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.

The FDA published the first of three announced guidance documents on June 19, 2018 for food defense. This release was less than one month after announcing they were “tantalizingly close” to releasing the first guidance at the 2018 Food Protection and Defense Institute conference. In the past, “tantalizingly close” has not been anywhere near soon, so I am happy for the FDA team that got this guidance done. The food defense rule for the prevention of intentional adulteration (IA) is the last of seven foundational rules of the Food Safety Modernization Act to be rolled out. If you are thinking “Whoa, I just figured out PCQI and my food safety plan,” then I suggest you start with the excellent FDA Final Rule Fact Sheets that summarize the FSMA rules and then go to the guidance documents.

Who needs to follow the Intentional Adulteration rule?
The FDA was very clear that the owner, operator or agent in charge is responsible.

    The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/ processes, packs, or holds food for consumption in the United States.

Here are some specific details. Just like the other FSMA rules, FDA rolls out the enforcement of the rule based on three sizes of businesses:

Businesses with more than 500 employees must comply in July 2019 by following a written food defense plan. FDA allows great flexibility on how a food defense plan is written and implemented, while providing detailed guidance. The food defense plan is a program for a facility and does not include the farm. The facility does not consider transportation to their location or transportation from their location in the food defense plan.

$10,000,000 is not a typo! The IA rule has a different definition of very small from the Preventive Controls for Human Food rule, the Produce rule or the Foreign Supplier Verification Program rule. Any business with less than $10,000,000 in annual revenue is exempt from compliance, and the business does not have to submit documents annually to the FDA to qualify. The business does have to provide documentation of annual revenue in person to an FDA inspector upon request for review and confirmation of the size of the business. Why, you ask?

The Intentional Adulteration rule is meant to prevent wide scale harm to public health.

From the guidance: Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality… acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA [i.e. economically motivated adulteration] is intended to obtain economic gain.

Note! Businesses whose sole operation is the storage of packaged food are exempt, except for the holding of liquid food in tanks. See the guidance IV. Exemptions B. Holding of Food.

Note! Once the food has been wrapped in its initial food-contact packaging, subsequent packaging and labeling of the individually-wrapped portions into packs or cases for sale is not included in the food defense plan.

What training is available now?
FREE training is available now. Ahead of the guidance document, online and free training was posted. The training was designed for line workers and their supervisors for food defense awareness. The best defense is a trained and informed workforce. At the end of the 20-minute session, a certificate is printed and added to the employee’s personnel file. Additional training will be rolled out over the next year from the Food Safety Preventive Controls Alliance and other organizations.

The first guidance from FDA has so much more information. Even if you are exempt from the rule, I encourage you to read over the guidance and provide the free training to your employees. 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

Start with the Written Food Safety Plan
As a member of the Expert Services team for ConnectFood, I recently completed a project writing a food safety plan in cooperation with a company owner. My perspective is always that the company I am working with remotely is doing the right things for food safety, and I am here to get plans written down and to put in place documentation of Good Manufacturing Practices (GMPs) or preventive controls. I believe the company to be innocent of any food safety shortcomings, until proven “guilty”, i.e. the identification of a gap in food safety. Since this company was complex, members of the Expert Services team logged on for a real-time walk through the facility as seen remotely on our computer screens. I found this step of working with the company to be very helpful. The food safety plan was written, edited, and revised until we had a final product. The company is doing a respectable job of recording the specifics of a kill step. In the past, that may have satisfied requirements for HACCP supported by GMPs, but the FDA Food Safety Modernization Act requires so much more.

Supply Chain Preventive Controls
There are two areas this company needs to expand, and your company may be in the same boat. One is the supplier approval program to prove safety of foods and ingredients where the supplier is controlling the hazards. These are supply chain preventive controls for which control is proven by verification, and verification generates copious logs and records. The inspector will ask to see your Standard Operating Procedure for supplier approval, Certificates of Analysis (COA) for every delivery of an ingredient or food with a supply chain preventive control, verification of the COA, an audit or inspection of the supplier, and any other records which build the case of food safety.

Environmental Monitoring Program
The second area is the environmental monitoring program for control of Listeria in ready-to-eat (RTE) products. All facilities manufacturing RTE products have documentation of a sanitation preventive control. The cleaning and sanitizing program is designed to obliterate biofilms and microbial niches and kill pathogens on equipment and in the manufacturing environment. Validation is not required by the Preventive Controls for Human Food rule, but a validation study is highly encouraged. How do you know cleaning and sanitizing is working, if not validated? Verification of the sanitation preventive controls requires swabbing for indicator organisms and Listeria itself. The goal of the environmental monitoring program is to detect Listeria. Some companies have a fulltime employee dedicated to monitoring and recordkeeping to stay on top of the environmental monitoring program. The inspector will ask how many swabs are tested weekly and from which sites, where were the positives, and what was the corrective action. A robust program is expected to find Listeria. The key is to take appropriate corrective action and follow up to verify the problem was eradicated.

Templates for Standard Operating Procedures, logs, and records are available in the ConnectFood Library. If you are new to ConnectFood, take inventory of all the resources. If you have been working with ConnectFood already, take a minute to see what is new that can support you in your job. As always, we are real humans here to support you in food safety. Reach out at any time; 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

It has been two weeks since the CDC updated the case count and epi curve on their website. The reasoning is good, because the outbreak of E. coli O157:H7 associated with Romaine lettuce is mostly over and data are arriving more slowly. There is no Romaine lettuce from the Yuma, Arizona growing region being harvested. All Romaine lettuce from the Yuma growing region is beyond its shelf-life and is no longer being consumed. The public health community is waiting for the reporting of any new cases and the fate of those stricken with the illness. It is sad to report that the death count raised from one to a total of five souls.

A look at the epi curve shows a normal distribution of cases, a week where the number of cases dwindled to single digits and days without new cases, great signs that the outbreak will soon be declared over by the CDC. An onset time of three weeks is possible coupled with time for medical diagnosis and reporting to CDC means there may be more cases reported. The case count currently is 197.

There are several striking features of this E. coli O157: H7 outbreak:

    • 89 people have been hospitalized. A hospitalization rate of 45% is high.
    • Similarly, the rate of patients developing hemolytic uremic syndrome (HUS), a form of kidney failure, is high at 13% for 26 people.
    E. coli O157:H7 with the same DNA fingerprint and associated with Romaine lettuce caused illness in Canada.
    • Illnesses have been reported in 35 states, including Alaska.

While the CDC continues to monitor the outbreak and many organizations, including the FDA, are investigating, one of the most striking features is that no Romaine lettuce is available for pathogen testing. Because of the typical, long onset time for the illness, any unconsumed Romaine is long discarded. Most outbreak investigations will gather samples from consumer homes, restaurants and grocery stores. In this outbreak, the implicated product availability is very limited. The outbreak investigation is very difficult as illustrated in the traceback model created by the FDA and showing some of the traceback for Romaine lettuce. With no common point of service, distribution center or processor, the source of contamination may be found in the growing region.

All this news should cause us to take a hard look at our own recall plans. If your company is audited, mock recalls are conducted at some frequency, and there are always learnings from mock recalls. If you are under compliance for the Preventive Controls for Human Food rule, a written recall plan is required as part of the food safety plan. I encourage you to take time now to review and update the recall plan. From my experience of working with companies on recall investigations, it is better to take time now to be prepared than to be figuring this out during a recall. 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