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Which FSMA certification scheme to choose?

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As FSMA certification grows in popularity, one of the first steps for facilities applying for FSMA certification is to choose between the two FSMA schemes.

In general, choosing the right certification for any scheme can be a difficult decision. But the selection process may become even more interesting with new schemes, especially if they address certification from a regulatory perspective rather than conformance with standards. Therefore, providing the right advice is key to helping clients make their selection between the FSMA VQIP or FSMA FSVP schemes.

FSMA VQIP Certification

The creation of FSMA VQIP certification scheme was triggered by the FSMA Accredited Third Party Certification (TPP) rule that for the first time ever, provided a roadmap for certification bodies like SGS to get accredited and start offering regulatory food safety certification to foreign facilities supplying food for consumption in the US.

The FSMA TPP rule though provides two specific mandates for VQIP certification:

  1. As a prerequisite for importers participating in the Voluntary Qualified Importer Program (expedited entry program)
  2. As a compliance tool in the FDA toolkit, whereby FDA may request facility certification as a prerequisite for admissibility of certain foods that may be considered high-risk

Because VQIP certification falls under FSMA TPP rule and is under the FDA’s direct supervision, there are specific requirements that certification must adhere to. For instance, audits must be unannounced, the same auditor cannot conduct regulatory audits at the same facility for a period of 13 months, regulatory audit reports must be shared with FDA, etc.

Therefore, FSMA VQIP certification is a regulatory tool recognized by FDA, but may be a bit of a stretch for foreign facilities that are just looking for proof of compliance outside the regulatory framework of the accredited third party certification rule. That’s where FSMA FSVP certification may be a more appealing option for such foreign suppliers.

FSMA FSVP Certification

FSMA FSVP certification carries the same weight as FSMA VQIP as a compliance scheme. However, FSMA FSVP is developed as a third-party voluntary scheme, for foreign suppliers who are simply looking for a compliance certificate.

FSVP certification is like any other voluntary certification scheme. It is done in two stages, audits are announced, and the requirements of TPP rule do not apply to it.

To help our clients decide which certification scheme to choose, we developed the following decision tree:

Decision tree

 

  1. If certification is required by the FDA, then supplier will have to follow the TPP path, which is FSMA VQIP certification
  2. If certification is required by the importer, then the next question to ask is if the importer needs it for the expedited entry program under (VQIP) or not
  3. If certification is requested for the expedited entry program, then VQIP certification would be the right scheme to choose, as it falls under the TPP rule

In the absence of requests from the FDA or importer, suppliers can still voluntarily choose to be certified either for VQIP or FSVP scheme. In that case, it will be up to the foreign supplier to decide whether to apply for FSMA VQIP certification under FDA or the FSMA FSVP certification for supplier verification.

Integrated Certification with GFSI schemes

Clients across the world have been inquiring about the possibility of combining FSMA certification with their GFSI audit. While GFSI schemes have come up with addendum modules for the PC Human Food rule, they make it clear however, that such modules are not for FSMA compliance purposes. Therefore, FSMA certification remains the only proof of FSMA compliance. To facilitate the process for GFSI certified clients, SGS has developed an integrated certification program for FDA FSMA compliance combined with GFSI. 

For foreign suppliers who are currently certified for a GFSI scheme, or planning on a joint certification, SGS offers integrated certification. The integrated certification approach provides many proven advantages for companies.

  • It creates audit efficiencies: with 1 audit covering 2 standards, leading to 2 certificates (FSMA and GFSI)
  • It addresses all the requirements of each scheme individually, with emphasis on the differences between FSMA certification requirements and GFSI schemes
  • It is a great option for foreign suppliers wanting to maintain both a FSMA certification and a GFSI certification

SGS is currently offering integrated certification for FSMA VQIP/FSVP and BRCGS. This integrated certification is unique in the market, as it leads to compliance certification for FDA's FSMA through VQIP & FSVP certification for clients who choose to maintain GFSI certification at the same time.

For the complete range of SGS services and support visit SGS Food Safety.

Hank Karayan
Global FSMA Program Director
t: +1 (514) 402 5810
www.sgs.com/linkedinfood