Statistical design operational monitoring

The type of statistical design in operational monitoring will be deterministic, that is, a design based on the existing knowledge or on experts judgement. In this case, it is not possible to extrapolate the results. 

Alert and Action Levels. Validated and established systems should be periodically monitored to confirm that they continue to operate within their design specifications and consistently produce water or air of acceptable quality. Monitored data may be compared to established process parameters or product specifications. A refinement to the use of process parameters and product specifications is the establishment of alert and action levels, which signal a shift in process performance. Alert and action levels are distinct from process parameters and product specifications in that they are used for monitoring and control rather than accept or reject decisions. The levels should be determined based on the statistical analysis of the data obtained by monitoring at the PQ step. 

The software program is tailored for each molded piece. An operator, led by a menu, performs all the indicated measurements. All sampling, the period between the statistical analysis of the data, remarks of the inspector are recorded under the corresponding design number of the part on the data-disc. The results of the measurements appear on the monitor along with the actual and index values and tolerance limits. 

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