Jump to content

  • Quick Navigation
Photo

Internal Audit Checklist for FSMA Regulations?

Share this

  • You cannot start a new topic
  • Please log in to reply
8 replies to this topic

shklegon

    Grade - Active

  • IFSQN Active
  • 7 posts
  • 0 thanks
0
Neutral

  • Albania
    Albania

Posted 13 December 2017 - 12:39 PM

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-



FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 590 thanks
206
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Oregon, USA

Posted 13 December 2017 - 05:01 PM

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.


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.

shklegon

    Grade - Active

  • IFSQN Active
  • 7 posts
  • 0 thanks
0
Neutral

  • Albania
    Albania

Posted 13 December 2017 - 05:07 PM

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.



Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 20,542 posts
  • 5662 thanks
1,544
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 13 December 2017 - 08:12 PM

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.


Kind Regards,

 

Charles.C


FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 590 thanks
206
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Oregon, USA

Posted 13 December 2017 - 10:17 PM

 

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".


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.

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 20,542 posts
  • 5662 thanks
1,544
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 14 December 2017 - 04:30 AM

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.


Kind Regards,

 

Charles.C


TruAseptics

    Grade - Active

  • IFSQN Active
  • 6 posts
  • 2 thanks
0
Neutral

  • United States
    United States

Posted 20 December 2017 - 09:39 PM

You can find some resources here....

 

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

 

There are checklists about half-way down the page.



mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,403 posts
  • 997 thanks
274
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Plant City, FL
  • Interests:Cooking, golf, firearms, food safety and sanitation.

Posted 20 December 2017 - 11:14 PM

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



FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 590 thanks
206
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Oregon, USA

Posted 22 December 2017 - 03:45 PM

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.


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.



Share this


0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users