Issues of documents

The pertinent issue of documents may not be the latest issue. You may have reason to use different issues of documents such as when building or repairing different versions... 

It is unnecessary to remove invalid or obsolete documents if you provide staff with the means of determining the pertinent issues of documents to use. There are often valid reasons for retaining obsolete documents. What may be obsolete in one situation may not be obsolete in another. In simple terms an obsolete document is one which is no longer required for operational purposes. As stated earlier, there are cases where various issues of the same document may need to be used and in such cases none of the documents is obsolete. One may need to remove copies of previous versions of a document but retain the master for reference purposes. You cannot demonstrate to an assessor that you corrected a deficiency if you don t retain the version that contained the deficiency as well as the subsequent version. 

Several minor lapses of the same content (incorrect issue of documentation in use in several areas) show a system breakdown and are therefore regarded as serious and upgraded as such. 

In spite of the fact that this is not intended to be a handbook, some very brief comments on what may be considered organizational aspects of laboratory practice may not be out of place. These may be considered within the wider context of precautions that should be exercised in all analytical laboratories. First of all, attention is drawn to the important principles of quality control, to procedures for numerical analysis of data, and to the important issue of documentation, all of which have been covered succinctly in a review (Keith et al. 1983) and more extensively in books (Keith 1988 1992). It cannot be too strongly emphasized that the analyst is part of a team, and that he or she should play an active part in both the planning and execution of the proposed investigation thereby, many pitfalls — and unnecessary irritation — may be avoided. For example, some conflict may arise over the number of samples required to answer the specific questions that are posed, and resolution of this issue should take priority in planning discussions. In addition, the level of accuracy should be decided at the outset, and care taken that sufficient samples are available for duplicates to be preserved for reanalysis if necessary — and that these are preserved in an acceptable manner. It is worth emphasizing that analytical results may be used in social or political contexts in which numbers may be readily misused. The level of accuracy and interpretation of the data are therefore of cardinal importance in such circumstances. 

William Walker s observation reasonably raises the issue of documenting the supply chain network because the scope of the supply chain extends far beyond company boundaries. Supply chain improvement efforts bring the need for efficient tools to chart supply chain flows. These should reduce the risk of bogging down the effort in tedious and unneeded analysis work. 

Code of Federal Kegulations Tide 29, Occupational Safety and Health Superintendent of Documents GPO Washington, D.C. 20402 Safety regulations and standards issued by OSHA. 

The changes have been in patent documents themselves as weU as in the means of documentation. The need to cope with a rapidly increasing volume of patent appHcations led a number of patent offices to switch, mostiy between 1964 and 1979, from a system in which all appHcations were examined and only those found to be worthy were issued a patent, to a system in which all appHcations are published and may or may not be examined at a later date or will ever become a patent. In the 1940s most pubHshed patent documents were patents in the 1990s most are unexamined appHcations. 

This annex of the Rules contains a flowchart identifying the key stages in the audit process from the initial request for certification through to issue of the certificate. Pre-audit is not a documentation audit. Supplier must provide all required data prior to site visit. 

It is a fact of life that people don t give a high priority to installing amendments to documents in their possession. Some will carry out the amendments immediately on receipt while others will allow them to pile up in the pending tray (out of sight, out of mind). To keep copies of your documents up-to-date you should adopt a method of issuing changes that minimizes the effort required to amend copies of documents. There are several options ... 

In the world of documents there are two categories those that are controlled and those that are not controlled. A controlled document is one where requirements have been specified for its development, approval, issue, revision, distribution, maintenance, use, storage, security, obsolescence, or disposal. You do not need to exercise control over each of these elements for a document to be designated a controlled document. Controlling documents may be limited to controlling their revision. On the other hand, you cannot control the revision of national standards but you can control their use, their storage, their obsolescence, etc. Even memoranda can become controlled documents if you impose a security classification upon them. 

The principal elements of document control are illustrated in Figure 5.5. This process provides for bringing existing documents under control, for controlling the preparation of new documents and for changing approved and issued documents. Each process could represent a procedure or a form. The processes may differ depending on the type of documents and organizations involved in its preparation, approval, publication, and use. One procedure may cater for all the processes but you may need several. 

Planning new documents, funding, prior authorization, establishing need, etc. Preparation of documents, who prepares, drafting process, text, diagrams, forms, etc. Standards for the format and content of documents, forms, and diagrams Document identification conventions Issue notation, draft issues, post approval issues... 

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 ... 

The term issue in the context of documents means that copies of the document are distributed. You will of course wish to issue draft documents for comment but obviously they cannot be reviewed and approved beforehand. The sole purpose of issuing draft documents is to solicit comments. The requirement should be that the documents are reviewed and approved prior to use. Some organizations insist that even drafts are approved for issue. Others go further and insist that copies cannot be taken from unapproved documents. This is nonsense and not what is intended by the standard. Your draft documents need to look different from the approved versions either by using letter issue notation (a common convention) or by printing on colored or watermark paper. If the approved document would carry signatures, the absence of any signature indicates that the document is not approved. 

The index may be issued or, so as to preclude use of obsolete indices, it may be prudent to keep no hard copies. With organizations that operate on several sites using common documentation it may well be sensible to issue the index so that users have a means of determining the current version of documents. 

The standard requires the supplier to ensure that the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the qualify system are performed. Note that the requirement does not apply to data. 

The standard requires purchasing documents to include, where applicable, the title or other positive identification, and applicable issue of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. 

Do record the issue status of documents used to fabricate product. 

The draft document address the issue of solvent recovered from a process and the use of these solvents in the same process or reused for different processes. It requires that recovery procedures be validated to ensure cross-contamination between recovered solvents and monitoring of the solvent composition at suitable intervals during the process. 

Other important alternate electrochemical methods under study for pCO rely on measuring current associated with the direct reduction of CO. The electrochemistry of COj in both aqueous and non-aqueous media has been documented for some time 27-29) interferences from more easily reduced species such as O2 as well as many commonly used inhalation anesthetics have made the direct amperometric approach difficult to implement. One recently described attempt to circumvent some of these interference problems employs a two cathode configuration in which one electrode is used to scrub the sample of O by exhaustive reduction prior to COj amperometry at the second electrode. The response time and sensitivity of the approach may prove to be adequate for blood ps applications, but the issue of interfering anesthetics must be addressed more thorou ly in order to make the technique a truly viable alternative to the presently used indirect potentiometric electrode. 

A patent file history, also called a file wrapper, is the complete set of documents for a patent filed with the U.S. Patent and Trademark Office. These papers chronicle communications and actions taken by the patent examiner, the applicant, and the applicant s attorney from the time of patent application to issue. File histories are available from commercial services such as Intellectual Property Network (described below). 

---