The Food Safety Modernization Act (FSMA) was signed into law in 2011. The goal is to make the food supply in the USA is safe by shifting the focus of federal regulators from responding to contamination to prevention.
By September 16, 2016 the majority of food processors need to have a Food Safety Plan that has been prepared by a "Preventive Controls Qualified Individual (PCQI)". This means that companies need to have a PCQI in place quickly so they can prepare and implement the Food Safety Plan. This raises a couple of questions for food processors.
While the list of FSMA’s new requirements is dense and varies greatly for some types of facility, one key change that applies to nearly all food companies is the introduction of a preventive controls qualified individual (PCQI). Not only does FSMA require facilities to have a food safety plan implemented by the deadline date, but the plan must be prepared and applied by a properly trained PCQI.
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Let’s look at these one by one. First, the general route to becoming qualified as a PCQI is to take the standardized training course taught by a "Preventive Controls Lead Instructor". This is an instructor that has applied to FSPCA, been accepted and completed the Lead Instructor training course. They are able to register the class with AFDO and students will receive an AFDO certificate if they successfully complete the class. This approach clearly meets the requirements defined in 117.180 (c)(1) of the preventive controls rule.
" To be a preventive controls qualified individual, the 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 FDA."
Taking the course recognized by FDA provides the PCQI with a certificate that demonstrates they have met the training requirement, it is a clear a straightforward way to become qualified.
"or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum."
Because the rule is new, it has not been demonstrated what experience the FDA would consider as at least equivalent to that provided through the standardized curriculum. However there are some clues given in the responses to public comments. The responses state:
" There are some differences in the requirements of the human preventive controls rule compared to the requirements of HACCP regulations for seafood, juice and meat and poultry such that training provided by the International HACCP Alliance may not be equivalent. Such an individual may need to obtain supplemental training specific to the rule. Alternatively, a person who has received the international HACCP Alliance training and has implemented a HACCP plan may be qualified through job experience."
This statement does not offer a clear answer, but points out that HACCP training alone may not be considered equivalent, but if the PCQI has done the implementation of a HACCP plan they might be considered qualified.
This leaves experienced HACCP professionals asking “Is this course beneficial for me, and is it necessary for me in order to be the PCQI?” As an experienced HACCP professional and a Lead Instructor for the preventive controls rule, I do see the course as beneficial for those experienced with HACCP. As stated in the quote from the rule (above) there are some differences in the requirements of the preventive controls rule and HACCP programs. By attending this course you will learn how the Preventive Controls rule approaches the Food Safety Plan, how it is similar to HACCP, and how it differs from HACCP. It is an opportunity to understand what the FDA is looking for, and determine if your system will need modification to be fully compliant.
It is not safe to assume that because you have a HACCP plan in place you meet all the requirements of the Preventive Controls rule. There are preventive controls required in this rule other than those that are typically included as CCPs, a HACCP system may not comply with all requirements. We can see that in this response from the FDA:
" Whether a particular HACCP program implemented by a trained individual would satisfy the requirements of the human preventive controls rule will depend on whether the particular HACCP program satisfies all of the requirements of the rule."
If you are experienced with HACCP, the standard course will cover information that you already know about food safety. However, it will also help you become knowledgeable about the rule, be able to evaluate your current system and be talking the same language when the inspectors arrive. It will also give you assurance that you can demonstrate your qualification as a PCQI, and turn that “may be qualified” into a Qualified.
In the end, the true measure of a qualified PCQI will be the effective implementation of a Food Safety Plan that complies with the Preventive Controls rule.
Free download from FDA: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117): Guidance for Industry Small Entity Compliance Guide
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October 28-30, 2019
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