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#1 Folsom2008

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Posted 04 April 2019 - 02:35 PM

Hello,

I am prepping for our next audit, and have a question regarding Supply Chain PC's.  We are a 3PL facility with many customers, some of which are food grade.  We were dinged on our last audit for our Food Safety Plan (HACCP) not having any PC's for supply chain.  Our company is an ambient storage facility, and we are box in box out.  We do not manufacture or package anything, so I am having a difficult time trying to figure out what, if any, our supply chain PC's would be.  Our customers order their own product from suppliers, we just store it.  So we do not have any "Approved Suppliers" per say, I would think that responsibility would fall on our customer to require documentation from approved suppliers?

 

Can anybody think of any supply chain PC's that a facility such as ours would have?  Thank you!!



#2 Scampi

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Posted 04 April 2019 - 02:57 PM

who dinged you????  regulatory or GFSI


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#3 Folsom2008

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Posted 04 April 2019 - 03:29 PM

One of our food grade customers actually sends in a 3rd party auditing company to audit our GMP's.



#4 Scampi

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Posted 04 April 2019 - 03:48 PM

GMP's are not the same as following FSMA which is an entire food safety program or system..............

 

I did find the following which looks like as a receiving facility, you are only required to obtain attestation from the vendor that THEY have PC in place .......I've also attached the link for your viewing pleasure

 

2. If my facility supplies raw materials or other ingredients to a manufacturer/processor covered by the human food preventive controls requirements, and my facility is responsible for controlling the potential hazards, what information should I provide to the receiving facility regarding my status as a qualified facility, or any change in status from qualified to “not a qualified facility”? In some circumstances, when a facility supplies a raw material or other ingredient to a manufacturer/processor that is covered by the human food preventive controls requirements, it is considered a “supplier” (see definition of “supplier” in 21 CFR 117.3). The manufacturer/processor is considered a “receiving facility.” A receiving facility must establish and implement a supply-chain program for raw materials and other ingredients when a hazard identified by the receiving facility is controlled by a supplier. (See 21 CFR 117.405(a)(1)). The receiving facility may rely on certain written assurances from a supplier that is a qualified Contains Nonbinding Recommendations 11 facility (see 21 CFR 117.430©) rather than rely on other verification methods, like an onsite audit. If you are a supplier to a receiving facility, the receiving facility must obtain written assurance from you that you are a qualified facility before first approving you as a supplier for an applicable calendar year, and on an annual basis thereafter, by December 31 of each calendar year, for the following calendar year (see 21 CFR 117.430©(1)). The receiving facility must also obtain other written assurance from you every two years that you are producing the raw material or ingredient in compliance with applicable FDA food safety regulations (or, when applicable, the food safety regulations of a country whose food safety system FDA has recognized as comparable or equivalent). This written assurance must include either: 1. a brief description of the preventive controls you are implementing to control the applicable hazards in the food; or 2. a statement that you are in compliance with State, local, county, tribal, or other applicable non-Federal food safety law. (See 21 CFR 117.430©(2)). If a receiving facility will rely on your written assurance that you are a qualified facility, you would provide the receiving facility with written assurance of your status as a qualified facility before the receiving facility approves you as a supplier, and on an annual basis thereafter. Because the human food preventive controls requirements require the receiving facility to obtain the written assurance by December 31 of each calendar year, a receiving facility has flexibility to work with you to determine the specific date within a calendar year for annual notification to the receiving facility. As a matter of a business agreement with the receiving facility, it is possible that you would provide the written assurance earlier than December 31 of each calendar year.

 

2. If my facility supplies raw materials or other ingredients to a manufacturer/processor covered by the human food preventive controls requirements, and my facility is responsible for controlling the potential hazards, what information should I provide to the receiving facility regarding my status as a qualified facility, or any change in status from qualified to “not a qualified facility”? In some circumstances, when a facility supplies a raw material or other ingredient to a manufacturer/processor that is covered by the human food preventive controls requirements, it is considered a “supplier” (see definition of “supplier” in 21 CFR 117.3). The manufacturer/processor is considered a “receiving facility.” A receiving facility must establish and implement a supply-chain program for raw materials and other ingredients when a hazard identified by the receiving facility is controlled by a supplier. (See 21 CFR 117.405(a)(1)). The receiving facility may rely on certain written assurances from a supplier that is a qualified Contains Nonbinding Recommendations 11 facility (see 21 CFR 117.430©) rather than rely on other verification methods, like an onsite audit. If you are a supplier to a receiving facility, the receiving facility must obtain written assurance from you that you are a qualified facility before first approving you as a supplier for an applicable calendar year, and on an annual basis thereafter, by December 31 of each calendar year, for the following calendar year (see 21 CFR 117.430©(1)). The receiving facility must also obtain other written assurance from you every two years that you are producing the raw material or ingredient in compliance with applicable FDA food safety regulations (or, when applicable, the food safety regulations of a country whose food safety system FDA has recognized as comparable or equivalent). This written assurance must include either: 1. a brief description of the preventive controls you are implementing to control the applicable hazards in the food; or 2. a statement that you are in compliance with State, local, county, tribal, or other applicable non-Federal food safety law. (See 21 CFR 117.430©(2)). If a receiving facility will rely on your written assurance that you are a qualified facility, you would provide the receiving facility with written assurance of your status as a qualified facility before the receiving facility approves you as a supplier, and on an annual basis thereafter. Because the human food preventive controls requirements require the receiving facility to obtain the written assurance by December 31 of each calendar year, a receiving facility has flexibility to work with you to determine the specific date within a calendar year for annual notification to the receiving facility. As a matter of a business agreement with the receiving facility, it is possible that you would provide the written assurance earlier than December 31 of each calendar year.


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#5 Folsom2008

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Posted 04 April 2019 - 06:14 PM

Thank you!



#6 Charles.C

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Posted 04 April 2019 - 07:42 PM

Hi Scampi,

 

Link for Post 4 ?


Kind Regards,

 

Charles.C


#7 Scampi

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Posted 04 April 2019 - 07:48 PM

https://www.fda.gov/...n/UCM499509.pdf


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