5 replies to this topic

[kss151]

Hello - My company imports some simple polyols and alternative sweeteners and I am responsible for FSVP. I have now gone through two separate FDA inspections for my FSVP programs and passed both with no issues, but something is bugging me when going back and reviewing the rule, that I might be missing:

 

When the rule says that you must review the supplier's relevant food safety records, what exactly is it talking about there? I believe I was told one time that it is not referring to things such as processing records (if applicable), metal detection sign off forms, etc, but is rather talking about statements and records saying they have these programs in place (which are backed up by their GFSI audit reports)? Personally, I dont see much merit in reviewing sign off forms and actual processing records that are just going to be in a language that I cant read, so I was havent pursued them.

 

Let me know your thoughts. Thank you!

Edited by kss151, 08 February 2019 - 08:31 PM.

[SQFconsultant]

Have you been to your suppliers to audit them or had audits done on your behalf of your foreign suppliers?

[kss151]

It's been a topic of discussion, but at this time no. A few reasons for that, 1. we are a distributor that is not using these products, 2. We have deemed these products to be low risk, 3. Because we are a distributor, the added cost of hiring a second party auditor to go there could essentially negate the profits we could make by sourcing these products overseas, so it's been tough to get upper management to fully buy in to that. So since we only import through GFSI audited suppliers (that I do verify on each database), we did not deem on site audits to be necessary for a verification activity. 

[Charles.C]

Will FSMA not accept local 3rd Party audits ?

[kss151]

They did accept the GFSI audit as part of the verification and accepted our rationale for not getting an independent auditor, and in the inspection, to my memory, they didnt say anything about getting the actual processing or sanitation records (etc) and that the statements were fine. But we all know how it is, maybe one inspector thinks one way of it than the two I got. Was wondering if any of you keep actual records like that in your plans.

Edited by kss151, 08 February 2019 - 09:43 PM.

[Charles.C]

Hello - My company imports some simple polyols and alternative sweeteners and I am responsible for FSVP. I have now gone through two separate FDA inspections for my FSVP programs and passed both with no issues, but something is bugging me when going back and reviewing the rule, that I might be missing:

 

When the rule says that you must review the supplier's relevant food safety records, what exactly is it talking about there? I believe I was told one time that it is not referring to things such as processing records (if applicable), metal detection sign off forms, etc, but is rather talking about statements and records saying they have these programs in place (which are backed up by their GFSI audit reports)? Personally, I dont see much merit in reviewing sign off forms and actual processing records that are just going to be in a language that I cant read, so I was havent pursued them.

 

Let me know your thoughts. Thank you!

 

What Records Should be Kept?

Any record requested by the FDA must be available within 24 hours and could go two years back. If you don’t have an automated system, it’s likely time to consider one, as it’s really the only way to manage the range of documents required by FSMA across your supplier base. Here are the nine records that should make up your FSVP below.

1. Hazard Analysis
2. Foreign supplier Approved list
3. Foreign supplier performance evaluation
4. Foreign supplier approval procedures
5. Procedures assuring only approved foreign suppliers are used
6. Verification activities & their frequency used to determine approved foreign suppliers
7. Performance of verification activities
8. Identified corrective actions needed
9. Re-evaluation of FSVP by cause, or at least every 3 years

 

 

 FSVP(1).pdf   319.16KB   96 downloads

 fsvp(2).pdf   1012.63KB   83 downloads

 

Also see -

 

https://www.fda.gov/...A/ucm361902.htm