Statistical Methods from the Perspective of ICH Q9 Quality Risk Management

In the news "ICH Q9 Training Package updated", we discussed the updates to the ICH Q9 training package. Among other things, the slides illustrating how statistical methods can support quality risk management have also been updated. What does this set of slides contain?

The slide set on 'supporting statistical tools' has been expanded from 22 slides to 34 slides and is designed very interestingly. It covers control charts, Design of Experiments (DoE), histograms, Pareto charts and process capability analyses. Statistical tools are considered helpful:

• for effective data evaluation
• for determining the necessity of data sets
• as a facilitator of transparent decision-making

Statistical Process Control

The first tool mentioned is Statistical Process Control (SPC), which can provide helpful information on:

• process capabilities or performance
• the effectiveness of process changes
• demonstrating process stability

The slides go on to discuss control charts and explain the considerations necessary before using a control chart. One slide discusses the presence of a normal distribution, stating that moderate deviations from the normal distribution do not significantly impair the accuracy of a control chart. A slide then clearly presents the possible use of control charts depending on the data type, data distribution and sample size. In more detail, acceptance control charts, Cusum charts and weighted control charts are then presented with reference to ISO standards. Examples of how to identify deviations in the charts are also presented.

Process Capability Indices

Process capability indices (CpK, PpK) are then covered across 10 slides. Strong emphasis is placed on the normal distribution of data in their application, and examples are given of how non-normally distributed data can be 'normalised'. The relationships between CpK and PpK values are explained.

Design of Experiments (DoE), Histograms and Pareto Charts

Four slides then introduce DoE, covering the individual phases and potential areas of application, with one slide each for histograms and two slides for Pareto charts.

Conclusion: This set of slides provides a highly focused introduction to statistical methods that can support risk management.

You can download the slides from the ICH website.

Are you interested in the statistical methods mentioned above? The ECA Academy is running the event 'Quality Statistics in the Pharmaceutical Industry - Hands-On with Minitab' on 19/20 May 2026 in Hamburg. These methods will also be applied there as part of a workshop using Minitab.