Process · Capability
Process capability (Cpk): the proof for streamlining.
To justify controlling less often, you need objective proof, not a hunch. That proof exists: process capability (Cpk), cross-referenced with deviation history. A highly capable, well-centered process doesn't drift between two controls — and that can be demonstrated, with the numbers to back it up.
Cpk > 1.33
the usual threshold for a "capable" process. Above 2, the process is so robust and well-centered that a deviation between two controls becomes highly unlikely.
Cpk measures both the spread of a parameter and its centering relative to the specifications. The higher it is, the more comfortable the margin. At a pharmaceutical site in Morocco, a tracked parameter showed a Cpk of 3.63 (measurements at 400–403 mg for a 390–410 mg specification): in other words, an out-of-spec drift between two samplings is almost impossible.
The real problem
We measure capability to validate… then forget it when it comes to steering.
Cpk is calculated during validation, then filed away in a report. Instead, it should inform a very concrete decision: how often to control? A process shown to be highly capable and with no deviation history doesn't need to be checked every 30 minutes — the data proves it, you just have to use it.
Reading capability
What Cpk really tells you.
Three simple benchmarks to turn a number into a decision.
| Cpk | Reading | Implication for control |
|---|---|---|
| < 1.0 | Process not capable | Close control justified; act on the process first |
| 1.0 – 1.33 | Borderline / to monitor | Keep the frequency; make it reliable before streamlining |
| 1.33 – 2.0 | Capable | Streamlining conceivable, cross-referenced with history and FMEA |
| > 2.0 | Highly capable and centered | Strong candidate for lower frequency, with the proof to support it |
Indicative benchmarks — the decision is always made by cross-referencing Cpk, deviation history and risk analysis.
The condition
Capable isn't enough: it must also be stable.
A high Cpk is a snapshot; the history is the movie. It's cross-referencing the two that makes the proof: a highly capable process and with no OOS/OOT over several years is demonstrably stable over time. At that level, control frequency mainly guards against a risk that no longer materializes — and machine barriers (automatic rejection out of tolerance, stop on exceedance) already cover the residual chance of error.
The complete method for streamlining IPC →Go further
From proof to decision.
Streamline IPC without risk
The 5-step method in which Cpk is the 3rd pillar.
Read the article → SamplingAQL applied to the batch record
How capability translates into frequency via an AQL plan.
Read the article → ConsultingSimplify deviation management
OOS/OOT history feeds the proof: detect, handle, learn.
Learn more →Frequently asked questions
Process capability & Cpk.
Let your capability speak.
Let's quantify the robustness of your processes to right-size your controls to real risk.