Does anyone have an FSMA internal audit checklist?

I am looking to do an internal audit against the new FSMA regulations only.  Does anyone have a checklist started?

Any help getting started on this task would be greatly appreciated.

I am looking to do an internal audit against the new FSMA regulations only.  Does anyone have a checklist started?

 

Any help getting started on this task would be greatly appreciated.

Hi Mazie,

Any particular product / process ?

Here is something I devised and am hoping it is sufficient for FSMA requirements.  Feel free to modify it any way that you see fit, but at least this can give you a template to begin with. I would Be happy to see any changes you make on it too, may be something I didn't think of.  For me I have different tabs for different groups of ingredients/ components/ etc.  Also I use a split pane window for ease of navigating. 

Anyway, hope this helps.  At least it can send you on the trail towards success. :rock:

PS, love your pic, (I'm a dachshund owner myself :silly:)

Here is something I devised and am hoping it is sufficient for FSMA requirements.  Feel free to modify it any way that you see fit, but at least this can give you a template to begin with. I would Be happy to see any changes you make on it too, may be something I didn't think of.  For me I have different tabs for different groups of ingredients/ components/ etc.  Also I use a split pane window for ease of navigating. 

Anyway, hope this helps.  At least it can send you on the trail towards success. :rock:

 

PS, love your pic, (I'm a dachshund owner myself :silly:)

Hi Jus'me,

Maybe the document got lost in transit ?

Mea culpa!!  Okay. let me try again.  I was wondering if my attachment got through last time.  Apparently not!  I just love these new fangled devices LOL!!! :roflmao:

Hopefully I got it figured out how to add it this time. :spoton:

Mea culpa!!  Okay. let me try again.  I was wondering if my attachment got through last time.  Apparently not!  I just love these new fangled devices LOL!!! :roflmao:

Hopefully I got it figured out how to add it this time. :spoton:

Hi Jus'me,

Thanks but I'm confused.

Internal audit checklist = hazard analysis template ?

Wow!!! And it isn't even Monday!!!  :headhurts: Can't use that as an excuse!!!  what can I say except I have been working on the hazard analysis lately and was so focused on that I got myself confused!!!  What a Dunderhead!!!  My face is extremely red w/ embarrassment presently!!!  I do apologize, obviously I am the one who is confused here.  :helpplease:  Please forgive me and if you will excuse me I will presently crawl back into my hole where I belong. :oops2: Sorry Mazie I couldn't help you after all, I did try for what its worth.

Hi Jus'me,

No problem at all. As you can see, a lot of people have found interest in yr substitution. :smile:  :thumbup:

Hopefully more thoughts on Mazie's query will emerge. I didn't even know that FSMA required an internal audit.

Thanks for trying Jus'me.  I hope your dog is happy and healthy.  My pic and name is in remembrance of my little dog.  My little wienie passed after giving me 15 years of love and companionship - bless her heart I miss her greatly.

I am doing this audit not because it is required by FSMA - but as a way to gauge how well we are meeting all of FSMA requirements.  In addition I hope to help other small companies with this audit.  

I was looking for just a basic template that covered 21 CFR 110 & 117.  Really - Charles.C - if you only do what is required are you a True Quality Professional? :giggle: 

I guess I will start with a 21 CFR 110 template and add to it as there does not appear to be anyone who is ahead of me in this task. 

Thanks all - I enjoyed the discussion.

We still have both of our wienie dogs and I am sure will ultimately get more before it is all done.  Me wife wants to get a herd of them and I want a border collie to herd them, so we will see.  They are a unique kind of dog that is for sure!

Okay, down to business...

Let me give it one more shot and try to redeem myself a little.  On the SQF site they have a an audit template that is SQF/FSMA

http://www.sqfi.com/...-Checklist.docx

they also have a guidance document for the audit

http://www.sqfi.com/...dance-Final.pdf

Not sure if this is exactly what you are looking for, but may give you some direction as to getting you on the right path.

And not near as important, but a by-product is now I will be able to sleep tonight knowing I have restored at least a miniscule amount of my dignity,  (I have so little anyway, even the most minutest amount counts, so I'll take it!!!  LOL). :giggle:

Anyway, I do hope this helps and at least gives you some idea.  Wish you the best of luck in your search and ultimate internal audit, may you be in 100% compliance. :happydance:

Another one of my google finds - An internal audit template for FSMA!

Another one of my google finds - An internal audit template for FSMA!

Hi bnue,

An Invisible one ?? :smile:

Thanks for trying Jus'me.  I hope your dog is happy and healthy.  My pic and name is in remembrance of my little dog.  My little wienie passed after giving me 15 years of love and companionship - bless her heart I miss her greatly.

 

I am doing this audit not because it is required by FSMA - but as a way to gauge how well we are meeting all of FSMA requirements.  In addition I hope to help other small companies with this audit.  

I was looking for just a basic template that covered 21 CFR 110 & 117.  Really - Charles.C - if you only do what is required are you a True Quality Professional? :giggle:

 

I guess I will start with a 21 CFR 110 template and add to it as there does not appear to be anyone who is ahead of me in this task. 

 

Thanks all - I enjoyed the discussion.

Hi Mazie,

Hope you are still following this thread.

Very sorry about yr dog. My condolences. I know how you feel.

IMO Post 10 offers an excellent route into yr OP's queries but is maybe usefully expanded a little. Some/much of the following may have been posted elesewhere, if so my apologies in advance.

The intended scope of FSMA is large. I have deduced  there are parts A - G but only 3 parts seem to be directly "Operational" - B,C.G according to the "summary checklist" usefully provided here -

http://www.ifsqn.com...st/#entry115157

SQF have attempted to "clarify" the FSMA maze to their credit. The main SQF page for the items in Post 10 is -

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

(the page is verrry slow to open for me)

Above page contains a wealth of FSMA related info / links. Unfortunately, at least in my case, it's a somewhat bewildering of riches.

I noted one specific checklist omission on the SQF page is for FSMA- GMP content (unlesss i missed it). I have attached a claimed checklist below (unchecked by myself but looks comprehensive and contains useful "hints") -

FSMA - GMP checklist.pdf   148.22KB   388 downloads

So Mazie, at least you now (theoretically) have checklists for the GMP / Preventive Controls (Post 10) aspects (B,C,G). I hope this helps.

Alternatively you could presumably go the SQF route and study the gap-list.

Good Luck !

Hi bnue,

 

An Invisible one ?? :smile:

Yikes! my sincere apologies.  In the past I would get an email every time there was a post here.... nowadays I don't hence the horrible delay, perhaps something changed. Anyways, attempting to attach again. I forget from where I downloaded it so I'm unable to quote the source. Also I did not check if someone else has already uploaded this checklist. So my apologies again. :oops:Blank FSMA-Gap Analysis.xlsx   39.67KB   183 downloads