Laboratory quality

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

EPA Environmental Monitoring Systems Laboratory, Quality Assurance... 

Within the scope of quality agreements in production, environment, or laboratory, quality is often stipulated to a standard value x0 (target value). For demands regarding quality, this standard value may be an upper limit (e.g. in case of pollution and contamination) or a lower limit (e.g. for active reagents). The statistical situation is the same when a quality criterion has to exceed or fall below a standard value. The problem is illustrated here by the practical situation of manufacturer and customer as shown in Fig. 4.11. 

To be able to define the responsibilities of staff at all levels towards laboratory quality. 

The Laboratory Quality Manual is up-to-date and is accessible to all staff. 

Chemical laboratories - Quality control. 2. Chemistry, Analytic - Quality control. 3. Chemistry, Analytic - Technique. I. Barwick, Vicki. II. Title. 

FDA device regulation is focused on the device and the device manufacturer. CLIA, on the other hand, focuses on laboratory quality, including the quality of the laboratory test results provided by the devices used, whether developed in-house or as a test kit in commercial distribution to multiple laboratories. The programs differ substantially in approaches and in data requirements. FDA requires unique submissions for each test under its purview, evaluates both performance and labeling, and requires demonstration of analytical validity and clinical validity as appropriate. CLIA inspects laboratories using a system approach based on key probes of the operating system. CLIA requires a demonstration of analytical performance and quality control but does not require a showing of either clinical validity or clinical utility. 

Snow, especially its water-soluble fraction, is one of the most sensitive and informative indicators of mass-transfer in the chain air - soil - drinking water. Therefore analytical data on snow-melt samples were selected for inter-laboratory quality control. Inter-laboratory verification of analytical results estimated in all the groups have shown that relative standard errors for the concentrations of all the determined elements do not exceed (5-15)% in the concentration range 0.01 - 10000 microg/1, which is consistent with the metrological characteristics of the methods employed. All analytical data collected by different groups of analysts were tested for reliability and... 

Because of the status of the CAC described above, the work that it has carried out in the area of laboratory quality assurance must be carefully considered. One of the CAC Committees, the Codex Committee on Methods of Analysis and Sampling (CCMAS), has developed criteria for assessing the competence of testing laboratories involved in the official import and export control of foods. These were recommended by the Committee at its 21st Session in March 19979 and adopted by the Codex Alimentarius Commission at its 22nd Session in June 1997 10 they mirror the EU recommendations for laboratory quality standards and methods of analysis. The guidelines provide a framework for the implementation of quality assurance measures to ensure the competence of testing laboratories involved in the import and export control of foods. They are intended to assist countries in then-fair trade in foodstuffs and to protect consumers. 

The following recommendations represent integrated approaches to IQC that are suitable for many types of analysis and applications areas. Managers of laboratory quality systems will have to adapt the recommendations to the demands of their own particular requirements. Such adoption could be implemented, for example, by adjusting the number of duplicates and control material inserted into a run, or by the inclusion of any additional measures favoured in the particular application area. The procedure finally chosen and its accompanying decision rules must be... 

Briefly, to assure quality assurance and quality control, samples are analyzed using standard analytical procedures. A continuing program of analytical laboratory quality control verifies data quality and involves participation in interlaboratory crosschecks, and replicate sampling and analysis. When applicable, it is advisable, even insisted upon by the EPA, that analytical labs be certified to complete the analysis requested. However, in many cases, time constraints often do not allow for sufficient method validation. Many researchers have experienced the consequences of invalid methods and realized that the amount of time and resources required to solve problems discovered later exceeds what would have been expended initially if the validation studies had been performed properly. 

Automation needs vary from laboratory to laboratory. Quality control laboratories might emphasize user simplicity and high throughput, while research laboratories might stress flexibility. 

The laboratory quality policy should be appropriate to the purpose of the laboratory and should include the commitment to quality and compliance... 

This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 170252005. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system , (refer joint ISO-ILAC-IAF Communique dated 18 June 2005)... 

Chemistry, Analytic—Quality control. 2. Chemical laboratories—Quality control. I. 

Laboratory Quality Assurance Support -Generation of audit trails. 

For common statistics, such as the Student s t value, chi-square, and Fisher F, Excel has functions that return the critical value at a given probability and degrees of freedom (e.g., =TINV (0.05,10) for the two-tailed Lvalue at a probability of 95% and 10 degrees of freedom), or which accept a calculated statistic and give the associated probability (e.g., =TDIST( t, 10, 2 ) for 10 degrees of freedom and two tails). Table 2.3 gives common statistics calculated in the course of laboratory quality control. 

In instrumental analysis, results produced by an instrument are too readily accepted, when provided in numerical form, because we have a tendency to confuse the precision of a number with that of a measurement. Unfortunately, in chemical analysis, as is the case elsewhere, an error can have serious consequences. For this reason, the heads of analysis laboratories have been essentially forced to redefine the norms that define laboratory quality. 

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