Documentation status

Do record the design documentation status used in the performance of calculations and analyses. 

Written procedures shall define how the system will be used and controlled, and periodic review of these procedures and the validation documentation status must be carried out. The periodic review procedure should define responsibilities and should include predetermined criteria for reporting that computer system validation is being satisfactorily maintained in alignment with the project validation plan. A GMP risk assessment should form part of each periodic review to reconfirm (or not) the findings of the previous risk analysis and provide information for any revalidation that is considered necessary. 

Decision state The document status (green hook and red cross) displays whether an alternative was selected or rejected and provide an indicator for further handling of a document. In this way, all decisions in the course of a project can be captured. Beyond that, the rational behind the decision is documented by an application of the Issue Based Information System, IBIS [798]. The benefit of documenting design rationale is pointed out e.g. by Conklin and Yakemovic [607] (see also Sect. 2.5). 

To document status and the results of treatment or training and to communicate with other involved... 

Seotlonir of this document vas prepared and written ty Je Ee Kaveokls, et. ale Instrument and Electrical Develoinent Operation to present and summarize the document status of new instrument systems, ir work is greatly appreciated. 

Analytical trees can be used in a variety of ways in the system safety effort. The most common application of analytical trees in current system safety programs is probably the use of fault trees for fault tree analysis (FTA). However, analytical trees can also be used as planning tools, project description documents, status charts, and feeder documents for several hazard analysis techniques (including fault tree analysis). Analytical trees can be multipurpose, life cycle documents and represent one of the most useful tools available to managers, engineers, and safety professionals. 

Implement Corrective Closure or Control Actions and Document Status on Hazard Report Form... 

To cater for the two types of test there are two ways in which samples are selected for progress to weighed and documented status and then to submission to the biologist. 

Review of all changes made since the last review and verification of correct documentation status. 

The gas sorption characteristics of glassy polymers are known to be history dependent [e.g. 89]. Therefore, in the studies of low temperature nitrogen adsorption in the conditioned polyphenylene oxides special attention was paid to ensure a well-documented status of the polymer sample at each measurement of its sorption characteristics. The detailed investigation of nitrogen adsorption in the conditioned polyphenylene oxide was performed in [67] using the Copolymer 1 sample. 

The requirements to the test procedures, order and status of the approval are specified in international and national documents of western countries. 

INPADOC (International Patent Documentation Center) is the most comprehensive tttbliographic database of scientific and technological patent documents in the world. The stock encompasses more than 26 miUion patent documents, more than 59 miUion legal status data, and about 10 million patent famihes (January, 2003). The database contains more than 35 milhon patent citations from 71 patent-issuing organizations (European Patent Office, World Intellectual Property Organization (WlPO)) and is updated weekly with about 40 000 new citations. 

Because each country has its own patent laws, the precise meaning of the bibhographic data and the legal significance of the pubUshed patent document vary from country to country. The Patent Cooperation Treaty (PCT) provides a recommended code to distinguish the various types of documents and to simplify storage and retrieval of patent data (2), but the code is implemented differentiy by different countries. For example, in the United States an A-document in 1995 was a patent in the Nethedands, an A-document was a pubUshed unexamined appHcation. It is essential to understand each country s system to interpret the status of its patent documents. 

INPADOC INPADOC, PATOLIS, DIALOG, ORBIT, STN International Patent Documentation Center international bibliographic data patent families legal status data for 16 countries... 

Pressure-Piping Code The code for pressure piping (ANSI B31) consists or a number of sections which collectively constitute the code. Table 10-14 shows the status of the B31 code as of December 1980. The sections are published as separate documents for simplicity and convenience. The sections differ extensively. 

It may be appropriate, based upon the hazards of the materials processed, for the client company to make a final site visit during the toll shutdown activities to review the toller s methods and completeness of process termination. This review could include termination status such as removal of all hazardous wastes and verification of associated documentation, and the adequate cleanup of equipment and the process area. 

The effects attributed to air pollutants range from mild eye irritation to mortality. In most cases, the effect is to aggravate preexisting diseases or to degrade the health status, making persons more susceptible to infection or development of a chronic respiratory disease. Some of the effects associated with specific pollutants are listed in Table 7-2. Further information is available in the U.S. Environmental Protection Agency criteria documents summarized in Chapter 22. 

The safety status of the process should be periodically reviewed against the guiding principles for the original design. Monitoring of add-ons can detect potentially dangerous modifications. Process hazards analysis or process safety audits are useful tools for this review. Documentation of inherently safer principles is critical to ensure that future changes don t nullify the positive features of the initial installation. 

A PSA consists of many tasks and subtasks some tasks are performed in parallel others are in series. The experience of personnel, availability of data, computer programs, and manpower determine the PSA schedule. Other considerations are the age of the plant, its operational status, availability of documentation, peculiarities of the design, and the availability of the analyses of similar fiiants,... 

An adequately documented requirement would be a written contract, schedule of work, and/or specification. However simple the requirement, it is wise to have it documented in case of a dispute later. The document needs to carry an identity and if subject to change, an issue status. In the simple case this is the serial numbered invoice and in more complicated transactions, it will be a multi-page contract with official contract number, date, and signatures of both parties. 

Within the design documentation you will need to provide for the attachment of modification plates on which to denote the modification status of the product. 

Decide on the conventions to be used in identifying the issue status of design documents during development and following design certification. 

Amending copies of issued documents, amendment instructions, amendment status... 

Indexing documents, listing documents by issue status... 

There are two types of external documents, those in the public domain and those produced by specific customers. In some cases the issues of both types of documents are stated in the contract and therefore it is important to ensure that you possess the correct version before you commence work. Where the customer specifies the issue status of public domain documents that apply you need a means of preventing their withdrawal from use in the event that they are revised during the term of the contract. Where the issue status of public domain documents is not specified you may either have a free choice as to the issue you use or, as is more likely, you may need to use the latest issue in force. Where this is the case you will need a means of being informed when such documents are revised to ensure that you can obtain the latest version. The ISO 9000 series for instance is reviewed every five years, so could well be revised at five-year intervals. With national and international legislation the situation is rather different as these can change at any time. You need some means of alerting yourself to changes that affect you and there are several methods from which to choose ... 

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. 

The standard requires that a master list or equivalent document contol procedure identifying the current revision status of documents be established and be readify available to preclude the use of invalid and/or obsolete documents. It is important to note that this requirement only applies to documents and not to data. 

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