Frequently Asked Question

Control-plan logic

A control plan defines what is controlled, where, how, how often, by whom, and what happens when the result is abnormal. Include setup approval, incoming material, in-process characteristics, final checks, measurement-system checks, maintenance, traceability, and rework. A reaction plan must stop or contain the process and define restart authorization.

Worked example

For a critical hole diameter, specify the gauge, calibration status, sampling frequency, limit, record, containment quantity, adjustment rule, and restart sample. “Inspect periodically” is not an adequate control because it does not define frequency or reaction.

Engineering check

For Control Plans and Reaction Plans, maintain traceability from requirement to risk, design output, evidence, and approval. Record the configuration, acceptance criterion, test or analysis conditions, open actions, and residual risk. A method is not complete when the document is filled in; it is complete when the evidence supports the decision and affected controls are updated.

Planning detail

For each controlled characteristic, identify the operation, specification, measurement method, frequency, record, reaction, containment quantity, adjustment rule, and restart authorization. Link the characteristic to the process-flow step and PFMEA failure mode. A control plan is effective only when the operator can execute it, the gauge is available and calibrated, and abnormal results trigger a defined response.

Planning detail

For each controlled characteristic, identify the operation, specification, measurement method, frequency, record, reaction, containment quantity, adjustment rule, and restart authorization. Link the characteristic to the process-flow step and PFMEA failure mode. A control plan is effective only when the operator can execute it, the gauge is available and calibrated, and abnormal results trigger a defined response.