Does anyone have a blanket statement for FSMA compliance?

Does anyone have a blanket statement for what they are doing as far as completeing the Preventive Controls requirement?  I'm talking about what is discussed at PCQI training, so if this is in the wrong forum, my appologies in advance.

We have customers that are requesting our hazard analysis profile for finished goods we send them - meaning they are wanting a hazard analyis for every ingredient.  In what we do (food flavorings), these can have, I have seen, up to 95 ingredients.  Until I went through the PCQI training myself, we have always done our HACCP plan based on our finished goods - not the individual ingredients.  We use over 3,200 ingredients in total, so as you see, my next year is going to be nothing but doing hazard analysis on every....single....one.

That being said, we are wanting to provide a "blanket statement" that we are working under FSMA compliance, but we cannot send out hazard analysis on all ingredients used.  We would be more than willing to show them all of this information if they would like to come and formally audit us, but as far as sending this out in document form, we cannot.

Does anyone have anything like this?

Thanks in advance,

Lynn

Rather than a blanket statement of compliance, why not make these ingredient risk assessments more modular. For example, come up with your company's risk assessment for different categories like:

1. Refrigerated

2. Commercially Sterile/retorted

3. Frozen

4. Shelf-stable

5. Imported

6. Packaging

7. High-risk (associated with recent recalls, sprouts, etc.)

8. Fruits and vegetables

9. Grains

10. Meat, poultry

11. Fishery

12. Raw

13. R-T-E

And do a detailed risk assessment for each category with controls or testing you will require. Then, as you go through each raw material, just assign it a risk code to refer to the appropriate assessment. For example, if you received raw tuna, you could have that ingredients risk categorized as 1-11-12 and refer to your risk assessments already performed. Do as many or as few categories as you need for the types of ingredients you buy.

This....my previous experience was in flavors so I know your pain.  I grouped them together based on the similarities.  To be honest, a lot of the flavor ingredients you use can be lumped into 3 or 4 categories total.  They don't differ THAT much from one another...  I'm trying to remember off-hand, but I believe I used:

1. Natural
2. Artificial
3. WONF
4. Juice/Berry Concentrates

I did PG and ethyl alcohol separately since those were the bases used in every flavor.

Rather than a blanket statement of compliance, why not make these ingredient risk assessments more modular. For example, come up with your company's risk assessment for different categories like:

 

1. Refrigerated

2. Commercially Sterile/retorted

3. Frozen

4. Shelf-stable

5. Imported

6. Packaging

7. High-risk (associated with recent recalls, sprouts, etc.)

8. Fruits and vegetables

9. Grains

10. Meat, poultry

11. Fishery

12. Raw

13. R-T-E

 

And do a detailed risk assessment for each category with controls or testing you will require. Then, as you go through each raw material, just assign it a risk code to refer to the appropriate assessment. For example, if you received raw tuna, you could have that ingredients risk categorized as 1-11-12 and refer to your risk assessments already performed. Do as many or as few categories as you need for the types of ingredients you buy.

As far as a blanket letter I would just provide a generic statement regarding your company being compliant with current FSMA requirements.  Leave it general and vague.  Sure, customers want specificity, but a lot of them are happy with just a statement because they want to cover their butts too.

We have a letter that we send when asked.  I have removed the parts that are specific to our company and products, so you get an idea of what a form letter can say.

As for the risk assessments, I feel your pain.  But you do need to perform risk assessments on all ingredients and mention each supplier.  I did them in an Excel format.

Martha

Thanks everyone for the replies!

MWidra, we don't use excel.  We have an excellent safety software we use and we are currently updating.  As I said, we reallize we have to do the risk assessments.  And I am currently sitting here on a Saturday working on them (what else do you do when there's a hurricane outside?? lol).  I was simply looking for some input.  We have until September of next year to complete this, but we want to have as much of it completed by December of this year as possible.  When you are the only person undertaking this task, it's momumental. 96 down, over 3200 still to go.

Rmills06, that is exaclty what we ended up doing, and it's been sufficient (at least this week!).  Thank you for your input!  Also, thank you for the header suggestions.  Right now, I am entering all the non-allergenic ingredients we use.  Then will move to the Natural, Artificial, etc.  As I do the non-allergenics, I can actually do this as I go, I'm finding.  WONF really only applies to our finished goods, and those hazards are listed on the labels and CofA's so we're good there.  We're actually going to put PG and alcohol under solvent systems, since they are carriers, along with the others we have.  

Earth20, thank you also - everything we have is ambient and pre-processed.  The only "raw" ingredient we use is vanilla beans, and those are irradiated before they enter the building.  The only ingredients we use that require refridgeration are juice concentrates and butter derrivatives...everything else is to help with shelf life only.  Thank goodness we dont' have that many categories, or I would lose my marbles!

Thanks again, everyone and hope you have a wonderful weekend!

Lynn

FYI...I found this article and it's a good one that breaks down the comparisons/differences between HACCP and FSMA Preventive Controls.

http://www.foodquali...n/?singlepage=1

Hi Ryan,

Thanks for the interesting Link.

The theme of this article is an extension/development of a nice post by the same author which I referenced in this post of a "FSMA-confusion" thread  –

http://www.ifsqn.com...le/#entry105396

For convenience I have combined the 3 dated items mentioned in above post into one file for which  see the central contribution  –

HARPC Confusion.pdf   647.57KB   225 downloads

IMO a fundamental  snag with this new attempt to simplify the conversion of an existing haccp plan into a harpc equivalent is the introduction/usage of further new “definitions”. This seems a rather dubious step within a FSMA defined System.

Additionally, as per my reading, the interpretation of a significant hazard  in traditional haccp as being generated solely by contamination is surely too narrow, eg micro. growth ?

Just another 0.1$ from a (thankfully) neutral observer of the FSMA saga. 10 months to go ?

PS - I take it that this September post is still the current situation ?

http://www.ifsqn.com...ns/#entry106028