Quality assurance information system

Fig. 9 A sample output from a quality assurance information system.

Probabilities can be established mathematically, based upon the probable failure rates of individual components within the system. Data on individual components may be obtained from manufacturers reliability statistics or quality assurance information. Specific failure rate data for individual items can also be obtained from reliability data banks such as that operated by the United Kingdom Atomic Energy Authority s (UKAEA) System Reliability Service. 

In the previous section we described several internal methods of quality assessment that provide quantitative estimates of the systematic and random errors present in an analytical system. Now we turn our attention to how this numerical information is incorporated into the written directives of a complete quality assurance program. Two approaches to developing quality assurance programs have been described a prescriptive approach, in which an exact method of quality assessment is prescribed and a performance-based approach, in which any form of quality assessment is acceptable, provided that an acceptable level of statistical control can be demonstrated. 

In a performance-based approach to quality assurance, a laboratory is free to use its experience to determine the best way to gather and monitor quality assessment data. The quality assessment methods remain the same (duplicate samples, blanks, standards, and spike recoveries) since they provide the necessary information about precision and bias. What the laboratory can control, however, is the frequency with which quality assessment samples are analyzed, and the conditions indicating when an analytical system is no longer in a state of statistical control. Furthermore, a performance-based approach to quality assessment allows a laboratory to determine if an analytical system is in danger of drifting out of statistical control. Corrective measures are then taken before further problems develop. 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

In Fig. 42.9 we show the simulation results obtained by Janse [8] for a municipal laboratory for the quality assurance of drinking water. Simulated delays are in good agreement with the real delays in the laboratory. Unfortunately, the development of this simulation model took several man years which is prohibitive for a widespread application. Therefore one needs a simulator (or empty shell) with predefined objects and rules by which a laboratory manager would be capable to develop a specific model of his laboratory. Ideally such a simulator should be linked to or be integrated with the laboratory information management system in order to extract directly the attribute values. 

The integration of different forms of study information from various locations and sources is possible with electronic information. Both study management and quality assurance are addressing critical issues associated with this process. Study Directors must now keep track of more data and study reports than ever before. Quality assurance (QA) departments must have systems in place to audit electronic data. 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

No health system in the world have unlimited access to all medicines. Rational selection of essential medicines is one of the core principles of national medicines policy. It focuses on therapeutic decisions, professional training, public information, financing, supply and quality assurance efforts on... 

In order to make reliable comparisons it is therefore suggested that, in future studies, decomposition methods that are known to release all the fluoride should be used. Use of certified reference materials (CRM) as part of the quality assurance system should be mandatory. In addition, sufficient information to enable proper comparison of data from different studies must be provided. 

Drug Information Association. Computerized Data Systems for Nonclinical Safety Assessment Current Concepts and Quality Assurance. Maple Glen, PA Drug Information Allocation, 1980. 

Despite the benefits from stringent legislation and advances in environmental technology, the increase in the fleet of automotive vehicles and overpopulation in urban areas results in bad ah quality. It is estimated that up to 45% of Europe s urban population remains exposed to particulate concentrations above limit values, and up to 30% to ozone concentrations above target levels that assure human health protection. The concentrations of various pollutants in the atmosphere in various cities across Europe are shown in Table 1.4. The data in the table are from WHO s Healthy Cities Air Management Information System and the World Resources Institute, which relies on various national... 

The review and approval (system acceptance) will include information about the approvers. All validation documents have to be reviewed and approved with involvement of the quality assurance unit. Figure 18.12 is an example. 

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