14 replies to this topic

[mkelly320]

I've searched the forums and read many of the posts, but I can't quite find the information I'm looking for.

 

We can fruit and pie fillings.  9 months of the year, we can from frozen or canned fruit.  The other 3 months, we can from fresh, from local growers.  The frozen fruit comes with a certificate of analysis, but we inspect the fresh fruit ourselves.  It's an acidified product, and our CCP is a time/temp recommended and validated by the can companies.

 

My predecessor and the rest of the HACCP team determined that the fresh fruit was a low risk, because we have controls to mitigate any potential physical or biological hazards, but that doesn't sit right with me. I thought we would need to classify it as a medium risk, because if we didn't have the CPs/CCP in place there would be potential for those hazards to make it to the finished product.  (I can agree that the supplier could be low risk, based on the documentation we require, and the fact that the company has had relationships with most of the farmers for 20-50 years.)

 

I value all the opinions and advice here, but I also need something to back it up.  What I've been able to find is primarily an assortment of risk matrix variations and decision trees, but what I need is something more concrete.  Any suggestions? Or am I completely wrong, and having these later steps to mitigate these risks means that the ingredient doesn't carry any inherent risks?

 

Thanks!

Mandy

[QAGB]

I've searched the forums and read many of the posts, but I can't quite find the information I'm looking for.

 

We can fruit and pie fillings.  9 months of the year, we can from frozen or canned fruit.  The other 3 months, we can from fresh, from local growers.  The frozen fruit comes with a certificate of analysis, but we inspect the fresh fruit ourselves.  It's an acidified product, and our CCP is a time/temp recommended and validated by the can companies.

 

My predecessor and the rest of the HACCP team determined that the fresh fruit was a low risk, because we have controls to mitigate any potential physical or biological hazards, but that doesn't sit right with me. I thought we would need to classify it as a medium risk, because if we didn't have the CPs/CCP in place there would be potential for those hazards to make it to the finished product.  (I can agree that the supplier could be low risk, based on the documentation we require, and the fact that the company has had relationships with most of the farmers for 20-50 years.)

 

I value all the opinions and advice here, but I also need something to back it up.  What I've been able to find is primarily an assortment of risk matrix variations and decision trees, but what I need is something more concrete.  Any suggestions? Or am I completely wrong, and having these later steps to mitigate these risks means that the ingredient doesn't carry any inherent risks?

 

Thanks!

Mandy

 

 

Hi Mandy,

 

I would be inclined to agree with you in that the ingredient risks in your ingredient hazard analysis would at least be a medium. I would also say the same for your CP/CCP step in your process hazard analysis as well. I know that risks can be chosen based on justification. If your predecessor has some sort of justification that makes sense to you to use, then you could use it. If you feel that the hazards should have higher severity, then you can make that change and provide your justification for it.

 

I understand that fresh fruit has several hazards: presence and growth of pathogens, spores, possible viral content, pesticide contamination, possible presence of undeclared food additives, possible presence of undeclared allergens, mycotoxins, and foreign materials. Based on this, I'd justify fresh fruit as at least a medium risk (I'd probably go with high) based on severity.

 

The frozen fruit may be aseptically packaged and/or you've done your supplier vetting, so that may have a low risk. I would separate those two out and have low risk for frozen fruit, and medium/high risk for fresh fruit. Your justification will be key here.

 

QAGB

[Charles.C]

Hi Mandy,

 

What FS standard is involved, eg FDA, BRC, etc ?

 

In many (private) FS Standards  these days the ingredient receiving step is pre-selected as a PRP which auto-implies low risk at that step. If FDA(?), may be a different, regulatory, approach. How any predicted BCPA hazards in the ingredient are handled at the PRP depends on what they are.

 

Other than for a PRP, the status of other steps, ie CCP or not  is based on risk assessment, ie likelihood of hazard to occur / severity which I'm sure you knew already.

 

So, IMO,  more info is required.

[QAGB]

Hi Mandy,

 

What FS standard is involved, eg FDA, BRC, etc ?

 

In many (private) FS Standards  these days the ingredient receiving step is pre-selected as a PRP which auto-implies low risk at that step. If FDA(?), may be a different, regulatory, approach. How any predicted BCPA hazards in the ingredient are handled at the PRP depends on what they are.

 

Other than for a PRP, the status of other steps, ie CCP or not  is based on risk assessment, ie likelihood of hazard to occur / severity which I'm sure you knew already.

 

So, IMO,  more info is required.

 

Hi Charles,

 

So if I'm understanding correctly, some private FS standards are not necessarily listing the ingredient receiving step as an actual part of the process; and that step is considered a PRP in the process hazard analysis?

 

QAGB

[mkelly320]

Hi Mandy,

 

What FS standard is involved, eg FDA, BRC, etc ?

 

In many (private) FS Standards  these days the ingredient receiving step is pre-selected as a PRP which auto-implies low risk at that step. If FDA(?), may be a different, regulatory, approach. How any predicted BCPA hazards in the ingredient are handled at the PRP depends on what they are.

 

Other than for a PRP, the status of other steps, ie CCP or not  is based on risk assessment, ie likelihood of hazard to occur / severity which I'm sure you knew already.

 

So, IMO,  more info is required.

We are SQF level 2.  Charles, I don't think I understand your statement about the ingredient receiving step being pre-selected as a PRP, making it low risk.  I'm trying to assess the risk level of a specific ingredient which is shipped, received, stored, handled and inspected under different conditions than all our other ingredients.  What it sounds like you're saying is that every ingredient would automatically be low risk, so salt has the same risk as raw milk.  I understand that the receiving step itself might be low risk, but if having the receiving step as a PRP makes every ingredient low risk, why would I need to assign a risk value to the ingredient?

[Charles.C]

Hi Charles,

 

So if I'm understanding correctly, some private FS standards are not necessarily listing the ingredient receiving step as an actual part of the process; and that step is considered a PRP in the process hazard analysis?

 

QAGB

 

Hi QAGB

 

The receiving stage is still part of the process as per the flowchart. The reality is that PRP has been (optionally) used for some process stages for a long time, especially the receiving stage, eg NACMCF 1997 –

 

Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system

 

http://www.fda.gov/F.../ucm2006801.htm

 

 Prerequisites - NACMCF.png   243.4KB   11 downloads

 

Two advantages for receiving are that it can substantially reduce the total CCP load (and documentation) plus occasionally auto-resolve arguments over whether CCP-or-not. ISO22002-1 is the extreme example, approx 20 preset PRPs. But I believe that USFDA/USDA may still use CCPs for the receiving stage for some products hence my caution.

[Charles.C]

We are SQF level 2.  Charles, I don't think I understand your statement about the ingredient receiving step being pre-selected as a PRP, making it low risk.  I'm trying to assess the risk level of a specific ingredient which is shipped, received, stored, handled and inspected under different conditions than all our other ingredients.  What it sounds like you're saying is that every ingredient would automatically be low risk, so salt has the same risk as raw milk.  I understand that the receiving step itself might be low risk, but if having the receiving step as a PRP makes every ingredient low risk, why would I need to assign a risk value to the ingredient?

Hi Mandy,

 

hazard analysis is typically concerned with the risk attached to the step, not the ingredient. Although ingredients can also be risk categorised if so desired.

 

Please inform the module / paragraph in SQF which you are trying to respond to.

 

Para. 2.4.5.4 .ii ??

[QAGB]

We are SQF level 2.  Charles, I don't think I understand your statement about the ingredient receiving step being pre-selected as a PRP, making it low risk.  I'm trying to assess the risk level of a specific ingredient which is shipped, received, stored, handled and inspected under different conditions than all our other ingredients.  What it sounds like you're saying is that every ingredient would automatically be low risk, so salt has the same risk as raw milk.  I understand that the receiving step itself might be low risk, but if having the receiving step as a PRP makes every ingredient low risk, why would I need to assign a risk value to the ingredient?

 

 

Hi QAGB

 

The receiving stage is still part of the process as per the flowchart. The reality is that PRP has been (optionally) used for some process stages for a long time, especially the receiving stage, eg NACMCF 1997 –

 

http://www.fda.gov/F.../ucm2006801.htm

 

Prerequisites - NACMCF.png

 

Two advantages for receiving are that it can substantially reduce the total CCP load (and documentation) plus occasionally auto-resolve arguments over whether CCP-or-not. ISO22002-1 is the extreme example, approx 20 preset PRPs. But I believe that USFDA/USDA may still use CCPs for the receiving stage for some products hence my caution.

 

 

Hi Charles,

 

 

Thank you for the clarification.

 

Our HACCP plans have an ingredient hazard analysis, and a process hazard analysis.

 

In those HACCP plans, all critical ingredients (ingredients with medium to high risk) are carried over to the process hazard analysis; ingredient receiving included. Critical ingredients need special care; be it PRPs, or further processing including CPs and CCPs. In this instance, if Mandy chooses fresh fruit to have a medium or high risk, fresh fruit receiving, storage, blending, etc. get carried over to the process hazard analysis. To reply to the ingredient receiving discussion, I'm not saying there is a risk by unloading a trailer or tanker at the receiving step, but the risk comes from bringing in a product with the possible hazards I listed in post 2.

 

In summary, based on the information, I'd consider the ingredient itself to be medium/high risk, and steps at or before controls can be applied (in the process hazard analysis) to the critical ingredient be medium/high risk.

 

 

QAGB

[Charles.C]

Hi QAGB,

 

 I think you are using a more traditional HACCP methodology which is neither Codex nor NACMCF. Not that it matters.

 

Is yr system certified to SQF?. I have no direct experience of SQF myself.

 

There are a variety of lists on this forum splitting Foods into High/Low Risk categories.

 

The (SQF) answer presumably depends on how one/SQF defines Low Risk and High Risk Ingredients, etc. Or maybe SQF don't care what procedure is used..

 

FWIW SQF do define High Risk Food in the Glossary. If otherwise it appears to be defined as Low Risk. I would classify the SQF definition of High Risk Food as part logical/part weird.

 

Additionally, Appendix 1 has a column of "Risk Levels" if one knows the Category

 

If this is section 2.4.5.4, there are many long, long threads over the multitude of elements in it and their interpretation. Similar to BRC's Supplier Approval.

[QAGB]

Hi QAGB,

 

 I think you are using a more traditional HACCP methodology which is neither Codex or NACMCF.

 

Is yr system certified to SQF?. I have no direct experience of SQF myself.

 

The answer presumably depends on how one/SQF defines Low Risk and High Risk Ingredients, etc. Or maybe SQF don't care.

 

FWIW SQF do define High Risk Food in the Glossary. If otherwise it appears to be defined as Low Risk.

 

Additionally, Appendix 1 has a column of "Risk Levels" if one knows the Category

 

If this is section 2.4.5.4, there are many long, long threads over the multitude of elements in it and their interpretation. Similar to BRC's Supplier Approval.

 

 

Hi Charles,

 

We're certified BRC Issue 7, and we've been certified since Issue 6. We also have numerous customer audits as well as other certifications, and no one has ever commented or taken exception to the methodology we use (not saying it is correct but I hope it is - and has been working for us).

 

Yes, ingredient risk and even process risk are all based on risk assessment. If you can justify your reasoning to an auditor, you're probably ok. I always try to put more information in and be more cautious than I probably need to be, because you never know what the auditor's interpretation will be. BRC does define high-care and high-risk products, but those designations don't take into consideration the chemical or physical aspects of HACCP hazard analysis (so those wouldn't be my true basis for risk assessing my ingredients or my process). I'm not familiar enough with SQF to know what the differences would be as far as risk assessments.

 

QAGB

[Charles.C]

Hi Mandy,

 

I assume we are talking about 2.4.5.4

 

Some guidelines are offered in this older (ver.7) thread (the def in post 4 is (initially) far more intelligible than the updated one below IMO) -

 

http://www.ifsqn.com...als-as-per-sqf/

 

The current def. of high risk food is -
 

 

7.2  High Risk Food

Food or food product with known attributes for microbiological growth, physical or chemical

contamination or a known food allergen, or which due to a process type may allow for the

survival of pathogenic microbial flora or other contamination which, if not controlled, may

contribute to illness of the consumer. It may also apply to a food that is deemed high risk

by a customer, declared high risk by the relevant food regulation or has caused a major

foodborne illness outbreak.

 

Just for reference, here is the previous version -

 

A food that may contain pathogenic microorganisms and will support formation of toxins or

growth of pathogenic microorganisms, and has a significant likelihood of growth causing

illness or injury to a consumer if not properly produced, processed, distributed and/or

prepared for consumption. It may also apply to a food that is deemed high risk by a

customer, declared high risk by the relevant food regulation or has caused a major

foodborne illness outbreak.

 

 

Peculiar English ! "known attributes" = ?

 

As per above i would say "fruit" is High Risk (more sure using older definition of HRF)

 

But   fresh fruit also appears in category 4 of SQF Code with a risk level of Low (unexplained).   i would also have classified that fruit as High

 

Confusing !. Clarifications only too Welcome !

 

PS - It should be noted that there is a bewildering array of  approaches to classifying  "Risk Levels of Foods" in use. Occasionally leading to totally opposite conclusions. A survey of some country-to-country  variations  is here -

http://www.fda.gov/F...s/ucm094143.htm

[Chris DeV]

Hi Mandy,

 

Charles references the correct element from the code above (I am an SQF practitioner, 2 plants, level 3). SQF requires risk assignment to raw materials and packaging materials, and thus, you have to perform risk assessment of each material. Coming from expereince in produce and RACs, I would suggest the following information for assessment:

 

1 - What is the history of the particular fruit? Have there been outbreaks or food safety issues with the fruit in the past? If so, how many and how severe?

2 - What growing region does the fruit come from, what other agricultural processes are nearby, etc. In other words, what are the environmental factors?

3 - How is the fruit handled and transported after harvest? Is there concern for introduction of hazards during these processes?

 

That's just a selection, and you can use any scoring matrix or decision tree based on the information you glean from the research to determine the risk factor. You may end up with the risk being anywhere from low to high, but inherent to your process (the sterilization step) is the CCP or CP to fix all three anyway. Whether you end up at low or high for the particular fresh fruit, you are still going to cook it anyway, right?

 

Chris

[QAGB]

Hi Charles,

 

We're certified BRC Issue 7, and we've been certified since Issue 6. We also have numerous customer audits as well as other certifications, and no one has ever commented or taken exception to the methodology we use (not saying it is correct but I hope it is - and has been working for us).

 

Yes, ingredient risk and even process risk are all based on risk assessment. If you can justify your reasoning to an auditor, you're probably ok. I always try to put more information in and be more cautious than I probably need to be, because you never know what the auditor's interpretation will be. BRC does define high-care and high-risk products, but those designations don't take into consideration the chemical or physical aspects of HACCP hazard analysis (so those wouldn't be my true basis for risk assessing my ingredients or my process). I'm not familiar enough with SQF to know what the differences would be as far as risk assessments.

 

QAGB

 

Mandy,

 

The information I pulled from in earlier posts is in the CFIA reference database for hazard identification. I have found it extremely useful over the years, and wish I could find more places as user friendly as that site. I don't know if you are familiar with it or not, but the hazard information for fresh fruit, canned fruit, and frozen fruit can be found below. You can take that information into account when forming your risk assessment.

 

FRUIT - FROZEN
Biological	Presence of virus (e.g., Norwalk virus, Hepatitis A virus, Rotavirus)
Chemical	Presence of undeclared allergens could impact on sensitive individuals
Chemical	Presence of mycotoxin - patulin (e.g., apple, peach, pear, berry)
Chemical	Contamination from environmental contaminants (e.g., pesticides, herbicides)
Chemical	Contamination from non-food chemicals (e.g., cleaners, sanitizers and lubricants)
Physical	Presence of hazardous extraneous material
FRUIT - SAUCE, PULP / PUREE, COMPOTE - CANNED
Biological	pH greater than 4.6 may result in under processing and growth of Clostridium botulinum in some high pH fruits (e.g., melons, cantaloupes, papayas, bananas)
Chemical	Metal ions contamination (e.g., tin, lead)
Chemical	Presence of mycotoxin - patulin (e.g., apple, peach, pear, berry)
Chemical	Contamination from environmental contaminants (e.g., pesticides, herbicides)
Chemical	Contamination from cleaners / sanitizers / lubricants
Physical	Presence of hazardous extraneous material
FRUIT FRESH / FRESH CUTS
Biological	Presence of protozoans (e.g., Cyclospora spp., Cryptosporidium spp.)
Biological	Presence of virus (e.g., Norwalk virus, Hepatitis A virus, Rotavirus)
Biological	Growth of pathogens from inappropriate storage temperatures / humidity
Biological	Presence of pathogens (e.g.: Escherichia coli O157:H7, Listeria monocytogenes, Salmonella spp, Shigella spp, Clostridium Botulinum)
Chemical	Contamination from environmental contaminants (e.g., pesticides, herbicides)
Chemical	Presence of undeclared allergens which could impact on sensitive individuals
Chemical	Presence of mycotoxin - patulin (e.g., apple, peach, pear, berry)
Chemical	Contamination by non-food chemicals (e.g., cleaners, sanitizers and lubricants)
Chemical	Presence of undeclared / non-permitted / exceeding allowable limits for food additives
Physical	Presence of hazardous extraneous material

[Charles.C]

Hi Mandy,

 

Hope you’re still around.

 

I suppose the (US) designation of which foods are high risk is shortly to be solved by FSMA since I presume “Regulatory” will supercedes SQF’s own notions/definition.

 

The long-anticipated list appears to have become a genuine hot potato. Afaik, the list has yet to appear.

 

I noticed this (2014) comment –

McEntire thinks that, with the way FDA has proposed its matrix of scoring risk, nearly all commodities could be labeled “high risk.”

“How will they draw the line between high-risk and what is not?” she asked.

http://www.foodsafet...e-for-disaster/

 

Echoes of HACCP.

 

For the present case, as I understand this is a fruit canning process so presumably category 15. This category is stated by SQF to be a HR product. Assuming the raw material category is linked to the final product I guess that makes the raw material HR also (in fact it’s difficult to see how it could be a lower risk?).

Of course, other standards may call this product Low Risk since storage can be ambient indefinitely.

 

This HR/LR terminology is the 3^rd  minefield of confusion I have met in SQF. But this time not totally due to SQF. If an auditor has a different opinion, as discussed in  previous posts, I guess you will just have to “go with the flow”.

[mkelly320]

Thanks so much for the responses.  I was out for a couple days and wanted to digest all of the information.

 

For some reason, the person who works directly with the farmers is resistant to changing the risk designation of the raw fruit because he thinks it opens us up to some kind of additional liability.  From my perspective, we are already treating the fruit as high risk, we just haven't labeled it high risk in our approved supplier register.  I also found that at our other plants, RACs are labeled high risk.  I think the information everyone has shared will help me to make my case to have this changed in our documents.  I really appreciate it!