- About 61% of U.S. food and beverage professionals said they feel their organizations are prepared to comply with FSMA regulations this year, according to a recent survey conducted by enterprise quality management software maker Sparta Systems, Inc.
- About 43% of respondents agreed that FSMA requirements will lead to improvements in visibility and safety throughout the supply chain.
- However, only 7% of respondents said their operations were fully automated, and automation is considered a key component in managing FSMA compliance for tracking and reporting food quality and safety. About 38% said their organizations have manual systems, and 56% said their processes were partially automated.
While this survey may paint a rosier picture of FSMA preparedness, other survey results have not been as positive. In another survey published last month, 68% of respondents said they were "somewhat ready" for FSMA, while only 25% confirmed they were ready for FSMA. Another 6% admitted they weren’t prepared at all.
In many cases, manufacturers believe the transition to the new regulations will be as simple as having a HACCP plan, prerequisite programs, and GFSI certification. But that may not account for all of the preventive measures and documentation that FSMA regulations now require.
The FDA does recognize that this is a process. Warning letters to companies have increased by 41% since FSMA was enacted in January 2011. But, "Providing there is no risk to consumers, FDA most likely will allow a facility to become compliant," Jim Cook, food scientific and regulatory affairs manager for SGS, a global cGMP and HARPC training and education provider, told Food Engineering.
Once manufacturers determine preventive measures and ensure they work, the next crucial step is documenting those procedures and their results in a way that is acceptable to the FDA. For many manufacturers, they have already been following the regulations all along but just haven't known best practices for documenting their processes.
In addition to FDA resources, manufacturers that need help developing and documenting their FSMA compliance plan can seek assistance from organizations like the Food Safety Preventive Controls Alliance. For certain products and product categories, manufacturers have collaborated through various associations to develop general HARPC programs they can then tailor to their individual operations.