Quality assurance measurements

Storage and receiving are activities that can greatly contribute to a safe and economic operation. It is here that quality control can be achieved at minimal cost. Label verification and other quality assurance measures can increase the confidence level that the correct chemicals have arrived, thereby potentially circumventing the use of wrong chemicals. Wrongly shipped chemicals can be returned to the manufacturer with minimal or no cost to the batch operation owner. As with all processes and activities it is of great importance to apply the principles of inherent safety, in particular the minimization and attenuation principles (CCPS G- 41). 

The food polymer science approach is being applied successfully in the food industry for understanding, improving, and developing food processes and products. However, to date, the glass transition generally remains more of a research and development tool than a routine quality assurance measure of food processability and stability. 

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. 

Internal quality control is undertaken by the inclusion of particular reference materials, called control materials , into the analytical sequence and by duplicate analysis. The control materials should, wherever possible, be representative of the test materials under consideration in respect of matrix composition, the state of physical preparation and the concentration range of the analyte. As the control materials are treated in exactly the same way as the test materials, they are regarded as surrogates that can be used to characterise the performance of the analytical system, both at a specific time and over longer intervals. Internal quality control is a final check of the correct execution of all of the procedures (including calibration) that are prescribed in the analytical protocol and all of the other quality assurance measures that underlie good analytical practice. IQC is therefore necessarily retrospective. It is also required to be as far as possible independent of the analytical protocol, especially the calibration, that it is designed to test. 

Quality assurance measures such as pre-analytical checks on instrumental stability, wavelength calibration, balance calibration, tests on resolution of chromatography columns, and problem diagnostics are not included. For present purposes they are regarded as part of the analytical protocol, and IQC tests their effectiveness together with the other aspects of the methodology. 

The FSA undertakes surveillance exercises, the data for which are acquired from analytical determinations. The Agency will take measures to ensure that the analytical data produced by contractors are sufficient with respect to analytical quality, i.e. that the results obtained meet predetermined analytical quality requirements such as fitness-for-purpose, accuracy and reliability. Thus when inviting tenders FSA will ask potential contractors to provide information regarding the performance requirements of the methods to be used in the exercise, e.g. limit of detection, accuracy, precision etc., and the quality assurance measures used in their laboratories. When presenting tenders, laboratories should confirm how they comply with these specifications and give the principles of the methods to be used. These requirements extend both to the laboratory as a whole and to the specific analytical determinations being required in the surveillance exercise. The requirements are described in three parts, namely ... 

ISO/IEC 17025 is the most important standard for quality assurance in analytical laboratories. All the quality assurance measures must be described in a quality manual. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

Where practical, the calibration standards used for production and quality assurance measurement equipment shall be traceable to the national standards of the National Bureau of Standards, Department of Commerce. If national standards are not practical for the parameter being measured, an independent reproducible standard shall be used. If no applicable standard exists, an in-house standard shall be developed and used. 

Quality assurance measures It is critical to perform and analyze H E sections from the TMA to confirm the presence of tissue of interest (usually tumor) in the TMA sections. In addition, H E should be performed at regular interval (e.g. on every 25th slide) on cuts from the TMA blocks. The above tests should be reviewed by a pathologist. 

Quality Assurance Measures in Plantation and Milling. Availability of good-quality crude palm oil is a prerequisite for the production of good-quality refined palm oil products. The criteria for good-quality crude palm oil are ... 

S248 Wilson, J.F., Tsanaclis, L.M., Williams, J., Tedstone, J.E. and Richens, A. (1989) Evaluation of assay techniques for the measurement of antiepileptic drugs in serum A study based on external quality assurance measurements. Ther. Drug Monit. 11, 185-195. 

Immunochemical technology is rapidly advancing in many areas development of field-portable formats, specific antibody generation, detection systems, quality control and quality assurance measures, and new applications. It is not a panacea but should be used when deemed to provide the most appropriate analysis. 

After the test is implemented, it will beocme part of a check sample program that is operated by FSIS. Other quality assurance measures may be taken by FSIS because tests are not expected to be useful without adequate performance controls. 

Oil inputs are to be measured within PLC-4 for the first time. To support external quality assurance measures and to obtain information on the proficiency of the nominated laboratories, an interlaboratory comparison on the determination of hydrocarbons in water was conducted before the start of routine monitoring. 

Summarising the results of this study, mineral oils can be determined in water samples by solvent extraction and gas chromatography. This test item will be mandatory within the framework of PLC-4. Nevertheless, further interlaboratory comparisons should be performed in the course of PLC-4 as an external quality-assurance measure within this monitoring programme. 

The principles and concepts of TQM have been formalized into a quality management process, as illustrated in Figure 19-3. The traditional framework for managing quality in a healthcare laboratory has emphasized the establishment of quality laboratory processes (QLPs), QC, and quality assessment (QA). A QLP includes analytical processes and the general poHcies, practices, and procedures that define how all aspects of the work get done. QC emphasizes statistical control procedures but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors. QA, as currently applied, is primarily concerned with broader measures and monitors of laboratory performance, such as turnaround time, specimen identification, patient identification, and test utility. Quality assessment is the proper name for diese activities rather than quality assurance. Measuring performance does not by itself improve performance and often does not detect problems in time to prevent harmful effects. Quality... 

Module V Includes individual center summary reports, quality assurance measures, statistical methods and analyses and randomization lists. 

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