Quality control protocol

TABLE 1. Examples of environmental, occupational and quality control protocols for industrial primary amines... 

Performing a thorough method validation can be a tedious process, but the reliability of the data generated with the method is linked directly to the application of quality assurance and quality control protocols, which must be followed assiduously (Table 6.5). 

The design of a total quality control protocol is based upon two fundamental components validation of the method and continuous... 

While methods validation and accuracy testing considerations presented here have been frequently discussed in the literature, they have been included here to emphasize their importance in the design of a total quality control protocol. The Youden two sample quality control scheme has been adapted for continuous analytical performance surveillance. Methods for graphical display of systematic and random error patterns have been presented with simulated performance data. Daily examination of the T, D, and Q quality control plots may be used to assess analytical performance. Once identified, patterns in the quality control plots can be used to assist in the diagnosis of a problem. Patterns of behavior in the systematic error contribution are more frequent and easy to diagnose. However, pattern complications in both error domains are observed and simultaneous events in both T and D plots can help to isolate the problems. Point-by-point comparisons of T and D plots should be made daily (immediately after the data are generated). Early detection of abnormal behavior reduces the possibility that large numbers of samples will require reanalysis. 

Meglen, Robert R. "A Quality Control Protocol for the Analytical Laboratory" Center for Environmental Sciences, University of Colorado at Denver, Special Publication (79 pages), 1983. 

Not all methods require each parameter detailed in table 8.2 to be established. For example, a method that only measures the active ingredient in a 100-mg cold cure as part of a quality control protocol is not concerned with limit of detection, the matrix is fixed, and the calibration range might only need to be established between 80 and 120 mg. An analysis that determines the presence or absence of the target analyte needs only to establish its selectivity, limit of detection, and ruggedness. Table 8.3 details some common analytical systems with their critical method validation parameters. 

Contamination is potentially the most serious problem. Therefore, it is prudent to compile a detailed record of media preparation and sterilization. For example, the filter may fail toward the end of a run, but the level of contamination is too low to be detected by the normal quality-control protocol, yet this may become apparent later. 

The desired citrus flavor is the result of volatile compounds in specific proportions. Citrus oils have unique composition profiles depending on the cultivar, the processing conditions, and the storage conditions. There have been more than 200 different compounds identified in citrus oils. However, the degree of unsaturation in monoterpenes leads to rapid oxidation and unstable compounds. The reactivity and volatility of citrus oils require strict quality control protocols. 

The characteristics of radiation instruments may change significantly in time, either due to aging of their optical components or due to environmental impacts on their optical characteristics. Therefore arises the necessity of applying strict absolute calibration, maintenance, and quality control protocols to assure the quality of the produced measurements. Only then, the measurements produced by instruments deployed at various locations can give comparable results, which can be safely used for scientific research. 

Boomer and Powell [242] have developed an analytical technique using inductively coupled plasma mass spectrometry to estimate the concentration of uranium in a variety of environmental samples including soil. The lower limit for quantitation is 0.1 ng/ml. Calibration is linear from the low limit to 100 ng/ml. Precision, accuracy and a quality control protocol were established. Results are compared with those obtained by the conventional fluorometric method. 

The ingredient buyer must ensure that acceptable quality is a prerequisite when ingredients are to be purchased. A quality control protocol must be drawn up and followed as each batch of feed ingredients is received at the feed plant. Ingredients grown on the farm should be analysed periodically and purchased ingredients should (where possible) be accompanied by a guaranteed analysis. 

Quality control protocols should be performed for the PET system on a regular basis. Furthermore, it is helpful to acquire a blank scan prior to the first patient examination each day. For this purpose, a transmission scan is initiated to assess differences in detector sensitivity. We use this scan for the correction of the patient data on a daily basis. 

HPLC analyses Quality control. Protocols established and applied by all... 

Approximately one liter of rainfall-runoff solution was collected from each of three experimental racks following rainfall events. Limestone and marble reference rocks were in two of the racks a third rack without a rock was used as a control (hereinafter referred to as a blank sample). Runoff volume, specific conductance, and pH measurements were determined at the exposure site as soon as possible after collection, typically within a few hours. Samples then were filtered through a 0.45-micrometer pore size membrane filter, placed in a clean polyethlyene bottle, and sent to the U.S. Geological Survey laboratory in Denver, Colorado, for chemical analysis. Sample preparation, analytical procedures, and laboratory quality-control protocols are described by Skougstad et al. (6). 

EPA sampled in the locations most likely to be contaminated with dioxin (i.e., loading, storage, or production areas). If offsite migration of contaminated material was suspected, EPA sampled outside the facility boundary. Quality assurance/quality control protocols, following Superfund-authorized procedures, were developed to ensure that all data generated would be of known quality. 

In electrophoresis, good reproducibility depends upon close adherence to quality control protocols. Details must be closely monitored for all phases of the process, including sample preparation, storage conditions, denaturation techniques, the volume of denaturant relative to the volume of the specimen, the source and... 

The final product should be well-documented and address hardware, networking capabilities, network and database security, and quality control. Protocols for daily and weekly back-ups are required. Daily back-ups onto tape or CDs should be stored in fire-resistant vaults on-site. Weekly off-site storage of back-up media is part of best practice. 

Chemical characterization of the UHMWPE powder is typically performed at the powder-manufacturing site as part of their quality control protocol. However, researchers may want to periodically verify the purity and composition of the powder. ASTM 648 outlines several tests that can be used to analyze the powder. With regards to chemical characterization, trace element analysis and Fourier transform infrared spectroscopy (FTIR) are the two common approaches. 

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