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One of the fundamental dilemmas very small facilities face is the need for a thorough food safety plan review, which often takes additional personnel time and resources that are not readily available. With that in mind, AIB created a free guide that helps gauge how prepared your facility is for compliance with the Preventive Controls Rule for Human Food (Part 117 of FSMA).
According to the FDA under Part 117, very small facilities are defined as businesses that average less than $1 million dollars per year in annual sales. The compliance deadline for facilities that fall into this bucket is September 17, 2018.
“As the deadline gets closer, very small facilities are thinking more seriously about the compliance status of their current food safety programs, and now actively searching for solutions.” said Stephanie Lopez, Vice President of Food Safety Services, Americas, AIB International.
Part 117 isn’t just about developing and implementing a food safety plan, there’s also an element of adding a preventive controls qualified individual (PCQI). PCQIs are responsible for:
Having access to a PCQI or training an employee allows very small facilities to meet the regulatory requirement. Taking a PCQI course will provide the information and tools needed to develop a FSMA-compliant food safety plan. All FDA investigators are taking the FSPCA Preventive Controls for Human Food course, so developing a food safety plan which reflects the expectations of the course, will go a long way in making an FDA visit much more successful.
There can be some unique challenges with these new rules. Most very small businesses have never swabbed their building or surfaces before and now must have a zoning plan with pre-planned corrective actions in the event the results are not what was expected. Finding an appropriate laboratory to do testing may be a challenge. Finding the time to document these changes is proving difficult as well, as many facilities do not include documentation review or training in their budgets.
The beauty of Preventive Controls for Human Food is that facilities decide where significant hazards are and how to control them. Facilities can choose to do a visual inspection after cleaning to ensure it is clean, or other methods that would reasonably demonstrate the hazard is minimized.
Food safety is no longer a competitive disadvantage since FSMA was signed into law in 2011. And a food safety plan goes beyond being compliant, it’s a management tool that can and must be used to manage food sanitation and safety effectively, but at minimum cost. It is the platform that allows development of Key Performance Indicators (KPIs), which are used to minimize inefficiencies related to food sanitation and safety programs and activities.
One thing very small facilities are known for is mastering unique challenges with ingenuity and a limited budget. This grassroots approach leads to brave new solutions with a total facility team effort. But FSMA compliance doesn’t have to be an all hands on deck approach, AIB International can help and the first step is to view our free download. AIB can save you time and offer practical, affordable solutions!
I am confused! your little guide and this article give the impression that very small businesses are subject to the full requirements of PCHF in Part 117.Very small businesses are qualified facilities and qualified facilities are exempt from the requirement of PCQI and the provisions in Subparts C and G!!Please clarify and advise.
Thank you for your inquiry regarding our blog post on PCHF Part 117 for very small businesses.There is a subtlety that may not have come through in our blog and we will clarify that.Very small business are only exempt from the requirement of PCQI and the provisions of Subparts C and G if they submit an attestation (Form 3942a) to the FDA requesting these exemptions. This was explained in the very final paragraph of the Challenges and Exemptions section.Here is an excerpt from that section:Very small facilities that are approved as qualified facilities fall under Subpart D which is the “Modified Requirements” section.They are only required to comply with some of the new rules. For example, they would be exempt from Subparts C and G (Preventive Control Rule and Supply Chain Program). In order to be considered a qualified facility, a company must apply and submit attestations, or evidence, that they meet the requirements.I hope this helps. If this is still unclear or you have further questions, I would be happy to put you in direct contact with one of our FSMA Subject Matter Experts.
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