Qualified Individual Services

Qualified Individual Services

In section 117.155 of the proposed preventative controls rule the FDA requires a “qualified individual” perform four tasks. A qualified individual most (a) prepare the food safety plan required in sec. 117.126(c), (b) validate the preventative controls in sec. 117.150(a)(1), (c) review records for implementation and effectiveness of preventative controls in sec. 117.150(d)(2), and (d) perform reanalysis of the food safety plan in sec. 117.150(f)(2).

To be qualified, an 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 the FDA” or “be otherwise qualified through job experience to develop and apply a food safety system.”

The FDA’s concern is adequate technical knowledge. The agency wants to ensure the individual is capable of identifying hazards and preventive controls specific to the facility’s industry, evaluate scientific and technical information, and manage a technical team.

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