How Do I Develop a Foreign Supplier Verification Program?
If you import products for consumption into the US, you likely are required to develop a foreign supplier verification program (FSVP).
Below is a step by step guide to developing and implementing an FSVP.
1. Determine your Qualified Individual
First, The FSVP must be prepared by a "qualified individual" who has the education, training or experience necessary to perform the activity. If this person is a 3rd party or consultant, that's fine. However, note that supplier verification is an ongoing process and it must always be completed by a qualified individual. For most companies, the easiest solution is to have someone on staff undergo a 2 day training course on developing a Foreign Supplier Verification Program.
Source 21 CFR 1.503
2. Decide How Your Program Works
Before you begin approving suppliers, you must establish the procedures you will use to approve suppliers. The goal is to provide assurance that hazards in the food you import are being prevented.
You can rely on a 3rd party to conduct your supplier verification if you review and assess the documentation yourself and document your review and assessment of the materials.
Examples of appropriate verification activities:
Onsite audit by a qualified individual
Sampling & testing
Review of foreign suppliers food safety records
Other appropriate supplier verification activities
3. Conduct Your Verification Activities
This step is the bulk of the process: collecting information from your suppliers, reviewing it, and documenting your review process.
You may rely on a 3rd party to conduct supplier verification activities (i.e. a 3rd party audit) if you assess their documentation with appropriate frequency. You must document your review and assessment of the activities and document that the activities were performed by a qualified individual.
The following are common verification methods for approving suppliers:
You are required to review a hazard analysis for each type of food you import. Hopefully, each of your foreign suppliers has completed one and can provide this to you. If not, then you must conduct a hazard analysis to determine whether there are any hazards requiring a control. This hazard analysis must be written and contain an evaluation of environmental hazards.
Some key points about the hazard analysis:
You must either conduct a hazard analysis for each type of food you import OR use a supplier hazard analysis.
If you are importing Raw Agricultural Commodities (RACs) then no biological hazards need be considered in the Hazard analysis.
If you are reviewing a hazard analysis supplied by the supplier or a 3rd party, then you must document your review of the hazard analysis and confirm that it was conducted by a qualified individual.
If no hazards are identified which require a preventive control, then no verification is required for those products. Still you must have a hazard analysis on file to show that this has been determined. This provision does not apply to produce.
Certain importers may wish to independently conduct onsite audits of the foreign supplier. Or, they may simply review the audit results conducted by a reputable 3rd party auditor.
An audit is required as part of the supplier verification process when there is "reasonable probability that exposure to the hazard will result in serious adverse health consequences or death" you must conduct or obtain documentation of an onsite audit at least annually. (1.506 (d) (ii) (2)
In this case, an audit may be replaced by written inspection results by the FDA, USDA, or a food safety authority of a country whose food safety system is equivalent to that of the US.
Sampling & Testing of Food
If you choose to use product testing and sampling as part of your verification, you must retain documentation of the following:
The number and type of samples tested
identification of the food tested (lot numbers)
tests conducted and the methods of the testing
Any corrective action taken into detection of hazards
Information identifying the lab
Documentation that the tests were performed by a qualified individual.
Review of Foreign Supplier's Food Safety Records
The most common method of supplier verification is the review of a foreign supplier's food safety records.
If you choose to use your foreign supplier's food safety records as part of your verification, you must retain the following information:
The records reviewed
Dates of review
General nature of the records reviewed
Conclusions of review
Any corrective actions taken in response to significant deficiencies identified.
Documentation that the review was conducted by a qualified individual.
You may not allow on the foreign supplier to conduct supplier verification activities for their own business.
Hazards Not Controlled by the Foreign Supplier
Does a 3rd party control one of the hazards on behalf of your supplier (i.e. your overseas milk supplier has their pasteurization completed offsite by another company.) If so, you must collect this verification data from the 3rd party or have your supplier send it to you.
Supplier Performance & History
It is perfectly acceptable to take into consideration your supplier's history, procedures, practices, storage, transportation, etc as part of your verification activities.
Document Your Verification Activities
Remember, it's not enough to simply collect these documents from your foreign suppliers -- you have to assess them and document that assessment.
For example, let's say I'm an importer of Ned's Italian Tomato Sauce and they send me their most recent audit result. Beyond having that audit result on file, I need to record that I reviewed that audit, that it showed me they controlling the hazards in their process, and that my review occurred on such-and-such date.
The Whole Picture
For fear of stating the obvious, you must approve your foreign suppliers on the basis of your evaluation. In other words, you must consider all the information you gather in your approval process and cannot discount any piece of information simply because it is contrary to the result that you're looking for.
This doesn't mean that one failed audit in your supplier's history means you cannot approve them. However, you must acknowledge this information if it is revealed in your verification activities or outside of them.
4. Approve your Suppliers and Maintain the Program
Once you have completed your verification activities, you may add the relevant supplier's to your approved supplier list and begin sourcing product from them. At that point, the program should require only occasional ongoing maintenance
Keeping Records of Your Foreign Supplier Verification Program (FSVP)
Your records should comply with the following provisions:
They must be originals, photocopies or digital records
You must keep them for 2 years unless otherwise specified
They must be available for review by the FDA
You do not need to have a specific copy of each record for the FDA (e.g. you can have one copy of a record to satisfy both a state requirement and a federal requirement)
There are several exemptions to Foreign Supplier Verification Requirements. This section applies to:
Taking Corrective Actions
You must take corrective actions if you determine that the food you are receiving is not meeting the requirements of the FDA regulations. Simply put, if the food you receive could cause harm to a consumer or is unsafe, then you must take some type of corrective action. This determination could be based on customer complaints or verification activities that you conduct (i.e. records review or viewing an inspection result.)
The appropriate corrective action to take could include discontinuing your use of that supplier until the hazards have been addressed.
If this determination occurs outside of the scope of your supplier verification activities, then it may reveal that your verification activities are not comprehensive. Simply put -- you didn't catch the mistake in your normal supplier verification practices therefore something is inherently wrong with your process. In this case you are obligated to update your plan so that you are able to adequately verify your suppliers.
You must re-evaluate your foreign suppliers (and document it),
Every 3 years, at minimum
When you learn anything new or when anything has changed that would warrant a re-evaluation.
You may use a 3rd party foreign supplier review as your re-evaluation, insofar as you document your assessment of that evaluation. The evaluation must be performed by a qualified individual.
This article applies to you if…
∆ You are a food importer
∆ The products you import are regulated by the FDA
∆ You do not qualify for a small-food-importer exemption (<$10mm/yr imported)
∆ You need to build a foreign supplier verification plan