What a control plan does
A control plan documents how the organization will control product and process characteristics. It tells the responsible person what to control, how to measure or monitor it, how often to do so, who is responsible, what record is required, and what to do when the result is unacceptable.
Fields that must be clear
What is controlled
Link each item to the applicable process step and define the product characteristic, process parameter, or requirement in unambiguous terms.
How it is controlled
State the specification or target, measurement or monitoring method, sample or frequency, responsible role, and the record needed to demonstrate performance.
Reaction plan
Define immediate containment, segregation, notification, disposition, correction, and restart or release criteria. “Notify quality” alone is not a complete reaction plan.
Control plan review checklist
- Every process step matches the approved process flow diagram.
- Controls address customer requirements and relevant PFMEA risks.
- Methods are feasible in the production environment, and needed gauges, fixtures, software, training, and records are available.
- The reaction plan identifies who can stop, contain, and release product—and the evidence required for release.
- The document is reviewed after changes, nonconformities, customer feedback, process audits, and lessons learned.
Reduce manual consistency checks
QA Assistant Studio MAX can link process flow, PFMEA, control plan, and work-instruction information, then highlight out-of-sync fields for review. Its approval workflow and document history can support controlled updates.
Explore Control Plan software