Applying FSMA

FDA introduced the term “Preventive Controls Qualified Individual (PCQI)” when it finalized the Preventive Controls (PC) rules for human food and animal food. While the term is becoming more familiar, there is still abundant confusion over the process of becoming a PCQI. The PCQI plays a substantial role in helping a facility comply with the applicable rules, because he or she must prepare, or oversee, the preparation of the mandatory food safety plan. This includes performing or overseeing the hazard analysis and validation studies (as applicable), performing records review, and conducting reanalysis of the food safety plan.

The definition of a PCQI is “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 is otherwise qualified through job experience to develop and apply a food safety system.”

WHO IS A PCQI? Let’s dig into this definition with answers to some of the most common questions on how to determine if you are a PCQI.

Q. Must you take a course?

A. No, taking a course is just one way to meet the requirements of becoming a PCQI. Job experience and education can also qualify a person.

Q. What standardized curriculum is recognized as adequate?

A. A training curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA), in collaboration with FDA, is currently the only curriculum that FDA recognizes as adequate. This course is being offered by numerous trainers, including many universities and trade associations, such as GMA.

Q. If you take a course, must it be the FSPCA course?

A. No. Although the FSPCA curriculum is the only one currently recognized as adequate by FDA, there may be other courses that cover the same information. At this point, however, GMA is not aware of any courses that purport equivalency with the FSPCA curriculum, although NEHA’s Certified in Comprehensive Food Safety credential states that “the CCFS credential holder is prepared to manage and evaluate food safety plans.” Again, taking a course is not required; what is required is the understanding of how to develop and implement an appropriate food safety plan. That understanding isn’t truly tested until an inspector evaluates the food safety plan.

Q. If I’ve gone through HACCP training, am I a PCQI?

A. Not necessarily. The PC rules differ from HACCP in that some programs and activities that might previously have been considered prerequisite programs or Good Manufacturing Practices (GMPs) may now be re-classified as preventive controls, which require more documentation. The key to developing a compliant food safety plan is understanding the difference between HACCP and the new requirements.

Q. Does the course have a test?

A. No. The FSPCA did not include any tests with the curriculum. Successful completion of the course and issuance of the certificate is based on full participation in the minimum 2.5-day course. However, individual instructors may develop their own assessments, and can require that they be completed in order to issue a certificate. This is at the discretion of the instructor and must be clearly explained in the material advertising the course.

Q. Does FDA approve the course and instructor?

A. No. FDA recognizes the FSPCA curriculum as adequate. All instructors offering the FSPCA course use the same slides and the same book. FDA does not approve individual instructors or courses. The FSPCA trains individuals who are allowed to teach the course, however, these instructors are not technically “approved” by FSPCA. In fact, FSPCA has advertising recommendations for lead instructors so that attendees are not misled.

Q.Can I say I’m a certified PCQI?

A. No. If you choose to participate in the 2.5-day FSPCA training, you will get a certificate issued by the FSPCA. This is not a certification. Certifications and certificates are different.

Q. What kind of job experience is needed to say I’m a PCQI?

A. FDA did not specify the type of job experience that would enable one to state that he or she is a PCQI. As noted in previous answers, the real measure of a PCQI is the adequacy of the food safety plans they are able to develop, as determined by a regulatory inspection. This requires a solid foundation in food safety as well as a clear understanding of the regulatory requirements.

Q. Will FDA ask to see my PCQI certificate?

A. That may depend on the inspector. But one thing is for certain: if upon review of a food safety plan, serious deficiencies are found that call into question the expertise or adequacy of the PCQI, expect that the inspector will seek to understand why the individual who developed the food safety plan believes he/she has sufficient experience and/or education to fill the role of a PCQI.

Q. If I have the PCQI certificate, does it mean my food safety plan is good?

A. No. Just because you have gone through the standardized curriculum does not guarantee that you know how to sufficiently apply the concepts taught in the course. The real determination of whether or not someone is truly a PCQI is the sufficiency of the food safety plans they are able to develop.

SUMMARY. While FDA offers flexibility in how one can become a PCQI, the real test is the ability to develop a solid food safety plan. Unfortunately, the only sure way to test that plan is through an FDA inspection, which is not the time to learn that you haven’t quite mastered the regulatory requirements. As such, it can be beneficial to have an external expert review of your food safety plan – before an inspector arrives at the door – such as that by GMA’s food safety staff which is available to association members. An extra pair of eyes never hurts!

The author is GMA vice president, science operations.