Although food companies have lots of experience creating records, these records have never been subject to the type of scrutiny they soon will face by the Food FDA under FSMA. The FDA will not only assess whether companies adopt programs that are adequate, but also will inspect whether these programs are consistently implemented.
Records review will become a key component of the FDA’s FSMA inspections, so companies need to be sure that their records help, rather than hurt. Records must be thoughtfully prepared, complete, and accurate. Below are five facts about records under FSMA of which you may not be aware, emphasizing why companies need to include training on record creation as part of their FSMA preparations.
The FDA Can Review All Of The Records Related To Your Food Safety Plan — Without Cause
Currently, the FDA only has broad records access in emergency situations when it uses authority grantedby the Bioterrorism Act. However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.
Records May Be Reviewed Out Of Context
The FDA’s records review will not occur only at your facility; you should expect that the FDA will want to make copies of records to take back for further agency review. This means that you may not have the opportunity to explain your records, so what they say on the page will be taken as gospel. For example, if your records show that you have a quality limit that was not met, but the record and your programs do not distinguish between what limits are necessary for food safety versus quality, the FDA could interpret this deviation as materially affecting the safety of your food. Records need to be able to stand on their own to keep this from happening.
You’re Only As Good As Your Records Say You Are
Deviations and gaps shown by your records will be scrutinized when assessing whether your process is under control. Even if you precisely follow your food safety plan, the FDA will not know this if your records do not demonstrate that is the case. Another way to understand this idea is to recognize that “if it isn’t documented, it didn’t happen.” Also, keep in mind that recordkeeping is a FSMA requirement. You not only need good records to show that you are taking the right actions for food safety, but also to comply with the regulations.
You Need To Do What Your Procedures Say You’ll Do
The FDA will expect you to execute your written programs and procedures, so you need to be sure that you’re actually following your programs as written. For example, if your program says you need to use acleaning solution at a specified concentration, but in practice you use a diluted solution, this will be viewed as a deviation. Regardless of whether you can justify the concentration you’re using, the FDA is going to take issue with the fact that you’re not doing what your procedure says you need to do.
Good Recordkeeping Practices Are Not Intuitive
The only way to become good at recordkeeping is through training and practice. Companies should implement training at all levels to ensure that employees understand how they can improve the records they are responsible for creating. It’s particularly effective to conduct this training using real, day-to-day examples with actual company records, and provide hands-on opportunities for employees to practice in a safe environment. Food companies also should consider conducting routine records audits, during which they should apply the same type of critical review that is expected from the FDA.
FSMA’s final rules are expected to provide companies with the flexibility to tailor programs as appropriate and necessary for food safety, but with this flexibility comes the responsibility to support your approach and then to execute your program. Both the support and execution need to be documented. Of course, once you master the art of good recordkeeping, you need to be sure you can actually find and produce on demand the records required for an FDA inspection!
About The Author
Maile Gradison Hermida is an Associate with the global law firm Hogan Lovells, practicing food and agriculture law. She represents food manufacturers, distributors, retailers, and their trade associations. Her practice has a particular focus on advising companies and trade associations on implementation of FSMA. For more information, visit www.hoganlovells.com.