You are assigned a new task to demonstrate that an existing process will have the capability to meet newer and tighter specifications. The change in specifications for critical-to-quality characteristic P is due to new regulatory requirements; hence, the specifications must be met. The task is doubly challenging because not only are the new specifications tight, but also the timelines.

How would you know what this process can achieve for characteristic P? Where would you start to make best use of the data at hand? How would you convince your colleagues that your ideas will bring about success? Read on to see how SPC techniques—through the voice of the process—can provide unique insights and guidance on the best way forward to rise to this challenge.

The baseline data

The baseline data—179 values for characteristic P—are shown in the postscript at the end of this article. In Figure 1, we see these data in a histogram, first against the current specifications for the key quality characteristic under study, and second against the newer specifications.

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