I have met recently with few representatives from the food industry and it appeared from our discussions that many were still unaware of the difference between the GFSI certification and FSMA compliance. For them, both equate, and the only steps required to export foods to the US market is to go through the registration process. There was some confusion about the mandatory requirement to develop and implement a Food Safety Plan (FSP) which was assumed to be the same as their existing HACCP plan, which is not the case.
Certification to a GFSI-benchmarked scheme (BRC, SQF, FSSC22000, IFS, etc.) and having an HACCP plan do not make the food facility compliant with the FSMA Preventive Controls Rule, yet it does make it ready to reach compliance.
While HACCP focuses on the determination of the Critical Control Points (CCPs) to prevent post-process contamination, under FSMA, the FSP goes far beyond the determination of the CCPs during processing to include risk-based preventive controls that are determined as critical elements in the sanitation and allergen control programs, and in the supplier chain program. The FSP must be created and overseen by a preventive controls-qualified individual (PCQI) and should be based on:
1- Hazard Analysis, identifying known or reasonably foreseeable biological, chemical, radiological and physical hazards
2- Documentation (written) of preventive controls including process controls, food allergen controls and sanitation controls, supply chain controls, and a recall plan
3- Documented implementation procedures which include monitoring the implementation of the preventive controls, corrective action, and verification procedures.
To export foods to the US market, It is mandatory to develop the Food Safety Plan that is compliant with FSMA Preventive Rule, NOT with HACCP
The difference between HACCP and GFSI compliance or to FSMA might not be practically easy to grasp without a PCQI training.
Why it is important to train PCQIs?
Under the FSMA rule, FDA is permitted to inspect domestic and foreign facilities (those based on non-US territories) at the times and in the manner permitted by the FD&C Act. As part of this, the FSP is inspected for its adequacy and any deficiencies or inadequacies identified means the PCQI (individual who developed the FSP) is not appropriately trained for the application of the risk-based preventive controls.
The difference between HACCP / GFSI compliance and FSMA might not be practically easy to grasp without a PCQI training
What may result out of this? In the event of having an inadequate food safety plan developed by unqualified staff, various scenarios are possible depending on the severity of the identified failure or if the food presents a threat of serious adverse health consequences or death to humans. Therefore, the FDA can take actions such as: suspension of the food facilities’ registration, product detention, issuing a warning letter and criminal charges and add to this the costly re-inspection visits. The cost for a foreign facility is $285 per hour.
Ensuring the FSP is prepared and overseen by a trained PCQI is certainly an added value and crucial to avoid the above mistakes. To help the food industry complies with the requirements of the Preventive Controls rules, the Food Safety Preventive Controls Alliance (FSPCA) developed the FDA-approved standardized curriculum for training PCQIs.
As a PCQI Lead Instructor, I am offering public and in-house FSPCA certified PCQI training. For more information on locations and dates, please follow the link here and navigate the calendar. You are welcome to subscribe to the newsletter to keep you updated on the PCQI training that will be organized in Germany and selected countries in the MENA region for the year 2019.