All FDA-regulated facilities are required to have at least one Preventive Controls Qualified Individual (PCQI) who is qualified and has successfully completed training in the development and application of risk-based preventive controls. So what makes someone qualified to be a PCQI?
PCQIs are required to have the necessary training, education, job experience, and/or completion of a course that is recognized by FDA. Currently the only standardized curriculum that is FDA recognized is that of Food Safety Preventive Controls Alliance (FSPCA) for Preventive Controls for Human Food and Preventive Controls for Animal Food.
Completing the FSPCA course does not, in and of itself, mean the PCQI is qualified and successful. The PCQI is required to perform or oversee preparation of the Food Safety Plan, validation of preventive controls, record review for preventive controls, and reanalysis of the Food Safety Plan. Successful completion will help determine if the person is qualified to be a PCQI.
PCQI success is partly determined by a facility’s successful passing of an inspection without incurring regulatory action. The PCQI’s responsibilities are essential for an effective food safety preventive controls program.
In most FDA-regulated facilities, if the PCQI is not part of management, he or she at least works closely with senior management. So a successful PCQI should share traits similar to those of a successful manager. A PCQI should be self-motivated, able to delegate wisely, a good communicator, confident, and humble.
A common mistake that facilities make is to select an underqualified person as the PCQI. Perhaps the person does not have the education or experience to oversee the implementation and management of the Food Safety Plan. Others may believe they have to conduct the validation and review all preventive controls records themselves. This is not the case, which is why the term oversee is used.
Not all PCQIs will be experts in processing authority or microorganisms. Additionally, the PCQI is not required to be an employee of the company, rather a company may choose to use a consultant as its PCQI. This may be the case when a company has limited resources to successfully implement and manage its Food Safety Plan.
Some facilities decide to have more than one PCQI. In fact, with the responsibility the position has for overseeing food safety, it may be most prudent for facilities to have more than one PCQI on staff, because people do get sick, go on vacation, and change employers. However, it is recommended that facilities with more than one PCQI have one of them identified as the primary PCQI.
Although it is not required to have the PCQI be at the plant when a regulatory agent is present, it would be wise for this individual to be readily accessible. This is especially important to consider if the PCQI is located far away from the plant. Additionally, when the facility is identifying the food safety team in the Food Safety Plan, all PCQIs should be listed.
In addition to the PCQI, other qualified positions recognized by the FDA are the qualified individual (QI) and qualified supervisor.
- The QI is generally a line employee or individual(s) responsible for monitoring activities per the food safety plan.
- The qualified supervisor will most likely be responsible for verification activities if the PCQI is not directly performing this activity.
The QI must have the education, training, experience, or combination thereof necessary to manufacture, process, pack, and/or hold clean and safe food as appropriate to his or her assigned duties.
As a lead instructor for the FSPCA Preventive Controls for Human Food, I often ask participants what surprises or challenges they expect. Prior to the course, many do not fully realize their role and level of responsibility as the primary PCQI. Participants also are surprised by the number of resources that are available through FDA and FSPCA.
Whichever way the PCQI attains his or her knowledge, the successful PCQI has all the necessary resources and management commitment to ensure the implementation and maintenance of the Food Safety Plan.
The ultimate demonstration of a successful PCQI is when the facility successfully passes an FDA inspection.