Maybe you’ve been there too, you need to take a risk-based approach to determine environmental monitoring, so you go to a HAACP or FMEA and realize those tools just do not work to provide information to determine how to distribute monitoring to best verify that processes are operating under control.
What you want to do is build a heat map showing the relative probability of contamination in a defined area or room| covering six areas:
- Amenability of equipment and surfaces to cleaning and sanitization
- Personnel presence and flow
- Material flow
- Proximity to open product or exposed direct product-contact material
- Interventions/operations by personnel and their complexity
- Frequency of interventions/process operations.
This approach builds off of the design activities and is part of a set of living risk assessments that inform the environmental monitoring part of your contamination control strategy.
Hope to see you in Bethesda to discuss more!