The processed food industry has evolved over the past several decades to keep pace with food safety advances, including the development of HACCP and, more recently, the implementation of GFSI-benchmarked food safety management programs. The implementation of FSMA is yet another revolutionary change that will have tremendous impact on the industry. Why? Because the food safety programs within facilities are no longer voluntary. They will be evaluated by FDA and require documentation and justification in a format that will be accepted by an FDA inspector, which is not necessarily the approach of a food manufacturer today. “Because we’ve always done it this way” won’t necessarily hold up with an FDA inspector in this new era. While documentation and record-keeping around historical PRPs is taking on new importance, in the pre-rule days, progressive companies realized that the “HACCP system” encompasses PRPs and care and attention was paid to them. One GFSI-benchmarked scheme goes so far as to call out operational PRPs that are required for the assurance of safety. That said, there may be instances where a regulator observes a process that they might consider a CCP only to find that the facility considers it a PRP. This will most commonly occur when a product is cooked to quality, far surpassing safety. In other words, in order to produce an edible product, the process by definition exceeds the conditions required for safety. An example could be cooked, ready-to-eat pasta. Another FSMA-related issue companies need to be aware of is managing the inspection process. As FDA transitions to a mentality where they are looking at the totality of food safety that results from a comprehensive approach to food safety, we can anticipate there will be times when a company and a regulator do not see eye to eye. This is part of the reason that being able to demonstrate thoughtful consideration of the programs and policies in place is imperative. We anticipate that FDA will release guidance documents to illustrate implementation options to firms. However, since many companies already implement, in one form or another, several of the programs that are now required by regulation, they may have approaches that differ from what is stated in the FDA guidance. We are hopeful that FDA will develop an escalation and appeals process so a company has an opportunity to share its justification of a specific decision or process with subject matter experts at the agency in order to gain recognition and acceptance of valid approaches that may stray from provisions specified in FDA guidance. Members of the food industry can take several steps now to begin preparing for compliance and the changed inspections:
- Review food safety plans and ensure that they include CCPs, preventive controls such as supplier verification and recall plans, and PRPs.
- Ensure sufficient documentation exists for every aspect of the decision-making process that identifies what is a CCP, PC, and PRP.
- Conduct a mock inspection of your facility to gauge preparedness and assess whether staff knows where and how to access relevant information in a timely manner.
FDA has indicated that it will be developing multiple guidance documents to aid the industry in FSMA implementation. In addition, several other groups, such as university Extension offices, consultants, and associations such as the Grocery Manufacturers Association, are launching comprehensive education and training programs as a resource to assist companies in filling the gaps that might be identified.
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