Figure 1 shows the Westgard Sigma Rules for 2 levels of control materials.

On first glance, it looks just like the Westgard Rules diagram except there is no 2 SD warning rule.
That is an important dis"nc"on, but the most important change is the Sigma-scale at the bo$om of
the diagram. That scale provides guidance for which rules should be applied based on the sigma
quality determined in your laboratory.

Here’s how it works. The dashed ver"cal lines that come up from the Sigma Scale show which rules
should be applied based on the sigma quality determined in your laboratory. For example:

 6-sigma quality requires only a single control rule, 13s, with 2 control measurements in each
run one on each level of control). The nota"on N=2 R=1 indicates that 2 control
 measurements are needed in a single run. See Figure 2.

 5-sigma quality requires 3 rules, 13s/22s/R4s, with 2 control measurements in each run (N=2,
R=1). See Figure 3.

 4-sigma quality requires addi"on of a 4th rule and implementa"on of a

13s/22s/R4s/41s mul"role, preferably with 4 control measurements in each run (N=4, R=1), or
alterna"vely, 2 control measurements in each of 2 runs (N=2, R=2), using the 41s rule to
inspect the control rules across both runs. This 2nd op"on suggests dividing a day’s work into
 2 runs and monitoring each with 2 controls. See Figure 4.

 <4-sigma quality requires a mul"rule procedure that includes the 8x rule, which can be
implemented with 4 control measurements in each of 2 runs (N=4, R=2) or alterna"vely with
2 control measurements in each of 4 runs (N=2, N=4). The first op"on suggests dividing a
days’ work into 2 runs with 4 control measurements per run, whereas the second op"on
suggests dividing a day’s work into 4 runs and monitoring each with 2 controls. See Figure 5.
A similar diagram shown in Figure 6 describes Westgard Sigma Rules for 3 levels of controls.

 6-sigma quality requires only a 13s rule and 1 measurement on each of 3 levels of controls. A

 5-sigma quality requires adding the 2of32s and R4s rules for use with 1 measurement on each
of 3 levels of controls.

 4-sigma quality requires adding a 31s rule for use with 1 measurement on each of 3 controls.

 <4-sigma quality requires a mul"rule procedure that includes the 6x rule and a doubling of
control measurements to a total of 6, which suggests that the 3 levels of controls be analyzed
in duplicate in one run (N=6, R=1) or the day’s work divided into 2 runs with 3 control
measurements per run (N=3, R=2). If a 9x rule were subs"tuted for the 6x rule, then a day’s
work could be divided into 3 runs with 3 controls per run (N=3,R=3).

What SQC is needed in the real world?

Based on data from which we have evaluated quality on the sigma scale, many highly automated
systems provide a majority of tests that perform at 5 to 6 sigma quality. For those with 6-sigma
quality, that means the use of a Levey-Jennings QC chart with control limits set as the mean ± 3SD
and analysis of 2 controls per run should provide reliable detec"on of medically important errors. For
those with 5 sigma quality, a simple mul"rule such as 13s/R4s/22s with 1 measurement on each of two
levels of controls should be adequate. Such systems also typically include a few tests of lower quality
which require more QC, with addi"on of the 41s and possibly the 8x rules and doubling the number of
control measurements to provide a total N of 4.

In Point-of-Care applica"ons, many test devices do not demonstrate high quality on the sigma scale,
therefore the SQC required may be very demanding. As a specific example, the HbA1c devices that
were evaluated by Lenters and Slingerland in the August 2014 issue of Clinical Chemistry [9]
demonstrate sigma quality that ranges from approximately 0.0 to 4.5 (see discussion elsewhere on
this website for the calcula"ons). All 7 of these devices were NGSP cer"fied as providing equivalent
test results and furthermore classified by FDA as “waived” tests, meaning operators need no formal
laboratory training, they only need to follow the manufacturer’s direc"ons for QC, and the devices
are not subject to ongoing assessment via proficiency tes"ng. However, there is clearly a need for
rigorous QC with use of many of these devices. Based on the sigma quality of these devices, the best
case for SQC would be a mul"rule procedure 13s/22s/R4s/41s with 4 control measurements. The others
require even more QC!

What’s the point?

Laboratories need to determine the sigma quality of their tests and methods if they are to manage
the tes"ng process properly. SQC is an essen"al tool for managing analy"cal quality, but the rules
and number of control measurements should be op"mized for quality and efficiency. It is very easy
to figure out the right SQC by using Westgard Sigma Rules! The hard part is defining how good a test
needs to be for its intended clinical use (e.g., the allowable Total Error, TEa), determining the
precision (SD, CV) from a replica"on experiment or from rou"ne SQC data, and determining accuracy
(bias) from a comparison of methods experiment or from periodic proficiency tes"ng results. ANer
calcula"on of sigma quality, the Westgard Sigma Rules diagram makes it easy to select the right
control rules and the right number of control measurements.

References

1. Westgard JO, Groth T. Design and evalua"on of sta"s"cal control procedures: Applica"ons of
a computer “Quality Control Simulator” program. Clin Chem 1981;27:1536-45.

2. Westgard JO, Groth T. Power func"ons for sta"s"cal control rules. Clin Chem 1979;25:863-9.

3. Koch DD, Oryall JJ, Quam EF, Feldbruegge, Dowd DE, Barry PL, Westgard JO. Selec"on of
medically useful Quality Control procedures for individual tests done in a mul"test analy"cal
system. Clin Chem 1990;36:230-3.

4. Westgard JO, Quam EF, Barry PL. Selec"on G