Example of Supply Chain Program and Raw Material Risk Assessment

Hi All,

I am developing Supply Chain Program and Raw Material Risk Assessment to comply with FDA and SQF (level 2). My products is ready to eat salad kits (fresh vegetables + cooked chicken + sauce). It is great if anyone can post examples of Supply Chain Program and Raw Material Risk Assessment for ready to eat foods or similar ones for reference. 

Thanks in advance.

O.C     

Hi All,

 

I am developing Supply Chain Program and Raw Material Risk Assessment to comply with FDA and SQF (level 2). My products is ready to eat salad kits (fresh vegetables + cooked chicken + sauce). It is great if anyone can post examples of Supply Chain Program and Raw Material Risk Assessment for ready to eat foods or similar ones for reference. 

 

Thanks in advance.

 

O.C     

Complex product.

Which SQF clauses are you responding to ? (I do not see any specific mention of Supply Chain Program in the SQF 8.1 Standard although it has significance regarding vulnerability assessment).

Dear Charles,

Supply Chain Program and Raw Material Risk Assessment are recommended by FDA so I have to develop them comply with FDA. I include SQF just because we are implementing it. My current priority is FDA compliance.  

Production is not really complicated. We buy ingredients (packed vegetable, packed cooked chicken or ham) from different suppliers and sauce is made in house. Then they all are assembled into kits.       

Thanks

O.C 

Dear Charles,

 

Supply Chain Program and Raw Material Risk Assessment are recommended by FDA so I have to develop them comply with FDA. I include SQF just because we are implementing it. My current priority is FDA compliance.  

 

Production is not really complicated. We buy ingredients (packed vegetable, packed cooked chicken or ham) from different suppliers and sauce is made in house. Then they all are assembled into kits.       

 

Thanks

 

O.C 

Hi OC,

 I have previously seen haccp plans for such mixes. Not so simple IMO. :smile:

(if only a straight mixing process then maybe is more simple)

IIRC there is a model FSMA-compatible "harpc" plan for yr product (but excluding the chicken/sauce) on this forum.

A detailed example of development of FSMA harpc for bagel product is here -

https://www.ifsqn.co...pc/#entry126430

A model harpc plan salad is attached (credit Marshall) -

harpc vegetable salad.pdf   841.74KB   142 downloads

Hopefully of some assistance.

PS - also some model harpc plans in the FSPCA training manual for FSMA.

 

A detailed example of development of FSMA harpc for bagel product is here -

 

https://www.ifsqn.co...pc/#entry126430

 

A model harpc plan salad is attached (credit Marshall) -

 

  harpc vegetable salad.pdf   841.74KB   8 downloads

 

Hopefully of some assistance.

 

Thanks Charles. The HARPC salad plan is informative. 

I still have some questions:

(1) If I integrate supply chain preventive controls into each HARPC plan like it was done in HARPC for salad, do I still need to develop a separate stand-alone Supply Chain Program to comply with FDA?  

(2) If I have developed a separate stand-alone Supply Chain Program in which I group raw materials (ingredients) and supplier into high risk, moderate risk and low risk based on FDA hazard guidance and supplier performance and establish proper preventive controls for each risk group such as on-site audit and/or GFSI audit, COAs provided for each lot etc.., can I just refer to that separate Supply Chain Program in Supply Chain preventive controls section in each HARPC plan? My purpose is to make the HARPC shorter/simpler but still comply with FDA.   

Thanks again.

O.C

Thanks Charles. The HARPC salad plan is informative. 

 

I still have some questions:

 

(1) If I integrate supply chain preventive controls into each HARPC plan like it was done in HARPC for salad, do I still need to develop a separate stand-alone Supply Chain Program to comply with FDA?  

 

(2) If I have developed a separate stand-alone Supply Chain Program in which I group raw materials (ingredients) and supplier into high risk, moderate risk and low risk based on FDA hazard guidance and supplier performance and establish proper preventive controls for each risk group such as on-site audit and/or GFSI audit, COAs provided for each lot etc.., can I just refer to that separate Supply Chain Program in Supply Chain preventive controls section in each HARPC plan? My purpose is to make the HARPC shorter/simpler but still comply with FDA.   

 

Thanks again.

 

O.C

Hi OC,

Sorry but I am fortunate in never having had to be a user of the formidable  FSMA so unfamiliar with detailed documentation/ implementation.

For (1,2) I noted there are "appended" sections in the salad harpc. And considerable additional detail in 1st attachment of the linked bagel post. I guess the specific format  required (if any?) depends on the relevant CFR requirements. Maybe see the FSPCA Manual ? .

I daresay FSMA users here may know also.

You will want some sort of supply chain program where you address how you mitigate risks from food fraud an/or support any supply-chain preventive controls, which I assume you have many of given your product and the fact that you probably bring in a variety of ingredients that all pose different risks either in your product or upstream before they're made non-perishable by drying etc.

Creating a multi-ingredient sauce is generally not a simple process from a HARPC perspective, a simple process would be more like "we bring in corn, and package it in smaller containers". Anytime you're mixing ingredients things get blown up fast. E.g. if you're not cooking your chicken and it's RTE in your salad kit, I would expect a supply chain preventive control for the biological hazards posed by chicken, and how you will verify that your supplier is implementing sufficient controls to make sure it does not carry those hazards into your meal kit.

To your question about where the information needs to be however, it's up to you, FDA does not have any requirements as to the formatting of your food safety plan. HOWEVER, you may run into some auditor trouble if your supply chain preventive controls aren't in the document called your "food safety plan" and are instead referenced elsewhere in an unfamiliar format to them. This is your call but do what makes the most sense for your business, don't build the plan for the auditors sake.

Similarly, when I have sanitation preventive controls I certainly would have most of those details in my sanitation SOP's, not in my FSP. So they key is to tie them together and make sure you don't duplicate a bunch of unnecessary information, that way you don't inadvertently update one and not the other down the road. Your critical limits etc. will need to be clearly spelled out in a way that helps you explain that you meet the intent of the rules.

 

You will want some sort of supply chain program where you address how you mitigate risks from food fraud an/or support any supply-chain preventive controls, which I assume you have many of given your product and the fact that you probably bring in a variety of ingredients that all pose different risks either in your product or upstream before they're made non-perishable by drying etc.

 

Creating a multi-ingredient sauce is generally not a simple process from a HARPC perspective, a simple process would be more like "we bring in corn, and package it in smaller containers". Anytime you're mixing ingredients things get blown up fast. E.g. if you're not cooking your chicken and it's RTE in your salad kit, I would expect a supply chain preventive control for the biological hazards posed by chicken, and how you will verify that your supplier is implementing sufficient controls to make sure it does not carry those hazards into your meal kit.

 

To your question about where the information needs to be however, it's up to you, FDA does not have any requirements as to the formatting of your food safety plan. HOWEVER, you may run into some auditor trouble if your supply chain preventive controls aren't in the document called your "food safety plan" and are instead referenced elsewhere in an unfamiliar format to them. This is your call but do what makes the most sense for your business, don't build the plan for the auditors sake.

 

Similarly, when I have sanitation preventive controls I certainly would have most of those details in my sanitation SOP's, not in my FSP. So they key is to tie them together and make sure you don't duplicate a bunch of unnecessary information, that way you don't inadvertently update one and not the other down the road. Your critical limits etc. will need to be clearly spelled out in a way that helps you explain that you meet the intent of the rules.

 

Thank you.