Preventive Controls Qualified Individual (PCQI) – January 14-16, 2020


FDA’s Preventive Controls Rule PCQI Requirement

“Many activities required by the final rule must be conducted (or overseen) by a Preventive Controls Qualified Individual, a new term we are coining here. A Preventive Controls Qualified Individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.”

FDA identifies the following as the PCQI’s responsibilities in § 117.180(a): “(a) One or more preventive controls qualified individuals must do or oversee the following:

  1. Preparation of the food safety plan (§ 117.126(a)(2));
  2. Validation of the preventive controls (§ 117.160(b)(1));
  3. Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable food;
  4. Determination that validation is not required (§ 117.160(c)(5));
  5. Review of records (§ 117.165(a)(4));
  6. Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;
  7. Reanalysis of the food safety plan (§ 117.170(d)); and
  8. Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and its role in the facility’s food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food.”

To facilitate compliance with this new requirement, FDA has established the Food Safety Preventive Controls Alliance (FSPCA) to develop a curriculum that FSPCA-trained Lead Instructors will use to educate individuals as PCQIs. The FSPCA is an alliance of government, academia, and industry whose mission is to assist with
implementation of the Food Safety Modernization Act (FSMA) in the food industry. As mentioned above, the final rule also provides for PCQI approval for those “otherwise qualified through job experience to develop and apply a food safety system.” However, FDA has not yet defined the process for becoming a PCQI through job experience.

The FSPCA began offering a “train-the-trainer” program in late-2015 to make Lead Instructors available to the food industry. IPIA Food Safety Consultant Chris Dunn attended and completed the training program for Lead Instructors as provided by the FSPCA. Chris has taught the class more than a dozen times. The advantage of taking the IPIA sponsored course is that while the classroom material conforms to all the FDA requirements, it is taught from the viewpoint of the packaged ice industry.


Workshop Schedule (Subject to revision)

1:00 PM to 6:00 PMTuesday, January 14, 2020

Lunch on own
Chapter 1 – Introduction
Chapter 2 – Food Safety Plan Overview
Chapter 3 – Good Manufacturing Practices and other prerequisite programs
Chapter 4 – Biological Food Safety Hazards

7:30 AM to 5:30 PMWednesday, January 15, 2020

Breakfast on own
Chapter 5 – Chemical, Physical, and Economically Motivated Food Safety Hazards
Chapter 6 – Preliminary Steps in Developing a Food Safety Plan
Chapter 7 – Resources for preparing Food Safety Plans
Chapter 8 – Hazard Analysis and Preventive Controls Determination
Lunch on own
Chapter 9 – Process Preventive Controls
Chapter 10 – Food Allergen Preventive Controls
Chapter 11 – Sanitation Preventive Controls
Chapter 12 – Supply Chain Preventive Controls

7:30 AM to 12:30 PMThursday, January 16, 2020

Breakfast on own
Chapter 13 – Verification and Validation Procedures
Chapter 14 – Recordkeeping Procedures
Chapter 15 – Recall Plan
Chapter 16 – FSMA Regulation Overview

All participants receive the 524 page PCQI Workbook and Manual, which is required for each participant.

Attendance is required for the entire workshop in order to receive FDA PCQI Certification.


Recently retired from NSF International, where he managed the global Beverage Quality program offering food safety certifications (NSF, SQF, BRC) as well as laboratory testing, food safety audits, consulting and training for bottled water, natural mineral water, flavored beverages and packaged ice. Chris is also qualified as a beverage auditor, food safety trainer as well as “Lead Instructor” for the FSPCA Preventive Controls for Human Food (PCQI) training program referenced under the FDA’s Preventive Controls regulations.

He holds a Bachelor’s degree from the University of Denver and a MBA from the Goizueta Business School at Emory University in Atlanta, Georgia.