ABSTRACT
Monitoring is necessary to observe variation in the measurements over time and what those variations mean to the stability of processes, and questions whether it is natural variation or something unusual. Measurement begins with a definition of the measure, the quantity that is to be measured, and it always involves a comparison of the measure with some known quantity of the same kind. A cause-and-effect analysis enables the variables that can affect conformity with the specified characteristics to be identified which itself identifies what to monitor and measure. Throughout the standard there are several clauses requiring monitoring, measurement, analysis or evaluation. Process monitoring is carried out by capturing data on process parameters such as throughput and yield which is computed from the measurement of outputs. The results of monitoring and measurement are used for different purposes, and therefore when their analysis and evaluation is carried out depends on there being sufficient data to make a decision.
