Hi All,
We run a production line 24 hours a day for 5 days in a row. I am currently swabbing prior to production start Sunday evening. We make RTE snack bars with a water activity below 0.70. We currently swab Zone 1 (food contact) and Zone 2 (adjacent to food contact like framework, buttons, machine adjustments) for EB, Zone 3 (production room floors, walls, drains etc...) for Listeria.
I am wrestling with how to react to an out of spec result for Zones 1, 2, and 3. I typically receive results on a Wednesday and we are right smack in the middle of a production week. Finished product lot codes are typically used for multiple days in a row.
My current thinking on Zone 1 - The area that failed and all subsequent equipment in the process flow will be recleaned, sanitized, reswabbed. Production will be allowed to resume BEFORE clean results come back but after thorough cleaning and inspection. My senior management will not allow us to be shut down for three days because of an indicator organism out of spec result.
Zone 2 - Same as Zone 1 except we do not need to clean all subsequent equipment
Zone 3 - Case by case risk assessment will be performed for each out of spec result. If the area (drain, floor) can be cleaned without risk to food or food contact surfaces we will halt production, clean and sanitize then retest the area. Production would resume once cleaned and sanitized.
I am struggling with the fundamentals of environmental monitoring program and how senior management would like to get away with operating under what the FDA would rule unsanitary conditions. Any suggestions or opinions will be appreciated!
Thank you!