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Quality assurance program, objective

The "feedback loop in the analytical approach is maintained by a quality assurance program (Figure 15.1), whose objective is to control systematic and random sources of error.The underlying assumption of a quality assurance program is that results obtained when an analytical system is in statistical control are free of bias and are characterized by well-defined confidence intervals. When used properly, a quality assurance program identifies the practices necessary to bring a system into statistical control, allows us to determine if the system remains in statistical control, and suggests a course of corrective action when the system has fallen out of statistical control. [Pg.705]

Ozone and ozone precursor concentrations at nonurban locations in the eastern United States were studied extensively. The three parts of the study were field measurements, a quality assurance program, and an airborne monitoring program. The main objective of the study was to establish a data base for nonurban ozone and precursor concentrations. Simultaneous statistical summaries of the concentrations of nitrogen dioxide and nonmethane hydrocarbons were also provided. Another objective was to search for relationships between ozone concentrations and nitrogen dioxide and nonmethane hydrocarbon concentrations. [Pg.147]

For these reasons, artifacts must be limited as part of a quality assurance program. As defined by the American Chemical Society Committee on Environmental Improvement (26), the objective of a quality assurance program is to reduce measurement errors to agreed upon limits and to assure that the results have a high probability of being acceptable quality. ... [Pg.271]

Quality assurance program plan A written assembly of management policies, objectives, principles, and general procedure that outlines how the laboratory intends to generate data of known and accepted quality. [Pg.597]

Management Assessment. Management at a 11 levels should periodically assess the integrated quality ASSURANCE program and its performance. Problems that hinder the organization from achieving its objectives should be identified and corrected. [Pg.41]

Static factors refer to the properties of the procedure and are not expected to change during the accident event. In ADS-IDAC, static factors include procedure type, step objectives, and step complexity. In the U.S., quality assurance program requirements require that plant operators to specify the manner in which procedures are to be executed (ANS3.2/ANSIN18.7,1976). [Pg.341]

External quality assessment is organized as a part of quality assurance programs with the object of improving analytical quality and thereby contributes with possibilities for method evaluation making corrections on a continuous basis. The external quality assessment may include... [Pg.57]

The answer to this question is important, because it is essential that the objectives of the validation activity be clearly stated. This understanding will enable the responsible group to plan the protocol and the test program needed to carry out the validation program. Quality assurance requires that the total PV document include the following [20] ... [Pg.796]

We can recognize three distinct but interdependent, effective standards 1) USP-NF standards, 2) current good manufacturing practices, and 3) in-house quality assurance or process validation protocols. The three programs are different but have the same objective drug product quality. The official standards are developed to be meaningful in this multiple context. In recent years, a similar array has occurred in most developed nations, and this is rightfully seen as a measure of success. [Pg.2847]

The system is manufactured based on design specifications. Quality control methodologies are essential during this step. All the parts, materials, and processes are controlled based on methodologies discussed in previous chapters in the area of quality assurance. One of the objectives of the quality control program is to make sure that the inherent reliability of the design is not degraded. [Pg.1925]

Quality Assurance and Research. Fire and flammability tests are also used in support of production control. The objective of a production control program is to ensure that a product that is sold in the marketplace is identical to the specimen that was originally tested for regulatory compliance. Often it is not practical or economically feasible to use the qualification test(s) in a follow-up production control program and a simple test is often adequate to verify consistency of the product. Relatively simple flammability tests are therefore most often used for the purpose of quality assurance. The same tests are then also used in research and development of new products. [Pg.3282]

A laboratory QA/QC program is an essential part of a sound management system. It should be used to prevent, detect, and correct problems in the measurement process and/or demonstrate attainment of statistical control through QC samples. The objective of QA/QC programs is to control analytical measurement errors at levels acceptable to the data user and to assure that the analytical results have a high probability of acceptable quality. [Pg.129]

Even though all CLP laboratories follow the same procedures, large differences in the quality of work exist. Depending upon the objectives of the analyses, the use of one laboratory may be necessary. However, even the use of one laboratory does not necessarily assure consistent results. Differences apparently exist between individud analysts. In many cases, the QA/QC plans are not adequately transferred to the laboratory bench. Under a routine analytical schedule, selected parameters yield poor QA/QC results independent of the laboratory. Special analytical program requests should be considered if such parameters are critical. [Pg.328]

Figure 3 Illustrates the problem faced by the IAEA in the broader context of their trace element laboratory intercomparison program. These data show the reported results of 16 laboratories for measurements of arsenic in the horse kidney intercomparison sample (H-8), based on various versions of atomic absorption spectrometry, optical emission spectrometry, neutron activation analysis, and Induced X-ray emission analysis. The objective of the horse kidney intercomparison was to assess (and refine) analytical methods for the determination of essential and toxic trace elements in this surrogate for human kidney (2). Kidney, as the main target organ which accumulates toxic elements, was of special Interest with respect to cadmium. Horse kidney, which contains similar levels of cadmium to the human kidney cortex, was selected for the development and maintenance of methods having a demonstrated level of quality to assure reliable biological monitoring of this element. Participants were Invited to analyze some 24 additional trace elements, however. Figure 3 Illustrates the problem faced by the IAEA in the broader context of their trace element laboratory intercomparison program. These data show the reported results of 16 laboratories for measurements of arsenic in the horse kidney intercomparison sample (H-8), based on various versions of atomic absorption spectrometry, optical emission spectrometry, neutron activation analysis, and Induced X-ray emission analysis. The objective of the horse kidney intercomparison was to assess (and refine) analytical methods for the determination of essential and toxic trace elements in this surrogate for human kidney (2). Kidney, as the main target organ which accumulates toxic elements, was of special Interest with respect to cadmium. Horse kidney, which contains similar levels of cadmium to the human kidney cortex, was selected for the development and maintenance of methods having a demonstrated level of quality to assure reliable biological monitoring of this element. Participants were Invited to analyze some 24 additional trace elements, however.
The objective is the effective implementation of the product-based assurance concept in which confidence in the program is not only based on the quality of its development (assurance-based process) but also on its properties as a product. [Pg.221]


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