Process / pipelineEngineering methods
Risk-based Process Capability Analysis
Risk-based Process Capability Analysis (RBPCA) combines classical process capability indices (Cp, Cpk, Pp, Ppk) with structured risk assessment tools — such as FMEA risk priority numbers — to prioritise improvement actions not merely by how capable a process is, but by the potential harm its failures can cause. The approach is widely used in automotive, aerospace, medical device, and pharmaceutical manufacturing to align quality engineering decisions with risk management requirements.
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Sources
- Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308
- Breyfogle, F. W. (2003). Implementing Six Sigma: Smarter Solutions Using Statistical Methods (2nd ed.). Wiley. ISBN: 978-0471265726