Statistical Process Control (SPC) uses control charts to monitor process stability. Process capability indices Cp and Cpk quantify how well a stable process fits within specification limits, with Cpk accounting for centering. SPC uses charts such as X-bar and R, individuals and p-charts, with rules that flag shifts and trends before parts go out of specification. Capability should only be calculated once a process is shown to be stable. In medical device manufacturing, SPC data supports process validation, ongoing monitoring under ISO 13485 clause 8.2.5 and CAPA trend analysis.

Why it matters

Process validation per the FDA/GHTF guidance expects capable and stable processes. Common medical-device targets are Cpk ≥ 1.33 for routine attributes and ≥ 1.67 for safety-critical ones.

Common pitfalls

•A common pitfall is calculating Cpk on unstable processes, leading to misleading capability assessments.
•Misinterpreting a high Cpk value as a guarantee of product quality without considering other factors like measurement system variability is a mistake.
•Failing to regularly monitor and react to SPC control chart signals can lead to process drift and non-conforming products.
•Only focusing on Cpk without attention to critical process parameters and their clinical impact is a pitfall.
•Setting arbitrary Cpk targets without a rational basis tied to risk assessment and product requirements can lead to inefficient resource allocation or inadequate quality control.

Sources

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