Report documents external

In the case of incident investigation, a major milestone is completed when the final incident investigation report is submitted. The incident report documents the investigation team s findings, conclusions, and recommendations. This chapter describes practical considerations for writing formal incident reports, a discussion of the attributes of quality reports, and the issue of commimicating the report findings to affected persons, both internally and externally. 

Revision 2 The Pre-Construction Safety Report (PCSR), Revision 2 has been completely restructured to accommodate general Nil comments on claims, arguments and evidence. The PCSR also includes a summary of new documents. External Hazards, a revised European DCD and a revised Environment Report. The PCSR also refers to the results of new evaluations, submitted in documents APIOOO Equivalency / Maturity Study of the U S. Codes and Standards, APIOOO UK Safety Categorization and Classification of Structures Systems and Components, and APIOOO UK Safety Categorization and Classification Methodology. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

It is more common for a complete PSA to take 16 to 24 months with several rnuiilhs tor preparation, review, and revision of the final report. The final report for a level 3 nuclear plant PSA, includes an analysis of external events, in several large volumes. Completeness and consistency in such a large document requires several months of team leadership and selected analysts. Given these resources, it may be possible to complete the technical analyses for a Level 1 PSA in a year or less, but the final report will take several more months to prepare. 

Aluminium toxicity is a major stress factor in many acidic soils. At soil pH levels below 5.0, intense solubilization of mononuclear A1 species strongly limits root growth by multiple cytotoxic effects mainly on root meristems (240,241). There is increasing evidence that A1 complexation with carboxylates released in apical root zones in response to elevated external Al concentration is a widespread mechanism for Al exclusion in many plant species (Fig. 10). Formation of stable Al complexes occurs with citrate, oxalate, tartarate, and—to a lesser extent— also with malate (86,242,243). The Al carboxylate complexes are less toxic than free ionic Al species (244) and are not taken up by plant roots (240). This explains the well-documented alleviatory effects on root growth in many plant species by carboxylate applications (citric, oxalic, and tartaric acids) to the culture media in presence of toxic Al concentrations (8,244,245) Citrate, malate and oxalate are the carboxylate anions reported so far to be released from Al-stressed plant roots (Fig. 10), and Al resistance of species and cultivars seems to be related to the amount of exuded carboxylates (246,247) but also to the ability to maintain the release of carboxylates over extended periods (248). In contrast to P deficiency-induced carboxylate exudation, which usually increases after several days or weeks of the stress treatment (72,113), exudation of carboxylates in response to Al toxicity is a fast reaction occurring within minutes to several hours... 

EPA. 1983b. Reportable quantity document for acrylonitrile. Cincinnati, OH U.S. Environmental Protection Agency, Environmental Criteria and Assessment Office. External Review Draft ECAO-CIN- R005. 

A very complete description of the accident, originating from internal as well as external, independent qualified documents or public investigation reports available from renowned institutes or companies such as CSB, NTSB, OSHA, TNO, INERIS, DNV, etc. Many recommendations and lessons to be learned are available. The coding has been done in an extensive way and an extensive abstract is available. 

An application on the prescribed form is submitted to the Department of Drug Registration (DDR) of the State Food and Drug Administration (SFDA). The DDR evaluates the completeness of the document and then forwards it to the Center for Drug Evaluation (CDE) for technical review. External experts may be consulted, and the CDE compiles a technical report for the DDR. 

All clinical trials should be subjected to QA, either by an in-house department or by external consultants. QA is defined as all those planned and systematic actions that are established to ensure that the trial is performed and the data generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements(s) (ICH GCP 1 -46). Those persons... 

Validation requires money, time, planning, and documentation. It also, however, requires human resources to push the buttons, collect the data, submit the samples, analyze the collected samples, summarize the reports, and gather the required signatures. Most validations are very resource-intensive undertakings. Somehow companies must assure that the requisite resources are available. Although not recommended, these resources may be external (contracted laboratory, consultants, etc.). With the exception of a qualified contract laboratory, the... 

Requirements for data presentation, records, and reporting Audit trail requirements and copying of records Communication with external devices Networking requirements Performance requirements Availability Security Maintenance Documentation... 

The other registration problem is reassessing. The requirements for the cissessment report are not yet clear. External experts working from case to case for the State Institute for Drug Control are very busy and overloaded with documentation. They are underpaid for the cissessment reports cind payments are sometimes delayed. The registration fees cannot... 

The testing and qualification of reference standards should continue such that the necessary documentation (internal and external reports, certificates of analysis, stability reports, supporting raw data) is complete from both a regulatory and scientific standpoint at the time of the NDA filing. 

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