6 replies to this topic

[Chakib]

Hello,

 

Can somebody help and clarify why a food manufacturer with a killing step and hot fill for an acidified product (pH less than 4.1, and shelf stable) in the final packaging are required to have an environmental monitoring program (Microbial). A risk assessment shown to the Auditor / certifying body technical team about the futility of having an environmental monitoring was not enough. Is there any explanation for this? 

Thanks

 

[Evans X.]

Greetings Chakib,

 

The environmental monitoring program is to check the possible spore forming microorganisms. Propably you will not have problems with the general microorganisms (TVC or ACC or APC whichever term you are familiar with).

However, you could be exposed to mold spores and from my experience both in research lab and in food industry they can literally grow on anything you can imagine. Acidified, oily, hot or cold, full on phenolic compounds (which btw have antimicrobial properties), extremelly poor on nutrient content, with alcohol, on food industry wastes with extremelly high osmotic concentration, literally the list is endless, but you name it and you will find an example of molds having grown on that.

So the risk assessment should be more to determine how often you will check (even once a year) and not if you will or will not do it.

They could have explained it better to you, but in this case I am on the auditor's side.

 

Regards!

[Scotty_SQF]

Did they give you an explanation as to why?  I would think they just can't say this isn't acceptable, and that they have to provide a reasoning behind their decision.  The only thing I can think of is maybe you need more evidence to make your claim, such as at least swabbing some areas once, to show no concerns.  Maybe also testing the final product again to show scientific proof of no concerns.  Most outside lab testing is priced fairly decent, depending on the test can cost just a couple hundred of dollars.  Anyway, if they didn't give your reasoning, reach out to them and ask to further explain.

[Scampi]

The answer is surprisingly simple

 

It is a REQUIRED element in the SQF code that you cannot ignore

 

However, you could just swab for generic e-coli once/year as per your RISK ASSESSMENT for your facility/process/products

 

OR you can try and apply for an exemption

 

The issue is, if your not following a really good sanitation program AND your not performing any enviro swabs........what is your deviation process if a product is say, processed at 4F less than it should be??  These would all be a part of your deviation plan

 

No one item is a stand-alone   they all work together

 

FYI---read this as well

https://www.fda.gov/...mental-sampling

 

 

 

You're under the assumption that your process is not at risk, which isn't true   You're scheduled process is based on the ingredients being wholesome when the process starts..........if your inadvertently contaminating it prior to process, your process may not be sufficient

[Scampi]

I should have added----you cannot just say in a risk assessment that it's not required----------you have to back up your decision with science, much like a CCP validation study

The answer is surprisingly simple

 

It is a REQUIRED element in the SQF code that you cannot ignore

 

However, you could just swab for generic e-coli once/year as per your RISK ASSESSMENT for your facility/process/products

 

OR you can try and apply for an exemption

 

The issue is, if your not following a really good sanitation program AND your not performing any enviro swabs........what is your deviation process if a product is say, processed at 4F less than it should be??  These would all be a part of your deviation plan

 

No one item is a stand-alone   they all work together

 

FYI---read this as well

https://www.fda.gov/...mental-sampling

 

 

 

You're under the assumption that your process is not at risk, which isn't true   You're scheduled process is based on the ingredients being wholesome when the process starts..........if your inadvertently contaminating it prior to process, your process may not be sufficient

[Chakib]

Greeting Evans, Scotty_SQF and Scampi-

 

Thank you so much for taking the time to provide help and answers. 

 

 

Evans, Thank you so much for the scientifically sound answer. I totally agree with your explanation. Our product is heated, and held in a surge tank at a high temperature (based on our internal Process authority and some additional scientific literatures) prior to hot-filling. The risk analysis we performed at our facility showed that filamentous fungi (Molds) are the target organisms (based on their resistance to low pH, and heat treatment). However, I was resilient to do any environmental monitoring based on the regulatory authority visits to the facility (EMP was not required) and of what I have seen in the FDA guidelines "Chapter 6: Use of heat treatment as a process control" Page 36 and 46 states "Soup Processor A/B does not conduct product testing for pathogens or environmental monitoring because the product, which is subjected to a heat treatment validated to be highly lethal to vegetative pathogens and filled hot, is not exposed to the environment after the heat treatment". But, I totally agree with your explanation, Really appreciated. I am just go ahead and implement the corrective action (Swabbing/Mold) in response to the finding. 

Scotty_SQF: Thank you, I tried but no explanation besides that the program is mandatory (what Scampi mentioned) independent of the risk analysis. 

[tadelong]

Scampi you have a knack for laying it out in obvious language. Always happy to hear

SQF's code is coached in so much self-referential drivel that the intent often gets lost, especially on the recently conscripted.

I have always been a proponent of plain text language. SQFI says you need an environmental program, sure. The sampling is all up to you, but you need to prove it works.

 

2.4.8.1 says a "risk-based environmental monitoring program shall be in place for all food manufacturing processes and immediate surrounding areas, which impact manufacturing processes"

 

 The EMP was recently hammered in to the SQF Code. IMO It still doesn't flow like the rest. Many sections of the code that sound similar in their imperative language are actually arguable. The language used seems to imply that if your facility is safe without testing, and you are very serious about saying it's safe without testing, you should be fine. You're obviously not fine. I know that, you know that, and SQF knows that, but...

 

 Sometimes it seems like SQF would rather you get it wrong, first.