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A quality manager and a colleague in a hairnet review a blank food safety plan binder beside a production line
Josh ClauserNov 4, 2026, 7:42:19 AM10 min read

PCQI 2.0: What Changed and Who Needs It

PCQI 2.0 is shorthand for Version 2.0 of the FSPCA Preventive Controls for Human Food curriculum, the standardized course the FDA recognizes for training a Preventive Controls Qualified Individual. The FDA recognized Version 2.0 on October 18, 2024, and since July 1, 2025 FSPCA courses are taught only in Version 2.0. The update folds in FDA's hazard analysis draft guidance, adds sesame to the allergen content, and sharpens the tools for building a food safety plan. PCQIs trained under the old version don't have to retake the course. Here's what changed, who needs a PCQI, and how to train.

At a glance

PCQI 2.0 at a Glance

Every FDA-registered food facility covered by the Preventive Controls for Human Food rule needs at least one PCQI behind its food safety plan. In 2024, the standard training curriculum behind the role got its first major overhaul since the rule was new.[1][2]

  • Oct 18, 2024FDA recognized FSPCA's Version 2.0 as the standardized PCQI curriculumFSPCA V2.0 FAQs
  • Jul 1, 2025FSPCA retired Version 1.2; courses run only on Version 2.0 sinceFSPCA V2.0 FAQs
  • 22Contact hours in the full FSPCA Version 2.0 courseKiwa ASI course page
  • 3 yearsFood safety plans must be reanalyzed at least this often, a core PCQI duty21 CFR 117.170

Key takeaways

  • A PCQI is a role under FDA's Preventive Controls rule, not a license: the person who prepares or oversees a facility's food safety plan, validation of its preventive controls, record review and reanalysis.[3]
  • PCQI training is not legally required. The rule accepts training at least equivalent to the FDA-recognized standardized curriculum or qualification through job experience; the FSPCA certificate is simply the standard way to document it.[4]
  • Version 2.0 is that standardized curriculum today: recognized by FDA in October 2024, taught exclusively since July 1, 2025. It adds FDA's hazard analysis draft guidance, sesame as a recognized allergen, and updated plan-building tools.[2]
  • PCQIs trained under Version 1.2 do not need to retake the course, and FSPCA certificates don't expire. Retraining is a choice, not a requirement.[2][5]

Sources checked as of November 3, 2026, against 21 CFR Part 117, FDA's rule pages, FSPCA's published Version 2.0 FAQs and Kiwa ASI's course pages.

The role

What Is a PCQI?

A Preventive Controls Qualified Individual is the person FDA's Preventive Controls for Human Food rule, 21 CFR Part 117, relies on to build and maintain a facility's food safety plan. The regulation defines a PCQI as a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or who is otherwise qualified through job experience to develop and apply a food safety system.[4]

The rule then hangs specific duties on the role. A PCQI must prepare the food safety plan, or oversee its preparation; validate that the preventive controls actually control the hazards, or document why validation isn't required; oversee the required review of records, including monitoring and corrective action records; and lead reanalysis of the plan, which is required whenever something significant changes and at least once every three years regardless.[3][6]

  • Who must have one. Facilities that register with FDA and are subject to the Preventive Controls rule need one or more PCQIs behind the written food safety plan the rule requires, unless an exemption applies.[7][1]
  • Who can be one. The PCQI does not have to be an employee: the rule says the individual may be, but is not required to be, an employee of the facility. A consultant, for example, can fill the role.[3]
  • What it is not. There is no government PCQI certification and no license. FDA doesn't certify PCQIs, and FSPCA doesn't certify individuals; what people call "PCQI certification" is the FSPCA certificate of successful completion earned by finishing the course.[5][8]
The law

Is PCQI Training Required by Law?

No, and this surprises people: the rule itself does not require a course. 21 CFR 117.180(c)(1) gives two equal routes to PCQI status: training at least equivalent to the FDA-recognized standardized curriculum, or qualification through job experience that equips you to develop and apply a food safety system.[3]

In practice, many PCQIs take the course anyway, for a practical reason: when an FDA investigator or a customer auditor asks who your PCQI is and why they're qualified, the FSPCA certificate of successful completion is the simplest one-page way to document the training route. FSPCA issues each certificate directly, with a unique identifier that employers can verify with FSPCA.[8]

No expiry, no mandatory renewal

The certificate also never expires, because the regulation has no renewal requirement for PCQI training. Any renewal cadence you see is a customer's or scheme's expectation, not FDA's.[2][5]

Version 2.0

What Changed in PCQI 2.0?

The FSPCA course had run on Version 1.2 for years. FDA recognized Version 2.0 as the standardized curriculum on October 18, 2024, FSPCA retired Version 1.2 on June 30, 2025, and since July 1, 2025 only Version 2.0 participant courses can be registered and delivered.[2]

What Version 2.0 changed
ChangeWhat it means in the classroom
FDA hazard analysis draft guidanceThe hazard analysis chapters now work from FDA's Hazard Analysis and Risk-Based Preventive Controls draft guidance, so the method taught matches the method FDA describes.[2][1]
Sesame in the allergen contentSesame has been added as a recognized food allergen in the chemical-hazards and allergen preventive controls chapters.[2]
Sharper plan-building toolsUpdated references, teaching examples and practical tools for building and maintaining the food safety plan, with a heavier emphasis on the connection between HACCP and preventive controls.[2][5]
Same legal standingBoth versions satisfy the rule's training route; Version 2.0 is simply the curriculum FSPCA teaches and FDA recognizes today.[2]

The structure is familiar: the course walks the 16 chapters of the curriculum, from food safety plan foundations and hazard analysis through process, allergen, sanitation and supply-chain preventive controls, to implementation, the recall plan and the regulation itself, in 22 contact hours.[5]

V1.2 holders

Do Existing PCQIs Need to Retrain?

No. FSPCA's own position is that since PCQIs aren't required to hold a training certificate to comply with the rule in the first place, retaking the course under Version 2.0 is not required. A Version 1.2 certificate remains what it always was: documentation that you completed the recognized curriculum of its day.[2]

When is retraining worth it anyway? Three honest cases: your plan is due for its three-year reanalysis and the team wants current methods at the table; your hazard analysis predates FDA's draft guidance and sesame; or you're the backup PCQI who learned the role secondhand and wants the full course once. Those are judgment calls, not obligations.[6][2]

Training

How Do You Become a PCQI?

Kiwa ASI teaches the full FSPCA Version 2.0 participant course both ways, always live with an FSPCA Lead Instructor, and every participant who completes the 22 contact hours receives the official FSPCA certificate.[5][9]

Either format suits the people the rule puts on the hook: food safety and quality managers who own the plan, operations leaders, HACCP team members, SQF practitioners at FDA-regulated sites, consultants who support clients' food safety plans, and anyone stepping into the role or backing it up.[5]

Training is offered through ASI Training and Consulting, LLC, which operates separately from the certification body and has no effect on audit outcomes.

FAQ

Frequently Asked Questions

What is PCQI 2.0?

Shorthand for Version 2.0 of the FSPCA Preventive Controls for Human Food curriculum, the standardized course FDA recognizes for PCQI training. FDA recognized Version 2.0 on October 18, 2024, and since July 1, 2025 FSPCA courses are taught only in Version 2.0.

Is PCQI training required by law?

No. The rule accepts either training at least equivalent to the FDA-recognized standardized curriculum or qualification through job experience. Many PCQIs take the FSPCA course because the certificate is the simplest way to document their qualification for inspectors and auditors.

Does PCQI certification expire?

No. The FSPCA certificate of successful completion carries no expiration date, and the regulation sets no renewal requirement for PCQI training. Any refresher cadence is a company or customer choice, not FDA's.

Do PCQIs trained under Version 1.2 need to retake the course?

No. FSPCA does not require Version 1.2 PCQIs to retrain, because the rule never required a certificate in the first place. Retraining is worth considering when your plan comes up for reanalysis or your hazard analysis predates FDA's draft guidance and the addition of sesame.

Is there a shorter bridge course from Version 1.2 to 2.0?

Not for participants. The refresher course FSPCA created is for its Lead Instructors, who deliver the training; for a PCQI, getting current means taking the full Version 2.0 course. Since retraining isn't required in the first place, that's a choice to make when it's worth the hours.

Can I take PCQI 2.0 in a blended or self-paced format?

FSPCA also offers Version 2.0 in a blended delivery format alongside the fully instructor-led course. Kiwa ASI teaches the course fully live, either online over five half-days or in person in St. Louis.

Is there an official government PCQI certification?

No. FDA doesn't certify PCQIs and FSPCA doesn't certify individuals. What people call PCQI certification is the FSPCA certificate you earn by completing the standardized curriculum, issued by FSPCA with a unique identifier that can be verified.

What does a PCQI have to do after the course?

Apply the role: prepare or oversee the food safety plan, oversee validation of preventive controls, oversee the required review of records, including monitoring and corrective action records, and lead reanalysis when anything significant changes and at least every three years.

Put a trained PCQI behind your plan

Take the FSPCA Preventive Controls for Human Food Version 2.0 course live with Kiwa ASI: online over five half-days, or in person in St. Louis.

Training is offered through ASI Training and Consulting, LLC, which operates separately from the certification body and has no effect on audit outcomes. Questions? Email US.Info@kiwa-asi.com or call 1 (800) 477-0778.

Keep reading

Sources

  1. U.S. FDA. FSMA Final Rule for Preventive Controls for Human Food (accessed November 3, 2026). fda.gov
  2. FSPCA. Preventive Controls for Human Food Version 2.0 training FAQs (as republished at food-industry.ca; accessed November 3, 2026). food-industry.ca
  3. U.S. FDA. 21 CFR § 117.180, Requirements applicable to a preventive controls qualified individual and a qualified auditor. ecfr.gov
  4. U.S. FDA. 21 CFR § 117.3, definition of preventive controls qualified individual. ecfr.gov
  5. Kiwa ASI. PCQI Certification Training Online, FSPCA V2.0 (accessed November 3, 2026). asifood.com
  6. U.S. FDA. 21 CFR § 117.170, Reanalysis. ecfr.gov
  7. U.S. FDA. 21 CFR § 117.126, Food safety plan. ecfr.gov
  8. FSPCA. Food Safety Preventive Controls Alliance: course and certificate verification (accessed November 3, 2026). fspca.net
  9. Kiwa ASI. PCQI Certification Training in St. Louis (accessed November 3, 2026). asifood.com