Quality control/assurance testing requirements

In addition, quality assurance/quality control (QA/QC) requirements for the biological tests are highly specific, because a calibration using reference material does not cover all aspects of biological variability (Simpson et al., 2005). 

Since important decisions affecting the health and welfare of humanity must be made on the basis of analytical results, considerable effort must be directed toward assuring greater confidence in the reliability of the output of analytical laboratories. The Commission of the European Communities, after performing a study to determine the comparability of chemical analyses for drinking water quality, concluded that analytical quality control must be required as a routine component of analytical work. They state ( ), "Only the combination of intralaboratory controls of precision and accuracy complemented by interlaboratory intercomparison tests can lead to a significant evaluation and improvement of analytical results."... 

STPM-06, "Control of Testing" requires that all tests be performed with formally prepared and approved procedures. DPSOP 336, 11.12, specifically requires that all tests be performed with formal procedures. Section 2.0 of the procedure states that the specified test activities are subject to the requirements of QAP 11.1, SRP Quality Assurance Manual (Reference 4). This meets the restart criteria. 

Ceitification and records for components and materials. The examiner shall be assured, by examination of certification, records, or other evidence, that the materials and components are of the specified grades and that they have received reqiiired heat treatment, examination, and testing. The examiner shall provide the inspec tor with a certification that all quality-control requirements of the code and of the engineering design have been met. 

In-process quality control is the control exercised over starting materials and intermediates. Its importance stems from the opportunities that it provides for the examination of a product at the stages in its manufacture at which testing is most likely to provide the most meaningful information. The WHO Requirements and national authorities stipulate many in-process controls but manufacturers often perform tests in excess of those stipulated, especially sterility tests (Chapter 23) as, by so doing, they obtain assurance that production is proceeding normally and that the final product is likely to be satisfactory. Examples of in-process control abound but three of different types should suffice. 

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 includes all the quality controls, the generation of expectations (acceptance limits) from the quality controls, plus a great number of other activities, such as (1) analyst training and certification (2) data review and evaluation (3) preparation of final reports of analysis (4) information given to clients about tests that are needed to fulfill regulatory requirements (5) use of the... 

The approximate cost for shallow soil mixing/thermaUy enhanced vapor extraction technology range from 60 to 100/yd of soils treated. Costs and applications of this technology are site specific. This cost may be reduced given the desired level of testing and quality assurance/quality control measures required (D13379J, p. 28). 

When using medical laboratories, physicians frequently assume that the results provided are accurate and precise. Those working in the laboratory environment know that this is true only within the constraints of the methods, technology and processes available. In this chapter we will explore how internal quality control (IQC) and external quality assurance (EQA) procedures can inform both the analyst and the physician about the limitations of laboratory testing and permit a more intelligent use of laboratory data, while at the same time indicating areas where improvement is required. 

Quality Assurance and Quality Control Increased QA/QC required as Phase II proceeds. Standardized test methods should be applied to confirm that the suspected substance is responsible for the toxicity observed in the test that originally triggered the TIE. 

Validation of a process often results in the reduction of in-process and finished-product testing requirements. Process controls established during validation may prove sufficient to assure product quality without excessive quality markers throughout the process. 

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