FSMA 1-on-1 with Len Steed and Cornelius Hugo

We interrupt your scheduled programming… 

I had the privilege of crashing a top secret FSMA dissection session last week. AIB’s own FSMA experts, Len Steed and Cornelius Hugo, along with about 5000 sheets of printed legal documents and handwritten notes, had taken over one of AIB’s larger meeting rooms. These men have been feverishly working around the clock since the FDA released the latest set of FSMA final rules in September in an effort to update AIB’s FSMA-related products and inform the industry about key changes in the final rule.

My abrupt interruption of their strategy session turned into an informal Q&A and I think you’ll be just as interested as I was in hearing some of their responses.

If you could pick only 3 key aspects of this 900+ page legal document to focus on, what would those they be?

Len: I think the key areas of the Preventive Controls ruling would be:

  1. Supply chain management and accountability
  2. Qualified individuals
  3. Hazard analysis

These concepts are not necessarily new to the food industry. Companies have been analyzing hazards and requiring supplier approval for quite some time. The key difference is that now each of these previously unregulated aspects of food safety are now legally required by companies, both large and small, across the entire supply chain. 

Supply chain management is a hot industry topic and a key concept with GFSI certification. What is it about this new ruling that is going to change the way the food industry manages the supply chain?

Cornelius: The food industry has always worked as a supply chain, from farm to fork, as it’s said. Up until now the supply chain has looked more like a set of unlinked chains. Along the way, much of the burden of food safety was placed at the manufacturer level, which allowed for cheating and corruption to take place both before (suppliers) and after (customers) the manufacturing process. The final rules for preventive controls place the responsibility and accountability for food safety on each individual contributor along the food chain. Meaning that each player is responsible for investigating their suppliers’ and customers’ hazards and accounting for the way those hazards are mitigated along the chain. There’s a much greater emphasis on the chain actually linking together and communicating both forward and backward to ensure that identified hazards are controlled throughout the process.
This supply chain program includes using approved suppliers, determining appropriate supplier verification activities, and conducting and documenting supplier verification activities. These activities could include onsite audits, sampling and testing, reviewing food safety records, and other appropriate activities based on the supplier performance and the associated risk. 

The proposed rule addressed the qualified individual and we were expecting the final rule to further describe the criteria food industry personnel must meet to be considered qualified individuals. Has the final rule further elaborated on this new regulatory requirement?  

Len: While the proposed rule did introduce the qualified individuals requirement, the final rule further elaborates on this newly established term and describes 4 different levels of qualifications for personnel engaged in manufacturing, processing, packing, or holding of food, dependent on position. The levels are 1) qualified employees, 2) supervisors of qualified employees, 3) preventive controls qualified individual (PCQI), and qualified auditor.

The PCQI is responsible for preparing the food safety (HARPC) plan, validating the preventive controls, reviewing records and corrective actions, and performing the required reanalysis. In order to become a PCQI, someone must complete training under a recognized curriculum or be otherwise qualified through a combination of education, training, or experience. 

The tricky thing about this new information is that a PCQI will not be found to be otherwise qualified if the conditions in the plant do not reflect the written food safety plan. In other words, a person can complete training and have years of food industry experience, but if an FDA inspector determines that the conditions in the plant do not align with the food safety plan, that person will not be found to be qualified, and the FDA could then issue a warning letter. This new information means that it will be more important now than ever before to truly create a food safety culture throughout the entire food operation from the line workers up through senior management in order to maintain food safe conditions.

How is FSMA’s hazard analysis and risk-based preventive controls (HARPC) program different from the HACCP plans that most food plants already have in place?

Cornelius: At first glance, HACCP and HARPC may look similar, but the two are markedly different. Facilities will be required to have a food safety plan for each different process or product produced, as well as for identified environmental hazards. These plans will have to include all hazards that are likely to occur and the preventive controls that are in place to control contamination and monitor effectiveness. While both HACCP and HARPC define hazards as biological, chemical and physical, HARPC adds radiological and intentionally introduced hazards to the list. With HACCP, hazard analysis is largely done for an industry using guidance documents. With HARPC, research must be performed and documented by each facility. Plus, HACCP uses the identification of critical control points, whereas HARPC uses the identification of preventive controls.

While HACCP makes use of sanitation standard operating procedures, HARPC’s preventive controls rule includes sanitation and allergen control programs, plus a recall plan, environmental monitoring, corrective actions, verification/validation, supplier verification, and reanalysis. 

Companies currently operating using a documented HACCP plan should be able to effectively offer documented raw material and process hazard analysis that identifies raw material and process-related hazards to be controlled by preventive programs. It is expected that regulators will identify any missing or inadequately defined hazards for raw materials and process during their physical inspections. One potential area of concern is that the content in a plant’s monitoring of preventive programs matches up with the regulator’s findings during a physical inspection. If plant or management personnel cannot adequately explain preventive controls or show objective evidence in monitoring records that identified hazards have been effectively controlled, it will be of great concern. It is anticipated that HARPC inspections will be more assertive, comprehensive, and inspection-oriented with enhanced enforcement. These regulatory requirements require an in-depth review of existing preventive controls and additional employee training to prepare for coming changes in FDA inspections.

AIB's Commitment

AIB’s professional staff have been reviewing and interpreting FDA’s latest updates and have updated our suite of training tools to help you comply. The FSMA: Pathway to Compliance seminar is offered at different locations throughout the year to give you practical advice for updating your food safety and food defense programs and we update the course content each time a final rule is published. Make sure your current food plant programs meet FSMA requirements with a FSMA Readiness Assessment. We’ll gauge your current food plant programs and suggest updates so you can discover and correct weaknesses before an FDA inspection and impress your customers with program improvements. If time is an issue, try our FSMA Awareness Webinar series to help you understand what the rules mean for your plant.

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