Site inspections

Anumber of defects with manual inspection indications clarified by AUGUR 4.2 records have been accepted for further operation in 1996 with prescription of next year AUGUR 4 2 inspection. Based on two consecutive inspections (1996-97 years) comparative analysis of AUGUR 4.2 data was executed. It was shown that the flaw configurations, reproduced by AUGUR 4.2 are stable and the small differences are conditioned only by system thresholds of linear coordinate and signal amplitude as well as variations in local conditions of in-site inspection. 

AUGUR-family expert NDE tools, developed in Russia, showed good capabilities of flaw sizing and characterization during on-site inspections at numerous Russian NPPs. 

Insofar as Ultrasonic Array probes have come onto the market from several years and are now moving from prototype stages into industrial tools for on-site inspections, methods and tools for acoustic characterization is becoming a real concern. Furthermore, the lack of standards, either national or European, enhances the needs for guidelines proposal. 

AIR-1 and PS-4 are used on-site for recording of A-scan data during the on-site inspection. UltraSIM is used for initial ultrasonic simulation, scan path generation and robot simulation (together with the ROBCAD robot simulation software), online control and monitoring of the real AIR-1 robot and finally for 3D reconstruction of ultrasonic A-scan data. 

On-site inspection of regions near the emergency service water intake structures revealed loss of up to 40% of the nominal pipe-wall thickness. Deposits were dried, ignited, and analyzed. A 1% solution of dried ash had... 

Determine interception points Existing site data, hydrologic for withdrawal options, areas literature site inspection of capping... 

At Site I, the prime contractor s SSAHP required daily site inspections, the documentation of safety and health deficiencies, and the abatement of deficiencies. Records of site deficiencies, however, were kept intermittently, and hazard abatement was not documented. The subcontractor s SSAHP did not address site inspections and hazard abatement, but its TSCA permit application included requirements for site inspections. Inspection documentation, however, was not available on site, and the site manager was unaware of these written requirements. The site manager did, however, indicate that he conducted site inspections using a mental checklist and that he conducted inspections of remediation equipment before each use. 

Has there been an on-site inspection by qualified persoimel to ensure diat die new equipment is installed in accordance with specifications and drawings ... 

The iiifornialioii from Tier II and on-site inspections should help the local fire department in the development of prefire plans. Tlie information submitted by facilities midcr Sections 311 and 312 must generally be made available to tlie public by state and local govermneiits during normal working hours. 

Sources of tliis information include site descriptions mid data from the preliminary assessment (PA), site inspection (SI), and remedial investigation (RI) reports. Other sources include local soil sur eys, wetland maps, aerial photographs, and reports by the National Oceanograpliic and Atmospheric Association (NOAA) and tlie U.S. Geological Sur ey (USGS). One cmi also consult with appropriate tecluiical e.xperts (e.g., hydrogeologists, air modelers) as needed to cluuacterize tlie site. 

Recommendations To the Committee requesting the inspection or to the Competent / Enforcement Authority for the site inspected. 

All phases of a multi-site regulatory study should be carried out in facilities that are members of the UK or a relevant national GLP compliance program. Pre-study test site inspections may be conducted if considered necessary. If an organization is considering using a particular test site, a copy of the test facility s current GLP certificate should be obtained and included in the QA multi-site file. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Site topography Exclusion Must have slope <1% Site must not be susceptible to flooding Shallow water table or tile drains must not interfere with sampling These are exclusion criteria that have to be carefully determined during on-site inspection Site must be level to prevent losses of agrochemical due to surface run-off and soil erosion Site must not be susceptible to runoff from other areas higher than test site... 

If the PA reveals that a contamination problem exists, but does not pose an immediate threat that warrants a removal, U.S. EPA will continue to study the site during a site inspection (SI). Based on data collected during the PA and the SI, U.S. EPA will evaluate the site using the hazard... 

FDA has recently indicated that FDA s traditional model of manufacturing site inspections and border examinations is simply not adequate in today s transformed world (Mullin, 2011). There is a general understanding that when companies outsource a function(s) to a CRO/CMO that these organisations in turn, become subject to the same regulatory responsibilities and scrutiny as their clients, i.e. control of the product s quality has to be maintained (Linna et al., 2008). 

Few in-depth studies have been made for any single accident in no case were the energetics developed to yield information on TNT equivalents nor were overpressures determined. The accidents were at industrial or government production plants and rarely was there an opportunity for an immediate on-site inspection after an incident. 

The population distribution is often defined as population density. Sources of population data for an area are census reports, detailed maps, aerial photographs, and site inspections. Special attention must be made to various... 

T. J. Novak (United States Dept, of the Army U, ed.), Microspot test methods and field test kit for on-site inspections of chemical agents. US patent 5935862. 19990810. 

As well as GCP site inspections, an examination is imdertaken of the raw or source data and records of Chemistry Manufacturing and Control (CMC), non-clinical and clinical reports that are the basis of the application. This is to ensure that the application dossier accurately reflects the source data. The procedure issued by PMDA details that list of raw data and records must be provided. The applicant is required to bring the data and records to PMDA on the specified days and when the examination finishes they should be retrieved. Therefore, the raw data and records stored at overseas sites are usually categorised as documents not to be submitted and not subject to reliability review by PMDA. Instead, the MHLW may investigate the data from non-Japanese studies at the site of storage since submission of a photocopy of the data is not permitted. 

Applications for provisional permits to operate hydraulic clam dredges have been received. On-site inspection of these dredges prior to harvesting is prescribed in the permit. One of the more notable operations seeking a provisional permit is a vessel-mounted subtidal razor clam dredge capable of harvesting clams in depths up to ten fathoms. This enterprise initially targeted the bait clam area but will shift to the human consumption area (i.e., Polly Creek) if and when bait contracts are filled. 

It is not essential to perform on-site inspections. As an alternative, evaluation questionnaires can be used. Vendors can also be certified based on an extensive review of historical analytical inspection data and their performance over the last 3 years. Alternatively, third-party audits may be conducted for a predefined period. 

Through on-site inspections for compliance with cGMPs... 

The third option outlined in Article 11 (7) provides for an exception in which, at the request of a member state of the EU, an individual inspection body in a third country can be approved following an assessment of that inspection body using appropriate means. This does not necessarily require an on-site inspection of the inspection body. However, this option has seen rather limited use, with just one instance up to mid 2003 (Swedish National Board of Trade 2003). 

Prior to starting up the process, a final check should be done to verify the status of recommended changes that emerged from the hazard and risk assessment. A site inspection should be conducted to form an impression of spatial dimensions, and the hazard and risk assessments should be brought up-to-date. Design changes at this point are expensive. 

The final step of raw material validation should involve an on-site inspection of the supplier to review the vendor s manufacturing operations and control procedures. The reliability of each vendor and how well each conforms to regulatory requirements must also be determined. 

For a stand-alone system the computer system normally undergoes factory acceptance testing at the supplier s premises, and as with associated instrumentation and regulating devices is shipped to the site, inspected, and where applicable is stored and then installed with the manufacturing process/plant equipment. 

Conditional on satisfactory on-site inspection, assembly, installation, SAT, critical instrument calibration, and design qualification, the computer system is available for the in situ qualification phases. 

Information can also be obtained by a site inspection, consideration of existing planning policies, and consideration of similar proposals. 

Performing, upon request by the sponsor, on-site inspections for selected field studies. 

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