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Posted 03 October 2018 - 11:13 PM

Can someone give me some clarity on the on-site audits for FSMA as far as: is this needed for all supplier that are high risk? I am only asking because we manufacture cheese and most ingredient if not all ingredients are added after milk is pasteurized. So will that mean all my ingredients added will be considered high risk because we are not longer taking care of the hazard and we are having the supplier control the hazard?. Will a 3rd party audit fulfill this requirement? If not what exactly needs to be included in this on-site audit?


We are SQF certified and we required all supplier to go thorough a supplier approval process, but looking into FSMA this approval process now requires on-sites audits. If I am wrong please let me know.


Thanks for any help :)


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Posted 04 October 2018 - 12:56 AM

Hi, ffkm.


From what I understand, this based on the risk you have assessed for the material (if the material is with significant hazard or not). Case in point, I'll be using microbiological hazard as an example.


Since you adding materials after pasteurization of milk then you may have a high risk process (depending on your HACCP and other PRPs you have in place). However, this does not mean necessarily that you have high risk materials.


If for example, I have cheese to which my ingredients are milk which is being pasteurized, salt and culture or whey powder added after pasteurization.


From most of the literature you may see that for your product (speaking only of pathogen of interest), you will see that culture and whey powder may have high risk for listeria and salmonella thus it is high risk material and may have significant hazard. As for salt, it is low risk thus may not be significant hazard for your process/product (based on your HACCP).


from this you could derive your supplier program. You may audit more frequent whey and culture. From what I also understand,  3rd party audits.


As for the supplier program, it is not limited to audit, food safety testing can also be used.

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Gerard H.

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Posted 08 October 2018 - 09:08 AM



In addition to the very useful information given above, please also consider your own process while carrying out the ingredients risk assessment.


That means, for example, that if you are sieving or filtering the ingredients before dosing, you are taking away the foreign body risk of these ingredients. The same is valid, if you carry out a metal detection or an X-ray inspection on the finished product.


If you're not doing this yet, you can consider it, to lower the risk of your raw materials.


And last but not least, include all food hazards in your ingredients risk assessment.


Kind regards,


Gerard Heerkens


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Posted 08 October 2018 - 02:01 PM

Hi ffkmm,


Not sure where in the FSMA final rule you found a requirement for on-site audits with the exception of verification of foreign suppliers. Other controls include the above with a proper hazard analysis of the ingredient and appropriate verification that those hazards are controlled, either through supplier requirements or your own analysis of incoming materials.

Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

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