Qualified Individual

The Preventive Controls Rule contains a series of new definitions. Understanding their intent and scope will be key for developing, implementing and managing an effective food safety plan. Over the next few weeks we will be sharing and discussing some of these definitions and their practical implications and applications.

Today we will review the definition of a “Qualified Individual”. The rule states that a Qualified Individual means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe 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.

The rule goes on to state that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must:

  • Be a qualified individual i.e., have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties; and
  • Receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties.

What does this mean in practical terms? Well, the underlined/italics parts of the above statements should be a heads-up. It means that above and beyond the basic cGMP training that all employees are subject to during onboarding, as well as the annual refresher training, management will now have to differentiate and identify additional training “as appropriate to the individual's assigned duties”. In other words, management will have to identify and document specific sanitary and food safety training, for the different departments and their personnel, so they can carry out their assigned duties in an “appropriate manner”. For example, if we look at allergen cross-contact prevention, which is mentioned 24 times in the updated cGMP component of Part 117, it is clear that certain specific allergen control training will apply to receiving, storage and handling, manufacturing, packaging and holding/shipping of finished product. Similarly, specific training to prevent allergen cross-contact will also be required for non-operational personnel, such as maintenance, sanitation, quality assurance, and temps.

I would venture to say that most well run facilities do have such specific additional training identified and implemented, however it will be wise to verify, by positions and/or employee groups within departments, that such “appropriate” training is identified, executed, followed-up for effectiveness and documented.

The rule also specifies “additional qualifications of supervisory personnel”. The rules stated that “it is the responsibility for ensuring compliance by individuals with the requirements of this part, which must be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food”.

Again, what does this mean in practical terms? As the statement implies supervisors will have to demonstrate they have the appropriate competencies to “supervise the production of clean and safe food”, i.e., they have what it takes to verify that qualified individuals are carrying out their assigned duties in a sanitary manner, to make appropriate decisions about the product and the employee when failures occur, to verify that corrections and corrective actions were effective, and to review records at appropriate frequencies to decide on the acceptability of the information contained, how to proceed when the records have errors, are incomplete, or are otherwise not acceptable.

Again, I would venture to say that well run facilities are doing this in an acceptable manner. Nevertheless, a review of these “additional qualifications of supervisory personnel” is called for to assure all supervisory positions are educated and trained to meet these requirements.

Finally, the rule mentions records. “Records that document training required by this section must be established and maintained”. Remember, all records related to manufacturing, processing, packing, or holding of food are subject to review by the FDA, upon oral or written request, including training records. What does this mean in practical terms? Make sure your training records for all “qualified individuals” do demonstrate the basic GMP training, as well as the more specific training as appropriate to the individual's assigned duties, for floor employees, as well as supervisory levels.

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