazard factors at stages of the technical process. There are presented results of the analysis data of monitoring for 6 critical control points over the five-year period. The quality control and safety system permit to decline food contamination risk during acceptance, preparation and supplying of in-flight meal. There was proved the efficiency of the implemented system. There are determined further ways of harmonization and implementation for HACCP principles in the plant.

Demonstrating PQS Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

PubMed

Ramnarine, Emma; O'Donnell, Kevin

2018-04-18

Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. Regulatory relief and flexibility in post approval change management and overall product lifecycle management will only be possible with effective application of science and risk-based concepts and demonstrated effectiveness of the PQS in assuring a state of control. Copyright © 2018, Parenteral Drug Association.

GEOSPATIAL QA

EPA Science Inventory

Geospatial Science is increasingly becoming an important tool in making Agency decisions. Quality Control and Quality Assurance are required to be integrated during the planning, implementation and assessment of geospatial databases, processes and products. In order to ensure Age...

Productive performance, egg quality, and hatching traits of Japanese quail reared under different levels of glycerin.

PubMed

Ghayas, A; Hussain, J; Mahmud, A; Javed, K; Rehman, A; Ahmad, S; Mehmood, S; Usman, M; Ishaq, H M

2017-07-01

This study evaluated subsequent effects of glycerin on productive performance, egg quality, and hatching traits in Japanese quail. A total of 200 birds was arranged according to a completely randomized design into 5 treatment groups having 5 replicates of 8 birds each (6 females and 2 males). Treatments consisted 5 levels of glycerin, i.e., 2.5, 5, 7.5, and 10% and the control group. Birds were fed with different levels of glycerin during a rearing period of 6 wk and their subsequent effects on productive performance, egg quality, and hatching traits were observed. Data were collected regarding productive performance for 16 wk; however, egg quality and hatching traits were recorded during pre-peak (at fourth wk), peak (at 12th wk), and post peak (at 16th wk) phase. Productive performance, egg quality, and hatching traits did not differ significantly throughout the experimental period. It was concluded that glycerin can be used as a replacement energy source, having no effect on productive and reproductive performance in Japanese quail. © 2017 Poultry Science Association Inc.

Quality control in the development of coagulation factor concentrates.

PubMed

Snape, T J

1987-01-01

Limitation of process change is a major factor contributing to assurance of quality in pharmaceutical manufacturing. This is particularly true in the manufacture of coagulation factor concentrates, for which presumptive testing for poorly defined product characteristics is an integral feature of finished product quality control. The development of new or modified preparations requires that this comfortable position be abandoned, and that the effect on finished product characteristics of changes to individual process steps (and components) be assessed. The degree of confidence in the safety and efficacy of the new product will be determined by, amongst other things, the complexity of the process alteration and the extent to which the results of finished product tests can be considered predictive. The introduction of a heat-treatment step for inactivation of potential viral contaminants in coagulation factor concentrates presents a significant challenge in both respects, quite independent of any consideration of assessment of the effectiveness of the viral inactivation step. These interactions are illustrated by some of the problems encountered with terminal dry heat-treatment (72 h. at 80 degrees C) of factor VIII and prothrombin complex concentrates manufactured by the Blood Products Laboratory.

Validation of high-quality potato seed production protocol under controlled conditions (CETS System) in cultivated potato species (Solanum tuberosum L.)

USDA-ARS?s Scientific Manuscript database

Low potato yield in Peru and other countries in the region are attributed to the use of low quality seeds and tuber recycling. Therefore, there is consensus on the need of incorporating seed production technologies that are effective and efficient but also consistent with the reality of potato in La...

Advanced manufacturing development of a composite empennage component for L-1011 aircraft

NASA Technical Reports Server (NTRS)

Alva, T.; Henkel, J.; Johnson, R.; Carll, B.; Jackson, A.; Mosesian, B.; Brozovic, R.; Obrien, R.; Eudaily, R.

1982-01-01

This is the final report of technical work conducted during the fourth phase of a multiphase program having the objective of the design, development and flight evaluation of an advanced composite empennage component manufactured in a production environment at a cost competitive with those of its metal counterpart, and at a weight savings of at least 20 percent. The empennage component selected for this program is the vertical fin box of the L-1011 aircraft. The box structure extends from the fuselage production joint to the tip rib and includes front and rear spars. During Phase 4 of the program, production quality tooling was designed and manufactured to produce three sets of covers, ribs, spars, miscellaneous parts, and subassemblies to assemble three complete ACVF units. Recurring and nonrecurring cost data were compiled and documented in the updated producibility/design to cost plan. Nondestruct inspections, quality control tests, and quality acceptance tests were performed in accordance with the quality assurance plan and the structural integrity control plan. Records were maintained to provide traceability of material and parts throughout the manufacturing development phase. It was also determined that additional tooling would not be required to support the current and projected L-1011 production rate.

[Research progress of Terahertz wave technology in quality measurement of food and agricultural products].

PubMed

Yan, Zhan-Ke; Zhang, Hong-Jian; Ying, Yi-Bin

2007-11-01

The quality concern of food and agricultural products has become more and more significant. The related technologies for nondestructive measurement or quality control of food products have been the focus of many researches. Terahertz (THz) radiation, or THz wave, the least explored region of the spectrum, is the electromagnetic wave that lies between mid-infrared and microwave radiation, which has very important research and application values. THz spectroscopy and THz imaging technique are the two main applications of THz wave. During the past decade, THz waves have been used to characterize the electronic, vibrational and compositional properties of solid, liquid and gas phase materials. Recently, THz technology has gained a lot of attention of researchers in various fields from biological spectral analysis to bio-medical imaging due to its unique features compared with microwave and optical waves. In the present paper, the properties of THz wave and its uniqueness in sensing and imaging applications were discussed. The most recent researches on THz technology used in food quality control and agricultural products inspection were summarized. The prospect of this novel technology in agriculture and food industry was also discussed.

Design and development of a LabVIEW-based LED-induced fluorescence spectroscopy system with applications in non-destructive quality assessment of agricultural products

NASA Astrophysics Data System (ADS)

Abbasi, Hamed; Nazeri, Majid; Mireei, Seyed Ahmad

2016-01-01

Over the past several years, the demand for high quality agricultural products has been remarkably increased. Thus, it is important to use non-destructive methods for product quality monitoring. LED-induced fluorescence spectroscopy has proved its potential for nondestructive detection of some defects in agricultural products, such as tissue browning and bruising. Due to such defects, changes in the polyphenol and chlorophyll contents occur which can be considered as the visible marks of decreasing fruit quality. In the present work, a fluorescence spectrometer (spectrofluorometer) controlled by LabVIEW software was designed and developed. In this spectrometer, a consumer-grade webcam was used as an imaging sensor. The spectrometer was able to measure the fluorescence spectra directly from the fruit and vegetable surface in the desired regions. To do so, the spectrometer was equipped with a suitable fiber-optic probe. The hardware solution was based on data acquisition working on the USB platform and controlled by the application running on the PC. In this system, light emitting diodes with different wavelengths were used as the excitation sources for inducing fluorescence spectra of some famous fruits and vegetables.

Quality monitoring of salt produced in Indonesia through seawater evaporation on HDPE geomembrane lined ponds

NASA Astrophysics Data System (ADS)

Jumaeri; Sulistyaningsih, T.; Alighiri, D.

2018-03-01

Salt is one of the primary ingredients that humans always need for various purposes, both for consumption and industry. The need for high-quality salt continues to increase, as long as industry growth. It must improve product quality through the development of salt production process technology. In this research, the quality monitoring of salt produced in Indonesia by evaporation of seawater on ponds lined using high-density polyethylene (HDPE) geomembrane has been studied. The manufacturing of salt carried out through the gradual precipitation principle on prepared ponds. HDPE geomembrane is used to coat evaporation ponds with viscosity 12-22°Be and crystallization ponds with a viscosity of 23°Be. The monitoring of the product is carried out in the particular periods during the salt production period. The result of control shows that the quality of salt produced in HDPE geomembrane coated salt ponds has an average NaCl content of 95.75%, so it has fulfilled with Indonesia National Standard (SNI), that is NaCl> 94.70%. The production of salt with HDPE geomembrane can improve the quality of salt product from NaCl 85.4% (conventional system) to 95.75%.

Nutritional value of milk and meat products derived from cloning.

PubMed

Tomé, Daniel; Dubarry, Michel; Fromentin, Gilles

2004-01-01

The development and use of milk and meat products derived from cloning depends on their safety and on the nutritional advantages they can confer to the products as perceived by consumers. The development of such products thus implies (i) to demonstrate their safety and security, (ii) to show that their nutritional value is equivalent to the traditional products, and (iii) to identify the conditions under which cloning could allow additional nutritional and health benefit in comparison to traditional products for the consumers. Both milk and meat products are a source of high quality protein as determined from their protein content and essential amino acid profile. Milk is a source of calcium, phosphorus, zinc, magnesium and vitamin B2 and B12. Meat is a source of iron, zinc and vitamin B12. An important issue regarding the nutritional quality of meat and milk is the level and quality of fat which usually present a high content in saturated fat and some modification of the fat fraction could improve the nutritional quality of the products. The role of the dietary proteins as potential allergens has to be taken into account and an important aspect regarding this question is to evaluate whether the cloning does not produce the appearance of novel allergenic structures. The presence of bio-activities associated to specific components of milk (lactoferrin, immunoglobulins, growth factors, anti-microbial components) also represents a promising development. Preliminary results obtained in rats fed cow's milk or meat-based diets prepared from control animals or from animals derived from cloning did not show any difference between control and cloning-derived products.

Comparative study of quality and efficacy of originator's and generic ABZ for the mass treatment of soil-transmitted nematode infections in Nepal

PubMed Central

Albonico, Marco; Mathema P., Pragya; Montresor, Antonio; Khakurel, Balkrishna; Reggi, Valerio; Pandey, Sharada; Savioli, Lorenzo

2017-01-01

Quality and efficacy of two locally-manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for de-worming children in Nepal since 1999 were tested against the originator product (GSK). The study conducted disintegration and dissolution testing and a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides GSK's (97.0%) and Royal Drug's (95.0 %) product provided significantly higher CR than Curex's (82.6%); however, all products provided ERR higher than 90%. For T. trichiura Curex's product showed significantly lower ERR (63.2%). For hookworm, GSK's product performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug's (CR 53.3%, ERR 80.8%) and Curex's (CR 50.7%, ERR 73.1%). Only GSK's product passed both disintegration and dissolution. Both generic products failed dissolution. Curex's product showed poor disintegration. Despite its lower efficacy the cheaper Curex's product achieved good results in controlling morbidity due to soil-transmitted helminth (STH) infections. This study shows that cost-effectiveness of drugs used in mass de-worming campaigns should not be inferred on the basis of one single quality testing parameter. PMID:17129592

Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.

PubMed

Orwa, J A; Keter, L K; Ouko, S P A; Kibwage, I O; Rukunga, G M

2004-06-01

To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Cross-sectional study. Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.

Impact of air pollution control costs on the cost and spatial arrangement of cellulosic biofuel production in the U.S.

PubMed

Murphy, Colin W; Parker, Nathan C

2014-02-18

Air pollution emissions regulation can affect the location, size, and technology choice of potential biofuel production facilities. Difficulty in obtaining air pollutant emission permits and the cost of air pollution control devices have been cited by some fuel producers as barriers to development. This paper expands on the Geospatial Bioenergy Systems Model (GBSM) to evaluate the effect of air pollution control costs on the availability, cost, and distribution of U.S. biofuel production by subjecting potential facility locations within U.S. Clean Air Act nonattainment areas, which exceed thresholds for healthy air quality, to additional costs. This paper compares three scenarios: one with air quality costs included, one without air quality costs, and one in which conversion facilities were prohibited in Clean Air Act nonattainment areas. While air quality regulation may substantially affect local decisions regarding siting or technology choices, their effect on the system as a whole is small. Most biofuel facilities are expected to be sited near to feedstock supplies, which are seldom in nonattainment areas. The average cost per unit of produced energy is less than 1% higher in the scenarios with air quality compliance costs than in scenarios without such costs. When facility construction is prohibited in nonattainment areas, the costs increase by slightly over 1%, due to increases in the distance feedstock is transported to facilities in attainment areas.

Quality control in the recycling stream of PVC from window frames by hyperspectral imaging

NASA Astrophysics Data System (ADS)

Luciani, Valentina; Serranti, Silvia; Bonifazi, Giuseppe; Di Maio, Francesco; Rem, Peter

2013-05-01

Polyvinyl chloride (PVC) is one of the most commonly used thermoplastic materials in respect to the worldwide polymer consumption. PVC is mainly used in the building and construction sector, products such as pipes, window frames, cable insulation, floors, coverings, roofing sheets, etc. are realised utilising this material. In recent years, the problem of PVC waste disposal gained increasing importance in the public discussion. The quantity of used PVC items entering the waste stream is gradually increased as progressively greater numbers of PVC products approach to the end of their useful economic lives. The quality of the recycled PVC depends on the characteristics of the recycling process and the quality of the input waste. Not all PVC-containing waste streams have the same economic value. A transparent relation between value and composition is required to decide if the recycling process is cost effective for a particular waste stream. An objective and reliable quality control technique is needed in the recycling industry for the monitoring of both recycled flow streams and final products in the plant. In this work hyperspectral imaging technique in the near infrared (NIR) range (1000-1700 nm) was applied to identify unwanted plastic contaminants and rubber present in PVC coming from windows frame waste in order to assess a quality control procedure during its recycling process. Results showed as PVC, PE and rubber can be identified adopting the NIR-HSI approach.

Use of a small molecule cell cycle inhibitor to control cell growth and improve specific productivity and product quality of recombinant proteins in CHO cell cultures.

PubMed

Du, Zhimei; Treiber, David; McCarter, John D; Fomina-Yadlin, Dina; Saleem, Ramsey A; McCoy, Rebecca E; Zhang, Yuling; Tharmalingam, Tharmala; Leith, Matthew; Follstad, Brian D; Dell, Brad; Grisim, Brent; Zupke, Craig; Heath, Carole; Morris, Arvia E; Reddy, Pranhitha

2015-01-01

The continued need to improve therapeutic recombinant protein productivity has led to ongoing assessment of appropriate strategies in the biopharmaceutical industry to establish robust processes with optimized critical variables, that is, viable cell density (VCD) and specific productivity (product per cell, qP). Even though high VCD is a positive factor for titer, uncontrolled proliferation beyond a certain cell mass is also undesirable. To enable efficient process development to achieve consistent and predictable growth arrest while maintaining VCD, as well as improving qP, without negative impacts on product quality from clone to clone, we identified an approach that directly targets the cell cycle G1-checkpoint by selectively inhibiting the function of cyclin dependent kinases (CDK) 4/6 with a small molecule compound. Results from studies on multiple recombinant Chinese hamster ovary (CHO) cell lines demonstrate that the selective inhibitor can mediate a complete and sustained G0/G1 arrest without impacting G2/M phase. Cell proliferation is consistently and rapidly controlled in all recombinant cell lines at one concentration of this inhibitor throughout the production processes with specific productivities increased up to 110 pg/cell/day. Additionally, the product quality attributes of the mAb, with regard to high molecular weight (HMW) and glycan profile, are not negatively impacted. In fact, high mannose is decreased after treatment, which is in contrast to other established growth control methods such as reducing culture temperature. Microarray analysis showed major differences in expression of regulatory genes of the glycosylation and cell cycle signaling pathways between these different growth control methods. Overall, our observations showed that cell cycle arrest by directly targeting CDK4/6 using selective inhibitor compound can be utilized consistently and rapidly to optimize process parameters, such as cell growth, qP, and glycosylation profile in recombinant antibody production cultures. © 2014 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

Modified Atmosphere Systems and Shelf Life Extension of Fish and Fishery Products

PubMed Central

DeWitt, Christina A. Mireles; Oliveira, Alexandra C.M.

2016-01-01

This review aims at summarizing the findings of studies published over the past 15 years on the application of modified atmosphere (MA) systems for shelf life extension of fish and fishery products. This review highlights the importance of CO2 in the preservation of seafood products, and underscores the benefits of combining MA technology with product storage in the superchilled temperature range. It is generally accepted that MA technology cannot improve product quality and should not be utilized as a substitute for good sanitation and strict temperature control. Benefits derived from application of MA, however, can significantly impact preservation of product quality and it subsequent shelf-life. For this reason, this review is the first of its kind to propose detailed handling and quality guidelines for fresh fish to realize the maximum benefit of MA technology. PMID:28231143

A new hyperspectral imaging based device for quality control in plastic recycling

NASA Astrophysics Data System (ADS)

Bonifazi, G.; D'Agostini, M.; Dall'Ava, A.; Serranti, S.; Turioni, F.

2013-05-01

The quality control of contamination level in the recycled plastics stream has been identified as an important key factor for increasing the value of the recycled material by both plastic recycling and compounder industries. Existing quality control methods for the detection of both plastics and non-plastics contaminants in the plastic waste streams at different stages of the industrial process (e.g. feed, intermediate and final products) are currently based on the manual collection from the stream of a sample and on the subsequent off-line laboratory analyses. The results of such analyses are usually available after some hours, or sometimes even some days, after the material has been processed. The laboratory analyses are time-consuming and expensive (both in terms of equipment cost and their maintenance and of labour cost).Therefore, a fast on-line assessment to monitor the plastic waste feed streams and to characterize the composition of the different plastic products, is fundamental to increase the value of secondary plastics. The paper is finalized to describe and evaluate the development of an HSI-based device and of the related software architectures and processing algorithms for quality assessment of plastics in recycling plants, with particular reference to polyolefins (PO). NIR-HSI sensing devices coupled with multivariate data analysis methods was demonstrated as an objective, rapid and non-destructive technique that can be used for on-line quality and process control in the recycling process of POs. In particular, the adoption of the previous mentioned HD&SW integrated architectures can provide a solution to one of the major problems of the recycling industry, which is the lack of an accurate quality certification of materials obtained by recycling processes. These results could therefore assist in developing strategies to certify the composition of recycled PO products.

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2010 CFR

2010-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

16 CFR 1000.29 - Directorate for Engineering Sciences.

Code of Federal Regulations, 2012 CFR

2012-01-01

... standards, product safety tests and test methods, performance criteria, design specifications, and quality control standards for consumer products, based on engineering and scientific methods. It conducts... consumer interest groups. The Directorate conducts human factors studies and research of consumer product...

Design requirements for SRB production control system. Volume 3: Package evaluation, modification and hardware

NASA Technical Reports Server (NTRS)

1981-01-01

The software package evaluation was designed to analyze commercially available, field-proven, production control or manufacturing resource planning management technology and software package. The analysis was conducted by comparing SRB production control software requirements and conceptual system design to software package capabilities. The methodology of evaluation and the findings at each stage of evaluation are described. Topics covered include: vendor listing; request for information (RFI) document; RFI response rate and quality; RFI evaluation process; and capabilities versus requirements.

Comparison of predictive control methods for high consumption industrial furnace.

PubMed

Stojanovski, Goran; Stankovski, Mile

2013-01-01

We describe several predictive control approaches for high consumption industrial furnace control. These furnaces are major consumers in production industries, and reducing their fuel consumption and optimizing the quality of the products is one of the most important engineer tasks. In order to demonstrate the benefits from implementation of the advanced predictive control algorithms, we have compared several major criteria for furnace control. On the basis of the analysis, some important conclusions have been drawn.

Microalgae Nutraceuticals.

PubMed

Nicoletti, Marcello

2016-08-22

Among the new entries in the food supplements sector, an important place must be assigned to nutraceuticals containing microalgae, nowadays accounting for a large and rapidly expanding market. The marketed products are mainly based on three production strains, i.e., Spirulina and Chlorella, followed at a distance by Klamath. It is a composite situation, since two of them are cyanobacteria and the second one is eukaryotic. The reality is that each presents similarities in shape and appearance concerning the marketed form and several utilizations, and peculiarities that need special attention and adequate studies. First, general information is reported about the current scientific knowledge on each microalga, in particular the nutritional value and properties in prevention and wellbeing. Second, original studies are presented concerning the quality control of marketed products. Quality control is a key argument in nutraceuticals validation. Microalgae are particular organisms that need specific approaches to confirm identity and validate properties. The proposed control of quality is based on microscopic analysis of the morphologic characteristics. The final parts of this paper are dedicated to the need for specificity in uses and claims and to considerations about the future of microalgae in food supplements.

Adverse effect versus quality control of the Fuenzalida-Palacios antirabies vaccine.

PubMed

Nogueira, Y L

1998-01-01

We evaluated the components of the Fuenzalida-Palacios antirabies vaccine, which is till used in most developing countries in human immunization for treatment and prophylaxis. This vaccine is prepared from newborn mouse brains at 1% concentration. Even though the vaccine is considered to have a low myelin content, it is not fully free of myelin or of other undesirable components that might trigger adverse effects after vaccination. The most severe effect is a post-vaccination neuroparalytic accident associated with Guillain-Barré syndrome. In the present study we demonstrate how the vaccines produced and distributed by different laboratories show different component patterns with different degrees of impurity and with varying protein concentrations, indicating that production processes can vary from one laboratory to another. These differences, which could be resolved using a better quality control process, may affect and impair immunization, with consequent risks and adverse effects after vaccination. We used crossed immunoelectrophoresis to evaluate and demonstrate the possibility of quality control in vaccine production, reducing the risk factors possibly involved in these immunizing products.

Microalgae Nutraceuticals

PubMed Central

Nicoletti, Marcello

2016-01-01

Among the new entries in the food supplements sector, an important place must be assigned to nutraceuticals containing microalgae, nowadays accounting for a large and rapidly expanding market. The marketed products are mainly based on three production strains, i.e., Spirulina and Chlorella, followed at a distance by Klamath. It is a composite situation, since two of them are cyanobacteria and the second one is eukaryotic. The reality is that each presents similarities in shape and appearance concerning the marketed form and several utilizations, and peculiarities that need special attention and adequate studies. First, general information is reported about the current scientific knowledge on each microalga, in particular the nutritional value and properties in prevention and wellbeing. Second, original studies are presented concerning the quality control of marketed products. Quality control is a key argument in nutraceuticals validation. Microalgae are particular organisms that need specific approaches to confirm identity and validate properties. The proposed control of quality is based on microscopic analysis of the morphologic characteristics. The final parts of this paper are dedicated to the need for specificity in uses and claims and to considerations about the future of microalgae in food supplements. PMID:28231149

Improving Quality of Seal Leak Test Product using Six Sigma

NASA Astrophysics Data System (ADS)

Luthfi Malik, Abdullah; Akbar, Muhammad; Irianto, Dradjad

2016-02-01

Seal leak test part is a polyurethane material-based product. Based on past data, defect level of this product was 8%, higher than the target of 5%. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control. In the design phase, a Delphi method was used to identify factors that were critical to quality. In the measure phase, stability and process capability was measured. Fault tree analysis (FTA) and failure mode and effect analysis (FMEA) were used in the next phase to analize the root cause and to determine the priority issues. Improve phase was done by compiling, selecting, and designing alternative repair. Some improvement efforts were identified, i.e. (i) making a checklist for maintenance schedules, (ii) making written reminder form, (iii) modifying the SOP more detail, and (iv) performing a major service to the vacuum machine. To ensure the continuity of improvement efforts, some control activities were executed, i.e. (i) controlling, monitoring, documenting, and setting target frequently, (ii) implementing reward and punishment system, (iii) adding cleaning tool, and (iv) building six sigma organizational structure.

System of error detection in the manufacture of garments using artificial vision

NASA Astrophysics Data System (ADS)

Moreno, J. J.; Aguila, A.; Partida, E.; Martinez, C. L.; Morales, O.; Tejeida, R.

2017-12-01

A computer vision system is implemented to detect errors in the cutting stage within the manufacturing process of garments in the textile industry. It provides solution to errors within the process that cannot be easily detected by any employee, in addition to significantly increase the speed of quality review. In the textile industry as in many others, quality control is required in manufactured products and this has been carried out manually by means of visual inspection by employees over the years. For this reason, the objective of this project is to design a quality control system using computer vision to identify errors in the cutting stage within the garment manufacturing process to increase the productivity of textile processes by reducing costs.

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

PubMed

do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

2017-01-01

Objective . The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods . A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results . Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion . Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

PubMed Central

do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

2017-01-01

Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

Climatological Processing of Radar Data for the TRMM Ground Validation Program

NASA Technical Reports Server (NTRS)

Kulie, Mark; Marks, David; Robinson, Michael; Silberstein, David; Wolff, David; Ferrier, Brad; Amitai, Eyal; Fisher, Brad; Wang, Jian-Xin; Augustine, David;

Improvement of the customer satisfaction through Quality Assurance Matrix and QC-Story methods: A case study from automotive industry

NASA Astrophysics Data System (ADS)

Sicoe, G. M.; Belu, N.; Rachieru, N.; Nicolae, E. V.

2017-10-01

Presently, in the automotive industry, the tendency is to adapt permanently to the changes and introduce the market tendency in the new products that leads of the customer satisfaction. Many quality techniques were adopted in this field to continuous improvement of product and process quality and advantages were also gained. The present paper has focused on possibilities that offers the use of Quality Assurance Matrix (QAM) and Quality Control Story (QC Story) to provide largest protection against nonconformities in the production process, throughout a case study in the automotive industry. There is a direct relationship from the QAM to a QC Story analysis. The failures identified using QAM are treated with QC Story methodology. Using this methods, will help to decrease the PPM values and will increase the quality performance and the customer satisfaction.

On-line welding quality inspection system for steel pipe based on machine vision

NASA Astrophysics Data System (ADS)

Yang, Yang

2017-05-01

In recent years, high frequency welding has been widely used in production because of its advantages of simplicity, reliability and high quality. In the production process, how to effectively control the weld penetration welding, ensure full penetration, weld uniform, so as to ensure the welding quality is to solve the problem of the present stage, it is an important research field in the field of welding technology. In this paper, based on the study of some methods of welding inspection, a set of on-line welding quality inspection system based on machine vision is designed.

Tire Production and Pollution Control. Environmental Education Curriculum. Revised.

ERIC Educational Resources Information Center

Topeka Public Schools, KS.

This unit was developed to introduce secondary students to the many facets of a typical, large manufacturing plant - the Topeka Goodyear Tire and Rubber Company - in an effort to increase awareness of sound environmental practices in industry. Its five major foci include the production of tires and quality control procedures; applications of…

Near Real-Time Automatic Data Quality Controls for the AERONET Version 3 Database: An Introduction to the New Level 1.5V Aerosol Optical Depth Data Product

NASA Astrophysics Data System (ADS)

Giles, D. M.; Holben, B. N.; Smirnov, A.; Eck, T. F.; Slutsker, I.; Sorokin, M. G.; Espenak, F.; Schafer, J.; Sinyuk, A.

2015-12-01

The Aerosol Robotic Network (AERONET) has provided a database of aerosol optical depth (AOD) measured by surface-based Sun/sky radiometers for over 20 years. AERONET provides unscreened (Level 1.0) and automatically cloud cleared (Level 1.5) AOD in near real-time (NRT), while manually inspected quality assured (Level 2.0) AOD are available after instrument field deployment (Smirnov et al., 2000). The growing need for NRT quality controlled aerosol data has become increasingly important. Applications of AERONET NRT data include the satellite evaluation (e.g., MODIS, VIIRS, MISR, OMI), data synergism (e.g., MPLNET), verification of aerosol forecast models and reanalysis (e.g., GOCART, ICAP, NAAPS, MERRA), input to meteorological models (e.g., NCEP, ECMWF), and field campaign support (e.g., KORUS-AQ, ORACLES). In response to user needs for quality controlled NRT data sets, the new Version 3 (V3) Level 1.5V product was developed with similar quality controls as those applied by hand to the Version 2 (V2) Level 2.0 data set. The AERONET cloud screened (Level 1.5) NRT AOD database can be significantly impacted by data anomalies. The most significant data anomalies include AOD diurnal dependence due to contamination or obstruction of the sensor head windows, anomalous AOD spectral dependence due to problems with filter degradation, instrument gains, or non-linear changes in calibration, and abnormal changes in temperature sensitive wavelengths (e.g., 1020nm) in response to anomalous sensor head temperatures. Other less common AOD anomalies result from loose filters, uncorrected clock shifts, connection and electronic issues, and various solar eclipse episodes. Automatic quality control algorithms are applied to the new V3 Level 1.5 database to remove NRT AOD anomalies and produce the new AERONET V3 Level 1.5V AOD product. Results of the quality control algorithms are presented and the V3 Level 1.5V AOD database is compared to the V2 Level 2.0 AOD database.

The relationship between quality measurement techniques of pork loins and chops

USDA-ARS?s Scientific Manuscript database

Objectives: Assessment of boneless pork loin quality under industrial conditions is used in plants for segregation of product into programs and for export as well as for routine quality control and research. This assessment is usually made on the exposed longissimus on the ventral side of the muscle...

Agent-based station for on-line diagnostics by self-adaptive laser Doppler vibrometry

NASA Astrophysics Data System (ADS)

Serafini, S.; Paone, N.; Castellini, P.

2013-12-01

A self-adaptive diagnostic system based on laser vibrometry is proposed for quality control of mechanical defects by vibration testing; it is developed for appliances at the end of an assembly line, but its characteristics are generally suited for testing most types of electromechanical products. It consists of a laser Doppler vibrometer, equipped with scanning mirrors and a camera, which implements self-adaptive bahaviour for optimizing the measurement. The system is conceived as a Quality Control Agent (QCA) and it is part of a Multi Agent System that supervises all the production line. The QCA behaviour is defined so to minimize measurement uncertainty during the on-line tests and to compensate target mis-positioning under guidance of a vision system. Best measurement conditions are reached by maximizing the amplitude of the optical Doppler beat signal (signal quality) and consequently minimize uncertainty. In this paper, the optimization strategy for measurement enhancement achieved by the down-hill algorithm (Nelder-Mead algorithm) and its effect on signal quality improvement is discussed. Tests on a washing machine in controlled operating conditions allow to evaluate the efficacy of the method; significant reduction of noise on vibration velocity spectra is observed. Results from on-line tests are presented, which demonstrate the potential of the system for industrial quality control.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Secondary lead production in Malaysia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lim, J.S.S.; Lim, C.L.

1988-04-01

In the absence of a lead producers' association in Malaysia and the continued presence of illegal operators whose activities are confined to remelting of cable scraps and/or smelting of battery scraps using a shaft furnace, this paper relies heavily on the information obtained from Metal Reclamation Industries, Sdn. Bhd. -the only modern integrated lead smelter in the country. Consequently, the authors can only present a semiquantitative and general paper on secondary lead production in Malaysia covering the following areas: history; secondary lead smelting; raw material; products; quality control; pollution controls; and future of secondary lead production in Malaysia. They concludemore » that if Malaysia is to become a major secondary lead producer in the Asian region, the industry must: (1) import raw materials in the form of scrapped batteries; (2) develop or acquire new technology; (3) cope with changing pollution regulations, and (4) develop technical skills and efficient quality controls to meet new challenges. 2 figures, 3 tables.« less

Improving Quality of Shoe Soles Product using Six Sigma

NASA Astrophysics Data System (ADS)

Jesslyn Wijaya, Athalia; Trusaji, Wildan; Akbar, Muhammad; Ma’ruf, Anas; Irianto, Dradjad

2018-03-01

A manufacture in Bandung produce kind of rubber-based product i.e. trim, rice rollers, shoe soles, etc. After penetrating the shoe soles market, the manufacture has met customer with tight quality control. Based on the past data, defect level of this product was 18.08% that caused the manufacture’s loss of time and money. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control (DMAIC). In the design phase, the object’s problem and definition were defined. Delphi method was also used in this phase to identify critical factors. In the measure phase, the existing process stability and sigma quality level were measured. Fishbone diagram and failure mode and effect analysis (FMEA) were used in the next phase to analyse the root cause and determine the priority issues. Improve phase was done by designing alternative improvement strategy using 5W1H method. Some improvement efforts were identified, i.e. (i) modifying design of the hanging rack, (ii) create pantone colour book and check sheet, (iii) provide pedestrian line at compound department, (iv) buying stop watch, and (v) modifying shoe soles dies. Some control strategies for continuous improvement were proposed such as SOP or reward and punishment system.

The influence of processing on the microbial risk associated with Rooibos (Aspalathus linearis) tea.

PubMed

Gouws, Pieter; Hartel, Toni; van Wyk, Rudean

2014-12-01

This review discusses the influence of processing on the microbial risk associated with Salmonella in Rooibos tea, the identification of Salmonella and preventative and control measures to control microbial contamination. Rooibos tea, like other plant products, naturally contains a high microbial load. Downstream processing steps of these products usually help in reducing any contaminants present. Due to the delicate flavour properties and nature of Rooibos, gentle processing techniques are necessary for the production of good quality tea. However, this has a major influence on the microbiological status of the product. The presence of Salmonella in Rooibos is poorly understood. The ubiquitous distribution of Salmonella in the natural environment and its prevalence in the global food chain, the physiological adaptability, virulence of the bacterial pathogen and its serious economic impact on the food industry, emphasises the need for continued awareness and stringent controls at all levels of food production. With the advances of technology and information at hand, the processing of Rooibos needs to be re-evaluated. Since the delicate nature of Rooibos prohibits the use of harsh methods to control Salmonella, alternative methods for the steam pasteurisation of Rooibos show great potential to control Salmonella in a fast, efficient and cost-effective manner. These alternative methods will significantly improve the microbiological quality of Rooibos and provide a product that is safe to consumers. © 2014 Society of Chemical Industry.

CRN5EXP: Expert system for statistical quality control

NASA Technical Reports Server (NTRS)

Hentea, Mariana

1991-01-01

The purpose of the Expert System CRN5EXP is to assist in checking the quality of the coils at two very important mills: Hot Rolling and Cold Rolling in a steel plant. The system interprets the statistical quality control charts, diagnoses and predicts the quality of the steel. Measurements of process control variables are recorded in a database and sample statistics such as the mean and the range are computed and plotted on a control chart. The chart is analyzed through patterns using the C Language Integrated Production System (CLIPS) and a forward chaining technique to reach a conclusion about the causes of defects and to take management measures for the improvement of the quality control techniques. The Expert System combines the certainty factors associated with the process control variables to predict the quality of the steel. The paper presents the approach to extract data from the database, the reason to combine certainty factors, the architecture and the use of the Expert System. However, the interpretation of control charts patterns requires the human expert's knowledge and lends to Expert Systems rules.

Critical review of controlled release packaging to improve food safety and quality.

PubMed

Chen, Xi; Chen, Mo; Xu, Chenyi; Yam, Kit L

2018-03-19

Controlled release packaging (CRP) is an innovative technology that uses the package to release active compounds in a controlled manner to improve safety and quality for a wide range of food products during storage. This paper provides a critical review of the uniqueness, design considerations, and research gaps of CRP, with a focus on the kinetics and mechanism of active compounds releasing from the package. Literature data and practical examples are presented to illustrate how CRP controls what active compounds to release, when and how to release, how much and how fast to release, in order to improve food safety and quality.

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

PubMed

Avalle, P; Pollitt, M J; Bradley, K; Cooper, B; Pearce, G; Djemai, A; Fitzpatrick, S

2014-07-01

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements. Copyright © 2014 Elsevier B.V. All rights reserved.

Express quality control of chicken eggs by machine vision

NASA Astrophysics Data System (ADS)

Gorbunova, Elena V.; Chertov, Aleksandr N.; Peretyagin, Vladimir S.; Korotaev, Valery V.; Arbuzova, Evgeniia A.

2017-06-01

The urgency of the task of analyzing the foodstuffs quality is determined by the strategy for the formation of a healthy lifestyle and the rational nutrition of the world population. This applies to products, such as chicken eggs. In particular, it is necessary to control the chicken eggs quality at the farm production prior to incubation in order to eliminate the possible hereditary diseases, as well as high embryonic mortality and a sharp decrease in the quality of the bred young. Up to this day, in the market there are no objective instruments of contactless express quality control as analytical equipment that allow the high-precision quality examination of the chicken eggs, which is determined by the color parameters of the eggshell (color uniformity) and yolk of eggs, and by the presence in the eggshell of various defects (cracks, growths, wrinkles, dirty). All mentioned features are usually evaluated only visually (subjectively) with the help of normalized color standards and ovoscopes. Therefore, this work is devoted to the investigation of the application opportunities of contactless express control method with the help of technical vision to implement the chicken eggs' quality analysis. As a result of the studies, a prototype with the appropriate software was proposed. Experimental studies of this equipment on a representative sample of eggs from chickens of different breeds have been carried out (the total number of analyzed samples exceeds 300 pieces). The correctness of the color analysis was verified by spectrophotometric studies of the surface of the eggshell.

Recycle of Inorganic Nutrients for Hydroponic Crop Production Following Incineration of Inedible Biomass

NASA Technical Reports Server (NTRS)

Bubenheim, David L.; Wignarajah, Kanapathipillai; Kliss, Mark H. (Technical Monitor)

1996-01-01

Recovery of resources from waste streams is essential for future implementation and reliance on a regenerative life support system. The major waste streams of concern are from human activities and plant wastes. Carbon, water and inorganics are the primary desired raw materials of interest. The goal of resource recovery is maintenance of product quality to insure support of reliable and predictable levels of life support function performance by the crop plant component. Further, these systems must be maintained over extended periods of time, requiring maintenance of nutrient solutions to avoid toxicity and deficiencies. Today, reagent grade nutrients are used to make nutrient solutions for hydroponic culture and these solutions are frequently changed during the life cycle or sometimes managed for only one crop life cycle. The focus of this study was to determine the suitability of the ash product following incineration of inedible biomass as a source of inorganic nutrients for hydroponic crop production. Inedible wheat biomass was incinerated and ash quality characterized. The incinerator ash was dissolved in adequate nitric acid to establish a consistent nitrogen concentration in all nutrient solution treatments. Four experimental nutrient treatments were included: control, ash only, ash supplemented to match control, and ash only quality formulated with reagent grade chemicals. When nutrient solutions are formulated using only ash following-incineration of inedible biomass, a balance in solution is established representing elemental retention following incineration and nutrient proportions present in the original biomass. The resulting solution is not identical to the control. This imbalance resulted in suppression of crop growth. When the ash is supplemented with nutrients to establish the same balance as in the control, growth is identical to the control. The ash appears to carry no phytotoxic materials. Growth in solution formulated with reagent grade chemicals but matching the quality of the ash only treatment resulted in growth similar to that of the ash only treatment. The ash product resulting from incineration of inedible biomass appears to be a suitable form for recycle of inorganic nutrients to crop production.

Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

PubMed

Stengele, Michael

2008-10-01

A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

A longitudinal study to identify the influence of quality of chronic care delivery on productive interactions between patients and (teams of) healthcare professionals within disease management programmes.

PubMed

Cramm, Jane Murray; Nieboer, Anna Petra

2014-09-19

The chronic care model is an increasingly used approach to improve the quality of care through system changes in care delivery. While theoretically these system changes are expected to increase productive patient-professional interaction empirical evidence is lacking. This study aims to identify the influence of quality of care on productive patient-professional interaction. Longitudinal study in 18 Dutch regions. Questionnaires were sent to all 5076 patients participating in 18 Disease Management Programmes (DMPs) in 2010 (2676 (53%) respondents). One year later (T1), 4693 patients still participating in the DMPs received a questionnaire (2191 (47%) respondents) and 2 years later (in 2012; T2) 1722 patients responded (out of 4350; 40% response). DMPs Patients' perceptions of the productivity of interactions (measured as relational coordination/coproduction of care) with professionals. Patients were asked about communication dimensions (frequent, accurate, and problem-solving communication) and relationship dimensions (shared goals and mutual respect). After controlling for background characteristics these results clearly show that quality of chronic care (T0), first-year changes in quality of chronic care (T1-T0) and second-year changes in quality of chronic care (T2-T1) predicted productive interactions between patients and professionals at T2 (all at p≤0.001). Furthermore, we found a negative relationship between lower educational level and productive interactions between patients and professionals 2 years later. We can conclude that successfully dealing with the consequences of chronic illnesses requires proactive patients who are able to make productive decisions together with their healthcare providers. Since patients and professionals share responsibility for management of the chronic illness, they must also share control of interactions and decisions. The importance of patient-centeredness is growing and this study reports a first example of how quality of chronic care stimulates productive interactions between patients and professionals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Is My Small School Really Just a Business.

ERIC Educational Resources Information Center

Ross, Lee A.; Chance, W. G.

1984-01-01

Discusses steps necessary to running small schools on a more business-like basis, including quality control, product (student) evaluation, production process monitoring, establishment of standards, improved recruitment, market research, and sales promotion. (MH)

Application of Statistical Quality Control Techniques to Detonator Fabrication: Feasibility Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jones, J. Frank

1971-05-20

A feasibility study was performed on the use of process control techniques which might reduce the need for a duplicate inspection by production inspection and quality control inspection. Two active detonator fabrication programs were selected for the study. Inspection areas accounting for the greatest percentage of total inspection costs were selected by applying "Pareto's Principle of Maldistribution." Data from these areas were then gathered and analyzed by a process capabiltiy study.

Diagnosis of the Computer-Controlled Milling Machine, Definition of the Working Errors and Input Corrections on the Basis of Mathematical Model

NASA Astrophysics Data System (ADS)

Starikov, A. I.; Nekrasov, R. Yu; Teploukhov, O. J.; Soloviev, I. V.; Narikov, K. A.

2016-10-01

Manufactures, machinery and equipment improve of constructively as science advances and technology, and requirements are improving of quality and longevity. That is, the requirements for surface quality and precision manufacturing, oil and gas equipment parts are constantly increasing. Production of oil and gas engineering products on modern machine tools with computer numerical control - is a complex synthesis of technical and electrical equipment parts, as well as the processing procedure. Technical machine part wears during operation and in the electrical part are accumulated mathematical errors. Thus, the above-mentioned disadvantages of any of the following parts of metalworking equipment affect the manufacturing process of products in general, and as a result lead to the flaw.

Quality requirements for allergen extracts and allergoids for allergen immunotherapy.

PubMed

Zimmer, J; Bonertz, A; Vieths, S

2017-12-01

All allergen products for allergen immunotherapy currently marketed in the European Union are pharmaceutical preparations derived from allergen-containing source materials like pollens, mites and moulds. Especially this natural origin results in particular demands for the regulatory requirements governing allergen products. Furthermore, the development of regulatory requirements is complicated by the so far missing universal link between certain quality parameters, in particular biological potency, on the one hand and clinical efficacy on the other hand. As a consequence, each allergen product for specific immunotherapy has to be assessed individually for its quality, safety and efficacy. At the same time, biological potency of allergen products is most commonly determined using IgE inhibition assays based on human sera relative to product-specific in house references, ruling out full comparability of products from different manufacturers. This review article aims to summarize the current quality requirements for allergen products including the special requirements implemented for control of chemically modified allergen extracts (allergoids). Copyright © 2017 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

Ion mobility spectrometry for food quality and safety.

PubMed

Vautz, W; Zimmermann, D; Hartmann, M; Baumbach, J I; Nolte, J; Jung, J

2006-11-01

Ion mobility spectrometry is known to be a fast and sensitive technique for the detection of trace substances, and it is increasingly in demand not only for protection against explosives and chemical warfare agents, but also for new applications in medical diagnosis or process control. Generally, a gas phase sample is ionized by help of ultraviolet light, ss-radiation or partial discharges. The ions move in a weak electrical field towards a detector. During their drift they collide with a drift gas flowing in the opposite direction and, therefore, are slowed down depending on their size, shape and charge. As a result, different ions reach the detector at different drift times, which are characteristic for the ions considered. The number of ions reaching the detector are a measure of the concentration of the analyte. The method enables the identification and quantification of analytes with high sensitivity (ng l(-1) range). The selectivity can even be increased - as necessary for the analyses of complex mixtures - using pre-separation techniques such as gas chromatography or multi-capillary columns. No pre-concentration of the sample is necessary. Those characteristics of the method are preserved even in air with up to a 100% relative humidity rate. The suitability of the method for application in the field of food quality and safety - including storage, process and quality control as well as the characterization of food stuffs - was investigated in recent years for a number of representative examples, which are summarized in the following, including new studies as well: (1) the detection of metabolites from bacteria for the identification and control of their growth; (2) process control in food production - beer fermentation being an example; (3) the detection of the metabolites of mould for process control during cheese production, for quality control of raw materials or for the control of storage conditions; (4) the quality control of packaging materials during the production of polymeric materials; and (5) the characterization of products - wine being an example. The challenges of such applications were operation in humid air, fast on-line analyses of complex mixtures, high sensitivity - detection limits have to be, for example, in the range of the odour limits - and, in some cases, the necessity of mobile instrumentation. It can be shown that ion mobility spectrometry is optimally capable of fulfilling those challenges for many applications.

Process-based quality for thermal spray via feedback control

NASA Astrophysics Data System (ADS)

Dykhuizen, R. C.; Neiser, R. A.

2006-09-01

Quality control of a thermal spray system manufacturing process is difficult due to the many input variables that need to be controlled. Great care must be taken to ensure that the process remains constant to obtain a consistent quality of the parts. Control is greatly complicated by the fact that measurement of particle velocities and temperatures is a noisy stochastic process. This article illustrates the application of quality control concepts to a wire flame spray process. A central feature of the real-time control system is an automatic feedback control scheme that provides fine adjustments to ensure that uncontrolled variations are accommodated. It is shown how the control vectors can be constructed from simple process maps to independently control particle velocity and temperature. This control scheme is shown to perform well in a real production environment. We also demonstrate that slight variations in the feed wire curvature can greatly influence the process. Finally, the geometry of the spray system and sensor must remain constant for the best reproducibility.

Critical outlook and trends for environmental reference materials at the Measurements & Testing Generic Activity (European Commission).

PubMed

Quevauviller, P; Bennink, D; Bøwadt, S

2001-05-01

It is now well recognised that the quality control (QC) of all types of analyses, including environmental analyses depends on the appropriate use of reference materials. One of the ways to check the accuracy of methods is based on the use of Certified Reference Materials (CRMs), whereas other types of (not certified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g. proficiency testing). The perception of these materials, in particular with respect to their production and use, differs widely according to various perspectives (e.g. RM producers, routine laboratories, researchers). This review discusses some critical aspects of RM use and production for the QC of environmental analyses and describes the new approach followed by the Measurements & Testing Generic Activity (European Commission) to tackle new research and production needs.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 820.50 - Purchasing controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Purchasing controls. 820.50 Section 820.50 Food... DEVICES QUALITY SYSTEM REGULATION Purchasing Controls § 820.50 Purchasing controls. Each manufacturer... control to be exercised over the product, services, suppliers, contractors, and consultants, based on the...

Real Time Quality Control Methods for Cued EMI Data Collection

DTIC Science & Technology

2016-03-14

contents be construed as reflecting the official policy or position of the Department of Defense. Reference herein to any specific commercial product...This project evaluated the effectiveness of in-field quality control (QC) procedures during cued electromagnetic induction (EMI) data collection. The...electromagnetic induction ESTCP Environmental Security Technology Certification Program hr hour ISO Industry Standard Object IVS Instrument

Development and Exchange of Instructional Resources in Water Quality Control Programs, IV: Selecting Instructional Media and Instructional Systems.

ERIC Educational Resources Information Center

Durham, W. Harry; And Others

This document is one of a series of reports which reviews instructional materials and equipment for water and wastewater treatment plant personnel. A system is presented to assist in standardizing the production of lesson plans and instructional materials in the water quality control field. A procedure for selecting appropriate instructional media…

Organic weed conrol and cover crop residue integration impacts on weed control, quality, and yield and economics in conservation tillage tomato - A case study

USDA-ARS?s Scientific Manuscript database

The increased use of conservation tillage in vegetable production requires more information be developed on the role of cover crops in weed control, tomato quality and yield. Three conservation-tillage systems utilizing crimson clover, brassica and cereal rye as winter cover crops were compared to ...

Analysis and quality control of carbohydrates in therapeutic proteins with fluorescence HPLC

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liu, Kun; Huang, Jian; Center for Informational Biology, University of Electronic Science and Technology of China, Chengdu 610054

Conbercept is an Fc fusion protein with very complicated carbohydrate profiles which must be carefully monitored through manufacturing process. Here, we introduce an optimized fluorescence derivatization high-performance liquid chromatographic method for glycan mapping in conbercept. Compared with conventional glycan analysis method, this method has much better resolution and higher reproducibility making it excellent for product quality control.

Quality Management and Control of Low Pressure Cast Aluminum Alloy

NASA Astrophysics Data System (ADS)

Zhang, Dianxi; Zhang, Yanbo; Yang, Xiufan; Chen, Zhaosong; Jiang, Zelan

2018-01-01

This paper briefly reviews the history of low pressure casting and summarizes the major production processes of low pressure casting. It briefly introduces the quality management and control of low pressure cast aluminum alloy. The main processes include are: preparation of raw materials, Melting, refining, physical and chemical analysis, K-mode inspection, sand core, mold, heat treatment and so on.

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis. © PDA, Inc. 2018.

Optimum profit model considering production, quality and sale problem

NASA Astrophysics Data System (ADS)

Chen, Chung-Ho; Lu, Chih-Lun

2011-12-01

Chen and Liu ['Procurement Strategies in the Presence of the Spot Market-an Analytical Framework', Production Planning and Control, 18, 297-309] presented the optimum profit model between the producers and the purchasers for the supply chain system with a pure procurement policy. However, their model with a simple manufacturing cost did not consider the used cost of the customer. In this study, the modified Chen and Liu's model will be addressed for determining the optimum product and process parameters. The authors propose a modified Chen and Liu's model under the two-stage screening procedure. The surrogate variable having a high correlation with the measurable quality characteristic will be directly measured in the first stage. The measurable quality characteristic will be directly measured in the second stage when the product decision cannot be determined in the first stage. The used cost of the customer will be measured by adopting Taguchi's quadratic quality loss function. The optimum purchaser's order quantity, the producer's product price and the process quality level will be jointly determined by maximising the expected profit between them.

Quality and human society

NASA Astrophysics Data System (ADS)

Stoll, W.

1991-02-01

Quality of products and services is seen as a necessity in our modern world. Quality also has important cross-links to safety in our society. It is however suggested, that human beings are living in their industrial environment under the stress of a fractured personality with anxieties and frustrations. Some cultural comparisons with other industrial nations are given. Quality control tailored to human nature is recommended.

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2011 CFR

2011-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2012 CFR

2012-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2013 CFR

2013-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2014 CFR

2014-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

46 CFR 160.001-5 - Production oversight.

Code of Federal Regulations, 2010 CFR

2010-10-01

...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Life Preservers, General § 160.001-5 Production oversight. (a... additional production tests and inspections necessary to maintain quality control and to monitor compliance..., each manufacturer of a life preserver and each laboratory inspector shall comply with the following, as...

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Improving the Quality of Welding Seam of Automatic Welding of Buckets Based on TCP

NASA Astrophysics Data System (ADS)

Hu, Min

2018-02-01

Since February 2014, the welding defects of the automatic welding line of buckets have been frequently appeared. The average repair time of each bucket is 26min, which seriously affects the production efficiency and welding quality. We conducted troubleshooting, and found the main reasons for the welding defects of the buckets were the deviations of the center points of the robot tools and the poor quality of the locating welding. We corrected the gripper, welding torch, and accuracy of repeat positioning of robots to control the quality of positioning welding. The welding defect rate of buckets was reduced greatly, ensuring the production efficiency and welding quality.

Procedures of Laboratory Fumigation for Pest Control with Nitric Oxide Gas.

PubMed

Liu, Yong-Biao; Yang, Xiangbing; Masuda, Tiffany

2017-11-24

Nitric oxide (NO) is a newly discovered fumigant for postharvest pest control. This paper provides detailed protocols for conducting NO fumigation on fresh products and procedures for residue analysis and product quality evaluation. An airtight fumigation chamber containing fresh fruit and vegetables is first flushed with nitrogen (N2) to establish an ultralow oxygen (ULO) environment followed by injection of NO. The fumigation chamber is then kept at a low temperature of 2 - 5 °C for a specified time period necessary to kill a target pest to complete a fumigation treatment. At the end of a fumigation treatment, the fumigation chamber is flushed with N2 to dilute NO prior to opening the chamber to ambient air to prevent the reaction between NO and O2, which produces NO2 and may damage delicate fresh products. At different times after NO fumigation, NO2 in headspace and nitrate and nitrite in liquid samples were measured as residues. Product quality was evaluated after 2 weeks of post-treatment cold storage to determine effects of NO fumigation on product quality. Keeping O2 from reacting with NO is critical to NO fumigation and is an important part of the protocols. Measuring NO levels is challenging and a practical solution is provided. Possible protocol modifications are also suggested for measuring NO levels in the fumigation chambers as well as residues. NO fumigation has the potential to be a practical alternative to methyl bromide fumigation for postharvest pest control on fresh and stored products. This publication is intended to assist other researchers in conducting NO fumigation research for postharvest pest control and accelerating the development of NO fumigation for practical applications.

Procedures of Laboratory Fumigation for Pest Control with Nitric Oxide Gas

PubMed Central

Liu, Yong-Biao; Yang, Xiangbing; Masuda, Tiffany

2017-01-01

Nitric oxide (NO) is a newly discovered fumigant for postharvest pest control. This paper provides detailed protocols for conducting NO fumigation on fresh products and procedures for residue analysis and product quality evaluation. An airtight fumigation chamber containing fresh fruit and vegetables is first flushed with nitrogen (N2) to establish an ultralow oxygen (ULO) environment followed by injection of NO. The fumigation chamber is then kept at a low temperature of 2 - 5 °C for a specified time period necessary to kill a target pest to complete a fumigation treatment. At the end of a fumigation treatment, the fumigation chamber is flushed with N2 to dilute NO prior to opening the chamber to ambient air to prevent the reaction between NO and O2, which produces NO2 and may damage delicate fresh products. At different times after NO fumigation, NO2 in headspace and nitrate and nitrite in liquid samples were measured as residues. Product quality was evaluated after 2 weeks of post-treatment cold storage to determine effects of NO fumigation on product quality. Keeping O2 from reacting with NO is critical to NO fumigation and is an important part of the protocols. Measuring NO levels is challenging and a practical solution is provided. Possible protocol modifications are also suggested for measuring NO levels in the fumigation chambers as well as residues. NO fumigation has the potential to be a practical alternative to methyl bromide fumigation for postharvest pest control on fresh and stored products. This publication is intended to assist other researchers in conducting NO fumigation research for postharvest pest control and accelerating the development of NO fumigation for practical applications. PMID:29286372

The drug regulatory and review process in Guyana.

PubMed

Woo-Ming, R B

1993-01-01

After the old "Sale of Food and Drugs" Ordinance, Cap. 144 was repealed, the new Food and Drugs Act was enacted in 1971. This new Act has considerable flexibility and gives the Minister extensive authority to make Regulations (for carrying out the purposes and provisions of the Act). The Act controls the manufacture, importation, sale, advertising, labeling, packaging, and distribution of drug samples, and the testing of drugs. The Act also controls raw materials and finished products of drugs at the point of entry into the country, with a single agency coordinating both the inspection and analytical services. Developing countries could ensure the procurement of safe, good quality, and effective drugs and devices with the enactment of a similar Food and Drugs Act only. Rapid assessment of Drug Safety, Quality and Efficacy is done through Guyana's participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. This certification scheme is highly commendable especially to third-world countries. The Food and Drug Regulations (1977) have several unique features for drug, cosmetic and device control and they allow for a system of centralized control with limited staff to enforce the legislation. In summary, enforcement of legislative control of imported pharmaceuticals and product evaluation can be considered strong points in the drug regulatory and review process in Guyana. A cautious attitude is observed so as to ensure efficacy, safety, and quality of drugs entering the market. This Drug Regulatory and Review Process is recommended for implementation by third-world countries with outdated drug legislation.(ABSTRACT TRUNCATED AT 250 WORDS)

Study of mechanism improving target course traceability in G-Vectoring Control

NASA Astrophysics Data System (ADS)

Yamakado, Makoto; Abe, Masato; Kano, Yoshio; Umetsu, Daisuke; Yoshioka, Thoru

2018-05-01

Production-type G-Vectoring Control vehicles are now being put on the market. Customers and reviewers have praised the handling quality and course traceability of these vehicles. This paper clarifies the mechanism behind this improvement in handling quality using a simple bicycle model and driver model analysis. It focuses on the residual yaw angular acceleration when the steering speed is zero and shows that GVC reduces its value. This result provides evidence for improved handling quality in GVC vehicles.

How gamma radiation processing systems are benefiting from the latest advances in information technology

NASA Astrophysics Data System (ADS)

Gibson, Wayne H.; Levesque, Daniel

2000-03-01

This paper discusses how gamma irradiation plants are putting the latest advances in computer and information technology to use for better process control, cost savings, and strategic advantages. Some irradiator operations are gaining significant benefits by integrating computer technology and robotics with real-time information processing, multi-user databases, and communication networks. The paper reports on several irradiation facilities that are making good use of client/server LANs, user-friendly graphics interfaces, supervisory control and data acquisition (SCADA) systems, distributed I/O with real-time sensor devices, trending analysis, real-time product tracking, dynamic product scheduling, and automated dosimetry reading. These plants are lowering costs by fast and reliable reconciliation of dosimetry data, easier validation to GMP requirements, optimizing production flow, and faster release of sterilized products to market. There is a trend in the manufacturing sector towards total automation using "predictive process control". Real-time verification of process parameters "on-the-run" allows control parameters to be adjusted appropriately, before the process strays out of limits. Applying this technology to the gamma radiation process, control will be based on monitoring the key parameters such as time, and making adjustments during the process to optimize quality and throughput. Dosimetry results will be used as a quality control measurement rather than as a final monitor for the release of the product. Results are correlated with the irradiation process data to quickly and confidently reconcile variations. Ultimately, a parametric process control system utilizing responsive control, feedback and verification will not only increase productivity and process efficiency, but can also result in operating within tighter dose control set points.

CONTROL OF REPRODUCTION

USDA-ARS?s Scientific Manuscript database

Control of reproduction is important for seed stock production, selective breeding, growth rate, feed efficiency, meat quality, and biosecurity. These needs to control reproduction differ among cultivars and even segments of the same industry. No matter the impetus for aquaculturists to want to alte...

Ozone production and its sensitivity to NOx and VOCs: results from the DISCOVER-AQ field experiment, Houston 2013

NASA Astrophysics Data System (ADS)

Mazzuca, Gina M.; Ren, Xinrong; Loughner, Christopher P.; Estes, Mark; Crawford, James H.; Pickering, Kenneth E.; Weinheimer, Andrew J.; Dickerson, Russell R.

2016-11-01

An observation-constrained box model based on the Carbon Bond mechanism, version 5 (CB05), was used to study photochemical processes along the NASA P-3B flight track and spirals over eight surface sites during the September 2013 Houston, Texas deployment of the NASA Deriving Information on Surface Conditions from COlumn and VERtically Resolved Observations Relevant to Air Quality (DISCOVER-AQ) campaign. Data from this campaign provided an opportunity to examine and improve our understanding of atmospheric photochemical oxidation processes related to the formation of secondary air pollutants such as ozone (O3). O3 production and its sensitivity to NOx and volatile organic compounds (VOCs) were calculated at different locations and times of day. Ozone production efficiency (OPE), defined as the ratio of the ozone production rate to the NOx oxidation rate, was calculated using the observations and the simulation results of the box and Community Multiscale Air Quality (CMAQ) models. Correlations of these results with other parameters, such as radical sources and NOx mixing ratio, were also evaluated. It was generally found that O3 production tends to be more VOC-sensitive in the morning along with high ozone production rates, suggesting that control of VOCs may be an effective way to control O3 in Houston. In the afternoon, O3 production was found to be mainly NOx-sensitive with some exceptions. O3 production near major emissions sources such as Deer Park was mostly VOC-sensitive for the entire day, other urban areas near Moody Tower and Channelview were VOC-sensitive or in the transition regime, and areas farther from downtown Houston such as Smith Point and Conroe were mostly NOx-sensitive for the entire day. It was also found that the control of NOx emissions has reduced O3 concentrations over Houston but has led to larger OPE values. The results from this work strengthen our understanding of O3 production; they indicate that controlling NOx emissions will provide air quality benefits over the greater Houston metropolitan area in the long run, but in selected areas controlling VOC emissions will also be beneficial.

Accounting for quality in the measurement of hospital performance: evidence from Costa Rica.

PubMed

Arocena, Pablo; García-Prado, Ariadna

2007-07-01

This paper provides insights into how Costa Rican public hospitals responded to the pressure for increased efficiency and quality introduced by the reforms carried out over the period 1997-2001. To that purpose we compute a generalized output distance function by means of non-parametric mathematical programming to construct a productivity index, which accounts for productivity changes while controlling for quality of care. Our results show an improvement in hospital performance mainly driven by quality increases. The adoption of management contracts seems to have contributed to such enhancement, more notably for small hospitals. Further, productivity growth is primarily due to technical and scale efficiency change rather than technological change. A number of policy implications are drawn from these results. Copyright (c) 2006 John Wiley & Sons, Ltd.

PLC based automatic control of pasteurize mix in ice cream production

NASA Astrophysics Data System (ADS)

Yao, Xudong; Liang, Kai

2013-03-01

This paper describes the automatic control device of pasteurized mix in the ice cream production process.We design a scheme of control system using FBD program language and develop the programmer in the STEP 7-Micro/WIN software, check for any bugs before downloading into PLC .These developed devices will able to provide flexibility and accuracy to control the step of pasteurized mix. The operator just Input the duration and temperature of pasteurized mix through control panel. All the steps will finish automatically without any intervention in a preprogrammed sequence stored in programmable logic controller (PLC). With the help of this equipment we not only can control the quality of ice cream for various conditions, but also can simplify the production process. This control system is inexpensive and can be widely used in ice cream production industry.

Enabling the Usability of Earth Science Data Products and Services by Evaluating, Describing, and Improving Data Quality throughout the Data Lifecycle

NASA Astrophysics Data System (ADS)

Downs, R. R.; Peng, G.; Wei, Y.; Ramapriyan, H.; Moroni, D. F.

2015-12-01

Earth science data products and services are being used by representatives of various science and social science disciplines, by planning and decision-making professionals, by educators and learners ranging from primary through graduate and informal education, and by the general public. The diversity of users and uses of Earth science data is gratifying and offers new challenges for enabling the usability of these data by audiences with various purposes and levels of expertise. Users and other stakeholders need capabilities to efficiently find, explore, select, and determine the applicability and suitability of data products and services to meet their objectives and information needs. Similarly, they need to be able to understand the limitations of Earth science data, which can be complex, especially when considering combined or simultaneous use of multiple data products and services. Quality control efforts of stakeholders, throughout the data lifecycle, can contribute to the usability of Earth science data to meet the needs of diverse users. Such stakeholders include study design teams, data producers, data managers and curators, archives, systems professionals, data distributors, end-users, intermediaries, sponsoring organizations, hosting institutions, and others. Opportunities for engaging stakeholders to review, describe, and improve the quality of Earth science data products and services throughout the data lifecycle are identified and discussed. Insight is shared from the development of guidelines for implementing the Group on Earth Observations (GEO) Data Management Principles, the recommendations from the Earth Science Data System Working Group (ESDSWG) on Data Quality, and the efforts of the Information Quality Cluster of the Federation of Earth Science Information Partners (ESIP). Examples and outcomes from quality control efforts of data facilities, such as scientific data centers, that contribute to the usability of Earth science data also are offered.

Quality control tests of lab-reared Cydia pomonella and Cactoblastis cactorum field performance: Comparison of laboratory and field bioassays.

USDA-ARS?s Scientific Manuscript database

Research, operational, and commercial programs which rely on mass-reared insects of high quality and performance, need accurate methods for monitoring quality degradation during each step of production, handling and release. With continued interest in the use of the sterile insect technique (SIT) a...

7 CFR 989.702 - Minimum grade standards for packed raisins.

Code of Federal Regulations, 2010 CFR

2010-01-01

... RAISINS PRODUCED FROM GRAPES GROWN IN CALIFORNIA Quality Control § 989.702 Minimum grade standards for... washed with water to assure a wholesome product. (2) Grades. (i) Marketing Order Grade A is a quality of... paragraph. (ii) Marketing Order Grade B is the quality of the Cluster Seedless raisins that have similar...

Revisiting the Procedures for the Vector Data Quality Assurance in Practice

NASA Astrophysics Data System (ADS)

Erdoğan, M.; Torun, A.; Boyacı, D.

2012-07-01

Immense use of topographical data in spatial data visualization, business GIS (Geographic Information Systems) solutions and applications, mobile and location-based services forced the topo-data providers to create standard, up-to-date and complete data sets in a sustainable frame. Data quality has been studied and researched for more than two decades. There have been un-countable numbers of references on its semantics, its conceptual logical and representations and many applications on spatial databases and GIS. However, there is a gap between research and practice in the sense of spatial data quality which increases the costs and decreases the efficiency of data production. Spatial data quality is well-known by academia and industry but usually in different context. The research on spatial data quality stated several issues having practical use such as descriptive information, metadata, fulfillment of spatial relationships among data, integrity measures, geometric constraints etc. The industry and data producers realize them in three stages; pre-, co- and post data capturing. The pre-data capturing stage covers semantic modelling, data definition, cataloguing, modelling, data dictionary and schema creation processes. The co-data capturing stage covers general rules of spatial relationships, data and model specific rules such as topologic and model building relationships, geometric threshold, data extraction guidelines, object-object, object-belonging class, object-non-belonging class, class-class relationships to be taken into account during data capturing. And post-data capturing stage covers specified QC (quality check) benchmarks and checking compliance to general and specific rules. The vector data quality criteria are different from the views of producers and users. But these criteria are generally driven by the needs, expectations and feedbacks of the users. This paper presents a practical method which closes the gap between theory and practice. Development of spatial data quality concepts into developments and application requires existence of conceptual, logical and most importantly physical existence of data model, rules and knowledge of realization in a form of geo-spatial data. The applicable metrics and thresholds are determined on this concrete base. This study discusses application of geo-spatial data quality issues and QA (quality assurance) and QC procedures in the topographic data production. Firstly we introduce MGCP (Multinational Geospatial Co-production Program) data profile of NATO (North Atlantic Treaty Organization) DFDD (DGIWG Feature Data Dictionary), the requirements of data owner, the view of data producers for both data capturing and QC and finally QA to fulfil user needs. Then, our practical and new approach which divides the quality into three phases is introduced. Finally, implementation of our approach to accomplish metrics, measures and thresholds of quality definitions is discussed. In this paper, especially geometry and semantics quality and quality control procedures that can be performed by the producers are discussed. Some applicable best-practices that we experienced on techniques of quality control, defining regulations that define the objectives and data production procedures are given in the final remarks. These quality control procedures should include the visual checks over the source data, captured vector data and printouts, some automatic checks that can be performed by software and some semi-automatic checks by the interaction with quality control personnel. Finally, these quality control procedures should ensure the geometric, semantic, attribution and metadata quality of vector data.

Quality-Related Monitoring and Grading of Granulated Products by Weibull-Distribution Modeling of Visual Images with Semi-Supervised Learning.

PubMed

Liu, Jinping; Tang, Zhaohui; Xu, Pengfei; Liu, Wenzhong; Zhang, Jin; Zhu, Jianyong

2016-06-29

The topic of online product quality inspection (OPQI) with smart visual sensors is attracting increasing interest in both the academic and industrial communities on account of the natural connection between the visual appearance of products with their underlying qualities. Visual images captured from granulated products (GPs), e.g., cereal products, fabric textiles, are comprised of a large number of independent particles or stochastically stacking locally homogeneous fragments, whose analysis and understanding remains challenging. A method of image statistical modeling-based OPQI for GP quality grading and monitoring by a Weibull distribution(WD) model with a semi-supervised learning classifier is presented. WD-model parameters (WD-MPs) of GP images' spatial structures, obtained with omnidirectional Gaussian derivative filtering (OGDF), which were demonstrated theoretically to obey a specific WD model of integral form, were extracted as the visual features. Then, a co-training-style semi-supervised classifier algorithm, named COSC-Boosting, was exploited for semi-supervised GP quality grading, by integrating two independent classifiers with complementary nature in the face of scarce labeled samples. Effectiveness of the proposed OPQI method was verified and compared in the field of automated rice quality grading with commonly-used methods and showed superior performance, which lays a foundation for the quality control of GP on assembly lines.

Quality risk management in pharmaceutical development.

PubMed

Charoo, Naseem Ahmad; Ali, Areeg Anwer

2013-07-01

The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

Practical applications of nondestructive materials characterization

NASA Astrophysics Data System (ADS)

Green, Robert E., Jr.

1992-10-01

Nondestructive evaluation (NDE) techniques are reviewed for applications to the industrial production of materials including microstructural, physical, and chemical analyses. NDE techniques addressed include: (1) double-pulse holographic interferometry for sealed-package leak testing; (2) process controls for noncontact metals fabrication; (3) ultrasonic detections of oxygen contamination in titanium welds; and (4) scanning acoustic microscopy for the evaluation of solder bonds. The use of embedded sensors and emerging NDE concepts provides the means for controlling the manufacturing and quality of quartz crystal resonators, nickel single-crystal turbine blades, and integrated circuits. Advances in sensor technology and artificial intelligence algorithms and the use of embedded sensors combine to make NDE technology highly effective in controlling industrial materials manufacturing and the quality of the products.

Competition and disclosure incentives: an empirical study of HMOs.

PubMed

Jin, Ginger Zhe

2005-01-01

I examine Health Maintenance Organizations' (HMOs) voluntary disclosure of product quality, which is not as complete as unraveling theories predict. After controlling for cost and demand factors, I find that HMOs use voluntary disclosure to differentiate from competitors, with lower disclosure rates in highly competitive markets. These findings are consistent with product differentiation, but challenge the intuition that competition should lead to more provision of quality information.

Atlantic Ocean CARINA data: overview and salinity adjustments

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tanhua, T.; Steinfeldt, R.; Key, Robert

2010-01-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the threemore » data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30 S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control including crossover analysis between stations and inversion analysis of all crossover data are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally was well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.« less

Atlantic Ocean CARINA data: overview and salinity adjustments

NASA Astrophysics Data System (ADS)

Tanhua, T.; Steinfeldt, R.; Key, R. M.; Brown, P.; Gruber, N.; Wanninkhof, R.; Perez, F.; Körtzinger, A.; Velo, A.; Schuster, U.; van Heuven, S.; Bullister, J. L.; Stendardo, I.; Hoppema, M.; Olsen, A.; Kozyr, A.; Pierrot, D.; Schirnick, C.; Wallace, D. W. R.

2010-02-01

Water column data of carbon and carbon-relevant hydrographic and hydrochemical parameters from 188 previously non-publicly available cruise data sets in the Arctic Mediterranean Seas, Atlantic and Southern Ocean have been retrieved and merged into a new database: CARINA (CARbon dioxide IN the Atlantic Ocean). The data have gone through rigorous quality control procedures to assure the highest possible quality and consistency. The data for the pertinent parameters in the CARINA database were objectively examined in order to quantify systematic differences in the reported values, i.e. secondary quality control. Systematic biases found in the data have been corrected in the three data products: merged data files with measured, calculated and interpolated data for each of the three CARINA regions, i.e. the Arctic Mediterranean Seas, the Atlantic and the Southern Ocean. These products have been corrected to be internally consistent. Ninety-eight of the cruises in the CARINA database were conducted in the Atlantic Ocean, defined here as the region south of the Greenland-Iceland-Scotland Ridge and north of about 30° S. Here we present an overview of the Atlantic Ocean synthesis of the CARINA data and the adjustments that were applied to the data product. We also report the details of the secondary QC (Quality Control) for salinity for this data set. Procedures of quality control - including crossover analysis between stations and inversion analysis of all crossover data - are briefly described. Adjustments to salinity measurements were applied to the data from 10 cruises in the Atlantic Ocean region. Based on our analysis we estimate the internal consistency of the CARINA-ATL salinity data to be 4.1 ppm. With these adjustments the CARINA data products are consistent both internally as well as with GLODAP data, an oceanographic data set based on the World Hydrographic Program in the 1990s, and is now suitable for accurate assessments of, for example, oceanic carbon inventories and uptake rates and for model validation.

Impact of chronic lymphatic filariasis on quantity and quality of productive work among weavers in an endemic village from India.

PubMed

Babu, B V; Swain, B K; Rath, K

2006-05-01

To assess the impact of hydrocele and lymphoedema on the quantity and quality of productive work of weavers. Case-control study in an endemic village in Andhra Pradesh, India. We collected qualitative data on work activities from cases and age- and sex-matched controls through informal discussions and observation. The mean (+/-standard deviation) daily work time of cases was 7.38 h (+/-2.47), significantly less than that of controls (8.17+/-2.41 h). Lost work time was equivalent to around 29 days of work in a year. Gender had significant influence on the mean number of working hours in this occupational group. Most cases could not weave, which is physically demanding, and preferred less strenuous tasks such as spinning, starching, dyeing or sizing. Hard physical labour constitutes 71.5% of total work time among patients and 83.7% in controls. As income also depends on the type of work, cases earn less. Filariasis has an adverse impact on the productivity of weavers, and morbidity management strategies and control programmes need to take this into account.

Quality control of antibiotics before the implementation of an STD program in Northern Myanmar.

PubMed

Prazuck, Thierry; Falconi, Isabelle; Morineau, Guy; Bricard-Pacaud, Véronique; Lecomte, Antoine; Ballereau, Francoise

2002-11-01

The ready availability of poor-quality drugs in developing countries leads to treatment failure and, consequently, excess mortality and morbidity. Moreover, the widespread availability of substandard drugs plays a key role in increasing the resistance to antimicrobial drugs.GOAL As a prerequisite to the establishment of a sexually transmitted disease (STD) control program, this study aimed to evaluate the quality of antibiotics recommended for treatment of STDs that were locally available in the capital of a province of Northern Myanmar. In addition to the hospital pharmacy, we selected at random 5 of the 41 drug sellers and 5 of the 40 general practitioners who sell antibiotics in the city of Myitkyina. Twenty-one marketing products corresponding to nine different antibiotics used for STD treatment were purchased (benzathine benzylpenicillin, benzylpenicillin, ceftriaxone, chlortetracycline, ciprofloxacin, clotrimazole, co-trimoxazole, doxycycline, and erythromycin). Drugs were sent to France, where they were analyzed according to the WHO guidelines. Drugs were considered to be standard if their dosage remained in the 10% range of the expected value. Among the 21 different specialty products, only three displayed the official "registered" label. Three drugs were expired and the expiration date was not available for six others. One product did not contain the active drug declared (chlortetracycline; Lombisin, Unicorn, China) and did not show any in vitro activity against bacteria. Seven of 21 products (33%) did not contain the stated dosage (1, more than stated dosage; 6, less than stated dosage). The highest deficit observed was 48% in two products (co-trimoxazole, Yong Fong, Myanmar; benzylpenicillin, China [city and manufacturer unknown]). The dosage was not available for five drugs. As a result, only 8 of 21 products (38%) did not contain the stated dosage of active drug. These findings suggest that public health policies based on national treatment guidelines should rigorously include the monitoring of quality control of available antimicrobial products. In the absence of such measures, specific treatment strategies are likely to fail and to generate drug resistance.

[The main directions of improving the system of state accounting and control of radioactive substances and radioactive waste products].

PubMed

2012-01-01

This paper describes a modification of the basic directions of state accounting and control of radioactive substances and radioactive waste products, whose implementation will significantly improve the efficiency of its operation at the regional level. Selected areas are designed to improve accounting and control system for the submission of the enterprises established by the reporting forms, the quality of the information contained in them, as well as structures of information and process for collecting, analyzing and data processing concerning radioactive substances and waste products.

Faculty Return to Industry. Final Report.

ERIC Educational Resources Information Center

Hulse, David R.

Lagging productivity and increased competitiveness from abroad are forcing U.S. management companies to adopt new management styles that promote efficiency and quality in production. High on the agenda is the incorporation of Statistical Process Control (SPC). SPC requires definition of process and product specifications to facilitate their…

Advances in Process Control.

ERIC Educational Resources Information Center

Morrison, David L.; And Others

1982-01-01

Advances in electronics and computer science have enabled industries (pulp/paper, iron/steel, petroleum/chemical) to attain better control of their processes with resulting increases in quality, productivity, profitability, and compliance with government regulations. (JN)

[Critical reflexion on quality improvement and networking].

PubMed

Adler, R

2012-06-06

Qualitiy-control and networking are two issues of debate in modern medicine. The origin of these terms is not to be found in medicine, but rather in industry. However their naive transfer to the field of medicine causes damage. It is relatively easy to test industrial products for their quality. Dealing with meaningful medical problems is far too complex. Simple data such as blood pressure, HbA1c, etc. may be assessed. The only means of quality-control of complex medical situations and actions are ward rounds by attending physicians, case presentations at staff meetings, etc. Issues of clinical quality-control are discussed on the basis of the history of an aged couple. Furthermore a personal clinical experience illustrates how doctors create a useful network with other physicians and how they eliminate "useless" colleagues from their network. Economists should have no influence or impact whatsoever on the quality-control and networking of physicians.

Acetic Acid Bacteria and the Production and Quality of Wine Vinegar

PubMed Central

Torija, María Jesús; García-Parrilla, María del Carmen; Troncoso, Ana María

2014-01-01

The production of vinegar depends on an oxidation process that is mainly performed by acetic acid bacteria. Despite the different methods of vinegar production (more or less designated as either “fast” or “traditional”), the use of pure starter cultures remains far from being a reality. Uncontrolled mixed cultures are normally used, but this review proposes the use of controlled mixed cultures. The acetic acid bacteria species determine the quality of vinegar, although the final quality is a combined result of technological process, wood contact, and aging. This discussion centers on wine vinegar and evaluates the effects of these different processes on its chemical and sensory properties. PMID:24574887

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

Quality, functionality, and shelf life of fermented meat and meat products: A review.

PubMed

Kumar, Pavan; Chatli, M K; Verma, Akhilesh K; Mehta, Nitin; Malav, O P; Kumar, Devendra; Sharma, Neelesh

2017-09-02

Fermentation of meat is a traditional preservation method used widely for improving quality and shelf life of fermented meat products. Fermentation of meat causes a number of physical, biochemical, and microbial changes, which eventually impart functional properties, sensory characteristics, and nutritional aspects to these products and inhibit the growth of various pathogenic and spoilage microorganisms. These changes include acidification (carbohydrate catabolism), solubilization and gelation of myofibrillar and sarcoplasmic proteins of muscle, degradation of proteins and lipids, reduction of nitrate into nitrite, formation of nitrosomyoglobin, and dehydration. Dry-fermented sausages are increasingly being used as carrier of probiotics. The production of biogenic amines during fermentation can be controlled by selecting proper starter cultures and other preventive measures such as quality of raw materials, hygienic measures, temperature, etc.

Allergen manufacturing and quality aspects for allergen immunotherapy in Europe and the United States: An analysis from the EAACI AIT Guidelines Project.

PubMed

Bonertz, A; Roberts, G; Slater, J E; Bridgewater, J; Rabin, R L; Hoefnagel, M; Timon, M; Pini, C; Pfaar, O; Sheikh, A; Ryan, D; Akdis, C; Goldstein, J; Poulsen, L K; van Ree, R; Rhyner, C; Barber, D; Palomares, O; Pawankar, R; Hamerlijnk, D; Klimek, L; Agache, I; Angier, E; Casale, T; Fernandez-Rivas, M; Halken, S; Jutel, M; Lau, S; Pajno, G; Sturm, G; Varga, E M; Gerth van Wijk, R; Bonini, S; Muraro, A; Vieths, S

2018-04-01

Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States. In some key parts, requirements in these areas are harmonized while other fields are regulated separately between both regions. Essential differences are found in the use of Reference Preparations, or the requirement to apply standardized assays for potency determination. As the types of products available are different in specific regions, regulatory guidance for such products may also be available in one specific region only, such as for allergoids in the European Union. Region-specific issues and priorities are a result of this. As allergen products derived from natural sources are inherently variable in their qualitative and quantitative composition, these products present special challenges to balance the variability and ensuring batch-to-batch consistency. Advancements in scientific knowledge on specific allergens and their role in allergic disease will consequentially find representation in future regulatory guidelines. © 2017 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.

Low-cost foods: how do they compare with their brand name equivalents? A French study.

PubMed

Darmon, Nicole; Caillavet, France; Joly, Caroline; Maillot, Matthieu; Drewnowski, Adam

2009-06-01

Consumers are increasingly relying on low-cost foods, although it is not clear if the nutritional quality of these foods is fully maintained. The aim of the present work was to analyse the relationship between cost and quality within a given food category. The relationship was analysed between nutritional quality and cost for 220 food products belonging to seventeen different categories, controlling for package type and package size. Given that a summary of nutrient information was not available on the product label, a novel ingredient quality score was developed based on listed product ingredients. Within a given category, the lowest-priced foods were not different from the equivalent branded products in terms of overall energy or total fat content. Nevertheless, a positive relationship, small but significant, was observed between the price and the ingredient quality score. On average, the branded products cost 2.5 times more than the low-cost products, for an equivalent energy and lipid content, and had a slightly higher (1.3 times) ingredient quality score. More studies are necessary to evaluate the nutritional quality of low-cost foods. This evaluation would be facilitated if nutrition labelling was mandatory. Yet in view of the present results, it does not seem to be justified to divert consumers, especially the poorest, from low-cost foods because this may have an adverse effect on the nutritional quality of their diet, by reducing further the fraction of their food budget spent on fresh fruit and vegetables.

Taguchi's off line method and Multivariate loss function approach for quality management and optimization of process parameters -A review

NASA Astrophysics Data System (ADS)

Bharti, P. K.; Khan, M. I.; Singh, Harbinder

2010-10-01

Off-line quality control is considered to be an effective approach to improve product quality at a relatively low cost. The Taguchi method is one of the conventional approaches for this purpose. Through this approach, engineers can determine a feasible combination of design parameters such that the variability of a product's response can be reduced and the mean is close to the desired target. The traditional Taguchi method was focused on ensuring good performance at the parameter design stage with one quality characteristic, but most products and processes have multiple quality characteristics. The optimal parameter design minimizes the total quality loss for multiple quality characteristics. Several studies have presented approaches addressing multiple quality characteristics. Most of these papers were concerned with maximizing the parameter combination of signal to noise (SN) ratios. The results reveal the advantages of this approach are that the optimal parameter design is the same as the traditional Taguchi method for the single quality characteristic; the optimal design maximizes the amount of reduction of total quality loss for multiple quality characteristics. This paper presents a literature review on solving multi-response problems in the Taguchi method and its successful implementation in various industries.

Durum wheat (Triticum turgidum spp. durum, cultivar Senatore Cappelli) production systems effects on grain and flours functional properties under Mediterranean conditions

NASA Astrophysics Data System (ADS)

Cavoski, Ivana; Turk, Jelena; Chami, Ziad Al

2015-04-01

The main goal of organic farming is the "production of high quality products". Integrity and vital quality of products should be preserved along the entire production chain. In order to evaluate the effect of organic vs. conventional production systems on durum wheat phenolic acids and antioxidant activity open field experiment has been carried out. During the whole process chain from field to fork, there are various factors influencing the quality of the end product. Organic production should rely on genotypes with high nitrogen use efficiency, disease and pest resistance, weed competitiveness and tolerance especially under Mediterranean conditions. In this study, production systems differed according to the practices and inputs applied to manage the soil fertility and plant protection. In conventional system, synthetic fertilizers and pesticides were used. Whereas, in the two organic systems, cow manure with fertilizers and temporary intercropping with fava bean (Vicia faba) and fertilizers were used to manage soil fertility. Biopesticides were used for plant protection for organic systems. One treatment without inputs was used as a control in order to evaluate environmental site and cultivar effect. Quantity of free, free and conjugated and bounded phenolic acids were evaluated in relation to overall quality and production systems. In addition, antioxidant capacities of each fraction by different assays were assessed. The organic production method assured higher overall quality in paricular functional properties compared to the conventional one. Therefore, understanding the functional links between production systems variables and physiological responses is essential to improve and standardize the quality of organic durum wheat products. Keywords: organic farming, soil fertility management, phenolic acids, antioxidant activity.

[Advances in the use of instrumental measurement of colour in the development, production and quality control of drugs, medicinal preparations and pharmaceutical auxiliary substances I ].

PubMed

Subert, Jan; Cižmárik, Jozef

2013-04-01

Colour is one of the important indices of the quality of drugs, medicinal preparations and pharmaceutical auxiliary substances. The paper summarizes the development and use of instrumental measurement of colour in pharmacy in recent ten years focusing on the drugs of synthetic origin and pharmaceutical auxiliary substances including their control.

An NCME Instructional Module on Quality Control Procedures in the Scoring, Equating, and Reporting of Test Scores

ERIC Educational Resources Information Center

Allalouf, Avi

2007-01-01

There is significant potential for error in long production processes that consist of sequential stages, each of which is heavily dependent on the previous stage, such as the SER (Scoring, Equating, and Reporting) process. Quality control procedures are required in order to monitor this process and to reduce the number of mistakes to a minimum. In…

Risk management in technovigilance: construction and validation of a medical-hospital product evaluation instrument.

PubMed

Kuwabara, Cleuza Catsue Takeda; Evora, Yolanda Dora Martinez; de Oliveira, Márcio Mattos Borges

2010-01-01

With the continuous incorporation of health technologies, hospital risk management should be implemented to systemize the monitoring of adverse effects, performing actions to control and eliminate their damage. As part of these actions, Technovigilance is active in the procedures of acquisition, use and quality control of health products and equipment. This study aimed to construct and validate an instrument to evaluate medical-hospital products. This is a quantitative, exploratory, longitudinal and methodological development study, based on the Six Sigma quality management model, which has as its principle basis the component stages of the DMAIC Cycle. For data collection and content validation, the Delphi technique was used with professionals from the Brazilian Sentinel Hospital Network. It was concluded that the instrument developed permitted the evaluation of the product, differentiating between the results of the tested brands, in line with the initial study goal of qualifying the evaluations performed.

Evaluation of Various Radar Data Quality Control Algorithms Based on Accumulated Radar Rainfall Statistics

NASA Technical Reports Server (NTRS)

Robinson, Michael; Steiner, Matthias; Wolff, David B.; Ferrier, Brad S.; Kessinger, Cathy; Einaudi, Franco (Technical Monitor)

2000-01-01

The primary function of the TRMM Ground Validation (GV) Program is to create GV rainfall products that provide basic validation of satellite-derived precipitation measurements for select primary sites. A fundamental and extremely important step in creating high-quality GV products is radar data quality control. Quality control (QC) processing of TRMM GV radar data is based on some automated procedures, but the current QC algorithm is not fully operational and requires significant human interaction to assure satisfactory results. Moreover, the TRMM GV QC algorithm, even with continuous manual tuning, still can not completely remove all types of spurious echoes. In an attempt to improve the current operational radar data QC procedures of the TRMM GV effort, an intercomparison of several QC algorithms has been conducted. This presentation will demonstrate how various radar data QC algorithms affect accumulated radar rainfall products. In all, six different QC algorithms will be applied to two months of WSR-88D radar data from Melbourne, Florida. Daily, five-day, and monthly accumulated radar rainfall maps will be produced for each quality-controlled data set. The QC algorithms will be evaluated and compared based on their ability to remove spurious echoes without removing significant precipitation. Strengths and weaknesses of each algorithm will be assessed based on, their abilit to mitigate both erroneous additions and reductions in rainfall accumulation from spurious echo contamination and true precipitation removal, respectively. Contamination from individual spurious echo categories will be quantified to further diagnose the abilities of each radar QC algorithm. Finally, a cost-benefit analysis will be conducted to determine if a more automated QC algorithm is a viable alternative to the current, labor-intensive QC algorithm employed by TRMM GV.

Manufacturing Execution Systems: Examples of Performance Indicator and Operational Robustness Tools.

PubMed

Gendre, Yannick; Waridel, Gérard; Guyon, Myrtille; Demuth, Jean-François; Guelpa, Hervé; Humbert, Thierry

Manufacturing Execution Systems (MES) are computerized systems used to measure production performance in terms of productivity, yield, and quality. In the first part, performance indicator and overall equipment effectiveness (OEE), process robustness tools and statistical process control are described. The second part details some tools to help process robustness and control by operators by preventing deviations from target control charts. MES was developed by Syngenta together with CIMO for automation.

Options for reducing food waste by quality-controlled logistics using intelligent packaging along the supply chain.

PubMed

Heising, Jenneke K; Claassen, G D H; Dekker, Matthijs

2017-10-01

Optimising supply chain management can help to reduce food waste. This paper describes how intelligent packaging can be used to reduce food waste when used in supply chain management based on quality-controlled logistics (QCL). Intelligent packaging senses compounds in the package that correlate with the critical quality attribute of a food product. The information on the quality of each individual packaged food item that is provided by the intelligent packaging can be used for QCL. In a conceptual approach it is explained that monitoring food quality by intelligent packaging sensors makes it possible to obtain information about the variation in the quality of foods and to use a dynamic expiration date (IP-DED) on a food package. The conceptual approach is supported by quantitative data from simulations on the effect of using the information of intelligent packaging in supply chain management with the goal to reduce food waste. This simulation shows that by using the information on the quality of products that is provided by intelligent packaging, QCL can substantially reduce food waste. When QCL is combined with dynamic pricing based on the predicted expiry dates, a further waste reduction is envisaged.

Operational Processing of Ground Validation Data for the Tropical Rainfall Measuring Mission

NASA Technical Reports Server (NTRS)

Kulie, Mark S.; Robinson, Mike; Marks, David A.; Ferrier, Brad S.; Rosenfeld, Danny; Wolff, David B.

1999-01-01

The Tropical Rainfall Measuring Mission (TRMM) satellite was successfully launched in November 1997. A primary goal of TRMM is to sample tropical rainfall using the first active spaceborne precipitation radar. To validate TRMM satellite observations, a comprehensive Ground Validation (GV) Program has been implemented for this mission. A key component of GV is the analysis and quality control of meteorological ground-based radar data from four primary sites: Melbourne, FL; Houston, TX; Darwin, Australia; and Kwajalein Atoll, RMI. As part of the TRMM GV effort, the Joint Center for Earth Systems Technology (JCET) at the University of Maryland, Baltimore County, has been tasked with developing and implementing an operational system to quality control (QC), archive, and provide data for subsequent rainfall product generation from the four primary GV sites. This paper provides an overview of the JCET operational environment. A description of the QC algorithm and performance, in addition to the data flow procedure between JCET and the TRNM science and Data Information System (TSDIS), are presented. The impact of quality-controlled data on higher level rainfall and reflectivity products will also be addressed, Finally, a brief description of JCET's expanded role into producing reference rainfall products will be discussed.

Developing a consumer evaluation tool of weight control strategy advertisements on the Internet.

PubMed

Luevorasirikul, Kanokrat; Gray, Nicola J; Anderson, Claire W

2008-06-01

To develop two evaluation tools for weight loss and weight gain advertisements on the Internet in order to help consumers to evaluate the quality of information within these advertisements. One hundred websites identified by Internet search engines for weight loss and weight gain strategies (50 websites each) were evaluated using two specific scoring instruments, developed by adapting questions from the 'DISCERN' tool and reviewing all related weight control guidelines and advertising regulations. The validity and reliability of the adapted tools were tested. Our evaluation tools rated the information from most websites as poor quality (70%). In the case of weight loss strategies, statements about rapid (18%) and permanent (28%) weight loss caused concern as well as lack of sensible advice about dieting and a lack of product warnings (84%). Safety concerns relating to weight gain products were the lack of warnings about side effects in products containing steroids and creatine (92%). The adapted tools exhibited acceptable validity and reliability. Quality of information within weight control advertisements on the Internet was generally poor. Problems of false claims, little advice on healthy ways to modify weight and few warnings on side effects have been highlighted in this study.

Ambiguity of Quality in Remote Sensing Data

NASA Technical Reports Server (NTRS)

Lynnes, Christopher; Leptoukh, Greg

2010-01-01

This slide presentation reviews some of the issues in quality of remote sensing data. Data "quality" is used in several different contexts in remote sensing data, with quite different meanings. At the pixel level, quality typically refers to a quality control process exercised by the processing algorithm, not an explicit declaration of accuracy or precision. File level quality is usually a statistical summary of the pixel-level quality but is of doubtful use for scenes covering large areal extents. Quality at the dataset or product level, on the other hand, usually refers to how accurately the dataset is believed to represent the physical quantities it purports to measure. This assessment often bears but an indirect relationship at best to pixel level quality. In addition to ambiguity at different levels of granularity, ambiguity is endemic within levels. Pixel-level quality terms vary widely, as do recommendations for use of these flags. At the dataset/product level, quality for low-resolution gridded products is often extrapolated from validation campaigns using high spatial resolution swath data, a suspect practice at best. Making use of quality at all levels is complicated by the dependence on application needs. We will present examples of the various meanings of quality in remote sensing data and possible ways forward toward a more unified and usable quality framework.

Development of service-oriented products based on the inverse manufacturing concept.

PubMed

Fujimoto, Jun; Umeda, Yasushi; Tamura, Tetsuya; Tomiyama, Tetsuo; Kimura, Fumihiko

2003-12-01

To achieve sustainability, resource consumption and waste generation must be drastically decreased. For societal acceptance, preservation of both quality of life and corporate profits are essential. One promising approach is to shift the source of value from the amount of product sold to the quality of services the product provides. This paper describes the need for redesigning recycling systems from a manufacturing perspective and then discusses the possibility of this "servicification" of products, describing our experience with prototype development. We discuss development of product prototypes and their business, using consumer facsimile machines as an example of "service-oriented products". Traditional thought presumes that only products comprising new materials and components are valuable. Consideration of a service-oriented product can serve as a stimulus to revise this mode of thought and to control delivery and quality of disposed products. This paper also provides a life cycle simulation of the developed service-oriented business. Simulation results indicate that service-oriented business can potentially reduce environmental impact while extending business opportunities from the viewpoint of whole product life cycles.

Computer vision for foreign body detection and removal in the food industry

USDA-ARS?s Scientific Manuscript database

Computer vision inspection systems are often used for quality control, product grading, defect detection and other product evaluation issues. This chapter focuses on the use of computer vision inspection systems that detect foreign bodies and remove them from the product stream. Specifically, we wi...

Factors controlling reservoir quality in tertiary sandstones and their significance to geopressured geothermal production

DOE Office of Scientific and Technical Information (OSTI.GOV)

Loucks, R.G.; Richmann, D.L.; Milliken, K.L.

1981-01-01

Variable intensity of diagenesis is the factor primarily responsible for contrasting regional reservoir quality of Tertiary sandstones from the upper and lower Texas coast. Detailed comparison of Frio sandstone from the Chocolate Bayou/Danbury Dome area, Brazoria County, and Vicksburg sandstones from the McAllen Ranch Field area, Hidalgo County, reveals that extent of diagenetic modification is most strongly influenced by (1) detrital mineralogy and (2) regional geothermal gradients. The regional reservoir quality of Frio sandstones from Brazoria County is far better than that characterizing Vicksburg sandstones from Hidalgo County, especially at depths suitable for geopressured geothermal energy production. However, in predictingmore » reservoir quality on a site-specific basis, locally variable factors such as relative proportions for porosity types, pore geometry as related to permeability, and local depositional environment must also be considered. Even in an area of regionally favorable reservoir quality, such local factors can significantly affect reservoir quality and, hence, the geothermal production potential of a specific sandstone unit.« less

Employee empowerment through team building and use of process control methods.

PubMed

Willems, S

1998-02-01

The article examines the use of statistical process control and performance improvement techniques in employee empowerment. The focus is how these techniques provide employees with information to improve their productivity and become involved in the decision-making process. Findings suggest that at one Mississippi hospital employee improvement has had a positive effect on employee productivity, morale, and quality of work.

Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan.

PubMed

Sultan, Sadia; Zaheer, Hasan Abbas; Waheed, Usman; Baig, Mohammad Amjad; Rehan, Asma; Irfan, Syed Mohammed

2018-01-01

Internal quality control (IQC) is the backbone of quality assurance program. In blood banking, the quality control of blood products ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients. The main objective of this study is to analyze the IQC of blood products as an indicator of our blood bank performance. An observational cross-sectional study was conducted at the blood bank of Liaquat National Hospital and Medical College, from January 2014 to December 2015. A total of 100 units of each blood components were arbitrarily chosen during the study. Packed red cell units were evaluated for hematocrit (HCT); random platelet concentrates were evaluated for pH, yield, and culture; fresh frozen plasma (FFP) and cryoprecipitate (CP) were evaluated for unit volume, factor VIII, and fibrinogen concentrations. A total of 400 units were tested for IQC. The mean HCT of packed red cells was 69.5 ± 7.24, and in 98% units, it met the standard (<80% of HCT). The mean platelet yield was 8.8 ± 3.40 × 10 9 /L and pH was ≥6.2 in 98% bags; cultures were negative in 97% of units tested. Mean factor VIII and fibrinogen levels were found to be 84.24 ± 15.01 and 247.17 ± 49.69 for FFP, respectively. For CP, mean factor VIII and fibrinogen level were found to be 178.75 ± 86.30 and 420.7 ± 75.32, respectively. The IQC of blood products at our blood bank is in overall compliance and met recommended international standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit, and staff competencies can improve the quality performance of the transfusion services.

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2011 CFR

2011-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2013 CFR

2013-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2014 CFR

2014-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2012 CFR

2012-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

Modelling and control for laser based welding processes: modern methods of process control to improve quality of laser-based joining methods

NASA Astrophysics Data System (ADS)

Zäh, Ralf-Kilian; Mosbach, Benedikt; Hollwich, Jan; Faupel, Benedikt

2017-02-01

To ensure the competitiveness of manufacturing companies it is indispensable to optimize their manufacturing processes. Slight variations of process parameters and machine settings have only marginally effects on the product quality. Therefore, the largest possible editing window is required. Such parameters are, for example, the movement of the laser beam across the component for the laser keyhole welding. That`s why it is necessary to keep the formation of welding seams within specified limits. Therefore, the quality of laser welding processes is ensured, by using post-process methods, like ultrasonic inspection, or special in-process methods. These in-process systems only achieve a simple evaluation which shows whether the weld seam is acceptable or not. Furthermore, in-process systems use no feedback for changing the control variables such as speed of the laser or adjustment of laser power. In this paper the research group presents current results of the research field of Online Monitoring, Online Controlling and Model predictive controlling in laser welding processes to increase the product quality. To record the characteristics of the welding process, tested online methods are used during the process. Based on the measurement data, a state space model is ascertained, which includes all the control variables of the system. Depending on simulation tools the model predictive controller (MPC) is designed for the model and integrated into an NI-Real-Time-System.

Using Deming To Improve Quality in Colleges and Universities.

ERIC Educational Resources Information Center

Cornesky, Robert A.; And Others

Of all the people known for stressing quality in industry, W. Edwards Deming is the pioneer. He stresses statistical process control (SPC) and a 14-point process for managers to improve quality and productivity. His approach is humanistic and treats people as intelligent human beings who want to do a good job. Twelve administrators in a university…

[Study thought of pharmaceutical preparations quality standards by dynamic quality control technology].

PubMed

Yu, Dan-Hong; Mao, Chen-Mei; Lv, Cheng-Zhe; Jin, Hui-Zhen; Yao, Xin; Jia, Xiao-Bin

2014-07-01

Pharmaceutical preparations, particularly as a "secret recipe" of traditional Chinese medicine in medical institutions, are the product of China's medical and health industry, and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies, the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know, the quality of pharmaceutical preparations is important to ensure the efficacy, especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this, we will improve the grade, stability, and clinical efficacy of pharmaceutical preparations by the advanced equipment, testing instruments and the process dynamic quality control technology. Finally, we hope we can provide new ideas for the quality control of pharmaceutical preparations.

Astronomical Instrumentation Systems Quality Management Planning: AISQMP

NASA Astrophysics Data System (ADS)

Goldbaum, Jesse

2017-06-01

The capability of small aperture astronomical instrumentation systems (AIS) to make meaningful scientific contributions has never been better. The purpose of AIS quality management planning (AISQMP) is to ensure the quality of these contributions such that they are both valid and reliable. The first step involved with AISQMP is to specify objective quality measures not just for the AIS final product, but also for the instrumentation used in its production. The next step is to set up a process to track these measures and control for any unwanted variation. The final step is continual effort applied to reducing variation and obtaining measured values near optimal theoretical performance. This paper provides an overview of AISQMP while focusing on objective quality measures applied to astronomical imaging systems.

Astronomical Instrumentation Systems Quality Management Planning: AISQMP (Abstract)

NASA Astrophysics Data System (ADS)

Goldbaum, J.

2017-12-01

(Abstract only) The capability of small aperture astronomical instrumentation systems (AIS) to make meaningful scientific contributions has never been better. The purpose of AIS quality management planning (AISQMP) is to ensure the quality of these contributions such that they are both valid and reliable. The first step involved with AISQMP is to specify objective quality measures not just for the AIS final product, but also for the instrumentation used in its production. The next step is to set up a process to track these measures and control for any unwanted variation. The final step is continual effort applied to reducing variation and obtaining measured values near optimal theoretical performance. This paper provides an overview of AISQMP while focusing on objective quality measures applied to astronomical imaging systems.

New patient-controlled abdominal compression method in radiography: radiation dose and image quality.

PubMed

Piippo-Huotari, Oili; Norrman, Eva; Anderzén-Carlsson, Agneta; Geijer, Håkan

2018-05-01

The radiation dose for patients can be reduced with many methods and one way is to use abdominal compression. In this study, the radiation dose and image quality for a new patient-controlled compression device were compared with conventional compression and compression in the prone position . To compare radiation dose and image quality of patient-controlled compression compared with conventional and prone compression in general radiography. An experimental design with quantitative approach. After obtaining the approval of the ethics committee, a consecutive sample of 48 patients was examined with the standard clinical urography protocol. The radiation doses were measured as dose-area product and analyzed with a paired t-test. The image quality was evaluated by visual grading analysis. Four radiologists evaluated each image individually by scoring nine criteria modified from the European quality criteria for diagnostic radiographic images. There was no significant difference in radiation dose or image quality between conventional and patient-controlled compression. Prone position resulted in both higher dose and inferior image quality. Patient-controlled compression gave similar dose levels as conventional compression and lower than prone compression. Image quality was similar with both patient-controlled and conventional compression and was judged to be better than in the prone position.

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

21 CFR 225.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 225.58 Section 225.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS Product Quality Control § 225.58 Laboratory controls. (a) The periodic assay of medicated feeds for drug components provides a measure of...

30 CFR 780.15 - Air pollution control plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Air pollution control plan. 780.15 Section 780....15 Air pollution control plan. (a) For all surface mining activities with projected production rates... application shall contain an air pollution control plan which includes the following: (1) An air quality...

30 CFR 780.15 - Air pollution control plan.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Air pollution control plan. 780.15 Section 780....15 Air pollution control plan. (a) For all surface mining activities with projected production rates... application shall contain an air pollution control plan which includes the following: (1) An air quality...

30 CFR 780.15 - Air pollution control plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Air pollution control plan. 780.15 Section 780....15 Air pollution control plan. (a) For all surface mining activities with projected production rates... application shall contain an air pollution control plan which includes the following: (1) An air quality...

30 CFR 780.15 - Air pollution control plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Air pollution control plan. 780.15 Section 780....15 Air pollution control plan. (a) For all surface mining activities with projected production rates... application shall contain an air pollution control plan which includes the following: (1) An air quality...

30 CFR 780.15 - Air pollution control plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Air pollution control plan. 780.15 Section 780....15 Air pollution control plan. (a) For all surface mining activities with projected production rates... application shall contain an air pollution control plan which includes the following: (1) An air quality...

New irradiation facilities for development of production methods of medical radionuclides at cyclotrons at Forschungszentrum Jülich

NASA Astrophysics Data System (ADS)

Spellerberg, S.; Scholten, B.; Spahn, I.; Felden, O.; Gebel, R.; Qaim, S. M.; Bai, M.; Neumaier, B.

2017-05-01

An essential basis for research and development work on radiopharmaceuticals is the efficient production of radionuclides of high quality. In this process research-oriented studies aiming for elucidation of biochemical processes require novel products. The radionuclide development at INM-5 entails basic research, e.g. the determination of nuclear reaction data, as well as technical aspects of practical production, such as high-current targetry, chemical separation, formulation and quality control. In this work developments, adaptation and optimization of irradiation facilities at the BC 1710, JULIC as Injector of COSY and COSY itself are summarized, which shall allow the extension of radionuclide production possibilities, aiming at innovations in medical applications.

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Controlling high-throughput manufacturing at the nano-scale

NASA Astrophysics Data System (ADS)

Cooper, Khershed P.

2013-09-01

Interest in nano-scale manufacturing research and development is growing. The reason is to accelerate the translation of discoveries and inventions of nanoscience and nanotechnology into products that would benefit industry, economy and society. Ongoing research in nanomanufacturing is focused primarily on developing novel nanofabrication techniques for a variety of applications—materials, energy, electronics, photonics, biomedical, etc. Our goal is to foster the development of high-throughput methods of fabricating nano-enabled products. Large-area parallel processing and highspeed continuous processing are high-throughput means for mass production. An example of large-area processing is step-and-repeat nanoimprinting, by which nanostructures are reproduced again and again over a large area, such as a 12 in wafer. Roll-to-roll processing is an example of continuous processing, by which it is possible to print and imprint multi-level nanostructures and nanodevices on a moving flexible substrate. The big pay-off is high-volume production and low unit cost. However, the anticipated cost benefits can only be realized if the increased production rate is accompanied by high yields of high quality products. To ensure product quality, we need to design and construct manufacturing systems such that the processes can be closely monitored and controlled. One approach is to bring cyber-physical systems (CPS) concepts to nanomanufacturing. CPS involves the control of a physical system such as manufacturing through modeling, computation, communication and control. Such a closely coupled system will involve in-situ metrology and closed-loop control of the physical processes guided by physics-based models and driven by appropriate instrumentation, sensing and actuation. This paper will discuss these ideas in the context of controlling high-throughput manufacturing at the nano-scale.

Profile of a cell test database and a corresponding reliability database

NASA Technical Reports Server (NTRS)

Brearley, George R.; Klein, Glenn C.

1992-01-01

The development of computerized control, and data retrieval for aerospace cell testing affords an excellent opportunity to incorporate three specific concepts to both manage the test area and to track product performance on a real-time basis. The adoption and incorporation of precepts fostered by this total quality management (TQM) initiative are critical to us for retaining control of our business while substantially reducing the separate quality control inspection activity. Test discrepancies are all 'equally bad' in cell acceptance testing because, for example, we presently do not discriminate between 1 or 25 mV for an overvoltage condition. We must take leadership in classifying such discrepancies in order to expedite their clearance and redirect our resources for prevention activities. The development and use of engineering alerts (or guardbanding) which more closely match our product capabilities and are toleranced tighter than the required customer specification are paramount to managing the test unit in order to remain both quality and cost effective.