Preventive Controls Qualified Individual (PCQI)

This week’s tip contains what is probably one of the most important new definitions of the Preventive Controls Rule, namely the Preventive Controls Qualified Individual, or PCQI.

The rule defines the Preventive controls qualified individual to mean “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”.

Let us first take a look at the duties the PCQI(s) will be responsible for. The rule states that the Food Safety Plan must be prepared, implemented, managed and re-analyzed by one or more preventive controls qualified individuals, or such functions overseen by such qualified individuals. The food safety plan, includes:

  • Risk Assessment
    • Hazard analysis methodology & results for raw materials, ingredients, food contact substances, the process, and the manufacturing environment
    • Evaluation of suppliers’ food safety compliance histories
  • Identification of preventive controls and where in the food supply chain the preventive control will be applied (supplier, facility, customer)
  • Supply-chain control program, as required upstream and/or downstream
  • Recall plan
  • Monitoring, corrective action (has 4 elements) and verification procedures
  • Validation of the preventive controls, as required
  • Records
  • Reanalysis of the food safety plan

Without getting into the details, nuances and variances in each of the duties assigned to the PCQI, let us review a few practical reflections.

  • How many PCQIs, as defined by the rule, will be necessary at your facility to develop, implement, manage and reanalyze an effective and compliant food safety plan?
  • How will you distribute the responsibilities for developing and managing the food safety plan amongst the PCQIs?
  • Who will be the PCQI leader?
  • How will you organize a transition team to update your current food safety program to meet HARPC requirements?

Now let us take a look at the part of the definition of the PCQI which addresses the qualifications of a PCQI. The definition seems to provide two options, namely training or job experience. The training is circumscribed by having to be at “least equivalent to that received under a standardized curriculum recognized as adequate by FDA”. Some practical questions come to mind, such as:

  • Should your facility have at least one PCQI lead trainer/assessor, who took the standardized curriculum recognized as adequate by the FDA?
  • How will you demonstrate the PCQIs have the appropriate “qualifications” based on training and experience, or combination thereof?
  • If you do not have enough appropriately trained and/or experienced PCQIs, how are you going to train them?

I think all of us would agree that either one by itself is not sufficient, i.e., that a combination of both training and experience will be necessary to demonstrate the PCQI(s) have the relevant competencies to develop and apply risk-based preventive controls in an effective manner. Thus, several options present themselves, as follows:

  • Train a lead trainer/assessor by taking the FDA approved curriculum developed by the Food Safety Product Control Alliance (FSPCA). Such person can then provide the FDA recognized training in-house. This might be the least challenging approach since there would be no question about the intent and scope of the in-house training being provided.
  • Alternatively. The facility could opt for having a third-party provide the PCQI training. Such outside trainers would have taken the lead trainer course provided by the FSPCA.
  • A third option is to compare training received from other respectable sources, compare such training with the FDA/FSPCA training curriculum and decide whether or not it meets or exceeds such FDA approved curriculum. If so, such training needs to be documented as equivalent. In turn, such a PCQIs could carry out the in-house training and the development of the Food Safety Plan.

The rule does state that “job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum”.

  • Thus, another alternative would be to evaluate individual employees’ job experiences and see if it would meet this requirement. Normally, such job experiences do contain a certain degree of training events as well. If so, such job qualifying experiences need to be documented.

Finally, the rule also states that all applicable training in the development and application of risk-based preventive controls must be documented in records, including the date of the training, the type of training, and the person(s) trained. So, make sure your training records do reflect such training. Remember, all records associated with manufacturing, processing, packing and holding of food are subject to review by the FDA. This includes your training records for all qualified individuals, PCQIs, and qualified auditors.

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