11 Easy steps to develop a cleanroom monitoring plan
1.Select parameters to be monitored
2.Select measurement method
3.Monitoring instrumentation: Accuracy, maintenance, and calibration
4.Monitoring Locations: shall be defined as 3D
5.Monitoring acceptance criteria or limits: Including the establishment of a single alarm level, or a dual alarm approach of alert and action levels.
6.Out of limits/criteria: Specification of the response
7.The need for and frequency of periodic cleanroom classification as per ISO 14644 Part 1
8.The format: Data recording
9.The methods: data trending or other appropriate analysis.
10.The Policy & Media : to record/store data
11.The frequency: for a review of the monitoring plan.