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Is an Approved Supplier Program a Supply-Chain Control?

FSMA HARPC Suppliers Approved Supplier Program Supply-Chain Control

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#1 jfox1

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Posted 11 December 2018 - 08:26 PM

I am working in an Animal Feed manufacturer as the Food Safety Manager. As I am building our Food Safety Plan I am feeling like a major way we can control our hazards in some instances is with an approved supplier program. At my old place of employment we used our Approved Supplier Program as a Supply-Chain Control under the FSMA regulation. However as I read it I do not think it meets the requirements of the Supply Chain Control under Sub part E. With all of the verification activities and record requirements I do not think it would be using the Approved Supplier Program in the right way...

 

Anyone have any advice on this? 



#2 MsMars

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Posted 11 December 2018 - 09:11 PM

Hi jfox1 - animal feed QM here also, previously in human food.  This requirement is the same with human and animal foods. To employ a Supply Chain Control, along with all of your Approved Supplier Program requirements you must verify that the supplier is mitigating the hazard that you've identified.  For instance, if you've identified metal as a foreign material hazard, you must obtain verification from the supplier that they have a foreign material control program, or particularly a metal detector. Make sense?



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#3 mgourley

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Posted 12 December 2018 - 12:30 AM

In other words, just having an Approved Supplier Program is not a "preventive control". As MsMars, says, you would have to specify, and provide evidence, what you are expecting your supplier to control.

As an example, FDA will not accept your requirement to have your supplier supply a COA if you have identified hazards in the material(s) you receive from them.

 

Marshall



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#4 Charles.C

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Posted 12 December 2018 - 08:03 AM

In other words, just having an Approved Supplier Program is not a "preventive control". As MsMars, says, you would have to specify, and provide evidence, what you are expecting your supplier to control.

As an example, FDA will not accept your requirement to have your supplier supply a COA if you have identified hazards in the material(s) you receive from them.

 

Marshall

 

Hi Marshall,

 

Maybe I misunderstand but the above seems illogical to me ?

 

For example, if the receiver has identified Salmonella as a potential hazard in the relevant material and the supplier produces a COA for a specific incoming Lot (assuming an acceptable samplng plan) showing Nil detection for all samples taken, is this not an acceptable Preventive Control ?


Kind Regards,

 

Charles.C


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#5 jfox1

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Posted 12 December 2018 - 01:29 PM

I think the way I was understanding it was somewhere in the middle. The way I understand the Supply-Chain PC is that it can be something like a COA can be a control but it must be from an approved supplier and it as well as the supplier must be verified through audits, testing, review of docs etc...

 

However after reviewing my notes it looks like it may be a moot point anyway because you must have an approved supplier program and in reality it is difficult if not impossible in our industry to determine who your actual suppliers are due to commingling at the elevators...

 

Thanks for all the advice! 



#6 MsMars

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Posted 12 December 2018 - 02:50 PM

I think the way I was understanding it was somewhere in the middle. The way I understand the Supply-Chain PC is that it can be something like a COA can be a control but it must be from an approved supplier and it as well as the supplier must be verified through audits, testing, review of docs etc...

 

However after reviewing my notes it looks like it may be a moot point anyway because you must have an approved supplier program and in reality it is difficult if not impossible in our industry to determine who your actual suppliers are due to commingling at the elevators...

 

Thanks for all the advice! 

 

You are on the right track. In my experience, Approved Supplier programs may or may not require COA's, etc. based upon risk level of the product.  However if you determine the supplier's product requires a preventive control, then some type of proof that the hazard is being mitigated by the supplier is required.  Theoretically this should be addressed in an Approved Supplier program anyway, but I've seen companies "risk-assess away" a COA requirement or testing verification based upon supplier history, etc. just so they wouldn't have to pay for extra testing or risk losing a low-cost supplier. That simply isn't going to fly under FSMA now.  

 

And yes, the elevator storage issue has been forefront in my mind... I'm not sure that there is a good solution for this yet other than good recordkeeping. 


Edited by MsMars, 12 December 2018 - 02:53 PM.


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