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Environmental Monitoring Zoning and Low Risk

Started by , Dec 30 2022 01:34 PM
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8 Replies
Hi,
 
I am risk assessing my environmental monitoring program with use of a zoning approach. 
 
We have an RTE Salad Factory where we have segregated High Care and Low-Risk areas. Our reduction step is a decontamination wash. 
in Low-Risk area - we would prep lettuce, mix baby leaves, mechanically slice lettuce, tip over leaves onto a conveyor belt to the washer and wash. 
 
High Care will dewater, dry, elevate to weigher, weigh, pack etc., then it will go back to Low Risk again (automatic process) for metal detection etc. 
 
I have a few questions.
 
Q1. Which zone is my low risk preparation falls into? 
Q2. I've read multiple literature that zone 1 should be tested for indicator organisms. 
What about in-production testing for pathogens? This will not only check the cleaning but also if the process works correctly. 
 
Previosuly I worked with one of the retailers in the UK and they demanded 70 -30 Food contact to non food conatct. Also we had to do our listeria swabbing during production. 
 

 

Zone 1

food contact area within RTE room

Areas in the plant that are direct product contact surfaces after reduction step and before product is sealed in the primary packaging

Zone 2

Non-food contact area within RTE room

Non-product contact areas in the plant that are closely adjecent to product contact surfaces

Zone 3

Other areas within RTE room

non product contact surfaces that are in open post reduction processing area, but not closely adjecent to zone 1

zone 5

areas outside RTE Room

areas remote from post reduction step processing areas

 

 

 

 

I have attached the guides I am using to develop this risk assessment. 

 

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SQF-2.4.8 - Is an Environmental Program Required? How to Include Adverse Events in Your Environmental Monitoring Program (EMP) How to Conduct an Environmental Risk Assessment under FSSC 22000 V6.0 Environmental testing plan - listeria & TVC Looking for a new Listeria Rapid Test for Environmental Monitoring
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Hi KingaZ,

 

Is yr query related to BRC (or  some other Standard) since afaik the former have their own specific interpretation of Low Risk etc Production areas ? .

Yes, BRC
low risk - open product area before decontamination step.
So this will compromise preparation, slicing, washing then product goes to high care via conveyor belts here it’s dried, packed and then goes back to low risk (boxing) where it is metal checked and packed into crates (it’s enclosed in heat sealed packaging).

Thank you

I personally would keep the same zone scheme.   i would use the categories as zone 1 - pre lethality and zone 1 - post lethality, etc.   

 

I have seen the documents that you mentioned  in the past and have skimmed them.   I think I see your point.  Your "low risk preparation" area seems to be unaccounted for in these plans.   

 

I agree that you are most likely to find pathogens in these areas as they are coming in on raw materials, etc.  But you also run the risk of transporting these pathogens to post lethality areas depending on the plant design and the policies in place.  They are important areas to monitor in your EMP program IMO.   find it and get rid of it.  

 

 

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Hi KingaZ

 

I note that for BRC,  EMPG and Production Risk Zones are separate,albeit inter-related, topics/Clauses.

 

 

EMPG for RTE salads appears to be quite complicated.

 

I assume your finished product specification has zero tolerance for L.monocytogenes ??. From a pathogen POV, L.mono seems to be the typical focus for vegetable salads/EMPG although I anticipate Salmonella (and pathogenic E.coli?) may also be relevant.

 

4 salad/EMPG related attachments are enclosed. 1st one is a well-recognized, US/Listeria oriented, detailed Procedure/discussion for Fresh Produce.  From a quick look, the NZ flowchart (Pg 14) /discussion in 2nd attachment is very logically (and readably) presented  as an introduction although using a Zone numbering style reverse to most other presentations (Layout some similarity to yr 3rd attachment).

 

guidance-on-EMPG listeria.pdf   1.85MB   77 downloads

EMPG,L.mono control.pdf   1.2MB   57 downloads

 

EMPG, FDA,Listeria Guidelines.pdf   77.91KB   51 downloads

(see section at end of document),[actually the article is FSIS not FDA].

 

This comment/source also seems useful -

In most circumstances a LEMP should not extend into raw processing areas (e.g., ingredients, raw meat and fish, and unpasteurized dairy products) as it is assumed these areas are likely contaminated. Some facilities may not have truly defined raw and RTE areas, in this case the all production room with exposed at-risk may be included (e.g. fresh cut produce, salad assembly)

 GMA, EMPG L.mono.pdf   383.48KB   59 downloads

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Hi, this guidance from AIB maybe will help you

 

Attached Files

2 Thanks

Yes, BRC
low risk - open product area before decontamination step.
So this will compromise preparation, slicing, washing then product goes to high care via conveyor belts here it’s dried, packed and then goes back to low risk (boxing) where it is metal checked and packed into crates (it’s enclosed in heat sealed packaging).

Thank you

Hi KingaZ,

 

I have attempted to perform a somewhat deeper look into this topic. Actually, there are several older BRC threads here deliberating, often without a consensus, on aspects similar to yr Queries.

IMO, BRC's interpretation of yr Query 1  likely relates to whether your process has an adequate, Validated, bactericidal step (and perhaps shelf life) such that a separation between proposed  Low Risk and High Care sections can be supported. Otherwise, most/all of the entire handling operation is likely to be classified High care as illustrated (Pg 75-6) in the European (ECFF) document attached below. The latter contains a detailed appraisal of chilled RTE Production and uses various process flow charts/risk analyses to demonstrate the range of possible Risk/Care scenarios. Oldish publication but content still practical and relevant IMO.

ECFF chilled food,2006.pdf   402.36KB   40 downloads

 

Regarding Query 2, BRC Interp.Guide (BRC8) implies a requirement for assessing pathogen risk due to "Listeria" and other indicator organisms. Presumably applicable to the overall handling process.

 

With respect to EMPG, it seems to me that the US/Canadian approaches are somewhat different to BRC.  My impression is that the US (for this Product) tend to regard the whole handling process as High Risk/Care but then focus primarily (but not necessarily exclusively) on Listeria/L.monocytogenes. Canada seems similarly focused on L.mono but inserts a preliminary Quantitative Decision Tree to usefully clarify the operational situation (and also I guess  since the RTE tolerance for L.mono varies between the 2 locations). The latter Decision Tree is attached below. The Canadian approach also offers a highly specific sampling/analysis scheme for L.mono to evaluate its EMPG significance (See source attached). 

Canada,Categorization RTE Foods,2022.pdf   223.59KB   42 downloads

Source -

Canada, Draft-Listeria-policy,2022.pdf   2.26MB   39 downloads

 

@ RafifUtamaPutra - Thks AIB. It's a very useful general document but rather surprisingly focuses almost entirely on Salmonella from a Pathogen POV. The consequence is tendency to avoidance pathogen testing of Zone 1 unlike, seemingly, situation for Listeria.

2 Thanks
Hello Charles, 
 
Apologies for the late reply. Yes, I cannot agree more that EMPG for RTE salads is quite complicated! 
 
Yes, we focus on L.monocytogenes - and the spec is not detected for both the finished product and environment. We test our finished products for Salmonella and E.Coli, which are associated with salad.
 
We do have a validated shelf life,  2 days beyond product life, for extra safety. 
 
The High Care area and Low Risk Area are completly segragated - different rooms - where product enters high care on a conveyor belt straight from the decontamination wash. 
 
Listera is the main focus, and it's not like we have a problem. I know how it sounds, we do some odd detections, and that's it, the factory was build in 2018 so fabrication is excellent. We do have a rigorous cleaning regime in both low-risk and high care areas. I choose to have the same cleaning regime in both areas, although I've been told by my chemical supplier technical team that it's overkill.
 
We wash our salad leaves in of course, validated wash with Peroxyacetic Acid. 
 
This includes striping accessible parts of machines, brushing, chemical clean with Caustic and Sodium hypochlorite chemical and then disinfectant spray. (I know that we already have a desinfecting agent in out main chamical). We clean the whole room, apart from walls which are cleaned every other week. I change the main cleaning chemical to acidic once a week for two days to change ph.
 
Then through swabbing, we verify cleaning in both High Care and Low Risk at least 6 hours after cleaning is completed to prevent false negatives. 
 
I have lots of points in Low Risk for indicators (TVC, ENT) and little less for Listeria - those are completed before production.
In High Care we verify cleaning with indicators (TVC, ENT) and we do Listeria after cleaning and also in production for most critical points - i.e. filling tubes used for all products running throughout the day.
 
Mid production cleaning - only water to remove debirs- leaves from previous run.
 
In my previous employments (same industry), treating low-risk product areas like high care was never common. There was no swabbing programme there either. 
 
Since we do not have a "kill step" but reduction only, keeping my low riks open product area in nearly the same standard as high care is essential. Neglecting it may lead to the growth of Listeria to the levels the decontamination wash would reduce, but still, those levels will be unacceptable since Listeria spec is "not detected". There is a biofilm formation issue as well. 
 
I thought that zoning would be the best industry standard, but i just couldn't make it work with my Low Risk. I definately do not want to stop verifying low risk as I strongly believe its too important. 
 
Thank you so much for all the attachments, I am very gratefull for your time. I am going to read those today!
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Hi KingaZ,

 

I forgot to mention that there are 2 compilations of EMPG related documents here -

 

https://www.ifsqn.co...ls/#entry100060

https://www.ifsqn.co...am/#entry119334

Several of above contain tables illustrating possible, zone (ie risk)-based sampling schedules.

 

Afai could see, in the context of EMPGs, none of the above wet/dry Process documents which are all US-oriented  refer to areas prior/post to a lethality stage as Low or High Risk. I think this simply reflects the terminologies which have been used in the historical development of US EMPGs. In contrast High/Low Risk Production areas have long been explicitly used in UK texts and I anticipate occur in the, afaik, Primary UK reference for Chilled RTE foods published by CFA   I assume BRC simply continued this tradition.

The decision as to whether to sample pathogens from Zone 1 areas seems to subjectively vary between texts .

I'm not sure what you exactly meant by -

<<< I thought that zoning would be the best industry standard, but i just couldn't make it work with my Low Risk. I definately do not want to stop verifying low risk as I strongly believe its too important.>>>

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