Quality Control 4. What are meant by median and mode?

Give examples from a set of data Characterize the other types of QC Charts.
a Levey- Jennings control chart (Fig. 4-25). Control charts graphically represent the observed values of a control material over time in the context of the upper and lower control limits. When the observed value falls with the control limits, it can be interpreted that the method is performed adequately. Points falling outside the controlimits may suggest that problems may be developing. Control limits are expressed as the mean _ SD using formulas previously described in this chapter. Control charts can detect errors in accuracy and imprecision over time (Fig. 4-25A). Analytic errors that can occur can be separated into random and systematic as discussed in a previous chapter. The underlying rationale for running repeated assays is to detect random errors that affect precision (Fig. 4-25B, middle). Random errors may be caused by variations in technique. Systemic errors arise from factors that contribute to constant differences between measurements; these errors may be either positive or negative (Fig. 4-25B, right). Systemic errors may be due to several factors, including poorly made standards, reagents, instrumentation problems, or poorly written procedures.

A chart is created for each test and level of control. The first step is to calculate decision limits. These limits are 1s, 2s and 3s from the mean. The mean for the Level I potassium control in
Mean is the sum of all results divided by the number of results. Also related are the median, which is the middle value that divides the distribution of data points into upper and lower halves (also called the 50th percentile); and the mode, which is the most common value. The mean, median, and mode are all measures of central tendency. The geometric mean is calculated as the nth root of the product of a distribution of n numbers; its use for estimating central tendency minimizes the effects from extreme values such as are found in a log-normal distribution. Figure 10-5 shows a Levey-Jennings (Levey, 1950), also called Shewhart (Shewhart, 1931), plot, which is the most common presentation for evaluating QC results. This format shows each QC result sequentially over time and allows a quick visual assessment of method performance, including trend detection. The mean value represents the target (or expected) value for the result, and the SD lines represent the expected imprecision for the method. Assuming a Gaussian (normal) distribution of imprecision, the results are distributed as expected, with results scattered uniformly around the mean, and with results observed more frequently closer to the mean than near the extremes of the distribution. Note that a few results are greater than 2 SD, and two results slightly exceed 3 SD, which is expected on the basis of a Gaussian distribution of imprecision. For a large number of repeated assays, the number of results expected within the SD intervals is as follows: 1 SD 68.3% of observations 2 SD 95.4% of observations 3 SD 99.7% of observations Interpretation of an individual QC result is based on its probability to be part of the expected distribution of results for the method when the method is performing correctly. A later section provides details regarding interpretive rules for evaluation of QC results.

1. ^ Tietz, N.W. (1987). "Fundamentals of Clinical Chemistry", Third Edition, W.B. Saunder Company. 2. ^ .Grant, E.L. and R.S. Leavenworth (1988). "Statistical Quality Control", Sixth Edition, McGraw-Hill Book Company. 3. ^ Westgard, J.O., P.L. Barry, and M.R. Hunt (1981). "A Multi-rule Shewhart Chart for Quality Control in Clinical Chemistry,"Clinical Chemistry, vol. 27, pp. 493-501. 4. ^ Westgard, J.O., P.L. Barry (1986). "Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes"AACC Press.

Common Types of Charts

The types of charts are often classified according to the type of quality characteristic that they are supposed to monitor: there are quality control charts for variables and control charts for attributes. Specifically, the following charts are commonly constructed for controlling variables:

X-bar chart. In this chart, the sample means are plotted in order to control the mean value of a variable (e.g., size of piston rings, strength of materials, etc.). R chart. In this chart, the sample ranges are plotted in order to control the variability of a variable. S chart. In this chart, the sample standard deviations are plotted in order to control the variability of a variable. S**2 chart. In this chart, the sample variances are plotted in order to control the variability of a variable.

For controlling quality characteristics that represent attributes of the product, the following charts are commonly constructed:

C chart. In this chart (see example below), we plot the number of defectives (per batch, per day, per machine, per 100 feet of pipe, etc.). This chart assumes that defects of the quality attribute are rare, and the control limits in this chart are computed based on the Poisson distribution (distribution of rare events). U chart. In this chart we plot the rate of defectives, that is, the number of defectives divided by the number of units inspected (the n; e.g., feet of pipe, number of batches). Unlike the C chart, this chart does not require a constant number of units, and it can be used, for example, when the batches (samples) are of different sizes. Np chart. In this chart, we plot the number of defectives (per batch, per day, per machine) as in the C chart. However, the control limits in this chart are not based on the distribution of rare events, but rather on the binomial distribution. Therefore, this chart should be used if the occurrence of defectives is not rare (e.g., they occur in more than 5% of the units inspected). For example, we may use this chart to control the number of units produced with minor flaws. P chart. In this chart, we plot the percent of defectives (per batch, per day, per machine, etc.) as in the U chart. However, the control limits in this chart are not based on the distribution of rare events but rather on the binomial distribution (of proportions). Therefore, this chart is most applicable to situations where the occurrence of defectives is not rare (e.g., we expect the percent of defectives to be more than 5% of the total number of units produced).

All of these charts can be adapted for short production runs (short run charts), and for multiple process streams.
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