Vendor documents

Install all hardware devices according to design drawings and vendor documentation. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

The use of a predefined checklist based on the URS to review the vendor documentation will assist the exercise and record that the key issues have been addressed in each one of the documents. The review team can also use the checklist to ensure that requirements are not duplicated and causing ambiguity. 

Vendor documentation Vendor audit reports Engineering peer reviews Module testing Protocols Protocol reports... 

Columns and review sections in journals or newsletters can help the professional keep abreast of new resources or provide comparative information on established resources in selected areas. Collections of reviews are also available online in such sources as Comprehensive Core Medical Library (CCML) by Ovid Technologies, Inc., Book Review Index (online and in print) by Wilson, and the National Library of Medicine s TOXLINE database. Reviews of popular works dealing with consumer health or environmental concerns can also be found in newspapers, popular magazines, and consumer organization newsletters. Summaries and reviews of online databases and databanks can be found in the information science journals, directories of online resources, and produc-er/vendor documentation. 

After combustion to remove the carbonaceous deposits, the catalysts are treated to disperse active metals. Vendor documents claim more than 95% recovery of activity and selectivity in these regenerations. Catalysts can undergo successive cycles of use and regeneration, providing long functional life with these expensive materials. 

Other PK/PD Software Kinetica, WinNonMix, and Trial Simulator are examples of other software tools that may be utilized within PK/PD organizations. Each of these products provide example tests (26-28) that may form the basis of the OQ. In many circumstances, it will be difficult to anticipate the full range of use of some tools. Nevertheless, the vendor documentation generally provides a wide range of examples of functionality, which can be incorporated into an OQ. 

A proper cost and economic analysis can only be made after all the invited manufacturers have fully complied with the details of the enquiry specification. The engineer must satisfy himself that this requirement has been properly met, otherwise a low bid price may indicate non-compliance or poor understanding of the enquiry specification. Apart from the important technical requirements there are often other engineering considerations that should be taken into account, e.g. vendor documentation, spare parts, delivery schedule, obsolescence, testing and inspection. Some of these aspects have a definite cost impact whereas some are somewhat intangible, e.g. history of performance, delivery schedule, obsolescence. 

While for the most part we have been able to avoid using Laplace transforms to describe controllers, there are many text books that do not. Many of the DCS vendors document their system in this way - which is incorrect since they should only be used for analog controllers. However so that the engineers can recognise them, the transforms for the common types of controller are listed here - along with their time domain equivalents. 

The hardware and software used to implement LIMS systems must be vahdated. Computers and networks need to be examined for potential impact of component failure on LIMS data. Security concerns regarding control of access to LIMS information must be addressed. Software, operating systems, and database management systems used in the implementation of LIMS systems must be vahdated to protect against data cormption and loss. Mechanisms for fault-tolerant operation and LIMS data backup and restoration should be documented and tested. One approach to vahdation of LIMS hardware and software is to choose vendors whose products are precertified however, the ultimate responsibihty for vahdation remains with the user. Vahdating the LIMS system s operation involves a substantial amount of work, and an adequate vahdation infrastmcture is a prerequisite for the constmction of a dependable and flexible LIMS system. 

The most effective specification is that which accomplishes the desired result with the fewest requirements. Properties and performance should be emphasized rather than how the objectives ate to be achieved. Excessive demonstration of emdition on the part of the writer or failure to recognize the usually considerable processing expertise held by the vendor results in a lengthy and overly detailed document that generally is counterproductive. Redundancy may lead to technical inconsistency. A requirement that cannot be assessed by a prescribed test method or quantitative inspection technique never should be included in the specifications. Wherever possible, tests should be easy to perform and highly correctable with service performance. Tests that indicate service life are especially useful. Standard test references, eg, ASTM methods, ate the most desirable, and those that ate needed should be selected carefully and the numbers of such references should be minimized. To eliminate unnecessary review activity by the would-be complier, the description of a standard test should not be paraphrased or condensed unless the original test is referenced. 

Disaster Planning. Plant managers should recogni2e the possibiHty of natural and industrial emergencies and should oversee formulation of a plan of action in case of disaster. The plan should be weU documented and be made known to all personnel critical to its implementation. Practice fire and explosion drills should be carried out to make sure that all personnel, ie, employees, visitors, constmction workers, contractors, vendors, etc, are accounted for, and that the participants know what to do in a major emergency. 

Another useful approach is to attempt to get a broad review of the specification draft by operations, maintenance, and engineering. The specification must have an author who can write the basic document and who later edits the draft into the scope and language of the final specification. Single authorship, with committee review, is preferred over committee authorship. Only in rare instances is vendor participation in the specification authorship really justified, except in partnership relationships. 

While it is somewhat tedious to document the myriad details that have at this point been agreed to, it is time to rewrite the inquiry specifications. Care should be taken regarding the vendor s cardiac health to use the same verbage so as not to appear to be springing surprises. The best way to upset the vendor is to write into the specification something completely new or different from all the previous agreements. 

After the coordination meeting, the user will begin receiving drawings, reports, and all the documents called for in the contract. These are reviewed and returned to the vendor as reviewed without comment, or... 

This section provides a detailed example of flare system specification. This is an example of a formal design document that would be provided by the plant designer to a flare system vendor. The reader should consider this section as an example of the types of information and level of detail needed in specifying the system, however the format and organization might certainly be changed to suit the particular needs of the plant operations. 

The vendor shall supply the following documents and data ... 

Comments by N P Refinery on the Vendor s documents do not relieve him of his responsibility. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Prior to orders being placed the purchasing documents should be checked to verify that they are fit for their purpose. Again this requirement is appropriate to subcontracts but only if you submit your purchasing documents to your vendors. The extent to which you carry out this activity should be on the basis of risk and if you choose not to review and approve all purchasing documents, your procedures should provide the rationale for your decision. The standard does not require that the review and approval be documented. In some cases orders are produced using a computer and transmitted to the vendor directly without any evidence that the order has been reviewed or approved. The purchase order does not have to be the only purchasing document. If you enter pur-... 

This report evaluates recent performance of DGs and all DG vendors with the exception of Transamerica Delaval, Inc. (TDl), because of the emphasis already being given to TDI diesels in other studies. For the period 1980 through 1983 inclusive, BNL reviewed and evaluated DG failure data, DG vendor inspection reports, the TDI lessons learned as they related to the other vendors, and previous pertinent studies. The data sources used for DG failure analysis were LERs, 10 CFR 50.55E, Part 21, NPRDS, and EPRI document files. The DG failures were classified relative to the DG component that failed (e.g., main bearings, starting system). The failures were also categorized and analyzed by mode, manufacturer, and cause. Manufacturers with significant failures are identified in the report. 

Another important parameter for column selection is the proper choice of sorbent porosity. The pore size of the sorbent determines the fractionation range of the column. The best way of doing this is by looking at the calibration curves of the columns, which are normally documented by the column vendor (cf. Fig. 9.3 for PSS SDV column calibration curves and PSS SDV fractionation ranges) (7). 

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