Environmental monitoring program corrective actions 24 hour operations
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!
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.
And what are you doing with potentially affected product? Do you place that day's production on hold while waiting for results?
Have you considered internal testing for a faster follow-up? Potentially ATP? or Hygiena makes an EB swab with ~8hr TAT.
Maybe you just didn't mention it here, but it is important to consider the source of all out of spec results regardless of Zone. You should specify root cause and corrective actions for each.
Also, are you doing Listeria spp or monocytogenes?
I second PP--ALL product should be put on hold pending a disposition decision.
I would also add, how was it determined that a 5 day around the clock production schedule was suitable for your finished good and process? Was sufficient testing done during a trial to prove that this was satisfactory?
Since i'm assuming your testing for listeria species and not Lmono----do you then have the lab identify the species? What does your current process say to do?
Hi Soups,
Potentially affected product would be on hold until it is tested clean for relevant pathogens. ATP testing would be performed as a preliminary clear. I am not sure if we would still need EB test at that point to confirm.
We are testing Listeria spp and will confirm which species. Any ideas on pros and cons to testing Listeria spp or L. mono?
Thank you
Hi Scampi,
Yes we did validate our cleaning frequency at once per week with sufficient justification. We implemented this in stages with a 2 day production run with testing for several months then extended it to 5 day production runs. We have had extremely good results.
This should help you a great deal (since the FDA is always skimpy on important/helpful informaton
https://inspection.c...4/1528201904208
FDA Listeria guidance for RTE foods. This is what a FDA inspector will use.
Hi Soups,
Potentially affected product would be on hold until it is tested clean for relevant pathogens. ATP testing would be performed as a preliminary clear. I am not sure if we would still need EB test at that point to confirm.
We are testing Listeria spp and will confirm which species. Any ideas on pros and cons to testing Listeria spp or L. mono?
Thank you
FDA also recommends Listeria spp. for environmental monitoring (see link kfromNE posted). The reason being that Listeria spp will not only catch L. mono but also other Listeria presence which would indicate ideal conditions for L mono growth. The whole idea is testing to find problem areas and then eliminating those problems before it affects actual product, so it makes more sense to do spp. than mono.
Back to zone 1/2, if you are having repeated issues in particular spots, then I think that justifies production shut down for deeper cleaning/disassembly and potentially more frequent cleaning than currently is happening. If it is an occasional hit, no trend seen, testing ok after recleaning, and with product testing ok then I think your plan sounds good.
Oh and I tend to only confirm species when there is a trend seen. Listeria spp positive or L mono positive should be treated the same way, so no point wasting the money.
Unless you want some L. mono positives to scare your senior management into acting right, haha....
GMA IIRC offer responses to detections in various Zones for some model swabbing scenarios in their famous publication for which an older version here -
https://www.ifsqn.co...am/#entry119334
(seemingly focused on Listeria for which the current scheme seems to have implemented a favorite "problem avoidance" option)
If you have a positive hit in the middle of a production run then all material produced prior to that failed test must by default go on hold. It sounds like you've got a lot of material to test and some very unpleasant calculus to do with regard to this testing plan. At the same time you need to order a full deep clean with someone you trust or yourself watching. If you have cameras and can watch the previous clean, then I'd have a look. All it takes is some idiot using the same rag on the floor as on the machines and you know exactly where you swabbed.
I know your management is probably going to suggest you're a reactionary and that they've had these situations happen all the time and nothing comes of them, but I would make sure that the data you are providing is via email or text messages and the direct order to ignore the data and proceed comes from someone else.
If you have a positive hit in the middle of a production run then all material produced prior to that failed test must by default go on hold. It sounds like you've got a lot of material to test and some very unpleasant calculus to do with regard to this testing plan. At the same time you need to order a full deep clean with someone you trust or yourself watching. If you have cameras and can watch the previous clean, then I'd have a look. All it takes is some idiot using the same rag on the floor as on the machines and you know exactly where you swabbed.
I know your management is probably going to suggest you're a reactionary and that they've had these situations happen all the time and nothing comes of them, but I would make sure that the data you are providing is via email or text messages and the direct order to ignore the data and proceed comes from someone else.
Hi Totes,
Re-^^^^(red) - I anticipate that this would typically not be the case for Zones 1/2 in OP as presently stated unless the (so far unstated) spec is unbelievably demanding, eg -
EMPG -Indicator micro. limits.pdf 61.65KB 65 downloads
(IMEX the APC values are unworkable).
(also see my comment/link in Post 10).
We are operating at limit 25 cfu/g EB currently. We have not had a result above limit for quite some time as expected since the production equipment has been cleaned/sanitized when I swab. I am considering increasing the limit slightly to give cushion as we start swabbing during production.
Thank you everyone so far for their input.
We are operating at limit 25 cfu/g EB currently. We have not had a result above limit for quite some time as expected since the production equipment has been cleaned/sanitized when I swab. I am considering increasing the limit slightly to give cushion as we start swabbing during production.
Thank you everyone so far for their input.
Hi JeremyW,
Maybe 25 cfu/XYZ cm2 ?
Hi Charles,
Ah yes that would make more sense thank you