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Variability · No. 22How to Read a QC Chart

Variability — reading the evidence

How to read a QC chart

A QC chart is not a verdict on randomness. Its patterns are questions about what changed, and in an injection method the first answer is usually how the sample got in.

By Medrado Analytical Innovations · Foundations, No. 22 · for the working analyst

In this piece · 8 min read
  1. How the chart is drawn
  2. What the chart was built for
  3. The normality question
  4. Inside the limits is not the same as only chance
  5. Where the variation comes from
  6. Six patterns, and what to look for
  7. Overlay the conditions
  8. Flattening the chart
  9. The judgement

Most working labs run a check sample day after day and plot its results, or should: a quality-control (QC) sample of known value, its results on a chart with a centre line and a pair of limits. While the points stay inside the limits, the method is treated as in control and the samples are released. A point beyond the action limit, or a pattern that breaks one of the chart's rules, means you investigate before treating the run as normal; your quality system says whether work pauses while you do.

That is how the chart is usually read, and it leaves most of its information on the table. In my experience, overlaying the lab's temperature on a QC chart often shows the results moving with it: the chart meant to show whether the method is fit for use is partly tracking the weather. This piece is about reading the chart for what it is telling you.

How the chart is drawn

First, what you are looking at. Each point is one result for the QC sample, in time order. The centre line is the average of those results over a period when nothing unusual was happening. The limits come from how much the results normally move from one run to the next in that same period; a common way, for one result at a time, is to use the average difference between consecutive results (the moving range) to estimate the standard deviation, and to set the action limits at three of those standard deviations either side of the centre line. Your method or practice gives the factor that turns one into the other. Limits drawn from a period that included problems come out too wide and hide the next problem.

A chart like this answers one question: is the method behaving the way it did when the limits were set? It does not tell you whether the method is right. A method can sit calmly inside its limits and still be biased; that is the job of a certified reference material, drawn on the chart as a separate reference line (the piece on whether the calibration is still holding covers this).

Check yourself

Answer in your head first, then open the answer. Any question can go into your Quiz me.

  1. What was the control chart built to do?

    Show the answer
    “The control chart was built to separate assignable causes, which you can find and fix, from the variation left once they are gone.”

    See it in the article ·

  2. Do Shewhart's 3s limits require normally distributed data?

    Show the answer
    “Shewhart's limits do not require normally distributed data.”

    See it in the article ·

  3. Every point is inside the limits, but the results have climbed for a week. What does that mean?

    Show the answer
    “A point inside the limits does not mean only chance causes remain.”

    See it in the article ·

Glossary

Assignable cause
A particular cause of variation you can find and remove: a new septum, a new lot, a change of analyst.
Chance cause
The many small causes of variation left when the assignable ones are gone; not worth chasing one by one.
Moving range
The difference between consecutive results; used to estimate the standard deviation for a chart of single results.
Run rule
An extra rule that flags a pattern the limits alone miss, such as eight points in a row on one side of the centre line.

Sources

  1. W. A. Shewhart, Economic Control of Quality of Manufactured Product (Van Nostrand, 1931).
  2. W. A. Shewhart, Statistical Method from the Viewpoint of Quality Control (Graduate School, US Department of Agriculture, 1939).
  3. D. J. Wheeler, "The Normality Myth", Quality Digest, 9 September 2019 (qualitydigest.com).
  4. ASTM D6299-26a, Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance, 1.6 (the normal-model assumption).
  5. Western Electric Co., Statistical Quality Control Handbook (1956).
  6. L. S. Nelson, "The Shewhart control chart: tests for special causes", Journal of Quality Technology 16(4), 237–239 (1984).