Functional Test procedures

FIG. 59. Objective tree for Levels 1-4 of defence in depth. Safety principle (258) validation of operating and functional test procedures. 

Are all requirements for the safety function properly covered by the inspection or function test procedure(s) ... 

Another advantage of factory testing is it provides an opportunity to verify the functional test procedures. These are going to be repeated at the site in the so-called PSAT stage. These same tests form the basis of regular proof testing procedures so the FAT is an ideal opportunity to get these procedures right with the equipment and with the end-user support technicians. 

Identification of the material properties as an estimation of transfer function (TF) for the black box model. In this case the problem of identification is solving according to the results of the input (IN) and output (OUT) actions. There is a transfer of notion of mathematical description of TF on characterization of the material. This logical substitution gives us an opportunity to formalize testing procedure and describe the material as a set of formulae, which can be used for quantitative and qualitative characterization of the materials. 

It is necessary to estabUsh a criterion for microbial death when considering a sterilization process. With respect to the individual cell, the irreversible cessation of all vital functions such as growth, reproduction, and in the case of vimses, inabiUty to attach and infect, is a most suitable criterion. On a practical level, it is necessary to estabUsh test criteria that permit a conclusion without having to observe individual microbial cells. The failure to reproduce in a suitable medium after incubation at optimum conditions for some acceptable time period is traditionally accepted as satisfactory proof of microbial death and, consequentiy, stetihty. The appHcation of such a testing method is, for practical purposes, however, not considered possible. The cultured article caimot be retrieved for subsequent use and the size of many items totally precludes practical culturing techniques. In order to design acceptable test procedures, the kinetics and thermodynamics of the sterilization process must be understood. 

Recent developments in the field-testing procedure have demonstrated that a motor-driven 35-mm camera at up to three frames per second produces superior results to a movie camera.The analysis of the film is carried nut by scaling the distance that fume advances from one consecutive photogi aph to the next. The diameter of the plume as a function of the distance above the source can be scaled directly off the photograph. 

To determine the optimal parameters, traditional methods, such as conjugate gradient and simplex are often not adequate, because they tend to get trapped in local minima. To overcome this difficulty, higher-order methods, such as the genetic algorithm (GA) can be employed [31,32]. The GA is a general purpose functional minimization procedure that requires as input an evaluation, or test function to express how well a particular laser pulse achieves the target. Tests have shown that several thousand evaluations of the test function may be required to determine the parameters of the optimal fields [17]. This presents no difficulty in the simple, pure-state model discussed above. 

All such animal procedures suffer from the obvious and basic problem that laboratory animals do not behave like humans and that humans cannot reliably interpret their reactions and behaviour. Thus we know that Parkinson s disease is caused by a degeneration of the dopaminergic nigrostriatal tract but its lesion in animals does not produce any condition which resembles human Parkinsonism, except in primates, even though there are functional tests (e.g. rotational movements) which readily establish that loss of dopamine function and also respond to its augmentation (Chapter 15). By contrast, there are many ways, e.g. electrical stimulation and the administration of certain chemicals, to induce convulsions in animals and a number of effective antiepileptic drugs have been introduced as a result of their ability to control such activity. Indeed there are some tests, as well as animals with varied spontaneous seizures, that are even predictive of particular forms of epilepsy. But then convulsions are a very basic form of activity common to most species and epileptic seizures that are characterised by behavioural rather than motor symptoms are more difficult to reproduce in animals. 

Also, electronic SOPs and protocols must be available to staff at all test sites for multisite studies. If the electronic documents are to be available at several sites, the validation phase of the system must include functionality testing at each site. Documentation of system validation needs to be available at each test site as well. Electronic SOPs must have a limited life span when printed to avoid the use of an outdated document. This may be achieved by stamping each SOP hard copy Printout not valid after date xx/xx/xx . This practice helps to ensure that system users will not retain printed SOPs long after the electronic SOP is revised. For company SOPs that are to be followed by an outside contractor who has no access to the electronic system, an alternative stamp may be used on the hard-copy SOPs that will be provided to the contractor that defines the date printed or indicates that the SOP is valid for use in a particular study. Whatever procedure is used, it must be clearly documented in an SOP. 

The design for the surface water-collector system is determined by an allowable flow rate divided by a required flow rate. Allowable rates for geocomposites are determined experimentally by exactly the same method as for geonets. The specific cross section used in the test procedure should replicate the intended design as closely as possible. For the required flow rate, Darcy s law or HELP36 37 can be used. Then the design-by-function concept is used to determine the DR, or FS. 

Hydrothermal stability (HTS). The stability of the chlorinated resins was determined by a test procedure described in the experimental. The resin according to the standard test is treated with water in a sealed flask at 200 °C for 24 hours to determine the loss in acid functionality and additionally, the level of chlorine released into the aqueous phase. 

The apparatus used to determine the explosive nature of vapors is shown in Figure 6-14. The test procedure includes (1) evacuating the vessel, (2) adjusting the temperature, (3) metering in the gases to obtain the proper mixture, (4) igniting the gas by a spark, and (5) measuring the pressure as a function of time. 

Validation of the SIS functionality is performed as part of a site acceptance test (SAT). Validation involves a full functional test that demonstrates the SIS actually works in the real-world installation. It proves the SIS devices execute the logic according to the specification and ensures that the SIS and its devices interact as intended with other systems, such as the BPCS and operator interface. From a systematic error standpoint, the SAT also provides an opportunity for a first-pass validation of the procedures developed for the operating basis (see next subsection). 

Laboratory procedures specific to galactosemia are dealt with below, but a number of other tests are also of value. Liver function tests, though sometimes helpful, are not always informative (see above, Section 2.2). Protein is usually present in the urine in untreated cases, but this occurs in other diseases. Aminoaciduria is a very common finding in galactosemia, though Holzel (H3) states it is absent in some older children with a mild form of galactosemia aminoaciduria occurs in other diseases and is frequently accompanied by proteinuria and glucosuria. 

But a model should surely tell us something about the business or design if we re allowed to do things any old way, what s the difference between a system that conforms to the model and one that doesn t The practical answer is that the information represented by each attribute should be in there somewhere. It should be possible to write a read-only function or procedure that retrieves the information from whatever weird format the designer has represented it. These abstraction or retrieval functions are a valuable aid to both documentation and debugging. (You ll find more about this in Chapter 6, Abstraction, Refinement, and Testing.)... 

To test the irritancy potential of substances, two tests which can reliably distinguish between skin corrosives and noncorrosives are endorsed by the European Centre for the Validation of Alternative Methods (ECVAM). The testing procedures are based on the transcutaneous electrical resistance (TER) measurements of rat skin and on a human skin model. Both test systems [141-145] will be briefly outlined below. Nevertheless, these tests are not suited for the group of mild irritants which do not induce an acute effect on the barrier function. For those substances, new markers need to be evaluated. First results are available for heat shock protein 27 where higher levels were observed in skin models after exposure to mildly irritating chemicals [146, 147]. 

In the stationary phase test discussed here, we use naphthalene and acenaphthene as our hydrophobic reference compounds, propranolol and amitriptyline as the compounds with basic functional groups, and dipropylphthalate and butylparaben for the determination of other polar selectivities of a packing. The mobile phase is a pH 7.00 phosphate buffer (35.0%) mixed with methanol (65.0%). The details of the test procedure are discussed in References 34, 38 and 39. 

A pulse test procedure [6] begins with an injection of a small pulse of the feed mixture to be separated into a desorbent stream flowing through a packed adsorbent column at a fixed flow rate and temperature. The on-line column effluent composition is then determined as a function of time or volume of desorbent passed by gas or liquid chromatography. Particularly important is the sequence and time when each of the feed components exit the packed adsorbent column because these characteristics describe the specific adsorbate and adsorbent interactions. By determining the interactions using the pulse test, the separation process can be optimized. 

The principle of the TER test is that the test material is applied for up to 24 h to the epidermal surfaces of skin discs taken from the pelts of humanely killed young rats. Corrosive materials are identified by their abUity to produce a loss of normal stratum comeum integrity and barrier function, which is measured as a reduction in the inherent TER below a threshold level (5 kil). Generally, materials that are noncorrosive in animals, but are irritating or nonirritating, do not reduce the TER below the threshold level. A dye-binding step can be incorporated into the test procedure for... 

The Peripheral Nerve Function test guideline (OPPTS 870.6850) defines procedures for evaluating certain aspects of the neurophysiological functioning of peripheral nerves. The purpose of the guideline is to evaluate the effects of exposures on the velocity and amplitude of conduction of peripheral nerves. Additional tests may be necessary to completely assess the neurophysiological effects of any substance. 

A list of procedures comprising a medical screen is given in Box 4.9. Particular studies may require additional procedures, such as lung function tests, coagulation studies, exercise or 24 h ECG or a psychiatric interview. 

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