Process control: guidance, not surveillance
The standard
A documented process control records which variables were measured and with what intervention deviations were answered. Without this record a result is a claim about the path that led to it.
Criteria
- The relevant variables are named in advance
- Their course is recorded at fixed intervals
- Every deviation is linked to a documented response
- The intervention remains traceable to the measured variable
Distinction
Process control ≠ final inspection: one accompanies the course, the other checks only the result. A documented process control requires a decision about the intervention, not an automatic regulation.