Avoiding The Pitfalls Of Recordkeeping and Sanitation Under FSMA

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit you records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

• Be kept as original or electronic records or true copies
• Contain factual observations and values
• Be legible, permanent, and accurate
• Must be done in real time
• Include the detail required to create a history of performed work
• Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product