Alert, Action, and Out Of Specifica

Alert, Action, and Out Of Specification (OOS) LevelsSampling could be performed from the same sample location for process control and quality control purposes. Different Alert and Action Levels could be established; however, process control levels may typically be established at tighter values than those for quality control.For an excursion above a specification limit, an investigation should be performed to determine, correct, and prevent the cause of the excursion from occurring in the future. In this case, the particular investigation would be an OOS investigation and the impact of this water on the product should be assessed.2.1.2.3 Sampling for Technical, Investigative, or Diagnostic ReasonsSampling performed for technical, investigative, or diagnostic reasons may include:• Gathering data to better understand (or pinpoint) the root cause of a process deviation or specification excursion• To determine the extent of contamination within a system• To spot check the long-term efficacy of a particular remedial action (e.g., from a CAPA response) by checking specific attribute levels at a specified locationAdditional sampling points, installed for technical, investigative, or troubleshooting purposes may not be routinely sampled. For instance, if a Reverse Osmosis (RO) membrane was prematurely scaling with hardness, it would be appropriate to sample upstream and downstream of a water softener to determine if hardness reduction levels were being achieved throughout the softener use cycle or if the water hardness increased since the equipment was originally set up.Data from technical, investigative, or diagnostic sampling can also be used to establish a baseline for non-routinely measured water attributes (such as the chemical attributes of the potable feed water during initial commissioning or validation) which may be valuable in future investigations. Samplings of this nature are typically done only occasionally and only when needed for long term profiling, or as part of an investigation.