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DMAIC|5 min read

Building a Control Plan that survives the audit

The Control phase of DMAIC is where gains die. A control plan is the sustainment architecture that prevents that. One row per Critical-to-Quality (CTQ) characteristic. One reaction plan per row. Signed and trained.

The 7 columns

ColumnExample
Process stepCapping — torque application
CTQ (what we monitor)Torque value
Specification10.5 ± 0.3 Nm
Measurement methodCalibrated digital torque driver, auto-log to MES
Sample size + frequencyn=1 per vial, continuous via driver; n=5 audit per shift
Responsible roleLine 2 Capping Operator (in-line); Shift Lead (audit)
Reaction planIf out-of-spec: stop line, verify driver calibration, escalate to Eng within 15 min

What separates good from bad

  • Reaction plan is specific and timed — not 'investigate and fix'
  • Responsible role is named — not 'team' or 'operator'
  • Sample size + frequency is rational — tied to risk, not convenience
  • Spec is numeric — not 'acceptable'
  • Every CTQ is in the plan — no gaps

Link to Standard Work

The control plan drives the Standard Work. Every CTQ and reaction should show up as a step or a note in the SOP the operator follows. A control plan that lives in a binder while operators follow a different SOP is theater.

The handover

A signed control plan without a named owner is a paper exercise. Handover requires: (1) a named process owner, (2) their commitment in writing, (3) the 30/60/90 day sustainment check dates on the calendar, (4) the finance verification of benefit. Miss any of those and the gain evaporates.

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