Report documents internal

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. 

The importance of documenting internal processes in the form of SOPs has already been mentioned. Any activity forming part of the development plan is a process. Each SOP should be looked on as a dynamic document and opportunities for improving each process should be sought continually. For example, the time that elapses between the last patient completing a clinical trial and production of the statistical report is an activity very much on the critical path. 

Detailed review of reported data reduces laboratory risk of producing invalid data. Important features of internal data review are the spot checks of calculations the verification of the acceptability of calibrations and laboratory QC checks and the second opinion in data interpretation. Laboratories document internal review in appropriate checklist forms that are kept on file with the rest of the project documentation and sample data. The internal data review process is generally described in Laboratory QA Manual and detailed in appropriate SOPs. 

The data management system through a series of reports and internal checks provides the documentation and verification that data have been completely cleaned. 

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. 

The longer that the chamber is out of tolerance, the more likely it is that the samples will be impacted. While the ICH states that excursions longer than 24 h should be evaluated and reported, any unplanned excursion should be evaluated and documented internally through some type of formal process. 

In December, the US Senate Select Committee on Intelligence released a summary report documenting the crimes of torture and enforced disappearances of terrorist suspects by the Bush-era CIA Drawing on millions of internal CIA docu-... 

This report documents the structural adequacy of Combustion Engineering s (C-E s) System 80+ ALWR steam generator internals to withstand a steam line rupture. 

Stress Engineering, Inc. is one of the major companies that has run multiple full-scale tests to validate the performance of numerous onshore pipeline composite repair products that are available in the market. Full reports documenting the vahdation of composite repair products are available (Alexander, 2005 Worth, 2005 Francini and Kiefner, 2006). Various publications on the development of the CRS for offshore riser application are also available under Chris Alexander of Stress Engineering, Inc. A program cosponsored by the Pipeline Research Council International, Inc. (PRCI) involves the full-scale testing of corroded risers with a CRS placed in a seawater test facility for 10,000 h subjected to combined pressure, tension and bending loads (Alexander, 2012). 

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. 

NIOSHTIC on compact disc from the Canadian Center for Occupational Health and Safety (ean buy at CCOHS web site). "NIOSHTIC(R) is a bibliographie database which provides comprehensive international coverage of documents on occupational health and safety, as well as related fields. It eontains detailed summaries of over 200,000 articles, reports and publications, spanning over 100 years. NIOSHTIC(R) sources include over 160 scientific and technical journals, NIOSH reports (published and unpublished), NIOSH research bibliographies, abstracts from CIS Abstracts, and personal files from respected professionals on selected topics. 

Produces internal control documentation and wemmentally required reports. Manifest printing from files containing information on approved transporters and disposers, waste materials, and historical data. 

Because of this, it s sensible to consider regular documentation as opposed to relying solely on oral reports or informal hallway updates. Even if your sponsors don t require much formal reporting, internal documentation of the group process can help keep the process itself on track and can also provide the foundation for documentation of the end results. 

The Failure and Inventory Reporting System (FIRS) program was developed by the Geological Survey Division of the U.S. Department of the Interior for safety and pollution prevention devices on offshore structures that produce or process hydrocarbons. The program collected data on mechanical and some electromechanical systems on offshore oil platforms. About 8,000 failure events were documented. Access has been limited to internal materials management system use. No real-time access or periodic output products have been available. 

The review of the data portion of the Indian Point 2 (IP2) and 3 (IPS) PRA (a 1982 internal document prepared by Consolidated Edison and the New York Power Authority) is confined to the plant-specific and generic component failure and service hour data sections because these were the only segments available to the reviewers. The LERs produced during a ten-year span of IP2 s operation were evaluated to determine their applicability to the PRA data needs. It was eventually decided to use only the LERs generated after IP2 became critical (from May 23, 1973 to December 31, 1979) for the component data base development, based on the availability of failure event information and more uniform operability, testing, and reporting criteria. 

World Commission on Environment and Development (1987) Report of the World Commission on Environment and Development Our Common Euture. Transmitted to the General Assembly as an Annex to document A/42/427 - Development and International Co-operation Environment. http //nnnv.un-documents.net/wced-ocf.htm. (Accessed May 2010). 

Any validation and verification work performed must always be documented in such a way that the results can be checked and the scope of a method is clear. International standards, e.g., ISO 17025, contain separate sections regarding documentation, which should be observed. The NMKL procedure on method validation states that It is of particular importance that the report includes all raw data from the experimental work, or references to where such data can be found . In some circumstances this complete documentation is impractical. Even where it is practical, it is usually impossible to publish these results together with the methods. 

Chemical Abstracts. Chemical Abstracts (CA) [23] is a collection of chemical information, with nearly 16 million abstracts of journal articles, patents, and other documents. In addition, the CAOLD database contains over 3 million abstracts from 1907-1966. Sources for CA include more than 8000 journals, patents, technical reports, books, conference proceedings, and dissertations from around the world. CA patent database covers 29 national patent offices and two international bodies. About 16% of the CA database, approximately 2.5 million records, are from the patent literature. Chemical Abstracts is commercially available from the American Chemical Society in several formats. 

Those wishing to find out more about these items should consult the various publications of the Internal Revenue Service. They can most easily be located by using the United States Government Publication Index, which is available in most large libraries. The individual reports can be purchased from the Superintendent of Documents in Washington, D. C. 

Industrial Chemical Prioritization and Determination of Critical Hazards of Concern. Technical Annex and Supporting Documents for International Task Force (IIF)40, Industrial Chemical Hazards Medical and Operational Concerns. UASCHPPM Report 47-EM-6154-03. US Army Center for Health Promotion and Preventive Medicine, Aberdeen Proving Ground, MD, 2003. 

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