Resources and documentation

In order to develop and maintain a safety metrics program, various resources must be identified. These resources include data sources and measurement techniques. If a more traditional approach to measuring safety performance is utilized, such as accident and injury rates, the data should be available and if not, part of the metrics program should involve the procedures for collecting the data and collating it at a central location for analysis. 

Documentation may include the procedures for the collection, analysis, and compilation of the measurements. Benchmarks, the comparisons of the measurements to the benchmarks, and the follow-up required by those results, should be included in the documentation. Additional resources may include financial and personnel resources needed to make the program work. Complex measurement and analysis programs may run into problems if adequate personnel and financial resources are not made available. 

When developing the objectives for the safety performance program established, the data needs should be identified. Data concerns that should addressed early involve determining if the data needed for the performance measures exist and if so, is the data reliable and readily available. Also, in order to measure a safety performance objective effectively, more than one measure maybe needed. It is best to use avariety of measures to ascertain performance rather than just one. Multiple measures provide a better picture of the true status of the safety performance. 

The data as discussed earlier should also have the characteristics of being valid and reliable. To be considered valid, the data has been tested and found to measure what it is intended to measure. For the data to be considered a reliable measure, the data reflect consistency in the measures. 

Procedures for the collection of the data should be developed and documented. Pertinent information as to how the data is recorded, when it is documented, and the frequency at which the data is collected is an important aspect of the data collection process. A procedure that infuses consistency over time in the data collection process will generate better comparisons, thus allowing the safety manager to draw more meaningful conclusions. 

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Resources and documents required for each specihc product... 

The user s needs are analyzed in order to determine appropriate prospective solutions. The prospective solutions are high-level solutions identifying major constraints, system interfaces, user interfaces, and proposed technologies. These solutions are also used to assess the criticality and complexity of each proposed system component (refer to Appendix D for more information). This assessment will provide information on the resources and documentation requirements for the project. 

The HL7 standard is used for exchanging information related to patients, doctors, resources and documents between hospitals. At this level there are also data synchronization protocols that ensure data persistence among applications. By using the HL7 standard, this data exchange can be performed independently of the software solutions, operating systems... 

Useful resources and documents for quality assurance programs... 

Organisation, resources and documentation, i.e. organisation of people, responsibilities, resources and documentation of the SHE management system,... 

Example An oil company has developed a contractor s SHE qualification guideline, based on these principles (Statoil, 1997). Seven elements in the contractor s SHE management system are considered. They include (compare the E P forum model in Figure 5.13) Leadership and commitment Policy and objectives Organisation, resources and documentation Evaluation and risk... 

Adequate support from the facility staff is absolutely essential. The facility staff must help the analysis team gather pertinent documents (e.g., PSilDs, procedures, software descriptions, material inventories, meteorological data, population data) and must describe current operating and maintenance practices. The facility staff must then critique the logic model(s) and calculation(s) to ensure that the assumptions are correct and that the results seem reasonable. The facility staff should also be involved in developing any recommendations to reduce risk so they will fully understand the rationale behind all proposed improvements and can help ensure that the proposed improvements are feasible. Table 12 summarizes the types of facility resources and personnel needed for a typical QRA. 

Direction and control communications evacuation and sheltering medical treatment facilities resource management cleanup and disposal decontamination and documentation. 

As stated in Part 2 Chapter 1, maintenance is concerned with retaining something in or restoring something to a state in which it can perform its required function. Quality systems comprise the organization, resources, and processes as well as the documentation needed for achieving quality, so you need to maintain more than the documentation. 

The kinds of resources needed are fairly straightforward. The primary resource requirement for most PSM implementation efforts will be staff-time, both professional and clerical/secretarial. It is also reasonable to expect to incur travel expenses at intervals throughout the process, especially for companies with multiple facilities. Support resources, such as telephone, computer time, facsimile, photocopying, and document production, will almost certainly be required in any initiative. 

The design should be summarized in a format to allow review and revisions prior to implementation. Required resources and schedules should be included in this document. 

Acute biological effects of the Chernobyl accident on local natural resources were documented by Sokolov et al. (1990). They concluded that the most sensitive ecosystems affected at Chernobyl were the soil fauna and pine forest communities and that the bulk of the terrestrial vertebrate community was not adversely affected by released ionizing radiation. Pine forests seemed to be the most sensitive ecosystem. One stand of 400 ha of Pirns silvestris died and probably received a dose of 80 to 100 Gy other stands experienced heavy mortality of 10- to 12-year-old trees and up to 95% necrotization of young shoots. These pines received an estimated dose of 8 to 10 Gy. Abnormal top shoots developed in some Pirns, and these probably received 3 to 4 Gy. In contrast, leafed trees such as birch, oak, and aspen in the Chernobyl Atomic Power Station zone survived undamaged, probably because they are about 10 times more radioresistant than pines. There was no increase in the mutation rate of the spiderwort, (Arabidopsis thaliana) a radiosensitive plant, suggesting that the dose rate was less than 0.05 Gy/h in the Chernobyl locale. 

It endorses sustained commitment of resources for all necessary activities, including material testing, as well as the timely completion and documentation of review, audit, and investigation action item resolutions. 

The location of the probe necessitates careful design and documentation to ensure that surrounding environmental conditions do not interfere with the subsequent interpretations of the measurement data. Examples of such minimal site descriptions are given in Table 6-3. Some of this information is now included with all the data logged into the epa s National Aerometric Data Bank, and some was provided by the control agencies. An example of a site description in southern California based on the requirements of the California Air Resources Board is shown in... 

Events develop too rapidly at the start of an incident to make use of anything other than immediately available resources and methods. Every stage of the process needs to be subject to rigorous quality assurance. Meticulous care and documentation is essential if any investigation is to be useful in bringing malefactors to justice. 

The laboratory should specify and document the laboratory processes (e g. the analytical methods) and the laboratory resources (irrstnrments, equipment etc.) that are necessary to produce the laboratory product i.e. the analysis results. 

Establishment of processes and documents and provision of resources specific to the product... 

A common format is of value to both applicants and reviewers as the order of documents is logical, more user-friendly, shortens review time, saves resources and facilitates the exchange of information and discussions. Janet Woodcock, Director of FDA s CDER, speaking at ICH 5, expects more reviewable applications, more complete, well-organised submissions, a format that is more predictable, and as a consequence, more consistent reviews. 

Type the name of a program, folder, document, or — Internet resource, and Windows will open it for you. 

There should be an appropriate and sufficient structured system, including organizational structure and documentation infrastructure, sufficient sufficient personnel and financial resources to perform validation tasks in a timely manner. Management and the personnel responsible for quality assurance should be involved in this discussion. Validation performance must be under the responsibility of appropriate and experience personnel that should represent different departments depending on the validation work to be performed. 

An observable advantage of purchasing excipients from a pharmaceutical excipient distributor is the ability of that distributor to consolidate the purchase of many excipients on behalf of the user. By this rationale, the distributor becomes an extension of the excipient user s sourcing and procurement departments. This presents obvious time-, resource-, and cost-saving opportunities to the user, because they can allocate their resources to other functions, while the distributor assembles all necessary documentation and executes all orders with the various excipient makers. 

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