How to verify suppliers are in compliance with FSMA
We just had a Silliker Food Safety System & GMP Audit and one of our corrective actions are that we don't have documentation that our brokers are accountable for bringing materials only from suppliers who are in compliance with FDA FSMA. How do we document this? For our suppliers that sell product from other countries do we have to have documentation that the US Company and Foreign supplier are register with the FDA?
Any help would be appreciated.
Thank You
We asked, at my previous company, on our supplier questionnaire if the supplier was registered with the FDA and what their registration number was. Most companies said they were registered but would not give the registration number.
As for the FSMA part... I'm not sure what you can do. You can just ask them if they comply with all applicable provisions of FSMA and if they say yes trust them... It can be part of your supplier risk analysis.
We do ask if they are registered with the FDA already. Do we have to have a separate statement saying they comply with FSMA?
If you need it then I would... it's just one line item on a questionnaire. We haven't run into this yet but that's how I would suggest going about it without trying to make a whole new system to find out.
I would suggest that you ask for a copy of their 3rd party audit.
We do ask for copies of their 3rd party audit and I have reviewed them but, they do not state anywhere in there that they are in compliance with the FSMA.
Right, but more and more places are adhering to GFSI standards I saw this a website "encourgaing facilities to get certified to one of the several Global Food Safety Initiative (GFSI) scheme options, so you are ready when FSMA’s final rules are published. While there is no question that GFSI certification will help to drive food safety initiatives and processes toward FSMA compliance, it is important to understand that there are differences between GFSI and FSMA".
Being GFSI certified does not mean that there are not differences, but it does move you more towards FSMA Requirements
We asked, at my previous company, on our supplier questionnaire if the supplier was registered with the FDA and what their registration number was. Most companies said they were registered but would not give the registration number.
OMG, don't give out your registration number! That's like your company's social security number! You can ship drugs & guns & other fun stuff with a stolen # and when the feds crack down they'll look at the company.
You still got that list? I know some people at the boarder....
I have received two separate supplier FSMA "compliance" questionnaires, from a couple of customers so far. One had the following questions (total of 8),
1. Are you subject to the FSMA Preventative Controls for Human food rule?
2. Are you currently compliant with all requiremenhts of the FSMA Preventive Controls for Human Food rule?
3. If not, will you have a fully develope dand validated FSMA (HARPC) Food Safety Plan in place by the compliance date of 8/2016?
4. Do you have a trained Preventative Controls Qualified Individual to oversee the development implementation and continual improvement of a FSMA (HARPC) Food Safety Plan?
5. Are there barriers to becoming compliant despite the requirement to do so?
6. Is your business a Small Business by FDA standards (fewer than 500 full time employees) and therefore implementation is 8/2017?
7. Is your business a Very Small Business by FDA standards (<$1 million adjusted for inflation) and therefore implementation is 8/2018?
8. Is your business covered by the PMO (Pasteurized Milk Ordinance) and therefore implementation is 8/2018?
Name: Title: Date:
Hope this helps,