Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment

Hi, I am looking for a sanity check...….. I was recently reviewing a Class 8 cleanroom and asked about routine monitoring and whether they had a Monitoring Plan, (as per ISO14644-2:2015 chapter 4). In practice, the cleanroom is subject to an annual re-certification and the monitoring frequency is 12-months. Consequently, other than the annual recertification, no other monitoring is performed and no Monitoring Plan or risk assessment justifying the 12-month period has been performed.

Looking back through ISO14644-2015, I can't see anything discussing the monitoring frequency, other than saying it should be specified. Can you simply provide a Risk Assessment saying once every 12 months is sufficient?



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Can annual monitoring even be considered monitoring? Having a risk assessment present is one thing, but would the content of that document really be able to justify annual "monitoring"? How would they possibly catch any excursions?
I know some manufacturers and all perform annual monitoring ( unless there is any condition which require revalidation). I will be so glad if anyone say something: Is 1-year period monitoring really sufficient?


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I would say annual monitoring would only be okay if the following were true:
- Particulates pose no or extremely low risk to the product.
- There was a previous period of monitoring at greater frequency showing the level of particulate remained the same over time.
- No changes have occurred which would affect the level of contamination (e.g., number of people have stayed the same, the product is the same, equipment is the same).

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