Jump to content

  • Quick Navigation
Photo
* * * * - 1 votes

FDA FSMA Compliance Audit


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

#1 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 11 April 2018 - 10:43 PM

Monday morning a FDA Investigator showed up at my firm to conduct a FSMA Compliance Audit.
Apparently they are reaching into the bucket and drawing names of companies to inspect. Our company does bread/rolls and cookies. The inspector intimated that the reason we were chosen was not because we are a "high risk" facility, but because we have a decent amount of allergens in the facility.

This was an actual FDA guy, not the contracted state officials. The audit was scheduled for 4 days.

This was not a FDA swoop in for massive swab taking. It was an audit to determine compliance to FSMA. Their stated goal is to "Educate while Regulating". 
Of course, if he found something egregious in the process(s), the audit would have taken on a different light.

 

He reviewed our Food Safety Plans, Recall Plan, sanitation programs, allergen programs, training, supplier verification, approval and monitoring plans, and associated procedures and monitoring records. He collected production records from one specific item. He did his own hazard analysis of ingredients in that product and compared it to my hazard analysis for the same ingredients and accepted by HA, RA and any controls.

He accepted my hazard analysis and determination of Preventive Controls for the process, with a few questions about how I came to the conclusions I did.

 

He was impressed that I was ahead of the curve in doing vulnerability assessments of ingredients for intentional adulteration/economically motivated adulteration.

 

He spent probably 8 hours on the floor, observing the process, people and material condition of the facility (we have a total of 6 lines under one roof).

 

The wrap up meeting is in the morning tomorrow, but there were only a couple of minor findings, which are simple additions to verbiage to a couple of our policies.

 

Recommendations:

 

Use the FDA guidance documents. If you are doing hazard analysis of ingredients based upon what they have published, you should be good.

FDA is not likely to accept supplier guarantees or COA's as a PC for things like allergens or biological hazard controls.

For allergens, if you can get documentation from your supplier that specifically shows how they control allergens in their facilities, that's a plus.

For things in bakeries, where they may want to see validation of a "kill step", use the AIB Kill Step Calculator. We did this for the bun/roll line, but had not yet done it for the cookie lines.

 

All in all, a fine audit. We learned what the FDA is looking for, and the inspector was not looking to hammer us, but to explain the guidance documents and how FDA is using them. They realize that industry has questions, and FSMA is a large undertaking. They are learning from us as they do these inspections.

 

This part can be edited out by Simon or Charles if I am sounding like I am endorsing a sponsor of this forum.

 

This facility uses SafeFood 360. The Inspector was highly complementary of the "software", in that it allowed me to access policies, documents and records quickly and without having to resort to consulting binders of paper (for the most part).

The Inspector made the offhand comment to the Plant Manager that the QA Manager and I should get a raise for our efforts to comply with the regulation and pare down the scheduled 4 day audit to 3 days, even with a lot of chit chat during the desk audit portion.  :spoton:

 

Marshall

 

 

 

 

 



#2 Scampi

Scampi

    Fellow

  • IFSQN Fellow
  • 3,493 posts
  • 948 thanks
553
Excellent

  • Canada
    Canada
  • Gender:Not Telling

Posted 12 April 2018 - 01:03 PM

Good on you Marshall!  We should all be working ahead of the curve, it's part of our continuous improvements!


Please stop referring to me as Sir/sirs


#3 MsMars

MsMars

    Grade - PIFSQN

  • IFSQN Principal
  • 606 posts
  • 194 thanks
150
Excellent

  • United States
    United States
  • Gender:Female

Posted 12 April 2018 - 01:14 PM

Thanks for the insight! I've been looking around for descriptions of FDA FSMA compliance audits as we have not had one yet and are not really sure what to expect.  Sounds like you did a nice job!



#4 FurFarmandFork

FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 584 thanks
187
Excellent

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

Posted 12 April 2018 - 03:00 PM

Thanks for sharing your experience!

 

 He did his own hazard analysis of ingredients in that product and compared it to my hazard analysis for the same ingredients and accepted by HA, RA and any controls.

 

 

Everyone I've talked through who's been through a part 117 FDA audit has reiterated this. FDA inspectors are treating the PC Guidance Appendix 1 as law for what FDA says your hazard analysis should address in your facility, if a hazard is identified in that guidance for a product or process in your plant, FDA isn't considering your plan compliant unless you have an associated preventive control or a REALLY good risk assessment detailing why it might not apply to your unique circumstances.


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.

Thanked by 3 Members:

#5 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 12 April 2018 - 09:00 PM

Here are the three things that the Inspector noted:

 

1. The thing with documentation of allergen controls by your suppliers. I'm still not sure exactly what FDA is looking for, even after asking the question several different ways. As I said in the OP, I'm thinking they want you to have some assurance of allergen controls by the manufacturer of the raw material.

 

2. Again from the OP, if you have a "kill step", FDA wants to see some scientific data that shows that the "kill step" is adequate and that you monitor temperatures (or whatever) to ensure the temperatures are maintained. Basically, they want to see this step as a Process Control. We do this on the bun line, but had not done it on the ovens for the cookie line.

 

3. The Fluke meter that Maintenance uses to check the calibration of the thermocouples was not itself calibrated.

 

Easy fixes and no 483's issued. 

Inspector said it would probably take a month to receive the final report.

 

Marshall



Thanked by 2 Members:

#6 FurFarmandFork

FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 584 thanks
187
Excellent

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

Posted 12 April 2018 - 09:19 PM

 

2. Again from the OP, if you have a "kill step", FDA wants to see some scientific data that shows that the "kill step" is adequate and that you monitor temperatures (or whatever) to ensure the temperatures are maintained. Basically, they want to see this step as a Process Control. We do this on the bun line, but had not done it on the ovens for the cookie line.

 

 

I bet the auditor felt good about that one, given that the example used in the Use of Heat Treatments as a process control guidance, literally used cookies as it's example lol  :doh:

 

Glad to hear it went well, definitely sounds like you were good to go and just had them swing by before you'd had enough time to polish everything.


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.

#7 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 12 April 2018 - 09:50 PM

Yeah, but the auditor, having not being in a cookie factory before, came away with the understanding that if the cookie is not "right" (high moisture), it is it's own control because we will not pack it.

I made the point that bun/rolls/cookies tell you when they are not right. If they do not meet certain quality specs, they will be discarded, thus controlling any hazard that may remain after baking.

One example of where the Inspector learned from industry.

 

Marshall



#8 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 12 April 2018 - 09:56 PM

And of course the process in your link is not what we do. It's a continual process from depositing on a band that runs through a 200 foot tunnel oven and then to cooling and packaging.

Every process step after the baking step I have listed as a hazard for salmonella, because the product is exposed to the environment. We have sanitation controls in place and and environmental monitoring program in place to ensure there is no salmonella around.

Marshall



#9 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 18,483 posts
  • 5170 thanks
1,161
Excellent

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

Posted 12 April 2018 - 11:17 PM

Yeah, but the auditor, having not being in a cookie factory before, came away with the understanding that if the cookie is not "right" (high moisture), it is it's own control because we will not pack it.

I made the point that bun/rolls/cookies tell you when they are not right. If they do not meet certain quality specs, they will be discarded, thus controlling any hazard that may remain after baking.

One example of where the Inspector learned from industry.

 

Marshall

 

Hi Marshall,

 

Could equally have learned it from the Baking CCP debates on this Forum. :smile:


Kind Regards,

 

Charles.C


#10 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 13 April 2018 - 12:25 AM

Charles,

 

Indeed. But to FFF's post, there is something to say about the FDA's guidance document re cookie baking. While the example they give in Section 6.13 of the document FFF links to, it assumes one product and one temperature and time.

We make several dozens of different types of cookies with various extrusion weights, various bake times and temperature and various finished product moisture.

 

To follow the FDA guidance, I would have to create a hundred or so Food Safety Plans with different parameters. Or, I could just create generic bake step parameters, which seem to defeat the goal of the Preventive Controls FDA want.

 

It's a Catch-22.

 

In the end, I will simply run an oven mole through each cookie oven and determine Log reduction and then put up chart recorders or probes that feed a database contained on a PC. Then have people duly write down oven temps on some schedule.

 

It's really a pointless exercise because if you are making a crunchy cookie, and the finished product after cooling is not crunchy, it goes in the bin. That's a bit of a simplification, but you get the point.

 

Marshall



#11 jaygil

jaygil

    Grade - Active

  • IFSQN Active
  • 9 posts
  • 3 thanks
0
Neutral

  • United States
    United States

Posted 18 April 2018 - 06:44 PM

The question of validating our kill step for baking white bread and rolls has had me stymied. As you say, if they don't reach an internal temperature of 200 degrees, they won't be " right" so will be discarded. I'm hoping all inspectors will understand this. We looked into having an outside company come in with an oven mole but it is very expensive! And we have 3 ovens and a large variety of sizes of products. Are bakeries contracting this out, or buying their own oven moles (also expensive!)?



#12 GrainGirl

GrainGirl

    Grade - Active

  • IFSQN Associate
  • 9 posts
  • 3 thanks
0
Neutral

  • Earth
    Earth

Posted 18 April 2018 - 07:49 PM

Many thanks for sharing your insights on your FDA FSMA audit, and congratulations for making it through unscathed. Sounds like you were really prepared. It is helpful to hear that FDA is in "education" mode.

 

You mention in your post, "He was impressed that I was ahead of the curve in doing vulnerability assessments of ingredients for intentional adulteration/economically motivated adulteration."

 

Would you mind sharing your approach and how you identified risks for intentional and economically motivated adulteration? This is an area that we haven't fully wrestled with yet and seems a bit amorphous.

 

 



#13 charles11011

charles11011

    Grade - Active

  • IFSQN Active
  • 7 posts
  • 0 thanks
0
Neutral

  • Nigeria
    Nigeria

Posted 20 April 2018 - 03:43 PM

Well said. Now how do i carry out a HACCP plan on our product. We Blend vitamins and minerals for food and beverages fortification. Its an area i've been wrangling with and i sincerely need help getting a solution. 



#14 FurFarmandFork

FurFarmandFork

    Food Safety Consultant, Production Supervisor

  • IFSQN Fellow
  • 1,264 posts
  • 584 thanks
187
Excellent

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

Posted 20 April 2018 - 04:12 PM

The question of validating our kill step for baking white bread and rolls has had me stymied. As you say, if they don't reach an internal temperature of 200 degrees, they won't be " right" so will be discarded. I'm hoping all inspectors will understand this. We looked into having an outside company come in with an oven mole but it is very expensive! And we have 3 ovens and a large variety of sizes of products. Are bakeries contracting this out, or buying their own oven moles (also expensive!)?

 

Do a validation study. It sounds a lot like you're trying to say "but if the hamburger is pink then it didn't reach temperature and we wouldn't serve it!" If you think that's true, then do a validation study to prove it. Demonstrate that at under 200º NONE of your loafs/rolls will appear to be cooked.

 

If I was a shrewed auditor, I would then say "so have any of your customers ever complainted that they received undercooked products?" If the answer is yes, than they identified a CCP failure and you should have recalled the product since it made it out the door without reaching temperature according to your theory!


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.

Thanked by 1 Member:

#15 scoot915

scoot915

    Grade - MIFSQN

  • IFSQN Member
  • 57 posts
  • 4 thanks
1
Neutral

  • United States
    United States

Posted 20 April 2018 - 07:12 PM

Interesting post.  I am also in Bakery and we had our first FDA FSMA inspection in February.

My experience was similar to yours in that it was not a swab a thon but a learning experience for FDA and us.

For what it is worth, the inspector said they usually do not swab unless they see a reason to do it while there or have had a report of a possible issue. Not sure if that is true and not expecting they wont swab next time, but that is what he said.

 

Our inspector explained he had not had the full training yet, so this would not be a "full" inspection. From your post I am assuming our inspector was a contractor.  

The inspection was somewhat odd, but all and all it went well.  No 483 and his findings were minor things.

 

He told me he was not allowed to look at my Hazard Analysis but would ask me questions about it. 

I found that odd but assumed that goes with not being a "full" inspection??

 

He also did not ask for scientific evidence for my process control of bake time and temperature.

I was thankful for that because I have not done a validation study myself yet, but did have documentation from AIB of their studies and was ready to explain that the product is not viable if not fully baked. 

 

Another thing I found odd was that he went after me on Mycotoxins. 

We are a small facility and do not do any testing. 

Our bulk flour comes with a COA but there is nothing on there related to Mycotoxins.

We have the companies 3rd party certification, HACCP plan and I also have a document from the flour company stating they test for Mycotoxins.

The inspector referred to this document as a "blurb" and told me to get more information.

He discussed the mycotxin "issue" in the final meeting but I am waiting for the final report to see exactly what he writes about this.

No clue what other information I am supposed to have.

 

My question to you is, other than in house testing, would you be willing to share what you do for Mycotoxins? Am I missing something?

Did FDA question this during your inspection?

 

Thank you



Thanked by 1 Member:

#16 Scampi

Scampi

    Fellow

  • IFSQN Fellow
  • 3,493 posts
  • 948 thanks
553
Excellent

  • Canada
    Canada
  • Gender:Not Telling

Posted 20 April 2018 - 07:21 PM

Here's an article from 2015 re: FDA and mycotoxins....

 

There are no Food and Drug Administration (FDA) regulations addressing mycotoxins in human foods. Nonetheless, a food that contains a mycotoxin will be adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) if it contains any “poisonous or deleterious substance which may render it injurious to health” or, in the case or naturally occurring substances, the substance is in a quantity that “ordinarily render[s] it injurious to health.” Food facilities may not ship or introduce into commerce any adulterated product.


Please stop referring to me as Sir/sirs


Thanked by 1 Member:

#17 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 07:43 PM

Do a validation study. It sounds a lot like you're trying to say "but if the hamburger is pink then it didn't reach temperature and we wouldn't serve it!" If you think that's true, then do a validation study to prove it. Demonstrate that at under 200º NONE of your loafs/rolls will appear to be cooked.

 

If I was a shrewed auditor, I would then say "so have any of your customers ever complainted that they received undercooked products?" If the answer is yes, than they identified a CCP failure and you should have recalled the product since it made it out the door without reaching temperature according to your theory!

 

Of course this also brings up the question of people that do "brown n serve" products. By nature they are "undercooked".

 

However, using a oven mole and the data plugged into the Kill Step Calculator, I'm thinking you would still get the necessary log reduction to kill off Salmonella.

 

Marshall



Thanked by 2 Members:

#18 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 07:46 PM

Interesting post.  I am also in Bakery and we had our first FDA FSMA inspection in February.

My experience was similar to yours in that it was not a swab a thon but a learning experience for FDA and us.

For what it is worth, the inspector said they usually do not swab unless they see a reason to do it while there or have had a report of a possible issue. Not sure if that is true and not expecting they wont swab next time, but that is what he said.

 

Our inspector explained he had not had the full training yet, so this would not be a "full" inspection. From your post I am assuming our inspector was a contractor.  

The inspection was somewhat odd, but all and all it went well.  No 483 and his findings were minor things.

 

He told me he was not allowed to look at my Hazard Analysis but would ask me questions about it. 

I found that odd but assumed that goes with not being a "full" inspection??

 

He also did not ask for scientific evidence for my process control of bake time and temperature.

I was thankful for that because I have not done a validation study myself yet, but did have documentation from AIB of their studies and was ready to explain that the product is not viable if not fully baked. 

 

Another thing I found odd was that he went after me on Mycotoxins. 

We are a small facility and do not do any testing. 

Our bulk flour comes with a COA but there is nothing on there related to Mycotoxins.

We have the companies 3rd party certification, HACCP plan and I also have a document from the flour company stating they test for Mycotoxins.

The inspector referred to this document as a "blurb" and told me to get more information.

He discussed the mycotxin "issue" in the final meeting but I am waiting for the final report to see exactly what he writes about this.

No clue what other information I am supposed to have.

 

My question to you is, other than in house testing, would you be willing to share what you do for Mycotoxins? Am I missing something?

Did FDA question this during your inspection?

 

Thank you

 

He mentioned mycotoxins, but did not beat me up on it. As Scampi mentioned there are no FDA regulations on mycotoxins, other than in the catch all clause.

 

I would think you have done your due diligence based on the documents you state you have.

 

We don't test for them, but have similar documentation to yours.

 

Marshall



#19 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 07:49 PM

The question of validating our kill step for baking white bread and rolls has had me stymied. As you say, if they don't reach an internal temperature of 200 degrees, they won't be " right" so will be discarded. I'm hoping all inspectors will understand this. We looked into having an outside company come in with an oven mole but it is very expensive! And we have 3 ovens and a large variety of sizes of products. Are bakeries contracting this out, or buying their own oven moles (also expensive!)?

 

You need to buy or rent a data logger that has multiple inputs. Download the appropriate Kill Step Calculator from the AIB web site, follow the instructions, and there ya go.

 

Marshall



#20 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 08:37 PM

Many thanks for sharing your insights on your FDA FSMA audit, and congratulations for making it through unscathed. Sounds like you were really prepared. It is helpful to hear that FDA is in "education" mode.

 

You mention in your post, "He was impressed that I was ahead of the curve in doing vulnerability assessments of ingredients for intentional adulteration/economically motivated adulteration."

 

Would you mind sharing your approach and how you identified risks for intentional and economically motivated adulteration? This is an area that we haven't fully wrestled with yet and seems a bit amorphous.

 

I do a Raw Material Vulnerability Assessment that asks some questions and assigns a point value based on the answer. The final point value indicates the level of risk for IA/EMA.

Point values are subjective, but should be meaningful and logical to come up with a realistic risk level. (That's the complicated part).

 

It takes a bit of tweaking, but if you run the model on an ingredient that has a well documented history of IA/EMA, you should come up with a result of at least a Medium, and probably High level of risk.

 

For example;

1. Ingredient Fraud History 

Yes (10)

Possible (5)

No (0)

 

2. Economic Factors

Likely to Occur (5)

May Occur (2)

Not Likely to Occur (0)

 

3. Geographic Origins

Foreign Supplier (3)

Domestic Supplier (0)

 

4. Complexity of Supply Chain

Complex (2)

Simple (0)

 

5. Ease of Access to Material

Ready Access - Materials are unprotected (5)

Minimal Access - Manufacturer may not have a robust Food Defense Program (3)

Unlikely Access - Nature of material or manufacturing. Manufacturer has a robust Food Defense Program (0)

 

6. Nature of the Material

Liquid/Powder - requires blending (1)

Natural/Bulk (0)

 

7. Cost of Materials

High (2)

Medium (1)

Low(0)

 

8. Supply Chain Confidence

Low (1)

High (0)

 

9. Supplier History

Bad (1)

Good(0)

 

10. Ingredient Testing Methods

None (3)

Occasional (1)

Robust (0)

 

11. Existing Controls

Weak (1)

Strong (0)

 

There are 34 possible points here. This is how I have my risk levels broken down:

Low 1-12

Medium 13-20

High 21-34

 

Let's look at how this would work for cinnamon. It has a fraud history (10), it is from a foreign supplier (3) so it's already Medium risk.

 

You can certainly make this as complicated as you wish, but the FDA guy was fine with my approach.

 

HTH,

Marshall



Thanked by 2 Members:

#21 scoot915

scoot915

    Grade - MIFSQN

  • IFSQN Member
  • 57 posts
  • 4 thanks
1
Neutral

  • United States
    United States

Posted 20 April 2018 - 09:04 PM

He mentioned mycotoxins, but did not beat me up on it. As Scampi mentioned there are no FDA regulations on mycotoxins, other than in the catch all clause.

 

I would think you have done your due diligence based on the documents you state you have.

 

We don't test for them, but have similar documentation to yours.

 

Marshall

Thank you.  I felt I did my due diligence it is good to know someone else agrees.  I am still wondering why he chose to beat me up on this. It was getting so ridiculous that when he referred to my document as a blurb it was hard to not laugh. ;)



Thanked by 1 Member:

#22 scoot915

scoot915

    Grade - MIFSQN

  • IFSQN Member
  • 57 posts
  • 4 thanks
1
Neutral

  • United States
    United States

Posted 20 April 2018 - 09:06 PM



Here's an article from 2015 re: FDA and mycotoxins....

 

There are no Food and Drug Administration (FDA) regulations addressing mycotoxins in human foods. Nonetheless, a food that contains a mycotoxin will be adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) if it contains any “poisonous or deleterious substance which may render it injurious to health” or, in the case or naturally occurring substances, the substance is in a quantity that “ordinarily render[s] it injurious to health.” Food facilities may not ship or introduce into commerce any adulterated product.

Thank you!



#23 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 09:36 PM

Thank you.  I felt I did my due diligence it is good to know someone else agrees.  I am still wondering why he chose to beat me up on this. It was getting so ridiculous that when he referred to my document as a blurb it was hard to not laugh. ;)

This is going to be a bone of contention as this moves on, I think.
PC plans and the HA's therein are supposed to be based on "absence of controls". I get that, but if you have documentation that states the supplier tests for mycotoxins, that should be sufficient.

But it may not be. Perhaps the supplier will have to test each lot and include that on the COA.

 

At some point, that becomes a ridiculous burden on industry.

 

Marshall



#24 jaygil

jaygil

    Grade - Active

  • IFSQN Active
  • 9 posts
  • 3 thanks
0
Neutral

  • United States
    United States

Posted 20 April 2018 - 09:40 PM

Do a validation study. It sounds a lot like you're trying to say "but if the hamburger is pink then it didn't reach temperature and we wouldn't serve it!" If you think that's true, then do a validation study to prove it. Demonstrate that at under 200º NONE of your loafs/rolls will appear to be cooked.

 

If I was a shrewed auditor, I would then say "so have any of your customers ever complainted that they received undercooked products?" If the answer is yes, than they identified a CCP failure and you should have recalled the product since it made it out the door without reaching temperature according to your theory!

Why didn't I think of this? I'm sure that we can validate this way - we've been baking bread for over 30 years and I have yet to see a loaf come out of the oven below 195 unless it was collapsed due to under-baking.

 

Thank you!



#25 mgourley

mgourley

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,263 posts
  • 938 thanks
206
Excellent

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

Posted 20 April 2018 - 09:46 PM

Why didn't I think of this? I'm sure that we can validate this way - we've been baking bread for over 30 years and I have yet to see a loaf come out of the oven below 195 unless it was collapsed due to under-baking.

 

Thank you!

 

Just to play Devil's Advocate here....FDA wants "scientific". The fact that a loaf of under baked bread will not have the cell structure to support a "viable" finished product (quality issue) does not mean that stupid line personnel might still package it and ship it  :shades:

 

Marshall






0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users