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Control plan and project handoff

The Control phase closes the DMAIC project by ensuring that the improvements made in Improve are locked in and sustained without the GB’s daily involvement. The primary deliverable is the control plan — a living document that tells operators and supervisors exactly what to monitor, how to monitor it, and what to do when something goes wrong.

Control plan: key columns

ColumnWhat it defines
Process stepWhich step in the process is being controlled
Input or output characteristicThe specific CTQ or key process input variable (KPIV) being monitored
Specification / targetThe acceptable range or target value (USL/LSL or target ± tolerance)
Measurement methodHow to measure it (which gage, procedure, sample point)
Sample size and frequencyHow many units and how often (every 30 min; every batch; every nth unit)
Control methodHow the process is controlled: SPC chart, visual check, automated alarm, go/no-go gage
Reaction planWhat to do when the measurement is out of spec or a control chart signal appears: stop, adjust, notify, quarantine, escalate
Responsible personWho owns this monitoring step

Worked example: Examplorphine fill weight control plan

After improving fill weight (spec 245–255 mg; mean re-centered from 251.5 to 250.0 mg with s = 1.2 mg, so Cpk rose from 0.97 to 5.0 / 3.6 = 1.39):

CharacteristicSpecMethodFrequencyControl methodReaction if OOS
Fill weight250.0 ± 5.0 mgCalibrated scale (MSA passed)Every 30 min; n=5X̅-R chart; alert if Nelson Rule 1 or 2Stop line; notify supervisor; quarantine last 30 min output; recalibrate auger; document
Auger calibrationPer PM scheduleCalibration SOP Rev 4Monthly + after each replacementPM log; calibration certificate on fileDo not run line until calibration confirmed

Response plan principles

A good response plan answers four questions when a signal occurs:

  1. Stop or continue? When does the process stop vs. when can it continue while investigating?
  2. Contain the impact. Quarantine, hold, or segregate potentially out-of-spec product.
  3. Who is responsible? Named roles, not job titles alone.
  4. When to escalate? If the root cause is not found in X hours, escalate to the GB or engineer.

Sustaining gains: what makes Control fail

Reason gains backslideCountermeasure
SOP not updatedUpdate SOP before project closes; version-control it
New operators not trainedTraining record tied to updated SOP; competency verification
Control chart exists but no one responds to signalsResponse plan on the chart; supervisor audit; escalation path
GB leaves; no process ownerFormal handoff sign-off with named process owner
Process change not evaluated against control planChange control requires review of control plan impact

Project handoff and closure

At the Control tollgate, the GB hands the project to the process owner (not the Champion). The handoff package typically includes:

The Champion signs off that the project is complete and gains are sustainable without GB daily involvement.

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More: Control charts · DMAIC overview · Project charter · Poka-yoke · Solution selection

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