Laboratory operator definition

The operational definition of raw data for the laboratory, especially as they relate to the automated data collection systems used, must be documented by the laboratory and made known to employees. 

An operational definition is considerably more practical. Operationally determined species are defined by the methods used to separate them from other forms of the same element that may be present. The physical or chemical procedure that isolates the particular set of metal species is used to define the set. Metals extracted from soil with an acetate buffer is an operational definition of a certain class. Lead present in airborne particles of less than 10 pm is another. In water analyses, simply filtering the sample before acidification can speciate the analytes into dissolved and insoluble fractions. These procedures are sometimes referred to as fractionation, which is probably a more properly descriptive term than speciation, as speciation might imply that a particular chemical species or compound is being determined. When such operational speciation is done, careful documentation of the protocol is required, since small changes in procedure can lead to substantial changes in the results. Standardized methods are recommended, as results cannot be compared from one laboratory to another unless a standard protocol is followed [124], Improvements in methodology must be documented and compared with the currently used standard methods to produce useful, readily interpretable information. 

A better characterization of laboratory operational procedures in order to optimize the diagnostic approaches may allow a most accurate and sensitive identification of genetic markers likely associated with diseases. Moreover, it may consent a better definition of personalized therapy with obvious repercussions in patient outcomes with neoplastic diseases. 

One advantage of this rubric to researchers and practitioners is that it provides operational definitions of widely used tenns or modifiers of the word inquiry. Thus, it places on firm footing the characteristics of laboratories that are stated to be guided-inquiry" or "structured-inquiry. ... 

Solvent extraction is an operational definition for a solvent-based process to isolate soluble material from the complex and heterogeneons mixtnre, which is coal. Unless the separation process is specified, including filter pore size or centrifngation clearing factor, the material isolated is not well defined and may not be the same as that isolated in other laboratories. This is especially true for coals subject to weathering. 

The system scope Where does a laboratory begin and end Clear definition of these two points helps to determine the scope of a LIMS. The six areas of system scope that define the matrix are laboratory operations, monitor and control of operations, laboratory management, reporting and communications, analytical decision-making, and organizational integration. This is the maximum scope of a LIMS. These comprise the horizontal axis of the matrix. The function carried out by each of these areas is outlined in Table 1. 

L. C. Towle (Naval Research Laboratory) As I understand your comments today and your preprint you state that the friction force observed with polymers is not given by the expression F = pN. My understanding of the definition of the coefficient of friction is that it has an operational definition, i.e. to measure the friction between solids A and B one forces A to slide against B under measured load N and simultaneously measures the tangential force F. The friction coefficient is then defined to be the ratio p = F/N. If this is the case, then it would seem that one always has F = pN being valid. If this is not the case, then I wonder how does one define the friction coefficient ... 

Each plant or laboratory should adopt definite rules and procedures for electrical iastahations and work. All iastahations should be ia accordance with the National Electrical Code (NEC) for the type of ha2ard, eg. Class I flammable gas or vapor Class II organic, metallic, or conductive dusts and Class III combustible fibers and the degree of process containment, eg. Division 1 open and Division 2 closed (67). Regardless of the flammabiUty of the materials ia the iastaHed operations, changes ia procedure involving use of such materials often occur, sometimes without concurrent alteration of the electrical iastaHation. 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

There is probably nothing more confusing than the definition of a laboratory. For the sake of consistency in this chapter a laboratory is defined as a building, space, room, equipment, or operation used for testing, analysis, research, instruction, or similar activities. To further explain this definition, a room is considered a laboratory if any of the following exist ... 

The book is addressed to the undergraduate student audience. The informal tone appeals to most laboratory students. The illustrations are delightful. The use of different type fonts is effective for emphasis. Also, Zubrick always explains why the particular sequence of operations is necessary, as well as how to manipulate and support the apparatus and substances. This is a definite strength. 

Some Areas of Application. I next summarize some areas of application where expert systems exist or are being developed, usually by several laboratories. Some of these areas are covered in detail in other presentations as part of this symposium. I want to emphasize that this is a partial list primarily of scientific and engineering applications. A similar list could easily be generated for operations research, economics, law, and so forth. Some of the areas are outside strict definitions of the fields of chemistry and chemical engineering, but I have included them to illustrate the breadth of potential applications in related disciplines. 

While throughout this chapter various challenges and pitfalls have already been discussed, this section provides the additional common difficulties in realizing a PA solution within routine production. In general PA requirements far exceed laboratory-based analytical methods, even for the simplest of applications. That is, a successfully implemented process analytical solution provides reliable quality data while withstanding the routine factory operational conditions (enviromnental, work practices, etc.). It also functions with negligible operator and expert intervention. Based on this definition a PA solution necessitates ... 

The range of the work covered should be defined in detail, but the laboratory s operation should not be restricted by this definition. 

Equipment used in GLP studies must be validated for appropriateness. Each piece of equipment must have SOPs for operation, calibration, and routine maintenance. All routine and nonroutine maintenance must be documented. What is the definition of a piece of equipment Any item that can have an impact on the results of an anal5dical procedure. In the typical non-GLP laboratory, records are kept on analytical equipment such as spectrophotometers or gas chromatography units. Under GLP, however, the definition expands to include items such as pipets, thermometers, incubators, refrigerators, and mixing devices, as long as it is possible that the use of the item can affect the outcome of the test. For the non-GLP lab, implementation of this standard will dramatically increase the number of equipment-related SOPs. 

Agencies or authorities such as ISO or lUPAC still do not provide any definition of ruggedness. In the chemical literature however, a ruggedness test was defined as [4,12] An intralaboratory experimental study in which the influence of small changes in the operating or environmental conditions on measured or calculated responses is evaluated. The changes introduced reflect the changes that can occur when a method is transferred between different laboratories, different experimentators, different devices, etc. . 

Some other sources have definitions that are different from the one given above [7,14]. The US Pharmacopeia [7] defines ruggedness as The ruggedness of an analytical method is the degree of reproducibility of test results obtained by the analysis of the same sample under a variety of normal test conditions, such as different laboratories, different analysts, different instruments, different lots of reagents, different elapsed assay times, different assay temperatures, different days, etc. Ruggedness is normally expressed as the lack of influence on test results of operational and environmental variables of the analytical method. Ruggedness is a measure of reproducibility of test results under normal, expected operational conditions from laboratory to laboratory and from analyst to analyst . In fact this is nearly the definition of reproducibility. This definition is also followed by other authors [15]. 

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