MEMBERS HELPING MEMBERS
PMA reached out to members for advice on FSMA inspections. We asked each member: What tips or advice would you give fellow growers and shippers regarding the best way to prepare for a FSMA food safety inspection? Responses include advice they wish they’d known prior to the inspection, successful approaches they have implemented to prepare their workforce for when inspectors are on-site, responses and outcomes when a challenge arose, knowing company rights in an inspection, which FSMA rule applies to their operation, and more.
Thank you to our industry contributors who took time to offer their thoughts and advice relevant to FSMA inspections, whether by FDA or state inspectors, for the benefit of all PMA members. We count on them for thoughtful, relevant advice.
When it comes to FSMA inspections, "never forget, the goal is to protect the consumer, your employees, and your business and business partners, not just check the box that says you passed or were complaint with the minimum requirements."
It is important to understand that under FSMA, the FDA FSMA compliance inspections can be conducted at any time, without any advance notice. As one contributor said, "you need to do the right thing every day as you can’t prepare for inspections, which are often not announced." Every day is audit day.
Below are some suggestions and lessons from our members on FDA FSMA inspections.
Documentation, Documentation, Documentation
During any FSMA inspections, the inspector will spend time doing a document review. Make sure to keep all your food safety related documentation current and organized.
All of the rules under FSMA are important, but your records are your proof that everything you say you do, was actually done. Make sure your records are in order and that you have a back-up person who knows where they are located in case the main person is out.
Holding internal meetings with mangers, supervisors, farming and packing operation contractors, and any other personnel deemed necessary prior to inspection is key. Make sure everyone is prepared and knows where and about all documents that are used during audits/recalls.
When an inspector arrives, it is OK to ask for a document review list so that someone can collect all the documents that are needed. Having your team understand and know where your documentation is allows you to not extend the time of an inspection.
In the event you do not have a needed document or register, be transparent. Let the inspector know but make a note so you can improve your program and make sure to have it signed by management and shared with the inspector in follow-up.
Sampling during an inspection is authorized and must be accommodated. If sampling is performed, make sure to document all aspects of that process in writing and pictures, and obtain a receipt from the inspector describing the samples. Taking duplicate samples during an inspection is not productive or a winning strategy.
Be Prepared
Assign a primary and backup employee to lead and shadow inspections. At least one of them should be a person who is on site during normal, daytime operations.
The person leading the inspection should know their company inside and out, meaning seasonality, products, acres, all activities that involve land prep, planting, cultural aspects of the labor force, etc. They should also have the knowledge on the FSMA rules, know the difference between the Produce Rule and Preventive Controls Rule, and where your operation fits and why with respect to those two rules, so when he or she is asked a question you have the assurance that what you are doing is in accordance with FSMA.
Create a set of written guidelines and policies for inspections, and train those who will lead the inspections as well as senior operations managers at least annually. Everyone in your company should know what to do if/when an inspector shows up – from the CEO to the receptionists that answer the phone.
Make sure front office staff or facility point-of-contacts know who the appropriate company contacts are so that when an inspector arrives, they can be immediately contacted. Appearing to be confused, uncertain, or unprepared is not a good way to start an inspection. Ideally, an inspector should be greeted by someone who can answer questions and get the ball rolling soon after arrival. If the facility is operating, putting the inspection off for a later date is not an option. Starting an inspection as quickly as possible not only shows respect for the inspector’s time, but also that you have your ducks in a row.
Train and incentivize the team to raise their hand if they detect a red button moment…this can be created for food safety but also social responsibility, sexual harassment, and health and hygiene. Train them on each so they can raise their hand and stop the process until corrected. Review and ensure that your corrective actions are effective. Inspectors, whether FDA or state, will be more inquisitive if they find corrective actions that are not complete or seemingly invalid to address the risk.
Know Your Rights
Never sign any affidavit they present during your inspection. Simply state it is your company policy to not sign these items without your attorney reviewing it first. The inspector won’t be mad, and it’s OK to state and stick with the policy.
For a typical packing operation, to understand what is and what is not an appropriate request from an inspector, inspection leaders and senior management should also become familiar with Sherman Act Chapter 2, Article 2 and Chapter 5, Article 5.
Some would say that you should never answer any question that you have not been asked, and that is often wise advice, but with good judgment there may be room to ask or reframe the questions and share experiences that can advance food safety goals. Inspectors may not be familiar with your specific process or products, so take the time to explain, in general terms, what you are doing and why, and give context to your operation and food safety program.
Pick your battles wisely. Regulatory inspectors are not always correct. If they state something that you feel is wrong, push it up to their supervisor if it is very important. For example, don’t argue over the color-coding of broom handles, you like blue, they prefer white – don’t fight it, but I would push back on more important issues if you know you are correct and they are not. It happens, so when pushing back do it as respectfully as possible.
Make sure to follow your company’s rules for visitors. Do not make the mistake of thinking that somehow, food safety inspectors are exempt from those rules. The inspector should present proper identification and Form 482, Notice of Inspection. Discuss why the inspector is there, for instance, is it a routine visit or is there a specific for-cause reason or issue of concern. Ask the inspector to outline their objectives. Review visitor policies and ensure that the inspector complies with them.
Once the inspector finalized their observations, we were given the opportunity to complete corrective actions for them to review and approve prior to finalizing their report.
The inspection should conclude with an exit interview. Take notes and make sure to correct or clarify any misunderstandings or statements that may have popped up along the way.
Be Cooperative – But Ask Questions
An inspector may wish to do something that violates your company’s rules. For instance, many companies prohibit the taking of pictures*, and inspectors often ask to take pictures to document their observations. I have never had an inspector make an unreasonable request in this regard, and it would be unusual if an accommodation could not be made. Be reasonable, be cooperative, and use common sense. You will generally find that inspectors are sensitive to this issue and with your assistance, will make sure that no proprietary and unnecessary information is recorded.
Sampling during an inspection is authorized and must be accommodated. As for collecting parallel and independently tested samples, there is some debate on that point, with many advising against duplicating samples. One may want to consider the fact that the greater number of samples collected, the greater the chance of an unanticipated result. But let’s be clear, an FDA positive trumps an internal negative.
Approach the inspection process as a learning experience for both your staff and the inspectors, if you have questions on the process, ask. Sometimes inspectors are not very clear on their questions, take a pause and ask to gain understanding. Clarifying a question can be a productive cross-learning opportunity that helps all parties.
The inspectors are often very helpful in letting you know what to expect during the inspection. They were willing to help with any questions you may ask.
*From FDA - Photographs are an integral part of an FDA inspection because they present an objective and contemporaneous representation of facility conditions. Examples of conditions or practices effectively documented by photographs include, but are not limited to: evidence of rodents or insect infestation; faulty construction or maintenance of equipment or facilities; product storage conditions; product labels and labeling; and, visible contamination of raw materials or finished products. Impeding or resisting photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator to be necessary to effectively conduct that particular inspection.
A good practice for every company is to practice inspections, traceability systems,
and recalls with your team. See if they can identify areas that could become a food safety hazard, and perform a complete root cause analysis, our teams need to have these tools to create a food safety culture.
