When the proposed Food Safety Modernization Act (FSMA) rules were first released, the word qualified was prolific. It could be found in four (if you count the preventive controls for humans and animals as separate rules) of the seven rules and in each of those rules, it could be found over and over again. “Qualified” was obviously going to be something very important to FSMA.
The trouble is, it’s an ambiguous term. What does “qualified” mean? As Marc Sanchez, FDA Attorney, puts it in our latest webinar, Qualify This: A Dive Into Preventive Controls Qualified Individual, it’s a little bit like asking someone what is reasonable. If you ask one person, they’ll tell you one thing, and if you ask another, they’ll tell you something else. It’s very hard to pin down the definition, hence the confusion with the proposed rules.
The preventive controls rules for human and animal food set a mandate stating you could only have a Qualified Individual (QI) complete the core activity of those rules—the food safety plan, the Foreign Supplier Verification Program (FSVP) rule used the term QI again as a type of person that ought to be involved in various activities when it comes to imports, and finally, QI pops up once more in the third-party accreditation rule, where it laid out strict requirements for qualified auditors under that rule.
So, you had one term—QI—and three different uses used in four different rules, thus a lot of ambiguity and confusion. One of the questions commonly asked within the comment period was, “How can we create unity and consistency between these rules?”
The FSVP rule, for example, is supposed to be the other half of the preventive controls rules, where the preventive controls rules cover domestic products and the FSVP rule covers imports. The question then is, if you’re FSVP rule qualified, would you also be qualified under the preventive controls rules? If these are intended to be similar requirements, it would make sense that if you have the qualifications for one, you would have the qualifications for the other. However, with the way the rules were written, it wasn't so clear cut.
With the final publications, FDA creates some consistency in the preventive controls and the FSVP rules. Now we have one definition for QI, but this is only half of the solution. The unified definition is:
The Qualified Individual under HARPC now means “education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties.”
The definition is basically asking if you have the proper education, training, or experience to perform your assigned duties. For example, if you’re assigned to packaging, are you qualified for packaging? Now we can see consistency on how this individual is defined across the rules.
While this definition helped clear some of the confusion, there was still a discussion around the QI within the preventive controls rules where there is many more requirements and criteria regarding what a QI was/is in terms of a food safety plan. Hence the other half to clarifying what a Qualified Individual is:
There is now a new term—Preventive Controls Qualified Individual (PCQI).
There is now a unified definition of QI (proper training, education, experience, or activity), but this does not cover the food safety plan that is a part of the preventive controls rules. When you come to that question, you need to ask if the person is a “PCQI.”
This is how FDA is bringing parity between the two rules (FSVP and preventive controls) and at the same time, making sure that the person writing your food safety plan is what the rule envisioned. There is now a new specific form of qualification for preventive controls.
When you have a facility, you have a little bit of a caution exercise. First, you have to let go of the thought you may have had about a QI under the proposed rules. A QI can do a lot in a facility, but a QI cannot work on preventive controls rules activities like the food safety plan.
You have two questions you need to ask:
- Is this person qualified for the non-food safety plan duties (the non-preventive controls rule duties)?
- For the person that is involved in the preventive controls, is this person preventive controls rule qualified, or are they the PCQI?
Can this be a team effort?
A common question is, is this the responsibility of an individual, or can this fall under a team? Given the name within the rule, this falls to an individual and not a team. There’s no qualified team term, and there’s no aggregation of abilities in the rule. This means that if you rely on a QA team or committee where you have one party doing an activity related to food science, and someone else doing the HACCP style drafting, between the two, you cannot say you’re qualified. You need to make sure that every person on the committee and on the team is PCQI. This may change some operations for some facilities.
Criteria for a PCQI
The above criteria is applied to each individual and both for the PCQI and the QI. This means every time you do an assessment of personnel, it’s on an individual basis. Right now there are two very broad sets of criteria for what would qualify as PCQI, but over the course of the year, we should receive more clarity and more finalization. We have to remember that the preventive controls rules are not in effect yet. They are finalized, but won’t go into effect until this coming year for most facilities. We do, however, have a general sense of what will be happening.
There are two ways to meet the PCQI requirements:
- Complete an FDA approved curriculum
- Fall under “Otherwise Qualified”, which is based on training and job experience, so long as that training and job experience is equal to the FDA curriculum.
There isn’t, as of yet, criteria to determine when the training and job experience under “Otherwise Qualified” is sufficient. For example, there’s no ability to submit resumes and certificates completed to get an assessment from the FDA. This may become part of the inspection or part of the Form 43 observation in which part of the food safety plan will be the qualifications of the person who created the food safety plan. We could also see the FDA authorize the same entity creating the curriculum to review qualifications for the approval process.
So, we know what the qualifications will be, but we don’t yet know how exactly those qualifications are going to come into practice.
FDA PCQI Curriculum
The FDA has enlisted the help of the Food Safety Preventative Controls Alliance in developing a curriculum for PCQI certifications. Here is a draft of the current curriculum (second item under FSPCA downloads). There are 15 chapters in the draft curriculum, and each chapter has a brief summary of what’s covered. What is clear from the final rule and draft curriculum is that the qualifications for the PCQI will be robust.
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.
Both routes, the curriculum and the “Otherwise Qualified”, are going to be product specific, risk focused, and will require an ability to properly identify hazards and controls. Ultimately, FDA wants someone in the facility writing and managing the food safety plan that can identify risks that are specific to the facility’s products or processes and understand how those risks can be assessed and controlled.
This is an excellent example for the third-party certification rule because it really serves as the motivation for what you see in that rule, but can also be used for our purposes to see if whether a PCQI would have made a difference in this particular scenario.
When you break down the outbreak to its simplest, you can pinpoint the potato washing system that contributed, if not was the sole factor, in the outbreak. This was a switch made after the recommendation of a third-party auditor. If a PCQI was in this facility receiving the recommendation to use the potato washing system, would they have identified the risk associated with that adoption?
In a facility making this decision today, we would expect that this would be part of a food safety plan. We would assume the PCQI would focus on the source of the water, the washing system itself, and making sure it has the appropriate temperatures in place. All of this would be part of the hazards list when drafting or updating a food safety plan. If the PCQI has the qualifications recommended within the rule, they should be able to foresee these potential issues.
If the PCQI was in the facility adopting the recommendation, would they have identified a potential mitigating kill step, or something else that could have mitigated the risk? This is hindsight, but we can say that a person with a scientific background required for the PCQI would have identified the risk and assessed potential ways of controlling it.
In an effort to better understand the rules, Marc suggests going through the headlines, taking an outbreak that has happened in the past decade, and running through the hypotheticals. It can also help to get to some of the questions as to how FDA sees the PCQI functioning and what FDA expects form a person with these certain qualifications to be doing under the preventive controls rule for human and animal food.
If you’re looking for a deeper dive into what is required of FSMA’s PCQI, tune into the Q&A session towards the end of our latest on-demand FSMA Club webinar, Qualify This: A Dive Into Preventive Controls Qualified Individual.
TraceGains hosted FDA attorney Marc Sanchez to 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
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