As a 10 year milestone of the Food Safety Preventive Controls Alliance (FSPCA) Preventive Controls Qualified Individual (PCQI) training launch, it seemed only appropriate that we celebrate by giving our take on the most recent Version 2.0 updates to the curriculum and training program. On February 11th, we hosted our first informal, client-only webinar on the topic and had a great turnout, so we decided to turn the highlights into a blog. Clients: stay tuned for more learning opportunities as a perk of working with us!
Both Jennifer and I were among the first to attend the FSPCA Lead Instructor training when it rolled out in 2015 - in fact, they were still pilots at this point! Recently, we attended the Lead Instructor 2.0 refresher courses in December and January, and came away with similar priority areas that we felt were worthwhile to share. Overall, attending the refresher was a great opportunity to revisit the changes (and refresh our memories!), visualize the evolution of the program, and better understand new approaches to hazard analysis.
Please note that PCQIs are not required to take the Version 2.0 training, though there may be benefits to better understand FDA’s current thinking since the curriculum has been updated to incorporate all of FDA’s guidance information that was issued after Version 1.2 was published. Lead Instructors are required to take the training if they want to deliver the V 2.0 training in the future (Version 1.2 will be phased out on June 30, 2025). If you are interested in attending the training, check out the FSPCA’s website for course listings.
Overall, most of the content changes to the training were related to conducting the hazard analysis with a greater emphasis on evaluating ingredients and supply chain controls. The training materials got an upgrade too. Additional edits were made to provide more detailed information for the model food company used in the participant exercises and knowledge checks, incorporation of updated FDA references, and inclusion of examples that may be more relevant to small/mid-size food producers. As a visual learner, I appreciated that the new training slides also contained more pictures and easy to understand graphics which made for a more engaging learning experience.
Here’s a few of our takeaways that might be valuable as you revisit your food safety program, and in particular, your hazard analysis. These insights are based on what we took away from the FSPCA V 2.0 Lead Instructor refresher training and our personal observations in working with industry members directly.
A major emphasis was placed on evaluating ingredients individually. This includes an evaluation of both the inherent hazards (e.g., for fresh produce, what pathogens could be likely introduced in the field) related to the ingredient as well as the hazards related to the process/facility (e.g., are there processing steps such as chopping/slicing that could introduce a pathogen from cross-contamination issues).
PCQIs and food safety practitioners should consider spending time reviewing FDA’s updated Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry released (Jan. 2024). The revised Appendix 1 may impact your hazard identification and hazard determination process. The new version of the training relies heavily on being able to utilize and navigate this document. Are you required to include the hazard in your plan if it is listed in FDA’s Appendix 1? You definitely should evaluate it and be prepared to justify your decision since you may find many regulators who will hang their hat on this document during the inspection process. While the revised Appendix 1 isn’t perfect, it does provide a good basis for considerations as you work through the hazard evaluation process. On the FSPCA hazard analysis template, column 4 (justify your decision column) is where you should spend a significant amount of time defending why/why not the hazard requires a preventive control, regardless of its inclusion on Appendix 1. This is a shortcoming of many hazard analyses that we review. Take advantage of the opportunity to explain your thinking.
Speaking of hazard identification and evaluation, one of the concepts emphasized during the training was to work through the hazard analysis worksheet vertically by column rather than horizontally (i.e., focus on hazard ID first – columns 1 & 2, then populate the columns 3 & 4 for whether a preventive control is required and your justification). This approach allows you to more thoroughly identify ALL hazards before diving in to whether they should be addressed with a preventive control or are OK being managed through your pre-requisite programs. Jennifer outlines some great tips here on some common mistakes in conducting the hazard analysis, including the importance of the justification of your decision.
I appreciated the additional discussion about how to determine whether a hazard is being adequately controlled through a pre-requisite program or whether it should be elevated to a preventive control. The two can be difficult to tease apart, for example – when is the master sanitation program appropriate and when would a specific sanitation control be required to address the hazard? As a refresher, here is the definition of a hazard requiring a preventive control:
A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
Essentially, think about the food someone is going to eat. What really needs to be managed to keep that food safe? If an activity or program is critical, it’s a preventive control, not a GMP.
Companies are encouraged to use trusted data sources to justify decisions – this includes leveraging the FDA’s data dashboard for warning letters, import alerts/refusals, recalls, and other supplier history information. This should be paired with your own historical information from your facility’s performance and product line(s). Remember - use these data sources in the ‘justify your decision’ column of the hazard analysis!
In light of these data and trends, FSPCA did place more emphasis on supplier evaluation and supply chain preventive controls since this seems to be a loop hole for many operations and an area that could present a major weakness to the overall food safety system. The instructors emphasized that the hazard must be evaluated for EACH SUPPLIER, not just for the product overall. For example, if you purchase shredded cheese from one company, but they have two different facilities that produce it for your purposes, BOTH facilities need to be evaluated as suppliers since their processes, programs, and assurances may differ.
A good reminder - validation is only required for process controls. Though you can do validation for other preventive controls, validation is only required by FDA for process preventive controls. Nothing new here - just a note since a few slides in the training were updated to roll validation under verification activities.
FSPCA’s Form 0064 – I found this to be a super helpful tool that helps to outline applicable regulations for different food facility types. Think of it as a quick reference tool to get you and/or your suppliers pointed in the right direction.
If we could recommend spending time and energy in any one place - it would be on your hazard analysis since this serves as the foundation for your entire food safety program. The FSPCA V 2.0 training provides a good starting place to learn the best approaches. If you still find yourself struggling to draft or update your hazard analysis or you simply need a second opinion or set of eyes - don’t hesitate to reach out to us!
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