Quality assurance assessment

Independent quality assurance assessment of validation effort... 

The Committee was informed that the external quality assurance assessment scheme had been ongoing over the last five to six years. An... 

Quality Assurance Assessment of Both Adhesive and Bonded Structure Adhesive manufacturer... 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

The focus of this chapter is on the two principal components of a quality assurance program quality control and quality assessment. In addition, considerable attention is given to the use of control charts for routinely monitoring the quality of analytical data. 

The written directives of a quality control program are a necessary, but not a sufficient, condition for obtaining and maintaining an analysis in a state of statistical control. Although quality control directives explain how an analysis should be properly conducted, they do not indicate whether the system is under statistical control. This is the role of quality assessment, which is the second component of a quality assurance program. 

Internal methods of quality assessment should always be viewed with some level of skepticism because of the potential for bias in their execution and interpretation. For this reason, external methods of quality assessment also play an important role in quality assurance programs. One external method of quality assessment is the certification of a laboratory by a sponsoring agency. Certification is based on the successful analysis of a set of proficiency standards prepared by the sponsoring agency. For example, laboratories involved in environmental analyses may be required to analyze standard samples prepared by the Environmental Protection... 

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. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

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. 

Using Control Charts for Quality Assurance Control charts play an important role in a performance-based program of quality assurance because they provide an easily interpreted picture of the statistical state of an analytical system. Quality assessment samples such as blanks, standards, and spike recoveries can be monitored with property control charts. A precision control chart can be used to monitor duplicate samples. 

Once a control chart is in use, new quality assessment data should be added at a rate sufficient to ensure that the system remains in statistical control. As with prescriptive approaches to quality assurance, when a quality assessment sample is found to be out of statistical control, all samples analyzed since the last successful verification of statistical control must be reanalyzed. The advantage of a performance-based approach to quality assurance is that a laboratory may use its experience, guided by control charts, to determine the frequency for collecting quality assessment samples. When the system is stable, quality assessment samples can be acquired less frequently. 

Quality assurance programs are designed to serve two functions (1) assessment of collected air quality data and (2) improvement of the data collection process. These two functions form a loop as air quality data are collected, procedures are implemented to determine whether the data are of acceptable precision and accuracy. If they are not, increased quality control procedures are implemented to improve the data collection process. 

The components of a quality assurance program are designed to serve the two functions just mentioned—control and assessment. Quality control operations are defined by operational procedures, specifications, calibration procedures, and standards and contain the following components ... 

Controlling health nsks from rosin (colophony) based solder fluxes How HSE assesses offshore safety cases WASP - Quality assurance for chemical analysis... 

In the Intoduction to ISO 9001 it states that the quality assurance models represent three distinct forms of quality system suitable for the purpose of a supplier demonstrating its capability and for the assessment of such capability by external parties. In other words, the standard is suitable for contractual as well as for assessment purposes, but it does not actually require demonstration of capability to the assessor or purchaser unless required by the contract. 

Provides air quality data analysis, source modeling and assessment, meteorological services, small business tccluiical assistance, a source m magcmcnt system, and quality assurance mid calibration standards for air monitoring... 

Quality Assurance/Quality Control parameter and metrics to ensure data reproducibility, e.g. the establishment of calibrated RNA samples and reference datasets to objectively assess the performance of different microarray platforms (see also MAQC project http //w w w.nature. com/nbt/focus/maqc/). 

Quantitative risk assessment is now used extensively for determination of chemical and microbial risks in food. This concept helps to systematically and scientifically judge whether certain hazardous compounds may reach unacceptable risk levels when ingested. Quantitative risk assessment can support both quality design and quality assurance but, we discuss it from the assurance perspective. In the past decade, much attention has been paid to assessment of microbial risks due to then-typical differences as compared to chemical risks ... 

The program quality assurance plan may need periodic or emergency revisions Ongoing review of the data should reveal whether any deficiencies are due to Inadequate performance of vendors or to defects In the quality assurance plan Defects In the plan could result from Inadequate quality assessment techniques If measured levels of contaminants were significantly different from anticipated levels, for example ... 

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