Source: Have We Lost Our Way With HACCP?
Source: Have We Lost Our Way With HACCP?
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.
Issued by President George Washington, at the request of Congress, on October 3, 1789
By the President of the United States of America, a Proclamation.
Whereas it is the duty of all nations to acknowledge the providence of Almighty God, to obey His will, to be grateful for His benefits, and humbly to implore His protection and favor; and—Whereas both Houses of Congress have, by their joint committee, requested me “to recommend to the people of the United States a day of public thanksgiving and prayer, to be observed by acknowledging with grateful hearts the many and signal favors of Almighty God, especially by affording them an opportunity peaceably to establish a form of government for their safety and happiness:”
Now, therefore, I do recommend and assign Thursday, the 26th day of November next, to be devoted by the people of these States to the service of that great and glorious Being who is the beneficent author of all the good that was, that is, or that will be; that we may then all unite in rendering unto Him our sincere and humble thanks for His kind care and protection of the people of this country previous to their becoming a nation; for the signal and manifold mercies and the favor, able interpositions of His providence in the course and conclusion of the late war; for the great degree of tranquility, union, and plenty which we have since enjoyed; for the peaceable and rational manner in which we have been enabled to establish constitutions of government for our safety and happiness, and particularly the national one now lately instituted; for the civil and religious liberty with which we are blessed, and the means we have of acquiring and diffusing useful knowledge; and, in general, for all the great and various favors which He has been pleased to confer upon us.
And also that we may then unite in most humbly offering our prayers and supplications to the great Lord and Ruler of Nations, and beseech Him to pardon our national and other transgressions; to enable us all, whether in public or private stations, to perform our several and relative duties properly and punctually; to render our National Government a blessing to all the people by constantly being a Government of wise, just, and constitutional laws, discreetly and faithfully executed and obeyed; to protect and guide all sovereigns and nations (especially such as have shown kindness to us), and to bless them with good governments, peace, and concord; to promote the knowledge and practice of true religion and virtue, and the increase of science among them and us; and, generally, to grant unto all mankind such a degree of temporal prosperity as He alone knows to be best.
FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA willcontinue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.
The five elements of FSMA encompass preventative controls, inspection and compliance, imported food safety, response to occurrences of contamination, and enhanced partnerships with producers. The biggest change FSMA brings is the FDAs ability to enforce the law. Prior to FSMA, the FDA was not allowed to shut down producer facilities, even those with multiple health violations. The new regulation allows an FDA inspector to shut down a facility for a minimum of 30 days with only a suspicion of the possibility of a violation. If evidence of a violation is found, the FDA is able to shut down a facility for a longer period or even indefinitely.
Under FSMA, every handler taking possession of a product or produces an item touching that product, such as packaging, must have a record keeping system. When a food safety issue is identified, the record keeping system allows an auditor to evaluate the chain of tracking records to determine where the contamination took place. If the auditor finds a break in the chain of records during their audit, the last person with records is liable for the food safety issue, even if contamination occurred prior to them taking possession of the product. Since the U.S. does not have jurisdiction over foreign producers, the broker who brings foreign product into the country is liable for any issue that took place before a product reached the border.
Producers and handlers may choose to keep paper records, however, this is not cost effective. A FSMA audit for a domestic operation is $224 per hour and $300 per hour plus travel for a foreign auditor per auditor. Each audit will include a minimum of one local, two state, and two federal auditors. The FDA is currently in the process of hiring 6,000 newemployees as FSMA auditors for this purpose.
There are many software and digital reporting systems available for FSMA compliance. The main requirement for digital systems is that information is held off-site by a third party. Usually, the third party is the FDA. Full-chain traceability that is compliant with FSMA, the 2002 Bio-Terrorism Law / Food Defense, Country of Origin, BMP, GAP’s, SSOP, HACCP, USDA-FSIS, and EU traceback laws for all food handlers can be achieved in as little as 15 minutes per day with a digital reporting system.
With digital reporting systems, a consultant works with a business to set up its entire operation and provide training, ongoing education, and support. In the case of nut producers, each orchard is coded. Ideally, operations, such as any applications, water tests, and pest control measures, are entered into the system on the day that they happen. During harvest, a label is printed for the product that includes all information on that orchard and the product. These labels provide immediate scanning and retrieval of site-specific records in real time. There is also an option to provide workers with coded name badges to track product using GPS that is accurate within 10 feet. In the case of shippers and haulers or processing facilities, a record of vehicle or facility maintenance operations, such as sanitization of equipment and times of those operations, is recorded. The label will need to be scanned when possession of the product changes hands so that information may be entered into the records of each consecutive handler. This information follows a product throughout the process, from seed to consumer, and even enables this information to be linked to a QR code printed on the packaging of a final product for consumer benefit. In compliance with the law, it is impossible to change or edit a previous recorded entry, however, notes may be added to correct information in entries that are incomplete or contain errors.
While complete compliance is not mandatory until 2016, there is a cost benefit to producers, processors, and handlers who currently have a traceback and traceability record keeping system in place. In anticipation of the possibility of loan default and higher instance of insurance claims resulting from a shut-down due to violations, insurance companies and banks are more likely to respond favorably toward customers who are currently in compliance with FSMA. Using an electronic system which holds information off-site allows producers to avoid the costs of an on-site audit that could result from the use of paper records. Some companies are willing to pay a premium because they believe products with a complete recorded history have a built-in, value-added element. This is allowing these producers to gain reputations as forward-thinking and establish new relationships with buyers before the rest of the industry follows.
Furthermore, in this new age of easily-accessed information and the ultra-concerned consumer, processors who are taking advantage of the option to link information to final packaging are finding they are gaining an edge in the marketplace. Consumers who value certain production practices or local products appreciate having information at their fingertips at the point of sale. For those consumers who are not as concerned about the specifics of production, it simply provides the reassurance that their food was produced as safely as possible. Increased information on packaging also provides the consumer with the confidence of a safe reliable food supply.
About The Author
P. Sweeten consulting was founded by owner Pamela Sweeten to help growers and consumers track their food from farm to table.
Through the use of tracking and data storage technology, we are insuring the safety and integrity of your food. Everyone should know exactly where their food came from, where it ends up and where it has been along the way. With our products you can rest assured knowing that you can track your crop every step of the way.
Pamela focuses on helping growers, transporters, and manufacturers reduce and improve operating efficiency. Got a question, comment, or column idea? She can be reached at email@example.com.
FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA will continue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.
February 10, 2015
1:00 pm – 4:00 pm EST
Harvey W. Wiley Federal Bldg., Wiley Auditorium,
5100 Paint Branch Pkwy., College Park, MD 20740
The purpose of this public meeting is to discuss the Draft Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption. This rule was proposed in January 2013 to help implement the FDA Food Safety Modernization Act (FSMA), with updates to certain provisions published in September 2014.
The FDA is seeking public input on the impacts identified in the Draft EIS. The purpose of the public meeting is to
For general questions about the meeting, contact: Cynthia Wise, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, telephone: 240-402-1357, e-mail: firstname.lastname@example.org.
Please note the following important dates: