16 replies to this topic

[YNA QA]

We are looking into purchasing an ingredient from a new supplier, one that we ordered from a previous supplier for years.  The processing aid apparently has a Biological Hazard (Salmonella) that they do not have a Preventative Control in place for.  So now they are requiring us to sign not only a release to purchase it, but they want us to tell them OUR Preventative Control in place before they will allow us to purchase this item. The actually rejected our initial answer as not being strong enough.  

 

Is this common in the industry and I just haven't encountered it, or is this some new way for companies to avoid putting proper controls in place, and try to pass the responsibility onto us? Ultimately it is my responsibility and I do have controls in place for this, but I'm just shocked that until I divulge some portions of my HACCP plan to a supplier that they will not sell me something.

 

Anyone else encountering this?

[MDaleDDF]

Absolutely no way I'd deal with this company.

[olenazh]

No, that's vise versa: your supplier must prove that their FSMS is compliant to regulatory, GFSI and customer requirements. 

[Duncan]

I've never encountered anything like that! To be honest, I'm quite impressed with the level of diligence that your supplier is demonstrating, but I'd say it's highly unconventional. 

[Charles.C]

We are looking into purchasing an ingredient from a new supplier, one that we ordered from a previous supplier for years.  The processing aid apparently has a Biological Hazard (Salmonella) that they do not have a Preventative Control in place for.  So now they are requiring us to sign not only a release to purchase it, but they want us to tell them OUR Preventative Control in place before they will allow us to purchase this item. The actually rejected our initial answer as not being strong enough.  

 

Is this common in the industry and I just haven't encountered it, or is this some new way for companies to avoid putting proper controls in place, and try to pass the responsibility onto us? Ultimately it is my responsibility and I do have controls in place for this, but I'm just shocked that until I divulge some portions of my HACCP plan to a supplier that they will not sell me something.

 

Anyone else encountering this?

HI YNA,

 

Yr query is Generic whereas I anticipate that the specifics might be relevant in some actual situations (eg Leverages?).

 

IMO, the, IMEX, unusually protective actions described, are logically related to the existence of  (a) an agreed Specification  and (b) Your Supplier Approval.

 

I suggest you could have simply asked this potential supplier to justify the reasons for their, IYO, unusual requirements. If unsatisfactory to you, exclude them from (b).

 

Generally, I speculate that this event may indirectly relate to the FDA's monolithic determination to impose FSMA's  concepts internally/externally on the Food Industry.?

[Ryan M.]

That's funny...I guess they are adverse to any type of liability.  Usually, suppliers will provide a disclaimer in their documentation to you about not having a process control for X.   If they make you sign something on this, fine, but wanting to know your hazard analysis and process?  Just say, no thanks.

 

Ahhhh...the unintended consequences of HARPC.

[kingstudruler1]

No, that's vise versa: your supplier must prove that their FSMS is compliant to regulatory, GFSI and customer requirements. 

 

In the USA, under FSMA, you must address all hazards.   It is "legal" to have a customer control a hazard.   Originally they were going to require written assurances, like what this supplier is doing.   However, they all but dropped that requirement -  as I recall.   

[kingstudruler1]

I wonder what the actual risk of salmonella is.    Is the original supplier addressing the risk (if there is risk) or just ignoring?    

 

Below is the legaleese of what the new supplier is trying to accomplish, for those unfamiliar with the law.      

https://www.accessda....cfm?fr=117.136

[rajeev1965]

internal audit with nc raised

[YNA QA]

HI YNA,

 

Yr query is Generic whereas I anticipate that the specifics might be relevant in some actual situations (eg Leverages?).

 

IMO, the, IMEX, unusually protective actions described, are logically related to the existence of  (a) an agreed Specification  and (b) Your Supplier Approval.

 

I suggest you could have simply asked this potential supplier to justify the reasons for their, IYO, unusual requirements. If unsatisfactory to you, exclude them from (b).

 

Generally, I speculate that this event may indirectly relate to the FDA's monolithic determination to impose FSMA's  concepts internally/externally on the Food Industry.?

 

They explained that it was due to recent recalls, and while not directly involved, they could be liable in a similar manner.  We've purchased from them for some time, and this ingredient in particular we've only purchased from them.  In the end they deemed our PC not strong enough and refused to sell this to us.  

 

We'll see what alternate suppliers say, but this is an unusual processing aid, so we may be in bind.

[Charles.C]

They explained that it was due to recent recalls, and while not directly involved, they could be liable in a similar manner.  We've purchased from them for some time, and this ingredient in particular we've only purchased from them.  In the end they deemed our PC not strong enough and refused to sell this to us.  

 

We'll see what alternate suppliers say, but this is an unusual processing aid, so we may be in bind.

Hi YNA QA,

 

Indeed, Back-Covering + Leverage often = Bind.

 

Just pass the buck upwards.

[Scampi]

I'm curious to know what processing aid could be carrying salmonella

 

Me thinks I smell a rat

[Bo16]

The FDA has issued Salmonella as a hazard for some products.  Even though we may not agree with their analysis, we have to live with it.  Microbial Filtration and and GMPs remove the hazard, but no "terminal Kill step" is applied to the product, and it is not manufactured according tp "ready to eat" standards.   I am sure there are other product types in the FDA's https://www.fda.gov/...9581/download  Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food - Appendix 1

[Ryan M.]

The FDA has issued Salmonella as a hazard for some products.  Even though we may not agree with their analysis, we have to live with it.  Microbial Filtration and and GMPs remove the hazard, but no "terminal Kill step" is applied to the product, and it is not manufactured according tp "ready to eat" standards.   I am sure there are other product types in the FDA's https://www.fda.gov/...9581/download  Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food - Appendix 1

 

Looks like they moved the site / link.

 

https://www.fda.gov/...rols-human-food

[Jason513]

I know this is older, but the reason your supplier is doing this is because the intent of FSMA is to show all hazards are controlled prior to the product entering general commerce. 

 

We manufacture a specialized blend at the facility i work at, we actually require the kill step from our customer as part of our food safety program to show that salmonella is controlled, since one of the raw materials has that as a hazard that is not controlled by the supplier, nor us....so it has to be controlled prior to entering commerce at a validated kill step. 

 

It is over kill currently, but it is absolutely the intention of FSMA and likely will be a requirement for FDA audits in the coming years. 

[kingstudruler1]

I know this is older, but the reason your supplier is doing this is because the intent of FSMA is to show all hazards are controlled prior to the product entering general commerce. 

 

We manufacture a specialized blend at the facility i work at, we actually require the kill step from our customer as part of our food safety program to show that salmonella is controlled, since one of the raw materials has that as a hazard that is not controlled by the supplier, nor us....so it has to be controlled prior to entering commerce at a validated kill step. 

 

It is over kill currently, but it is absolutely the intention of FSMA and likely will be a requirement for FDA audits in the coming years. 

 

Yes, the written assurances that the customer is controlling the hazard was built into FSMA.   Those are rules are still in place.  The last I heard, the FDA stated that they are using "enforcement discretion" with written assurances.   Some auditing standards require them to be in place.   

Edited by kingstudruler1, 28 August 2023 - 05:09 PM.

[PQAManager]

If you are going to continue to deal with them the liability is on your company and you will probably be the one signing off on the PCs (you're taking all the responsibility).  Risk analysis need to be done at every stage of the process (HACCP/HARPC-Food Safety Plans.)  Do you have a kill step to introduce a CCP?  You will need to add Salmonella to your Environmental monitoring.  You will have to have your cross-contamination, sanitation, and CCP training done.  I would include your hand washing procedures, GMPs, and your flow chart for your (HACCP/HARPC-Food Safety Plans.)  You always need at least 2 suppliers for each ingredient.  Even backups are good to have in emergency cases.  I would keep looking.