Tag Archive for: record management

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The Complexities of FSMA

The Food Safety Modernization Act (FSMA), which was signed into law in January of 2011, was created with the intent to regulate the way foods are grown, harvested, and processed. This rule allows the Food and Drug Administration (FDA) to step into the food safety chain to protect the public by assessing, regulating, and ultimately strengthening the food safety system. FSMA focuses on five main topics according to the FDA’s fact sheet, each of which has subtopics that relate to your food safety depending on the classification, facility size and employee count, and the purpose of your food company:

    1. Prevention
    2. Inspection and Compliance
    3. Response
    4. Imports
    5. Enhanced Partnerships

Back in November of 2016, we released a blog entitled “What is the Food Safety Modernization Act?”, which began our continuous discussion of FSMA. For the past few months, ConnectFood has been releasing blogs that touch upon the topics most relating specifically to the safe production and hazards around human food. For example, we discussed every aspect of record management regarding safe production, documentation, logs and records, and food safety plans. (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6) We also discussed the importance of practicing mock recalls and the more specific and intimate details of recall planning and writing your food company’s recall plan.

Whether you are a food manufacturer, a distribution plant, a restaurant, small food producer, or anything in between, your facility or kitchen must be compliant with FMSA regulations. You should assume that an FDA Inspector will arrive to perform an audit on your facility at any time, on any day of the week. Sometimes, these visits are scheduled, but often, you should be ready for a surprise. Get ready to hand over your required documentation, explain your processes, justify your Good Manufacturing Practices (GMPs), and most of all, get ready to be expected to implement some changes.

Over the next few weeks, ConnectFood’s goal is to continue to educate you on the segments of FSMA and the regulations surrounding food safety policies. We will be having food safety experts write on the following topics:

1. Sanitary Transportation of Human & Animal Food
Sanitary transportation is an element of FSMA that has a rule finalized by the FDA. According to their online documentation, “The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation… The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.”

2. Foreign Supplier Verification
The final rule on foreign supplier verification began implementation on May 30th, 2017. The online documentation states: “The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders.”

3. Preventive Controls for Animal Food
As you know, ConnectFood talks about human food constantly, but there is equal importance in making sure our pets are fed safely. Let’s not forget our furry friends in our safety planning. Check out the FDA’s final rule fact sheet here until we release our blog on the subject.

4. Strategies to Protect Food from Intentional Adulteration
Intentional Adulteration is not a topic to skim through – we will be having our own Kathy Knutson, Ph.D., PCQI, (who is trained in the prevention of Intentional Adulteration) write a post focusing solely on the topic. Until you get to read her writing on the subject, take a read through of the FDA’s webpage here.

All of this information may be overwhelming no matter if it is old news or fresh news. As always, if you have any questions regarding FSMA and how it relates to your food company, the team at ConnectFood is always here to help. Don’t hesitate to reach out for help if you need it. The time for compliance is the present – don’t be caught without a FSMA-compliant food safety plan in place. Contact us.

About the Author

Johanna Seidel, PCQI

Johanna Seidel is an administrative member of the ConnectFood team, where she works as manager of operations and manager of social content. Johanna received her Preventive Controls Qualified Individual (PCQI) certification in November of 2017. She received a Bachelor of Fine Arts Degree upon graduation from West Texas A&M University in May of 2016. When she is not working with food safety experts, Johanna also works as a dance instructor for The Chicago School of Ballet, as well as a professional contemporary dancer in the city of Chicago.

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5 Ways Food Safety is like Football

NOTE: The author is proud to be a cheesehead from Wisconsin. She is passionate about food safety… and football.

Pre-season football has begun, and the tourists have descended upon my hometown of Green Bay, Wisconsin. Each year there is a bit of quiet during the months of May and June – after the NFL draft and before training camp in July. The rest of year, my town revolves around Packer games and activities. I can’t help but think about how food safety is like football.

Score is kept; records are established.
This year is the hundredth season for the Packers. There are 99 years of rosters, wins, losses, and stellar plays. Every adult in Green Bay over the age of 70 claims to have been at the Ice Bowl.

How does your company keep score? There are records for manhours, number of lines, number of SKUs, and how much of each product is manufactured daily, weekly, monthly, quarterly, and annually. Keeping documentation is critical to business. Management will know if it is a winning year or a losing year by analyzing the numbers made.

The organization has a reputation.
What do people say about your company and your product? Every detail of your organization from CEO to ball-inflater is not discussed on sports radio, but the details are discussed at the photocopier, on the line, and in the breakroom. What do your employees think? One way to see what your employees or former employees think is on the website glassdoor. Glassdoor is used by job seekers to see comments by your employees about your company. Check it out. You will probably be surprised, because it is mostly likely going to be the “armchair coaches” complaining about the company. It is easy to say what we would do if we were in charge.

What do your neighbors and community know about you, the company next door? Like the Packer organization, your company may be a large employer in a small town, where everyone knows someone who works for the organization. As an employee, you represent the organization and have an opportunity to help establish a good reputation. You see each other at the grocery store and in church. (Yes, I must brag for a moment that I see Packer players with their families at church.)

Another group you hear from is your customers. The company collects consumer complaints and feedback on the product. Routinely review this information with the food safety team to know what your customers think.

You need a good team to win.
It helps to have a superstar like Aaron Rodgers to lead your team, but manufacturing a safe product is teamwork and the effort of many. Every employee has a role, a position, if you will, to play. Individuals require training and development to learn their role and for you to provide resources to perform their job using best practices. When you invest in your players, they can do great things. Make training and development a part of the culture. Year after year, fill key positions with the best talent you can find. Players will move into new positions, and you will lose players. Recruit the best players. Surround yourself with excellence.

People are passionate about your product.
If you are not a sports fan, think of something you are passionate about – your family, your hobbies, etc. If you do follow a team, you feel the passion I’m referring to. You have clothes and paraphernalia with the team logo branded on them. You enjoy being with people who share your same passion. You celebrate wins and analyze and mourn the losses. You are willing to dedicate time to your passion; it is a priority. Instill this passion in your employees regarding food safety and best practices.

Your customers are loyal to the product, and your company takes brand loyalty seriously. The greatest sign of loyalty I have seen is customers during a recall saying they are going to eat the product anyway! While I am not a proponent of the decision, I respect the sentiment. Blue Bell ice cream has such a loyal following that when manufacturing was shut down and their ice cream was not available in the store, Blue Bell ice cream could be found for sale on eBay.

You need depth in key positions.
Life happens. Who would have predicted that Aaron Rodgers, the Packer’s 20+ million dollar man, would have a broken collar bone twice and be out the rest of each season? Employees get ill or go on vacation, often at the most inopportune time. How is your depth in food safety? If you only have one Preventive Controls Qualified Individual (PCQI), what do you do if they leave? We are seeing companies have multiple PCQIs trained per facility to avoid issues if a situation were to arise. Companies that value food safety and want a food safety culture will invest in their key players.

Will your team have a winning season?
Like the football season, we don’t know what lies ahead for wins and losses. Who will step up to lead the team? Who will throw the Hail Mary for the exhilarating last-second win?! Many of my clients are now in their busy season leading to Halloween, then Thanksgiving, Christmas, and New Year. As you follow your team, I will be following my favorite team, the Green Bay Packers, until February and the Super Bowl in Atlanta. Go Pack Go!

Always remember: the way you practice is the way your company will perform.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

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Logs & Record Keeping

In this blog we are going to talk about logs and record keeping. If you seem to continue seeing this topic as a constant theme within the food safety industry, it is because it is the way that all companies have to keep “score” in the food safety world. Documentation is what allows us to benchmark our progress. Records and logs exist so that an organization can tell their food safety story to both regulators and to their customers. Logs are a necessity for your food safety chain, and you can find example forms for logs and record keeping on connectfood.com.

An example of where records are important is if you have a deviation in the food production process. An instance of this would be that your chart recorder ceases to work during a thermal process, say batch heating a product with a pH below 4.1, and at the end of the run you realize that you do not have the chart-recorded log. In this case, other measurements such as handheld temperature monitoring or visual readouts of a redundant thermocouple could be used to showcase that you still have a safe product for the target consumer. You will then use these records and logs to show that you did, in fact, follow your process and that with adequate testing and record review the product would be safe to ship.

    “Implementation records document the actual implementation of the Food Safety Plan. In other words, implementation records demonstrate that you did what you were supposed to do. Examples of implementation records include, where applicable, records that document the actual monitoring of preventive controls, corrective actions taken, different verification activities performed, validation activities performed (if needed), the supply‐chain program checks and applicable training records.” –FSPCA Preventive Controls for Human Food course curriculum.

Records and logs tell a story: from the time a supplier provides an ingredient until the time the product is delivered to the consumer, there is documentation. This story can include a manufacturer asking for the records and logs of how an ingredient was processed to how it was shipped and stored before arriving. This story could follow the documentation of a low moisture ingredient that is shipped at ambient temperature but needs certain humidity controls. Or, it could be an example of fresh fish where the records must show temperature control and amount of time the product has been in transit. These records are all things that an FDA regulator will ask for and that a facility must be able to provide within the 24-hour restriction set by the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

Another area that companies wonder about in regards to record keeping is: how long do I need to keep records, and what if I want to use electronic records?

“Electronic or computerized records are acceptable in a preventive controls system as long as they are equivalent to paper records and electronic signatures are equivalent to traditional handwritten signatures. Controls are necessary to ensure that records are authentic, accurate and protected from unauthorized changes.” – FSPCA Preventive Controls for Human Food course curriculum. ConnectFood talked about the move towards electronic records in a recent online interview with Food Safety News.

When it comes to how long records need to be kept, the answer is a minimum of two years from the date the log or the record was created. The records that relate directly to the food safety plan and the product’s completed food safety plan must be kept on site. Collecting proper records and logs and having them readily available is how companies demonstrate that the food safety plan is working. You can find many of these best practices in the FSPCA manual.

Most important to remember when it comes to records and logs are that, 1. you know what you are monitoring and, 2. you have trained personnel in your facility. All the logs and records in the world will not make a difference if the person tracking and monitoring the records do not know why they are taking these records and how they impact the food safety plan. Having A Preventive Controls Qualified Individual on site that can review and sign off on logs is a critical part of your food safety process. The worst-case scenario is to have a complete plan and a detailed hazard analysis but then have records and logs that do not reflect the accuracy of your production. This can lead to recalls and other issues that jeopardize the company and the consumer.

Your recordkeeping is your product’s story: make sure you’re telling a good one. ConnectFood can help you get your documentation in order and provide you with example sheets for logging. Send us a message.

About the Author

Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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