Accreditation of certification bodies, such as NSF International, under the FDA Third-Party Accredited Certification Program requires that the certification body establish a system for managing the certification process integrity, demonstrate auditor and personnel competence, training and qualifications, and maintain records of certification activities.
The audit duration and cost are variable depending on the scope and complexity of the requested audit, and are determined by the requirements of the accredited certification body. Typically the full process from application to certification decision requires three to four months to complete. The certification process is similar to third-party food safety certification programs in several ways, including:
- Application and contract review;
- Determination of scope and assignment of auditor;
- Document and records review;
- Resolution of any non-conformance from document review;
- Certification audit;
- Technical review for accuracy and quality of report;
- Non-conformance corrective action and closure; and
- Certification decision and report issued within 45 days of audit.
Following a positive certification decision, the certificate is valid for 12 months. In cases where the product is seasonal, the certificate is valid only for the audited season of production. Additional audits are required for multiple seasons within the annual production cycle.
Broad adoption of this newly available and flexible solution will help to reduce audit fatigue on the part of the manufacturers and suppliers engaging in supplier verification activity to comply with FSMA. The scope of the audit can be broad to service the full range of production at a supplier site or limited to only a narrow scope of product or process. It recognizes the robust structures in place established through GFSI while also covering the gap for FDA-specific compliance verification.
Whether the audit is conducted at the supplier for eligibility for VQIP, as FDA import certification, or as an FSVP verification activity, the audit against FDA regulations provides a consistent standard of equivalent compliance, regardless of the origin of the food.
Allen is the associate managing director of Supply Chain Food Safety Operations at NSF International. Reach her at [email protected].
ACCESS THE FULL VERSION OF THIS ARTICLE
To view this article and gain unlimited access to premium content on the FQ&S website, register for your FREE account. Build your profile and create a personalized experience today! Sign up is easy!
GET STARTED
Already have an account? LOGIN