Preparing for Inspections
Though they can be a source of worry, the fact of the matter is that many animal food facilities often think about preparing for inspections as the inspectors walk through their doors. One of the reasons for this is because the "what if" questions can be large in number, and so facilities get frustrated with trying to come up with a plan. With this in mind, we asked some regulators what advice they have for facilities in order to be proactive and help make the process go more smoothly. This document presents a number of practices that are not required, but might be useful as facilities prepare for, are subjected to, and evaluate the results of inspections.
What regulations are you required to comply with?
It is important to first know and understand the regulations your facility is required to comply with. Inspections can be comprehensive, covering multiple regulations at a time. Some regulations* to be aware of are:
- Food Safety Modernization Act
- Bovine Spongiform Encephalopathy (BSE)/Ruminant Feed
- Veterinary Feed Directive (VFD)
- Medicated Feed Current Good Manufacturing Practice
- Bioterrorism Preparedness and Response Act
*This list is not all-inclusive. It is the responsibility of each facility to determine which rules/regulations apply.
In addition to having multiple inspections occur during a single visit, multiple inspectors may also be present. This allows inspectors to learn from one another as they visit different facilities with different operations or record-keeping practices. As new regulations are passed and implemented, inspectors are learning at the same time as the facilities and are educating before and during regulatory activities.
Assemble an inspection team
Routine inspections are generally unannounced and may occur on any date and at any time during normal working hours for the facility. Having an inspection team is not a requirement, but could be helpful in the inspection process.
Think about who will accompany the inspectors in your facility. Having multiple people prepared to accompany inspectors is a good practice just in case inspectors arrive on a day your primary person is not there. Any employee that may have this responsibility should be knowledgeable of the whole operation and where the required and relevant records for each regulation are located. In some cases, the same record may be relevant to more than one regulation. Discuss instances where this may be the case and prepare accordingly. For example, will you choose to duplicate records, or will they be located in only one place (binder, file drawer, etc.) with cross-references listed as needed?
An inspection team may be made up of members of your food safety team, management, quality control or other staff familiar with processes and records. As an example, facilities that are required to comply with the Preventive Controls for Animal Food rule of FSMA should have a member of their on-site staff who can explain the facility’s food safety plan and hazard analysis, even if this person isn’t the designated Preventive Controls Qualified Individual (PCQI). Someone should be able to speak with an inspector about how the hazard analysis was conducted, how hazards were determined and evaluated, and produce referenced SOPs, relevant records and any preventive control management components.
An inspection team can be useful in preparing a facility for inspections. Use this group to determine facility-specific policies for inspections and to prepare facility staff for their roles during inspections. It is not required for all employees to engage with inspectors, but it is helpful to inspectors if employees can answer simple operational questions about what they are responsible for in order to better understand the facility.
Interacting with inspectors is up to the management of each facility and should be discussed prior to inspections. If employees are allowed to speak with inspectors, they should be comfortable explaining their job tasks.
For example: To lessen anxiety about answering questions from inspectors, management may prompt employees to explain to inspectors what they do and how they do it.
When visitors or inspectors arrive at a facility, it is important that it be made clear where they should report. It is not a good practice to allow visitors to wander around a facility looking for their point of contact. Facilities may choose to have signs posted to direct visitors to a specific area with sign-in sheets to wait for further instruction.
If your facility has biosecurity procedures in place, this should also be communicated to visitors prior to entering the facility.
For example: If a visiting inspector is unable to meet the requirements of the facility’s biosecurity policy, a discussion with the inspector about options for completing the inspection should be held. Such discussions will often include upper management for the facility as well as regulatory personnel.
Upfront communication is important. Once a visitor steps into a facility, it may be too late to implement biosecurity protocols. These protocols should be written and visible to all visitors and employees arriving on site. This does not imply that facilities should call inspection agencies to communicate biosecurity policies, but rather that facilities should be prepared to have these conversations when inspectors arrive on site. Inspectors may not legally be allowed to sign all documentation, but are allowed to answer yes/no to biosecurity questions. If your facility requires PPE, have it readily available beforehand.
Facility and document inspections
As part of FSMA, a walk-through inspection is conducted to evaluate Current Good Manufacturing Practice (CGMP) compliance. Have an individual or team responsible for escorting inspectors around the facility. Inspectors should be accompanied by a facility employee at all times during a facility tour. It is helpful for the tour to be planned, though it is not necessary for the tour to go in order of production. Keep in mind any biosecurity or zoning procedures in place to minimize cross-contamination, if necessary, and communicate this with the inspector.
For example: if your facility is concerned with cross contamination from raw ingredient receiving, you may decide to start the tour with finished product, or loadout, and proceed with the tour in reverse, ending with raw ingredient receiving in order to prevent contaminating the finished product with pathogens from raw ingredients.
After the facility walk-through, have a space prepared for inspectors to complete document inspections. You may choose to have an employee or employees available during the inspection to provide documentation as requested. Facilities may choose to provide documentation and records in a number of ways, but the process should be streamlined so that employees can find information quickly and efficiently. The longer the process takes, the longer the inspection will be and it becomes more likely for inspectors to see potential violations.
At the end of each inspection, inspectors should conduct a closeout meeting. This meeting will capture the important findings from the inspection. Facilities should have a responsible team member or group present to record these findings and communicate them to management. The employee present for closeout meetings should be able to make decisions based on the results of the inspections and communicate any issues as needed. If the designated individual is not available for the closeout meeting, inform the inspectors and be prepared to have a backup.
Closeout meetings also communicate corrections that occurred during the inspection to management or designated employees. These meetings prepare the facility for information letters or corrective action plan letters that might be sent as a result of the inspection findings. The final actions by the regulatory agency will depend on the inspection history of the facility, violations, and corrections or corrective actions taken by the facility during the inspection.
Once a letter is drafted and sent to a facility, it is important for the facility to respond. It is not required, but shows the facility has acknowledged the findings. The response is recorded as part of the facility’s inspection history and helps to build a relationship with the regulatory agency.
Publication date: July 22, 2020
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