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.