PCQI Requirements
While the list of FSMA’s new requirements is dense and varies greatly for some types of facility, one key change that applies to nearly all food companies is the introduction of a preventive controls qualified individual (PCQI). Not only does FSMA require facilities to have a food safety plan implemented, but the plan must be prepared and applied by a properly trained PCQI.
How Can I become a PCQI?
There are different ways that you can meet this training requirement. You want to take a course that offers the FSPCA certificate to make sure that the training is recognized. </p>
Registrar Corp has the only fully online self-paced PCQI training with the official FSPCA certificate. We developed this using the FSPCA preventive controls for human food course material, so it is the standardized curriculum and all students receive the association of food and drug officials AFDO Certificate.
The general route to becoming qualified as a PCQI is to take the standardized training course taught by a “Preventive Controls Lead Instructor”. This is an instructor that has applied to FSPCA, been accepted, and completed the Lead Instructor training course. They are able to register the class with AFDO and students will receive an official FSPCA/AFDO certificate if they successfully complete the class. This approach clearly meets the requirements defined in 117.180 (c)(1) of the preventive controls rule.
” To be a preventive controls qualified individual, the individual must have 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.”
Taking a course recognized by FDA provides the PCQI with a certificate that demonstrates they have met the training requirement, it is a clear a straightforward way to become qualified. Our course uses the FSPCA’s standard curriculum, is recognized by FDA, and includes the official certificate.
Why is a PCQI necessary?
The PCQI plays an important role in meeting the requirements of the rule. There are specific responsibilities related to the food safety plan that must be completed by a PCQI, so that means that all facilities that are subject to Subpart C must have a PCQI to perform or oversee those responsibilities.
In many or most cases, the PCQI is an employee and as the company size gets larger there may be a need to have more than one PCQI to keep up with the responsibilities. They do not need to be an employee of the facility, but they must be available to complete those responsibilities. The PCQI could be somebody outside the company but they definitely need to be available for those responsibilities.
What is the PCQI responsible for?
Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include the responsibility to oversee or perform:
- Preparation of the Food Safety Plan,
- Validation of the preventive controls,
- Records review,
- Reanalysis of the Food Safety Plan, and other activities as appropriate to the food.
The preventive controls qualified individual must be involved in doing the hazard analysis and creating a food safety plan. During the hazard analysis, the food safety team led by the PCQI will identify the hazards that are associated with a certain food. They will determine which of these hazards need a preventive control.
Then the food safety team will identify the type of preventive control that will be used. For example, a process control such as cook step where you’re heating the product so that you are killing a pathogen or a sanitation control used to eliminate environmental pathogens. Then the PCQI along with the rest of the food safety team will identify different monitoring procedures to ensure that those preventative controls have been implemented effectively.
The next step is identifying corrective action to be taken if monitoring shows that the limits or parameters are not being met. The team will identify verification activities and any supply chain activities. A recall plan is developed for any hazard that requires a control, required records are identified and the plan is complete. The final step is to perform a reanalysis of the food safety plan when changes occur if the plan or part of the plan is not effective and every three years.
Is the Food Safety Plan the same as the HACCP Plan?
If you are familiar with HACCP and HACCP Plans, this is similar to, but not exactly the same as a HACCP Plan. For this food safety plan, preventive controls can include process controls, sanitation controls, allergen controls, and supply chain controls. That is one of the differences between this and a HACCP Plan, HACCP plans do not typically include sanitation or supply chain controls.
