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FSMA/HARPC Queries for Dairy Products


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#1 kzimmers

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Posted 07 June 2018 - 11:36 PM

From where do I start... I'm working on my HARPC, already outlined my Hazard Analysis/Preventive Control Program Not sure if I did it right because I have to spare time to work on Nutrition Label program too... (You know working in the Dairy Industry you'll have to wear a bunch of Hats!) Supply Chain Program, here is where I'm stuck ...(side note: I gave this assignment to another coworker and he just could't develop anything because is not his area of expertise). We produce/manufacture Yogurt and Sour Cream...

 

My questions:

 

I have a Food Safety Plan/ Old HACCP Plan, Do i need to completely toss that in the garbage? I was told by an auditor that i cannot continue using it...

 

We do not have any other allergen other than Milk, Do I need to create an Allergen program even though all of our products contain just milk?

 

Food Fraud / Vulnerability Risk

 

Do I need to perform an assessment for each ingredient and on each product?

 

I think that you can see that I'm all over the place... Any help would be very appreciated.

 

Sincerely,

 

KZimmers

 

 



#2 Charles.C

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Posted 08 June 2018 - 12:24 AM

From where do I start... I'm working on my HARPC, already outlined my Hazard Analysis/Preventive Control Program Not sure if I did it right because I have to spare time to work on Nutrition Label program too... (You know working in the Dairy Industry you'll have to wear a bunch of Hats!) Supply Chain Program, here is where I'm stuck ...(side note: I gave this assignment to another coworker and he just could't develop anything because is not his area of expertise). We produce/manufacture Yogurt and Sour Cream...

 

My questions:

 

I have a Food Safety Plan/ Old HACCP Plan, Do i need to completely toss that in the garbage? I was told by an auditor that i cannot continue using it...

 

We do not have any other allergen other than Milk, Do I need to create an Allergen program even though all of our products contain just milk?

 

Food Fraud / Vulnerability Risk

 

Do I need to perform an assessment for each ingredient and on each product?

 

I think that you can see that I'm all over the place... Any help would be very appreciated.

 

Sincerely,

 

KZimmers

 

Not my Product area/Location but i suspect you need to think about "PCQI". Unless you've been through that already of course ?


Kind Regards,

 

Charles.C


#3 Fishlady

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Posted 14 June 2018 - 08:56 PM

You should not need to toss your HACCP plan in the garbage- it will probably form the basis for your Process Controls.  You will, of course, need to add Supplier Controls, Allergen Controls, and Sanitation Controls as appropriate to your product and process.

 

If milk is the only allergen being processed, then you should not need Allergen Controls as part of your Food Safety Plan, although you would want to make sure that your employees are not introducing allergens by, for instance, not washing their hands after eating lunch.  This could be addressed in an allergen control plan which would not necessarily be accessible to FDA (although it would be required by most third-party certification schemes).

 

Food fraud/vulnerability, under FDA rules, is limited to hazards that would impact food safety.  Third-party schemes broaden that definition to include other forms of economically motivated adulteration (such as substituting a lower quality grade of ingredient) that would not necessarily be a food safety hazard.  But FDA does require you to consider the potential that someone within your company could intentionally adulterate your product and put in place measures to prevent that from happening.

 

I am not a dairy expert so can't comment on specific measures you would need.  But remember that there are a lot of things that are required by GFSI certification schemes that are NOT in the US regulations (although they are good to do anyway).



#4 mgourley

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Posted 14 June 2018 - 09:30 PM

Just to amplify on the above. 

HACCP plans assume prerequisite programs are already in place to mitigate hazards. 21 CFR 117 (and associated guidance documents) specifically state that you have to develop your Food Safety Plan(s) assuming NO controls are in place.

You do not have to jettison your HACCP plan. You do have to tweak it though. Thoroughly review your HACCP Plan. If you have process steps that assume a PRP as a control, you will have to re-think that and determine if you need a Preventive Control at that step.

As discussed above, your product only has one allergen, but you still need some sort of allergen control program. Even if it is ensuring that finished product containers or labels have correct allergen information. Also stated above, you need to have some policy that mitigates cross contact. If employee A has a peanut butter and jelly or a tuna salad sandwich for lunch, you should ensure that they are properly washing hands before returning to the line.

 

Marshall



#5 Fishlady

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Posted 14 June 2018 - 10:03 PM

[quote name="mgourley" post="127041" timestamp="1529011830"]

Just to amplify on the above. 

HACCP plans assume prerequisite programs are already in place to mitigate hazards. 21 CFR 117 (and associated guidance documents) specifically state that you have to develop your Food Safety Plan(s) assuming NO controls are in place.

You do not have to jettison your HACCP plan. You do have to tweak it though. Thoroughly review your HACCP Plan. If you have process steps that assume a PRP as a control, you will have to re-think that and determine if you need a Preventive Control at that step.

As discussed above, your product only has one allergen, but you still need some sort of allergen control program. Even if it is ensuring that finished product containers or labels have correct allergen information. Also stated above, you need to have some policy that mitigates cross contact. If employee A has a peanut butter and jelly or a tuna salad sandwich for lunch, you should ensure that they are properly washing hands before returning to the line.

 

 Marshall, you are correct regarding allergen labeling. That has been a CCP for every seafood HACCP plan I have written, but I was not thinking of it in the context of HARPC/PCHF rule.



#6 mgourley

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Posted 14 June 2018 - 11:14 PM

[quote name="mgourley" post="127041" timestamp="1529011830"]

Just to amplify on the above. 

HACCP plans assume prerequisite programs are already in place to mitigate hazards. 21 CFR 117 (and associated guidance documents) specifically state that you have to develop your Food Safety Plan(s) assuming NO controls are in place.

You do not have to jettison your HACCP plan. You do have to tweak it though. Thoroughly review your HACCP Plan. If you have process steps that assume a PRP as a control, you will have to re-think that and determine if you need a Preventive Control at that step.

As discussed above, your product only has one allergen, but you still need some sort of allergen control program. Even if it is ensuring that finished product containers or labels have correct allergen information. Also stated above, you need to have some policy that mitigates cross contact. If employee A has a peanut butter and jelly or a tuna salad sandwich for lunch, you should ensure that they are properly washing hands before returning to the line.
 

 

Marshall, you are correct regarding allergen labeling. That has been a CCP for every seafood HACCP plan I have written, but I was not thinking of it in the context of HARPC/PCHF rule.

 

 

In our HACCP Plan, we "assumed" correct printing of allergen labeling on packaging received. Because that's what the supplier is supposed to do. We have a procedure where the packaging lead/supervisor is supposed to "verify" that the packaging allergen statement is correct before using the packaging.

Under PCHF, we make it a Process Control at the "Recieve packaging" step that QA verifies that the printing is correct for each batch of packaging that is received. We continue to require that the packaging is visually verified in the packaging area prior to use. As well as recording lot numbers for traceability purposes.

Marshall



#7 kzimmers

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Posted 14 June 2018 - 11:54 PM

Thank you Guys! I do appreciate your feed back.



#8 mgourley

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Posted 15 June 2018 - 12:00 AM

As for material vulnerability assessments for fraud/intentional adulteration, the answer is yes.

 

Marshall






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