Some rules regarding facility visits and inspections are no brainers, but others raise questions which do not have a simple answer or solution. Facilities often face challenges with important company policies regarding visits and official audits, but what about the not-so-common, such as employee interviews, requesting true documentation, taking photos, swabbing, and collecting samples. These events often yield a more exciting and dynamic outcome posing the big question, “Can the inspector do that?”
Not all facilities are aware, nor comfortable, with FDA’s legal right to interview personnel to assess the qualified individual requirements included in the Food Safety Modernization Act (FSMA). However, FDA investigators will and can assess compliance with this requirement based on the results of the inspection, including interviews with employees in charge of preventive controls, such as process, allergen, sanitation and supply-chain preventive controls.
Facilities need to review their employee training program to assure that all relevant qualified employees are properly educated and trained as appropriate to their assigned duties and responsibilities to enable them to manufacture clean and safe food products. Many food companies have not made the necessary changes at the operator and supervisory level in their GMP/food safety training that reflect the new requirements contained in FSMA for trained personnel.
Not all facilities are aware of the FDA’s legal right to request copies of documents related to manufacturing/processing, packing, and holding of food for review. Some are not aware of the 24 hour limit to make copies of requested information available.
Though it differs, some facilities depend on their corporate office to make such documentation available to the FDA. It is important that each facility updates its documentation retention and maintenance policy, as well as the protocol to make pertinent documentation available to the FDA upon request.
This policy should include:
- A list of documents, which must be made available to the FDA upon request, according to Part 117 of FSMA. By exemption, all other documents would not be subject to request by the FDA.
- A list of pre-approved documents at each facility that can be given to the FDA immediately to facilitate delivery as soon as possible within the 24 hour limit.
- A list of company documents that the FDA does not have a right to request, such as sales data, financial records, employee health records, etc.
While the FDA’s authority to take photos while inspecting a facility has been a contentious issue over the years, the agency insists on its legal right to do so and is training is investigators accordingly. Some facilities currently allow taking pictures, others refuse permission, while others offer a compromise such as them taking the pictures and making them available to the FDA.
It is essential that your facility develops and implements a written no photograph policy to include research and understanding about the legal cases the FDA used to develop its arguments for its rights to take photographs. The policy should include the necessary flexibility to accommodate FDA’s “rights” to take photographs if it is believed that the inspection will not be a positive experience if a reasonable accommodation is not made. Pertinent personnel should be educated and trained to address a situation when an FDA employee insists on taking photographs.
Don't fall victim to challenging inspection scenarios where unknowns may exist due to lack of updating and preparation. The outcome could cost your business a loss of productivity as the outcome could be additional official activity by the FDA. AIB's FSMA Compliance Connection gives you the tools needed to engage your food safety team and track your compliance efficiently so you'll have time to focus on the important stuff (like making a safe, quality product).
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