The Role of Qualified Individuals in FSMA

AIB UPDATE - Features

What will be needed to understand and implement Part 117: Current GMPs, Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food?

December 11, 2015

The final rule for the current Good Manufacturing Practices (cGMP) and requirements for Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food was issued in September 2015 with some significant changes. The definition for qualified individuals has a much broader implication in that it affects all personnel including operators, supervisors, and preventive control qualified individuals (PCQI) who must attend FDA-recognized training currently provided by the Food Safety Preventive Control Alliance (FSPCA) or be otherwise qualified through job experience to develop and apply a food safety system.

So how does this new definition impact your existing prerequisite programs and HACCP plan? What additional information for hazard analysis and implementation will be necessary to prepare for regulatory inspections set to occur for most companies in September 2016? Qualified individuals must analyze, implement, maintain, and update their risk-based preventive controls, otherwise known as prerequisite programs, process steps, operational practices, and plant environment.

The annual Reportable Food Registry Report (RFR) lists the different categories of food/commodity, the number of recalls associated with each product, and the stated hazards.

There are basically two ways to be designated a high-risk or not high-risk food for facilities required to register with the FDA. Your facility could be designated as high risk if your regulatory compliance history indicates that your facility had either official or voluntary action indicated to correct unsanitary conditions. High-risk facilities can expect a regulatory inspection every three years and not-high-risk facilities can expect them every seven years.

Once you’ve determined if you are a high-risk or not-high-risk facility, the next step is to thoroughly read and understand how the new cGMPs have emphasized allergen cross-contact prevention in your operation. It is expected that the facility would have to evaluate any preventive control in place to prevent cross contact and/or to prevent an undeclared allergen in product from entering commerce. Even if allergen control is not applicable to your plant, the cGMPs are applicable to all facilities with the goal of preventing unsanitary conditions that could result in contaminated food.

If your product is classified as ready to eat (i.e., normally eaten in its raw state or any other food including processed foods) then preventive controls would have to be in place to significantly minimize any biological hazards, namely Salmonella and Listeria. Facilities would have to evaluate possible contamination situations through an environmental monitoring program and/or operational conditions that could allow for unsanitary practices. If your organization does not have personnel competent in the application of microbiological controls, it would be best to get that expertise prior to evaluating biological hazards requiring preventive controls. The PCQI, or a group of personnel given that task, should be aware of any regulatory guidance documents, including foreign countries if applicable, for that product or commodity. To view the list of guidance documents available from the FDA visit:

The PCQI will be responsible for developing the following documentation:

  • Preparation of a food safety plan(s).
  • Validation of preventive controls.
  • Review of records for implementation and effectiveness of preventive controls.
  • Appropriateness of corrective actions.
  • Reanalysis of food safety plan.

Hazard analysis must be documented regardless of the outcome. Additional preventive controls that are necessary to prevent an inherent hazard in raw materials or the product and conditions in which that product has been produced must be identified, as should the entity that will control the identified hazard. The hazard categories include biological, chemical, physical, radiological, and economically motivated adulteration (EMA). You will have to determine who controls identified hazards: the supplier, supplier to the supplier, receiving entity, or customer.

If the hazard is controlled by someone other than the receiving entity, then the facility will have to establish a supply-chain program (as detailed in Subpart G). If a facility elects to have the supplier control the identified hazard, it will be required to have a supplier-verification program that includes:

  • Onsite audits.
  • Sampling and testing of raw material or other ingredient.
  • Review of the supplier’s relevant food safety records.
  • Supplier performance review:
    • Supplier’s regulatory history.
    • Audit results, actions taken, product testing, COAs, etc.

This section is new and can be quite involved depending on the complexity of the supply chain. FDA will be issuing more guidance and expectations for this requirement.

Although HACCP principles were used to develop the framework and requirements for these new cGMP and risk-based preventive controls, it is quite clear that additional documentation and evaluation is necessary to demonstrate effective implementation. This will require facilities to take a fresh look at their prerequisite programs, process steps, and plant conditions to provide documented hazard analysis and conclusions for having or not having documented preventive controls. For FSMA training or an evaluation of your current compliance status visit,


The author is Global Manager, Food Safety Services Innovation, AIB International.