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Environmental monitoring for a NOT-RTE processing environment?

EMP Environmental Monitoring Sanitation Verification Raw Processing

Best Answer Charles.C, 04 December 2018 - 06:36 AM

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

Process Haccp requires risk assessment. The risk assessment includes hazards from the environment. A significant hazard (or associated PRP) requires monitoring.

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

Covered via surface swabbing micro. standards/guidelines. Detailed elsewhere in forum. eg -

https://www.ifsqn.co...ntact-surfaces/

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

depends on definition of zone 1

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

Covered via Scope of haccp plan / Risk Assessment / Sampling Plan.

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

Rhetorical.

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

Hi Ike,

 

See ^^^^.

 

Additionally, Regulatory Requirements, if any, would prioritize.

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#1 IKE

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Posted 04 December 2018 - 01:09 AM

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

 

 

 

 

 

 

 

 



#2 Charles.C

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Posted 04 December 2018 - 06:36 AM   Best Answer

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

Process Haccp requires risk assessment. The risk assessment includes hazards from the environment. A significant hazard (or associated PRP) requires monitoring.

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

Covered via surface swabbing micro. standards/guidelines. Detailed elsewhere in forum. eg -

https://www.ifsqn.co...ntact-surfaces/

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

depends on definition of zone 1

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

Covered via Scope of haccp plan / Risk Assessment / Sampling Plan.

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

Rhetorical.

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

Hi Ike,

 

See ^^^^.

 

Additionally, Regulatory Requirements, if any, would prioritize.


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Kind Regards,

 

Charles.C


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#3 IKE

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Posted 04 December 2018 - 06:58 AM

Thanks much Charles. Good insights regarding the HACCP plan connection. The link to the swabbing guidelines is very helpful. It is making more sense now. 

 

I will try to keep the griping down in the future. 



#4 Charles.C

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Posted 04 December 2018 - 07:14 AM

Thanks much Charles. Good insights regarding the HACCP plan connection. The link to the swabbing guidelines is very helpful. It is making more sense now. 

 

I will try to keep the griping down in the future. 

 

Hi Ike,

 

No problem. Gripes are interesting. :smile:

 

"Spoken in Haste, Repent at Leisure"


Kind Regards,

 

Charles.C


#5 Scampi

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Posted 04 December 2018 - 01:58 PM

I'm going to play devil's advocate here

 

You WILL test positive for listeria (although probably not monocytogenes ) Listeria is naturally present in soil. So if you're going to swab for listeria, I suggest that you DO NOT swab for the family but specifically for L.monocytogenes 

 

So if you swab for generic listeria and get a positive hit........then what?  You will never be able to eradicate it as it will be constantly coming into your plant via the soil. 

 

The repercussions can be mild (total plant shut down) to massive (product recall)............so I will repeat. make sure if your swabbing you are swabbing for L.Mono and not generic

 

 

What exactly are you processing...........roots....carrots? onions? turnip?  You said washing roots.........understanding your commodity will help here


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#6 VickieLew

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Posted 05 December 2018 - 06:51 PM

It seems that everyone that has replied so far, doesn't question the requirement or need for an environmental monitoring program for your facility.  I could be missing something....but I do question this.  Are you SURE you need an pathogen environmental monitoring program? 

I pulled this excerpt directly off of the FDA FSMA website:

"Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control."

1. Have you completed a hazard analysis, including hazard identification and risk assessment (severity x likelihood)? 

2. Did the hazard analysis identify a hazard requiring a preventive control? 

3. Where Is the hazard requiring control controlled?  

     A.  Is it controlled by your process in your facility?  

          1) at this process step? 

          2) at a later process step? 

     B.  Does your customer or customer's customer need to control the hazard? Can the item be consumed without further processing, irrespective of food safety?   

You are calling this a NON-RTE item, and your process descriptions supports that.  To me, it doesn't sound like you have a preventive control in place that requires monitoring, corrective actions and/or verification.  Pathogen environmental testing is a verification activity for Sanitation-Preventive controls, done to ensure that sanitary conditions are established and maintained throughout the process.

I recommend checking around with external experts, knowledgeable with your process and item, get their input...before spending too much on a consultant!

good luck!

 


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#7 Scampi

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Posted 05 December 2018 - 07:06 PM

VivkieLew...couldn't agree more......but it would appear BRC DEMANDS it and SQF requires at the very least a risk assessment to be done supporting your argument not to

We process shelf stable products with literally tons of research about the lack of pathogens ability to survive and even then SQF gave me the ridiculous run around...

CFIA has the same stand as you've mentioned above..................seems GFSI's at least partially think they know something the scientists do not


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#8 IKE

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Posted 05 December 2018 - 07:34 PM

VickieLew and Scampi

 

Thanks for chiming in. Yes we are stuck with the requirement thanks to GFSI. You are exactly right about FDA requirements and that was my response to the desk auditor, but alas it was deemed insufficient. His grounds for requirement was that GFSI is a "global" standard and therefore trumps our regulatory requirements (hence my snide remark about the GFSI ego stroking). I understand the point but it seems that they should provide a scientific rationale for the requirement. IMO the regulators are showing much better application of logic here than GFSI. 

 

And to clean up the rest of the questions. 

 

Scampi - I probably shouldn't delve deep into our process or product since it is a very novel product and it would give away who my employer is,  but out of your list of the veggies list I would say turnip is close. product begins as a raw root and the product that leaves our site is a dried "vegetable chip" that is still considered a WIP item until it is milled into a powder by a co-packer. The product we sell is the veggie powder. No kill step occurs until our customer. 

 

We do NOT sell to the general public and we verify our customer's application of a kill step. 

 

Yes all of my HACCP logic and our HACCP plan tells me we don't need this program,  unfortunately I can't seem to dissuade the auditors. Our SQF is done through NSF and our GMP was done by Merieuix and that auditor also mentioned that EMP is always required for their version of SQF so it is definitely a standard and not an auditor preference. 



#9 Scampi

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Posted 06 December 2018 - 02:02 PM

 

 

Yes all of my HACCP logic and our HACCP plan tells me we don't need this program,  unfortunately I can't seem to dissuade the auditors. Our SQF is done through NSF and our GMP was done by Merieuix and that auditor also mentioned that EMP is always required for their version of SQF so it is definitely a standard and not an auditor preference. 

 

What the BLEEEEEEEP is this?????????????  They are to follow the standard as written by SQFI where it CLEARLY states the EMP is risk based and if your RA has taken all factors/possibilities into account and comes up with a not required you are done with it!!!!!!!!!!


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#10 MsMars

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Posted 06 December 2018 - 02:18 PM

The guidance document may be where they got the "requirement" idea: 

 

What the SQF Code says:

2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing processes. 

What does it mean?

An environmental monitoring program must be in place for food processes that are handled, exposed, stored, processed or packed. This program should be included for food processes of all risk levels.

 

Not saying that it's right or wrong, but knowing my SQF auditors (and FDA auditors, and USDA auditors...), the guidance doc tends to be the Gospel of auditing.


Edited by MsMars, 06 December 2018 - 02:18 PM.


#11 trubertq

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Posted 06 December 2018 - 02:42 PM

Don't swab for pathogens if it's not on the legislative list.

 

I have a client with a non-RTE product which is sold onto processors who require listeria free, this causes no end of problems for us as we have no kill step the product is raw, from the wild environment, and is only cleaned and boxed. I have to test for listeria for customers but once the competent authority saw Listeria on the sampling plan they hounded me for years until I finally got written confirmation from the food safety authority that this product is a primary product and is not required under EU 2073/2005 to be tested for listeria. The CA expected me to contact them every time I detected Listeria with a view to initiating a recall which is crazy stuff.

 

I don't know if the US has a similar piece of legislation as 2073/2005. 

 

So, in your situation I would check surfaces  for TVC and E coli. prior to start-up to ensure they had been properly cleaned and leave it at that. Risk assess it and prepare to stand your ground.


I'm entitled to my opinion, even a stopped clock is right twice a day

#12 Scampi

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Posted 06 December 2018 - 03:22 PM

This is CFIA's stance on listeria testing..............but I will add that my Cb didn't think this was good enough..............this plus 5+ research papers that prove listeria cannot survive in my product

 

http://www.inspectio...3/1370541911699

 

 

Fight hard

 

I just had to revise my RA to include silly things like employees touching a wall and then their elbow somehow touching the product......


Because we always have is never an appropriate response!






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