Tag Archive for: documentation

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

Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:

Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.