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Quality Management (QMS) 16 items

Statistical Process Control (SPC) Implementation Checklist

A checklist for implementing statistical process control including chart selection, subgrouping, control limits, capability studies, and out-of-control reaction per the AIAG SPC reference manual.

AIAG SPCIATF 16949:2016

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Characteristic Selection & Planning

  • Have special/significant characteristics requiring SPC been identified from the control plan and PFMEA? *
  • Is the measurement system for the characteristic validated (MSA/Gauge R&R acceptable)? *
  • Is the appropriate chart type selected for the data (variables vs. attribute)? *
  • Characteristic / parameter under control *

Control Chart Setup

  • Is a rational subgroup size and sampling frequency defined? *
  • Are control limits calculated from process data (not specification limits)? *
  • Are control charts established using an adequate number of subgroups (typically 25+) for baseline? *
  • Are the center line and control limits recalculated when the process changes?

Process Stability & Capability

  • Is the process demonstrated to be in statistical control (stable) before capability is assessed? *
  • Are capability (Cp/Cpk) and performance (Pp/Ppk) indices calculated for the characteristic? *
  • Do capability indices meet the customer or internal minimum (e.g., Cpk ≥ 1.33)? *
  • Measured Cpk value

Out-of-Control Reaction

  • Are out-of-control rules (e.g., points beyond limits, runs, trends) defined for chart interpretation? *
  • Is a documented reaction plan available for out-of-control conditions? *
  • Are operators trained to interpret charts and respond to signals? *
  • Are out-of-control events recorded with actions taken? *

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