Who can develop a food safety plan?
Do you have a Preventive Controls Food Safety Plan? Has is been developed by a Preventive Controls Qualified Individual (PCQI)?
For FDA regulated facilities, understanding who can develop a FSMA-compliant food safety plan is important to ensuring your inspections with the FDA go well. Regulatory inspectors and third-party auditors will want to see that your food safety plan has been developed and is being overseen by someone qualified to do so, and fortunately, the regulation explicitly defines who is qualified.
A food safety plan must be developed by a PCQI. A PCQI, or Preventive Controls Qualified Individual, is a person qualified through either standardized training or extensive job experience to develop and apply a food safety system with risk-based preventive controls. According to 21 CFR 117.180, only a PCQI may perform or oversee the development, validation, reanalysis, and record review of a food safety plan.
The role of the PCQI involves assessing potential risks in a written hazard analysis, designing and implementing preventive controls, monitoring their effectiveness, taking corrective actions when necessary, and documenting all of the above activities. By having a PCQI overseeing the food safety plan, companies can effectively address potential hazards, reduce the risk of contamination, and ensure compliance with regulatory standards.
A PCQI develops the FSMA-compliant Food Safety Plan for fresh fruit processing facility.
A PCQI may be an employee of the company but is not required to a be; a food safety consultant may serve as the PCQI if needed. A facility may choose to employ more than one PCQI, and it is often helpful if more that one member of the food safety team has received PCQI training. Multiple PCQIs on a food safety team can contribute to greater team ownership of the food safety plan, and the training provides a common language for discussing food safety concepts.
In addition to the regulatory requirement, having a PCQI demonstrates a commitment to food safety, instills consumer confidence, builds brand strength, and protects public health. A PCQI will give your operation the expertise needed to develop a food safety plan that effectively reduces food safety risk for your customers, while simultaneously meeting the FDA’s expectation for qualification.
A PCQI develops a FSMA-compliant Food Safety Plan for a potato chip manufacturing facility.
