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Quality Assurance Inspections

The other method for quality assurance inspection of pellet wt in the primer eliminates the need for a comparator oxygen-containing standard. Here, the Cu in the cup-anvil combination in the primer is used as an internal standard by comparing the 0.511 MeV positron annihilation radiation from 62Cu produced by the 63Cu(n,2n)62Cu reaction to the 6.1 MeV 7 from l6N produced by oxygen activation. In this case the actual determination of pellet wt is not required the ratio of Cu to O, which should be fixed for a pro-... [Pg.366]

This feasibility study shows that determination of pellet wt by fast neutron oxygen activation analysis can be used for quality assurance inspection of M34 primers. Either direct oxygen analysis, where a comparison standard (such as lucite) is used, or a ratio method, utilizing the Cu in the cup-anvil combination as an internal standard, can be applied. In general, the uniformity of production primers is quite satisfactory, as is usually the case where production procedures are standardized. It seems likely that the light pellet is one which has been improperly manufd and will probably be well below specifications in pellet wt. Production experience with such primers indicates that only one in 3x10s primers is expected to show low pellet wt therefore, one would not expect to find a reject in a small sampling. Nevertheless, detection and rejection of this one bad unit is critical for the prevention of weapon malfunctions and possible injuries to personnel... [Pg.368]

Quality assurance, inspection and certification of organic foods... [Pg.41]

Installation of fire water underground as early as possible Performance acceptance test Quality assurance inspections Emergency plan/drill... [Pg.27]

If the accuracy of the design space model cannot be established a priori with statistical significance within portions of the parameter hyperspace, operation in such regimes should initiate supplementary quality assurance (inspection) activities until the design space model can be updated and revalidated. [Pg.338]

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. [Pg.159]

Other documentation targeted for storage in archives include the master schedule sheet, copies of protocols, and records of quality assurance inspections, summaries of training and experience, job descriptions, records and reports of the maintenance and calibration and inspection of equipment. In any case, ensure that the protocol or SOPs address the proper archiving of appropriate materials. [Pg.1274]

With regard to Quality Assurance inspections, it can be observed that, in principle, there are two kinds of them Either an inspection is directly concerned with the conduct of a specific study or study part, or the inspection is taking stock of the general state of the test facility in a manner not related to any study. Both of these will have to be described in detail in the respective Quality Assurance Standard Operating Procedures. [Pg.139]

The key to the successful operation of Quality Assurance functions lies, as everywhere, in a good planning. Logically, prospective planning should concern not only Quality Assurance inspections, but it has to be applied to all of the various Quality Assurance activities. However, due to the special nature of study- and process-based inspections, and to the time restrictions connected with them, the need for proper instruments and procedures is very much obvious in this special area. Certain critical study activities may be performed in only a few minutes if the Quality Assurance inspector would wish to inspect exactly this specific phase of the study, he or she had better be present at the precise time, when this activity would be going on. Since this is a prerequisite for the required precision in the attendance at specific activities or study phases, a well developed communication network between Quality Assurance and study personnel can be seen as an obvious necessity. [Pg.148]

Quality Assurance personnel is required by the GLP Principles to promptly report any inspection results in writing to management and to the Study Director,. .. . Since it is also required that records of such inspections should be retained , the work of the Quality Assurance personnel exhibits in many aspects the resemblance of a study There is a plan (exacted by the master schedule), there are raw data (the inspection results, e.g. the filled-in check- lists, see as an example figure 14), and there will be a final report on the findings which has to be submitted to the relevant authorities, in this case the Study Director and the responsible management. However, since the Quality Assurance reports serve an important function, the attention of the addressees of these reports should not be blunted through continuous inundation by reports full of irrelevant details. Therefore, in the case of the Quality Assurance inspection report, this document should describe only the deficien-... [Pg.153]

Figure 14 Example of some excerpts from a Quality Assurance inspection report, with additional remarks by the Quality Assurance inspector. Figure 14 Example of some excerpts from a Quality Assurance inspection report, with additional remarks by the Quality Assurance inspector.
One might possibly be tempted to interpret the economy issue in Quality Assurance resource utilisation also in an additional way, namely that Quality Assurance could perform report audits for short-term studies in just a random fashion, analogous to the inspectional practice. This possibility, however, is precluded by the GLP Principles. They require that Quality Assurance inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately... [Pg.161]

Quality assurance inspections of Study were made and... [Pg.165]

It may be debatable for how long it is useful and thus necessary to retain records, samples and specimens from studies, or check-lists from Quality Assurance inspections, whose results may long have been superseded by new data or by simple experience from the use of the test item. [Pg.279]

National GLP monitoring authorities may request information relating to the nature and dates of Quality Assurance inspections. However, Quality Assurance inspection reports should not normally be examined for their contents by national monitoring authorities as this may inhibit Quality Assurance when preparing inspection reports. Nevertheless, national monitoring... [Pg.403]

The structural integrity of the reactor coolant system support components is ensured by quality assurance inspections in accordance with Section III of the ASME Code during fabrication. The non-integral supports are procured by individual equipment specifications which impose appropriate quality assurance requirements commensurate with the respective component s functions. [Pg.212]

Have quality assurance inspection reports, covering fabrication, assembly and installation, been completed in accordance with the project s quality assurance plan and reports filed with the equipment and design basis documentation ... [Pg.118]

Quality assurance includes the setting of standards with documentation and also includes the documentation of the method of checking against the specified standards. Quality assurance can also include a third-party approval from a recognized authority, such as ISO. With quality assurance, inspection and control are still the basic approach, but in addition one would also expect a comprehensive quality manual jointly agreed by the supplier and the purchaser. [Pg.82]

Internal auditing for compliance with the Quality Assurance Inspection Manual... [Pg.42]


See other pages where Quality Assurance Inspections is mentioned: [Pg.112]    [Pg.156]    [Pg.257]    [Pg.360]    [Pg.67]    [Pg.210]    [Pg.11]    [Pg.346]    [Pg.99]    [Pg.83]    [Pg.138]    [Pg.141]    [Pg.153]    [Pg.157]    [Pg.327]    [Pg.350]    [Pg.161]    [Pg.144]   


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