FDA’s Hazard Analysis and Risk-based Preventive Control (HARPC) rule relies heavily on tasks performed by a “Preventive Controls Qualified Individual” (PCQI). This is a new term in the final rule as compared to just "Qualified Individual" in the proposed rules.
- Have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum (not yet released) recognized as adequate by FDA, or
- Be otherwise qualified through job experience to develop and apply a food safety system
- Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.
Additionally, we know that one or more PCQIs for each registered food facility subject to HARPC requirements must do or oversee the following:
- Preparation of the food safety plan
- Validation of the preventive controls
- Review of records
- Reanalysis of the food safety plan
FDA’s primary concern is that every food facility must have one or more persons, either employees or outside experts, with the technical knowledge of the food being made and processes in use to evaluate risk and identify the means to control them.
Obviously, the selection of a PCQI is critical to a company’s food safety program. The company should keep in mind this is the person the FDA will most likely want to hear from if the agency ever has any questions or concerns about the adequacy of the company’s safety program or any particular product. If a consumer ever claims to have been harmed by one of the company’s products, the PCQI will and his or her team will be critical to resolving the claim and, if necessary, defending the company in a civil lawsuit.
Are you subject to the preventive control requirements of the HARPC rule?
If your company processes food, and you are not exempt because of very small size and limited area of distribution, or you make alcoholic beverages, or are covered by seafood or juice HACCP, you are almost certainly subject to the some or all of HARPC. Read more about HARPC and get a detailed overview of FSMA.
What is FDA doing to develop its “standardized" curriculum?
In 2011, FDA funded the Food Safety Preventive Controls Alliance (FSPCA), a collaboration among federal and state regulatory officials, academic food safety researchers and educators, and U.S. food industry representatives. It is charged with development of the “standardized curriculum” that FDA will require for PCQIs.
FSPCA has posted its topics for curriculum outline online. (http://www.iit.edu/ifsh/alliance/ - 2nd item under FSPCA Downloads)
Topics in the curriculum include:
- Introduction to Course
- Overview of a Food Safety Plan
- GMPs and Prerequisite Programs
- Biological Food Safety Hazards
- Chemical, Physical and Economically
- Motivated Hazards
- Preliminary Steps in Developing a
- Food Safety Plan
- Process Preventive Controls
- Allergen Preventive Controls
- Sanitation Preventive Controls
- Supplier Preventive Controls
- Recall Plan
- Verification and Validation Procedures
- Record-keeping Procedures
- Regulation Overview
- Resources for Preparing Food Safety Plans
- Food Safety Plan Examples and Exercises
- The Animal Food Course emphasizes additional topics relevant to pet food and animal feed production
Appendix 1: FDA Regulation on cGMPs and Hazard Analysis and Risk-based Preventive Controls for Human Food (FSMA Sec. 103)
The regulation is provided for reference.
Appendix 2: Food Safety Plan Worksheets
Blank worksheets examples are provided for student use. Other formats may also be used.
Appendix 3: Food Safety Plan Example: Frozen Omelets
This example Food Safety Plan is used throughout the course to illustrate concepts.
Appendix 4: Foodborne Pathogen Supplementary Information
This provides reference material on specific pathogen growth and inactivation parameters.
Appendix 5: Sanitation Basics, Hygienic Zoning and Environmental Monitoring Supplemental Information
This is supplementary information for instructor use in classes that need additional information on basic sanitation or environmental monitoring.
Appendix 6: Evolution of Risk-based Food Safety Preventive Controls
This supplementary information may be used by instructors for classes that want to understand the difference between HACCP and Food Safety Preventive Controls approaches.
Those familiar with FDA’s seafood training requirements will recognize the similarity between this outline and the Basic Seafood HACCP Course. It is intentionally modeled on what FDA has done before. However, HARPC’s requirements for a PCQI are broader than that required for seafood and juice rules.
Enforcement of HARPC will likewise follow a similar path to that used during the first years of seafood HACCP, with perhaps an even greater emphasis on education for a longer time before the need to use regulatory action. FDA is well aware of the size and scope of changes FSMA will bring to food manufacturing and is promising to educate while regulating.
From a legal perspective, education and training serve critical offensive and defensive purposes. On the offensive side, they help the company implement practices and procedures to minimize the risk of food contamination or other safety issues and, thus, help to reduce the risk of regulatory and consumer actions in the first place. However, some risk inevitably remains.
Education and training become important defensive tools if the company faces a regulatory action or consumer lawsuit. The company cannot absolve of liability by simply showing its PCQI and other safety personnel were well trained and took all reasonable steps to prevent the problem. However, there are considerations for how these actions will be resolved. The FDA is more willing to work cooperatively with a company which can show its good faith efforts to implement an effective food safety program, which necessarily includes education and training. Plaintiff’s lawyers and juries also consider these factors when resolving consumer lawsuits.
If you’re looking for a deep dive into what is required of FSMA’s PCQI, tune into our latest on-demand FSMA Club webinar, Qualify This: A Dive Into Preventive Controls Qualified Individual.
TraceGains hosted FDA attorney Marc Sanchez to help explain the PCQI requirement and clarify what sort of training and experience FDA expects the author of your food safety plan to have.
Specifically, this FSMA Club webinar covers:
- Who is covered by the HARPC requirement for a PCQI
- Who is responsible for developing a food safety plan
- Validation of preventative controls
- Reanalysis of the food safety plan
- Employees vs. a third-party serving as the PCQI