What is PCQI?
PCQI means Preventive Controls Qualified Individual and is an important part of the Preventive Controls for Human Food Rule (21 CFR Part 117) and Preventive Controls for Animal Rule (21 CFR Part 507). The term is defined in 21 CFR 117.3 and 21 CFR 507.3:
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.
Do I have to be certified to become a PCQI?
No. You are not required to take any specific classes or receive any specific certificates to become a PCQI. You can qualify though job experience, training and education. However, it is a good idea to consider taking a class offered through the Food Safety Preventive Controls Alliance (FSPCA) because the certificate can be shown to FDA in support of justifying a person’s role as a PCQI.
What tasks under the Preventive Controls Rules must be performed by PCQIs?
The following tasks must be performed by PCQIs:
- Preparing the food safety plan
- Validating preventive controls
- Reanalyzing the food safety plan
- Justifying delaying the above tasks beyond certain timeframes established by FDA in the rules.
How does a PCQI differ from a QI?
Both the Preventive Controls Rules for Human and Animal Food rules define the term qualified individual (QI):
a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe (animal) food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. 21 CFR 117.3, 21 CFR 507.3
Does the FSVP Rule also define QI?
Yes. The Foreign Supplier Verification Program Rule (FSVP) also defines the term:
a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under this subpart, and can read and understand the language of any records that the person must review in performing this activity. A qualified individual may be, but is not required to be, an employee of the importer. A government employee, including a foreign government employee, may be a qualified individual. 21 CFR 1.500.
Is there an FSVP QI course?
Yes the FSPCA created an FSVP course. Our founder Erik Lieberman was a member of the group that created the original training materials for the course.
Where can I find information on PCQI and QI courses?
You can find a listing of future course offerings around the world here.
Does US Food Imports offer QI services for FSVP?
Yes. We serve as the qualified individuals for many importers across the food industry. As the qualified individuals we write and implement your FSVP program, and may assist in handling FDA FSVP audits.
Is my company required to have a QI or PCQI as an employee?
No. The regulations clearly state that you are not required to have a QI or PCQI as an employee. Therefore you can use an outside firm or consultant in the roles.