Independent assessment instrument

Major risk factors include current smoker, low body weight (<127 lb in postmenopausal women), history of osteoporotic fracture in a first-degree relative, and personal history of low-trauma fracture as an adult. Other independent risk factors include age, high bone turnover, low body mass index (<19 kg/m2), rheumatoid arthritis, and glucocorticoid use. Decision tools may help identify individuals who should undergo BMD testing, such as the Osteoporosis Risk Assessment Instrument and the Simple Calculated Osteoporosis Risk Estimation. 

With the widespread acceptance of the independently assessed ISO 9000 scheme, many companies will accept the analysis of the raw material supplier. Once the quality and consistency of the raw material are proven, only vital tests may be carried out. Because of the moisture sensitivity, opening and sampling of the drums may lead to faulty material if the drums are not properly resealed. The three vital control instruments are ... 

For clinical trial and audit purposes in large samples, three simple questions group patients into those who are completely recovered, those who are still symptomatic but independent, and those who are dependent, or dead (Dermis et al. 1997a,b). Various more detailed assessment instruments are available that are designed to test different domains (Lyden and Hantson 1998 Warlow et al. 1996) ... 

Determinate errors may be constant or proportional. The former have a fixed value and the latter increase with the magnitude of the measurement. Thus their overall effects on the results will differ. These effects are summarized in Figure 2.1. The errors usually originate from one of three major sources operator error instrument error method error. They may be detected by blank determinations, the analysis of standard samples, and independent analyses by alternative and dissimilar methods. Proportional variation in error will be revealed by the analysis of samples of varying sizes. Proper training should ensure that operator errors are eliminated. However, it may not always be possible to eliminate instrument and method errors entirely and in these circumstances the error must be assessed and a correction applied. 

Precision and accuracy Quantitative analysis by NMR is very precise with relative standard deviations for independent measurements usually much lower than 5%. The largest errors in NMR measurements are likely due to sample preparation, not the NMR method itself. If a good set of standards is available and all NMR measurements for the test and standard samples are performed under the same acquisition conditions, the quantitative results can be readily reproduced on different instruments operated by different analysts at different times. Therefore, good intermediate precision can also be achieved. An accurate quantitative NMR assay will require accurately prepared standards. The accuracy of an NMR assay can be assessed, for example, by measuring an independently prepared standard or an accurate reference sample with the assay. In many cases, a spike recovery experiment can also be used to demonstrate the accuracy of an NMR assay. 

From those techniques given in Table 1 my personal preference is for failure mode, effects, and criticality analysis (FMECA). This technique can be applied to both equipment and facilities and can be used to methodically break down the analysis of a complex process into a series of manageable steps. It is a powerful tool for summarizing the important modes of failure, the factors that may cause these failures, and their likely effects. It also incorporates the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability. It must be stressed, however, that the outcome of the risk assessment process should be independent of the tool used and must be able to address all of the risks associated with the instrument that is being assessed. 

Once the severity and the probability corresponding to a scenario are estimated, that is, the risk is assessed, a decision can be made on the nature of the protection system to be implemented. If a safety instrumented system (SIS) is to be used, consisting of one or more independent protection levels (IPL), the required reliability of the protection system, constituting a so-called Safety Integrated Level (SIL) can be determined by using this risk assessment, respective of the required risk reduction. 

Penicillin-induced hepatotoxicity may not be as uncommon as has been thought. There have been three reviews. The first was a comparison of the assessment of drug-induced liver injury obtained by two different methods, the Council for International Organizations of Medical Sciences (CIOMS) scale and the Maria Victorino (M V) clinical scale (66). Three independent experts evaluated 215 cases of hepatotoxicity reported using a structured reporting form. There was absolute agreement between the two scales in 18% of cases, but there was no agreement in cases of fulminant hepatitis or death. The authors concluded that the CIOMS instrument is more likely to lead to a conclusion compatible with the specialist s empirical approach. 

The third approach is to use experimental methods to assess the error structure. Independent identification of error structure is the preferred approach, but even minor nonstationarity between repeated measurements introduces a significant bias error in the estimation of the stocheistic variance. Dygas emd Breiter report on the use of intermediate results from a frequency-response analyzer to estimate the variance of real and imaginary components of the impedance. Their approach allows assessment of the variance of the stochastic component without the need for replicate experiments. The drawback is that their approach cannot be used to assess bias errors and is specific to a particular commercial impedance instrumentation. Van Gheem et have proposed a structured multi-sine... 

Evaluation of the performance of a method or an instrument represents the largest use of CRMs. Examples are widely reported in the literature. One could even say that the development of a new method or instrument without evaluation of the performances with (a) CRM(s) is an incomplete task. Besides these research tasks, CRMs for calibration or validation are also used to assess the performance of instruments by the manufacturer himself to demonstrate the possibilities of his instrument or by the customer who wishes to evaluate the proposed instrument before purchasing it. CRMs produced by independent official or regulatory bodies to validate instrument performance or calibration sets have been under development for several years. They have in particular allowed the solution of inaccuracy problems in the biomedical sector where calibration test kits of automatic instrument manufacturers were not comparable and even led to different results between countries such arguments supported many BCR projects for... 

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