Qualification Process

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Shaddy Shokralla - One of the best experts on this subject based on the ideXlab platform.

  • modelling and validation of eddy current response to changes in factors affecting pressure tube to calandria tube gap measurement
    Ndt & E International, 2015
    Co-Authors: Shaddy Shokralla, Sean Sullivan, Jordan Morelli, Thomas W Krause
    Abstract:

    Abstract Procedures employed to non-destructively examine nuclear power plants must undergo inspection Qualification to ensure that they meet their respective inspection specification requirements. Modelling is a powerful tool that can be exploited in the inspection Qualification Process. The gap between pressure tubes (PTs) and calandria tubes (CTs) in CANDU (CANada Deuterium Uranium) fuel channels is periodically measured, as contact can result in localized cooling and potential cracking. This work shows how an analytical model can be employed to characterize the effects of PT wall thickness and resistivity variation on gap measurement, and details its validation against physical experiments.

Thomas W Krause - One of the best experts on this subject based on the ideXlab platform.

  • modelling and validation of eddy current response to changes in factors affecting pressure tube to calandria tube gap measurement
    Ndt & E International, 2015
    Co-Authors: Shaddy Shokralla, Sean Sullivan, Jordan Morelli, Thomas W Krause
    Abstract:

    Abstract Procedures employed to non-destructively examine nuclear power plants must undergo inspection Qualification to ensure that they meet their respective inspection specification requirements. Modelling is a powerful tool that can be exploited in the inspection Qualification Process. The gap between pressure tubes (PTs) and calandria tubes (CTs) in CANDU (CANada Deuterium Uranium) fuel channels is periodically measured, as contact can result in localized cooling and potential cracking. This work shows how an analytical model can be employed to characterize the effects of PT wall thickness and resistivity variation on gap measurement, and details its validation against physical experiments.

Esteban Rodríguez - One of the best experts on this subject based on the ideXlab platform.

  • Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers.
    PDA journal of pharmaceutical science and technology, 2015
    Co-Authors: Carles Parés, Manuel Martínez, Joaquim Messeguer, Esteban Rodríguez
    Abstract:

    Manufacturers of human plasma-derived products ensure, through their Qualification departments, the quality and safety of human plasma—the biological starting material of the industrial fractionation Process. The Qualification department has established written procedures to approve the plasma supplier (i.e., initial Qualification) according to current regulations and to the manufacturer9s plasma specifications. Once the plasma supplier is approved, a periodical assessment is necessary (i.e., continuous Qualification) to guarantee the level of compliance. In addition, a signed quality agreement between the plasma supplier and the manufacturer defines the duties and the responsibilities of both parties. The Qualification department implements the following requirements to ensure the quality of plasma from suppliers: (i) a regular audit program to confirm the satisfactory initiation of the quality arrangements and (ii) monitoring of the quality and safety of plasma including critical quality parameters. For several years, the Grifols Qualification Department has worked with several plasma suppliers of the European Union (EU) and has performed a detailed, continuous assessment of the audits, deviations, operational incidences, epidemiological data, and quality controls. In this article, we will report data from this Grifols assessment from 2010 through 2013 on plasma suppliers from four EU countries. In the future, additional data will be collected and studied to confirm and verify the conclusions and trends observed in this study.

David H. Mckenna - One of the best experts on this subject based on the ideXlab platform.

  • Establishment of an unrelated umbilical cord blood bank Qualification program: ensuring quality while meeting Food and Drug Administration vendor Qualification requirements.
    Transfusion, 2013
    Co-Authors: Fran Rabe, Diane Kadidlo, Lisa Van Orsow, David H. Mckenna
    Abstract:

    Background Qualification of a cord blood bank (CBB) is a complex Process that includes evaluation of multiple aspects of donor screening and testing, Processing, accreditation and approval by professional cell therapy groups, and results of received cord blood units. The University of Minnesota Medical Center Cell Therapy Laboratory has established a CBB vendor Qualification Process to ensure the CBB meets established regulatory and quality requirements. Study Design and Methods The deployed Qualification of CBBs is based on retrospective and prospective review of the CBB. Results Forty-one CBBs were evaluated retrospectively: seven CBBs were disqualified based on failed quality control (QC) results. Eight CBBs did not meet the criteria for retrospective Qualification because fewer than 3 cord blood units were received and the CBB was not accredited. As of March 2012, three US and one non-US CBBs have been qualified prospectively. One CBB withdrew from the Qualification Process after successful completion of the comprehensive survey and subsequent failure of the provided QC unit to pass the minimum criteria. One CBB failed the prospective Qualification Process based on Processing methods that were revealed during the paper portion of the evaluation. Conclusions A CBB Qualification Process is necessary for a transplant center to manage the Qualification of the large number of CBBs needed to support a umbilical cord blood transplantation program. A transplant center that has utilized cord blood for a number of years before implementation of a Qualification Process should use a retrospective Qualification Process along with a prospective Process.

Eric Sabourin - One of the best experts on this subject based on the ideXlab platform.

  • Agri-food Qualification & certification Process as an interface between exchange marketing and reciprocity.
    2010
    Co-Authors: Eric Sabourin
    Abstract:

    This paper mobilizes the theory of reciprocity to analyze family farm product Qualification Process effects in Brazil. All Qualification Processes that guarantee the origin, the specificity, the quality Process or the standards of a product, may contribute to reduce the effects of competition and speculation, which are distinctive of the capitalist exchange. My hypothesis is that a Qualification Process can contribute to establish a binary symmetrical relation of reciprocity between producer and buyer. It can also contribute to generate a sharing structure (of quality) among the group of producers. However, apart from this group of qualified producers and also for the marketing of other products which are not quality, it is the rules of the capitalistic exchange market that apply. So, Qualification and certification could also induce exclusion. That is why; one has to resort to some kind of interface: that of the certification mechanism, which makes it possible to reintroduce a dimension of reciprocity into the capitalist exchange market system. The paper presents, in the case of Brazil, various initiatives of setting up such co-certification, group certification or participative certification systems.

  • family farm product Qualification and relationship of reciprocity draft
    Re-inventing the rural between the social and the natural : XXIII ERS Congress Vaasa Finland 17-21 August 2009, 2009
    Co-Authors: Eric Sabourin
    Abstract:

    This paper mobilizes the theory of reciprocity to analyze family farm product Qualification Process effects in Brazil. All Qualification Processes that guarantee the origin, the specificity, the quality Process or the norms of a product, contribute to reduce the effects of competition and speculation peculiar to the capitalist exchange. My hypothesis is that a Qualification Process can contribute to establish a binary symmetrical relation of reciprocity between producer and buyer. They also can contribute to generate a sharing structure (of quality) among the group of producers. When the producer's name is at stake, reciprocity relationships generate values of trust, reputation, honor and responsibility. It is often these ethical values that guarantee the legitimacy and the authority of the certification Process of quality and origin standards. In fact, it thus creates a territoriality of reciprocity around a specific product. However, apart from this group of qualified producers and also for the marketing of other products which are not be labeled by them, it is the rules of the capitalistic exchange market that apply. Qualification and certification could also induce exclusion. That is why, in the case of a centrifugal Qualification Process, one has resort to some kind of interface: that of the certification mechanism, which makes it possible to reintroduce reciprocity dimension (the domestic unit, the peasant community, the cooperative) into the capitalist exchange market system. The paper presents in the case of Brazil, various initiatives of setting up such co-certification, group certification, or even, the so-called participative certification systems, between producers or between producers and consumers. (Resume d'auteur)

  • Family farm product Qualification and relationship of reciprocity
    2009
    Co-Authors: Eric Sabourin
    Abstract:

    This paper mobilizes the theory of reciprocity to analyze family farm product Qualification Process effects in Brazil. All Qualification Processes that guarantee the origin, the specificity, the quality Process or the norms of a product, contribute to reduce the effects of competition and speculation peculiar to the capitalist exchange. My hypothesis is that a Qualification Process can contribute to establish a binary symmetrical relation of reciprocity between producer and buyer. They also can contribute to generate a sharing structure (of quality) among the group of producers. When the producer's name is at stake, reciprocity relationships generate values of trust, reputation, honor and responsibility. It is often these ethical values that guarantee the legitimacy and the authority of the certification Process of quality and origin standards. In fact, it thus creates a territoriality of reciprocity around a specific product. However, apart from this group of qualified producers and also for the marketing of other products which are not be labeled by them, it is the rules of the capitalistic exchange market that apply. Qualification and certification could also induce exclusion. That is why, in the case of a centrifugal Qualification Process, one has resort to some kind of interface: that of the certification mechanism, which makes it possible to reintroduce reciprocity dimension (the domestic unit, the peasant community, the cooperative) into the capitalist exchange market system. The paper presents in the case of Brazil, various initiatives of setting up such co-certification, group certification, or even, the so-called participative certification systems, between producers or between producers and consumers.