What is an inspection? What is an audit? How are they different? And how do they fit into FSMA?
As the song goes, “Let’s start at the very beginning, a very good place to start.” At the very beginning of the Food Safety Modernization Act (FSMA), audits and inspections are defined, and it is made clear where they fit in the overall design for the production of safer food.
Inspections - A Reactive Approach
When I ask government-related lawyers or consumer groups what an inspection is, they typically describe it as an activity where FDA enters a facility to physically examine its condition. This most often occurs when a negative food safety incident has been identified. Interestingly, AIB International’s Consolidated Standards for Inspection were originally developed as a response to the food industry’s call for help in managing FDA inspections. A food plant inspection is, by definition, a physical examination of the facility.
FDA Moves Toward Audits
In working with FDA during the development phases of the new FSMA requirements, I heard mention on several occasions, “We (FDA) need to learn how to audit.” Meaning, the inspectors would have to change their approach from a physical examination to an understanding and review of records assessing the adequacy of programs and compliance with policies and operational procedures. This shift toward program review was done intentionally in an effort to encourage the development of programs that aid in the prevention of food safety incidents, rather than simply responding after the fact.
The Broken International Supply Chain
The reality is that the proactive use of both activities is critical to developing the preventive food safety culture that FSMA is attempting to establish and regulate worldwide. In the U.S. and internationally, the supply chain provides products from farm to fork and the level of food safety compliance in that chain varies greatly.
FSMA puts the burden of managing food safety in the hands of the producer or, in the case of imported products, the purchaser or broker. Ideally, the food chain would have stage-gates with checks on safety, and all processes and programs would be followed rigorously with a well-managed audit trail.
However, the food supply chain is not that orderly. FSMA will require audits for high-risk facilities in the U.S. as well as international companies wishing to export product to the U.S. And, of course, the audit review must take into consideration controlled safety of the food producer’s supply chain.
Safe from Start to Finish
Embedded within FSMA’s emphasis on audits is the requirement that food safety fundamentals, good manufacturing practices, and prerequisite programs are met. By definition, FSMA’s focus on prevention requires that production facilities, storage and warehouse units, and transportation throughout the supply chain can demonstrate that their food products do not present reasonable belief that the product will cause serious adverse health consequences or death to humans. This must be done on paper and in practice.
Preparing for FSMA Audits
There are many producers, both domestically and abroad, that are not yet prepared for FSMA’s requirements to take effect or for the audits that will be required. Training and preparation for audits and inspections will be the key to success of any program. This training must be targeted at all levels, from the corporate suite to floor managers. FSMA is a game changer. The oversight that we have known in the past will continue, but the bar has been raised and expectations enhanced.
The role of audits and inspections in FSMA is to ensure that producers are following science-based preventive practices that will lead to production of safe food. These activities will impact food producers and their supply chains worldwide.