Internal Audit Checklist for FSMA Regulations?

I would like to conduct an internal audit of my facility and my paperwork to meet or exceed the FSMA regulations. Does anyone have a checklist or an internal audit form to accomplish this?

Thanks for your help.

Steve-

FSMA is more comprehensive than a checklist activity, that's kind of like saying "is there a checklist for being compliant with FDA".

A full list of all the rules are here: https://www.fda.gov/...A/ucm253380.htm

Your primary concern is registering with FDA and learning about the preventive controls rule. One of the first requirements is to have a "qualified individual" capable of implementing the rule. It sounds like you do not yet have that person in your facility, so you may want to look into attending a training approved by FSPCA. That will be a big step into getting you started and helping you generate a "list" of things you need to accomplish.

^{I understand but we do have a PCQI ... simply looking for something like SQF where we could check off if he are missing something or not ...thanks.}

I would like to conduct an internal audit of my facility and my paperwork to meet or exceed the FSMA regulations. Does anyone have a checklist or an internal audit form to accomplish this?

Thanks for your help.

Steve-

Actually, offhand, it seems not totally unreasonable to me to wish to generically compare FDA's FSMA/FS requirements (for a manufacturing facility) with those of, for example, BRC or SQF. Might be a Herculean Challenge though. :smile:

Generic "checklists" do exist for BRC/SQF etc.

Whether any meaningful, publically available,  generic summaries/lists of the expectations of FDA for FSMA  exist in the form of a checklist  I hv no idea. The collection of offerings detailed within 3F's link suggests the possible scope of any such list.

Personally I'm still waiting to see a coherent explanation of FDA's requirements for the operational determination of preventive controls.

 

Personally I'm still waiting to see a coherent explanation of FDA's requirements for the operational determination of preventive controls.

My personal quick-and-dirty interpretation is basically "if this didn't happen would you be expected to recall".

My personal quick-and-dirty interpretation is basically "if this didn't happen would you be expected to recall".

Sorry, I was referring to the,IMO, notorious phrase "in the absence of ......". Yet to see an FDA explanation/example although derided elsewhere.

You can find some resources here....

http://www.sqfi.com/...-resource-page/

There are checklists about half-way down the page.

Generally, if you are certificated to a GFSI approved standard, you are about 85% compliant with FSMA,

The issue really is that FDA does not actually know what the requirements are, nor have they provided complete guidance to industry on how to comply.

This document, issued in August (one month before the rule became law for "small" businesses), is the best they have done. There are still key sections for which there is no guidance provided (Three months after).

Do your due diligence. You already have a PCQI. Make sure your Food Safety Plans follow the guidance in the document and in the training material the PCQI received.

FDA has already said that if and when they come inspecting, they will be educating, not necessarily "enforcing" if you don't have all things in place.

FSMA, unlike BRC or SQF is legislation, not a black and white standard. One would think it would have been more "user friendly" to ensure compliance, but the fact is, it's not.

Marshall

You can find some resources here....

 

http://www.sqfi.com/...-resource-page/

 

There are checklists about half-way down the page.

Note that these checklists are for companies who are already compliant with the SQF standard and are performing a FSMA gap analysis.