The first step in establishing a Contamination Control Strategy in an Environmental Monitoring program is to define the parameters that will be monitored as part of the site’s Quality Risk Management requirements.
The next phase is to assess Risk Management through Measurement, Analysis,
Decision Making and Feedback.
Monitoring of these areas is based upon a formal Risk Assessment (RA) of the critical locations, monitoring is performed at intervals also identified during the RA. The RA material is available to support where these sample locations are assigned, but consideration will be given to those that have the most significant impact on product quality. The RA also uses data from previous activities (room qualification and classification), to ensure that consistency of process is maintained.
The establishment of alert and action levels is based on historical data, it can also be assigned with different thresholds depending on the state, or mode, the cleanroom is currently functioning in: operational, at rest, etc. These levels, if exceeded, should alert operators to out-of-tolerance conditions and to also review practices and make changes or interventions as required. Alert and action levels also form the basis of the reports generated, demonstrating that control was maintained during production.
The environmental monitoring data should be analyzed, trended and used to identify why excursions occurred and what corrective or preventative actions might be done to ensure they are not repeated, or contribute to system performance enhancements. Thereby defining the Contamination Control Strategy (CCS).
The Review and Feedback step could have several outcomes that better control the process based on the insight gained in the Decision Making step. It might cause a review of the purpose of monitoring in certain locations, or change the SOP for a process. It will certainly demonstrate that a process is fully understood and part of a wider Quality Risk Management (QRM) system.
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