The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control, in "runs" consisting of measurements of multiple samples. They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control. [1] They are plotted on Levey–Jennings charts, wherein the X-axis shows each individual sample, and the Y-axis shows how much each one differs from the mean in terms of standard deviation (SD). The rules are: [2]
Rule | Criteria | Suspected | Example |
---|---|---|---|
12s | One measurement exceeds 2 standard deviations either above or below the mean of the reference range. | Inaccuracy and/or imprecision | |
13s | One measurement exceeds 3 standard deviations either above or below the mean of the reference range. | Inaccuracy and/or imprecision | |
22s | 2 consecutive measurements exceed 2 standard deviations of the reference range, and on the same side of the mean. | Inaccuracy and/or imprecision | |
R4s | Two measurements in the same run have a 4 standard deviation difference (such as one exceeding 2 standard deviations above the mean, and another exceeding 2 standard deviations below the mean). | Imprecision. | |
41s | 4 consecutive measurements exceed 1 standard deviation on the same side of the mean. | Inaccuracy. | |
10x | 10 consecutive measurements are on the same side of the mean. | Inaccuracy. |
The recommended consequences when any of the above patterns occur is to reject the run, except for the rule of 12s (top in table), which serves as a warning and a recommendation of careful inspection of the data. [2]
A histogram is an approximate representation of the distribution of numerical data. The term was first introduced by Karl Pearson. To construct a histogram, the first step is to "bin" the range of values—that is, divide the entire range of values into a series of intervals—and then count how many values fall into each interval. The bins are usually specified as consecutive, non-overlapping intervals of a variable. The bins (intervals) must be adjacent and are often of equal size.
In telecommunication, an eye pattern, also known as an eye diagram, is an oscilloscope display in which a digital signal from a receiver is repetitively sampled and applied to the vertical input (y-axis), while the data rate is used to trigger the horizontal sweep (x-axis). It is so called because, for several types of coding, the pattern looks like a series of eyes between a pair of rails. It is a tool for the evaluation of the combined effects of channel noise, dispersion and intersymbol interference on the performance of a baseband pulse-transmission system. The technique was first used with the WWII SIGSALY secure speech transmission system.
A scatter plot is a type of plot or mathematical diagram using Cartesian coordinates to display values for typically two variables for a set of data. If the points are coded (color/shape/size), one additional variable can be displayed. The data are displayed as a collection of points, each having the value of one variable determining the position on the horizontal axis and the value of the other variable determining the position on the vertical axis.
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line. Control charts are classified into Shewhart individuals control chart and CUSUM(CUsUM)(or cumulative sum control chart)(ISO 7870-4).
Reflection high-energy electron diffraction (RHEED) is a technique used to characterize the surface of crystalline materials. RHEED systems gather information only from the surface layer of the sample, which distinguishes RHEED from other materials characterization methods that also rely on diffraction of high-energy electrons. Transmission electron microscopy, another common electron diffraction method samples mainly the bulk of the sample due to the geometry of the system, although in special cases it can provide surface information. Low-energy electron diffraction (LEED) is also surface sensitive, but LEED achieves surface sensitivity through the use of low energy electrons.
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap. SPC can be applied to any process where the "conforming product" output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
The Western Electric rules are decision rules in statistical process control for detecting out-of-control or non-random conditions on control charts. Locations of the observations relative to the control chart control limits and centerline indicate whether the process in question should be investigated for assignable causes. The Western Electric rules were codified by a specially-appointed committee of the manufacturing division of the Western Electric Company and appeared in the first edition of a 1956 handbook, that became a standard text of the field. Their purpose was to ensure that line workers and engineers interpret control charts in a uniform way.
Nelson rules are a method in process control of determining whether some measured variable is out of control. Rules for detecting "out-of-control" or non-random conditions were first postulated by Walter A. Shewhart in the 1920s. The Nelson rules were first published in the October 1984 issue of the Journal of Quality Technology in an article by Lloyd S Nelson.
Powder diffraction is a scientific technique using X-ray, neutron, or electron diffraction on powder or microcrystalline samples for structural characterization of materials. An instrument dedicated to performing such powder measurements is called a powder diffractometer.
The Fast Auroral SnapshoT Explorer was a NASA plasma physics satellite, and was the second spacecraft in the Small Explorer program (SMEX). It was launched on 21 August 1996, from Vandenberg Air Force Base aboard a Pegasus XL launch vehicle. The spacecraft was designed and built by NASA's Goddard Space Flight Center (GSFC). Flight operations were handled by GSFC for the first three years, and thereafter were transferred to the University of California, Berkeley's Space Sciences Laboratory.
A run chart, also known as a run-sequence plot is a graph that displays observed data in a time sequence. Often, the data displayed represent some aspect of the output or performance of a manufacturing or other business process. It is therefore a form of line chart.
In engineering, science, and statistics, replication is the repetition of an experimental condition so that the variability associated with the phenomenon can be estimated. ASTM, in standard E1847, defines replication as "... the repetition of the set of all the treatment combinations to be compared in an experiment. Each of the repetitions is called a replicate."
An oscilloscope is a type of electronic test instrument that graphically displays varying voltages of one or more signals as a function of time. Their main purpose is capturing information on electrical signals for debugging, analysis, or characterization. The displayed waveform can then be analyzed for properties such as amplitude, frequency, rise time, time interval, distortion, and others. Originally, calculation of these values required manually measuring the waveform against the scales built into the screen of the instrument. Modern digital instruments may calculate and display these properties directly.
Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and whenever patient results seem inappropriate. Quality control material should approximate the same matrix as patient specimens, taking into account properties such as viscosity, turbidity, composition, and color. It should be simple to use, with minimal vial-to-vial variability, because variability could be misinterpreted as systematic error in the method or instrument. It should be stable for long periods of time, and available in large enough quantities for a single batch to last at least one year. Liquid controls are more convenient than lyophilized (freeze-dried) controls because they do not have to be reconstituted, minimizing pipetting error. Dried Tube Specimen (DTS) is slightly cumbersome as a QC material but it is very low-cost, stable over long periods and efficient, especially useful for resource-restricted settings in under-developed and developing countries. DTS can be manufactured in-house by a laboratory or Blood Bank for its use.
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