The basic tenet applying to quality control data is that such data be compared to standards or limits and that decisions (usually "pass" or "fail") made on the basis of that comparison.
The underlying principle of process control data (e.g., equipment speeds, times, temperatures, pressures) is that they should be compared with predetermined limits validated as the limiting parameters of satisfactory product quality. The equipment should be then adjusted in response to the data to ensure that the process remains within these control limits.
Environmental monitoring data have a greater similarity to process control data than to quality control data, but there is little opportunity for precise process adjustment to bring controlled environments into control because microbiological indices of environmental control are crude, and limits subject to interpretation.
Nonetheless, outcomes of environmental monitoring data are the same as any other quality or process monitors. Processes may require adjustment, may have to be shut down, or the product may have to be reworked or rejected.
Was this article helpful?