With the travel restrictions surrounding the coronavirus (COVID-19), the Food and Drug Administration (FDA) and other agencies have been forced to change the way they routinely handle food audits and inspections.
“Currently, FDA has suspended routine food safety inspections,” said Earl Arnold, manager, food defense/FSMA quality assurance, North America, for AIB International. “They are continuing for cause inspections, while providing support and oversight on recalls.
Baking & Snack asked Mr. Arnold, one of the leading experts on FDA inspections and audits, on what to expect on the inspection front with various travel and stay-at-home restrictions and what inspectors may be looking for if they show up at a food facility.
Overall, the FDA, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration and other government agencies are providing a host of guidance on their websites. However, ultimate answers to many questions involve assessing the facts of each case individually and often in conjunction with local or state jurisdictions.
AIB International, for instance, is providing an array of virtual services, such as remote consulting, virtual inspections and online instruction and training, for the international baking community.
Additionally, its instructors are providing free weekly webinars as well as the latest resources on COVID-19 and food safety at www.aibinternational.com.
Baking & Snack: What areas of an FDA inspection might be more important now than in the past?
Earl Arnold: Though FDA has suspended routine food safety inspections, there are two areas of the audit that might be more important than ever, the first of which is sanitation. More emphasis may be needed on daily cleaning tasks for areas such as doors, break rooms and restrooms. Additionally, some facilities may be conducting longer production runs with fewer products.
This could create issues they have not considered before. The second area of importance is the self-inspection program. This should be more focused on reviewing personnel practices like washing hands, monitoring signs of employee illnesses, confirming that equipment cleaning and maintenance is occurring as needed, and other items.
How are they determining which ones to visit because of travel restrictions?
FDA is only visiting those facilities that are involved in potential food safety issues like customer complaints to FDA that may be the result of unsafe food, or in the event facilities initiate a recall.
What is the proper way for a food company to handle a situation where they have concerns about the health of a government or outside inspector wanting to inspect their bakery?
FDA has stated they will work with facilities to ensure worker health and safety. Some agencies are providing letters stating the health of the inspector, while others are submitting to temperature checks. FDA has also stated they could review records remotely.
What is FDA looking at more closely because of the COVID-19 situation?
Before this health crisis, FDA had been focusing most of their routine inspections on a “back to basics” philosophy. Most of the areas that facilities should be focusing on are included in the regulatory common good manufacturing practices, such as hand washing and employee illness.
Additionally, the Food Safety Modernization Act asks facilities to review food safety and food defense plans when significant changes occur. As this health crisis continues and facilities modify production, hire more temporary personnel and make other changes, each needs to be reviewed to determine if new or temporary controls are needed.
What GMPs are most critical now? Any good tips?
Adhering to the GMPs is critical. This includes washing hands frequently and as required, wearing food safety equipment and uniforms correctly, and employees reporting to supervisors when they are not feeling well. Also important are cleaning programs, as daily cleaning schedules may need to be increased and should include handwashing sinks, restrooms, common employee areas and high-traffic areas.
What is AIB International providing in terms of virtual services?
Our virtual solutions include training, inspections and consulting. Each of these are convenient, cost-effective and provide our expertise without travel. Being virtual also gives manufacturers the opportunity to immediately apply what they've learned and raise the standard for food safety in their facilities.
