Project documentation

As was stated in Section 1.2.1, the project design should start with a clear specification defining the product, capacity, raw materials, process, and site location. If the project is based on an established process and product, a full specification can be drawn up at the start of the project. For a new product, the specification will be developed from an economic evaluation of possible processes, based on laboratory research, pilot plant tests and product market research. 

The technical know-how for the process could come from the operating company or could be licensed from the contractor or a technology vendor. The operating company, technology provider, and contractor will work closely together throughout all stages of the project. 

On many modern projects, the operating company may well be a joint venture between several companies. The project may be carried out between companies based in different parts of the world. Good teamwork, communications, and project management are therefore critically important in ensuring that the project is executed successfully. 

General correspondence within the design group and with 

Government departments Equipment vendors Site personnel The client 

In good contracts, organisation of the correspondence and project documentation is clearly stipulated. The number of copies and the addresses are precisely defined. Additional stipulations or demands may be  

All documents should be assigned a code number for easy cross referencing, filing and retrieval. 

The design engineer should develop the habit of setting out calculations so that they can be easily understood and checked by others. It is good practice to include on calculation 

Drawings should conform to accepted drawing conventions, preferably those laid down by the national standards. The symbols used for flow-sheets and piping and instrument diagrams are discussed in Chapter 4. Drawings and sketches are normally made on detail paper (semi-transparent) in pencil, so modifications can be easily made, and prints taken. 

In most design offices Computer Aided Design (CAD) methods are now used to produce the drawings required for all the aspects of a project flow-sheets, piping and instrumentation, mechanical and civil work. 

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As shown in Figure 1.5 and described in Section 1.4, the design and engineering of a chemical process requires the co-operation of many specialist groups. Effective cooperation depends on effective communications, and all design organisations have formal procedures for handling project information and documentation. The project documentation will include ... 

Each piece of equipment shown on the flow-sheet must be identified with a code number and name. The identification number (usually a letter and some digits) will normally be that assigned to a particular piece of equipment as part of the general project control procedures, and will be used to identify it in all the project documents. 

Source From UNIDO, Project Document, United Nations Industrial Development Organization, Industrial Sectors and Environment Division, Vienna, Austria, April 1995. 

WHO/IPCS. 2005. Chemical-specific adjustment factors for interspecies differences and human variability Guidance document for use of data in dose/concentration-response assessment. Harmonization Project Document No. 2. http /whqlibdoc.who.int/publications/2005/9241546786 eng.pdf... 

A WHO/IPCS (2005) Harmonization Project Document has proposed using chemical-specific toxicological data instead of default assessment factors, when possible. The concept of Chemical-Specific Adjustment Factors (CS AFs) has been introduced to provide a method for the incorporation of quantitative data on interspecies differences or human variability in either toxicokinetics or toxicodynamics into the risk assessment procedure, by modifying the relevant default UF of 10. Incorporation of toxicokinetic or toxicodynamic data becomes possible if each factor of 10 is divided into appropriately weighted sub-factors as suggested by Renwick (1991, 1993) and adopted by WHO/IPCS (1994), see Section 5.2.1.3. 

Under this project, an IPCS Harmonization Project Document on the Principles of Characterizing and Applying Human Exposure has been published (WHO/IPCS 2005). This document sets out the characteristics of exposure assessment models that should be described to aid in model selection by exposure assessors. The document summarizes current practice in exposure modeling and principles for evaluating exposure models, but does not provide a comprehensive list of existing exposure models. The focus of the document is on the discussion of general properties of exposure models and how they should be described. The characteristics of different modeling frameworks are examined, and 10 principles are recommended for characterization, evaluation, and use of exposure models in order to help model users select and apply the most appropriate models. The report also discusses issues such as validation, input data needs, time resolution, and extrapolation of the model results to different populations and scenarios. 

WHO/IPCS. 2004. IPCS glossary of key exposure assessment terminology. In IPCS Risk Assessment Terminology. Harmonization Project Document No. 1. Geneva WHO. http //www.inchem.org/documents/sids/ sids/risk assess.pdf... 

Environmental and Social Impact Assessment. Baku-Tbilisi-Ceyhan Georgia. Non-technical guiding summary. Project documentation for public advertising April 2002. 

User requirement specifications cover more aspects than only the GMP requirement, because the URS is not written only for the validation procedure in fact, a URS is a very important project document covering technical as well as economic requirements of the technical system. Pharmaceutical manufacturing departments not only check the GMP aspects of a system additionally, following good engineering practice they will review the technical and economic aspects of a technical system. Obviously, the more experience a company gains, the more comprehensive a URS become. Past experiences such as project faults, inefficient technical systems, and bad commissioning can be included in a URS. 

Identify the project documentation (and task responsibilities) to support the validation program... 

Finally, it is important that biomonitoring projects document (in widely available reports or in the communications database discussed in Chapter 6) the ethical challenges and solutions (and evaluations of those solutions) that they face. Biomonitoring sponsors could aid in this task by requiring that project proposals address how they will document the issues. The data can... 

The selection of deliverables for each validation level may differ from those indicated in the Deliverables Matrices depending on the project documentation deliverables policies used by each regulated company. 

Support documentation such as maintenance records, change control records, and project documentation should be retained as required by the GLPs. Refer to 58.195. This requirement is applicable to paper-based and electronic-based records. 

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. 

Data validation is a systematic process for reviewing a body of data against a pre-established set of acceptance criteria defined in a project document (NFESC, 1999). If a systematic review establishes that the data meet the acceptance criteria specified in the SAP, then the data are considered to be valid hence the term... 

References to the SAP and other project documents used in data collection... 

The study director should review study procedures and data at every stage of the project. Documentation of regular reviews, frequency, and compliance of... 

Broins Companies, The Future is Now for Cellulosic Ethanol, USDA-ERS Biofuels Modeling Workshop, Washington DC (2007). http //www.farmfoundation.org/projects/documents/ BroinCoCellulosic.pdf... 

Part 2 of this Harmonization Project Document is on data quality for chemical exposure assessment, because of its importance to the acceptance and credibility of the evaluation of uncertainty in an exposure analysis. Data quality for the purposes of this report deals with the completeness and clarity with which uncertainty is explained. This means that data with high uncertainty may be of high quality if the data and its uncertainty are clearly explained and carefully documented. A high-quality evaluation of uncertainty in an exposure analysis would provide the readers with the ability to re-evaluate all the choices and trade-offs made in the evaluation and to explore alternative choices and trade-offs. This is a difficult goal to achieve in most cases. 

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