Technical documents

The documentation that supplements the plant specific EOPs and provides justification for the EOP development programme can be divided into two groups, the technical documents and the administrative documents. The list that follows is not exhaustive. There is no fixed requirement as to what type of documents should be available. It is up to the nuclear power plant to decide which specific documents will be added for the review, for licensing or QA purposes or any other reasons. Some of the documents logically follow the structure of the EOP reference system and its methodology if such has been used as a basis for the programme. 

Items (a), (b) and (c) below are recommended as the minimum technical documentation supporting the EOP s development, verification, and validation  

These are a self-sufficient full set of documents providing the instructions which have to be available in the control room. They can be either computerized or in paper form. The EOPs shall contain all the information necessary for the operator to do his job. Not only do they need to contain the instructions themselves, but also all the diagnostic tools, the monitoring tools as well as the administrative and technical notes and/or warnings. The information can be in different formats text, charts, flow diagrams, figures, tables of values, etc. A detailed hst of possible elements contained in an EOP is provided in Ret [3]. 

These documents provide a detailed explanation of the overall organization, purpose and structure of every procedure and its hnks with other procedures. They also provide details on each action, instruction and element of each procedure. The two basic purposes these documents serve are  

During EOF development the proposed strategies and actions are checked through an analysis to optimize and validate the operating strategies before transcribing them into specific operator instructions. These analyses should also be included in the EOF background document, or at least referenced. 

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R. E. Mowers Cyogenic Properties ofPoly(Chlorotrifluoroethylene), Technical Document Report No. RTD-TDR-63-11, Air Eorce Contract No. AE04(611)-6354,1962. 

Brown, D. F., W. E. Dunn, and M. A. Lazaro, 1997a, CASRAM The Chemical Accident Stochastic Risk Assessment Model Technical Documentation, BetaVersion 0.8, ANL,... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

Bacharach. Combustion and Environmental Measurement Instruments. Technical documents and promotional literature. Bacharach, Inc., USA, 1998. 

Schuck, Joseph. Boiler Water Treatment, A Discussion of the Basic Control Programs. Technical Document No. 84-01 ChemLink (now Baker Petrolite), USA, 1984. 

Figure 6.1 Diagrammatic representation of the organization of the Common Technical Document (CTD) (from ICH M4 Guide).

M4(R3) Common Technical Document Superstructure document granularity... 

Electronic Common Technical Document (eCTD) specifications. www.ich.org... 

Assembling technical documentation that provides evidence of conformity with the essential requirements is a fundamental part of all conformity assessment procedures. The appropriate essential requirements annex may be used as a checklist, against which documents demonstrating the adopted solutions may be identified... 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

Readers may also be aware that under the auspices of the ICH a document is being developed on the organization of the Common Technical Document. It is intended that this will result in a common format (and, to at least some extent, content) of marketing authorization applications in the jurisdictions of those party to the ICH process (Japan, the EEA, and the United States). At the time of writing, a draft document had been circulated for comment. When adopted and implemented, this will result in a considerable amendment to the format and sequencing of information in a marketing authorization application. 

CPMP/1CH/2887/99 Note for guidance on Organisation of Common technical document Draft consensus guideline (released for comment July 2000)... 

We will discuss the main features of the offered system. At the lower level the state of all potentially dangerous sites - both natural and technogenic will be controlled. The periodicity and the facilities for carrying out the control over these sites is the concern of special expert subsystems, established on the basis of technical documents (for technical sites) or of data from the Ministry for ecological protection (for natural objects). For example, the sites of the first category should be equipped with special checking for the reliability of the security systems located directly on the site and continuous supervision of the status. 

The accident investigation report is written using the principles of technical documentation. Items 1-4 are objective and should not include the authors opinions. Items 5-7 appropriately contain the opinions of the authors (investigation team). This technical style allows readers to develop their own independent conclusions and recommendations. As a result of these criteria, the accident investigation report is a learning tool, which is the major purpose of the investigation. 

Adcock, S.W. 2009b. The Canadian Database of Geochemical Surveys Technical documentation for the data model. Geological Survey of Canada Open File 5938, 1 CD-ROM. 

The main feature of the harmonisation is guidelines and Common Technical Documents (CTD). The CTD gives a harmonised format and content for new product applications and in 2003 there was an agreement on implementation, in USA, Europe and Japan. 

PROBLEMS OF RUBBER GOODS IN TECHNICAL DOCUMENTS OF THE EUROPEAN COMMUNITY... 

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